(154 days)
Not Found
No
The summary describes a microprocessor-controlled blower system with various modes for treating sleep apnea and respiratory insufficiency. It does not mention AI, ML, or any related terms, nor does it describe any features or functionalities that would typically involve AI/ML, such as image processing or complex data analysis for diagnosis or treatment optimization beyond standard algorithms.
Yes
The device is indicated for the "treatment" of various conditions such as obstructive sleep apnea (OSA) and respiratory insufficiency, which directly implies a therapeutic purpose.
No
The VPAP Tx is described as a treatment device for conditions like obstructive sleep apnea and respiratory insufficiency, providing various modes (CPAP, Bilevel, etc.) to maintain an "air splint." There is no mention of it being used to diagnose conditions or capture diagnostic data.
No
The device description explicitly states that the system comprises a "flow generator, patient tubing, mask (patient interface) and optional HumidAire 2i humidifier," which are all hardware components. It also mentions a "micro-processor controlled blower system." 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 respiratory conditions like sleep apnea and respiratory insufficiency. This involves delivering air pressure to the patient's airway.
- Device Description: The device is described as a "micro-processor controlled blower system" that generates air pressure. It includes components like a flow generator, tubing, mask, and humidifier. These are all components of a respiratory therapy device, not a device used for testing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
Therefore, the VPAP Tx is a therapeutic device used for respiratory support, not an in vitro diagnostic device.
N/A
Intended Use / Indications 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.
Product codes (comma separated list FDA assigned to the subject device)
73 MNS
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).
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
clinical environment.
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 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.
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 Adapt (K051364), V8 (VPAP ST) (K080131), VPAP III ST-A (K033276), AutoSet Clinical (K952429)
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
§ 868.5895 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).
0
DEC 22 2009
| RESMED | VPAP Tx
Traditional 510(k) Premarket Notification |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 510(k) Summary - VPAP Tx |
| Date Prepared | 15 JULY 2009 |
| Official Contact | Steven Lubke
Director Regulatory Affairs
ResMed Ltd
1 Elizabeth Macarthur Drive
Bella Vista, NSW 2153
Australia
Tel: +61 (2) 8884 1000
Fax: +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) - Primary
V8 (VPAP ST) (K080131) - Secondary
VPAP III ST-A (K033276) - Secondary
AutoSet Clinical (K952429) - Secondary |
| Reason for submission | New Device |
KU9:2186
·
1
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.
2
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.
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); 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
4
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)
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15 July, 2009