Predicate Devices

K841529, K871354, K861707, K852771, K923444/A, K854036, K890932, K893786, K841157, K942091, K960010, K946306

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, or any related concepts like deep learning, neural networks, or image processing for analysis. The device description focuses on hardware and standard ventilation capabilities.

Therapeutic

Yes
The KION Anesthesia System assists with breathing and administers anesthesia, directly treating or alleviating a condition.

Diagnostic

No

The device is an anesthesia system designed to assist patient breathing and administer anesthesia, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states that KION is a "modular anesthesia system" available as a "set of hardware and software options." It details physical components like a trolley, column, and integrated user interface, including pneumatic inlets, power supply, battery, gas delivery system, vaporizer holder, servo bellows absorber, patient cassette, control panel, and monitor. This clearly indicates it is a hardware device with accompanying software, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use/Indications for Use: The intended use clearly describes a device used to administer anesthesia and assist patient breathing. This is a direct interaction with the patient's respiratory system, not the examination of specimens derived from the human body.
Device Description: The description details a system for delivering gases and controlling ventilation, which aligns with the function of an anesthesia machine.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting substances within those samples, or providing information for diagnosis based on such analysis.

IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. The KION Anesthesia System's function is entirely focused on supporting and controlling a patient's breathing during anesthesia.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

73BSZ, 73ELI, 74DRT, 74BWS, 74DQA, 73BZQ, 80BWX, 74CAA, 74FLO, 73FLS, 74FLP, 74DSI, 74DXJ, 74MLD, 74DXN, 73CCK

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 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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Adult and Infant, Infants to Adults, Adult and Pediatric

Intended User / Care Setting

Healthcare Professionals, trained in the administration of anesthesia / operating room or any other hospital location where administration of anesthesia is necessary.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Assessment of non-clinical performance data for equivalence: See the testresults under section In-house Testion T, in this submission.
Assessment of clinical performance data for equivalence: Clinical trials ongoing.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K841529, K871354, K861707, K852771, K923444/A, K854036, K890932, K893786, K841157, K942091, K960010, K946306

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

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 | Classification
n 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:

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 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 Systems
Division | Siemens-Elema AB,
Electromedical Systems
Division | - |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------------|
| 510(k) number | Predicate devices
Siemens 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 Device
Klon Anesthesia System
K number to be decided | - |
| Parameters General | Predicate devices: All | Modified Device
Klon Anesthesia System | Explanation of the differences compared
to the Predicate devices |
| Applications and Intended Use | Infants to Adults | Same | - |
| Gas Delivery System | Pneumatic Powered Servo
Controlled "Bag in Bottle"
system. | Same | - |
| Battery Back up | No | Yes | Battery backup for the 900C is only available
with an external system. |
| Parameters Gas Dosage | Predicate devices
Siemens Servo ventilator 900C

K841529
Servo Anesthesia Circle 985 -
K893786. | Modified Device
Kion Anesthesia System | Explanation of the differences compared
to the Predicate devices |
| Fresh gas dosage
Range | Range:500 ml/min - 40 l/min | Range: 100 ml/min - 18lpm | Enhanced functionality on Kion for low flow
applications |
| 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 Delivery
Modules | Predicate devices
Siemens Vaporizers
950/951/952 and Ohmeda
Tec5 | Modified Device
Kion Anesthesia System
Vaporizers | Explanation of the differences compared
to the Predicate devices |
| Operating Principle | High pressure precision
injector | Same | - |

Magazine for three

vaporizers mounting

3

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 SV 900 and Servo
Anesthetic Circle Kion Anesthesia System Predicate devices |---------------------- | Circle System | Auxiliary Fresh Gas Outlet systems (e.g. Bain, T-piece) |
| Adjustable Pressure Regulating
(APL) valve | No | Ventilation Modes SV 900C Kion Anesthesia System Predicate devices | Manual | Volume Controlled Ventilation | Pressure Controlled Ventilation | Pressure Support | Ventilatory Control Settings SV 300 Kion Anesthesia System Predicate devices | Preset Minute Volume | Tidal Volume | CMV Rate anesthesia requirements | I:E Ratio anesthesia requirements | Pause Time Control Mode ( except for I:E | Predicate devices
985 | Modified Device
| Explanation of the differences compared to the
|
-----------------------------|----------------------------------------------------------------|------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Yes | Same | |
| No | Yes | Enhanced functionality to support external breathing
| Adjustable to 90 cm H2O | Improved functionality |
| Predicate devices
| Modified Device
| Explanation of the differences compared to the
|
| Yes | Same | |
| Yes | Same | |
| Yes | No | Planned for future enhancement in Kion |
| Yes | No | Planned for future enhancement in Kion |
| Predicate devices
| Modified Device
| Explanation of the differences compared to the
|
| 0.5 - 45LPM | Same | |
| 2 - 1500 ml | 20 - 1500 ml | Altered functionality, no neonatal capability on Kion. |
| 0.5 - 120 | 6 - 99 | Enhanced functionality due to specific clinical
|
| 1:4 - 4:1 in seven steps. | 1:3 - 4:1 in five steps. | Enhanced functionality due to specific clinical
|
| 0, 5, 10, 20, 30% of cycle | 10% of cycle in Volume

4:1 = 0%) | Enhanced functionality due to specific clinical
anesthesia requirements |
| Inspiratory Gas Flow | Maximum 180 lpm | Same | |
| Monitored Ventilatory &
Respiratory parameters | Predicate Devices
SV 900 and Servo Screen
390 | Modified Device
Kion Anesthesia System | Explanation of the differences compared to the
Predicate 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 / Analogue
Display | Yes | Same | - |
| Ventilatory Alarms | Predicate Device
SV900 | Modified Device
Kion Anesthesia System | Explanation of the differences compared to the
Predicate devices |
| | This device has the following | Same | Enhanced functionality. In addition Kion also have the
following alarms |

This device has the following	Same	Enhanced functionality. In addition Kion also have the
alarms: High Airway
Pressure, 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

4

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.

6

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

7

Page_1_of_1__

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

Device Name: ________________________________________________________________________________________

Indications for Use:

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.

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