Use of the KION Anesthesia Workstation is indicated in order to allow for the provision of anesthesia to the neonatal to adult patient populations in all ventilation modes except for Volume Control in the Circle System, where it is not intended for use on neonates. It is intended to be used in an environment where patient care is provided by Healthcare professionals, trained in the administration of anesthesia, when the professional determines that a device is required to assist the breathing of a patient undergoing anesthesia. The device can be used to administer anesthesia while controlling the entire ventilation for patients without any ability to breath, as well as supporting patients with reduced ability to breath.

Device Description

The KION Anesthesia Workstation - Extended Modes Functionality, adds primarily new functions for Pressure Support and Non-rebreathing to the already cleared KION Anesthesia Workstation with Pressure Control Functionality.

AI/ML Overview

The provided text is related to a 510(k) summary for the KION Anesthesia Workstation - Extended Modes Functionality. This document, like many 510(k) submissions for medical devices, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and expert-adjudicated ground truth data typically found in AI/ML device submissions.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be extracted from the provided text because it describes a traditional medical device submission, not an AI/ML diagnostic system. The document does not describe a study involving algorithms, human readers, or performance metrics like sensitivity, specificity, or AUC against a ground truth dataset in the way an AI/ML device would.

Here's an analysis based on the information that is present:

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" in this document is related to demonstrating substantial equivalence to legally marketed predicate devices, rather than meeting specific quantifiable performance metrics against a clinical ground truth as would be seen for an AI/ML device. The device's "performance" is assessed in terms of its clinical performance being "equivalent" to the predicate devices.

Acceptance Criteria (Implied by Substantial Equivalence and Device Description)	Reported Device Performance
Deliver operator set concentrations of oxygen and anesthesia gases.	Not explicitly quantified, but implied by substantial equivalence.
Deliver controlled breaths to the patient with constant or decelerating flow.	Not explicitly quantified, but implied by substantial equivalence.
Allow for provision of manual ventilation.	Not explicitly quantified, but implied by substantial equivalence.
Allow for provision of spontaneous ventilation.	Not explicitly quantified, but implied by substantial equivalence.
Intended for use on neonatal to adult patient populations (with exceptions).	Stated in Intended Use and Device Description.
Equivalent clinical performance to predicate devices.	Stated: "results show that the KION anesthesia Workstation. Extended Modes functionality has the equivalent clinical performance."
Functional equivalence for Pressure Support and Non-rebreathing modes.	"adds primarily new functions for Pressure Support and Non-rebreathing to the already cleared KION Anesthesia Workstation"

Study Details

The document describes a 510(k) submission for the KION Anesthesia Workstation - Extended Modes Functionality, claiming substantial equivalence to predicate devices. It does not describe a clinical study in the typical sense of evaluating diagnostic performance with a test set, ground truth, or human-AI comparison.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. The document does not describe a "test set" for performance evaluation in the context of an AI/ML device. The comparison is against predicate devices based on technological characteristics and intended use.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. There is no mention of establishing ground truth by experts for a test set. This is a traditional medical device submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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. This device is an anesthesia workstation, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic diagnostic device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this submission is implicitly the established safety and effectiveness of the legally marketed predicate devices, against which equivalence is claimed.
The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
How the ground truth for the training set was established: Not applicable.

In summary, the provided text concerns a traditional 510(k) submission for an anesthesia workstation, focusing on demonstrating substantial equivalence to predicate devices based on design, intended use, and technological characteristics. It does not provide the type of performance study details requested for an AI/ML diagnostic or assistive device.

Summary

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MAR 2 3 2004

	Document TypeTraditional 510(k)	Section-PageE-2
Object/SubjectKION Anesthesia Workstation - Extended Modes Functionality -510(k) Summary & Certification		Doc-IDEVU 113 905	Issue00

510 (k) Summary as required by section 807.92(c)

Subscribers Name & Address

Siemens-Elema AB Electromedical Systems Division, Life Support Systems Röntgenvägen 2 SE-171 95 Solna, Sweden Tel: (011) 46 8 7307000 Fax: (011) 46 8 986017

Contact Person for this submission:

Mikael K. Johansson, Regulatory Affairs Anesthesia

Official Correspondent:

Timothy W Capehart Manager Regulatory Submissions, Siemens Medical Solutions USA, Inc. 51 Valleystream Parkway, Malvern PA 19355

Trade Name

KION Anesthesia Workstation - Extended Modes Functionality

Device Classification

Common Name	ClassificationNumber	Class	Regulation Number
Gas machine, Anesthesia	73 BSZ	II	21 CFR 868.5160
Gas machine, Analgesia	73 ELI	II	21 CFR 868.5160
Arrhythmia detector and alarm	74 DSI	III	21 CFR 870.1025
Non-rebreathing valve	CBP	II	21 CFR 868.5870

Predicate Device Identification

Legally marketed devices to which equivalence is being claimed	510(k) #
KION Anesthesia Workstation	K973971
Modification to KION Anesthesia Workstation	K001315
KION Anesthesia Workstation - Pressure Control Functionality	K010923
Servo Ventilator 300A	K970839
Servo Ventilator 900C Siemens-Elema AB	K811102
Servo Anesthesia Circle 985 Siemens-Elema AB	K893786

Other relevant submissions

Devices	510(k) #
Servo-I	K010925
Servo Ventilator 300 Auto Mode	K970839

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SIEMENS	Document Type	Section-Page
	Traditional 510(k)	E-3
Object/Subject	Doc-ID	Issue no.
KION Anesthesia Workstation - Extended Modes Functionality -510(k) Summary & Certification	EVU 113 905 - 00

Device Description (for detailed description see Section F)

Intended Use:

The KION Anesthesia Workstation is intended for general anaesthesia use. The KION Anesthesia Workstation will deliver operator set concentrations of oxygen and anesthesia gases as well as deliver controlled breaths to the patient with either a constant or a decelerating flow pattern. KION Anesthesia Workstation is also intended to allow for the provision of manual ventilation and spontaneous ventilation.

Intended Operator:

The KION Anesthesia Workstation is intended for use by Healthcare professionals who are trained in the administration of anesthesia

Intended Patient Populations:

The KION Anesthesia Workstation is intended for use on the neonatal to adult patient populations in all ventilation modes. The exception is in Volume Control in the Circle System, where it is not intended for use on neonates.

Intended Use Environment:

The KION Anesthesia Workstation is intended to be used in the environments where anesthesia is to be administered by Healthcare professionals trained in administering anesthesia. It is not intended for transport use in ambulances or helicopters. It is not intended for use in Magnetic Resonance Imaging Suites.

Summary of technological characteristics of Device and Predicate Device:

The KION Anesthesia Workstation - Extended Modes Functionality is substantially equivalent to it's previous versions KION Anesthesia Workstation (K973971), Modification to KION Anesthesia Workstation (K001315) and KION Anesthesia Workstation with Pressure Control Functionality (K010923) as well as to the predicate devices, the Siemens Servo Ventilator 900 C (K811102), Siemens Servo Ventilator 300 (K902859), and Servo Anesthesia Circle 985 (K893786).

The technical differences are more of physical dimensions (compared to the SV900 and SV300), simplified user interaction for fast and reliable user operation, and use of modern components. The technology used is assessed and the results show that the KION anesthesia Workstation. Extended Modes functionality has the equivalent clinical performance.

Siemens-Elema AB

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular design with the department's name around the perimeter. In the center is a stylized caduceus, a symbol often associated with healthcare, consisting of a staff with two snakes coiled around it.

MAR 2 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jamie Yieh Manager, Regulatory Affairs Maquet Inc. c/o Siemens Medical Solutions USA, Inc. 1140 Route 22 East, Suite 202 Bridgewater, NJ 08807

Re: K024213

Trade/Device Name: Siemens Kion Anesthesia Workstation Regulation Number: 870.1025 Regulation Name: Physiological Patient Monitor w/ Arrhythmia Detection or Alarms Regulatory Class: III Product Code: DSI, BSZ Dated: December 23, 2003 Received: December 24, 2003

Dear Mr. Yich:

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. Jamie Yieh

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 (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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SIEMENS	Document TypeTraditional 510(k)	Section-PageH-2
Object/SubjectKION Anesthesia Workstation - Extended Modes Functionality-Indicated Use Statement		Doc-IDEVU 113 905 - 00

510(k) Number (if known): KOZYZ 3

Device Name: KION Anesthesia Workstation

Indications For Use:

MRI Compatibility Statement:

Siemens KION anesthesia Workstation is not compatible for use in a MRI magnetic field. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

GAmth

Division of Anesthesiology, General Hospital,

5.10(k) Number: K024213

COMPANY CONFIDENTIAL

Siemens-Elema AB

extended modes 510k file (evu 113 905) 17

)62(568)

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.