(119 days)
A patient interface accessory for use with CPAP and bi-level systems used in the treatment of adult OSA and / or ventilatory support. Single patient, multi-use and Multi-patient, multi-use
The proposed nasal patient interface incorporates a number of features, which are designed to maximize seal and comfort, and maintain the mask in the correct position throughout use.
- . Three (3) sizes of nasal inserts to assure a good fit
- . Integral fixed leak port
- . Headgear for attachment
The provided text is a 510(k) Pre-market Notification for a CPAP nasal mask. It details the device's description, indications for use, and a comparison to a predicate device. However, it does not contain information about acceptance criteria or a specific study proving the device meets those criteria, as typically found in clinical trials or performance studies involving specific metrics and statistical analysis.
The 510(k) process is primarily about demonstrating substantial equivalence to a legally marketed predicate device, not necessarily proving specific performance metrics through a dedicated clinical study with acceptance criteria.
Therefore, most of the requested information regarding acceptance criteria and a study to prove them cannot be extracted from this document.
Here's a breakdown of what can be inferred from the document regarding comparative features, which serves as the basis for the 510(k) submission:
1. A table of acceptance criteria and the reported device performance
This document does not specify formal "acceptance criteria" in terms of performance metrics (e.g., leakage rates, pressure stability, comfort scores) with corresponding reported device performance, as would be expected from a dedicated performance study. The "performance" in this context is demonstrated by showing substantial equivalence to the predicate device based on features and indications for use.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Comparative Features) |
|---|---|
| Indications for Use: Comparable to predicate | "A patient interface accessory for use with CPAP and bi-level systems used in the treatment of adult OSA and / or ventilatory support." - Same as predicate. |
| Environment of Use: Comparable to predicate | "Home, Hospital, Sub-acute Institutions, Sleep labs" - Same as predicate. |
| Patient Population: Comparable to predicate | "Adult" - Same as predicate. |
| Contraindications: Comparable to predicate | "None" - Same as predicate. |
| Usage: Single patient, multi-use / Multi-patient, multi-use | "Yes" - Same as predicate. |
| Number of Sizes: Sufficient for good fit | "Yes - three" (Predicate had five, but three are deemed sufficient for a good fit as stated in Device Description) |
| Components: Similar to predicate | "Headgear, Nasal prongs, Tubing, Connectors" - Same as predicate. |
| Dead Space: Within acceptable limits | "Nasal piece - largest 23 ml" (Predicate: 5 to 18 ml; 23ml is presented without further justification as acceptable) |
| Fixed Leak Port: Present | "Yes" - Same as predicate. |
| Materials: Similar to predicate | "Polypropylene, PVC tubing, Silicone" - Same as predicate. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The document does not describe a "test set" in the context of a performance study with a specific sample size. The 510(k) relies on comparison to a predicate device using readily available specifications and general knowledge, not new clinical data from a "test set."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable / Not provided. There is no mention of "experts" establishing a "ground truth" for a test set, as this is not a clinical study assessing a diagnostic or predictive device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No test set or adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable / Not provided. This device is a physical medical device (CPAP nasal mask), not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study is irrelevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Not provided. The "ground truth" for this 510(k) submission is the established performance and safety profile of the legally marketed predicate device (InnoMed - Nasal Aire K022465), against which the new device is compared for substantial equivalence. No new "ground truth" data for the new device is presented through a clinical study.
8. The sample size for the training set
- Not applicable / Not provided. This is not an AI/machine learning device that would involve a training set.
9. How the ground truth for the training set was established
- Not applicable / Not provided. As above, no training set is relevant.
In summary: The provided document is a 510(k) summary focused on demonstrating substantial equivalence of a new CPAP nasal mask to an existing predicate device. It primarily does this by comparing design features and indications for use, rather than presenting a performance study with detailed acceptance criteria, clinical data, or expert-adjudicated ground truth.
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Premarket Notification 510(k) Section 5 – 510(k) Summary
RemGenic
Non-Confidential Summary of Safcty and Effectiveness
Page 1 of 2 22-Feb-08
JUN 2 3 2008
| RemGenic LLC |
|---|
| 3734 Lincoln Place Dr. |
| Des Moines, IA 50312 |
| Tel - 515-339-7722 | |
|---|---|
| Official Contact: | Russell Bird |
| Proprietary or Trade Name: | LaminAir CPAP nasal mask |
| Common/Usual Name: | Patient interface for use with CPAP systems |
| Classification Name: | Ventilator, non-continuous (respirator), accessoryBZD - 868.5905 |
| Device: | CPAP nasal mask with pillows |
| Predicate Devices: | InnoMed - Nasal Aire K022465 |
Device Description:
The proposed nasal patient interface incorporates a number of features, which are designed to maximize seal and comfort, and maintain the mask in the correct position throughout use.
- . Three (3) sizes of nasal inserts to assure a good fit
- . Integral fixed leak port
- . Headgear for attachment
| Indications for Use: | A patient interface accessory for use with CPAP and bi-level systems used in the treatment of adult OSA and / or ventilatory support. Single patient, multi-use and Multi-patient, multi-use |
|---|---|
| Patient Population: | Adults with OSA |
| Environment of Use: | Hospitals, Home, sub-acute care settings, sleep labs |
| Contraindications: | None |
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Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 22-Feb-08
Comparative table:
| Features | Predicate InnoMedNasal AircK022465 | Proposed Device |
|---|---|---|
| Indications for use | An accessory to positive pressureventilation devices for patientssuffering from OSA requiring positivepressure breathing therapy (i.e. CPAP,bi-level) | A patient interface accessory for use withCPAP and bi-level systems used in thetreatment of adult OSA and / or ventilatorysupport. |
| Environment of Use | Home, Hospital, Sub-acute Institutions,Sleep labs | Same |
| Patient Population | Adult | Same |
| Contraindications | None | None |
| Single patient, multiuseMulti-patient, multi-use | Yes under K022465 clearance | Yes |
| Multiple sizes of nasalcushions | Yes - five | Yes - three |
| Components | HeadgearNasal prongsTubingConnector | HeadgearNasal prongsTubingConnectors |
| Dead space | Nasal pieces - 5 to 18 ml | Nasal piece - largest 23 ml |
| Fixed leak port | Yes | Yes |
| Materials | PolypropylenePVC tubingSilicone | PolypropylenePVC tubingSilicone |
Differences Between Other Legally Marketed Predicate Devices:
.
The proposed device is viewed as substantially equivalent to the predicate device, K022465.
There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem that resembles a stylized eagle or bird with outstretched wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 3 2008
RemGenic LLC C/O Mr. Paul Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134-2958
Re: K080516
Trade/Device Name: LaminAir CPAP Nasal Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: May 13, 2008 Received: May 14, 2008
Dear Mr. Dryden:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 – Mr. Dryden
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Runnes
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
Page 1 of 1
510(k) Number:
Device Name: LaminAir CPAP nasal mask
Indications for Use:
A patient interface accessory for use with CPAP and bilevel systems used in the treatment of adult OSA and / or ventilatory support.
Prescription Use XX (Part 21 CFR 801 Subpart D)
or
Over-the-counter use_ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K080516
§ 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).