(132 days)
Not Found
No
The summary describes a traditional anesthesia workstation with monitoring capabilities and mentions no AI/ML-specific features or performance metrics.
Yes
The device is an anesthesia system, which delivers anesthetic vapor and performs ventilation, both of which are therapeutic interventions.
No
The device is an anesthesia system, explicitly indicated for continuous flow anesthesia, ventilation, and delivery of gases and anesthetic vapor. While it monitors various parameters like oxygen concentration, breathing pressure, and cardiovascular parameters, its primary function is therapeutic (anesthesia and ventilation delivery) rather than solely providing information for diagnosis.
No
The device description explicitly states it is an "Anesthesia Workstation" and mentions "Cardiovascular and Strip Chart Recorder Pods," indicating it is a hardware system with integrated software, not a standalone software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "continuous flow anesthesia system" used for delivering gases, anesthetic vapor, ventilation, and monitoring various physiological parameters within the patient (oxygen concentration, breathing pressure, respiratory volume, cardiovascular parameters, anesthetic agent identification and concentration).
- Device Description: The description reinforces its function as an "Anesthesia Workstation" with added monitoring capabilities.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens from the human body (like blood, urine, tissue) to provide information about a physiological state, health, or disease. This device does not perform such analysis on specimens.
The device is a life support and monitoring system used directly on a patient during anesthesia, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
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.
Product codes
73BSZ, 74 MLC
Device Description
The NM6000 Anesthesia Workstation has been modified to include optional Cardiovascular and Strip Chart Recorder Pods.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Qualification of the NM6000 w/ CV & SCR included hazard analysis, functional, communication, environmental, and electromagnetic compatibility testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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.
2
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:
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.
(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)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
Division Sign-Off
Division of Cardiovascular, Respiratory, ind Neurological Devi 510(k) Number 3826