The e500 Ventilator is intended to provide continuous (ET tube) or non-continuous (mask) ventilatory support and monitoring for infant, pediatric, and adult patients with a tidal volume of ≥ 20 mL. The device is prescription use only.

The intended environments include hospital, hospital-type, and intra-hospital transport environments. Hospital use typically includes general care floors, operating rooms, special procedure areas, and intensive and critical care areas within the hospital. Hospital-type use includes facilities such as or similar to surgicenters, sub-acute centers, and special nursing facilities outside of the hospital transport includes patient transport within the hospital or hospital-type facility.

Device Description

The Newport e500 Wave Ventilator is a pneumatically powered, microprocessor controlled ventilator cleared through Premarket Notification.

Performance characteristics and clinical features support infant/pediatric (>20 mL) through adult patients.

Front panel controls allow trained operators to select ventilation controls under volume control, pressure control and volume target pressure control breath types in A/CMV, SIMV and SPONT modes.

A comprehensive alarm system is built-in to alert the user to violations of preset safety limits.

The alarms associated with the e500 meet or exceed standards of critical care ventilators and have been developed in compliance with ISO9703-1, ISO9703-2 and EN475. The alarms of the e500 span both technical (ventilator related) alarms and non technical alarms (patient related alarms).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Newport e500 Wave Ventilator, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance
Ventilation Control Modes	Selectable under volume control, pressure control, and volume target pressure control breath types in A/CMV, SIMV, and SPONT modes.
Patient Population Supported	Infant/pediatric (>20 mL) through adult patients.
Alarms - Standards Compliance	Meet or exceed standards of critical care ventilators and developed in compliance with ISO9703-1, ISO9703-2, and EN475.
Alarms - Type	Span both technical (ventilator related) and non-technical (patient related) alarms.
Tidal Volume Support	≥ 20 mL
Intended Environments	Hospital-type, and intra-hospital transport environments. Hospital use (general care, OR, special procedures, ICU/critical care). Hospital-type use (surgicenters, sub-acute, special nursing facilities). Intra-hospital transport.
Overall Performance	All test results met pre-defined acceptance criteria for hardware, software, electrical safety, functional safety, EMC, packaging, and environmental testing.

Missing Information:
The document states that "All test results met pre-defined acceptance criteria," but it does not explicitly list the specific values or thresholds for these criteria (e.g., what constitutes "meeting" a standard, or the exact ranges for performance metrics). It provides a high-level statement of compliance.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the test set.
The document does not specify the data provenance (e.g., country of origin, retrospective or prospective). It describes "Comprehensive verification and validation testing," which implies laboratory or simulated testing rather than clinical data from human subjects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The testing described is verification and validation, likely against engineering specifications and industry standards, not against "ground truth" established by clinical experts in the sense of diagnostic accuracy.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the testing described (hardware, software, electrical safety, etc.), an adjudication method by human experts for a "test set" in the context of diagnostic performance is not applicable. The device's performance was evaluated against technical specifications and safety standards.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study was not done or mentioned. This type of study is relevant for AI/diagnostic devices where human readers interpret medical images or data. The Newport e500 Wave Ventilator is a continuous ventilator, not a diagnostic imaging device.

6. Standalone (i.e. algorithm only without human-in-the loop performance) Study

The document describes "Comprehensive verification and validation testing" including hardware, software, electrical safety, functional safety, EMC, packaging, and environmental. This implies standalone testing of the device's components and overall system performance without human intervention in the loop, to ensure it meets its pre-defined specifications and safety standards. However, it's not "algorithm only" in the sense of a standalone AI model's performance being evaluated. It's the performance of the integrated device system.

7. Type of Ground Truth Used

The "ground truth" for the testing appears to be pre-defined acceptance criteria based on:
- Engineering specifications and design requirements.
- Compliance with international standards (ISO9703-1, ISO9703-2, EN475 for alarms).
- Functional safety requirements.
- Electrical safety requirements.
- EMC (Electromagnetic Compatibility) standards.

8. Sample Size for the Training Set

This information is not provided. The concept of a "training set" is typically associated with machine learning or AI models that learn from data. While the ventilator is microprocessor-controlled, the document does not suggest it uses a machine learning algorithm that would require a distinct "training set" for its core functionality as described.

9. How the Ground Truth for the Training Set Was Established

As a "training set" is not indicated for this device's type of functionality in the provided text, this information is not applicable or provided.

Summary

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K061094

JUL 2 8 2006

ATTACHMENT 3, page 22 510(k) SUMMARY

A. Sponsor

Newport Medical Instruments, Inc.

1620 Sunflower Ave

Costa Mesa, California 92626

Telephone: (714) 427-5811

Fax: (714) 427-0839

Contact Person: Richard Waters

Vice President, Regulatory Affairs & Quality Assurance

B. Date Prepared

4/18/2006

். Device Name

Trade Name: Newport e500 Wave Ventilator

Classification Name: Continuous Ventilator

D. Device Description

The Newport e500 Wave Ventilator is a pneumatically powered, microprocessor controlled ventilator cleared through Premarket Notification.

Performance characteristics and clinical features support infant/pediatric (>20 mL) through adult patients.

Front panel controls allow trained operators to select ventilation controls under volume control, pressure control and volume target pressure control breath types in A/CMV, SIMV and SPONT modes.

A comprehensive alarm system is built-in to alert the user to violations of preset safety limits.

E. Intended Use

The e500 Ventilator is intended to provide continuous (ET tube) or non-continuous (mask) ventilatory support and monitoring for infant, pediatric, and adult patients with a

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ATTACHMENT 3, page 23

tidal volume of ≥ 20 mL. The device is prescription use only. The intended environments include hospital-type, and intra-hospital transport environments. Hospital use typically includes general care floors, operating rooms, special procedure areas, and intensive and critical care areas within the hospital-type use includes facilities such as or similar to surgicenters, sub-acute centers, and special nursing facilities outside of the hospital. Intra-hospital transport includes patient transport within the hospital or hospital-type facility.

F. Cleared/Predicate Device

Cleared Device

Newport e500 Ventilator, K030780

Predicate Devices

Drager EvitaXL K051263, July 12th, 2005

Maquet Servo-I Ventilator, K041223, July 29th, 2004

Puritan-Bennett 840, K984535, December 28, 1998

G. Summary of Substantial Equivalence

The Newport e500 Wave Ventilator is substantially equivalent to the cleared/predicate devices in intended use, physical characteristics, performance specifications and safety characteristics.

H. Testing

Comprehensive verification and validation testing was performed with the Newport e500 Wave Ventilators including; hardware, software, electrical safety, functional safety, EMC, packaging, and environmental. All test results met pre-defined acceptance criteria.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three stripes forming its wings and body. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 8 2006

Mr. Richard Waters Vice President, Regulatory Affairs & Quality Assurance Newport Medical Instruments, Incorporated 1620 Sunflower Avenue Costa Mesa, California 92626

Re: K061094

Trade/Device Name: Newport e500 Wave Ventilator Regulation Number: 21 CFR 868,5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: July 12. 2006 Received: July 13, 2006

Dear Mr. Waters:

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 vour device in the Federal Register.

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Page 2 - Mr. Waters

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Ching-Lin, Ph.D.

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

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ATTACHMENT 1, page 20 INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: _Newport e500 Wave Ventilator

Indications for Use:

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1_of 1_

(Posted November 13, 2003)

Aun. M. Wem

Sign-C)
n of Anesthesiology, General Hospital,
n Control, Dental Devices
KOCIO94

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).