SPACELABS ARKON ANESTHESIA WORKSTATION

K113051 · Spacelabs Healthcare · CBK · Mar 22, 2012 · Anesthesiology

Device Facts

• Record ID: K113051
• Device Name: SPACELABS ARKON ANESTHESIA WORKSTATION
• Applicant: Spacelabs Healthcare
• Product Code: CBK · Anesthesiology
• Decision Date: Mar 22, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician.

Device Story

Arkon Anesthesia Workstation integrates pneumatic circuitry, controls, monitoring, and gas delivery systems; manages oxygen, air, and nitrous oxide distribution; facilitates anesthetic vapor delivery via dismountable vaporizer. Used in hospital operating rooms by qualified physicians. Device provides controlled gas/vapor delivery to patient breathing circuits; supports mechanical ventilation. Healthcare providers monitor system output to manage patient anesthesia and respiratory support during surgical procedures. Benefits include precise control of anesthetic delivery and ventilation, supporting patient stability during surgery.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified against standards including IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), ISO 10993-1 (biocompatibility), ASTM F1101-90 (ventilator performance), and IEC 60601-2-13 (anesthetic systems). Usability validated per IEC 60601-1-6 and IEC 62366. Software verified and validated per IEC 62304 and FDA guidance.

Technological Characteristics

Anesthesia workstation with integrated pneumatic circuitry, gas mixing, and mechanical ventilation. Materials verified per ISO 10993-1. Connectivity includes standard medical gas interfaces (CGA V-5). Complies with IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), and IEC 60601-2-13 (anesthetic systems). Software developed per IEC 62304. Includes alarm systems per IEC 60601-1-8.

Indications for Use

Indicated for use in hospital operating rooms by qualified physicians for the delivery of oxygen, air, nitrous oxide, and anesthetic vapors to patients via breathing circuits, with or without mechanical ventilation.

Regulatory Classification

Identification

A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

Predicate Devices

• Spacelabs BleaseSirius Anesthesia Workstation (K101850)

Submission Summary (Full Text)

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K113051

## MAR 2 2 2012

:

# 510(k) Summary

| Submission Date: | 11 October 2011 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Submitter: | Spacelabs Healthcare Ltd.<br>1 Harforde Court, John Tate Road<br>Hertford, SG13 7NW United Kingdom |
| Submitter Contact: | Mr. David J. Geraghty<br>Spacelabs Medical, Inc. (for Spacelabs Healthcare)<br>Phone: [phone], ext 5889 |
| | Fax: [phone]<br>Email: [e-mail] |
| Official<br>Correspondent: | Thomas Kroenke<br>Principal Consultant<br>Speed To Market, Inc. |
| | PO Box 3018<br>Nederland, CO 80466 USA<br>[e-mail]<br>[phone] |
| Manufacturing Site: | Spacelabs Medical, Inc.<br>5150 220th Avenue SE<br>Issaquah, WA 98029 USA |
| Trade Name: | Spacelabs Arkon Anesthesia Workstation |
| Common Name: | Anesthesia workstation with continuous ventilator |
| Classification Name: | Ventilator, continuous, facility use;<br>Gas-machine, anesthesia |
| Classification<br>Regulation: | 21 CFR §868.5895;<br>21 CFR §868.5160 |
| Primary Product<br>Code: | CBK |
| Secondary Product<br>Code: | BSZ |

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### 510(k) Summary

| Substantially<br>Equivalent Devices: | New Spacelabs Model | Predicate<br>510(k) Number | Predicate<br>Manufacturer / Model |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|--------------------------------------------------|
| | Spacelabs Arkon<br>Anesthesia Workstation | K101850 | Spacelabs BleaseSirius<br>Anesthesia Workstation |
| Device Description: | The Spacelabs Arkon Anesthesia Workstation (Arkon) is an anesthesia<br>workstation that contains all the pneumatic circuitry, controls,<br>monitoring, ancillaries and storage required to control, distribute and<br>mix medical gases and anesthetic agents in order to deliver them to a<br>patient system. It is capable of delivering oxygen, air and nitrous oxide<br>in a controlled manner to various patient breathing circuits with or<br>without the use of a mechanical ventilator, and may be used for the<br>delivery of anesthetic vapor by use of a dismountable vaporizer. | | |
| Intended Use: | The Spacelabs Arkon Anesthesia Workstation is intended for use in the<br>hospital environment and operating room. It may be used for the<br>delivery of oxygen, air and nitrous oxide in a controlled manner to<br>various patient breathing circuits with or without the use of mechanical<br>ventilator, and may be used for the delivery of anesthetic vapor by use<br>of a dismountable vaporizer. | | |
| | The device is intended for use only by a suitably qualified physician. | | |
| Technology<br>Comparison: | The Spacelabs Arkon Anesthesia Workstation employs the same<br>technological characteristics as the predicate device.fs | | |
| Summary of Performance Testing: | | | |
| Biocompatibility | Patient contact materials within the Arkon and its accessories were | | |

verified in accordance with the following standard: Verification ISO 10993-1: 2009, Biological evaluation of medical devices – Part .

- 1 : Evaluation and testing within a risk management process.
Verification results indicated that the materials comply with the standard.

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# 510(k) Summary

| Software Testing | The Arkon software was designed and developed according to a robust<br>software development process, and was rigorously verified and<br>validated. Software information is provided in accordance with internal<br>requirements and the following standards and guidance documents:<br>FDA guidance: The content of premarket submissions for software<br>contained in medical devices, 11 May 05; FDA guidance: Off-the-shelf software use in medical devices, 09<br>Sep 99; and FDA guidance: General principles of software validation; Final<br>guidance for industry and FDA staff, 11 Jan 02. IEC 62304: 2006, Medical device software – Software life cycle<br>processes. ISO 14971: 2007, Medical devices – Application of risk<br>management to medical devices Test results indicate that the Arkon complies with its predetermined<br>specifications and the applicable standards and guidance documents. |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrical Safety<br>Testing | The Arkon was tested for patient safety in accordance with the<br>following standards:<br>IEC 60601-1: 1988, Am1: 1991, Am2: 1995, Medical Electrical<br>Equipment, Part 1: General Requirements for Safety; and UL 60601-1: 2006, Medical Electrical Equipment, Part 1:<br>Particular Requirements for Safety. Test results indicated that the Arkon complies with the applicable<br>Standards. |
| Electromagnetic<br>Compatibility<br>Testing | The Arkon was tested for EMC in accordance with the following<br>standard:<br>IEC 60601-1-2: 2007, Medical Electrical Equipment, Part 1: Part<br>1-2: General Requirements for Safety – Collateral Standard:<br>Electromagnetic Compatibility-Requirements and Tests. Test results indicated that the Arkon complies with the applicable<br>Standard. |

.

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### 510(k) Summary

#### The Arkon was tested for performance in accordance with internal Performance Testing requirements and the following standards:

- IEC 60601-1-6: 2004, Medical electrical equipment Part 1-6: . General requirements for basic safety and essential performance -Collateral standard: Usability.
- IEC 60601-1-8: 2006, Medical electrical equipment General . requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.
- ASTM F1101-90 (2003) e1, Standard Specification for ventilators . intended for use during anesthesia.
- CGA C-9: 2004, Standard Color Marking of Compressed Gas . Containers for Medical Use.
- CGA V-5: 2008, Diameter Index Safety System . (Noninterchangeable Low Pressure Connections for Medical Gas Applications).
- IEC 60601-2-13: 2003, Am1: 2006, Medical electrical equipment -. Particular requirements for the safety and performance of anesthetic systems.
- IEC 62366: 2007, Medical devices Application of usability . engineering to medical devices.
- ISO 5356-1: 2004, Anaesthetic and respiratory equipment Conical . connectors - Part I: Cones and sockets.
- ISTA Procedure IB, Non-simulation integrity performance test . procedure - Packaged-products over 150 lb (68 kg).

Test results indicate that the Arkon complies with its predetermined specifications and the applicable standards.

Verification and validation activities were conducted to establish the Conclusion performance and safety characteristics of the Arkon. The results of these activities demonstrate that the Arkon is safe and effective when used in accordance with its intended use and labeling.

> Therefore, the Arkon is considered substantially equivalent to the predicate device.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/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 an abstract image of an eagle or bird-like figure with three wing-like shapes.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002

MAR 2 2 2012 .

Spacelabs Healthcare, LTD C/O Mr. Thomas Kroenke Principal Consultant Speed To Market, Inc. P.O. Box 3018 Nederland, Colorado 80466

Re: K113051

Trade/Device Name: Spacelabs Arkon Anesthesia Workstation Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK, BSZ Dated: February 23, 2012 Received: February 24, 2012

Dear Mr. Kroenke:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Kroënke

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

K

510(k) Number (if known):

Device Name:

Indications for Use:

Spacelabs Arkon Anesthesia Workstation

The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer.

The device is intended for use only by a suitably qualified physician.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for. L. Schutheis
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number. K11/3

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