(32 days)
No
The description focuses on a microprocessor-controlled blower system and mentions no terms related to AI or ML.
Yes
The device is indicated for the treatment of Obstructive Sleep Apnoea (OSA), which is a medical condition. It delivers various therapy modes (CPAP, Bilevel, Vset) to maintain an "air splint" for effective treatment, directly impacting a patient's health.
No
The device is described as providing therapies (CPAP, Bilevel, Vset) to treat Obstructive Sleep Apnoea, rather than diagnosing it. It is a blower system that maintains an "air splint" for treatment.
No
The device description explicitly lists hardware components such as a "micro-processor controlled blower system," "Flow Generator," "HumidAire 2i," "patient tubing," "mask," and "ResLink with Smart Media Card." This indicates it is a hardware-based medical device with integrated software, not a software-only device.
Based on the provided information, the VPAP Malibu is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the treatment of Obstructive Sleep Apnoea (OSA) in adult patients by providing airway pressure. This is a therapeutic function, not a diagnostic one.
- Device Description: The description details a system that generates airway pressure to treat a condition. It doesn't mention analyzing biological samples (like blood, urine, or tissue) or providing information about a patient's health status based on such analysis, which is the core function of an IVD.
- Lack of IVD-related terms: There are no mentions of analyzing samples, diagnostic tests, or any other activities typically associated with IVD devices.
Therefore, the VPAP Malibu is a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications 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.
Product codes
73 BZD
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
Intended User / Care Setting
hospital and home.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
VPAP III (K030843), AutoSet Spirit (K013843)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
・・・
RESMED
VPAP Malibu Traditional 510(k) Premarket Notification
| 510(k) Summary - VPAP Malibu | |
|---|---|
| Date Prepared | 1st August, 2006 |
| Official Contact | Dr Lionel King |
| V.P., Quality Assurance & Regulatory Affairs | |
| ResMed Ltd | |
| 97 Waterloo Road | |
| North Ryde, NSW 2113 | |
| Australia | |
| Tel: +61 (2) 9886 5000 | |
| Fax: +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) - Primary |
| AutoSet 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
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