(87 days)
The International Respiratory Systems, Inc's Manual Resuscitator is designed to provide The International respence of reversible apnea, commonly associated with cardiopulmonary arrest.
International Respiratory Systems, Inc.'s Manual Resuscitator
I am sorry, but the provided document is a 510(k) clearance letter from the FDA for a Manual Pulmonary Resuscitator. It confirms that the device is substantially equivalent to legally marketed predicate devices.
This document does not contain information about:
- Acceptance criteria and reported device performance in a table format.
- Details of a study proving the device meets acceptance criteria, including sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
Therefore, I cannot fulfill your request based on the provided text.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, with three overlapping profiles facing to the right. The profiles are arranged in a way that suggests movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
୧ 1338 JUL
Mr. E.J. Smith International Respiratory Systems, Inc. c/o Smith Associates P.O. Box 4341 Crofton, MD 21114
K981307 Re: Manual Pulmonary Resuscitator Regulatory Class: II (two) Product Code: 73 BTM Dated: April 7, 1998 Received: April 10, 1998
Dear Mr. Smith:
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 leqally 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 regulations affecting your device can be found in the Code of Federal Requlations, 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 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. E.J. Smith
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 (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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510(k)m Number:K981307
Device Name: International Respiratory Systems, Inc.'s Manual Resuscitator
Classification Panel:
Indication for Use:
The International Respiratory Systems, Inc's Manual Resuscitator is designed to provide The International respence of reversible apnea, commonly associated with cardiopulmonary arrest.
Patient Population: Adult
Child Infant
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
or
ﺎ Prescription Use
. -
Over the Counter Use
Mark Kramer
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number
§ 868.5915 Manual emergency ventilator.
(a)
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.(b)
Classification. Class II (performance standards).