(74 days)
The VPAP Auto system is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients weighing more than 66 lb (30 kg). The optional integrated HumidAire 3i is indicated for humidification of the air delivered from the VPAP Auto device. The VPAP Auto system and HumidAire 3i are intended for use in the hospital and home.
The VPAP Auto System is similar to the predicate devices, VPAP Malibu (K062291), S8 Pioneer (K041209), and S7 Elite CPAP System (K013909). The VPAP Auto provides CPAP, Bilevel and Vset therapy modes to adult patients with OSA. This is achieved through the use of a micro-processor controlled blower system that generates airway pressures as required to maintain an "air sployout" for effective treatment of OSA.
The system comprises the Flow Generator, HumidAire 3i, patient tubing, mask (patient interface), Smart Card and USB Adapter.
The performance and functional characteristics of the VPAP Auto system includes all the clinician and user friendly features of the predicate devices, VPAP Malibu (K062291), S8 Pioneer (K041209), and S7 Elite CPAP System (K013909).
The provided text describes a 510(k) premarket notification for the ResMed VPAP Auto System. However, it does not contain the specific details about acceptance criteria, device performance results, sample sizes for test or training sets, expert qualifications, or adjudication methods that would be needed to fully answer the request.
The document focuses on demonstrating substantial equivalence to predicate devices, outlining the device's intended use and general description, and confirming that design and verification activities were performed.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be extracted or inferred, and what cannot:
1. Table of acceptance criteria and the reported device performance
The document broadly states: "All tests confirmed the VPAP Auto System met the predetermined acceptance criteria." However, it does not list what those specific acceptance criteria were nor does it provide a table of reported device performance metrics against those criteria. It only mentions compliance with general FDA guidance documents for ventilators and software.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | "All tests confirmed the VPAP Auto System met the predetermined acceptance criteria." (Specific metrics not provided) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document.
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)
This information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This information is not provided in the document. The device is a "Noncontinuous ventilator (IPPB)" and its functionality is described as a "micro-processor controlled blower system that generates airway pressures," suggesting it does not involve AI or human "readers" in the context of diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a noncontinuous ventilator, not a diagnostic algorithm. Performance would be assessed through engineering and clinical validation related to pressure delivery, safety, and effectiveness in treating OSA, rather than standalone algorithm performance in a diagnostic sense. The document implies functional testing was performed ("Design and Verification activities were performed"), but details are not given.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document. Given the nature of the device (ventilator for OSA), ground truth for performance would likely relate to objective measures of pressure delivery and potentially physiological outcomes (e.g., AHI reduction), but no specifics are given.
8. The sample size for the training set
This information is not provided in the document. The device is a hardware system; while it contains a microprocessor, the document doesn't suggest it uses machine learning in a way that typically involves "training sets" for an AI model.
9. How the ground truth for the training set was established
This information is not provided in the document. (Refer to point 8).
{0}------------------------------------------------
L071171
RESMED
VPAP Auto Traditional 510(k) Premarket Notification
510(k) Summary - VPAP Auto System
| Date Prepared | 19 th April, 2007 |
|---|---|
| --------------- | ------------------------------ |
JUL 10 2007
| Official Contact | Dr Lionel King |
|---|---|
| V.P., Quality Assurance & Regulatory Affairs | |
| ResMed Ltd | |
| 1 Elizabeth Macarthur Drive | |
| Bella Vista, NSW 2153 | |
| Australia | |
| Tel: +61 (2) 8884 1000 | |
| Fax: +61 (2) 8884 2021 | |
| Classification Reference | 21 CFR 868.5905 |
| Product Code | 73 BZD |
| Common/Usual Name | Noncontinuous ventilator (IPPB). |
| Proprietary Name | VPAP Auto System |
| Predicate Device(s) | VPAP Malibu (K062291) - Primary |
| S8 Pioneer (K041209) - Secondary | |
| S7 Elite CPAP System (K013909) - Secondary | |
| Reason for submission | New Device |
Intended for Use
The VPAP Auto system is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients weighing more than 66 lb (30 kg). The optional integrated HumidAire 3i is indicated for humidification of the air delivered from the VPAP Auto device. The VPAP Auto system and HumidAire 31 are infonded for use in the hospital and home.
.
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Image /page/1/Picture/1 description: The image shows the word "RESMED" in bold, black font. The letters are all capitalized and evenly spaced. The font appears to be sans-serif.
Substantial Equivalence
The new device has the following similarities to the previously cleared predicate device.
- A Similar intended use
- 产 Similar operating principle
- ﺧﺮ Same technologies
- ﺗﯜ Same manufacturing process
Design and Verification activities were performed on the VPAP Auto System as a result of the risk analysis and product requirements. All tests confirmed the VPAP Auto System met the predetermined acceptance criteria. ResMed has determined that the new device is Substantially Equivalent to the predicate devices. The new device complies with the applicable standards and requirements referenced in the FDA guidance documents:
-
FDA Draft Reviewer Guidance for Ventilators (July 1995)
- FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical /A Devices (May 11, 2005)
- 洪 FDA Off-the-Shelf Software Use in Medical Devices (September 9,1999)
Intended Use
The VPAP Auto system is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients weighing more than 66 lb (30 kg). The optional integrated HumidAire 3i is indicated for humidification of the air delivered from the VPAP Auto device. The VPAP Auto system and HumidAire 3i are intended for use in the hospital and home.
Device Description
The VPAP Auto System is similar to the predicate devices, VPAP Malibu (K062291), S8 Pioneer (K041209), and S7 Elite CPAP System (K013909). The VPAP Auto provides CPAP, Bilevel and Vset therapy modes to adult patients with OSA. This is achieved through the use of a micro-processor controlled blower system that generates airway pressures as required to maintain an "air sployout" for effective treatment of OSA.
The system comprises the Flow Generator, HumidAire 3i, patient tubing, mask (patient interface), Smart Card and USB Adapter.
The performance and functional characteristics of the VPAP Auto system includes all the clinician and user friendly features of the predicate devices, VPAP Malibu (K062291), S8 Pioneer (K041209), and S7 Elite CPAP System (K013909).
Conclusion
The VPAP Auto is substantially equivalent to the VPAP Malibu (K062291), S8 Pioneer (K041209), and S7 Elite CPAP System (K013909).
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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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.
JUL 1 0 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ResMed Limited C/O Mr. David D'Cruz Vice President, US Clinical & Regulatory Affairs ResMed Corporation 14040 Danielson Street Poway, California 92064-6857
Re: K071171
Trade/Device Name: VPAP Auto System Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: April 19, 2007 Received: April 27, 2007
Dear Mr. D'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.
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Page 2 -Mr. D'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 (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.
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.
Sumite H. Michie MD
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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Indication for Use
510{k) Number (if known):
Device Name:
VPAP Auto System
Indication for Use
The VPAP Auto system is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients weighing more than 66 lb (30 kg). The optional integrated HumidAire 3i is indication of the air delivered from the VPAP Auto device. The VPAP Auto system and HumidAire 31 are intended for use in the hospital and home.
Prescription Use X
ANDIOR
Over-The-Counter Use_
(Part 21 CFR 801 Subpart D)
(Part 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)
Page 1 of_____________________________________________________________________________________________________________________________________________________________________
ission Sign-Off)
I Mision of Anesthesiology, General Hospital, Control, Dental Devices
510(k) Number: K071121/
§ 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).