(173 days)
Not Found
No
The summary describes a standard anesthesia system with monitoring capabilities and does not mention any AI or ML features. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is an anesthesia system used for delivering anesthetic vapor and performing ventilation, which are therapeutic interventions.
Yes
The device monitors several physiological parameters such as oxygen concentration, breathing pressure, respiratory volume, cardiovascular parameters, and anesthetic agent concentration, which are used to assess a patient's condition during anesthesia. This monitoring function serves a diagnostic purpose, even if the primary function is anesthesia delivery.
No
The device description clearly states it is a "continuous flow gas anesthesia system with cardiovascular monitoring," indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The primary function described is a "continuous flow anesthesia system" used for delivering gases, anesthetic vapor, and monitoring various physiological parameters within the patient's body (oxygen concentration, breathing pressure, respiratory volume, cardiovascular parameters).
- Device Description: It's described as a "continuous flow gas anesthesia system with cardiovascular monitoring."
- Lack of IVD Characteristics: There is no mention of analyzing samples outside the body (like blood, urine, tissue, etc.) to diagnose diseases or conditions. IVDs are specifically designed for in vitro examination of specimens.
The monitoring functions described are related to the patient's physiological state during anesthesia, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The Narkomed 6400 w/ Integrated Patient Monitoring (NM6400 w/ IPM) may be used for spontaneous, manually assisted, or automatic ventilation of patients during anesthesia, and delivery of gases and anesthetic vapor. The NM6400 w/ IPM can monitor oxygen, breathing pressure, respiratory volume, CO2, N2O, cardiovascular parameters and anesthetic agent identification and concentration and provide portioned data.
The NM6400 w/IPM is indicated as a continuous flow anesthesia system. The NM6400 w/IPM 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.
Product codes
BSZ
Device Description
The Narkomed 6400 w/ Integrated Patient Monitoring is a continuous flow gas anesthessa system with cardiovascular monitoring.
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 NM6400 w/ IPM included a hazard ana!ysis and system level qualification 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
§ 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
APR 2 6 2004
Image /page/0/Picture/1 description: The image shows the number K033498 written in black ink. The numbers are written in a slightly slanted manner, with the top of the numbers leaning to the right. The numbers are written in a simple, sans-serif font.
Summary of Safety and Effectiveness Data Relating to Substantial Equivalence
Proprietary Name:Narkomed 6400 w/ Integrated Patient Monitoring
Classification Name:Gas-Machine, Anesthesia 73BSZ
Device Class:Class II
Manufacturer:Draeger Medical Inc. 3135 Quarry Road Telford, Pennsylvania 18969
Establishment Registration Number:2517967
Devices to which substantial equivalence is claimed: Narkomed 6000 w/ Cardiovascular and Strip Chart Recorder Pods K993826 Marquette SL Series Transport Remote Acquisition (TRAM) K921669 Solar 7000/8000 System K993757
Device Description:
The Narkomed 6400 w/ Integrated Patient Monitoring is a continuous flow gas anesthessa system with cardiovascular monitoring.
Intended Use:
The Narkomed 6400 w/ Integrated Patient Monitoring (NM6400 w/ IPM) may be used for spontaneous, manually assisted, or automatic ventilation of patients during anesthesia, and delivery of gases and anesthetic vapor. The NM6400 w/ IPM can monitor oxygen, breathing pressure, respiratory volume, CO2, N2O, cardiovascular parameters and anesthetic agent identification and concentration and provide portioned data.
Substantial Equivalence:
The base functionality of the product line remains essentially the same. Like the NM6000 w/ CV Pod, the NM6400 w/ IPM uses the TRAM technology for cardiovascular monitoring capabilities. The NM6400 w/ IPM differs in that it also uses TRAM technology to provide Wedge Pressure information.
The NM6400 w/ IPM also provides the ability to do cardiac trial calculations. Several messages for user clarification were added, along with an alarm indicating the presence of two agents.
Qualification of the NM6400 w/ IPM included a hazard ana!ysis and system level qualification testing.
1
Image /page/1/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" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure, representing health and human services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 6 2004
Mr. Gale Winarsky Regulatory Affairs Project Manager Draeger Medical, Incorporated 3135 Quarry Road Telford, Pennsylvania 18969
Re: K033498
Trade/Device Name: Narkomed 6400 Anesthesia Workstation w/IPM Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: II Product Code: BSZ Dated: February 23, 2004 Received: February 24, 2004
Dear Mr. Winarsky:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed prodicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Mr. Winarsky
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), "You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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 vours.
CluR
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K033498
Device Name:
Indications for Use:
The NM6400 w/IPM is indicated as a continuous flow anesthesia system. The NM6400 w/IPM 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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
Page 1_of 1
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number