The Fabius GS/Fabius Tiro is indicated as a continuous flow anesthesia system. The Fabius GS/Fabius Tiro can be used for spontaneous, manually assisted, automatic, pressure support, or synchronized mandatory intermittent 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/Fabius Tiro is a continuous flow gas anesthesia system.

AI/ML Overview

The provided document is a 510(k) summary for the Fabius GS/Fabius Tiro Anesthesia System, specifically for a software modification to include Synchronized Intermittent Mandatory Ventilation with Pressure Support (SIMV/PS) as an optional ventilation mode.

Based on the content, here's an analysis of the acceptance criteria and study information:

Description of Acceptance Criteria and Reported Device Performance

The document describes the addition of SIMV/PS mode to the existing Fabius GS/Fabius Tiro Anesthesia System. The acceptance criteria are implicitly based on demonstrating substantial equivalence to existing predicate devices (Evita 4 Ventilator K961687 and 7900 Ventilator K023366) with SIMV with Pressure Support ventilation modes. The substantial equivalence is claimed based on functional similarities and that the device "meets" these similarities.

Acceptance Criteria (Implicit from Substantial Equivalence Claim)	Reported Device Performance (as described in the document)
SIMV Mode Functionality
User settable number of volume controlled ventilator delivered breaths per minute.	"All provide a user settable number of volume controlled ventilator delivered breaths per minute."
Synchronizes to spontaneous breaths.	"All synchronize to spontaneous breaths."
Option of adding pressure support to assist the patient's spontaneous breaths between ventilator breaths.	"All incorporate the option of adding pressure support to assist the patient's spontaneous breaths between ventilator breaths."
User Selectable Ventilation Parameters (SIMV/PS)
Maximum Ventilation Pressure (Pmax)	"All provide user selectable ventilation parameters during SIMV/PS for; Maximum Ventilation Pressure (Pmax)..."
Tidal Volume (Vt)	"...Tidal Volume (Vt)..."
Ventilator Frequency (Freq)	"...Ventilator Frequency (Freq)..."
Inspiratory Time (TInsp)	"...Inspiratory Time (TInsp)..."
Positive End Expiratory Pressure (PEEP)	"...and Positive End Expiratory Pressure (PEEP)."
User Selectable Ventilation Parameters (with Pressure Support)
Inspiratory Pressure Setting (ΔPPS)	"Additionally, when SIMV is augmented with Pressure Support, all provide user selectable ventilation parameters for; Inspiratory Pressure Setting (ΔPPS)..."
Inspiratory Flow	"...Inspiratory Flow..."
Trigger Level	"...and Trigger Level."
Safety and System Integrity
Hazard analysis conducted.	"Qualification included hazard analysis..."
System level qualification conducted.	"...system level qualification..."
Verification/validation tests conducted.	"...and verification/validation tests."

Study Details:

This document describes a 510(k) submission, which primarily relies on demonstrating substantial equivalence to predicate devices rather than a standalone clinical study on the device's performance against specific acceptance criteria. Therefore, many of the requested details typically found in the clinical study report are not explicitly present.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of this 510(k) submission. No patient-level test set data is mentioned for performance evaluation in the conventional sense. The "test set" here refers to the parameters and functionalities that were verified against the predicate devices.
- Data Provenance: Not specified. The submission relies on a comparison of technical specifications and features with previously cleared predicate devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a comparison against predicate devices' functionalities, not a diagnostic or clinical performance study requiring expert ground truth establishment. The "ground truth" for substantial equivalence is the functionality of the predicate devices.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There's no clinical data adjudication described in this type of submission.
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:
- No MRMC study was conducted. This device is an anesthesia system, not an AI-powered diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No standalone algorithm performance study was described. The submission focuses on the integration of a new ventilation mode (software change) into an existing, cleared anesthesia system. Performance claims are based on similarity to predicate devices already cleared for use.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission is the established functionality and regulatory clearance of the predicate devices (Evita 4 Ventilator and 7900 Ventilator) regarding their SIMV with Pressure Support ventilation modes. The new device's SIMV/PS mode is deemed substantially equivalent based on matching these functionalities and parameters.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI algorithm in the sense that it requires a training set of data. The "training set" would implicitly be the established engineering and design principles used to develop the software, which are not quantified in terms of sample size here.
How the ground truth for the training set was established:
- Not applicable for the same reasons as above. The "ground truth" for the development of the SIMV/PS mode would stem from medical knowledge of ventilation, engineering specifications, and the functionality observed in the predicate devices.

Summary

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007 8 - 2004

K042418

SUMMARY OF SAFETY AND EFFECTIVENESS DATA RELATING TO SUBSTANTIAL EQUIVALENCE

Proprietary Name:	Fabius GS/Fabius 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/Fabius Tiro Anesthesia System – K042080Evita 4 Continuous Ventilator - K9616877900 Ventilator - K023366

Device Description:

The Fabius GS/Fabius Tiro is a continuous flow gas anesthesia system.

Intended Use:

The Fabius GS/Fabius Tiro may be used for spontaneous, manually assisted, automatic, pressure support, or synchronized intermittent mandatory ventilation of patients during anesthesia, and delivery of gases and anesthetic vapor. The Fabius GS/Fabius Tiro can monitor inspired oxygen concentration, breathing pressure, and respiratory volume.

Substantial Equivalence:

The current software used in the Fabius GS/Fabius Tiro Anesthesia System (K042086) is being modified to include Synchronized Intermittent Mandatory Ventilation with Pressure Support (SIMV/PS) as an optional ventilation mode. The addition of SIMV/PS is essentially a software change and is incorporated in Fabius GS/Fabius Tiro software version 3.00. The only hardware change was the addition of a SIMV/PS hard key on the operator control panel. The basic infrastructure, operating principle, alarm strategies, fault detection circuitry, and mechanical/pneumatic subassemblies within the Fabius GS/ Fabius Tiro remain unchanged.

SIMV/PS mode is a mechanical ventilation mode influenced by spontaneous breathing. In SIMV/PS mode, when the patient breathes spontaneously, the ventilator will synchronize mechanical ventilation to the patient efforts. Between these intervals, mandatory (automatically delivered) un-synchronized ventilation is delivered to ensure a minimum degree of ventilation. SIMV ventilation strokes are the same as those for Volume Controlled ventilation. The synchroneous trigger mechanism for SIMV/PS is the

510(k) Summary Page 1 of 2

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same as that used in pure pressure support mode. Adjustable parameters are Tidal Volume (Vt), Ventilator Frequency (Freq), Inspiratory Time (Tinsp), Inspiratory Pause (TIP: TI), and Positive End Expiratory Pressure (PEEP).

Pressure Support ventilation can be added to augment the patient's spontaneous breathing efforts by adjusting the Inspiratory Pressure Setting (ΔPPS) level to a value other than "Off." When turned "On", the Pressure Support aspect of SIMV functions the same as the Pressure Support ventilation mode cleared for commercial distribution on the Fabius GS/Fabius Tiro under 510(k)s K030624 and K042086.

Adjustable ventilation settings available in SIMV/PS are:

-Maximum Ventilation Pressure (Pmax)
Tidal Volume (Vt) -
-Ventilator Frequency (Freq)
-SIMV Inspiratory Time (TInsp)
Inspiratory Pause (TIP:TI) -
Positive End Expiratory Pressure (PEEP) -
Inspiratory Pressure Setting (APPS)* -
Inspiratory Flow* -
-Trigger Level*

For Pressure Support aspect of SIMV if Inspiratory Pressure Setting (ΔPPS) is set to a value other than "Off."

The SIMV/PS ventilation mode for the Fabius GS/Fabius Tiro is substantially equivalent to the SIMV with Pressure Support ventilation mode in the Evita 4 Ventilator (K961687) and 7900 Ventilator (K023366). Similarities are:

All provide a user settable number of volume controlled ventilator delivered breaths per minute.
-All synchronize to spontaneous breaths.
-All incorporate the option of adding pressure support to assist the patient's spontaneous breaths between ventilator breaths.
All provide user selectable ventilation parameters during SIMV/PS for; Maximum । Ventilation Pressure (Pmax), Tidal Volume (Vt), Ventilator Frequency (Freq), Inspiratory Time (TInsp), and Positive End Expiratory Pressure (PEEP). Additionally, when SIMV is augmented with Pressure Support, all provide user selectable ventilation parameters for; Inspiratory Pressure Setting (APPS), Inspiratory Flow, and Trigger Level.

Qualification 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 seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, composed of three parallel lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus, indicating the department's name and national affiliation.

Public Health Service

OCT 8 - 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Michael A. Kelhart Regulatory Affairs Project Manager Dräeger Medical, Incorporated 3135 Quarry Road Telford, Pennsylvania 18969

Re: K042419

Trade/Device Name: Fabius GS/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: September 3, 2004 Received: September 7, 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 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 vours.

Quls

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): Koyz419_

Device Name: Fabius GS/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)

Aun Sileom

Page 1_of 1

(Division Sign-OK) Division of Anesthesiology, General Hospital, Infection Control. Dental Devic

510(k) Number K042819

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).