E100M VENTILATOR (E100M)

K972833 · Newport Medical Instruments, Inc. · CBK · Sep 23, 1999 · Anesthesiology

Device Facts

• Record ID: K972833
• Device Name: E100M VENTILATOR (E100M)
• Applicant: Newport Medical Instruments, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Sep 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

Newport E100M is a positive pressure ventilator designed for hospital use across all patient populations (neonatal to adult). Operated by or under the direction of licensed practitioners, the device delivers mechanical ventilation to support patient respiratory function. It functions as a life-support system, providing controlled or assisted breathing to patients unable to maintain adequate ventilation independently. Clinical utility involves managing respiratory failure or insufficiency, thereby stabilizing patient oxygenation and ventilation status. The device is intended for clinical environments where continuous monitoring and professional oversight are available.

Technological Characteristics

Positive pressure ventilator; hospital-grade; supports neonatal, infant, pediatric, and adult patient populations. Technical specifications and materials are not detailed in the provided documentation.

Indications for Use

Indicated for neonatal, infant, pediatric, and adult patients requiring positive pressure ventilation in a hospital setting. Prescription use only.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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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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.

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canno A Weitighouse Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Device

(Optional Format 3-10-98)