The V60 ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with spontaneous respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician.

The Ventilator is intended to support pediatric patients weighing 20kg (44 lbs) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. The Ventilator is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists.

The ventilator is intended to be used only with various combinations of Respironics recommended patient circuits, interfaces (masks), humidifiers and other accessories.

Device Description

The V60™ ventilator is a microprocessor controlled positive pressure ventilatory assist system incorporating a user interface with multifunction keys, real-time graphic displays, and integral patient and system alarms. The ventilator provides noninvasive and invasive ventilatory support for spontaneously breathing adult and pediatric patients.

AI/ML Overview

The provided text describes a 510(k) submission for the Respironics V60 Ventilator. The summary states that "Bench performance testing was performed comparing the new V60 and the predicate devices, and was found to be substantially equivalent." and "Performance testing and human factors testing demonstrate that the device is as safe, as effective and performs as well as or better than the predicate device."

However, the document does not provide specific acceptance criteria, reported device performance metrics, detailed study designs, sample sizes, information on ground truth establishment, or any details about multi-reader multi-case (MRMC) comparative effectiveness studies.

Therefore, I cannot populate the table or answer most of the questions based on the provided text. The document focuses on demonstrating substantial equivalence to predicate devices through general performance and human factors testing, rather than presenting a detailed clinical study with quantitative acceptance criteria.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified in the provided text	Not specified in the provided text

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Bench performance testing" and "human factors testing" but does not specify sample sizes for any test sets, nor does it provide details about data provenance (e.g., country of origin, retrospective or prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not specified in the provided text. The document does not describe the establishment of a "ground truth" using experts for the performance testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not specified in the provided text.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study is mentioned. The device is a ventilator, and the testing described is performance and human factors testing of the device itself, not a study evaluating human reader performance with or without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable in the context of a ventilator. The described "Performance testing" is inherently standalone in the sense that it tests the device's functionality.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically defined for diagnostic AI studies using expert consensus or pathology is not applicable to the performance testing of a ventilator as described in this document. The "ground truth" for a ventilator's performance would be engineering specifications and established physiological parameters it is designed to achieve.

8. The sample size for the training set

Not applicable. The document describes a medical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. The document describes a medical device, not an AI/ML algorithm that requires a training set.

Summary

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K082660 page 1 of 3

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JAN - 9 2009

510(k) Summary

Submitter: Respironics Inc. Address: 2271 Cosmos Court Carlsbad, CA 92011 Telephone: 760 918 7458 Fax: 760 918 0169

Contact: Mara Caler Regulatory Affairs Telephone: 760 918 7458 Fax: 760 918 0169 Email: mara.caler@respironics.com

Date Prepared: 10 September 2008

Trade name: V60 Ventilator Common Name (Device Type): Assist Ventilator Classification Regulation (CFR): 21 CR 868.5895 Class: 2 Product Code: 73 -- MNT Panel: Division of Anesthesiology, General Hospital, Infection Control and Dental Devices (73)

Predicate Device: Vision Ventilator with Auto-Trak (K982454) BiPAP Synchrony with AVAPS (K070328) Esprit Ventilator (K981072)

Indications for Use:

The Ventilator is intended to support pediatric patients weighing 20kg (44 lbs) or greater to adult patients. It is also intended for intubated patients meeting the same selection

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criteria as the noninvasive applications. The Ventilator is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists.

The ventilator is intended to be used only with various combinations of Respironics recommended patient circuits, interfaces (masks), humidifiers and other accessories

Substantial Equivalence to Predicate Devices:

The predicate devices are the Respironics BiPAP Vision Ventilatory Support System (K982454), the BiPAP Synchrony with AVAPS ventilator, K070328, for AVAPS breath mode and the Esprit ventilator, K981072, which includes the pediatric population.

The proposed V60 ventilator is substantially equivalent to the BiPAP Vision . Ventilatory Support System and the BiPAP Synchrony with AVAPS ventilator and the Esprit in intended use, technology and performance.
. Bench performance testing was performed comparing the new V60 and the predicate devices, and was found to be substantially equivalent.

List of Similarities:

Similar intended use the intended use is similar .
- The Vision Ventilator is intended for use by qualified medical personnel o in providing ventilatory support for adult patients as prescribed by a physician. The Esprit is intended for both adult and pediatric patients, with very similar performance parameters. Both Vision and the V60 ventilators are intended for use in either invasive or non-invasive applications.
Similar patient population the patient population similar .
- Spontaneously breathing individuals who require mechanical ventilation: o patients with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea.
- The addition of the pediatric population is comparable to K981072, Esprit o Ventilatory System.
Same operating principle -- the operating principle is unchanged .
- Both the Vision and the V60 ventilators are microprocessor controlled, o electrically powered, mechanical ventilators. There have been no changes to the operating principle of the equipment.
  - The breathing system is under microprocessor control 트
  - . The user interface is under microprocessor control, featuring a touch screen and graphical user interface technology.
  - 지 The integral air source is built into the ventilator, eliminating the requirement for a central compressor and piped, medical grade

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wall air and/or an individual stand alone compressor for each ventilator.

The ability to provide variable oxygen concentrations (21% to 트 100% O2) from a medical oxygen gas source, including medical grade gas cylinders with suitable regulators
Same technology the technology is unchanged ♥
- Both the Vision and the V60 ventilators are microprocessor controlled, o electrically powered, mechanical ventilators.

List of Differences:

The V60 includes the pediatric population, similar to the secondary predicate, the . Esprit ventilator, K981072
Breathing modes there are new breath types or breathing modes included in the . V60 which combine the breath delivery modes of the BiPAP Vision and the BiPAP Synchrony.

Conclusion:

Performance testing and human factors testing demonstrate that the device is as safe, as effective and performs as well as or better than the predicate device.

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Image /page/3/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 three overlapping wings, representing service to the nation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 9 2009

Ms. Mara Caler Regulatory Affairs Respironics California, Incorporated 2271 Cosmos Court Carlsbad, California 92011

Re: K082660

Trade/Device Name: V60 Ventilator, Model V8000 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: MNT Dated: December 11, 2008 Received: December 12, 2008

Dear Ms. Caler:

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 requires 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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mcan 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 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 vours.

Suette Y. Mcheen Dins

Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name: V60 Ventilator

Indications for Use:

The ventilator is intended to be used only with various combinations of Respironics recommended patient circuits, interfaces (masks), humidifiers and other accessories.

Prescription Use X And/or (Part 21 CFR 801, Subpart D)

Over-the-Counter Use (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)

Nodda

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

510(k) Number: K082660

Respironics, California, Inc.

Regulation Number and Section

§ 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).