(22 days)
Not Found
No
The description focuses on a hardware modification (adding a heater plate) to an existing anesthesia system. There is no mention of AI, ML, or any software functionality that would suggest the use of such technologies. The operation of the heater is described as a simple on/off switch, not involving complex algorithms or learning.
Yes.
The device is described as a continuous flow anesthesia system that provides ventilation and delivers anesthetic vapor, which are direct interventions for patient care.
No
The device is described as an "anesthesia system" that delivers gases and anesthetic vapor, and monitors oxygen concentration, breathing pressure, and respiratory volume. While it monitors vital signs, its primary function is therapeutic (anesthesia), not to diagnose a disease or condition.
No
The device description explicitly states that the modification is a "hardware change only" and describes physical components like a heater foil, metal plate, insulator plate, and power cable. The core device itself is also described as a "continuous flow gas anesthesia system," which is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as a "continuous flow anesthesia system" used for ventilation, gas delivery, and monitoring of patients during anesthesia. This is a life support and monitoring device used directly on a patient.
- Device Description: The description details a system for delivering anesthetic gases and managing breathing, with a modification to a breathing system component (heater plate). This aligns with an anesthesia delivery system, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), detecting diseases or conditions based on such analysis, or providing information for diagnosis or treatment based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the body, not to directly interact with or support the body's functions like an anesthesia system does.
N/A
Intended Use / Indications for Use
The Fabius GS may be used for spontaneous, manually assisted, automatic, or pressure support ventilation of patients during anesthesia, and delivery of gases and anesthetic vapor. The Fabius GS can monitor inspired oxygen concentration, breathing pressure, and respiratory volume.
The Fabius Tiro may be used for spontaneous, manually assisted or automatic, or ventilation of patients during anesthesia, and delivery of gases and anesthetic vapor. The Fabius Tiro can monitor inspired oxygen concentration, breathing pressure, and respiratory volume.
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 anesthetic vapor, and monitoring oxygen concentration, breathing pressure and respiratory volume of patients during anesthesia. Federal law restricts this device to sale by or on the order of a physician.
The Fabius Tiro is indicated as a continuous flow anesthesia system. The Fabius Tiro can be used for spontaneous, manually assisted or automatic ventilation, delivery of gases and anesthetic vapor, and monitoring oxygen concentration, breathing pressure and respiratory volume of patients during anesthesia. 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)
BSZ
Device Description
The Fabius GS and Fabius Tiro are continuous flow gas anesthesia systems.
The compact breathing system (COSY) used with the Fabius GS (K030624) and Fabius Tiro (K031400) anesthesia systems is being modified to incorporate a heater plate. The addition of a heater plate is a hardware change only. The basic infrastructure, operating principle, alarm strategies, fault detection circuitry, and mechanical/pneumatic subassemblies within the Fabius GS/Tiro remain unchanged.
The heater consists of a heater foil, metal plate and insulator plate that are mounted between the absorber canister and COSY block. The heater subassembly is connected via a power cable to a separate power supply mounted externally to a Fabius GS/Tiro Anesthesia System.
Like the heater plate utilized in the NM6400's (K033498) Divan ventilator, the heater incorporated into the COSY is intended to warm the breathing system to minimize moisture accumulation in the breathing system components, especially during cases utilizing low flow anesthesia and/or during cases of low ambient environmental temperatures. It is not intended to control or maintain a set temperature of the patient breathing gas or to humidify the gas. Once activated, the heating plate in the COSY, like the NM6400, heats up to a constant temperature. This heat is then transferred, through conduction, to the components of the breathing system above it. In the NM6400, the heater plate is activated when the NM6400 System Power switch is turned to the "On" position and is de-activated when the NM6400 is switched to "Standby." With the COSY, heater activation is independent of the Fabius GS/Tiro. To activate the heater, the user is required to switch the heater power supply to the "On" position. To deactivate, the user is required to switch the power supply to the "Off" position.
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 modified compact breathing system included hazard analysis, system level qualification, and verification/validation tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Fabius GS Anesthesia System - K030624, Fabius Tiro Anesthesia System - K031400, Narkomed 6400 Anesthesia System - K033498
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
JUL = 8 2004
SUMMARY OF SAFETY AND EFFECTIVENESS DATA RELATING TO SUBSTANTIAL EQUIVALENCE
| Proprietary Name: | Fabius GS Anesthesia System
Fabius Tiro 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 - K030624
Fabius Tiro Anesthesia System - K031400
Narkomed 6400 Anesthesia System - K033498 |
Device Description:
The Fabius GS and Fabius Tiro are continuous flow gas anesthesia systems.
Intended Use:
The Fabius GS may be used for spontaneous, manually assisted, automatic, or pressure support ventilation of patients during anesthesia, and delivery of gases and anesthetic vapor. The Fabius GS can monitor inspired oxygen concentration, breathing pressure, and respiratory volume.
The Fabius Tiro may be used for spontaneous, manually assisted or automatic, or ventilation of patients during anesthesia, and delivery of gases and anesthetic vapor. The Fabius Tiro can monitor inspired oxygen concentration, breathing pressure, and respiratory volume.
Substantial Equivalence:
The compact breathing system (COSY) used with the Fabius GS (K030624) and Fabius Tiro (K031400) anesthesia systems is being modified to incorporate a heater plate. The addition of a heater plate is a hardware change only. The basic infrastructure, operating principle, alarm strategies, fault detection circuitry, and mechanical/pneumatic subassemblies within the Fabius GS/Tiro remain unchanged.
The heater consists of a heater foil, metal plate and insulator plate that are mounted between the absorber canister and COSY block. The heater subassembly is connected via a power cable to a separate power supply mounted externally to a Fabius GS/Tiro Anesthesia System.
1
Like the heater plate utilized in the NM6400's (K033498) Divan ventilator, the heater incorporated into the COSY is intended to warm the breathing system to minimize moisture accumulation in the breathing system components, especially during cases utilizing low flow anesthesia and/or during cases of low ambient environmental temperatures. It is not intended to control or maintain a set temperature of the patient breathing gas or to humidify the gas. Once activated, the heating plate in the COSY, like the NM6400, heats up to a constant temperature. This heat is then transferred, through conduction, to the components of the breathing system above it. In the NM6400, the heater plate is activated when the NM6400 System Power switch is turned to the "On" position and is de-activated when the NM6400 is switched to "Standby." With the COSY, heater activation is independent of the Fabius GS/Tiro. To activate the heater, the user is required to switch the heater power supply to the "On" position. To deactivate, the user is required to switch the power supply to the "Off" position.
Qualification of the modified compact breathing system included hazard analysis, system level qualification, and verification/validation tests.
2
Indications for Use
510(k) Number (if known):
Device Name: Fabius GS Anesthesia System
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 anesthetic vapor, and monitoring oxygen concentration, breathing pressure and respiratory volume of patients during anesthesia. 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)
Page 1 of 1
3
Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 8 2004
Mr. Michael A. Kelhart Regulatory Affairs Project Manager Draeger Medical, Incorporated 3135 Quarry Road Telford, Pennsylvania 18969
Re: K041622
Trade/Device Name: Fabius Tiro Anesthesia System Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: II Product Code: BSZ Dated: June 15, 2004 Received: June 16, 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 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.
4
Page 2 - Mr. Kelhart
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 vour 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 yours,
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): Koylle 22
Device Name: Fabius Tiro Anesthesia System
Indications for Use:
The Fabius Tiro is indicated as a continuous flow anesthesia system. The Fabius Tiro can be used for spontaneous, manually assisted or automatic ventilation, delivery of gases and anesthetic vapor, and monitoring oxygen concentration, breathing pressure and respiratory volume of patients during anesthesia. 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)
Page 1 of 1
Auy Sylbom
Division Sign Division of Anesthesiology, General Hospital. Infection Control, Dental Devices
510(k) Number: K041622