The Narkomed M (NM M) is a continuos flow anesthesia system. The NM M may be used for spontaneous, manually assisted or automatic ventilation of patients during anesthesia. It may be used for the delivery of oxygen, air, and/or nitrous oxide and anesthetic vapor. It is capable of monitoring oxygen concentration, breathing pressure, and respiratory volume. Federal law restricts this device to sale by or on the order of a physician.

Device Description

The NM M is a continuous flow gas anesthesia system.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Narkomed M Anesthesia System, based on the provided text:

Acceptance Criteria and Device Performance (Implicit from Substantial Equivalence Claim):

The document doesn't explicitly list numerical acceptance criteria. Instead, it asserts substantial equivalence to a predicate device, the Narkomed GS (NMGS). Therefore, the "acceptance criteria" are implicitly met by demonstrating that the Narkomed M performs comparably to the Narkomed GS for its intended use, despite minor differences.

Acceptance Criteria (Implied)	Reported Device Performance
Safety: Device must perform safely.	Hazard analysis performed. System qualified.
Effectiveness: Device must operate effectively for intended use.	System-level qualification testing performed.
Environmental Suitability: Device must withstand environmental conditions.	Environmental testing performed.
Electromagnetic Compatibility: Device must not interfere with or be affected by EM fields.	Electromagnetic compatibility testing performed.
Functional Equivalence to Predicate: Device must have same intended use and principle of operation as Narkomed GS.	"The NM M and the NM GS have the same intended use and principal of operation and are substantially equivalent."
Integrated Monitoring: Oxygen concentration, breathing pressure, respiratory volume monitoring.	"The NM M like the NM GS is an anesthesia system with integrated monitors for oxygen concentration, breathing pressure and respiratory volume."
Gas Delivery System, Ventilator, Software, Alarms Management: Same design as predicate.	"The gas delivery system, ventilator, software, and alarms management of the NM M are the same design that is used on the NM GS."
Vitalink® serial communication port capability.	"The NM M like the NM GS is available with a Vitalink® serial communication port."

Study Information:

Sample size used for the test set and the data provenance:
- The document describes a device qualification process, rather than a clinical study with human subjects or a defined "test set" in the context of AI/machine learning.
- The testing involved a hazard analysis, system-level qualification testing, environmental testing, and electromagnetic compatibility testing. The sample size for these engineering tests would typically refer to the number of devices tested or the number of specific test conditions applied. This detail is not provided in the summary.
- Data provenance: Not applicable in the sense of clinical patient data. The "data" comes from engineering and functional tests conducted presumably by the manufacturer.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a device qualification for an anesthesia system, not a diagnostic device requiring expert interpretation of results for ground truth. Ground truth for these tests would be defined by engineering specifications and standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically used in clinical studies or AI validation where inter-rater variability needs to be resolved to establish ground truth.
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 MRMC study was done. This document is for an anesthesia system, specifically a 510(k) submission claiming substantial equivalence to a predicate device, not an AI-enabled diagnostic tool requiring an MRMC study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-only device. It's a medical device with integrated monitoring and control functionalities, where the performance is inherently tied to its physical and software components.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the device's performance is based on engineering specifications, established medical device standards, and the performance characteristics of the predicate device (Narkomed GS). For example, during environmental testing, the ground truth would be that the device functions within specified parameters after exposure to certain conditions.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that relies on a "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned or implied.

Summary

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R11425

SEP | 0 1997

Summary of Safety and Effectiveness Data Relating to Substantial Equivalence

Narkomed M Anesthesia System Proprietary Name:

Classification Name: Gas-Machine, Anesthesia 73BSZ

Class II Device Class:

North American Dräger Manufacturer: 3135 Quarry Road Telford, Pennsylvania 18969

Establishment Registration Number: 2517967

Devices to which substantial equivalence is claimed:

K963994 Narkomed GS Anesthesia System

Device Description:

The NM M is a continuous flow gas anesthesia system.

Intended Use:

The NM M may be used for spontaneous, manually assisted, or automatic ventilation of patients during anesthesia. It may be used for the delivery of gases and anesthetic vapor. The NM M is capable of monitoring oxygen concentration, breathing pressure, and respiratory volume.

Substantial Equivalence:

The NM M is substantially equivalent to the Narkomed GS (NMGS).

The NM M, like the NM GS is an anesthesia system with integrated monitors for oxygen concentration, breathing pressure and respiratory volume. The gas delivery system, ventilator, software, and alarms management of the NM M are the same design that is used on the NM GS. The NM M like the NM GS is available with a Vitalink® serial communication port.

The NM M differs slightly from the NM GS in that; the NM M allows for switching the ventilator drive gas from oxygen to air, the absorber is a single canister absorber, only one Dräger-Vapor® 2000 vaporizer can be mounted on the machine at a time, the manual/automatic selector is activated by turning a knob on the NM M and by moving a lever on the NM GS. The NM M does not provide the option of turning the ventilator on via the

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manual/automatic selector valve. The NM M uses the same flat panel display as the NM GS mounted outside of the front panel of the machine. The NM M utilizes the same PEEP valve as the NM GS, but does not include PEEP bypass, which is included on the NM GS. The NM M utilizes dual tapered flowmeters with a range of flows from 0-8 1/min., the NM GS utilizes dual flowmeters (course and fine) with a range of 0-10 Vmin. The NM M has no storage drawers or electrical convenience outlets.

The NM M and the NM GS have the same intended use and principal of operation and are substantially equivalent.

Qualification of the NM M included a hazard analysis, system level qualification testing, environmental testing, and electromagnetic compatibility testing.

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Image /page/2/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 three stripes forming its wing and tail feathers. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

SEP 1 0 1997

Mr. James J. Brennan North American Drager 3135 Quarry Road Telford, Pennsylvania 28969

Re: K971425 Narkomed M Anesthesia System Requlatory Class: II (two) Product Code: 73 BSZ Dated: July 31, 1997 Received: July 31, 1997

Dear Mr. Brennan:

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 - Mr. James J. Brennan

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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DUPLICAT

K971425/A'

Page _ 1 _ of _ l

K971425 510(k) Number (if known):

Device Name: Narkomed M Anesthesia System (NM M)

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

A. A. Cirls

Prescription Device

9/8/97 bazant

Regulation Number and Section

§ 868.5160 Gas machine for anesthesia or analgesia.

(a)
Gas machine for anesthesia —(1)Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).(2)
Classification. Class II (performance standards).