(166 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and performance studies do not indicate the use of such technologies.
No
The device is described as a continuous flow gas anesthesia system, and its intended use includes ventilation and delivery of gases and anesthetic vapor, which are supportive functions during medical procedures, not direct therapeutic interventions for a disease or condition. While essential for patient care, it facilitates a procedure rather than directly treating a medical condition itself.
No
Explanation: The device is described as a continuous flow gas anesthesia system used for ventilation and delivery of gases and anesthetic vapor, and can monitor oxygen concentration, breathing pressure, and respiratory volume. While it monitors physiological parameters, its primary function is supporting ventilation and delivering anesthesia, not diagnosing a medical condition.
No
The device description and performance studies clearly indicate the NMGS is a hardware system (continuous flow gas anesthesia system) with associated 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 describes a system for ventilation, gas delivery, and monitoring of physiological parameters (oxygen concentration, breathing pressure, respiratory volume). This is related to supporting a patient's breathing and delivering anesthetic, which are direct patient care activities.
- Device Description: The description confirms it's a "continuous flow gas anesthesia system." This aligns with the intended use of supporting breathing and delivering anesthesia.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. IVDs are specifically designed for these purposes.
Therefore, the NMGS is a medical device used for patient support and anesthesia delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NMGS may be used for spontaneous, manually assisted, or automatic ventilation, and delivery of gases and anesthetic vapor. The NMGS can monitor oxygen concentration, breathing pressure, and respiratory volume.
Product codes
73BSZ
Device Description
The NMGS is a continuous flow gas anesthesia system.
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
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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 NMGS included hazard analysis, software verification, and 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.
Narkomed 2C Anesthesia System K930351/A, Narkomed AV2+ Anesthesia Ventilator K953228
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.
Not Found
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).
Not Found
§ 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).
0
MAR 1 9 1997
Summary of Safety and Effectiveness Data Relating to Substantial Equivalence
Narkomed GS Anesthesia System Proprietary Name: Gas-Machine, Anesthesia 73BSZ Classification Name:
Device Class: Class II
North American Dräger Manufacturer: 3135 Quarry Road Telford, Pennsylvania 18969
Establishment Registration Number: 2517967
Devices to which substantial equivalence is claimed: Narkomed 2C Anesthesia System K930351/A Narkomed AV2+ Anesthesia Ventilator K953228
Device Description:
The NMGS is a continuous flow gas anesthesia system.
Intended Use:
The NMGS may be used for spontaneous, manually assisted, or automatic ventilation, and delivery of gases and anesthetic vapor. The NMGS can monitor oxygen concentration, breathing pressure, and respiratory volume.
Substantial Equivalence:
The NMGS is substantially equivalent to the Narkomed 2C (NM2C) and the AV2+ Anesthesia Ventilator (AV2+).
The NMGS, like the NM2C is an anesthesia system with integrated monitors for oxygen concentration, breathing pressure and respiratory volume. The gas delivery system, absorber and scavenger of the NMGS are the same design that is used on the NM2C. The NMGS uses the AV2+ anesthesia ventilator. The AV2+ is marketed as an integral subassembly of North American Dräger anesthesia systems, including the NM2C.
The NMGS like the NM2C is available with a serial interface for communication via the Vitalink serial link protocol to devices such as NAD's Vitalert 2000 and 3000 monitors.
1
The NMGS differs from the NM2C by offering an optional two vaporizer configuration of the system as well as the three vaporizer configuration.
The NMGS and the NM2C have the same intended use and principal of operation and are substantially equivalent.
Qualification of the NMGS included hazard analysis, software verification, and qualification testing, environmental testing, and electromagnetic compatibility testing.
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