(32 days)
The VPAP Malibu is indicated for the treatment of adult patients with Obstructive Sleep Apnoea (OSA). It is intended for use in the hospital and home.
The VPAP Malibu System is similar to the predicate devices, VPAP III (K030843) and AutoSet Spirit (K013843). The VPAP Malibu 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 splint" for effective treatment of OSA. The system comprises the Flow Generator, HumidAire 2i (K013843), patient tubing, mask (patient interface) and ResLink with Smart Media Card (K024191). The performance and functional characteristics of the VPAP Malibu system includes all the clinician and user friendly features of the predicate devices, VPAP III (K030843) and AutoSet Spirit (K013843).
This document, K062291, is a 510(k) premarket notification for the RESMED VPAP Malibu, a noncontinuous ventilator (IPPB) intended for the treatment of adult patients with Obstructive Sleep Apnea (OSA). The submission focuses on demonstrating substantial equivalence to predicate devices (VPAP III and AutoSet Spirit) rather than presenting a de novo study with detailed acceptance criteria and performance data for a new, novel device.
As such, the provided text does not contain the detailed information requested for a study proving device performance against specific acceptance criteria. The submission focuses on substantial equivalence based on similar intended use, operating principle, technologies, and manufacturing processes, supported by design and verification activities.
Here's an analysis of what is and isn't available based on your request:
1. A table of acceptance criteria and the reported device performance:
The document does not provide a public table of specific acceptance criteria or detailed reported device performance data in the format you requested. The submission states: "Design and Verification activities were performed on the VPAP Malibu as a result of the risk analysis and product requirements. All tests confirmed the VPAP Mailbu met the predetermined acceptance criteria." However, the exact criteria and corresponding performance metrics are not disclosed in this 510(k) summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No information is provided regarding the sample size used for any test set or the data provenance (country of origin, retrospective/prospective nature) in the provided text. The "Design and Verification activities" are mentioned generically, without specifics about the subjects or data involved.
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. This device is a medical device (ventilator) whose performance would typically be evaluated against engineering specifications and clinical endpoints, not against expert-established ground truth for diagnostic accuracy, which is common for AI/imaging devices. The concept of "ground truth" and expert adjudication as described in your request is not relevant to the type of device and submission presented here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. As with point 3, adjudication methods for expert-established ground truth are not relevant to this type of device and submission.
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 physical medical device (ventilator) and does not involve AI assistance for human "readers" or diagnostic interpretation. Therefore, an MRMC study and AI-assisted improvements are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a physical medical device. The concept of a "standalone algorithm" is not relevant here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For a noncontinuous ventilator, "ground truth" would generally refer to engineering specifications, physiological measurements (e.g., pressure, flow, volume, respiratory rate), and potentially clinical outcomes related to OSA treatment (e.g., AHI reduction). The document implicitly states that internal design and verification activities confirmed the device met predetermined acceptance criteria, which would be based on these types of "ground truth" or specifications, but it does not elaborate on them.
8. The sample size for the training set:
Not applicable. This device is a physical medical device and is not described as involving machine learning or AI models that would require a "training set."
9. How the ground truth for the training set was established:
Not applicable. As with point 8, the concept of a training set and its associated ground truth is not relevant to this traditional medical device submission.
Summary of what the document provides regarding acceptance criteria and study:
The 510(k) submission for the VPAP Malibu asserts that "Design and Verification activities were performed... All tests confirmed the VPAP Mailbu met the predetermined acceptance criteria." This statement is the primary evidence provided in the summary regarding performance validation. However, the details of these activities, the specific acceptance criteria, or the performance data are not included in the public-facing 510(k) summary document provided. The submission relies on demonstrating substantial equivalence to existing predicate devices (VPAP III and AutoSet Spirit) rather than presenting a detailed de novo clinical or performance study.
{0}------------------------------------------------
・・・
RESMED
VPAP Malibu Traditional 510(k) Premarket Notification
| 510(k) Summary - VPAP Malibu | |
|---|---|
| Date Prepared | 1st August, 2006 |
| Official Contact | Dr Lionel KingV.P., Quality Assurance & Regulatory AffairsResMed Ltd97 Waterloo RoadNorth Ryde, NSW 2113AustraliaTel: +61 (2) 9886 5000Fax: +61 (2) 9878 5517 |
| Classification Reference | 21 CFR 868.5905 |
| Product Code | 73 BZD |
| Common/Usual Name | Noncontinuous ventilator (IPPB). |
| Proprietary Name | VPAP Malibu |
| Predicate Device(s) | VPAP III (K030843) - PrimaryAutoSet Spirit (K013843) -Secondary |
| Reason for submission | New Device |
Intended for Use
The VPAP Malibu is indicated for the treatment of adult patients with Obstructive Sleep Apnoea (OSA).
It is intended for use in the hospital and home.
:
1 * August, 2006
Page 17
{1}------------------------------------------------
VPAP Malibu Traditional 510(k) Premarket Notification
RESMED
Substantial Equivalence
The new device has the following similarities to the previously cleared predicate device.
. . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
- ﺎ Similar intended use
- ﺎ، Similar operating principle
- ﺮ ﺍ Same technologies
- ﺎ ﺍ Same manufacturing process
Design and Verification activities were performed on the VPAP Malibu as a result of the risk analysis and product requirements. All tests confirmed the VPAP Mailbu 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:
- ﺎ FDA Draft Reviewer Guidance for Ventilators (July 1995)
- FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical , L Devices (May 11, 2005)
- FDA Off-the-Shelf Software Use in Medical Devices (September 9,1999) ﺮ ﺍ
Intended Use
The VPAP Malibu is indicated for the treatment of adult patients with Obstructive Sleep Apnoea (OSA), It is intended for use in the hospital and home.
Device Description
The VPAP Malibu System is similar to the predicate devices, VPAP III (K030843) and AutoSet Spirit (K013843). The VPAP Malibu 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 splint" for effective treatment of OSA.
The system comprises the Flow Generator, HumidAire 2i (K013843), patient tubing, mask (patient interface) and ResLink with Smart Media Card (K024191).
The performance and functional characteristics of the VPAP Malibu system includes all the clinician and user friendly features of the predicate devices, VPAP III (K030843) and AutoSet Spirit (K013843).
Conclusion
The VPAP Malibu is substantially equivalent to the VPAP III (K030843) and AutoSet Spirit (K013843).
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image contains the text "Public Health Service". The text is written in a simple, sans-serif font. The words are arranged horizontally, with "Public" and "Health" on the first line and "Service" on the second line. The text appears to be part of a document or sign.
Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The seal is black and white and appears to be a simple, official design.
SEP - 8 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ResMed Limited C/O Mr. David D'Cruz V.P., Quality Assurance & Regulatory Affairs ResMed Corporation 14040 Danielson Street Poway, California 92064-6857
Re: K062291
Trade/Device Name: VPAP Malibu Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: August 1, 2006 Received: August 7, 2006
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.
{3}------------------------------------------------
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
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}------------------------------------------------
VPAP Malibu Traditional 510(k) Premarket Notification
RESMED
Indication for Use
510(k) Number (if known):
Device Name:
VPAP Malibu
Indication for Use
The VPAP Malibu is indicated for the treatment of adult patients with Obstructive Sleep Apnoea (OSA). It is intended for use in the hospital and home.
Prescription Use _ × 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)
Amy Solcom
lon Sign-On) on of Anesthesiology, General Host John Control, Dental Devic
Number: K062291
Page 1 of 1
151 August, 2006 ·
Page 14
§ 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).