(74 days)
Not Found
No
The summary describes a microprocessor-controlled blower system for CPAP/Bilevel therapy, similar to predicate devices, with no mention of AI, ML, or related concepts.
Yes
The device is indicated for the "treatment of Obstructive Sleep Apnea (OSA)".
No
The device is indicated for the treatment of Obstructive Sleep Apnea (OSA), clearly stating its purpose as a therapy device, not for diagnosis.
No
The device description explicitly lists hardware components such as a Flow Generator, HumidAire 4i, patient tubing, mask, Smart Card, and USB Adapter.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of Obstructive Sleep Apnea (OSA) by providing airway pressure. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a system that generates and delivers air pressure to the patient. This is consistent with a respiratory therapy device, not a device used to examine specimens from the human body.
- No mention of biological samples: There is no indication that this device interacts with or analyzes any biological samples (blood, urine, tissue, etc.), which is a core characteristic of IVDs.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device directly treats a condition by providing mechanical support to the airway.
N/A
Intended Use / Indications for Use
The VPAP ST is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients weighing more than 66 lb (30 kg). The optional integrated HumidAire 4i is indicated for humidification of the air delivered from a ResMed compatible CPAP therapy device. The VPAP ST and HumidAire 4i are intended for use in the hospital and home.
Product codes (comma separated list FDA assigned to the subject device)
73 BZD, BZD, BTT
Device Description
The VPAP ST is similar to the predicate devices, VPAP Malibu (K062291), S8 Pioneer (K041209), Sullivan VPAP II ST (K961783), and VPAP Auto (K071171). The VPAP ST provides CPAP, Bilevel and VAuto 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 4i, patient tubing, mask (patient interface), Smart Card and USB Adapter.
The performance and functional characteristics of the VPAP ST includes all the clinician and user friendly features of the predicate devices, VPAP Malibu (K062291), S8 Pioneer (K041209), Sullivan VPAP II ST (K961783), and VPAP Auto (K071171).
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
patients weighing more than 66 lb (30 kg).
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 ST as a result of the risk analysis and product requirements. All tests confirmed the VPAP ST 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:
- A 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)
- FDA Off-the-Shelf Software Use in Medical Devices (September 9,1999) 公
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
VPAP Malibu (K062291), S8 Pioneer (K041209), Sullivan VPAP II ST (K961783), VPAP Auto (K071171)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 ST Traditional 510(k) Premarket Notification
510(k) Summary - VPAP ST
| Date Prepared | 14th Jan, 2008 |
|---|---|
| APR - 1 2008 | |
| 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 2004 |
| Classification Reference | 21 CFR 868.5905 |
| Product Code | 73 BZD |
| Common/Usual Name | Noncontinuous ventilator (IPPB). |
| Proprietary Name | VPAP ST |
| Predicate Device(s) | VPAP Malibu (K062291) - Primary |
| S8 Pioneer (K041209) - Secondary | |
| Sullivan VPAP II ST (K961783) - Secondary | |
| VPAP Auto (K071171) - Secondary | |
| Reason for submission | New Device |
Intended for Use
The VPAP ST is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients weighing more than 66 lb (30 kg). The optional integrated HumidAire 4i is indicated for humidification of the air than oo ib (oo hg). "The optional megrated Prairial in device. The VPAP ST and HumidAire 4i are intended for use in the hospital and home.
1
Substantial Equivalence
The new device has the following similarities to the previously cleared predicate device.
- ﺣﺮ ﺍ Similar intended use
- 公 Similar operating principle
-
Same technologies
- 公 Same manufacturing process
Design and Verification activities were performed on the VPAP ST as a result of the risk analysis and product requirements. All tests confirmed the VPAP ST 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:
- A 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)
- FDA Off-the-Shelf Software Use in Medical Devices (September 9,1999) 公
Intended Use
The VPAP ST is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients weighing more than 66 lb (30 kg). The optional integrated HumidAire 4i is indicated for humidification of the air delivered from a ResMed compatible CPAP therapy device. The VPAP ST and HumidAire 4i are intended for use in the hospital and home.
Device Description
The VPAP ST is similar to the predicate devices, VPAP Malibu (K062291), S8 Pioneer (K041209), Sullivan VPAP II ST (K961783), and VPAP Auto (K071171). The VPAP ST provides CPAP, Bilevel and VAuto 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 4i, patient tubing, mask (patient interface), Smart Card and USB Adapter.
The performance and functional characteristics of the VPAP ST includes all the clinician and user friendly features of the predicate devices, VPAP Malibu (K062291), S8 Pioneer (K041209), Sullivan VPAP II ST (K961783), and VPAP Auto (K071171).
Conclusion
The VPAP ST is substantially equivalent to the VPAP Malibu (K062291), S8 Pioneer (K041209), Sullivan VPAP II ST (K961783), and VPAP Auto (K071171).
2
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 eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, clean design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 1 2008
ResMed Limited C/O Mr. David D' Cruz Vice President, Clinical & Regulatory Affairs ResMed Corporation 14040 Danielson Street Poway, California 92064-6857
Re: K080131
Trade/Device Name: VPAP ST Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD, BTT Dated: January 14, 2008 Received: January 18, 2008
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) 276-0115. 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,
Senate Y. Michie, M.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
Indication for Use
510(k) Number (if known):
Device Name:
VPAP ST
Indication for Use
The VPAP ST is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients weighing more than 66 lb (30 kg). The optional integrated HumidAire 4i is indicated for humidification of the air delivered from a ResMed compatible CPAP therapy device. The VPAP ST and HumidAire 41 are intended for use in the hospital and home.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ X AND/OR
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) | |
|---|---|
| (Division Sign-Off) | Page 1 of 1 |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K040131 |
14" Jan, 2008
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