SIMS 1ST RESPONSE MANUAL RESUSCITATOR, ADULT by SIMS

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.

Device Description

SIMS 1st Response™ Manual Resuscitator, Adult

AI/ML Overview

This FDA letter is a 510(k) clearance document for the SIMS 1st Response™ Manual Resuscitator, Adult. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain the specific acceptance criteria for device performance or a study proving it meets those criteria, as typically found in a clinical study report or a more detailed submission. 510(k) clearances are primarily based on demonstrating substantial equivalence to a predicate device, which often relies on comparison of technological characteristics and intended use, rather than extensive clinical performance studies for novel devices.

Therefore, for your questions regarding acceptance criteria and a study proving their fulfillment, the provided document does not contain the necessary information.

To elaborate:

1. A table of acceptance criteria and the reported device performance: Not present in this document.
2. Sample size used for the test set and the data provenance: Not present in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not present in this document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a manual resuscitator, not an AI-assisted diagnostic device, and such a study is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a manual resuscitator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present in this document.
8. The sample size for the training set: Not applicable, as this is a medical device, not a machine learning algorithm, and no training set is mentioned.
9. How the ground truth for the training set was established: Not applicable, as this is a medical device, not a machine learning algorithm.

This FDA letter primarily confirms the regulatory clearance based on substantial equivalence, rather than detailing a specific performance study.

Summary

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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.

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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

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510(k) Number (if known) K972283

Device Name : SIMS 1st Response™ Manual Resuscitator, Adult

Indications for Use:

(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)

Over-The-Counter Use_

un. Pncy.

(Optional Format 1-2-96)

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number

Regulation Number and Section

§ 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).