Disposable manual resuscitator with CO2 detection for use with patients requiring manual ventilatory support. The CO2 detector is located on the expiratory port. It may be supplied separately and attached to any resuscitator expiratory port. The CO2 detector assists in verification of the endotracheal tube placing during endotracheal or nasotracheal intubation. The CO2 detector detects approximate ranges of CO2 by color comparison. It is intended for use by qualified healthcare professionals in any environment where pulmonary support resuscitation is indicated such as in the hospital, transport, mobile or home settings.

Device Description

The EMS Disposable Manual Resuscitator is a bag-valve-mask device with the capability of delivering supplemental oxygen. It incorporates a feature CO2 detection.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the EMS Disposable Manual Resuscitator with CO2 Detection, based on the provided text:

Preamble:

It's important to note that this document is a 510(k) submission, not a full clinical study report. The primary goal of a 510(k) is to demonstrate substantial equivalence to a predicate device, rather than proving novel efficacy or conducting extensive new performance studies. Therefore, the "study" referred to here is primarily a comparison to existing, legally marketed devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the attributes of the predicate devices. The "reported device performance" is the statement of equivalence to these attributes.

Attribute	EMS DMR with CO₂ (Modification)	Predicate Devices (EMS DMR K912203B, K924610A, NPB DMR Plus with CO₂ K973419)	Acceptance Criteria (implied by predicate)	Reported Device Performance
Use
Intended to provide manual ventilatory support	Yes	Yes	Yes	Yes
Intended to assist in verification of tube placement by expired CO₂ detection	Yes	Yes (for CO₂-enabled predicates)	Yes	Yes
Used in hospitals, home, transport, mobile settings	Yes	Yes	Yes	Yes
Single Patient Use	Yes	Yes	Yes	Yes
Design
CO₂ detector placed on expiratory port of manual resuscitator	Yes	Yes (for CO₂-enabled predicates)	Yes	Yes
CO₂ detection by color comparison	Yes	Yes (for CO₂-enabled predicates)	Yes	Yes
CO₂ detector good for up to 2 hours	Yes	Yes (for CO₂-enabled predicates)	Yes	Yes
Can be replaced if needed	Yes	Yes (for CO₂-enabled predicates)	Yes	Yes
Materials
Materials in CO₂ detection media exactly the same as predicate	Yes	Yes (for CO₂-enabled predicates)	Yes	Yes
All other materials exactly the same as predicate	Yes	Yes (for non-CO₂ enabled predicates)	Yes	Yes
Packaging
Provided clean, non-sterile	Yes	Yes	Yes	Yes
Performance Standards / Specifications
None applicable under Section 514	Yes	Yes	Yes	Yes

Summary of Device Performance:

The document explicitly states: "There are no differences between the proposed modification, that of adding CO2 detection capabilities to the exhalation port of the manual resuscitator, and the predicates." This statement implies that the EMS Disposable Manual Resuscitator with CO₂ Detection meets all the acceptance criteria by being functionally and materially identical or equivalent to the predicate devices with CO₂ detection capabilities, and other attributes identical to other predicates.

Regarding "The Study That Proves the Device Meets the Acceptance Criteria":

The provided text doesn't describe a traditional "study" with a test set, experts, and ground truth in the way one might expect for a novel device's performance evaluation. Instead, the "proof" for a 510(k) submission primarily relies on:

Comparison to legally marketed predicate devices: The core argument is that the device is substantially equivalent to existing devices, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.
Verification of attributes: The table explicitly compares attributes of the new device to predicates, indicating "Yes" for matching characteristics.
Statement of no differences: The crucial statement "There are no differences between the proposed modification... and the predicates" serves as the primary evidence.

Given this context, the following points address your specific questions:

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size for Test Set: Not applicable in the context of a 510(k) substantial equivalence submission based on predicate device comparison. There isn't a "test set" of patient data or device performance data gathered for this specific submission beyond the functional demonstration inherent in comparing specifications.
Data Provenance: Not applicable. The "data" here is the descriptive comparison of the device's design, materials, and intended use against legally marketed predicate devices (EMS DMR K912203B, K924610A, and Nellcor Puritan Bennett DMR2 Plus with CO2 Detection K973419, and Nellcor Puritan Bennett EasyCap CO₂ Detector K894053 and K944400). This is a retrospective comparison of device specifications/features to already approved devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. Ground truth, in the sense of expert consensus on patient data or clinical outcomes, is not established for this type of submission. The "ground truth" is effectively the established safety and effectiveness of the predicate devices as determined by their prior FDA clearances.

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication method" in the context of this 510(k) submission. The comparison is a direct assessment of device characteristics against pre-defined market standards (the predicate devices).

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 medical device (resuscitator with CO₂ detection), not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are irrelevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a manual medical device, not an algorithm. Its function inherently involves human operation.

7. The Type of Ground Truth Used

Implicit "Ground Truth": The "ground truth" is the established safety and effectiveness of the predicate devices (EMS Disposable Manual Resuscitator K912203B, K924610A, and Nellcor Puritan Bennett DMR2 Plus Manual Resuscitator with CO2 Detection K973419, and Nellcor Puritan Bennett EasyCap CO₂ Detector K894053 and K944400). The current device is deemed safe and effective because its characteristics are substantially equivalent to these already approved devices.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. See point 8.

Summary

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1953

EMS Engineered Medical Systems		Attribute	EMS DMRwith CO₂(Modification)	EMS DMRK912203BK924610A	NPB DMRPlus with CO₂K973419
2055 EXECUTIVE DRIVE • INDIANAPOLIS, IN 46241 • (317) 246-5500 • FAX (317) 246-5501		Use
Non-Confidential Summary of Safety and Effectiveness		Intended to provide manualventilatory support	Yes	Yes	Yes
page 1 of 3		Intended to assist in verification oftube placement by expired CO₂ detection	Yes	--	Yes
May 28, 1999		Used in hospitals, home, transportmobile settings	Yes	Yes	Yes
Engineered Medical Systems, Inc.2055 Executive Dr.Indianapolis, IN 46241	Tel - (317) 246-5500	Single Patient Use	Yes	Yes	Yes
	Fax - (317) 246-5501	Design
Official Contact:	Bonnie Holly - Quality Manager	CO₂ detector placed on expiratoryport of manual resuscitator	Yes	--	Yes
Proprietary or Trade Name:	EMS Disposable Manual Resuscitator with CO2 Detection	CO₂ detection by color comparison	Yes	--	Yes
Common/Usual Name:	Disposable Manual Resuscitator with CO₂ Detection	CO₂ detector good for up to 2 hours	Yes	--	Yes
Classification Name:	Emergency Manual Ventilator Resuscitator	Can be replaced if needed	Yes	--	Yes
Device:	EMS Disposable Manual Resuscitator with CO₂ Detection	Materials
Predicate Devices:	EMS Disposable Manual Resuscitator with CO₂ Detection -K912203B and K924610A	Materials in CO₂ detection media theexactly the same as predicate	Yes	--	Yes
	Nellcor Puritan Bennett - DMR2 Plus Manual Resuscitator with CO2Detection - K973419	All other materials exactly thesame as predicate	Yes	Yes	--
	Nellcor Puritan Bennett - EasyCap CO₂ Detector - K894053 andK944400	Packaging
Provided clean, non-sterile	Yes	Yes	Yes
Performance Standards / Specifications
None applicable under Section 514	Yes	Yes	Yes

Device Description - Research - Comments - Research - Research - Mar - Mar - Mar -

The EMS Disposable Manual Resuscitator is a bag-valve-mask device with the capability of delivering supplemental oxygen. It incorporates a feature CO2 detection.

Intended Use of the may be the state of the county of the county of the first of the first

Intended for use where pulmonary support resuscitation is indicated and Indicated Use -exhaled CO2 detection is desirable.

Environment of Use --Hospital, Transport, Mobile and Home settings

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Non-Confidential Summary of Safety and Effectiveness

page 2 of 3 May 28, 1999

Comparison to Predicate Devices:

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Non-Confidential Summary of Safety and Effectiveness

page 3 of 3 May 28, 1999

Differences Between Other Legally Marketed Predicate Devices | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

There are no differences between the proposed modification, that of adding CO2 detection capabilities to the exhalation port of the manual resuscitator, and the predicates.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which consists of three stylized human figures intertwined, representing health and well-being. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 1 1999

Ms. Bonnie Holly Engineered Medical Systems 2055 Executive Drive Indianapolis, IN 46241

Re: K991953 Disposable Manual Resuscitator with CO2 Detection Requlatory Class: II (two) Product Code: 73 BTM Dated: May 28, 1999 June 1, 1999 Received:

Dear Ms. Holly:

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 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). 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 reqistration, 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 Requlations, 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 - Ms. Bonnie Holly

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. Callehan

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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ATIONS FOR USE

Pursuant to the Notice of February 6, 1996 regarding listing of Indications for Use on a separate sheet, the following is per that request.

510(k) Number:	(To be assigned)
Device Name:	EMS Disposable Resuscitator with CO2 Detector
Intended Use :	Disposable manual resuscitator with CO2 detection for use with patients requiring manual ventilatory support. The CO2 detector is located on the expiratory port. It may be supplied separately and attached to any resuscitator expiratory port. The CO2 detector assists in verification of the endotracheal tube placing during endotracheal or nasotracheal intubation. The CO2 detector detects approximate ranges of CO2 by color comparison. It is intended for use by qualified healthcare professionals in any environment where pulmonary support resuscitation is indicated such as in the hospital, transport, mobile or home settings.

510(k) Number:

(To be assigned)

Device Name:

EMS Disposable Resuscitator with CO2 Detector

Intended Use :

Concurrence of CDRH, Office of Device Evaluation (ODE)

Atl. A. Cirlouski.

(Division Sign-Off) Division of Cardiovascu and Neurological Devic 510(k) Number ..

Prescription Use
(Per CFR 801.109)

Over-the-counter use

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).