(63 days)
No
The document describes a standard anesthesia system with monitoring capabilities and does not mention any AI or ML features.
No.
The device is an anesthesia system used to deliver gases and anesthetic vapor, and monitor vital signs during anesthesia, but it does not directly treat or cure a disease or condition.
No
The device is described as an "anesthesia system" that delivers anesthetic vapor and provides ventilation. While it monitors various physiological parameters (oxygen, CO2, breathing pressure, etc.), this monitoring is for the purpose of controlling the anesthesia and ventilation delivery, not for diagnosing a patient's medical condition. It's a therapeutic and life-support device, not a diagnostic one.
No
The device description clearly states it is a "continuous flow gas anesthesia system" that "delivers anesthetic vapor" and provides "automatic and manual modes of ventilation," indicating it is a hardware-based system with integrated software for control and monitoring.
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 physiological parameters like oxygen, CO2, pressure, volume, and anesthetic agent. This is a system used on a patient during a medical procedure, not for testing samples from a patient in a lab.
- Device Description: The description reinforces its function as a system for delivering anesthetic vapor, providing ventilation, and monitoring gases and agents during anesthesia.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Primus US does not fit this description.
N/A
Intended Use / Indications for Use
The Primus US is indicated as a continuous flow anesthesia system. The Primus US may be used for manually assisted, or automatic ventilation, and delivery of gases, anesthetic vapor, and monitoring of; oxygen and CO2 concentration, breathing pressure, respiratory volume, and anesthetic agent identification and concentration. Federal law restricts this device to sale by or on the order of a physician.
Product codes
73 BSZ
Device Description
The Primus US, is a continuous flow gas anesthesia system that delivers anesthetic vapor, provides for automatic and manual modes of ventilation, and is equipped with a monitoring system for ventilation, inspired and expired gas, and agent identification.
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
Operating, induction and recovery rooms
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
Qualification of Primus US included a risk analysis, system level qualification, and verification/validation testing.
Key Metrics
Not Found
Predicate Device(s)
K041622, K983635, K033498, K980208, K040847
Reference Device(s)
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
NOV 26 2004
Image /page/0/Picture/1 description: The image shows the logo for Dräger Medical. The word "Dräger" is in a bold, sans-serif font, with an umlaut over the "a". The word "medical" is in a thinner, sans-serif font. The logo is black on a white background.
A Drager and Siemens Company
Summary of Safety and Effectiveness Data Relating to Substantial Equivalence
| Proprietary Name: | Primus US |
|---|---|
| Common Name: | Gas Machine-Anesthesia |
| Classification Name: | Gas Machine -Anesthesia |
| Product Codes: | 73 BSZ |
| Device Class: | Class II |
| Manufacturer: | Draeger Medical AG & Co KGaA |
| 53/55 Moislinger Allee | |
| Luebeck, Germany | |
| Establishment Registration Number: 9611500 | |
| Devices to which substantial equivalence is claimed: | |
| Fabius GS Anesthesia Workstation (Fabius GS) | K041622 |
| Julian Anesthesia Workstation (Julian) | K983635 |
| Narkomed 6400 w/IPM Anesthesia Workstation (NM6400) | K033498 |
| Divan Ventilator | K980208 |
| Vamos w/ Return Sample Gas (Vamos w/ RGS) | K040847 |
Device Description:
The Primus US, is a continuous flow gas anesthesia system that delivers anesthetic vapor, provides for automatic and manual modes of ventilation, and is equipped with a monitoring system for ventilation, inspired and expired gas, and agent identification.
Indications for Use:
The Primus Us is indicated as a continuous flow anesthesia system. The Primus US may be used for manually assisted, or automatic ventilation, and delivery of gases, anesthetic
1
vapor, and monitoring of; oxygen and CO2 concentration, breathing pressure, respiratory volume, and anesthetic agent identification and concentration. Federal law restricts this device to sale by or on the order of a physician.
Intended Use:
The Primus Us is an inhalation anesthesia machine for use in operating, induction and recovery rooms. It can be used with rebreathing systems, semi closed to virtually closed systems with low flow and minimal flow techniques, and non-rebreathing systems.
It may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Anesthetic agent can be delivered via vaporizers mounted on the machine.
Substantial Equivalence:
Like the Fabius GS, the Primus US provides integrated electronic monitoring for inspired O2, breathing pressure, respiratory volume. The Primus US also provides integrated patient gas monitoring like the Julian. The Primus US uses the same Gas measurement technology as the Scio patient gas monitor (K031340).
Like the NM6400, Primus US has a color screen display with a combination of a rotary knob, hard keys, and soft keys for the user interface. Information presented on the screen includes machine status, numerics, alarms, graphics, and prompt fields, ventilation, gas measurement and monitoring parameters.
Like the Fabius GS the Primus US has a battery back up system which is automatically enabled in the event of an AC power failure.
Electronic flow sensor technology is used by the Fabius GS and the Primus US for the virtual and total flow meters. Control of the flow meters is via corresponding color coded mechanical flow control knobs. Both devices are available with an auxiliary 02 flow meter and O2 flush valve.
The oxygen ratio controller (ORC) of the Primus US and Fabius GS are identical in the way they control the percentage of O2 to N2O to prevent a hypoxic mixture, and cut off the flow of N2O in case of an O2 supply failure.
Like the Fabius GS, the ventilator of Primus US is an electronically controlled, electrically driven piston ventilator with fresh gas decoupling. The ventilators are volume or pressure controlled preset, time cycled, pressure limited, with electronic timing, pneumatic circuitry, and controls for frequency, inspiratory to expiratory ratio (inspiratory time), inspiratory flow rate, tidal volume and inspiratory pressure limit.
Both have an integrated breathing system consisting of inspiratory and expiratory valves with patient hose connectors, pneumatic connectors, rotary style APL valve, breathing bag, and a standard 1.5 liter absorber, or the Drägersorb CLIC disposable absorber.
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Respiratory volume is derived via thermo anemometry flow sensors in both systems. A difference is that the Primus US uses flow sensors in the inspiratory and expiratory limbs, while the Fabius GS provides a flow sensor only in the expiratory limb. By adding the inspiratory flow sensor, leaks within the system can be measured, the functionality of the inspiratory valve can be monitored, and a better trigger performance for triggered patient ventilation modes is achieved.
Ventilation modes available in both the Primus US and the Fabius GS are: Manual/Spontaneous, Volume-Controlled, Pressure-Controlled, Pressure Support, and Pressure Support with Apnea ventilation. Like the Fabius GS the Primus US ventilator is piston driven.
Like the NM6400 the Primus US also offers synchronized intermittent mandatory ventilation (SIMV). Like the Evita 4, Primus US provides an optional synchronized volume controlled ventilation with pressure support mode, synchronized pressure controlled ventilation, and pressure support.
The ventilation parameters of the Fabius GS and Primus US are user adjustable via keys and an incremental encoder/confirmation knob.
The heated breathing circuit in Primus US and the Divan ventilator used in the NM6400, operate on the same principle to warm the gas in the patient breathing circuit.
Both the Fabius GS and Primus US can deliver up to three gases and one agent at a time, and use pipeline connections and back up gas cylinders for O2, N2O and Air.
The Primus Us is designed to interface with the same Anesthesia Gas Scavenger as the Fabius GS, or the passive scavenger system available for use Julian. An optional suction system is also provided.
Prior to use, the user is prompted to run a preuse checkout procedure. Like the NM6400, the checkout is run automatically by the machine, and prompts the user for interactions as necessary.
Electrical power is supplied to the ventilators via the anesthesia system's power supply.
Like the Fabius GS, Primus US can accommodate up to three vaporizers for use with either the Dräger Vapor® Selectatec ™ interlock systems or the Dräger Auto Exclusion 3 Vaporizer Mount. The Dräger Auto Exclusion 2 Vaporizer Mount may also be used on Primus US.
Qualification of Primus US included a risk analysis, system level qualification, and verification/validation testing.
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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract emblem resembling an eagle or bird with stylized feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 6 2004
Mr. James J. Brennan Director, Regulatory Affairs Draeger Medical, Incorporated 3135 Quarry Road Telford, Pennsylvania 18969
Re: K042607
Trade/Device Name: Primus US Anesthesia Workstation Regulation Number: 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: II Product Code: BSZ Dated: September 23, 2004 Received: September 24, 2004
Dear Mr. Brennan:
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 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) 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 vour 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.
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Page 2 - Mr. Brennan
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 (240) 276-0120. 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 yours,
Carl
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
5
Indications for Use
510(k) Number (if known):
Device Name: Primus US Anesthesia Workstation
Indications For Use:
The Primus US is indicated as a continuous flow anesthesia system. The Primus US may be used for manually assisted, or automatic ventilation, and delivery of gases, anesthetic vapor, and monitoring of; oxygen and CO2 concentration, breathing pressure, respiratory volume, and anesthetic agent identification and concentration. 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 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aay Svelson
(Division Side-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K042667
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