(72 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 féatures 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).
The provided text is a 510(k) summary for the Newport e360™ Ventilator and does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML powered medical device.
The document describes a conventional medical device (a ventilator) and its submission for 510(k) clearance by the FDA. The "study" mentioned is a series of nonclinical tests to verify changes to the ventilator, not a study evaluating an AI algorithm's performance against acceptance criteria.
Therefore, I cannot provide the requested information from the given text.
Here's why each point cannot be extracted:
- A table of acceptance criteria and the reported device performance: Not present. The document focuses on regulatory clearance for a ventilator, not performance metrics of an AI.
- Sample size used for the test set and the data provenance: Not present. The "tests" refer to nonclinical verification of engineering changes to the ventilator, not a test set for an AI.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No ground truth establishment for an AI is discussed.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not present. No AI test set, no adjudication.
- 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 present. This document is not about an AI-assisted device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. No algorithm is being evaluated.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not present. No ground truth for an AI.
- The sample size for the training set: Not present. No AI training set.
- How the ground truth for the training set was established: Not present. No AI training set.
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510(k) Summary
Newport e360™ Ventilator
This summary of 510(k) safety and effectiveness information is being submitted in . accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The term "substantial equivalence" as used in this Premarket Notification is limited to the definition found in the Federal Food, Drug, and Cosmetic Act, 21 CFR 807, Subpart E, and relates only to whether the proposed device may be marketed without prior reclassification or clinical approval. This submission is therefore not related to the coverage of any patent and is not to be interpreted as admission or used as evidence in a patent infringement law suit or any other patent matters. [Reference Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355).1
| I. | Submitter Information: | Newport Medical Instruments, Inc.1620 Sunflower AvenueCosta Mesa, CA 92626 |
|---|---|---|
| Contact Person: | Tom ColonnaDirector, RAQA | |
| Summary Date: | 21 June 2010 |
II. Device Name
| Proprietary: | Newport e360 TM Ventilator |
|---|---|
| Common: | Ventilator, Continuous, Facility Use |
| Classification: | II |
| Product Code: | CBK |
| CFR Section: | 868.5895 |
III. Predicate Devices
The e360 is substantially equivalent to the following legally marketed predicate devices:
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IV. Device Description
The Newport e360. Ventilator is a pneumatically powered, microprocessor controlled ventilator. Performance characteristics and clinical féatures 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).
V. 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-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.
This is the same Intended Use as the previously cleared Newport e360 Ventilator (K053502).
VII. Nonclinical Data
The Newport e360 ventilator was subjected to a series of tests which verified the following changes:
- Flex Cycle option added to allow the Expiratory Threshold to adjust within a . specific range to minimize the end-inspiratory pressure overshoot.
- Minor changes (did not affect safety, efficacy, intended use, principle of . operation, or control mechanism of the e360) to the software and design which have been implemented incrementally since the initial release of the Newport e360 Ventilator.
All test results confirm the device to meet its current design, performance, and safety specifications.
VIII. Clinical Data
No clinical or animal data were included in this submission.
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IX. Conclusions
All testing demonstrates that the Newport e360 performs as intended and has acceptable mechanical properties when used in accordance with its labeling; the device is therefore suitable for its intended use which is unchanged from the currently cleared version of the Newport e360 ventilator. As the device's intended use is comparable to the referenced predicate devices, and its operating principles, ventilation modes and performance parameters are comparable to the predicate devices, the e360 is substantially equivalent to the predicate devices.
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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 is circular and features the department's name around the perimeter. In the center of the circle is a stylized image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Tom Colonna Director, Regulatory Affairs & Quality Engineering Newport Medical Instruments, Incorporated 1620 Sunflower Avenue Costa Mesa, California 92626
Re: K101803 ·
Trade/Device Name: Newport e360™ Ventilator Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: August 6, 2010 Received: August 9, 2010
SEP 0 8 2010
Dear Mr. Colonna:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Colonna
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
s d'autres
Anthony D. Watson, B.S., M.S., M.B.A. 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):
SEP 08 2010
Device Name:
Newport e360 TM 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
P. Schultze
Division Sign-Off) Division of Anesthesiology, General Hospital :nfection Control, Dental Devices
Page 1 of 1
510(k) Number: K101803
§ 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).