SIMS 1ST RESPONSE MANUAL RESUSCITATOR, ADULT

K972283 · Sims · BTM · Sep 17, 1997 · Anesthesiology

Device Facts

• Record ID: K972283
• Device Name: SIMS 1ST RESPONSE MANUAL RESUSCITATOR, ADULT
• Applicant: Sims
• Product Code: BTM · Anesthesiology
• Decision Date: Sep 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5915
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SIMS 1st Response Manual Adult Resuscitator is a pulmonary-assist device intended to provide respiratory support to adult patients suffering from respiratory distress by forcing a volume of fresh gas into the patient via compression of the ventilator bag.

Device Story

Manual resuscitator (bag-valve-mask) provides respiratory support to adult patients in respiratory distress. Device consists of a flexible ventilator bag; operator manually compresses bag to deliver volume of fresh gas to patient airway. Used in clinical or emergency settings by healthcare professionals. Device facilitates manual ventilation; assists in maintaining patient oxygenation and ventilation during respiratory failure.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Manual pulmonary-assist device; consists of a flexible ventilator bag for manual gas delivery. Non-powered, mechanical operation. No software or electronic components.

Indications for Use

Indicated for adult patients suffering from respiratory distress requiring pulmonary support via manual bag-valve-mask ventilation.

Regulatory Classification

Identification

A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.

Submission Summary (Full Text)

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Image /page/0/Picture/10 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three overlapping profiles, creating a sense of depth and movement. The overall design is simple and clean, with a focus on the eagle as a symbol of strength and freedom.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

SEP 1 7 1997

Mr. Avia Toney Smiths Industries Medical Systems 5100 Tice Street Ft. Myers, Florida 33905

Re: K972283 SIMS 1st Response™ Manual Resuscitator, Adult Regulatory Class: II (two) Product Code: 73 BTM Dated: June 18, 1997 Received: June 19, 1997

Dear Mr. Toney:

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 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 regulations 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 Regulation (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 regulations.

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Page 2 - Mr. Avia Toney

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 requlation 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/dsmamain.html".

Sincerely yours,

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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510(k) Number (if known) K972283

Device Name : SIMS 1st Response™ Manual Resuscitator, Adult

Indications for Use:

The SIMS 1st Response Manual Adult Resuscitator is a pulmonary-assist device intended to provide respiratory support to adult patients suffering from respiratory distress by forcing a volume of fresh gas into the patient via compression of the ventilator bag.

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---------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use_

un. Pncy.

(Optional Format 1-2-96)

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number