(154 days)
The VPAP Tx is indicated for the treatment of patients weighing more than 66 lb (> 30 kg) with obstructive sleep apnea (OSA), respiratory insufficiency, central or mixed apneas, or periodic breathing.
The VPAP Tx is intended to be used in a clinical environment.
The VPAP Tx is similar to the predicate devices, VPAP Adapt (K051364), VPAP ST (K080131), VPAP III ST-A (K033276) and AutoSet Clinical (K952429). The VPAP Tx provides CPAP, Auto-itirating, Bilevel, VAuto and ASV modes to treat OSA and/or respiratory insufficiency in patients weighing more than 66 lb. This is achieved through the use of a micro-processor controlled blower system that generates as required to maintain an "air splint" for effective treatment of OSA and/or respiratory insufficiency.
The VPAP Tx system comprises the flow generator, patient tubing, mask (patient interface) and optional HumidAire 2i humidifier.
The performance and functional characteristics of the VPAP Tx includes all the clinician and user friendly features of the predicate devices, VPAP Adapt (K051364), VPAP ST (K080131), VPAP III ST-A (K033276) and AutoSet Clinical (K952429).
This document describes a 510(k) premarket notification for the ResMed VPAP Tx, a respiratory therapy device. The submission claims substantial equivalence to previously cleared predicate devices.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly list specific numerical acceptance criteria or performance metrics for the VPAP Tx. Instead, it states a general conclusion about meeting predetermined criteria.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Product met predetermined acceptance criteria based on design and verification activities. | "All tests confirmed the product met the predetermined acceptance criteria." |
| Compliance with applicable standards and FDA guidance documents. | "The new device complies with the applicable standards and requirements referenced in the FDA guidance documents." |
| Substantial Equivalence to predicate devices in intended use, operating principle, technologies, and manufacturing process. | "The new device has the following similarities to the previously cleared predicate devices... ResMed has determined that the new device is Substantially Equivalent to the predicate devices." |
| Biocompatibility requirements met for air path materials. | "The materials used in the air path are either predicate materials... or have been tested and found compliant with the biocompatibility requirements." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for any test set related to direct device performance evaluation. It also does not mention data provenance (e.g., country of origin, retrospective/prospective). This is typical for a 510(k) summary focused on substantial equivalence rather than a clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish a "ground truth" in the context of a test set for performance evaluation. The substantial equivalence claim is based on engineering design, verification activities, and comparison to predicate devices, not on a clinical ground truth established by experts.
4. Adjudication Method for the Test Set
Since there is no mention of a test set requiring ground truth establishment by experts, there is no adjudication method described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document does not mention any MRMC comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. This device is a ventilator, not an AI-powered diagnostic tool that would typically involve such studies.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The device is a continuous non-life-supporting ventilator. Its performance is inherent in its electromechanical operation and software control, not an "algorithm only" in the sense of a diagnostic or interpretive AI. Therefore, the concept of "standalone performance" as it applies to AI algorithms is not directly applicable here. The device's performance itself is what was assessed in verification activities.
7. The Type of Ground Truth Used
For this type of device, the "ground truth" for its performance is typically established through engineering specifications, biomechanical models, and established clinical parameters for respiratory support. For example, pressure accuracy, flow delivery, and patient synchronization would be assessed against design requirements and recognized performance standards. The document indirectly refers to this by mentioning "design and verification activities" that confirmed the product met "predetermined acceptance criteria."
8. The Sample Size for the Training Set
The document does not mention any training set. This device uses a micro-processor controlled blower system with established control algorithms, not a machine learning model that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set, this question is not applicable.
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DEC 22 2009
| RESMED | VPAP TxTraditional 510(k) Premarket Notification |
|---|---|
| 510(k) Summary - VPAP Tx | |
| Date Prepared | 15 JULY 2009 |
| Official Contact | Steven LubkeDirector Regulatory AffairsResMed Ltd1 Elizabeth Macarthur DriveBella Vista, NSW 2153AustraliaTel: +61 (2) 8884 1000Fax: +61 (2) 8884 2000 |
| Classification Reference | 21 CFR 868.5895 |
| Product Code | 73 MNS |
| Common/Usual Name | Ventilator, continuous, non-life-supporting |
| Proprietary Name | VPAP Tx |
| Predicate Device(s) | VPAP Adapt (K051364) - PrimaryV8 (VPAP ST) (K080131) - SecondaryVPAP III ST-A (K033276) - SecondaryAutoSet Clinical (K952429) - Secondary |
| Reason for submission | New Device |
KU9:2186
·
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RESMED
Indication for Use
The VPAP Tx is indicated for the treatment of patients weighing more than 66 lb (> 30 kg) with obstructive sleep apnea (OSA), respiratory insufficiency, central or mixed apneas, or periodic breathing.
The VPAP Tx is intended to be used in a clinical environment.
Device Description
The VPAP Tx is similar to the predicate devices, VPAP Adapt (K051364), VPAP ST (K080131), VPAP III ST-A (K033276) and AutoSet Clinical (K952429). The VPAP Tx provides CPAP, Auto-itirating, Bilevel, VAuto and ASV modes to treat OSA and/or respiratory insufficiency in patients weighing more than 66 lb. This is achieved through the use of a micro-processor controlled blower system that generates as required to maintain an "air splint" for effective treatment of OSA and/or respiratory insufficiency.
The VPAP Tx system comprises the flow generator, patient tubing, mask (patient interface) and optional HumidAire 2i humidifier.
The performance and functional characteristics of the VPAP Tx includes all the clinician and user friendly features of the predicate devices, VPAP Adapt (K051364), VPAP ST (K080131), VPAP III ST-A (K033276) and AutoSet Clinical (K952429).
Substantial Equivalence
The new device has the following similarities to the previously cleared predicate devices.
- A Similar intended use
- A Similar operating principle
-
Similar technologies
- V Similar manufacturing process
The materials used in the air path are either predicate materials (previously cleared for the same intended use) or have been tested and found compliant with the biocompatibility requirements.
Design and Verfication activities were performed on the VPAP Tx as a result of the risk analysis and design requirements. All tests confirmed the product 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)
- A FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)
- A FDA Off-the-Shelf Software Use in Medical Devices (September 9,1999)
Conclusion
The VPAP Tx is substantially equivalent to the previously cleared predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 emblem of a stylized eagle or bird-like figure with outstretched wings.
Public Health Service
DEC 22 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
ResMed Limited C/O Mr. David D'Cruz Vice President, Clinical & Regulatory Affairs ResMed Corporation 9001 Spectrum Center Boulevard San Diego, California 92123
Re: K092186
Trade/Device Name: VPAP Tx Regulation Number: 21 CFR 868.5895 Regulation Name: Noncontinuous Ventilator Regulatory Class: II Product Code: MNS Dated: December 8, 2009 Received: December 10, 2009
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
hh for
Anthony D. Watson, B.S., M.S., M.B.A. 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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RESMED
Indication for Use
510(k) Number (if known): K092186
Device Name:
VPAP Tx
Indication for Use
The VPAP Tx is indicated for the treatment of patients weighing more than 66 lb (> 30 kg) with obstructive sleep apnea (OSA), respiratory insufficiency, central or mixed apneas, or periodic breathing.
The VPAP Tx is intended to be used in a clinical environment.
L Schultr
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
1092 86 510(k) Number:
Prescription Use ______X
AND/OR
Over-The-Counter Use_
(Part 21 CFR 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)
Page 1 of_ 1
15 July, 2009
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).