SIEMENS KION ANESTHESIA WORKSTATION - EXTENDED MODES FUNCTIONALITY, MODELS: 64 62 910 E392E, 65 22 572 E397E, 65 03 655

K024213 · Siemens Medical Solutions USA, Inc. · DSI · Mar 23, 2004 · Cardiovascular

Device Facts

• Record ID: K024213
• Device Name: SIEMENS KION ANESTHESIA WORKSTATION - EXTENDED MODES FUNCTIONALITY, MODELS: 64 62 910 E392E, 65 22 572 E397E, 65 03 655
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: DSI · Cardiovascular
• Decision Date: Mar 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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.

Device Story

KION Anesthesia Workstation delivers operator-set concentrations of oxygen and anesthesia gases; provides controlled, manual, and spontaneous ventilation. Inputs include operator settings for gas concentration and flow patterns (constant or decelerating). Device supports patients with reduced or absent breathing ability. Used in clinical anesthesia environments by trained healthcare professionals. Output consists of delivered gas mixtures and mechanical ventilation support. Clinical benefit includes precise control of patient ventilation and anesthesia delivery during procedures. Device is not MRI compatible.

Clinical Evidence

Bench testing only. No clinical data provided. Technological assessment confirmed equivalent clinical performance to predicate devices.

Technological Characteristics

Anesthesia workstation providing gas delivery and mechanical ventilation. Features include Pressure Support and Non-rebreathing modes. Utilizes modern components compared to legacy Servo 900C/300 models. Designed for clinical environment use; not MRI compatible.

Indications for Use

Indicated for neonatal to adult patients requiring anesthesia. Used for controlled, manual, or spontaneous ventilation. Contraindicated for neonates in Volume Control mode within the Circle System. Not for use in MRI suites or transport (ambulances/helicopters).

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• 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)

Reference Devices

• Servo-I (K010925)
• Servo Ventilator 300 Auto Mode (K970839)

Submission Summary (Full Text)

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# MAR 2 3 2004

| | Document Type<br>Traditional 510(k) | Section-Page<br>E-2 | |
|------------------------------------------------------------------------------------------------------------------|-------------------------------------|-----------------------|-------------|
| Object/Subject<br>KION Anesthesia Workstation - Extended Modes Functionality -<br>510(k) Summary & Certification | | Doc-ID<br>EVU 113 905 | Issue<br>00 |

## 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: [phone] Fax: [phone]

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

#### Device Description (for detailed description see Section F)

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.

#### 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 [phone]. 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 [phone] or [phone] 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 Type<br>Traditional 510(k) | Section-Page<br>H-2 |
|----------------------------------------------------------------------------------------------------------|-------------------------------------|----------------------------|
| Object/Subject<br>KION Anesthesia Workstation - Extended Modes Functionality-<br>Indicated Use Statement | | Doc-ID<br>EVU 113 905 - 00 |

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

Device Name: KION Anesthesia Workstation

## Indications For Use:

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.

#### 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)

OR

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)