(146 days)
K963994 Narkomed GS Anesthesia System
Not Found
No
The summary describes a traditional anesthesia system with monitoring capabilities, and explicitly states that AI, DNN, or ML are not mentioned.
No.
The device is an anesthesia system used for delivering gases and monitoring during surgery, not for treating a disease or condition.
No
The device is an anesthesia delivery system, which is a therapeutic and monitoring device, not a diagnostic device.
No
The device description clearly states it is a "continuous flow gas anesthesia system," which is a hardware device. The performance studies also mention system-level qualification testing and environmental testing, further indicating a hardware component.
Based on the provided information, the Narkomed M (NM M) is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a system for delivering anesthetic gases and monitoring physiological parameters during anesthesia. This is a device used directly on a patient for a medical procedure, not for testing samples in vitro (outside the body).
- Device Description: The description confirms it's a "continuous flow gas anesthesia system," which aligns with its use in patient care.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other typical components of an IVD device.
Therefore, the Narkomed M is a medical device used for anesthesia delivery and monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
73BSZ
Device Description
The NM M is a continuous flow gas anesthesia system.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Qualification of the NM M included a hazard analysis, system level qualification testing, environmental testing, and electromagnetic compatibility testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K963994 Narkomed GS Anesthesia System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
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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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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:
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.
(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