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.

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.

AI/ML Overview

This document describes the Fabius GS and Fabius Tiro Anesthesia Systems with a modification: the addition of a heater plate to the compact breathing system (COSY). The acceptance criteria and supporting study details are based on the provided text, which is a 510(k) premarket notification summary.

It's important to note that this document is a 510(k) summary for a hardware modification to an existing medical device, not a new, AI-powered diagnostic device. Therefore, many of the typical elements expected for AI/ML device studies (e.g., sample size for AI, ground truth establishment, MRMC studies) are not applicable here. The evaluation focuses on the safety and effectiveness of the hardware change relative to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format with specific performance metrics such as accuracy, sensitivity, or specificity, as would be common for diagnostic AI algorithms. Instead, the "acceptance criteria" are implied by the scope of the premarket notification: to demonstrate that the modified device remains substantially equivalent to legally marketed predicate devices and that the hardware change does not introduce new safety or effectiveness concerns.

The performance is implicitly demonstrated by the comparison to predicate devices and the completion of standard engineering verification and validation.

Feature/Criterion	Reported Device Performance
Safety and Effectiveness (General)	The device with the heater plate modification is deemed substantially equivalent to predicate devices (K030624, K031400, K033498), implying it meets the same safety and effectiveness standards. The addition of the heater plate is a hardware change only. The basic infrastructure, operating principle, alarm strategies, fault detection circuitry, and mechanical/pneumatic subassemblies remain unchanged.
Heater Function (Minimize moisture accumulation)	The heater is "intended to warm the breathing system to minimize moisture accumulation... especially during cases utilizing low flow anesthesia and/or during cases of low ambient environmental temperatures." This function is analogous to the heater plate in the predicate NM6400's Divan ventilator. When activated, it heats up to a constant temperature, transferring heat through conduction to the breathing system components above it. No quantitative performance data related to moisture reduction is provided, but functional equivalence to the predicate is asserted.
Heater Intended Use (Not for gas temperature/humidity)	The heater is explicitly not intended to control or maintain a set temperature of the patient breathing gas or to humidify the gas. This clarifies its functional scope and prevents misinterpretation of its capabilities.
Activation/Deactivation Mechanism	For the COSY, heater activation is independent of the main Fabius GS/Tiro unit. The user is required to switch a separate power supply to "On" to activate and "Off" to deactivate. This is different from the NM6400, where activation is tied to the system power switch. This difference is noted but not presented as a non-conformance.
Verification/Validation Testing	"Qualification of the modified compact breathing system included hazard analysis, system level qualification, and verification/validation tests." This confirms that standard engineering and regulatory processes were followed to ensure the safety and functionality of the modified device. No specific results or metrics from these tests are detailed in the provided summary.

Study Details:

The supporting "study" is a collection of engineering tests and regulatory analyses performed to ensure the modified device (Fabius GS/Tiro with heater plate) remains safe and effective and continues to be substantially equivalent to its predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: This concept doesn't directly apply in the context of this 510(k) for a hardware modification. There isn't a "test set" of patient data in the way an AI/ML diagnostic algorithm would have. Instead, the "testing" involves internal engineering verification and validation of the physical device, including hazard analysis and system-level qualification. The sample size for these engineering tests would likely refer to the number of units tested, the number of test cycles, or the specific operating conditions evaluated, which are not detailed in this summary.
Data Provenance: Not applicable in the context of patient data for an algorithm. The "data" comes from internal engineering and manufacturing records, hazard analyses, and performance testing of the device hardware.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. There is no "ground truth" established by experts for a test set of data in this context. The evaluation is of hardware performance and substantial equivalence to predicate devices, not of diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable. No expert adjudication method (like 2+1, 3+1 consensus) would be used for this type of hardware modification submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is relevant for evaluating the impact of an AI algorithm on human reader performance (e.g., radiologists interpreting images). This submission is for a hardware modification to an anesthesia machine and does not involve human readers analyzing medical cases with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No. This device is a piece of hardware, an anesthesia machine, which inherently requires human operation and interaction for its intended use. There is no standalone "algorithm only" performance to evaluate.

7. The Type of Ground Truth Used

Not applicable in the typical sense of diagnostic algorithms (e.g., pathology, outcomes data). The "ground truth" for this submission revolves around:

Engineering specifications and design requirements.
Performance against established safety standards.
Functional equivalence compared to predicate devices (e.g., the NM6400's heater plate).
Results from internal verification and validation testing, which confirm the device meets its design intent.

8. The Sample Size for the Training Set

Not applicable. There is no AI/ML algorithm involved, and therefore no "training set" of data.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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K041622

JUL = 8 2004

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 - K030624Fabius Tiro Anesthesia System - K031400Narkomed 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:

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Qualification of the modified compact breathing system included hazard analysis, system level qualification, and verification/validation tests.

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Indications for Use

510(k) Number (if known):

Device Name: Fabius GS Anesthesia System

Indications for Use:

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

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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.

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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

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Indications for Use

510(k) Number (if known): Koylle 22

Device Name: Fabius Tiro Anesthesia System

Indications for Use:

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

Regulation Number and Section

§ 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).