Use of the KION Anesthesia System is indicated for adult or infant populations 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 the patient. This device can be used to administer anesthesia while controlling the entire ventilation for patients without any ability to breathe, as well as for supporting patients with reduced ability to breathe.

Device Description

KION is a modular anesthesia system. It is available as a set of hardware and software options, which can be added to take the system from being a low-cost, general purpose anesthesia machine, to a complete state-of-the-art anesthesia workstation. This gives the opportunity to specify a system and then upgrade and modify the system as needs change in the future. The KION anesthesia system is designed to enable the operator to work with the basic components of an anesthesia system in the most suitable way for each patient case. As such, the system is mounted on wheels to allow it to be easily moved into an optimum position, where many of the components can also be individually rotated. The KION system is intended for use on adult and pediatric patients. Physically, the KION consists of three main sections: The Trolley which contains the main pneumatic inlets, power supply and power inlets, battery, communication ports, and the gas delivery system. The Column consists of a revolving Vaporizer Holder, Servo Bellows Absorber and Patient Cassette. The Integrated User Interface consists of the Control Panel and the Monitor. The KION offers the following standard ventilation capabilities: Volume controlled ventilation, Manual ventilation.

AI/ML Overview

The provided text is a 510(k) summary for the KION Anesthesia System, which is a submission to the FDA requesting clearance to market a medical device. This document focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than an in-depth study proving novel acceptance criteria for an AI/ML device. Therefore, much of the requested information about device performance, study design, and ground truth establishment is not typically found in such a document for this type of device.

However, I can extract the relevant information based on the typical content of a 510(k) submission for a non-AI/ML medical device like an anesthesia system.

Here's an analysis of the provided text with respect to your questions:

1. A table of acceptance criteria and the reported device performance

For a device like an Anesthesia System, acceptance criteria are typically related to fundamental performance characteristics (e.g., accuracy of gas delivery, ventilation parameters, alarm functionality) and compliance with international standards. The document primarily establishes equivalence to predicate devices and adherence to relevant standards.

The table below summarizes the key performance parameters mentioned in the "Table of Device Similarities and differences to predicate device" (Section 6) and implicitly considers these as performance benchmarks. However, explicit "acceptance criteria" with specific thresholds are not detailed in this summary, as is common for 510(k) summaries of non-AI devices when claiming equivalence. The "reported device performance" is essentially that the KION system meets or improves upon the performance of the predicate devices.

Parameter	Acceptance Criteria (Implied / Predicate Device Performance)	Reported Device Performance (KION Anesthesia System)
Applications and Intended Use	Infants to Adults	Same (Infants to Adults)
Fresh gas dosage Range	Predicate: 500 ml/min - 40 l/min	100 ml/min - 18lpm (Enhanced functionality for low flow applications)
Fresh gas dosage Accuracy	+/- 10%	Same (+/- 10%)
Oxygen Percent	21% / 25% - 100% (Air / N₂O)	21% / 28% - 100% (Air / N₂O) (Enhanced anti-hypoxic measures)
Oxygen/Nitrous Oxide Ratio	Anti-hypoxia device present	Same (Anti-hypoxia device present)
Tidal Volume	Predicate: 2 - 1500 ml	20 - 1500 ml (Altered functionality, no neonatal capability on Kion, but still within adult/pediatric range and specified)
CMV Rate	Predicate: 0.5 - 120	6 - 99 (Enhanced functionality due to specific clinical anesthesia requirements)
I:E Ratio	Predicate: 1:4 - 4:1 in seven steps	1:3 - 4:1 in five steps (Enhanced functionality due to specific clinical anesthesia requirements)
Pause Time	Predicate: 0, 5, 10, 20, 30% of cycle	10% of cycle in Volume Control Mode (except for I:E - 4:1 = 0%) (Enhanced functionality due to specific clinical anesthesia requirements)
Monitored Parameters	Inspired Tidal Volume, Expired Tidal Volume, Rate, Peak airway Pressure, Mean Airway Pressure, Pause Pressure, PEEP/CPAP, Airway pressure / Analogue Display (from predicate devices)	Same (All listed monitored parameters are present in KION)
Ventilatory Alarms	High Airway Pressure, High Continuous Airway Pressure, Disconnect, Low Minute Volume, Low O₂ Concentration (from predicate device)	Same, plus new alarms: Low Air Supply Wall and Tank, Low O₂ Supply Wall and Tank, Low N₂O Supply Wall and Tank, High Air Supply Wall and Tank, High O₂ Supply Wall and Tank, High N₂O Supply Wall and Tank, Low Battery Capacity (Enhanced functionality)
Standards Compliance	IEC 601-1, IEC 601-1-1, IEC 601-1-2, ISO/DIS 8835-1.2, prEN 794-1, ISO 7767	KION complies to these standards. This is a critical acceptance criterion for medical devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states: "See the test results under section In-house Testion T, in this submission." This indicates that in-house testing was performed. However, the 510(k) summary does not provide details on the sample size used for this testing, nor the data provenance (e.g., country of origin, retrospective/prospective nature). For a device like an anesthesia system, "test set" would typically refer to the various simulations, bench tests, and potentially animal studies, as well as the manufacturing quality control tests conducted during development.

3. 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)

This information is not provided in the 510(k) summary. For this type of device, ground truth (or verification/validation reference) would be established through engineering specifications, validated test equipment, and recognized scientific and medical principles for measurement accuracy and safety, rather than through expert consensus in the way it might be for AI/ML imaging devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the 510(k) summary. Adjudication methods are typically associated with human review processes, often in clinical studies or for establishing ground truth for AI/ML models. For an anesthesia system, verification and validation would follow engineering testing protocols.

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

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is specific to diagnostic imaging devices, particularly those involving human interpretation (readers) and AI assistance. This device (KION Anesthesia System) is an anesthesia delivery and monitoring system and does not involve "readers" or "AI assistance" in the diagnostic interpretation sense. Therefore, this type of study was not conducted or applicable.

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

No. This refers to the standalone performance of an algorithm, typically for AI/ML devices. The KION Anesthesia System is a physical medical device with hardware and integrated software for control and monitoring, not a standalone software algorithm in the context of AI/ML.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For an anesthesia system, the "ground truth" for performance would be engineering specifications, validated measurement standards and equipment, and established physiological parameters. For example, the accuracy of gas flow would be measured against calibrated flow meters, and alarm thresholds would be set based on clinical safety guidelines and physiological limits. The summary does not explicitly detail these "ground truth" methods but implies them through adherence to standards and in-house testing.

8. The sample size for the training set

This question is not applicable as the KION Anesthesia System is not an AI/ML device that requires a "training set" in the context of machine learning.

9. How the ground truth for the training set was established

This question is not applicable as the KION Anesthesia System is not an AI/ML device that requires a "training set" or ground truth for such a set.

Summary

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K973971

510(k) SUMMARY

as required per 807.92(c)

1. Submitters Name, Address:
  Siemens Medical Systems, Inc. Electromedical Systems Group, PCS Danvers, MA 01923 Tel: (508) 750-7500 Fax: (508) 777-3398

Official Correspondent: David Simard, Director Quality Assurance & Regulatory Affairs

Contact person for this submission: Wulf R. Trepte Quality Assurance Date submission was prepared: 16/10/97

Trade Name, Common Name and Classification Name: 2.

Trade Name: A
KION Anesthesia System

Common Name, Classification Name, Class and Regulation Number: B.

Common Name	Classificationn Number	Class	Regulation Number
Gas-machine, Anesthesia	73BSZ	II	21 CFR 868.5160
Gas-machine, Analgesia	73ELI	II	21 CFR 868.5160
Cardiac monitor	74DRT	II	21 CFR 870.2300
Pulse rate monitor	74BWS	II	21 CFR 870.2300
Pulse oximeter	74DQA	II	21 CFR 870.2700
Breathing Frequency Monitor	73BZQ	II	21 CFR 868.2375
Clinical Electronic Thermometer	80BWX	II	21 CFR 880.2910
Indwelling Blood Pressure Monitor	74CAA	II	21 CFR 870.1110
Heart Rate Monitor, Neonatal	74FLO	II	21 CFR 870.2300
Ventilatory Effort Monitor (Apnea Detector)	73FLS	II	21 CFR 868.2375
Monitor Blood Pressure, Neonatal, Invasive	74FLP	II	21 CFR 870.1110
Arrhythmia detector & Alarm	74DSI	III	21 CFR 870.1025
Medical Cathode-Ray Tube Display	74DXJ	II	21 CFR 870.2450
ST Segment Monitor with Alarm	74MLD	III	21 CFR 870.1025
Non-indwelling Blood Pressure Monitor	74DXN	II	21 CFR 870.1130
End-tidal Carbon-Dioxide Monitor	73CCK	II	21 CFR 868.1400

COMPANY CONFIDENTIAL

Sicmens-Elema AB Electromedical Systems Division

Röntgenvägen 2 S-171 95 Solna SWEDEN

Tel. (46) 8 730 7228 Fax. (46) 8 98 63 05

{1}------------------------------------------------

3. Predicate Device Identification:

Legally marketed devices to which equivalence is being claimed	510(k) #
Siemens Servo Ventilator 900C	K841529
Servo Ventilator 900C/D Electronic gas supply unit	K871354
Servo Ventilator 900C/D CAV 1.0 Master Program Flow & Prs, CO2 Lung Monitor	K861707
Servo Ventilator 900C/D P.C. Interface	K852771
Servo Ventilator 900C/D CAV 4.0 Software Servo Graphics	K923444/A
Servo Ventilator 900C/D Man. Vent. Acc.	K854036
Servo Ventilator 900C/D/E CAV 3.0 Software	K890932
Siemens Servo Anesthesia Circle 985	K893786
Siemens Vaporizers 950/951/952	K841157
Ohmeda Tec5 Vaporizer	K942091
Siemens Servo Ventilator 300	K960010
Siemens SC9000/SC9015 Bedside Monitoring System	K946306

4. Device Description:

Physically, the KION consists of three main sections:

The Trolley which contains the main pneumatic inlets, power supply and power 1. inlets, battery, communication ports, and the gas delivery system.
The Column consists of a revolving Vaporizer Holder, Servo Bellows Absorber 2. and Patient Cassette.
The Integrated User Interface consists of the Control Panel and the Monitor. 3.

The KION offers the following standard ventilation capabilities:

. Volume controlled ventilation
. Manual ventilation

5. Intended Use:

The intended use for the KION is as a modular anesthesia system for use on Adult and Infant patient populations. The unit is designed to be used in the operating room or any other hospital location where administration of anesthesia is necessary.

2 COMPANY CONFIDENTIAL

Siemens-Elema AB Electromedical Systems Division

Röntgenvägen 2 S-171 95 Solna SWEDEN

Tel. (46) 8 730 7228 Fax. (46) 8 98 63 05

{2}------------------------------------------------

6. Table of Device Similarities and differences to predicate device

Manufacturer	Siemens-Elema AB,Electromedical SystemsDivision	Siemens-Elema AB,Electromedical SystemsDivision	-
510(k) number	Predicate devicesSiemens Servo ventilator 900C - K841529 Siemens Servo Ventilator 300 - K960010 Servo Anesthesia Circle 985 - K893786. Siemens Vaporisers 950, 951, 952 - K841157. Ohmeda Tec 5 vaporiser - K942091. Siemens Servo Screen - K960168	Modified DeviceKlon Anesthesia SystemK number to be decided	-
Parameters General	Predicate devices: All	Modified DeviceKlon Anesthesia System	Explanation of the differences comparedto the Predicate devices
Applications and Intended Use	Infants to Adults	Same	-
Gas Delivery System	Pneumatic Powered ServoControlled "Bag in Bottle"system.	Same	-
Battery Back up	No	Yes	Battery backup for the 900C is only availablewith an external system.
Parameters Gas Dosage	Predicate devicesSiemens Servo ventilator 900C- K841529Servo Anesthesia Circle 985 -K893786.	Modified DeviceKion Anesthesia System	Explanation of the differences comparedto the Predicate devices
Fresh gas dosageRange	Range:500 ml/min - 40 l/min	Range: 100 ml/min - 18lpm	Enhanced functionality on Kion for low flowapplications
Accuracy	+/- 10%	Same	-
Oxygen Percent	21% / 25% - 100%(Air / N2O)	21% / 28% - 100%(Air / N2O)	Enhanced anti-hypoxic measures
Gas Mixture Setting	O₂/Air or O₂/N₂O	Same	-
Anti-hypoxia device(Limits O₂/N₂O fresh gas ratio)	Yes	Same	-
Ventilator Integral	Yes	Same	-
Anesthetic Vapour DeliveryModules	Predicate devicesSiemens Vaporizers950/951/952 and OhmedaTec5	Modified DeviceKion Anesthesia SystemVaporizers	Explanation of the differences comparedto the Predicate devices
Operating Principle	High pressure precisioninjector	Same	-

Magazine for three

vaporizers mounting

Single vaporizer mounting

COMPANY CONFIDENTIAL

Siemens-Elema AB Electromedical Systems Division

Vaporizer mounting

Röntgenvägen 2 S-171 95 Solna SWEDEN

Tel. (46) 8 730 7228 Fax. (46) 8 98 63 05

Enhanced functionality.

{3}------------------------------------------------

Breathing Systems	Predicate devicesSV 900 and ServoAnesthetic Circle 985	Modified DeviceKion Anesthesia System	Explanation of the differences compared to thePredicate devices
Circle System	Yes	Same
Auxiliary Fresh Gas Outlet	No	Yes	Enhanced functionality to support external breathingsystems (e.g. Bain, T-piece)
Adjustable Pressure Regulating(APL) valve	No	Adjustable to 90 cm H2O	Improved functionality
Ventilation Modes	Predicate devicesSV 900C	Modified DeviceKion Anesthesia System	Explanation of the differences compared to thePredicate devices
Manual	Yes	Same
Volume Controlled Ventilation	Yes	Same
Pressure Controlled Ventilation	Yes	No	Planned for future enhancement in Kion
Pressure Support	Yes	No	Planned for future enhancement in Kion
Ventilatory Control Settings	Predicate devicesSV 300	Modified DeviceKion Anesthesia System	Explanation of the differences compared to thePredicate devices
Preset Minute Volume	0.5 - 45LPM	Same
Tidal Volume	2 - 1500 ml	20 - 1500 ml	Altered functionality, no neonatal capability on Kion.
CMV Rate	0.5 - 120	6 - 99	Enhanced functionality due to specific clinicalanesthesia requirements
I:E Ratio	1:4 - 4:1 in seven steps.	1:3 - 4:1 in five steps.	Enhanced functionality due to specific clinicalanesthesia requirements
Pause Time	0, 5, 10, 20, 30% of cycle	10% of cycle in VolumeControl Mode ( except for I:E- 4:1 = 0%)	Enhanced functionality due to specific clinicalanesthesia requirements
Inspiratory Gas Flow	Maximum 180 lpm	Same
Monitored Ventilatory &Respiratory parameters	Predicate DevicesSV 900 and Servo Screen390	Modified DeviceKion Anesthesia System	Explanation of the differences compared to thePredicate devices
Inspired Tidal Volume	Yes	Same
Expired Tidal Volume	Yes	Same
Rate	Yes	Same
Peak airway Pressure	Yes	Same
Mean Airway Pressure	Yes	Same
Pause Pressure	Yes	Same	-
PEEP/CPAP	Yes	Same	-
Airway pressure / AnalogueDisplay	Yes	Same	-
Ventilatory Alarms	Predicate DeviceSV900	Modified DeviceKion Anesthesia System	Explanation of the differences compared to thePredicate devices
	This device has the following	Same	Enhanced functionality. In addition Kion also have thefollowing alarms

This device has the following	Same	Enhanced functionality. In addition Kion also have the
alarms: High AirwayPressure, High Continuous		following alarms:
Airway Pressure, Disconnect,		Low Air Supply Wall and Tank, Low 02 Supply Wall
Low Minute Volume, Low 02		and Tank, Low 02 Supply Wall and Tank, Low N20
Concentration		Supply Wall and Tank, High Air Supply Wall and
		Tank, High 02 Supply Wall and Tank, High N20
		Supply Wall and Tank, Low Battery Capacity

COMPANY CONFIDENTIAL

Siemens-Elcma AB Electromedical Systems Division

Röntgenvägen 2 S-171 95 Solna SWEDEN

Tcl. (46) 8 730 7228 Fax. (46) 8 98 63 05

{4}------------------------------------------------

1. Assessment of non-clinical performance data for equivalence: See the testresults under section In-house Testion T, in this submission.
1. Assessment of clinical performance data for equivalence: Clinical trials ongoing.
1. Biocompatability: Not applicable

Sterilization: Not applicable

11. Standards and Guidances:

KION complies to the following standards:

· IEC 601-1 (EN 60601-1) Medical Electrical Equipment, part 1: General requirements for safety.
· IEC 601-1-1 (EN 60601-1-1) Medical Electrical Equipment, part 1.1: Safety Requirements for medical electrical systems.
· IEC 601-1-2 (EN 60601-1-2) Medical Electric Equipment, part 1.2: Electromagnetic Compatibility- Requirements and Tests
· ISO/DIS 8835-1.2 (Forthcoming IEC 60601-2-13, 2nd Ed.) Anesthesia Workstations and Their Components.
· prEN 794-1 Lung ventilators-Part 1: Particular Requirements for Critical Care Ventilators.
· ISO 7767 Oxygen monitors for monitoring patient breathing mixtures- Safety Requirements.

COMPANY CONFIDENTIAL

Siemens-Elema AB Electromedical Systems Division

Röntgenvägen 2 S-171 95 Solna SWEDEN

Tel. (46) 8 730 7228 Fax. (46) 8 98 63 05

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 3 1999

Mr. David Simard Simens Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923

Re: K973971 KION Anesthesia System III (three) Requlatory Class: Product Code: 73 BSZ and 74 DSI July 20, 1999 Dated: Received: July 21, 1999

Dear Mr. Simard:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. David Simard

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page_1_of_1__

K973971 510(k) Number (if known):__

Device Name: ________________________________________________________________________________________

Indications for Use:

MRI Compatibility Statement:

Siemens KION is not compatible for us in a MRI magnetic field.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

	Concurrence of CDRH, Office of Device Evaluation (ODE)
--	--------------------------------------------------------

signature

Prescription Use	✓	OR	Over-The-Counter Use
(Per 21 CFR 801.109)

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number	K973971

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).