(87 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as having a "micro-processor controlled blower system" and software changes, but no mention of AI/ML algorithms.
Yes
The device is indicated for the treatment of various respiratory conditions, which inherently implies a therapeutic purpose.
No
Explanation: The device is indicated for the treatment of obstructive sleep apnea, respiratory insufficiency, central or mixed apneas, or periodic breathing, and its description focuses on providing therapy modes (CPAP, Bilevel, ASV, iVAPS) to maintain an "air splint" for effective treatment. There is no mention of diagnostic functions such as measuring or analyzing physiological signals for the purpose of diagnosis.
No
The device description explicitly states that the device comprises a "flow generator" and a "micro-processor controlled blower system," which are hardware components. While there are software changes mentioned (addition of iVAPS mode), the device itself is not solely software.
Based on the provided text, the VPAP Tx device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "treatment of patients" with various respiratory conditions. This indicates a therapeutic purpose, not a diagnostic one.
- Device Description: The description focuses on the device's function in generating airflow to treat these conditions ("maintain an 'air splint'"). It doesn't mention analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening
The VPAP Tx is a therapeutic device used to assist breathing and treat sleep apnea and respiratory insufficiency.
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
73 MNS
Device Description
The modified VPAP Tx device has a similar operating principle, and the same technology and manufacturing process as the VPAP Tx (K092186). The hardware (electromechanical operation and materials) also remain unchanged from the predicate VPAP Tx (K092186). The therapy modes contained in the predicate VPAP Tx (K092186) provides CPAP, Auto-titrating, Bilevel, VAuto and ASV modes to treat OSA and/or respiratory insufficiency, central or mixed apneas or periodic breathing in patients weighing more than 66 lb, and remain unchanged. The device contains a micro-processor controlled blower system that generates as required to maintain an "air splint" for effective treatment of OSA and/or respiratory insufficiency, central or mixed apneas or periodic breathing.
The changes to the modified VPAP Tx device include the addition of the iVAPS therapy mode, from the predicate device Stellar 150 (K103167), the addition of SlimLine tubing as cleared in K091947, the addition of EasyBreathe in S-mode, the addition of Mirage FX (K102746) and Quattro FX (K091129) masks, and the removal of CAD (Closed Airway Detection) in CPAP mode.
The modified VPAP x system comprises the flow generator, patient interface) and optional HumidAire 2i humidifier.
The performance and functional characteristics of the modified VPAP Tx includes all the clinician and user friendly features of the predicate devices, VPAP Tx (K092186) and Stellar 150 (K103167).
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
The VPAP Tx is intended to be used in a 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 Verification activities were performed on the modified VPAP Tx as a result of the risk analysis and design requirements. Endurance testing was not repeated as the change relates to the inclusion of iVAPS (software change only) and therefore, the test report D251-178 remains valid as supplied in the VPAP Tx (K092186) submission, and is held on file at ResMed. As the VPAP Tx device is technologically identical to the VPAP Tx (K092186), predicate therapy performance ventication was directly applicable to the modified VPAP Tx device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
VPAP Tx (K092186), Stellar 150 (K103167)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
RESMED
510(k) Summary – VPAP Tx
DEC 2 9 2011
| Date Prepared | 29 September 2011 |
|---|---|
| Submitter | Nicole Gaddi |
| Regulatory Affairs Manager | |
| ResMed Ltd, Australia | |
| Official Contact | Mr. David D'Cruz |
| V.P., Clinical & Regulatory Affairs | |
| ResMed Corp | |
| 9001 Spectrum Center Boulevard | |
| San Diego, CA 92123 | |
| USA | |
| Tel: (858) 836 5984 | |
| Fax: (858) 836 5522 | |
| 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 Tx (K092186) - Primary |
| Stellar 150 (K103167) - Secondary | |
| Reason for submission | New Device |
1
Indication for Use
The VPAP Tx is indicated for the treatment of patients weighing more than 66 lb (> 30 kg) with obstructive sleep apnea (CSA), respiratory insufficiency, central or mixed apneas, or periodic breathing.
The VPAP Tx is intended to be used in a clinical environment.
Substantial Equivalence
The modified VPAP Tx device has the following similarities to the previously cleared predicate devices.
-
Same intended use
-
Similar operating principle
-
Same technologies
-
Same manufacturing process
Design and Verification activities were performed on the modified VPAP Tx as a result of the risk analysis and design requirements. Endurance testing was not repeated as the change relates to the inclusion of iVAPS (software change only) and therefore, the test report D251-178 remains valid as supplied in the VPAP Tx (K092186) submission, and is held on file at ResMed. As the VPAP Tx device is technologically identical to the VPAP Tx (K092186), predicate therapy performance ventication was directly applicable to the modified VPAP Tx device. ResMed has determined that the modified VPAP Tx device has not allered the safety and effectiveness of treatment for patients with respiratory or Obstructive Sleep Apnoea (OSA) who weigh more than 66 lb (>30 kg).
The VPAP Tx complies with the applicable requirements:
- 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
- IEC 60601-1-2:2007, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance -> Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 60601-1:1988 Ed 2, Medical electrical equipment Part 1: General requirements for safety ア
Device Description
The modified VPAP Tx device has a similar operating principle, and the same technology and manufacturing process as the VPAP Tx (K092186). The hardware (electromechanical operation and materials) also remain unchanged from the predicate VPAP Tx (K092186). The therapy modes contained in the predicate VPAP Tx (K092186) provides CPAP, Auto-titrating, Bilevel, VAuto and ASV modes to treat OSA and/or respiratory insufficiency, central or mixed apneas or periodic breathing in patients weighing more than 66 lb, and remain unchanged. The device contains a micro-processor controlled blower system that generates as required to maintain an "air splint" for effective treatment of OSA and/or respiratory insufficiency, central or mixed apneas or periodic breathing.
The changes to the modified VPAP Tx device include the addition of the iVAPS therapy mode, from the predicate device Stellar 150 (K103167), the addition of SlimLine tubing as cleared in K091947, the addition of EasyBreathe in S-mode, the addition of Mirage FX (K102746) and Quattro FX (K091129) masks, and the removal of CAD (Closed Airway Detection) in CPAP mode.
The modified VPAP x system comprises the flow generator, patient interface) and optional HumidAire 2i humidifier.
The performance and functional characteristics of the modified VPAP Tx includes all the clinician and user friendly features of the predicate devices, VPAP Tx (K092186) and Stellar 150 (K103167).
Conclusion
The modified VPAP Tx is substantially equivalent to the predicate devices VPAP Tx (K092186) and Stellar 150 (K103167).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the caduceus. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
ResMed Limited Vice President, Clinical and Regulatory Affairs ResMed Corporation 9001 Spectrum Center Boulevard San Diego, California 92123
DEC 2 9 2011
Re: K112914
Trade/Device Name: VPAP Tx Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: MNS Dated: September 29, 2011 Received: October 3, 2011
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 (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.
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.goy/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Nh far
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
4
Indication for Use
510(k) Number (if known):
Device Name: VPAP Tx
Indication for Use
The VPAP Tx is indicated for the treatment of patients weighing more than 66 ib (> 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.
for L. Scheffers
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
811 2914 510(k) Number: ___
Prescription Use _____________________________________________________________________________________________________________________________________________________________
.
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)
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