(127 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on a micro-processor controlled blower system, which is standard for CPAP devices and does not inherently imply AI/ML.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The VPAP Auto system is indicated for the treatment of Obstructive Sleep Apnea (OSA)". Treating a medical condition like OSA clearly defines it as a therapeutic device.
No
The device is described as a "Micro-processor controlled blower system that generates Continuous Positive Airway Pressure (CPAP) from 4-20 cmHzO as required to maintain an "air splin" for effective treatment of OSA." This suggests a therapeutic function (delivering positive airway pressure) rather than a diagnostic one (identifying or characterizing a disease). Its intended use is "for the treatment of Obstructive Sleep Apnea (OSA)," which is a therapeutic purpose.
No
The device description explicitly states it is a "Micro-processor controlled blower system" and includes hardware components like a "flow generator, patient interface, and humidifier." It also mentions a "new and improved power supply and heater controller." This indicates it is a hardware device with embedded software, not a software-only medical device.
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 positive airway pressure. This is a therapeutic function, not a diagnostic one.
- Device Description: The description details a blower system that generates air pressure for treatment. It does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) which is the core function of an IVD.
- Lack of IVD Indicators: There are no mentions of analyzing samples, diagnostic markers, or any other activities typically associated with in vitro diagnostics.
Therefore, the VPAP Auto system is a therapeutic device, not an IVD.
N/A
Intended Use / Indications 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 interrated HumidAire 3 is indication 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.
Product codes (comma separated list FDA assigned to the subject device)
73 BZD
Device Description
The VPAP Auto System is similar to the predicate device, (VPAP Auto with HumidAire 3 (K071171)) with a new and improved power supply and heater confroller for the HumidAire 3i. Micro-processor controlled blower system that generates Continuous Positive Airway Pressure (CPAP) from 4-20 cmHzO as required to maintain an "air splin" for effective treatment of OSA. The system comprises the flow generator, patient interface) and humidifier.
The performance and functional characteristics of the VPAP Auto system includes all the clinician and user friendly features of the predicate devices.
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
Not Found
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 Vertification activities were performed on the VPAP Auto System 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 has not altered the safety and effectiveness of CPAP treatment for palients with Obstructive Sleep Apnoea (OSA) who weigh more than 66 lb (>30 kg).
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 Auto (K071171), Fisher and Paykel, HC604 CPAP Humidifier (K041900)
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
510(k) Summary - VPAP Auto System
JAN 1 3 2009
KOR26005
Date Prepared
1st Sep, 2008
P
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 2243 |
|---|---|
| Fax: | +61 (2) 8884 2000 |
| Classification Reference | 21 CFR 868.5905 |
|---|---|
| Product Code | 73 BZD |
| Common/Usual Name | Non continuous ventilator (IPPB). |
| Proprietary Name | VPAP Auto System |
| Predicate Device(s) | VPAP Auto (K071171) |
| Fisher and Paykel, HC604 CPAP Humidifier (K041900) |
Reason for submission
New Technology
1
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 interrated HumidAire 3 is indication 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.
Substantial Equivalence
The new device has the following similarities to the previously cleared predicate devices.
- Same intended use A
- Similar operating principle
- Similar technologies A
- Same manufacturing process A
Design and Vertification activities were performed on the VPAP Auto System 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 has not altered the safety and effectiveness of CPAP treatment for palients with Obstructive Sleep Apnoea (OSA) who weigh more than 66 lb (>30 kg). The new device complies with the applicable 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 Devices (May A 11, 2005)
-
FDA Off-the-Shelf Software Use in Medical Devices (September 9,1999)
Device Description
The VPAP Auto System is similar to the predicate device, (VPAP Auto with HumidAire 3 (K071171)) with a new and improved power supply and heater confroller for the HumidAire 3i. Micro-processor controlled blower system that generates Continuous Positive Airway Pressure (CPAP) from 4-20 cmHzO as required to maintain an "air splin" for effective treatment of OSA. The system comprises the flow generator, patient interface) and humidifier.
The performance and functional characteristics of the VPAP Auto system includes all the clinician and user friendly features of the predicate devices.
Conclusion
The VPAP Auto System is substantially equivalent to the Predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ResMed Limited C/O Mr. David D'Cruz Vice President, Clinical & Regulatory Affairs ResMed Corporation 14040 Danielson Street Poway, California 92064-6857
JAN 1 3 2009
Re: K082605
Trade/Device Name: VPAP Auto System Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: January 6, 2009 Received: January 8, 2009
Dear Mr. D'Cruz;
We have reviewed your Section 510(k) premarket notification of intent to market the device i 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 (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. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Anton Dimockfin
Ginette Y. Michaud, M.D. Acting Division Director . Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indication for Use
510(k) Number (if known): |( 0 82 6 6 U S
Device Name: VPAP Auto System
Indication for Use
The VPAP Auto system is indicated for the treatment of Obstructive Steep Apnea (OSA) in patients weighing more than 66 Ib (30 kg). The optional integrated HumidAire 31 is indication 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.
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)
ﯽ
Page 1 of__1
Mel Y. Dahl
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K082605