K Number
K051364
Device Name
VPAP ADAPT
Manufacturer
Date Cleared
2005-08-16

(83 days)

Product Code
Regulation Number
868.5895
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VPAP ADAPT is intended to provide non-invasive ventilatory support to treat adult patients with OSA and Respiratory Insufficiency caused by central and/or mixed apneas and periodic breathing.
Device Description
The VPAP ADAPT is a non-invasive flow generator device designed to provide adaptive servo-ventilation therapy (ASV) to stabilize a patient's ventifation. The device continually measures the patient's instantaneous ventilation, and calculates a target ventilation equal to 90% of the patient's recent average ventilation (time constant 100 seconds). It then adjusts the degree of support to servo-control the patient's ventilation to at least equal the target ventilation. The VPAP ADAPT is fitted with alarms to alert the user to changes that will affect the treatment. Some of the alarms are pre-set (fixed) whereas others are clinically selectable. Also, a graphic user interface displays clinical data and enables the user (patient/clinician) to set and adjust certain parameters.
More Information

No
The description details a servo-control system that adjusts ventilation based on a calculated target ventilation derived from recent average ventilation, which is a deterministic algorithm, not AI/ML. There is no mention of AI, ML, or related terms, nor any description of training or test data sets typically associated with AI/ML development.

Yes
The device is intended to treat medical conditions like OSA and respiratory insufficiency and provides therapy by stabilizing the patient's ventilation.

No

The device is described as a flow generator providing ventilatory support and ASV therapy, not diagnosing conditions. While it measures ventilation and displays clinical data, its primary purpose is therapeutic control, not diagnostic assessment like identifying the presence of a disease or condition.

No

The device description explicitly states it is a "non-invasive flow generator device" and describes hardware components like alarms and a graphic user interface, indicating it is a physical device with integrated software, not a software-only device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to provide non-invasive ventilatory support to treat patients with sleep apnea and respiratory insufficiency. This is a therapeutic function, not a diagnostic one.
  • Device Description: The device is described as a "non-invasive flow generator device designed to provide adaptive servo-ventilation therapy." It measures ventilation and adjusts support, which are actions related to treatment, not diagnosis.
  • Lack of Diagnostic Function: There is no mention of the device analyzing biological samples (like blood, urine, or tissue) or providing diagnostic information about a patient's condition based on such analysis. IVDs are specifically designed for this purpose.

The device is a therapeutic device used to manage respiratory conditions.

N/A

Intended Use / Indications for Use

The VPAP ADAPT is intended to provide non-invasive ventilatory support to treat adult patients with OSA and Respiratory Insufficiency caused by central and/or mixed apneas and periodic breathing.

Product codes

73MNS

Device Description

The VPAP ADAPT is a non-invasive flow generator device designed to provide adaptive servo-ventilation therapy (ASV) to stabilize a patient's ventifation. The device continually measures the patient's instantaneous ventilation, and calculates a target ventilation equal to 90% of the patient's recent average ventilation (time constant 100 seconds). It then adjusts the degree of support to servo-control the patient's ventilation to at least equal the target ventilation.

The VPAP ADAPT is fitted with alarms to alert the user to changes that will affect the treatment. Some of the alarms are pre-set (fixed) whereas others are clinically selectable. Also, a graphic user interface displays clinical data and enables the user (patient/clinician) to set and adjust certain parameters.

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

Not Found

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 ADAPT as a result of the risk analysis and product requirements. All tests confirmed that the VPAP ADAPT met the acceptance criteria. The VPAP ADAPT complies with the applicable standards and requirements referenced in the following quidance documents:

  • FDA Draft Reviewer Guidance for Ventilators (July 1995)
  • FDA Reviewer Guidance for Premarket Notification Submissions (November ﺎ 1993)
  • FDA Reviewer's and Industry, Guidance for the content of premarket submissions for software contained in medical devices, May 1998

Predicate bench testing and clinical studies were used to show substantial equivalence between the VPAP ADAPT and VPAP III ST-A.

In the predicate bench testing, the minute ventilation and tidal volume produced by VPAP ADAPT and the VPAP 111 ST-A were measured under various patient breathing efforts. The results show the VPAP ADAPT behaves similar to the predicate device, the VPAP III ST-A.

The findings of the VPAP ADAPT equivalence study demonstrated that the VPAP ADAPT is effective for use in patients with central, mixed apnea or periodic breathing. The primary endpoints were achieved, showing clinically equivalent ApnealHypopnea (AHI) and Respiratory-related Arousal Index (RAI) sleep and respiratory parameters between the VPAP ADAPT and VPAP III ST-A devices. Furthermore, the non-equivalent AHI results indicated that the VPAP ADAPT device is superior (statistically significant p=0.001) to the VPAP III ST-A device for providing effective therapy. Additionally, all secondary endpoints provided further evidence of the equivalency of the devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

VPAP III ST-A (K033276)

Reference Device(s)

Not Found

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

AUG 16 2005

Sponsor

  1. 11

ResMed Ltd

K051364

Traditional 510(k) Premarket Notification

VPAP ADAPT

510(k) Summary – AutoSet CS2 [As required by §807.92 (c) ]

Submitter Name:ResMed Corp.
Submitter Address:14040 Danielson Street, Poway CA 92064-6857, USA
Contact Person:David D'Cruz, VP Requlatory & Clinical Affairs US
Phone Number:(858) 746 2238
Fax Number:(858) 746 2915
Date Prepared:May 19, 2005
Device Trade NameVPAP ADAPT
Device Common Name/
Classification ReferenceBi level Positive Pressure Ventilator/ Continuous
Ventilator, Passive Exhalation Port, Non-Critical Care.
21 CFR868.5895
Product Code73MNS
Predicate Devices:VPAP III ST-A (K033276)
Reason for submissionNew device
Intended Use:The VPAP ADAPT is intended to provide non-invasive
ventilatory support to treat adult patients with OSA and
Respiratory Insufficiency caused by central and/or mixed
apneas and periodic breathing.

1

Device Description

The VPAP ADAPT is a non-invasive flow generator device designed to provide adaptive servo-ventilation therapy (ASV) to stabilize a patient's ventifation. The device continually measures the patient's instantaneous ventilation, and calculates a target ventilation equal to 90% of the patient's recent average ventilation (time constant 100 seconds). It then adjusts the degree of support to servo-control the patient's ventilation to at least equal the target ventilation.

The VPAP ADAPT is fitted with alarms to alert the user to changes that will affect the treatment. Some of the alarms are pre-set (fixed) whereas others are clinically selectable. Also, a graphic user interface displays clinical data and enables the user (patient/clinician) to set and adjust certain parameters.

Performance Data

Design and verification activities were performed on the VPAP ADAPT as a result of the risk analysis and product requirements. All tests confirmed that the VPAP ADAPT met the acceptance criteria. The VPAP ADAPT complies with the applicable standards and requirements referenced in the following quidance documents:

  • FDA Draft Reviewer Guidance for Ventilators (July 1995)
  • FDA Reviewer Guidance for Premarket Notification Submissions (November ﺎ 1993)
  • FDA Reviewer's and Industry, Guidance for the content of premarket submissions for software contained in medical devices, May 1998

Substantial Equivalence

The VPAP ADAPT (new device) and the VPAP III ST-A (predicate device) are both positive pressure flow generators comprising of a blower (motor/fan assembly), flow and pressure sensors, and processing electronics. The blower supplies pressurized air to the patient via a mask and air tubing. The VPAP ADAPT has the same intended use as the VPAP III ST-A.

Predicate bench testing and clinical studies were used to show substantial equivalence between the VPAP ADAPT and VPAP III ST-A.

In the predicate bench testing, the minute ventilation and tidal volume produced by VPAP ADAPT and the VPAP 111 ST-A were measured under various patient breathing efforts. The results show the VPAP ADAPT behaves similar to the predicate device, the VPAP III ST-A.

The findings of the VPAP ADAPT equivalence study demonstrated that the VPAP ADAPT is effective for use in patients with central, mixed apnea or periodic breathing. The primary endpoints were achieved, showing clinically equivalent ApnealHypopnea (AHI) and Respiratory-related Arousal Index (RAI) sleep and respiratory parameters between the VPAP ADAPT and VPAP III ST-A devices. Furthermore, the non-equivalent AHI results indicated that the VPAP ADAPT device is superior (statistically significant p=0.001) to the VPAP III ST-A device for providing effective therapy. Additionally, all secondary endpoints provided further evidence of the equivalency of the devices.

Conclusion

The VPAP ADAPT is substantially equivalent to the VPAP III ST-A.

2

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle faces to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

AUG 16 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David D'Cruz Vice President, Regulatory & Clinical Affairs ResMed Limited 14040 Danielson Street Poway, California 92064-6857

Re: K051364

Trade/Device Name: VPAP Adapt Regulation Number: 21 CFR 868.5895 Regulation Name: Bi-Level positive Pressure Ventilator/Continuous Ventilator Regulatory Class: II Product Code: MNS Dated: May 20, 2005 Received: May 31, 2005

Dear 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

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

Indications for Use

510(k) Number (if known):

VPAP ADAPT Device Name: ____________________

Indications For Use:

The VPAP ADAPT is intended to provide non-invasive ventilatory support to treat adult patients with OSA and Respiratory Insufficiency caused by central and/or mixed apneas and periodic breathing.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Aun Sufeom

(Division Sign-Off) Division of Anesthasiology, General Hospital, Infection Control, Dental Devices

510(k) Number:

.

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