(87 days)
Error: Predicate Device(s) not found.
Not Found
No
The summary describes a manual resuscitator and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as for details related to training/test sets and performance studies typically associated with AI/ML devices.
Yes
The device is designed to address reversible apnea, a medical condition, by providing "the international respenose," which likely refers to respiratory support or resuscitation. This indicates a therapeutic intent.
No
The device is described as a "Manual Resuscitator" designed to "provide The International respence of reversible apnea," which indicates it is a therapeutic device for resuscitation, not for diagnosing medical conditions.
No
The device description explicitly states "Manual Resuscitator," which is a hardware device used for manual ventilation. The summary does not mention any software component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide respiratory support for reversible apnea, which is a direct intervention on a patient's physiological function.
- Device Description: The description is for a "Manual Resuscitator," which is a device used to manually ventilate a patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. IVDs are typically used to diagnose, monitor, or screen for diseases or conditions by examining samples taken from the body.
This device is a therapeutic device used to support breathing, not a diagnostic device used to analyze samples.
N/A
Intended Use / Indications 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.
Product codes
73 BTM
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult
Child
Infant
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
2
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