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

The provided text describes a 510(k) submission for the EMS Disposable Manual Resuscitator with CO₂ Detection. The submission focuses on demonstrating substantial equivalence to predicate devices rather than conducting a de novo study to establish new performance criteria. Therefore, several of the requested categories are not applicable or cannot be extracted directly from this type of document.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics from a formal study. Instead, it relies on demonstrating equivalence to predicate devices. The "Performance Standards / Specifications" section explicitly states "None applicable under Section 514," indicating that no specific performance standards were applied or tested against as part of this submission for the modified device.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance	Comments
Not explicitly defined as quantitative criteria for this submission. The submission focuses on substantial equivalence to predicate devices.	Functionally equivalent to predicates, specifically regarding CO₂ detection and manual resuscitation.	The device performs the same functions and has similar design attributes as already-cleared predicate devices. The "Performance Standards/Specifications" section indicates no specific standards were applicable under Section 514, implying performance was assessed based on comparison to predicates without needing new quantitative targets.

Study Information:

Due to the nature of a 510(k) submission based on substantial equivalence, a traditional "study that proves the device meets acceptance criteria" as might be seen for a novel device or a de novo application is not detailed in this document. The focus is on comparison to predicates.

Sample size used for the test set and the data provenance: Not applicable / Not specified in this 510(k) summary. The document compares the modified device to predicate devices based on attributes and materials, not on a formal test set with clinical data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable / Not specified. Ground truth establishment would typically be for a de novo study involving clinical data, which is not detailed here.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable / None specified.
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 resuscitator with a CO₂ detector, not an AI-powered diagnostic device involving human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The ground truth concept is generally for diagnostic or prognostic devices, where a reference standard is needed for comparison. This submission relies on substantial equivalence and material/design comparisons to predicate devices.
The sample size for the training set: Not applicable / Not specified. This document does not describe a training set as it's not a machine learning or AI-based device.
How the ground truth for the training set was established: Not applicable / Not specified.

Summary

{0}------------------------------------------------

K991955

Engineered Medical Systems ISO 9001 Certified 2055 EXECUTIVE DRIVE • INDIANAPOLIS, IN 46241 • (317) 246-5500 • FAX (317) 246-5501 Non-Confidential Summary of Safety and Effectiveness

	page 1 of 3
	May 28, 1999
Engineered Medical Systems, Inc.2055 Executive Dr.	Tel - (317) 246-5500
Indianapolis, IN 46241	Fax - (317) 246-5501
Official Contact:	Bonnie Holly - Quality Manager
Proprietary or Trade Name:	EMS Disposable Manual Resuscitator with CO₂ Detection
Common/Usual Name:	Disposable Manual Resuscitator with CO₂ Detection
Classification Name:	Emergency Manual Ventilator Resuscitator
Device:	EMS Disposable Manual Resuscitator with CO₂ Detection
Predicate Devices:	EMS Disposable Manual Resuscitator with CO₂ Detection -
	K912203B and K924610A
	Nellcor Puritan Bennett - DMR2 Plus Manual Resuscitator with CO₂
	Detection - K973419
	Nellcor Puritan Bennett - EasyCap CO₂ Detector - K894053 and
	K944400

Device Description | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 12 - 102

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 - - Real 11 - 30

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

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

{1}------------------------------------------------

Non-Confidential Summary of Safety and Effectiveness

page 2 of 3

May 28, 1999

Comparison to Predicate Devices: 11 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -

Attribute	EMS DMRwith CO₂(Modification)	EMS DMRK912203BK924610A	NPB DMRPlus withCO₂K973419
Use
Intended to provide manualventilatory support	Yes	Yes	Yes
Intended to assist in verification oftube placement by expired CO₂ detection	Yes	--	Yes
Used in hospitals, home, transportmobile settings	Yes	Yes	Yes
Single Patient Use	Yes	Yes	Yes
Design
CO₂ detector placed on expiratoryport of manual resuscitator	Yes	--	Yes
CO₂ detection by color comparison	Yes	--	Yes
CO₂ detector good for up to 2 hours	Yes	--	Yes
Can be replaced if needed	Yes	--	Yes
Materials
Materials in CO₂ detection media theexactly the same as predicate	Yes	--	Yes
All other materials exactly thesame as predicate	Yes	Yes	--
Packaging
Provided clean, non-sterile	Yes	Yes	Yes

Performance Standards / Specifications
----------------------------------------

None applicable under Section 514	Yes	Yes	Yes
-----------------------------------	-----	-----	-----

{2}------------------------------------------------

Non-Confidential Summary of Safety and Effectiveness

page 3 of 3 May 28, 1999

Differences Between Other Legally Marketed Predicate Devices - Predicate Device College Co

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.

{3}------------------------------------------------

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 a stylized eagle with three horizontal lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 6 1999

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

Re: K991955 Disposable Manual Resuscitator with CO2 Detection Requlatory Class: II (two) Product Code: 73 BTM Dated: May 28, 1999 Received: June 1, 1999

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 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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.

{4}------------------------------------------------

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. Callahon

Thomas J. Vallahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

INDICATIONS 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)

Arle A. Ciarkowski.

Respiratory.

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).