CareFusion Food and Drug Administration

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CareFusion, Device Description The Puresom Nasal CPAP Mask is intended to be used with positive. airway pressure devices such as CPAP It provides a seal such that positive. pressure from positive pressure source is directed into the patient s nose It. is held in place with an adjustable headgear it may be cleaned with a mild. detergent such as Ivory dishwashing liquid or unscented baby shampoo in. The design consists of latex free silicone cushion designed to fit over the. patients nose The cushion isdesigned in such a way that it minimizes. leaks and iscomfortable for the patient The cushion shall be connected to. a polycarbonate frame that supports the cushion and provides a. connection for a 902 elbow The elbow shall be capable of rotating freely. through 3602 The silicone cushion isdesigned in such a way that it can be. easily removed by the patient from the polycarbonate frame for cleaning. or replacement purposes, The elbow connects to a conventional air delivery hose between the mask. and the positive airway pressure source via a 22mm polycarbonate fitting. on the elbow The 22 mm connector isdesigned in such a way that it can. rotate freely through 3602, The built in vent openings are molded into the front side of the elbow and. a snap on shroud isassembled to the elbow to direct the air away from the. patient s face and chest The vent openings may be visually inspected for. obstruction prior to use, Predicate Device Information The predicate devices are Advantage Series II mask. K031935 Advantage Series mask K 012207 and Mirage Echo. Summary of Technological Characteristics,of Device Compared to the Predicate Device.
The Puresom Nasal CPAP is the same device as the Advantage Nasal Mask which was cleared. for market under 510 k Advantage Nasal Mask No 1 012207. Modifications to the Nasal Mask that are associated with this submittal are as follows. Use of a lower dlurometer silicone dlurometer that is more pliable and will tend to. conforms better to the patients face, Use of 3 replaceable cushion sizes allows the physician to select the proper cushion. sizes that accommodate the patient, The Elbow Connection Method was changed from a clip to snap fit. CareFusion, The modified Nasal Puresomn mask has the following similarities to those which previously. received 510 k concurrence,have the same indicated use. use the same nasal mask operating principle, incorporate the same basic nasal design with the exception of modifications described.
in this submittal, are manufactured and packaged utilizing the same basic processes. Summary of Nonclinical Testing Far The,Device and Conclusions. Attribute Requirement Parameter Result, All materials used in the construction of All material which may. the Puresom Nasal Mask shall be contact the patient or the. Biocompatibility compliant with 1S010993 1 clinician must be Pass. Biocompatible,Interconnections to the, Interconnections to the patient circuit patient circuit shall be. Interconnections shall be compliant with ISO 5356 1 compliant with ISO 5356 Pass. EN1281 1 and ISO 5367 1 EN1281 1 and ISO, Dead space volume the maximum dead The cavities of each.
space for the Nasal mask shall be as model shall not exceed. follows maximum dead space,Dead Space 1 Small 180CC volume of Pass. 2 Regular 190CC 1 Small 180 CC,3 large 5200 CC 2 Regular 190 CC. 3 Large 5200 CC, Carbon dioxide retention Under normal condition the relative The relative C02 increase. during operation C02 increase shall not exceed 20 when shall not exceed 20. requirement tested at the min rated ShPa ScmH2O when tested at the min Ps. and 1OhPA l0cmH2O pressure rated 5hPa 5cmH2O and Ps. 1OhPA 1OcmH2O, No flow maximum carbon Under single fault condition the relative The relative C02 increase Pass. dioxide level requirement C02 increase shall not exceed 60 after shall not exceed 60 after. monitor stabilizes monitor stabilizes,CareFusion, Characteristics as follow All sample plots shall be.
1 Pressure of 3cmH2O the flow shall be within the 10 tolerance. 20 LPM 10 SPL 542 2 dBA limit of the flow rate All. 2 Pressure of ScmH2O the flow shall be sound pressure levels. 26 LPM 10 SPIL 43 9 dBA shall be S5stated max,3 Pressure of 7cmH2O the flow shall be values. CPAP pressure vs Flow 30 4 LPM 10 SPLS545 3 dBA, requirements Sound 4 Pressure of l0cmH2O the flow shall be Pass. pressure level 36 LPM 10 SPL 547 7 dBA,5 Pressure of l2cmH2O the flow shall be. 30 4 LPM 10 SPL 545 3 dBA,6 Pressure of l6cmH20z the flow shall be. 44 4 LPM 10 SPIAS1 1 dIBA,7 Pressure of 2OcmHzO the flow shall be.
50 1 LPM 10 SPLSS3 7 dIBA, The Puresom Nasal Mask shall be All units shall not have. Drop Test capable oftwithstanding 6 six drops any damages Pass. from 6 without damage, The device when enclosed in a bulk Device shall not have any. Shipping Test shipping box shall comply with ISTA Pre damage Pass. shipm ent test 2A 2004, The device shall operate within Device shall perform and. specification 20 to 70C up to 95 non meet specification within. Storage Test condensing the temperature and Pass,humidity range. specification, In conclusion verification testing performed verified that the Pursom Nasal meets it s.
performance requirements and that this device is substantially equivalent to medical. devices currently legally marketed in the United States. DEPARTMENT OF HEALTH HUMAN SERVICES Public Health Service. Food and Drug Administration,10903 New Hlampshire Avenue. Document Control Room W066 0 609,Silver Spring MD 20993 0002. MAR 10 2010,Mr Monther Abushaban,Regulatory Affairs Manager. Cardinal Health 207 Incorporated,22745 Savi Ranch Parkway. Yorba Linda California 92887,Re K093124,Trade Device Name Puresom Nasal Mask.
Regulation Number 21 CFR 868 5905,Regulation Name Noncontinuous Ventilator. Regulatory Class 1I,Product Code BZD,Dated November 19 2009. Received February 16 201 0,Dear Mr Abushaban, We have reviewed your Section 5 10 k premarket notification of intent to market the device. referehced above and have determined the device is substantially equivalent for the. indications for use stated in the enclosure to legally marketed predicate devices marketed in. interstnte commerce prior to May 28 1976 the enactment date of the Medical Device. Amendments or to devices that have been reclassified in accordance with the provisions of. the Federal Food Drug and Cosmetic Act Act that do not require approval of al peremarket. approval application PMA You may therefore market the device subject to the genera. controls provisions of the Act The general controls provisions of the Act include. requirements for annual registration listing of devices good manufacturing practice. labeling and prohibitions against misbranding and adulteration. If your device is classified see above into either class 11 Special Controls or class Ill. PMA it may be subject to additional controls Existing major regulations affecting your. device can be found in the Code of Federal Regulations Title 2 1 Parts 800 to 898 In. addition FDA may publish further announcements concerning your device in the Federal. Page 2 Mr Abushaban, Please be advised that FDA s issuance of a substantial equivalence determination does not. mean that FDA has made a determination that your device complies with other requirements. of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act s requirements including but not limited to registration. and listing 21 CFR Part 807 labeling 21 CFR Part 801 medical device reporting. reporting of medical device related adverse events 21 CFR 803 good manufacturing. practice requirements as set forth in the quality systems QS regulation 21 CFR Part 820. and if applicable the electronic product radiation control provisions Sections 53 1 542 of. the Act 21 CFR 1000 1050, If you desire specific advice for your device on our labeling regulation 21 CFR Part 801.
please go to http www fda g ov AboutFDA Centers Offices CDRI ICDRHOffices. ucm1 15809 htm for the Center for Devices and Radiological Health s CDRH s Office of. Compliance Also please note the regulation entitled Misbranding by reference to. premarket notification 2I1CFR Part 807 97 For questions regarding the reporting of. adverse events under the MDR regulation 21 CFR Part 803 please go to. http www tda gov cdrh mdr for the CDRH s Office of Surveillance and. Biometrics Division of Postmarket Surveillance, You may obtain other general information on your responsibilities under the Act from the. Division of Small Manufacturers International and Consumer Assistance at its toll free. number 800 638 2041 or 240 276 3 150 or at its Internet address. http www 1 da gov cdrh industr suipport index html. Sincerely yours,Division of Anesthesiology General Hospital. Infection Control and Dental Devices,Office of Device Evaluation. Center for Devices and,Radiological FHealth,CardinalHealth. A 510 K Number if Known,Device Name Puresom Nasal Mask.
indications for Use,Device Name Puresom Nasal Mask. Inications for Use, The Puresom Nasal CPAP Mask system is for use with continuous positive airway. pressure devices CPAP operating at or above 3cmH2O for the treatment of. e obstructive sleep apnea The mask is intended for single patient use and can be. V used in the home or in a hospital institutional environment The mask is to be. used on adult patients 30Kg for whom continuous positive pressure airway has. been prescribed,Prescription Use X AND OR Over the Counter Use. Part 21C FR 801 sub p art 0 Part 21 CFR 601 Subpart C. PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF. Concurrence of CDRH Office of Device Evaluation ODE. Division SIV nd,Division olf Hospital,GnshsoonyGneral. Infection Control Dental k vices,51 0 k Number 2 I.
Special 510K Notification Puresom Nasal Mask Page B2 of B2. CareFusion MAR ItO 2010 510 K Summary 510 K Summary as required by 21 CFR 807 92 SlO K Submitter Cardinall ealth 207 Yorba Linda CA 92887 714 283 2228 Contact Person Monther Abushaban 714 919 3660 Monther Abushaban CardinalHealth com Establishment Registration Number 2050001 Date Prepared March 3 2010 Name of the Device Puresom Nasal Mask Common usual name Mask for use

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