(199 days)
Not Found
Not Found
No
The summary describes a manual resuscitation device and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML development.
Yes
The device is used to maintain lung ventilation during resuscitation and when natural breathing is insufficient or absent, which are therapeutic interventions.
No
The device is described as a resuscitator intended to maintain lung ventilation, which is a treatment or life support function, not a diagnostic one.
No
The device description is not found, but the intended use describes a "Reusable Resuscitator," which is a physical medical device used for ventilation. This strongly suggests a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "maintain lung ventilation during resuscitation and other critical situations and when natural breathing is insufficient or absent." This describes a device used on a patient to support a physiological function (breathing).
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a person's health. They are used outside the body (in vitro).
The description clearly indicates a device used directly on a patient for life support, which is not the function of an IVD.
N/A
Intended Use / 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.
Product codes
73 BTM
Device Description
Not Found
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical personnel
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 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.
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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 (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/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