The Pocket BVM is a manual emergency ventilator device whose purpose is to manually apply positive pressure to a patient's airways to support ventilation and oxygenation. The Pocket BVM incorporates bags and valve assemblies and is intended to provide emergency respiratory support to a patient through a face mask or a tube inserted into the patient's airway.

The Pocket BVM can apply ventilation to a patient either through a mask (supplied with the device) or an artificial airway (not supplied). The Pocket BVM device maintains the functionality of existing devices and also has the advantage of small external dimensions (when packed) and light weight. It can be unpacked and made operational in seconds. The Pocket BVM complies with ISO 10651-4:2002; Particular requirements for operator powered resuscitators.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device called the "Pocket BVM." This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device that requires extensive clinical studies for performance evaluation.

Here's an analysis of the provided text in relation to your questions:

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

The acceptance criteria for the Pocket BVM are compliance with the international standard ISO 10651-4:2002, "Particular requirements for operator powered resuscitators." The reported device performance is that it "complies with all the requirements of ISO 10651-4:2002."

Acceptance Criteria	Reported Device Performance
Compliance with ISO 10651-4:2002 standard	The Pocket BVM complies with all requirements of ISO 10651-4:2002.

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

The document states "Non-clinical testing: The Pocket BVM has been tested and complies with all the requirements of ISO 10651-4:2002." This typically implies laboratory-based, non-clinical testing performed according to the specified standard.

Sample size: Not specified. Testing for standards compliance often involves a limited number of test units to demonstrate consistent performance within manufacturing specifications.
Data provenance: Not explicitly stated, but non-clinical testing for international standards is generally conducted in a controlled laboratory environment. The submitter is MicroBVM Systems Ltd., Jerusalem, ISRAEL, so it's likely the testing was supervised or conducted in Israel or by contract labs following international guidelines. This would be considered prospective testing for the purpose of regulatory submission.

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)

This question is not applicable to the provided information. The "ground truth" for this device's acceptance is its technical compliance with an international standard (ISO 10651-4:2002), which defines objective performance characteristics (e.g., flow rates, pressure limits, material compatibility). This does not involve expert interpretation or clinical ground truth in the way an imaging AI device would.

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

Not applicable. As explained in point 3, the evaluation of this device is based on objective measurements against a standard, not on expert adjudication of subjective results.

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. This device is a manual emergency ventilator, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI assistance evaluation is irrelevant.

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

Not applicable. This is a mechanical medical device, not an algorithm. Its performance is inherent in its design and manufacturing, tested against physical specifications.

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

The "ground truth" or benchmark for this device's performance is compliance with the technical and performance specifications outlined in the ISO 10651-4:2002 standard. This standard dictates measurable parameters for manual resuscitators.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning system that requires a training set.

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

Not applicable. As this is not an AI/machine learning system, there is no training set and therefore no ground truth establishment for a training set.

Summary

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K093081

Summary of Safety and Effectiveness 510k Summary

This summary of safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

Submitter:

MicroBVM Systems Ltd., 11 Ruzin Street Jerusalem 93870, ISRAEL Tel. +972.54.479.2777

FEB - 5 2010

Name and address of contact person:

Dr. Eli M. Orbach International Regulatory Consultants POB 6718, Efrat 90435, Israel Tel. +972.2.993.2768

Name of the Device: Pocket BVM.

Classification name: The subject of this application is a Manual Emergency Ventilator.

Common name: Manual Emergency Ventilator.

Predicate Devices: The Pocket BVM is substantially equivalent to the Ambu SPUR II Adult Single Patient Use Resuscitator manufactured by Ambu Inc. (subject of K042682).

Indications For Use:

The Pocket BVM Resuscitator is intended for manual pulmonary resuscitation and emergency respiratory support of adult patients.

Description of the Device:

Substantial Equivalence:

The Pocket BVM is substantially equivalent to the Ambu SPUR II Adult Single Patient Use Resuscitator manufactured by Ambu Inc. (subject of K042682). The operation and technological characteristics of the Pocket BVM are identical to the predicate device's operation and technological characteristics. Both devices have the same intended use and are Emergency Manual Ventilators. Examination of

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specifications and test data leads to the conclusion that the devices aresubstantial equivalence

Non-clinical testing:

The Pocket BVM has been tested and complies with all the requirements of ISO
10651 - 2000 10651-4:2002,

Rar

February 4, 2010

Date

Mr. Ron Reisman, President

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features the department's emblem, which consists of a stylized caduceus-like symbol with three abstract human figures. The emblem is positioned to the right of the department's name, which is arranged in a circular pattern around the emblem. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MicroBVM Systems Limited C/O Dr. Eli M. Orbach General Manager International Regulatory Consultants POB 6718 Efrat 9435 ISRAEL

Re: K093081

Trade/Device Name: Pocket BVM Regulation Number: 21 CFR 868.5915 Regulation Name: Manual Emergency Ventilator Regulatory Class: II Product Code: BTM Dated: January 22, 2010 Received: January 29, 2010

Dear Dr. Orbach:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

FEB - 5 2010

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Dr. Orbach

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

h fer

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices

Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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APPENDIX 2

Indications For Use (separate page):

Page 1 of 1

510(k) Number (if known) K093081 .

Device Name Pocket BVM

Indications For Use:

: : :

The Pocket BVM Resuscitator is intended for manual pulmonary resuscitation and emergency respiratory support of adult patients.

U.S. Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner. のですが、その他の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X(Per 21 CFR 801.109)	OR	Over The Counter Use
	L Schatthien(Division Sign-Off)	(Optional Format 1-2-96)
	Division of Anesthesiology, General HospitalInfection Control, Dental Devices
	510(k) Number:	K093081

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).