PLUS REUSABLE RESUSCITATOR

K974141 · Schiff & Co. · BTM · May 21, 1998 · Anesthesiology

Device Facts

• Record ID: K974141
• Device Name: PLUS REUSABLE RESUSCITATOR
• Applicant: Schiff & Co.
• Product Code: BTM · Anesthesiology
• Decision Date: May 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5915
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Plus Reusable Resuscitators are intended for use by trained medical personnel to maintain lung ventilation during resuscitation and other critical situations and when natural breathing is insufficient or absent.

Device Story

Plus Reusable Resuscitator is a manual ventilation device used by trained medical personnel in clinical or emergency settings. It provides positive pressure ventilation to patients with insufficient or absent natural breathing. The device is operated manually by the clinician to deliver air or oxygen to the patient's lungs during resuscitation or critical care. It serves as a life-support tool to maintain oxygenation and ventilation, directly impacting clinical decision-making by providing immediate respiratory support in acute situations.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on device description and intended use.

Technological Characteristics

Manual resuscitator device; reusable design; intended for use with supplemental oxygen or ambient air. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for trained medical personnel to provide lung ventilation to patients experiencing respiratory insufficiency or apnea during resuscitation or critical care scenarios.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right. The eagle is drawn with thick, black lines, giving it a bold and recognizable appearance.

Public Health Service

Rockville MD 20857

MAY 2 1 1998

Mr. Andrew I. Sealfon Repro-Med Systems, Inc. 24 Carpenter Road Chester, NY 10918

Re: K974141 Plus Reusable Resuscitator Regulatory Class: II (two) Product Code: 73 BTM Dated: March 19, 1998 Received: March 24, 1998

Dear Mr. Sealfon:

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 regulation (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 Regist . . 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.

{1}------------------------------------------------

## Page 2 - Mr. Andrew I. Sealfon

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 regulation (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/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

{2}------------------------------------------------

510(k) Number (if known): Not assigned yet Plus Reusable Resuscitator Device Name: Indications for Use: Plus Reusable Resuscitators are intended for use by trained medical personnel to maintain lung ventilation during resuscitation and other critical situations and when natural breathing is insufficient or absent. (Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use or Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96) (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number