CPR FILTERSHIELD by PLASCO, INC.

The CPR FILTERSHIELD is a highly portable, single use, physical barrier for use in performing mouth-to mouth resuscitation on adults and children by personnel train in CPR techniques.

Device Description

The configuration of this device is a plastic PVC sheet with a hole in the center. Sealed around the hole is two plastic molded supports. An electret fiberous media filter is sealed to the proximal molded support.

AI/ML Overview

This 510(k) summary does not contain the level of detail necessary to complete all sections of your request comprehensively. Specifically, it focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with quantified acceptance criteria and performance metrics.

However, based on the provided text, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Flow Resistance	Found equivalent to the Laerdal Resusci™ Face Shield.
Effects of Temperature	Found equivalent to the Laerdal Resusci™ Face Shield.
Barrier Effectiveness	Found equivalent to the Laerdal Resusci™ Face Shield.
Biological Evaluation (Material Components)	Complies with ISO 10993-1 1992 Biological evaluation of medical devices (surface device, mucosal membrane, contact duration A).

Note: The document states the CPR FILTERSHIELD "was found equivalent to the Laerdal shield for the following." This implies the acceptance criterion for each aspect was likely "performance equivalent to the predicate device." The specific quantitative thresholds for "flow resistance," "effects of temperature," and "barrier effectiveness" are not detailed in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified. The summary focuses on demonstrating equivalence through various tests, but the number of units or measurements included in these tests (e.g., for flow resistance or barrier effectiveness) is not provided.
Data Provenance: Not specified. The document does not indicate the country of origin where the tests were conducted or if the data was retrospective or prospective. It implies internal testing by the manufacturer or a contracted lab.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: Not applicable/Not specified. This type of device relies on engineering and material science testing, not expert interpretation of outputs like radiological images. Therefore, the concept of "ground truth established by experts" as typically understood in AI/medical imaging studies is not relevant here. The "ground truth" for material compliance would be the results from standardized lab tests.
Qualifications of Experts: Not applicable/Not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human reviewers (e.g., radiologists) in studies involving subjective interpretation. This is an engineering/performance test, not an interpretation study.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a physical barrier, not an AI diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Study: This question is not applicable to a physical medical device. The device itself is "standalone" in its function as a barrier, but it doesn't involve algorithms or human-in-the-loop performance in the context of AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: The "ground truth" for this device's performance would be derived from:
- Validated engineering test methods: For properties like flow resistance, effects of temperature, and barrier effectiveness.
- International standards compliance: For biological evaluation (ISO 10993-1).
- Performance of the predicate device: The direct comparison to the Laerdal Resusci™ Face Shield served as the benchmark for "equivalence."

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This summary describes a 510(k) submission for a physical device, not an AI/machine learning algorithm. Therefore, there is no "training set."

9. How the ground truth for the training set was established

How Ground Truth for Training Set was Established: Not applicable, as there is no training set for a physical device.

Summary

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1111 1 6 1998

』MORRISON DRIVE ・ GURNEE ILLINOIS 60031 ・ (847) 662-4400 ・ FAX (847) 662-1084

510(k) Summarv

K1980066

Submitted By and Contact Person:

Gary S. Botsford 4080 Morrison Dr. Gurnee, IL 60031 847-662-4400 Ext. 218

Fax: 847-662-1084

Date Prepared: 115/98

Name of Device:

Proprietary Name: Classification Name: Common/Usual Name: CPR FILTERSHIELD™ Ventilator, Emergency, Manual (868.5915) FACE SHIELD

Equivalent device:

Laerdal Resusci ™ Face Shield 46 00 01 (K880450)

Device description:

Device use:

The CPR FILTERSHIELD is a highly portable, single use, physical barrier for use in performing mouth resuscitation on adults and children by personnel train in CPR techniques.

The CPR FILTERSHIELD performs the same function and is technologically equivalent to the Laerdal Resusci ™ Face Shield. The CPR FILTERSHIELD was found equivalent to the Laerdal shield for the following:

FLOW RESISTANCE EFFECTS OF TEMPERATURE BARRIER EFFECTIVENESS

The material compounds used for the patient/rescuer contact components comply with ISO 10993 -1 1992 Biological evaluation of medical devices (surface device, mucosal membrane, contact duration A).

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Jul 1 6 1998

Mr. Gary S. Botsford Plasco, Inc. 4080 Morrison Drive Gurnee, IL 60031

K980066 Re: CPR Filtershield Regulatory Class: II (two) Product Code: 73 BTM Dated: April 22, 1998 Received: April 23, 1998

Dear Mr. Botsford:

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 requlations 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.

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Page 2 - Mr. Gary S. Botsford

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 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

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The CPR FILTERSHIELD is a highly portable, single use, physical barrier for use in performing mouth-to mouth resuscitation on adults and children by personnel train in CPR techniques. .

Prescription use

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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).