(28 days)
The Fabius GS and Fabius Tiro are indicated as a continuous flow anesthesia systems. The Fabius GS and Fabius Tiro are indicated for spontaneous, manually assisted, automatic or pressure support ventilation; delivery of gases and anesthetic vapor of patients during anesthesia. The Fabius GS and Fabius Tiro can monitor inspired oxygen concentration, breathing pressure and respiratory volume of patients during anesthesia. The Fabius GS and Fabius Tiro are to be used only in the order of a physician.
The Fabius GS and Fabius Tiro are continuous flow gas anesthesia systems.
The provided document does not contain specific acceptance criteria or a detailed study description for the Fabius GS and Fabius Tiro Anesthesia Systems' Apnea Ventilation feature in the same way one would expect for a machine learning or AI-driven device.
Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices based on a hazard analysis, system-level qualification, and verification/validation tests. The Apnea Ventilation feature is described as a software change.
Therefore, many of the requested details (like sample sizes for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable or not provided in this type of regulatory submission, which predates the common expectations for AI/ML device descriptions.
However, I can extract the available information and indicate where details are not provided.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission for a software change to an existing device, the "acceptance criteria" are framed in terms of maintaining safety and effectiveness and demonstrating substantial equivalence to predicates. Performance is described functionally rather than with quantitative metrics typically found in AI/ML performance tables.
| Acceptance Criterion (Implicit/Derived) | Reported Device Performance |
|---|---|
| Safety & Efficacy equivalent to predicates (Evita 4 and 7900 Ventilator) | - Apnea Condition Prevention: The Fabius GS/Tiro Apnea Ventilation feature, like its predicates, triggers (delivers a Pressure Support breath) when a patient's spontaneous breathing rate falls below a minimum frequency setting, thereby preventing an apnea condition. - User Alert: All three devices (Fabius GS/Tiro, Evita 4, 7900 Ventilator) alert the user to the apnea condition. - User Disablement: The Apnea Ventilation feature can be disabled by the user, similar to the predicate devices. - Backup Function: Intended as a short-term backup to prevent apnea if spontaneous effort fails. - Core Functionality: Basic infrastructure, operating principle, alarm strategies, fault detection circuitry, and mechanical/pneumatic subassemblies remain unchanged. |
| Hazard Analysis & Qualification Success | Qualification included hazard analysis, system level qualification, and verification/validation tests were performed, implying successful completion. (Specific results or metrics from these tests are not detailed in this summary). |
| Functional Equivalence | - All devices are triggered if a user-selected time elapses without a spontaneous breath during pressure support ventilation. - All prevent an apnea condition. - All alert the user to the condition. - All can be disabled by the user. |
| (Implied) No adverse impact on existing device features | The document states the change is "software only" and that the "basic infrastructure... remain unchanged," implying functionality not related to the Apnea Ventilation feature is unaffected. |
Study Details:
The document describes the evidence for substantial equivalence, which primarily constituted a comparison to predicate devices and internal qualification processes.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided: This submission focuses on a software change to an existing device and its substantial equivalence to predicate devices. There is no mention of a "test set" in the context of patient data or algorithm performance used in a way that generates sample sizes for statistical analysis relevant to AI/ML. The "test" here refers to verification and validation of the software feature itself and its integration into the system.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Provided: Ground truth in the context of patient data adjudicated by experts is not described for this type of submission. The "ground truth" here would relate to the functional correctness of the software and its ability to prevent apnea as designed, which is established through engineering and clinical validation rather than expert labeling of empirical patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: As no "test set" requiring expert adjudication is described, no adjudication method is mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable / Not Provided: This device is an anesthesia system with an apnea detection and response feature, not a diagnostic AI/ML tool designed to assist human readers (e.g., radiologists). Therefore, an MRMC study is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Partially Applicable / Implicitly Done: The "Apnea Ventilation feature" is a software algorithm that operates autonomously when triggered by the absence of spontaneous breaths. The "system level qualification, and verification/validation tests" would have evaluated its standalone (algorithm-only) performance within the device infrastructure. However, specific performance metrics or a detailed description of these tests (e.g., how apnea was simulated and how the system responded) are not provided in this summary. The device's overall use involves a human operator, but the apnea feature itself is an automated response.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Functional/Design Specification Ground Truth: The "ground truth" for this device's feature would be its adherence to engineering specifications for detecting apnea conditions and successfully delivering a pressure support breath as designed, and its equivalence to the functional behavior of the predicate devices. This would be established through bench testing, simulated scenarios, and potentially animal or human studies to confirm physiological response, though details are not supplied in this specific summary.
8. The sample size for the training set
- Not Applicable / Not Provided: This is a deterministic software feature, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" here would refer to software development and debugging.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided: As there is no "training set" for an AI/ML model, this question is not relevant. The ground truth for the device's design and function comes from established medical standards for ventilation and anesthesia, engineering principles, and the functional behavior of predicate devices.
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SUMMARY OF SAFETY AND EFFECTIVENESS DATA RELATING TO SUBSTANTIAL EQUIVALENCE
| Proprietary Name: | Fabius GS Anesthesia SystemFabius Tiro Anesthesia System |
|---|---|
| Classification Name: | Gas Machine, Anesthesia - 73 BSZ |
| Device Class: | Class II |
| Initial Distributor: | Draeger Medical, Inc.3135 Quarry RoadTelford, Pennsylvania 18969 USA |
| Establishment Registration No.: | 2517967 |
| Devices to which substantialequivalence is claimed: | Fabius GS Anesthesia System - K041622Fabius Tiro Anesthesia System - K041622Evita 4 Continuous Ventilator - K9616877900 Ventilator - K023366 |
Device Description:
AUG 3 1 2004
The Fabius GS and Fabius Tiro are continuous flow gas anesthesia systems.
Intended Use:
The Fabius GS and Fabius Tiro 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 and Fabius Tiro can monitor inspired oxygen concentration, breathing pressure, and respiratory volume.
Substantial Equivalence:
The current Fabius GS/Tiro Anesthesia Systems (K041622) are being modified to incorporate an Apnea Ventilation feature into the Pressure Support ventilation mode. The addition of Apnea Ventilation is a software change only. The basic infrastructure, operating principle, alarm strategies, fault detection circuitry, and mechanical/pneumatic subassemblies within the Fabius GS/Tiro remain unchanged.
The Apnea Ventilation feature is intended as a short term backup to prevent an apnea condition should a patient's spontaneous effort fail to trigger Pressure Support ventilation or cease entirely. It is not intended as a long term substitute for patient triggered pressure support ventilation. When Apnea Ventilation is enabled, if the patient spontaneous breathing rate falls below the minimum ventilation frequency (Freq Min) setting, the ventilator automatically delivers a Pressure Support breath at the pre-set Pressure Support settings.
510(k) Summary Page 1 of 2
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The Apnea Ventilation feature in the Fabius GS/Tiro is substantially equivalent to the Apnea Ventilation feature in the Evita 4 (K961687) and the Apnea Backup Mode feature in the 7900 Ventilator (K023366). All three are triggered if a user selected time elapses without a spontaneous breath during pressure support ventilation and all three can be disabled by the user. As stated earlier, when Apnea Ventilation is triggered in the Fabius GS, a pressure support breath is delivered at the pre-set Pressure Support settings. The Fabius GS/Tiro stays in Pressure Support mode. In the Evita 4, when Apnea Ventilation is triggered, the ventilator switches to Volume Controlled ventilation at a pre-set tidal volume and breath rate. The Evita 4 then stays in Volume Controlled mode unless the user switches back to Pressure Support mode. In the 7900 Ventilator, when Apnea Backup Mode is triggered, the ventilator switches to Synchronized Intermittent Mandatory Ventilation - Pressure Controlled (SIMV - PC) mode at a pre-set inspired pressure, breath rate and inspiratory time. The 7900 Ventilator stays in SIMV-PC mode unless the user switches back to Pressure Support mode. From a safety and efficacy standpoint, all three devices prevent an apnea condition and alert the user to the condition.
Oualification included hazard analysis, system level qualification, and verification/ validation tests.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping waves or stripes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 1 2004
Mr. Michael A. Kelhart Regulatory Affairs Project Manager Draeger Medical, Incorporated 3135 Quarry Road Telford, Pennsylvania 18969
Re: K042086
Trade/Device Name: Fabius GS and Fabius Tiro Anesthesia Systems Regulation Number: 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: II Product Code: BSZ Dated: August 2, 2004 Received: August 3, 2004
Dear Mr. Kelhart:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave refrenced your becatermined 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 Interstate conmisered proves that have been reclassified in accordance with the provisions of Amendinens, or to arress and Cosmetic Act (Act) that do not require approval of a premarket the Fouch I vou, Drag, and Coou may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of in 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 If your device is olabilition (see as additional controls. Existing major regulations affecting (1 Mr), it may of subject to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be foundsh further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Kelhart
Please be advised that FDA's issuance of a substantial equivalence determination does not Fleast that FDA has made a determination that your device complies with other requirements moan that i Dr mas made statutes and regulations administered by other Federal agencies. of the Act of ally 1 oderal bake and successed including, but not limited to: registration r out must comply with as 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 807), arelity systems (QS) regulation (21 CFR Part 820); and if requirents us sectionic 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) This letter will anow you the bogan finding of substantial equivalence of your device to a premarket notified.com - 11.0 - 21.0 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), If you desire specific at 750 to: Joins 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 may ovean 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,
Cure
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
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Indications for Use
510(k) Number (if known): _Koy Zo &b
Device Name: __Fabius GS and Fabius Tiro Anesthesia Systems
Indications for Use:
The Fabius GS and Fabius Tiro are indicated as a continuous flow anesthesia systems. The Fabius GS and Fabius The are meleated for spontaneous, manually assisted, The Fablus OS and I abrus Tre Call of about station, delivery of gases and anesthetic was of paties automatic or pressure support venthanon; don't st gases or and respiratory volume of patients
monitoring oxygen concentration, breathing pressure and respiratory of a momiloring oxygen concentration, orcating pressure in the order of a physician.
X Prescription Use (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)
uom
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K042086
Page 1 of 1
§ 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).