(95 days)
The AirFit™ N10 channels airflow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bilevel device.
The AirFit™ N10 is:
to be used by patients (> 66 lb/30 kg) for whom positive airway pressure has been prescribed
intended for single-patient re-use in the home environment and multipatient re-use in the hospital / institutional environment.
The AirFit™ N10 is an externally worn mask that provides an air seal, such that air flow from a positive pressure source is directed to the patient's nose. The mask is held in place with an adjustable headgear. It connects to a conventional PAP device air delivery hose via a standard 22mm swivel. The mask may be cleaned with mild soap.
continuous air leak to prevent rebreathing of dead space CO2
AirFit™ N10 is a prescription device supplied non-sterile.
Here's an analysis of the provided text regarding the AirFit™ N10 Traditional 510(k) submission, focusing on the acceptance criteria and the study used to demonstrate equivalence.
It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific device performance against strict, novel acceptance criteria in a clinical study. Therefore, some of the requested information (especially for AI/ML device evaluations like MRMC studies, specific expert qualifications for ground truth, and separate training/test sets with large sample sizes) is not applicable or directly available in this type of submission for a physical medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Bench/Non-clinical Tests) | Reported Device Performance (Satisfied/Equivalent) |
|---|---|
| CO2 Washout Performance: Ensure adequate venting to flush out expired CO2, including physical and functional dead-space measurements. | Satisfied: "The device satisfied all predefined" (implicitly, the CO2 washout requirements) and was found to be substantially equivalent to the predicate Ultra Mirage II device (K050359). |
| Pressure Flow and Flow Impedance: Equivalent to predicate devices. | Substantially Equivalent: "Pressure-flow and through impedance bench test results of the new mask were also substantially equivalent to the predicate Swift FX Nano device (K123789)." |
| Mechanical Integrity Performance: Withstand simulated normal use and reasonable abuse scenarios, storage temperature, humidity, and transportation shock & vibration. | Satisfied: "Mechanical integrity performance of the new device was tested to simulated normal use and reasonable abuse scenarios. The device was also tested to demonstrate that it can withstand the effects of storage temperature, humidity and transportation shock & vibration." "The device satisfied the pass/fail criteria." |
| Cleaning and Reuse (Single/Multi-patient): Function as intended after validated disinfection protocols (e.g., 20 cycles). | Satisfied: "Validation of cleaning and reuse was completed... After 20 cycles of cleaning/disinfection... the device has been shown to function as intended. The device satisfied the pass/fail criteria and was shown to be substantially equivalent to the predicate devices." |
| Biocompatibility (Path of heated humidified gas pathway - permanent external communicating devices): Adherence to ISO 10993-1 for Genotoxicity, Cytotoxicity, Implantation, and Sensitization. | Passed: "The appropriate biological tests conducted and passed for these components, in accordance with FDA guidance #G95-1 were: ISO 10993-3 Genotoxicity, ISO 10993-5 Cytotoxicity, ISO 10993-6 Implantation and ISO 10993-10 Sensitization." |
| Biocompatibility (Permanent skin contact components): Adherence to ISO 10993-1 for Cytotoxicity, Sensitization, and Irritation. | Passed: "The appropriate biological tests conducted and passed for components considered to be in permanent skin contact, in accordance with FDA guidance #G95-1, were: ISO 10993-5 Cytotoxicity, ISO 10993-10 Sensitization and Irritation." |
| Risk Management: Compliance with ISO 14971:2007. | Complied: "development of the AirFit™ N10 device complies with ISO 14971:2007, Medical devices - Application of risk management to medical devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a separate "test set" in the context of clinical data for performance evaluation. The evidence is based on bench testing of the device itself, rather than a dataset of patient cases. For the cleaning/disinfection tests, the testing involved a single device (or set of components) undergoing 20 cycles. Biocompatibility tests would involve material samples.
- Data Provenance: The data is from bench testing conducted by ResMed Ltd. The country of origin for the testing itself is not specified but would presumably be associated with the manufacturer's R&D facilities. This is a prospective assessment of the manufactured device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable: This device is a physical mask, and the evaluation is based on objective, quantifiable physical and material properties (CO2 washout, pressure-flow, mechanical integrity, biocompatibility). Clinical "ground truth" established by experts in the typical sense for AI/ML devices is not relevant here. The evaluation relies on established engineering and material science standards.
4. Adjudication Method for the Test Set
- Not Applicable: There was no "adjudication" of expert opinions for a test set as this was not an AI/ML device or a clinical observational study requiring such consensus. The acceptance criteria are based on objective pass/fail thresholds for physical properties.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No: No MRMC comparative effectiveness study was done. This type of study focuses on human reader performance with and without AI assistance, which is irrelevant for a physical CPAP mask.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not Applicable: This is not an algorithm or software device. The "standalone" performance refers to the device's physical function as outlined in the bench tests.
7. The Type of Ground Truth Used
- For the physical/material tests, the "ground truth" aligns with:
- Objective Measurement Standards: e.g., defined CO2 levels, pressure differentials, physical integrity thresholds, and chemical properties for biocompatibility.
- Comparative Equivalence: Demonstrating that the device performs "substantially equivalent" to predicate devices as measured by these objective standards.
8. The Sample Size for the Training Set
- Not Applicable: There is no "training set" in the context of an AI/ML algorithm for this physical device submission. The design and development of the device would involve iterative testing and refinement, but this is distinct from "training data" for a machine learning model.
9. How the Ground Truth for the Training Set was Established
- Not Applicable: As there's no training set for an AI/ML algorithm, this question is not relevant. The "ground truth" during device development (design, prototyping, and early testing) would be based on engineering specifications, user needs, and established medical device standards.
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DEC 2 0 2013
RESMED
AirFit™ N10 Traditional 510(k)
| 510(k) SUMMARY[As required by 21 CFR 807.92(c)] | |
|---|---|
| Date Prepared | September 16th, 2013 |
| Owner's Name | ResMed Ltd1 Elizabeth Macarthur DriveBella Vista, NSW, 2153 Australia |
| Prepared & submitted by | Mr. Kim Kuan LEESenior Regulatory Affairs ManagerTel: +61 2 8884 2232Fax: + 61 2 8884 2004kim.lee@resmed.com.au |
| Official Contact | Mr. Jim CassiVice President - Quality Assurance AmericasResMed Corp.9001 Spectrum Center BlvdSan Diego CA 92123 USATel: +1 858 836 6081Fax: +1 858 836 5519jim.cassi@resmed.com.au |
| Device Trade Name | AirFit™ N10 |
| Device Common Name | Vented Nasal Mask |
| Classification &Classification Name | 21 CFR 868.5905, 73 BZD (Class II)Noncontinuous Ventilator (IPPB) |
| Legally MarketedPredicate Devices | Swift FX Nano (K123789)Ultra Mirage II (K050359)SleepNet Mojo (K060273) |
| Intended Use | The AirFit™ N10 channels airflow noninvasively to a patient froma positive airway pressure (PAP) device such as a continuouspositive airway pressure (CPAP) or bilevel device.The AirFit™ N10 is:to be used by patients (> 66 lb/30 kg) for whom positiveairway pressure has been prescribedintended for single-patient re-use in the home environmentand multipatient re-use in the hospital / institutionalenvironment. |
| Reason for Submission | New Device |
| Device Description | The AirFit™ N10 is an externally worn mask that provides an airseal, such that air flow from a positive pressure source is directedto the patient's nose. The mask is held in place with an adjustableheadgear. It connects to a conventional PAP device air deliveryhose via a standard 22mm swivel. The mask may be cleaned withmild soap. |
| continuous air leak to prevent rebreathing of dead space CO2AirFit™ N10 is a prescription device supplied non-sterile. | |
| Intended Use comparison | Comparison with predicate Swift FX Nano (K123789)The new device and the predicate Swift FX Nano mask haveidentical intended uses. Both are intended to be used withPositive Air Pressure therapy equipment and for the sameidentical patient population. |
| TechnologicalCharacteristicscomparison | Comparison with predicate Swift™ FX Nano (K123789)Similarities:The new device and the predicate mask, provide a seal via asilicone interface. Both devices incorporate a silicone cushion thatseals around the patient's nose. Both masks are offered inmultiple sizes to ensure adequate fit over the extended patientpopulation. |
| Both masks connect to a conventional air delivery hose betweenthe mask and the positive airway-pressure source via standard22mm conical connectors (ref: ISO 5356-1:2004). | |
| Both masks are constructed using molded plastic and siliconecomponents and fabric / nylon headgear. All the components ofboth masks are fabricated using materials deemed safe. (ref. ISO10993-1). | |
| In addition, development of the AirFit™ N10 device complies withISO 14971:2007, Medical devices - Application of riskmanagement to medical devices. | |
| Both the new mask and the predicate device are designed tooperate on the same Pillows, Mirage or Swift ResMed flowgenerator settings. The pressure-flow characteristics and flowimpedance of both devices are identical. | |
| Both the new mask and the predicate device can be reused in thehome and hospital / institution environment. | |
| The main differences with the new device are:(a) The headgear fixes to the mask at 4 attachment points.(b) Magnets are incorporated in the headgear clip design toimprove usability.(c) Mask reassembly is made simpler through parts integration. | |
| (d) The exhaust port design is of a diffused vent type.Comparison with predicate SleepNet Mojo (K060273)Both devices incorporate magnets in the headgear clip design.The clips are self-locating and they also provide audible andtactile feedback to indicate successful mechanical engagement. | |
| Non-clinical testing andperformance datacomparison | The CO2 washout performance of the new device was tested toensure the mask design provides adequate venting to flush outthe expired CO2. The testing included physical and functionaldead-space measurements. The device satisfied all predefined |
・
16" Sept 2013
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the predicate Ultra Mirage II device (K050359).
Pressure-flow and through impedance bench test results of the new mask were also substantially equivalent to the predicate Swift FX Nano device (K123789).
Mechanical integrity performance of the new device was tested to simulated normal use and reasonable abuse scenarios. The device was also tested to demonstrate that it can withstand the effects of storage temperature, humidity and transportation shock & vibration.
Validation of cleaning and reuse was completed to establish that the device can be safely reused by a single patient, or multipatient reuse in the hospital/institutional environment following validated disinfection protocols. After 20 cycles of cleaning/disinfection in accordance with the methods described in the cleaning / disinfection quide, the device has been shown to function as intended. The device satisfied the pass/fail criteria and was shown to be substantially equivalent to the predicate devices.
Materials used in the construction of components that contact the heated humidified gas pathway are classified as permanent "external communicating devices" (with tissue/bone/dentin). The appropriate biological tests conducted and passed for these components, in accordance with FDA guidance #G95-1 were:
- ISO 10993-3 Genotoxicity, .
- ISO 10993-5 Cytotoxicity, .
- ISO 10993-6 Implantation and .
- ISO 10993-10 Sensitization .
The appropriate biological tests conducted and passed for components considered to be in permanent skin contact, in accordance with FDA guidance #G95-1, were:
- ISO 10993-5 Cytotoxicity .
- ISO 10993-10 Sensitization and Irritation
Use of vented nasal masks with CPAP or Bilevel therapy is Clinical Data proven technology and is well accepted by the medical community. Clinical data was not relied upon to demonstrate Substantial Equivalence to predicate devices. Bench testing alone is sufficient.
Substantial Equivalence Conclusion
- it has the same intended use; -
devices:
· .
-
it has identical technological characteristics to the predicate devices;
The new AirFit™ N10 is as safe and effective as the predicate -
the new device did not raise any new questions of safety . or effectiveness:
-
it is at least as safe and effective as the predicate devices.
.
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Image /page/3/Picture/1 description: The image shows a logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around a symbol. The symbol is a stylized depiction of an eagle or bird with outstretched wings. The text is in a bold, sans-serif font, and the symbol is in black. The overall design is simple and clean, with a focus on conveying a sense of authority and trustworthiness.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W066-G609 Silver Spring, MD 20993-00002
December 20, 2013
ResMed Limited Mr. Jim Cassi Vice President - Quality Assurance Americas 9001 Spectrum Center Boulevard SAN DIEGO CA 92123
Re: K132887
Trade/Device Name: AirFit N10™ Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Non-continuous Ventilator (Respirator) Regulatory Class: Class II Product Code: BZD Dated: November 15, 2013 Received: November 18, 2013
Dear Mr. Cassi:
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
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Page 2 - Mr. Cassi
:
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 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/4/Picture/8 description: The image contains a signature or logo on the left side, which is stylized and difficult to decipher. To the right of the signature, there is text that reads "Tejashri Purohit-Sheth, M.D.," followed by "Clinical Deputy Director" and "DAGRID." The word "FOR" is located in the bottom right corner of the image.
Erin I. Keith, M.S. Acting 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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RESMED
Airft N10 Traditional 510(k)
Indication for Use
610(k) Number (if known): K 152887 ALFR™ N10 Device Name: indication for Ung
The AirFil® N10 channels airflow noninvasively to a patient from a positive airway pressure (PAP) deelse such as a continuous positive airway pressure (CPAP) or bilevel device.
The Abfil™ NHO iss
- to be used by patients (> 66 ib/30 kg) for whom positive streay pressure has been presenthed .
- intended for single-patient re-use in the home environment and multipatient re-use in the . hospitalinstitutional environment.
AND/OR Over-The-Counter Use Presoription Use X (Pert 21 OFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of Device Evaluation (ODE)
:
Anya C. Harry -S 2013.12.20 14:34:22 -05'00'
§ 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).