(252 days)
The Nasal Interface is intended for use with nasal CPAP and bilevel devices for the treatment of adult patients with Obstructive Sleep Apnea. The Nasal Interface may be used in the home, hospital, nursing home, sub-acute care center or other location where nasal CPAP or bilevel therapy is applied. The Nasal Interface will facilitate nasal CPAP or bilevel therapy via a silicone seal which makes contact solely with the patient's nose on the external aspects of the nares. This device is further supported by padded protuberances, which rest on the patient's cheeks below the zygomatic processes. The device is held in place with headgear, which extends back from the nasal interface around the back and top of the patient's head.
Nasal Interface
The provided document is a 510(k) clearance letter from the FDA for a medical device called "Nasal Interface Model 7910." This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.
It is critical to understand that this type of FDA clearance letter (510(k)) generally does not include detailed device performance acceptance criteria or the study data that "proves" the device meets these criteria.
Instead, a 510(k) submission demonstrates that a new device is as safe and effective as a legally marketed predicate device. This typically involves comparing technological characteristics, intended use, and performance data if necessary, to show substantial equivalence. The actual performance data and acceptance criteria would be contained within the 510(k) submission itself, which is not publicly released in this format.
Therefore, based solely on the provided text:
1. A table of acceptance criteria and the reported device performance:
- Not available in the provided document. The document describes the device's intended use and design, but does not list specific quantitative acceptance criteria or performance metrics (e.g., leakage rate, pressure stability, comfort scores, etc.) for the Nasal Interface.
2. Sample size used for the test set and the data provenance:
- Not available in the provided document. The letter does not mention any specific test sets, sample sizes, or data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not available in the provided document. No information regarding ground truth establishment or expert involvement in a test set is provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not available in the provided document. No information about test set adjudication is provided.
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. The device is a Nasal Interface (likely for CPAP/Bilevel therapy), not an AI-powered diagnostic imaging or interpretation tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. As above, this device is a physical medical device, not an algorithm. Standalone performance for an algorithm is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not available in the provided document. Information on ground truth for any potential studies is not mentioned.
8. The sample size for the training set:
- Not available in the provided document. Information on any training set is not mentioned.
9. How the ground truth for the training set was established:
- Not available in the provided document. Information on how ground truth for any training set was established is not mentioned.
In summary: The provided FDA 510(k) clearance letter confirms the regulatory status of the device but does not contain the detailed technical performance data, study designs, or acceptance criteria that would typically be found within the full 510(k) submission itself. Without access to the actual submission, these details cannot be extracted.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 4 1998
Ms. Betsy Cortelloni Respironics, Inc. 1255 Kennestone Circle Marietta, GA 30066
Re: K974453 Nasal Interface Model 7910 Regulatory Class: II (two) Product Code: 73 BZD Dated: June 9, 1998 Received: June 10, 1998
Dear Ms. Cortelloni:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Betsy Cortelloni
This letter will allow you to beqin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Callshan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Center for Devices and Radiological Heath
Page _ of
510(k) Number (if known): K974453
Device Name: Nasal Interface
Indications for Use:
The Nasal Interface is intended for use with nasal CPAP and bilevel devices for the treatment of adult patients with Obstructive Sleep Apnea. The Nasal Interface may be used in the home, hospital, nursing home, sub-acute care center or other location where nasal CPAP or bilevel therapy is applied. The Nasal Interface will facilitate nasal CPAP or bilevel therapy via a silicone seal which makes contact solely with the patient's nose on the external aspects of the nares. This device is further supported by padded protuberances, which rest on the patient's cheeks below the zygomatic processes. The device is held in place with headgear, which extends back from the nasal interface around the back and top of the patient's head.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurence of CDRH, Office of Device Evaulation (ODE)
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FOR PRESERIPTION USE
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number
§ 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).