(384 days)
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML models. The description focuses on the device's function as an anesthesia system and ventilation capabilities.
Yes
The device is described as an "anesthesia system" and provides "ventilation" and "delivery of gases and ancillaries in patients during anesthesia," which are medical treatments or interventions, qualifying it as a therapeutic device.
No
Explanation: The device is described as a continuous flow anesthesia system and ventilator, used for delivering gases and ancillaries during anesthesia. Its function is to support patient respiration and deliver anesthetic agents, not to diagnose a medical condition.
No
The device description explicitly states it is a "continuous flow gas anesthesia system," which is a hardware device. The summary also mentions "system level qualification, and verification/validation tests" which are typical for hardware devices.
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 an "anesthesia system" used for "delivery of gases and ancillaries in patients during anesthesia." This describes a device used on a patient for a medical procedure, not a device used to test samples from a patient in a lab setting.
- Device Description: The description reinforces this by calling it a "continuous flow gas anesthesia system."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory tests.
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 Fabius GS does not fit this description.
N/A
Intended Use / Indications for Use
The Fabius GS is indicated as a continuous flow anesthesia system. The Fabius GS can be used for spontaneous, manually assisted, automatic or pressure support ventilation, delivery of gases and anesthetics in patients during anesthesia, and 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
BSZ
Device Description
The modified Fabius GS 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
Physician
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 modified Fabius GS included hazard analysis, system level qualification, and verification/validation tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
MAR 1 7 2004
SUMMARY OF SAFETY AND EFFECTIVENESS DATA RELATING TO SUBSTANTIAL EQUIVALENCE
| Proprietary Name: | Fabius GS Anesthesia System |
|---|---|
| Classification Name: | Gas Machine, Anesthesia - 73 BSZ |
| Device Class: | Class II |
| Initial Distributor: | Draeger Medical, Inc. |
| 3135 Quarry Road | |
| Telford, Pennsylvania 18969 USA | |
| Establishment Registration No.: | 2517967 |
| Devices to which substantial | |
| equivalence is claimed: | Fabius GS Anesthesia System -- K011404 |
| Evita 4 Continuous Ventilator -- K961687 |
Device Description:
The modified Fabius GS is a continuous flow gas anesthesia system.
Intended Use:
The modified Fabius CS may be used for spontaneous, manually assisted, automatic, or The modified i dolus of patients during anesthesia, and delivery of gases and pressure support venthanon of partins GS can monitor inspired oxygen concentration, breathing pressure, and respiratory volume.
Substantial Equivalence:
The current Fabius GS Anesthesia System (K011404) is being modified to include The current Paoras OS Incounted a Joional ventilation mode. The addition of Pressure Fressure Support Ventiation is an opportune change. The only hardware change was the Support Venthanon is essenzary hard key on the operator control panel. With the exception of minor incremental changes that did not require a 510(k) notification, the exception of inmor merentental sixtingle, alarm strategies, fault detection circuitry, and basic infrastration operating printesp within the Fabius GS remain unchanged from the initially released Fabius GS. Adjustable ventilation settings available in Pressure Support mittany released i ublis Sb. Frigger Level (sensitivity level at which a breath is mode at Support Pressure 2017) ----------------------------------------------------------------------------------------------------------------------------------------------uctected), Maximum mopiratevel are new settings. Maximum Inspiratory Flow and I Tessure Ecver and Trigger 2017 are ventilation settings already available to the user in the current automatic ventilation modes.
Like the Evita 4 Continuous Ventilator (K961687), Pressure Support Ventilation (PSV) in the Fabius GS is flow triggered and flow cycled.
Qualification of the modified Fabius GS included hazard analysis, system level qualification, and verification/validation tests.
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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 image of an eagle or bird-like figure, with stylized wings and body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 7 2004
Mr. Michael A. Kelhart Regulatory Affairs Project Manager Draeger Medical Incorporated 3135 Quarry Road Telford, PA 18969
Re: K030624
Trade/Device Name: Fabius GS Anesthesia System Regulation Number: 868.5160 Regulation Name: Gas Machine, Anesthesia Regulatory Class: II Product Code: BSZ Dated: February 18, 2004 Received: February 19, 2004
Dear Mr. Kelhart:
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 your device can may or dayer to our it of 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rease or as mode a determination that your device complies with other requirements of the Act than + Federal statutes and regulations administered by other Federal agencies. You must
2
Page 2 - Mr. Michael Kelhart
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 CFK Fart 807), labeling (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This production control pro histor pro raise (ing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally prematication. The PDF intellig of cation 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 If you desire specific at 100 100 100 100 (301) 594-4646. Also, please note the regulation entitled, Comation of Collied of Collier of Commarket notification" (21CFR Part 807.97). You may obtain Misoranums of reference to presence to promosibilities under the Act from the Division of Small other general 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,
J.H. Wubben
$\beta_1$
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
of Page -
510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________ K030624
Device Name: ______________Fabius GS Anesthesia System
Indications for Use:
The Fabius GS is indicated as a continuous flow anesthesia system. The Fabius GS can The I ablus OD is manually assisted, automatic or pressure support ventilation, be used for sponancous, manaary assemant and monitoring oxygen concentration, breathing denvory of gases and ancellers in potients during anesthesia. Federal law restricts this device to sale by or on the order of a physician.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ V (Per 21 CFR 801.109)
OR
Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrerice of CDRH, Office of Device Evaluation (ODE)
ivision Sian-Off rision of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number