(785 days)
The Newport E100M is intended to provide positive pressure ventilation for neonatal, infant, pediatric and adult patients, for use in the hospital environment. The device is intended for use by or at the direction of a licensed practitioner.
Not Found
This looks like a 510(k) clearance letter for a medical device (Newport E100M Ventilator), not a study report describing acceptance criteria and device performance. Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, and ground truth establishment is not available in the provided document.
The document primarily focuses on FDA's determination of substantial equivalence for the device to a legally marketed predicate device, allowing it to be marketed. It does not contain the detailed technical or clinical study data that would typically include acceptance criteria and performance metrics.
However, I can extract the following limited information:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not applicable. This document is a regulatory clearance letter, not a performance study report. It does not present specific acceptance criteria or reported device performance metrics in tabular form or otherwise.
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable. The document does not describe a "test set" or any specific study involving data, sample sizes, or data provenance (country of origin, retrospective/prospective). The substantial equivalence determination is based on the comparison to a predicate device, as described in the 510(k) submission, not necessarily a new clinical study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not applicable. No such information is present in this regulatory letter.
4. Adjudication Method for the Test Set:
- Not applicable. No information on adjudication methods is present.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. There is no mention or indication of an MRMC study being conducted or its results in this document. The clearance is based on substantial equivalence, not necessarily a comparative effectiveness study showing improvement with AI assistance.
6. Standalone (Algorithm Only) Performance Study:
- Not applicable. The device is a ventilator, not an AI algorithm. Therefore, "standalone algorithm performance" is not relevant in this context and is not discussed.
7. Type of Ground Truth Used:
- Not applicable. This document does not describe the establishment of ground truth for any study.
8. Sample Size for the Training Set:
- Not applicable. There is no mention of a "training set" as this device is a physical ventilator, not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, no training set or ground truth establishment is mentioned.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States. The logo features a stylized depiction of an eagle or bird with three wing-like strokes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 3 1999
Ms. Karon Morell Newport Medical Instruments, Inc. 760 West 16th Street, Bldg. M Costa Mesa, CA 92627
Re : K972833 E100M Ventilator Requlatory Class: II (two) Product Code: 73 CBK Dated: June 25, 1999 Received: June 25, 1999
Dear Ms. Morell:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Ms. Karon Morell
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): ___K972833
Device Name: Newport E100M
Indications For Use: The Newport E100M is intended to provide positive pressure ventilation for neonatal, infant, pediatric and adult patients, for use in the hospital environment. The device is intended for use by or at the direction of a licensed practitioner.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
canno A Weitighouse Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Device
(Optional Format 3-10-98)
§ 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).