(29 days)
The Hospital Nasal Mask is an accessory to a non-continuous ventilator (Respirator) intended for single patient, multi-use for adults prescribed continuous positive airway pressure (CPAP) or Bilevel therapy in hospitals or clinics.
This is a disposable mask. It is intended to be used for the short-term (7 days) treatment of a single patient only, then discarded.
The Hospital Nasal Mask is a respirator mask covering the nose. It is a patient interface accessory to CPAP and bilevel devices for use in hospitals and clinics. The Hospital Nasal Mask is strapped to the patient's face covering the nose. It is connected via tubing to a CPAP or bi-level flow generator. Positive pressure ventilation is thus applied to the lungs in a non-invasive way. The Hospital Nasal Mask is a single patient multiple-use medical accessory. The mask will be marketed to clinics and hospitals for short-term use.
The provided text describes a 510(k) premarket notification for a medical device, the ResMed Hospital Nasal Mask. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies to establish novel performance metrics. As such, the information typically found in a clinical study report or performance evaluation regarding acceptance criteria and detailed device performance metrics (e.g., sensitivity, specificity for diagnostic devices, or specific quantitative performance targets) for a new algorithm or diagnostic system will not be present in this type of document.
The document primarily states that the Hospital Nasal Mask is a modified version of an existing predicate device (Modular Mask, K961783) and that its safety and effectiveness are established by showing substantial equivalence through design input requirements, risk analysis, and materials biocompatibility testing.
Therefore, the following information, if applicable, would be derived from the provided text as best as possible, with many points being "Not Applicable" or "Not Provided" due to the nature of a 510(k) for a physical medical device like a mask:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (from risk analysis and design inputs) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Materials Biocompatibility (compliant with ISO 10993 or predicate materials) | Materials used are either predicate materials or compliant with ISO 10993 standards. |
| Safety and Effectiveness substantially equivalent to predicate device | Performance data and materials biocompatibility testing show substantial equivalence with the unmodified predicate mask. |
| Design Input Requirements Met (derived from risk analysis) | Performance testing derived from the risk analysis is provided to ensure design input requirements have been met. |
| Intended Use: accessory to CPAP/bilevel devices, single patient multiple-use, short-term (7 days) | Device description and Indications for Use confirm these parameters. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated for performance testing. Given it's a physical device (mask), testing would likely involve bench testing, material testing, and potentially limited user perception studies, rather than a clinical trial with a "test set" in the sense of a diagnostic algorithm.
- Data Provenance: Not specified. likely internal lab testing/bench testing.
- Retrospective/Prospective: Not specified, but generally refers to internal engineering/ biocompatibility testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a physical device like a nasal mask, "ground truth" as it applies to diagnostic algorithms (e.g., expert consensus on an image) is not relevant. Performance is assessed against engineering specifications, biocompatibility standards, and equivalence to a predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are typically for subjective assessments in clinical trials or for establishing ground truth in diagnostic studies. This is not described for the performance evaluation of a mask.
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. This device is a nasal mask, not an AI-powered diagnostic tool. MRMC studies are not relevant for its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable in the traditional sense. The "ground truth" for this device's evaluation is primarily based on:
- Compliance with ISO 10993 standards for biocompatibility.
- Verification against design input requirements (which are engineering specifications and user needs).
- Demonstration of substantial equivalence to the predicate device's established safety and effectiveness.
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is not a machine learning or AI-powered device.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set, there is no ground truth to establish for it.
{0}------------------------------------------------
APR - 2 2004
040566
510(k) SUMMARY—Hospital Nasal Mask
| Submitter Name: | ResMed Ltd |
|---|---|
| Submitter Address: | 97 Waterloo Road, North Ryde NSW 2113, Australia |
| Contact Person: | David D'Cruz, VP Regulatory & Clinical Affairs US |
| Phone Number: | (858) 746 2238 |
| Fax Number: | (858) 746 2915 |
| Date Prepared: | March 2, 2004 |
| Device Trade Name: | ResMed Hospital Nasal Mask |
| Device Common Name/Classification Name: | Nasal Mask |
| Predicate Devices: | K961783 Modular Mask - cleared as part of the VPAP II ST system |
| Device Description: | The Hospital Nasal Mask is a respirator mask covering the nose. It is a patient interface accessory to CPAP and bilevel devices for use in hospitals and clinics. |
{1}------------------------------------------------
Device Technological Characteristics and Comparison to Predicate Device(s):
The Hospital Nasal Mask is strapped to the patient's face covering the nose. It is connected via tubing to a CPAP or bi-level flow generator. Positive pressure ventilation is thus applied to the lungs in a non-invasive way.
The Hospital Nasal Mask is a single patient multiple-use medical accessory. The mask will be marketed to clinics and hospitals for short-term use.
The Hospital Nasal Mask is a modified version of the Modular Mask (cleared by FDA in K961783). The Hospital Nasal Mask is shown to be substantially equivalent to the Modular Mask. Both masks have the same intended use, operating principle, technological characteristics and a similar manufacturing process. The intended life of the Hospital Nask is restricted to 7 days to reflect the clinical needs of a hospital and clinic mask.
Risk Analysis and Performance Data:
The risk analysis for the modified device is provided in section 5.2.1. Performance testing derived from the risk analysis is provided (section 5.2.2) in order to demonstrate safety and effectiveness of the Hospital Nasal Mask and ensure that the design input requirements have been met.
Materials Biocompatibility:
The materials used for the mask components, which contact the skin and/or the air-path, are either predicate materials (i.e., cleared previously for the same intended use), or are compliant with ISO 10993 standards. Results are provided in section 5.4.
Conclusion:
The results of the performance data and materials biocompatibility testing show that the mask is substantially equivalent with the unmodified predicate mask.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three horizontal lines forming its body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR = 2 2004
Mr. David D' Cruz Resmed Limited Vice President Regulatory & Clinical Affairs US Resmed Corporation 97 Waterloo Road North Ryde NSW 2113 AUSTRALIA
Re: K040566
Trade/Device Name: Resmed Hospital Nasal Mask Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: March 2, 2004 Received: March 4, 2004
Dear Mr. Cruz:
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.
{3}------------------------------------------------
Page 2 -Mr. David Cruz
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 (301) 594-5613. 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/dsma/dsmamain.html.
Sincerely yours,
Susan Runne
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
{4}------------------------------------------------
Indications for Use
510(k) Number (if known):_ K040566
Device Name: Hospital Nasal Mask
Indications For Use:
The Hospital Nasal Mask is an accessory to a non-continuous ventilator (Respirator) intended for single patient, multi-use for adults prescribed continuous positive airway pressure (CPAP) or Bilevel therapy in hospitals or clinics.
This is a disposable mask. It is intended to be used for the short-term (7 days) treatment of a single patient only, then discarded.
Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/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)
Losh h h
Page 1 of ________
Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K040566
§ 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).