(25 days)
The e360 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. Intra-hospital transport includes patient transport within the hospital or hospital-type facility
The Newport e360 Ventilator is a pneumatically powered, microprocessor controlled ventilator. Performance characteristics and clinical features support infant/pediatric (≥20 mL) through adult patients. Front panel controls allow trained operators to select ventilation controls for 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. When fully charged, the internal battery provides approximately 45 minutes of power. The alarms associated with the e360 meet or exceed standards of critical care ventilators and have been developed in compliance with the FDA Draft Reviewer Guidance for Ventilators (1995). The alarms of the e360 span both technical (ventilator related) alarms and non technical alarms (patient related alarms).
This document is a 510(k) summary for the Newport e360 Ventilator. The information provided focuses on the device's description, intended use, and general testing, rather than a detailed study proving performance against specific acceptance criteria in a clinical context. Therefore, many of the requested categories about clinical study design and outcomes cannot be fully addressed from this document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Hardware Performance | Met pre-defined acceptance criteria (implicit) |
| Software Performance | Met pre-defined acceptance criteria (implicit) |
| Electrical Safety | Met pre-defined acceptance criteria (implicit) |
| Functional Safety | Met pre-defined acceptance criteria (implicit) |
| EMC (Electromagnetic Compatibility) | Met pre-defined acceptance criteria (implicit) |
| Packaging | Met pre-defined acceptance criteria (implicit) |
| Environmental | Met pre-defined acceptance criteria (implicit) |
| Alarm System Performance | "The alarms associated with the e360 meet or exceed standards of critical care ventilators and have been developed in compliance with the FDA Draft Reviewer Guidance for Ventilators (1995)." |
Explanation: The document states, "Comprehensive verification and validation testing was performed with the Newport e360 Ventilators including; hardware, software, electrical safety, functional safety, EMC, packaging, and environmental. All test results met pre-defined acceptance criteria." However, it does not provide specific numerical or qualitative acceptance criteria for these categories, nor does it detail the specific performance results for each. It only states that the criteria were met. The alarm system's performance is specifically mentioned as meeting or exceeding critical care ventilator standards and FDA guidance.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in this document. The testing described is verification and validation, which often involves engineering and regulatory tests, not necessarily a "test set" in the context of clinical data for AI/ML performance.
- Data Provenance: Not applicable. This document describes testing for a ventilator device, not an AI/ML algorithm that relies on patient data for its performance validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is not a study involving expert-established ground truth from clinical data. The "ground truth" for a ventilator's performance is typically defined by engineering specifications, regulatory standards, and physical measurements.
4. Adjudication method for the test set
- Not applicable. This is not a study requiring adjudication of expert opinions or clinical outcomes.
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 document describes a medical device (ventilator) and its engineering-based verification and validation, not an AI-assisted diagnostic or interpretive system that would be subject to an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not a study of an algorithm.
7. The type of ground truth used
- The "ground truth" for the device's performance would be based on:
- Engineering Specifications: Designed performance parameters.
- Regulatory Standards: Compliance with FDA Draft Reviewer Guidance for Ventilators (1995) and other relevant industry standards for medical devices (e.g., electrical safety, EMC).
- Physical Measurements and Testing: Verification of output pressures, volumes, modes, alarm thresholds, etc., using specialized equipment.
8. The sample size for the training set
- Not applicable. This is not an AI/ML system requiring a training set from data.
9. How the ground truth for the training set was established
- Not applicable.
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JAN 1 0 2006
ATTACHMENT 4, page 162 510(k) SUMMARY
A. Sponsor
Newport Medical Instruments, Inc. 1620 Sunflower Ave Costa Mesa, California 92626 Telephone: (714) 427-5811 Fax: (714) 427-0559 Contact Person: Richard Waters Vice President, Regulatory Affairs / Quality Assurance
Date Prepared B.
12/15/2005
C. Device Name
Trade Name: Newport e360 Ventilator
Classification Name: Continuous Use Ventilator
D. Device Description
The Newport e360 Ventilator is a pneumatically powered,
microprocessor controlled ventilator. Performance characteristics and clinical features support infant/pediatric (≥20 mL) through adult patients.
Front panel controls allow trained operators to select ventilation controls for 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.
When fully charged, the internal battery provides approximately 45 minutes of power.
The alarms associated with the e360 meet or exceed standards of critical care ventilators and have been developed in compliance with the FDA Draft Reviewer Guidance for Ventilators (1995). The alarms of the e360 span both technical (ventilator related) alarms and non technical alarms (patient related alarms).
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ATTACHMENT 4, page 163
ய் Intended Use
The e360 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. Intra-hospital transport includes patient transport within the hospital or hospital-type facility.
F. Cleared/Predicate Device
Newport e500 Ventilator (K030780).
Summary of Substantial Equivalence G.
The Newport e360 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 e360 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 is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of an eagle.
Public Health Service
JAN I 0 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Richard Waters Vice President, Regulatory Affairs/Quality Assurance Newport Medical Instrument, Incorporated 1620 Sunflower Avenue Costa Mesa, California 92626
Re: K053502
Trade/Device Name: NewPort e360 Ventilator Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: December 15, 2005 Received: December 16, 2005
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 your 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Suptie H. Michien Om-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 2, page 160: INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: _Newport e360 Ventilator
Indications for Use:
The e360 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. Intra-hospital transport includes patient transport within the hospital or hospital-type facility
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)
Suette H. Muchin Omd
n Control, Dental Devices
§ 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).