The 840 Ventilator with Volume Ventilation Plus™ Option is used to provide continuous ventilation to patients requiring respiratory support. This device is used for a wide range of patients from infant to adult and for a wide variety of clinical conditions.

The 840 Ventilator with Neomode and Volume Ventilation Plus™ Options provides continuous ventilation to patients requiring respiratoroy support. The Neomode Option, which is used on neonatal patients with Ideal Body Weights (IBW) as low as 0.5kg, is intended to cover a variety of clinical conditions. The 840 Ventilatory with Neomode and Volume Ventilation Plus Options is intended for use in hospitals and hospital-type facilities. It may be used during hospital and hospital-type facility transport provided that electrical power and compressed gas are supplied.

Device Description

The VV+ modification provides the 840 Ventilator System with two new breath types, VC' and VS. The VV+ feature is implemented on the 840 Ventilator through additional functionality in software and by use of the existing User Interface panel. No hardware or firmware changes or additions were required. The 840 Ventilator is a dual-microprocessor controlled, critical care ventilator intended to provide continuous ventilation for neonate to adult (with NeoMode Option) or infant to adult (without NeoMode Option) patients who require either invasive ventilation or non-invasive ventilation (via face mask).

AI/ML Overview

The provided document describes a 510(k) premarket notification for the 840 Ventilator System with Volume Ventilation Plus™ Option (VV+). However, it does not contain a table of acceptance criteria or a detailed study proving the device meets specific performance criteria outlined in the input request.

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a performance study with detailed acceptance criteria, sample sizes, ground truth establishment, or expert adjudication.

Here's an analysis of the information that is available in relation to your request:

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

Not provided. The document does not define specific performance metrics or acceptance criteria (e.g., accuracy, precision, sensitivity, specificity for diagnostic devices) for the VV+ option. Instead, it asserts that "the technical characteristics of the device modification do not introduce new questions regarding safety or effectiveness of critical care ventilators" and that the device is "safe and effective for its intended use" based on substantial equivalence.

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

Not explicitly mentioned. While the document states that "Software design and development (including verification testing, test and software quality procedures) were conducted," it does not specify the sample size of any test sets or the provenance of data used in these tests. The focus is on the development process, not a clinical or performance study with a dedicated test set of patient data.

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 applicable/Not mentioned. Since no explicit "test set" and "ground truth" establishment are detailed in the context of a performance study, this information is not provided. The device is a ventilator with new breath types, not a diagnostic tool requiring expert interpretation of results.

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

Not applicable/Not mentioned. No adjudication method is described as there's no mention of a diagnostic interpretation task requiring consensus among experts.

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:

Not applicable. This device is a ventilator, not a diagnostic AI-assisted tool meant to be used by human readers for interpretation. Therefore, an MRMC study is not relevant to this submission.

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

Not directly applicable. The device is an electro-mechanical ventilator with software-controlled breath types. Its "performance" would be assessed through engineering verification and validation testing, ensuring it delivers the intended ventilation parameters safely and accurately. The document states that "Software design and development (including verification testing, test and software quality procedures) were conducted," which implies standalone testing of the software's functionality, but no specific results or acceptance criteria for these tests are provided in the summary.

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

Not explicitly defined in the context of a performance study. For a ventilator, "ground truth" would likely relate to objective physical measurements (e.g., delivered tidal volume, pressure, flow) against known standards or specifications, rather than clinical diagnoses or pathology. The document doesn't detail what specific "ground truth" was used for its verification testing.

8. The sample size for the training set:

Not applicable/Not mentioned. This device is not an AI/ML device that requires a "training set" in the conventional sense. The software functionality for the new breath types is developed through traditional software engineering, programming, and testing.

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

Not applicable/Not mentioned. As there is no "training set" for an AI/ML model, this information is not relevant.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence of the 840 Ventilator System with the Volume Ventilation Plus™ Option to existing predicate devices based on intended use, materials, design, and adherence to software development guidelines. It does not present a detailed performance study with explicit acceptance criteria, sample sizes, or ground truth methodologies as would be expected for a diagnostic device or a new technology requiring such extensive clinical validation.

Summary

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AUG 1 3 2002

K02/573

2200 Faraday Avenue Carlsbad, CA 92008

Tele: 925 463-4427 Fax: 925 463-4020

510(k) Summary

Submitted by:	Puritan-Bennett Corporation2200 Faraday AvenueCarlsbad, CA 92008
Company Contact:	Gina ToSenior Regulatory Affairs Project Manager(925) 463-4427(925) 463-4020 - FAX
Date Summary Prepared:	August 1, 2002
Product Name:	840 Ventilator System with Volume Ventilation Plus™Option (VV+)
Common Name:	Ventilator
Classification:	Class II; Continuous Ventilator per 21 CFR §868.5895
Legally Marketed(Unmodified) Device:	Puritan-Bennett Corp. 840 Ventilator System, K970460Puritan-Bennett Corp. 840 Ventilator System with Neomode Option, K001646
Predicate Devices:	Siemens Servo 300 with Pressure Regulated Volume Control (PRVC) and Volume support (VS), K902859Draeger Evita 4 with AutoFlow, K961687Draeger Evita 2 Dura with AutoFlow, K970165Hamilton Galileo with Adaptive Pressure Ventilation (APV), K001686

DEVICE DESCRIPTION

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INDICATIONS FOR USE

840 Ventilator System with Volume Ventilation Plus Option

840 Ventilator System with Neomode and Volume Ventilation Plus Options

The 840 Ventilator with Neomode and Volume Ventilation Plus™ Options provides continuous ventilation to patients requiring respiratoroy support. The Neomode Option, which is used on neonatal patients with Ideal Body Weights (IBW) as low as 0.5kg, is intended to cover a variety of clinical conditions. The 840 Ventilatory with Neomode and Volume Ventilation Plus Options is intended for use in hospital-type facilities. It may be used during hospital and hospital-type facility transport provided that electrical power and compressed gas are supplied. The device is for prescription use only.

DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The intended use of the 840 Ventilator with VV+ Option is the same as that for conventional, currently marketed, critical care ventilators with a VV+-like function. The materials and design of this device are similar to those of the predicate devices. The technical characteristics of the device modification do not introduce new questions regarding safety or effectiveness of critical care ventilators. Furthermore, the labeling associated with the 840 Ventilator with VV+ Option provides similar information as the predicate devices.

Information provided in this Special 510(k) submission provides comparative, predicate device information and describes development procedures that support the determination of substantial equivalence and assertion that the modified device is safe and effective for its intended use, Software design and development. (including verification testing, test and software quality procedures) were conducted using FDA`s Guidance for the Content of Pre-market Submissions for Software contained in medical devices, dated May 29, 1998, as a guidance and per internal company requirements.

In summary, Puritan-Bennett Corporation has provided information that indicates the 840 Ventilator with VV+ Option to be safe and effective. This device is considered to be substantially equivalent to currently marketed devices, incorporating a VV+-like function, that have been previously cleared by FDA.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines above them that resemble wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 3 2002

Ms. Gina To Senior Regulatory Affairs Project Manager Puritan-Bennett Corporation 2200 Faraday Avenue Carlsbad, California 92008

Re: K021573

Trade/Device Name: 840 Ventilator System with Volume Ventilation Plus Option Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: July 17, 2002 Received: July 18, 2002

Dear Ms. To:

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.

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.

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Page 2 - Ms. To

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely vours.

Patacci Cocente /for,

Timothy A. Ulatowski 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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510(k) Number: K021573

840 Ventilator System with Volume Ventilation Plus Option Device Name:

Indications For Use:

840 Ventilator System with Neomode and Volume Device Name: Ventilation Plus Options

Indications For Use:

Prescription Use: Yes (per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

f. A. Walter Johnson

ivision of Dental, Infection Cor and General Hospital De 510(k) Number

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).