(90 days)
Not Found
Not Found
No
The summary describes a manual resuscitator, a mechanical device, and contains no mention of AI, ML, or related concepts.
Yes
The device is intended to provide "respiratory support to adult patients suffering from respiratory distress," which constitutes a therapeutic intervention.
No
Explanation: The device is described as a "pulmonary-assist device intended to provide respiratory support," which means it aids in breathing rather than diagnosing a condition. Its function is to "force a volume of fresh gas into the patient," not to identify or monitor medical conditions.
No
The device description explicitly states it is a "Manual Adult Resuscitator," which is a physical, hardware-based device used for ventilation. There is no mention of software as the primary or sole component.
Based on the provided information, the SIMS 1st Response Manual Adult Resuscitator is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "pulmonary-assist device intended to provide respiratory support to adult patients... by forcing a volume of fresh gas into the patient". This describes a device that interacts directly with the patient's respiratory system to provide mechanical support.
- IVD Definition: In vitro diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. The SIMS 1st Response Manual Adult Resuscitator does not perform this function. It's a therapeutic device, not a diagnostic one.
- Lack of IVD-related information: The provided text does not mention any analysis of biological samples, diagnostic testing, or any other activities typically associated with IVDs.
Therefore, the SIMS 1st Response Manual Adult Resuscitator falls under the category of a medical device used for respiratory support, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SIMS 1st Response Manual Adult Resuscitator is a pulmonary-assist device intended to provide respiratory support to adult patients suffering from respiratory distress by forcing a volume of fresh gas into the patient via compression of the ventilator bag.
Product codes
73 BTM
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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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/10 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three overlapping profiles, creating a sense of depth and movement. The overall design is simple and clean, with a focus on the eagle as a symbol of strength and freedom.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
SEP 1 7 1997
Mr. Avia Toney Smiths Industries Medical Systems 5100 Tice Street Ft. Myers, Florida 33905
Re: K972283 SIMS 1st Response™ Manual Resuscitator, Adult Regulatory Class: II (two) Product Code: 73 BTM Dated: June 18, 1997 Received: June 19, 1997
Dear Mr. Toney:
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 requlation (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. Avia Toney
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 requlation (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 requlation 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, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
2
510(k) Number (if known) K972283
Device Name : SIMS 1st Response™ Manual Resuscitator, Adult
Indications for Use:
The SIMS 1st Response Manual Adult Resuscitator is a pulmonary-assist device intended to provide respiratory support to adult patients suffering from respiratory distress by forcing a volume of fresh gas into the patient via compression of the ventilator bag.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
---------------------------------------Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
un. Pncy.
(Optional Format 1-2-96)
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number