The NM6000 w/ CV & SCR in indicated as a continuous flow anesthesia system. The NM6000 w/ CV & SCR may be used for manually assisted, or automatic ventilation, and delivery of gases, anesthetic vapor, and monitoring of; oxygen concentration, breathing pressure, respiratory volume, cardiovascular parameters, anesthetic agent identification and concentration and provides printed data. Federal law restricts this device to sale by or on the order of a physician.

Device Description

The NM6000 Anesthesia Workstation has been modified to include optional Cardiovascular and Strip Chart Recorder Pods.

AI/ML Overview

This document does not contain information about acceptance criteria or specific studies proving device performance in the manner requested (e.g., performance metrics, sample sizes, expert ground truth, statistical methods).

The provided text, identified as a "Summary of Safety and Effectiveness Data Relating to Substantial Equivalence" for the Narkomed 6000 Anesthesia System, focuses on demonstrating substantial equivalence to previously marketed predicate devices, rather than presenting a performance study with detailed acceptance criteria and results.

Here's what the document does say regarding testing and comparison:

Device Description: The NM6000 Anesthesia Workstation has been modified to include optional Cardiovascular (CV) and Strip Chart Recorder (SCR) Pods.
Intended Use: Details the medical applications for the NM6000 with CV & SCR.
Substantial Equivalence Claim: The document asserts that the "base functionality of the NM6000 product line remains essentially the same."
Comparison to Predicate Devices:
- CV Pod: Uses a combination of Draeger Medical Inc. electronics and TRAM technology, both designed to monitor basic cardiovascular physiological parameters (ECG, temperature, invasive/non-invasive BP, cardiac output, pulse oximetry, ST segment analysis, synchronized cardioversion). It notes that the NM6000 CV pod differs from TRAM in that respiration, arrhythmia detection, and associated alarms will not be functional in the NM6000 CV pod.
- SCR Pod: Similar to the one in the Narkomed 4 Anesthesia System, differing only in communication type (standard parallel to parallel vs. serial to parallel).
Qualification Activities: "Qualification of the NM6000 w/ CV & SCR included hazard analysis, functional, communication, environmental, and electromagnetic compatibility testing."

This type of submission (a 510(k) premarket notification) for a Class II device like this typically relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through engineering analysis, functional testing, and demonstrating that any differences do not raise new questions of safety or effectiveness. It usually does not involve a clinical performance study with human readers or specific statistical acceptance criteria for diagnostic accuracy as might be found for an algorithm-based diagnostic device.

Therefore, I cannot fill out the requested table or provide information for most of the points because the provided text describes a regulatory submission for substantial equivalence, not a performance study as you've outlined.

To directly answer your numbered points based on the provided text:

A table of acceptance criteria and the reported device performance: Not provided. The document states "Qualification of the NM6000 w/ CV & SCR included hazard analysis, functional, communication, environmental, and electromagnetic compatibility testing," implying these were generally met, but no specific criteria or performance metrics are detailed.
Sample sized used for the test set and the data provenance: Not applicable/not provided. This was a qualification of a medical device, not a data-driven performance study on a test set of patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided.
Adjudication method for the test set: Not applicable/not provided.
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 is not an AI/algorithm-based diagnostic device or an MRMC study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used: Not applicable. The "ground truth" for this device's qualification would be adherence to engineering specifications, safety standards, and functional requirements, rather than a clinical ground truth from patient data.
The sample size for the training set: Not applicable. This is not an AI/machine learning device that uses a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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K93876

Summary of Safety and Effectiveness Data Relating to Substantial Equivalence

Narkomed 6000 Anesthesia System Proprietary Name: Gas-Machine, Anesthesia 73BSZ Classification Name: Class II Device Class: Draeger Medical Inc. Manufacturer: 3135 Ouarry Road Telford, Pennsylvania 18969

Establishment Registration Number: 2517967

Devices to which substantial equivalence is claimed:

Narkomed 6000 Anesthesia Workstation K980553 Marquette SL Series Transport Remote Acquisistion K921669 Narkomed 4 Anesthesia System K901713

Device Description:

The NM6000 Anesthesia Workstation has been modified to include optional Cardiovascular and Strip Chart Recorder Pods.

Intended Use:

The NM6000 with optional Cardiovascular and Strip Chart Recorder Pods (NM6000 w/ CV & SCR) may be used for spontaneous, manually assisted, or automatic ventilation of patients during anesthesia, and delivery of gases and anesthetic vapor. The NM6000 w/ CV & SCR can monitor oxygen, breathing pressure, respiratory volume, CO2, N20, cardiovasuclar parameters and anesthetic agent identification and concentration, and provide printed data.

Substantial Equivalence:

The base functionality of the NM6000 product line remains essentially the same.

The NM6000 CV pod uses a combination of Draeger Medical Inc. electronics and TRAM technology for the cardiovascular monitoring parameters. Both products are designed to monitor a patient's basic cardiovascular physiological parameters and offer the following functions:

Multiple ECG lead monitoring, Dual temperature channels.

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Invasive blood pressure channels, A noninvasive blood pressure channel, Thermodilution cardiac output, Pulse oximetry. ST segment analysis, Synchronized cardioversion

Like the TRAM, the CV pod provides and receives information through an interface to a host.

The NM6000 CV pod differs from the TRAM technology in that respiration, arrhythmia detection and associated alarms, will not be functional in NM6000 CV pod.

The NM6000 SCR pod uses a SCR similar to the one currently marketed in the Narkomed 4 Anesthesia System. They differ only in that the NM6000 SCR uses the standard parallel to parallel communication, where the NM4 SCR is modified to allow serial to parallel communication.

Qualification of the NM6000 w/ CV & SCR included hazard analysis, functional, communication, environmental, 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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings outstretched.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 2000

Mr. Gale E. Winarsky Dräger Medical, Inc. 3135 Quarry Road Telford, PA 18969

Re : K993826 Narkomed 6000 Regulatory Class: II (two) Product Code: 73 BSZ, 74 MLC Dated: March 1, 2000 Received: March 2, 2000

Dear Mr. Winarsky:

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 leqally 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 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 In addition, FDA may publish further announcements requlatory action. 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. Gale E. Winarsky

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/dsma/dsmamain.html".

Sincerely yours,

Jean A. Wetmore for.

James E. Dillard III Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K993826 510(k) Number (if known):

Device Name: Narkomed 6000 Anesthesia Workstation w/ Optional Cardiovascular and Strip Chart Recorder Pods (NM6000 w/ CV & SCR)

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

Over-The-Counter Use_

(Optional Format 1-2-96)

Division Sign-Off

Division of Cardiovascular, Respiratory, ind Neurological Devi 510(k) Number 3826

Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).