(160 days)
The Skynector CPAP Mask channels airflow non-invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bi-level system.
The Skynector CPAP Mask is to be used by adult patients (>661b />30kg) for whom positive airway pressure has been prescribed.
The Skynector CPAP Mask is intended for single patient re-use in the home environment and/or multi-patient reuse in the hospital /institutional environment.
The Skynector CPAP masks are designed based on human facial shape and structure, and the operating characteristics during application, they are injection mold of hard PC plastic and soft silicone rubber materials, with high level of air tightness, convenient operation and comfortable to wear, etc. They are used for the interfacing devices that are used to provide users with Continuous Positive Airway Pressure (CPAP) ventilation or biphasic positive airway pressure (BiPAP) ventilation treatment.
This document is a 510(k) summary for the Skynector CPAP Mask, indicating substantial equivalence to predicate devices. It does not contain information about an AI-powered device or its acceptance criteria and studies as described in the prompt. The device is a medical instrument (CPAP mask) and the document focuses on its physical and performance characteristics compared to existing masks.
Therefore, I cannot provide the requested information.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus-like symbol with three human profiles facing right, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 24, 2015
Sky Wise Medical Instrument (Shenzhen) Co., Ltd. C/O Field Fu Official Correspondent Shenzen Joyantech Consulting Co., Ltd. 4th Floor, Jinhui Building Nanhai BLVD. Nanshan District Shenzhen, Guang Dong, 518000 CHINA
Re: K150685
Trade/Device Name: Skynector CPAP Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: Class II Product Code: BZD Dated: July 17, 2015 Received: July 23, 2015
Dear Mr. Fu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced 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 interstate 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 a premarket approval application (PMA). You may, therefore, market the device, subject to the general 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
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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 devicerelated 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 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith M.S. Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150685
Device Name Skynector CPAP Mask
Indications for Use (Describe)
The Skynector CPAP Mask channels airflow non-invasively to a patient from a positive arway pressure device such as a continuous positive airway pressure (CPAP) or bi-level system.
The Skynector CPAP Mask is to be used by adult patients (>661b />30kg) for whom positive airway pressure has been prescribed.
The Skynector CPAP Mask is intended for single patient re-use in the home environment and/or multi-patient reuse in the hospital / institutional environment.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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SECTION 05 510(k) Summary
This summary of 510(K) safety and effectiveness information is submitted as Required by requirements of SMDA and 21 CFR §807.92.
1 Administrative Information
| Date of Summaryprepared | Feb, 28, 2014 |
|---|---|
| Manufacturerinformation | Company title:Sky Wise Medical Instrument (Shenzhen) Co.Ltd.Company address:No 12 South Ping Xi Road XinshengCommunity, Longgang Street, LonggangDistrict, Shenzhen, Guangdnog, ChinaPhone: +86-755-28491103Fax: +86-755-28494339Contact Person: Hu hanhanE-mail: 942526346@qq.com |
| SubmissionCorrespondent | Shenzhen Joyantech Consulting Co., Ltd.4th Floor, Jinhui Building, Nanhai BLVD,Nanshan District, Shenzhen, Guangdong,China.Contact person: Mr. Field.FuE-Mail: cefda13485@163.comQQ: 670312758Website: www.cefda.com |
| Image: Joyantech logo | |
| Establishment registrationnumber | No. |
2 Device Information
| Type of 510(k)submission: | Traditional |
|---|---|
| Trade Name: | Skynector CPAP Mask |
| Model: | FM-02, NM-03 |
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Version:A/0
| Product: Skynector CPAP Mask |
|---|
Ventilator, Non-Continuous (Respirator). Classification name: Anesthesiology Review Panel: BZD Product Code: Device Class: ll 868.5905 Regulation Number: |
3 Predicate Device Information
| Sponsor: | ResMed Limited;Respironics, Incorporated. |
|---|---|
| Device: | Mirage Quattro Full Face Mask;ComfortGel Nasal Mask. |
| 510(K) Number: | K113127, K092835 |
4 Device Description
The Skynector CPAP masks are designed based on human facial shape and structure, and the operating characteristics during application, they are injection mold of hard PC plastic and soft silicone rubber materials, with high level of air tightness, convenient operation and comfortable to wear, etc. They are used for the interfacing devices that are used to provide users with Continuous Positive Airway Pressure (CPAP) ventilation or biphasic positive airway pressure (BiPAP) ventilation treatment.
5 Intended Use
The Skynector CPAP Mask channels airflow non-invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bi-level system.
The Skynector CPAP Mask is to be used by adult patients (>661b />30kg) for whom positive airway pressure has been prescribed.
The Skynector CPAP Mask is intended for single patient re-use in the home environment and/or multi-patient reuse in the hospital /institutional environment.
6 Indications for Use
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The Skynector CPAP Mask channels airflow non-invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bi-level system.
The Skynector CPAP Mask is to be used by adult patients (>661b />30kg) for whom positive airway pressure has been prescribed.
The Skynector CPAP Mask is intended for single patient re-use in the home environment and/or multi-patient reuse in the hospital /institutional environment.
7 Technological characteristics of the proposed device compared to the predicate device
The proposed device and the Predicate device have the same intended use, design principle, and similar material composition. The differences don't impact safety and effectiveness of the device. The proposed device is substantially equivalent to the predicate devices. The compared details are listed in tables below:
| Subject Device: | Predicate Device: | Remarks: | ||
|---|---|---|---|---|
| Device:Skynector CPAP Full-face MaskManufacturer:Sky Wise MedicalInstrument(Shenzhen) Co.,Ltd. | Device:Mirage Quattro FullFaceMaskManufacturer:ResMed LTD. | |||
| 510(k) Number:To be determined | 510(k) Number:K113127 | |||
| IntendedUse | The Skynector CPAP Maskchannels airflow non-invasively to a patient from apositive airway pressuredevice such as a continuouspositive airway pressure(CPAP) or bi-level system.The Skynector CPAP Mask isto be used by adult patients(>66lb / >30kg) for whompositive airway pressure hasbeen prescribed. | The Mirage Quattro channelsairflow non-invasively to apatient from a positiveairway pressure device suchas a continuous positiveairway pressure (CPAP) orbi-level system.The Mirage Quattro is to beused by adult patients (>30kg) for whom positiveairway pressure has beenprescribed. | Both masks arenoninvasive andthe meanings ofintended use aresame. | |
| Subject Device: | Predicate Device: | Remarks: | ||
| intended for single patient re-use in the home environmentand/or multi-patient reuse inthe hospital /institutionalenvironment. | single-patient re-use in thehome environment andmulti-patient re-use in thehospital/institutionalenvironment. | |||
| PatientPopulation | Patients(>30 kg) | Patients > 66 lbs/30 kg | Same | |
| Environmentof use | Home or Hospital/institutionalEnvironment | Home orHospital/institutionalEnvironment | Same | |
| ProductCode | BZD | BZD | Same | |
| ProvidedSterile orNon-Sterile | Provided Non-Sterile | Provided Non-Sterile | Same | |
| PatientUsageType | Single Patient Use in thehome or multi-patient use inthe hospital/institutionalenvironment. | Single Patient Use in thehome or multi-patient use inthe hospital/institutionalenvironment. | Same | |
| Design | Face interface and headgear | Face interface and headgear | Same | |
| Material | FM-02:bracket, swivel, connector,elbow: Polycarbonate;forehead pad, cushion, valve:Silicone Rubber;pick off port:Polyvinylchloride;faceplate: Polypropylene;headgear: nylon, polyester.FM-03:bracket, faceplate, swivel,connector, support armassembly, elbow:Polycarbonate:forehead pad, cushion, valve:Silicone Rubber;pick off port:Polyvinylchloride;headgear: nylon, polyester.FM-05: | Moulded plastic and siliconecomponents and fabric /nylon headgear. | All thematerialscomposed theSkynectorCPAP maskswere evaluatedper ISO 10993-1.Based on thetestingperformed, thedifferences willnot affect thesafety oreffectiveness ofthe device. | |
| Subject Device: | Predicate Device: | Remarks: | ||
| bracket, faceplate, swivel,connector, support armassembly, cushion clip,elbow: Polycarbonate;forehead pad, cushion, valve:Silicone Rubber;pick off port:Polyvinylchloride;headgear: nylon, polyester. | ||||
| Number ofPick off ports: | One | Two | The designdifference willnot affect thesafety oreffectiveness ofthe device. | |
| Shape andsize offaceplate | The shape of the faceplatefollows the contours of theface allowing clearance offacial features, covering themouth and nose for therapy.The faceplate attaches to asilicone cushion via aretaining ring. | The shape of the faceplateand cushion clip offered invarious sizes to ensureadequate fit over theextended patient population. | The designdifference willnot affect thesafety oreffectiveness ofthe device. | |
| Shape andsize ofcushion | The cushions of the FM-02and FM-05 are made of singlelayer silicone with dampinggroove to increase thecomfort.The cushion of the FM-03 ismade of double layer siliconeto increase the comfortable fit. | The previously cleared maskprovides characteristics sealvia silicone interface. Thepreviously cleared maskoffered in various sizes toensure adequate fit over theextended patient population. | Base on thetesting ofleakage, thedesignmodificationwill not affectsthe safety oreffectiveness ofthe device. | |
| Safety Valve | Contain an anti-asphyxiavalve (AAV) to enable thepatient to breathe fresh air inthe event that airflow from theflow generator is impeded. | Contain an anti-asphyxiavalve (AAV) to enable thepatient to breathe fresh air inthe event that airflow from theflow generator isimpeded. | Same | |
| Exhalationdevice | No accessory exhalationdevice is required. The full-face masks incorporateintentional vent holes to | No accessory exhalationdevice is required. Themasks incorporate ventsto provide continuous airflow to flush out andminimize the amount of CO2 | Same | |
| Subject Device: | Predicate Device: | Remarks: | ||
| reduce carbon dioxide re-breathing. | re-breathed by the patient. | |||
| AnatomicalSites | Mouth and nose | Mouth and nose | Same | |
| PatientCircuitConnection | 22 mm entrainment valveelbow | 22 mm entrainment valveelbow | Same | |
| PressureRange | 4-20 cmH2O | 4-40 cmH2O | Verificationtesting of themodified devicedid not raiseany newquestions ofsafety andefficacy. | |
| Number ofMask Sizes | FM-02: Three- small,medium, and largeFM-03: Three- small,medium, and largeFM-05: Three- small,medium, and large | Four- extra small, small,medium, and large | The differencewill not affectits function andeffectiveness. | |
| MaskDeadspace | size | FM-02Full-facemask | MirageQuattro FullFace Mask | The dead spaceis calculated bythe identicalmethods. Thedead space hasno pass/failcriteria,reportable valueonly. It appearsa little largerthan thepredicatedevice, but itwill not affectits function andeffectiveness. |
| L | 358 | 242 | ||
| M | 311 | Noinformationavailable | ||
| S | 280 | Noinformationavailable |
Table 1: Device Comparison Table to K113127
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Product: Skynector CPAP Mask
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SEC_005:001_510K Summary
Product: Skynector CPAP Mask
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Product: Skynector CPAP Mask
{10}------------------------------------------------
| Version:A/0 |
|---|
| Subject Device: | Predicate Device: | Remarks: | ||||
|---|---|---|---|---|---|---|
| Leak rate | This leak rate isprovided for thehealthcareprofessional todetermine if it iscompatible withCPAP or bi-level therapydevice. Itappears the leakrates of CPAPmask is similarwith the MirageQuattro FullFace Mask, leakrate increasesstably when airpressureincreases. | |||||
| PressureDrop | Specificationsand models | Flow(L/min) | Drop inPressure(cmH2O) | MirageQuattroFull FaceMask | drop ismeasured by thesame testconfiguration. Itappears thepressure drop ofthe CPAP Full-face mask is alittle larger than | |
| Full-Facemask | FM-02L | 100L/min | 1.5 | 50L/min | face mask is alittle larger than | |
| FM-02M | 50L/min | 0.5 | 0.1cmH2O | the MirageQuattro Full | ||
| FM-02S | 50L/min | 0.5 | 0.4cmH2O | Face Mask.The pressure | ||
| ValveOpen toAtmosphere | FM-02 Full-Facemask:0.5cmH2O | Mirage QuattroFull Face Mask:1.1cmH2O | drop is nominaland it will notaffect itsfunction andeffectiveness.The valve willfully open toatmospherewhen the maskpressure reachesthe opening |
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SEC_005:001_510K Summary
Product: Skynector CPAP Mask
Version:A/0
| Subject Device: | Predicate Device: | Remarks: | |
|---|---|---|---|
| pressure andremains fullyopen as thepatient inhalesand exhales. | |||
| ValveClose toAtmosphere | FM-02 Full-Facemask:0.8cmH2O | Mirage QuattroFull Face Mask:1.6cmH2O | The valve willfully close toatmospherewhen theactivationpressure is metor exceeded. |
Table 2: Device Comparison Table to K092835
| Table 2: Device Comparison Table to K092835 | |||
|---|---|---|---|
| Subject Device: | Predicate Device: | Remarks: | |
| Device:Skynector CPAP Nasal MaskManufacturer:Sky Wise MedicalInstrument(Shenzhen)Co.,Ltd.510(k) Number:To be determined | Device:ComfortGel Nasal MaskManufacturer:Respironics, Inc.510(k) Number:K092835 | ||
| IntendedUse | The reusable CPAP maskswith headgear are intendedfor use as patient interfacefor a CPAP or bi-levelsystem by adultpatients(>30 kg) for whomCPAP or bi-level therapyhas been prescribed. Thenasal mask covers the nose,and it is to be for single-patient re-use in the homeand multi-patient re-use inthe hospital/institutionalenvironment. | The ComfortGel Nasal Mask isintended to provide aninterface for application ofCPAP or bi-level therapy topatients. The mask is for singlepatient use in the home ormulti-patient use in thehospital/institutionalenvironment. The mask is to beused by patients (>66lbs/30kg)for whom CPAP or bi-leveltherapy has been prescribedusing a CPAP or bi-levelsystem. | Both masks arenoninvasive and themeanings ofintended use aresame. |
| PatientPopulation | Patients(>30 kg) | Patients > 66 lbs/30 kg | Same |
| Environmentof use | Home orHospital/institutionalEnvironment | Home or Hospital/institutionalEnvironment | Same |
| ProductCode | BZD | BZD | Same |
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SEC_005:001_510K Summary
Product: Skynector CPAP Mask
| Subject Device: | Predicate Device: | Remarks: | |
|---|---|---|---|
| ProvidedSterile orNon-Sterile | Provided Non-Sterile | Provided Non-Sterile | Same |
| PatientUsageType | Single Patient Use in thehome or multi-patient use inthe hospital/institutionalenvironment. | Single Patient Use in the homeor multi-patient use in thehospital/institutionalenvironment. | Same |
| Design | Nasal interface andheadgear | Nasal interface and headgear | Same |
| Material | NM-01 :bracket, faceplate, swivel,support arm assembly,quick clip, elbow:Polycarbonate;forehead pad, cushion:Silicone Rubber;headgear: nylon, polyester;pick off port:Polyvinylchloride.NM-03:bracket, faceplate, swivel,support arm assembly,cushion clip, elbow:Polycarbonate;forehead pad, cushion:Silicone Rubber;headgear: nylon, polyester;pick off port:Polyvinylchloride. | Faceplate: PolycarbonateFace seal: Gel cushion withpolyester overlayCushion Flap: SiliconeExhalation Elbow:PolycarbonateExhalation Port: DelrinForehead Pad: SiliconeHeadgear: UBL, UrethaneFoam, and Lycra | All the materialscomposed theSkynector CPAPmasks wereevaluated per ISO10993-1.Based on the testingperformed, themodification willnot affect the safetyor effectiveness ofthe device. |
| Number ofPick off ports: | One | None | The designdifference will notaffect the safety oreffectiveness of thedevice. |
| Shape andsize offaceplate | The shape of the faceplatefollows the contours of theface allowing clearance offacial features, covering thenose only for therapy.The faceplate attaches to asilicone cushion via aretaining ring. | The shape of the faceplatefollows the contours of the faceallowing clearance of facialfeatures, covering the noseonly for therapy.The faceplate attaches to asilicone sealing flap via aretaining ring. | Same |
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SEC_005:001_510K Summary
Product: Skynector CPAP Mask
| Subject Device: | Predicate Device: | Remarks: | |||
|---|---|---|---|---|---|
| Shape andsize ofcushion | The cushions of the NM-01and NM-03 are made ofdouble layer silicone toincrease the comfortable fit. | Gel cushion to allow for amore comfortable fit andimproved mask performance(fewer leaks). | The materials ofcushion aredifferent. Thedesign modificationwill not affect thesafety oreffectiveness of thedevice. | ||
| Safety Valve | N/A- nasal mask | N/A- nasal mask | Same | ||
| Exhalationdevice | No accessory exhalationdevice is required. Anexhalation vent isintegrated. | No accessory exhalation deviceis required. 54 pin holesexhalation ports are integrated. | Based on the testingperformed, thedesign differencewill not affect thesafety oreffectiveness of thedevice. | ||
| AnatomicalSites | Nose | Nose | Same | ||
| PatientCircuitConnection | 22 mm exhalation elbow | 22 mm exhalation elbow | Same | ||
| PressureRange | 4-20 cmH2O | 4-30 cmH2O | Verification testingof the modifieddevice did not raiseany new questionsof safety andefficacy. | ||
| Number ofMask Sizes | NM-01: Four- petite, small,medium, and large;NM-03: Three- small,medium, and large. | Four- petite, small, medium,and large | The difference willnot affect itsfunction andeffectiveness. | ||
| MaskDeadspace | The dead space iscalculated by theidentical methods.The dead space has | ||||
| size | NM-03nasalmask | TheComfortGelNasal Mask | no pass/fail criteria,reportable value | ||
| L | 180 | 142.6 | only. It appears a | ||
| M | 160 | 121.3 | little larger than thepredicate device,but it will not affectits function andeffectiveness. | ||
| S | 150 | 111.4 | effectiveness. |
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SEC_005:001_510K Summary
Product: Skynector CPAP Mask
| Subject Device: | Predicate Device: | Remarks: | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Leak rate | This leak rate is provided for the healthcare professional to determine if it is compatible with CPAP or bi-level therapy device. It appears the leak rates of CPAP mask is similar with the ComfortGel Nasal Mask, leak rate increases stably when air pressure increases. | ||||||||||||||||||||
| PressureDrop | Specificationsand models Flow(L/min) Drop inPressure(cmH2O) ComfortGelNasal Mask Nasalmask NM-03L 100L/min 0.3 50L/min NM-03M n 0.1cmH2O NM-03S 50L/min 0.1 100L/min0.25cmH2O | The pressure drop is measured by the same test configuration. It appears the pressure drop of the CPAP Nasal mask is a little larger than the ComfortGel Nasal Mask. The pressure drop is nominal and it will not affect its function and effectiveness. | |||||||||||||||||||
| ValveOpen toAtmosphere | N/A- nasal mask | N/A- nasal mask | Same | ||||||||||||||||||
| ValveClose toAtmosphere | N/A- nasal mask | N/A- nasal mask | Same |
8 Brief discussions of the nonclinical tests
Skynector CPAP Masks conform to the following standards:
- ↑ ISO 5356-1:2004 Anaesthetic and respiratory equipment -- Conical connectors -- Part 1: Cones and sockets;
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| Product: Skynector CPAP Mask | Version: A/0 |
|---|---|
| ------------------------------ | -------------- |
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for ゃ In Vitro cytotoxicity;
- � ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization;
- & ISO 10993-6:2007 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation;
- � ISO 10993-3:2003 Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity;
- � ISO 17510-2:2007 Sleep apnoea breathing therapy - Part 2: Masks and application accessories;
- ゃ ASTM D3045-92 Standard Practice for Heat Aging of Plastics Without Load.
| No. | The title of test report | Items or Annex in ISO17510-2:2007 |
|---|---|---|
| 01 | 001_Connecting Test Report for the ConnectorUsed on FM-05 Apnea Mask | Item 5.1 |
| 02 | 002_Leak rate test report | Annex B |
| 03 | 003_Resistance to flow (Pressure drop) test report | Annex C |
| 04 | 004_Anti-asphyxia valve pressure test report | Annex D |
| 05 | 005_Breathing during single fault condition-Determination of the inspiratory and expiratoryresistance | Annex E |
| 06 | 006_CO2 re-breathing test report | Annex F |
| 07 | 007_Vibration and noise test report | Annex G |
| 08 | 008_Dead space test report | Not requested bystandard, but conductedon predicate device |
The performance test based on ISO 17510-2:2007 are as follow:
9 Brief discussions of clinical tests
Not applicable.
10 Other information (such as required by FDA guidance)
No other information.
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11 Conclusions
The subject device--- Skynector CPAP Masks (FM-02, NM-03) are respectively substantially equivalent to Mirage Quattro Full Face Mask(K113127), ComfortGel Nasal Mask(K092835).
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).