The DMR2 Plus™ Disposable Manual Resuscitator with integrated CO2 detection is a portable, nonsterile, single-patient use device intended for use on patients requiring manual ventilatory support. During artificial ventilation, the resuscitator can be operated from ambient air or provide oxygen-enriched air using the oxygen accumulator and connecting the supply tubing to a metered oxygen source. The integrated CO2 detector can be used to assist the verification of tube placement during endotracheal or nasotracheal intubation. The integrated CO2 detector detects approximate ranges of CO2 by color comparison.

The DMR2 Plus™ is available in three sizes and is for use on the following patient populations:

Adult is indicated for use on adults >40 kg. .
Child is indicated for use on children 10 40 kg. .
· Infant is indicated for use on infants 5 10 kg

The DMR2 Plus™ Disposable Manual Resuscitator with integrated CO2 detection is intended for use by qualified healthcare professionals in any environment where pulmonary support resuscitation is indicated such as hospital, transport, mobile and home.

Device Description

The DMR2 Plus™ Disposable Manual Resuscitator with integrated CO2 detection is a portable, nonsterile, single-patient use device intended for use on patients requiring manual ventilatory support.

The DMR2 Plus™ is available in three sizes: adult, child and infant. It may be used by qualified healthcare professionals in any environment where pulmonary support resuscitation is indicated; such as, hospital, transport, mobile and home.

The DMR2 Plus™ consists of a compressible resuscitator bag that is available in either processed natural rubber or PVC. The swivel, patient connection and CO2 detector cartridge are connected to the nonrebreathing Valve (NRV) housing - all housings are K-resin. The oxygen accumulator assembly enables the use of three different styles of oxygen accumulators: large bore, small bore or flat bag.

During artificial ventilation, the resuscitator can be operated from ambient air or provide oxygen-enriched air using the oxygen accumulator and connecting the supply tubing to a metered oxygen source. The integrated CO2 detector can be used to assist the verification of tube placement during endotracheal or nasotracheal intubation. The integrated CO2 detector detects approximate ranges of CO2 by color comparison.

AI/ML Overview

The provided text does not contain specific acceptance criteria with numerical targets or detailed results of a study designed to prove the device meets those criteria. Instead, it states that "The safety and effectiveness of the DMR2 Plus™ has been demonstrated by design and testing." It then lists the standards and guidance followed for this testing.

Therefore, the requested information cannot be fully extracted as there is no table of acceptance criteria with reported device performance, information on sample sizes for test or training sets, ground truth establishment, expert involvement, or comparative effectiveness studies.

Based on the provided text, here is what can be inferred and stated:

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

The document does not provide a table with specific acceptance criteria (e.g., minimum flow rates, CO2 detection thresholds, etc.) or quantitative reported device performance data. It broadly states that the device was tested to relevant standards, implying it met the general requirements of those standards.

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

This information is not provided in the document.

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 information is not provided in the document. The CO2 detection relies on "color comparison," which typically implies a visual assessment by a healthcare professional rather than a complex ground truth establishment process involving multiple experts.

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

This information is not provided in the 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

No such study is mentioned or implied. The device is a manual resuscitator with an integrated CO2 detector, which is a physical device providing a direct visual indication (color change) rather than an AI-assisted diagnostic tool for human readers.

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

This is not applicable as the device is a manual resuscitator with a simple integrated CO2 detector (color comparison), not an algorithm or AI system. Its function is to provide a visual cue for human interpretation.

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

For the CO2 detection aspect, the "ground truth" would likely be based on actual CO2 levels as measured by a gold-standard CO2 analyzer, or verification of endotracheal tube placement by other clinical methods (e.g., direct visualization). However, the document only states that the detector "detects approximate ranges of CO2 by color comparison," indicating a visual, qualitative assessment. The safety and effectiveness demonstrations relied on adherence to international standards for resuscitators (ISO 8382, ISO 5356-1, ASTM F 920-93) and environmental testing. These standards define performance requirements and test methods for the physical and functional aspects of the device, rather than requiring a complex "ground truth" as might be seen for diagnostic imaging.

8. The sample size for the training set

This information is not provided in the document and is not applicable given the nature of the device (not an AI/learning algorithm).

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

This information is not provided in the document and is not applicable given the nature of the device.

Summary

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K973419

Nellcor Puritan Bennett DMR 2 Plus ™ Disposable Manual Resuscitator
with integrated CO2 detection
510(k) Summary
December 18, 1997
Page 1 of 3	MAR 25 1998

1. Company Information

Establishment:

Nellcor Puritan Bennett Inc. 4280 Hacienda Drive Pleasanton, CA 94588 (510) 463-4177

DMR2 Plus™ Disposable Manual

Resuscitator with integrated CO2

Disposable Manual Resuscitator

with integrated CO2 detection

Shervil A. Mathews Official Correspondent: Regulatory Affairs Assistant

2. Device Name

Proprietary:

Common/Usual:

Classification:

73BTM

detection

3. Equivalent Device

1. CAPNO-FLO™ End-Tidal CO2 Detector/Monitor Kirk Specialty Systems - K933626
1. Nellcor Puritan Bennett DMR/CO2 Combo Kit K960468

Device Description 4.

The DMR2 Plus™ Disposable Manual Resuscitator with integrated CO2 detection is a portable, nonsterile, single-patient use device intended for use on patients requiring manual ventilatory support.

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Nellcor Puritan Bennett DMR2 Plus™ Disposable Manual Resuscitator with integrated CO2 detection 510(k) Summary December 18, 1997 Page 2 of 3

5. Intended Use

The DMR2 Plus™ is available in three sizes and are intended for use on the following patient populations:

· Adult is indicated for use on adults >40 kg.
· Child is indicated for use on children 10 40 kg.
· Infant is indicated for use on infants 5 10 kg

The DMR2 Plus™ is intended for use by qualified healthcare professionals in any environment where pulmonary support resuscitation is indicated such as hospital, transport, mobile and home.

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Nellcor Puritan Bennett DMR2 Plus™ Disposable Manual Resuscitator with integrated CO2 detection 510(k) Summary December 18, 1997 Page 3 of 3

6. Technological Characteristics

The method of operation and the CO2 detector technology of the DMR2 Plus™ are equivalent to the CAPNO-FLO and the Nellcor Puritan Bennett DMR/CO2 Combo Kit. A comparison of the devices' design features, methods of operation and labeling support technical equivalency.

The safety and effectiveness of the DMR2 Plus™ has been demonstrated by design and testing. Testing was conducted in accordance with the requirements of ISO 8382: Resuscitators Intended for Use With Humans; ISO 5356-1: Anaesthetic and respiratory equipment - Conical connectors; and ASTM F 920-93: Standard Specification for Minimum Performance and Safety Requirements for Resuscitators Intended for Use With Humans.

In addition, environmental testing was conducted as recommended by applicable sections of the Draft Reviewer's Guidance for Premarket Notification Submissions, November 1993.

Test results demonstrate and/or labeling indicates how all applicable requirements have been addressed.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a bird or eagle, with three curved lines forming the body and wings.

MAR 25 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Sherry Mathews Nellcor Puritan Bennett Inc. 4280 Hacienda Drive Pleasanton, CA 94588-2719

Re: K973419 DMR2 Plus Disposable Manual Resuscitator Regulatory Class: II (two) Product Code: 73 BTM January 7, 1998 Dated: Received: January 9, 1998

Dear Ms. Mathews:

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 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. Sherry Mathews

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 regulation (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/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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Page _________________________________________________________________________________________________________________________________________________________________________ of

510(k) Number (if known):

Unknown Ka73419

Device Name: DMR2 Plus™ Disposable Manual Resuscitator with integrated CO2 detection

Indications For Use:

The DMR2 Plus™ is available in three sizes and is for use on the following patient populations:

Adult is indicated for use on adults >40 kg. .
Child is indicated for use on children 10 40 kg. .
· Infant is indicated for use on infants 5 10 kg

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

3/24/98 C. Avery for Superstar, Branch, teling Chief

Prescription Use
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number.

Over-The-Counter Use __

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 1-2-96)

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).