(163 days)
Not Found
Not Found
No
The summary describes a manual resuscitation device and explicitly states "Not Found" for mentions of AI, DNN, or ML, and lacks information typically associated with AI/ML device submissions (training/test sets, performance metrics like AUC, etc.).
Yes
Explanation: The device is intended for manual resuscitation, which is a therapeutic intervention to restore or maintain vital functions in patients.
No
Explanation: The device is described as a system for manual resuscitation, which is a therapeutic intervention, not a diagnostic one. There is no mention of it being used to identify or determine a medical condition.
No
The device is described as a "Disposable Bag Mast Resuscitator," which is a physical medical device used for manual resuscitation. The summary does not mention any software component.
Based on the provided information, the Golemb Disposable Bag Mast Resuscitator is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "manual resuscitation," which is a direct medical intervention on a patient to support breathing.
- Device Description (or lack thereof): While the description is "Not Found," the intended use clearly points to a device used on a patient, not for testing samples from a patient.
- No mention of testing or analysis: There is no indication that this device is used to test or analyze biological samples (like blood, urine, tissue, etc.) to provide diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health, diagnose conditions, or monitor treatment. The Golemb Disposable Bag Mast Resuscitator is a therapeutic device used to support respiration.
N/A
Intended Use / Indications for Use
The Golemb Disposable Bag Mast Resuscitator is a single patient use system for manual resuscitation.
Product codes (comma separated list FDA assigned to the subject device)
73 BTM
Device Description
The Golemb Disposable Bag Mask Resuscitator is a single patient use system for manual resuscitation.
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
The Golemb Disposable Bag Mast Resuscitator is designed to be used for adults, pediatrics, and infants.
Intended User / Care Setting
The primary intended use for the product is in the Emergency Medical Service(EMS) Industry; however, the product can be used when manual resuscitation is required.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 stylized eagle or bird symbol, composed of three curved lines, positioned to the right. Encircling the bird symbol are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JA 2 9 1998
Mr. Vernon Trimble Allied Healthcare Products, Inc. 1720 Sublette Avenue St. Louis, MO 63110
Re: K973106 Golemb Disposable Bag Mask Resuscitator Regulatory Class: II (two) 73 BTM Product Code: December 2, 1997 Dated: December 9, 1997 Received:
Dear Mr. Trimble:
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 You provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 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.
1
Page 2 - Mr. Vernon Trimble
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
Page _ of _
510(k) Number (if known): K973/06
Solemp Dispasak Bag Mask Device Name:
Indications For Use:
Application for the Product
The Golemb Disposable Bag Mast Resuscitator is a single patient use system for manual resuscitation.
Population
The Golemb Disposable Bag Mast Resuscitator is designed to be used for adults, pediatrics, and infants.
Environment for use
The primary intended use for the product is in the Emergency Medical Service(EMS) Industry; however, the product can be used when manual resuscitation is required.
Revised 11/12/97
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Division of Cardiovascular, R and Neurological Devices K973100 510(k) Number . Prescription Use v Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ રીકે (Per 21 CFR 801.109) (Optional Format 1-2-96)
iGriginal Format 1-2-46