SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION

K101850 · Spacelabs Healthcare, Ltd. · CBK · Mar 2, 2011 · Anesthesiology

Device Facts

• Record ID: K101850
• Device Name: SPACELABS BLEASESIRIUS ANESTHESIA WORKSTATION
• Applicant: Spacelabs Healthcare, Ltd.
• Product Code: CBK · Anesthesiology
• Decision Date: Mar 2, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Spacelabs BleaseSirius 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

Anesthesia workstation; controls, mixes, and distributes medical gases (O2, air, N2O) and anesthetic vapors to patient breathing circuits. Operates with or without mechanical ventilation; utilizes dismountable vaporizers. Used in hospital operating rooms by qualified physicians. Provides controlled gas delivery to support anesthesia administration. Substantially equivalent to previous Blease Frontline Sirius models; maintains same breathing circuit compatibility and core pneumatic functionality.

Clinical Evidence

Bench testing only. No clinical data provided. Device performance verified against predetermined specifications and applicable electrical safety and EMC standards. Software verified and validated through a robust development process.

Technological Characteristics

Anesthesia workstation; pneumatic gas mixing and delivery system. Includes dismountable vaporizers and mechanical ventilator integration. Compatible with existing Blease Frontline Sirius breathing circuits. Complies with applicable electrical safety and EMC standards.

Indications for Use

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

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 Blease Frontline Sirius 2000, 3000 (K051629)

Submission Summary (Full Text)

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# 510(k) Premarket Notification Spacelabs Healthcare Ltd. BleaseSirius Anesthesia Workstation 510(k) Summary

KI01850 MAR - 2 2011

| Submission Date: | 28 June 2010 | | |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|----------------------------------------------------|
| 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, Ltd.)<br>Phone: [phone], ext 5889<br>Fax: [phone]<br>Email: [e-mail] | | |
| Official Contact: | Thomas Kroenke<br>Principal Consultant<br>Speed To Market, Inc.<br>PO Box 3018<br>Nederland, CO 80466 USA<br>[e-mail]<br>303 956 4232 | | |
| Manufacturing Site: | Spacelabs Medical, Inc.<br>5150 220th Avenue SE<br>Issaquah, WA 98029 USA | | |
| Trade Name: | Spacelabs BleaseSirius Anesthesia Workstation | | |
| Common Name: | Anesthesia Gas Machine | | |
| Classification Name: | Gas-machine, Anesthesia | | |
| Classification<br>Regulation: | 21 CFR §868.5160 | | |
| Product Code: | BSZ | | |
| Substantially<br>Equivalent Devices: | New Spacelabs Model | Predicate<br>510(k) Number | Predicate<br>Manufacturer / Model |
| | Spacelabs BleaseSirius<br>Anesthesia Workstation | K051629 | Spacelabs Blease<br>Frontline Sirius 2000,<br>3000 |

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### 510(k) Premarket Notification Spacelabs Healthcare Ltd. BleaseSirius Anesthesia Workstation 510(k) Summary

The Spacelabs BleaseSirius Anesthesia Workstation (BleaseSirius) is Device Description: an anesthesia workstation that contains all the pneumatic circuitry, controls, monitoring, ancillaries and storage required to control, distribute and mix medical gases and anesthetic agents in order to deliver them to a patient system. It is capable of delivering 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 Spacelabs BleaseSirius is the latest generation product in a family of anesthesia workstations. The same breathing circuits used with the predicate device, the Blease Frontline Sirius 2000, 3000 cleared by FDA in 510(k) premarket notification K051629, are used with the Spacelabs BleaseSirius. The Spacelabs BleaseSirius Anesthesia Workstation is intended for use Intended 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. The Spacelabs BleaseSirius Anesthesia Workstation employs the same Technology technological characteristics as the predicate device. Comparison: Summary of Performance Testing: The Spacelabs BleaseSirius was tested for patient safety in accordance Electrical Safety with applicable Standards. Test results indicated that the Spacelabs BleaseSirius complies with its predetermined specification and with the applicable Standards. The Spacelabs BleaseSirius was tested for EMC in accordance with Electromagnetic applicable Standards. Compatibility Test results indicated that the Spacelabs BleaseSirius complies with its Testing predetermined specification and with the applicable Standards.

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# 510(k) Premarket Notification Spacelabs Healthcare Ltd. BleaseSirius Anesthesia Workstation 510(k) Summary

| Performance Testing | The Spacelabs BleaseSirius was tested for performance in accordance<br>with predetermined specifications and applicable Standards. |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Test results indicated that the Spacelabs BleaseSirius complies with its<br>predetermined specification and with the applicable Standards. |
| Software Testing | Software for the Spacelabs BleaseSirius was designed and developed<br>according to a robust software development process, and was rigorously<br>verified and validated. |
| | Test results indicated that the Spacelabs BleaseSirius complies with its<br>predetermined specification. |
| Conclusion | Based upon a comparison of devices and performance testing results,<br>Spacelabs BleaseSirius is substantially equivalent to the predicate<br>device. |

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo features a stylized image of an eagle or bird with outstretched wings, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Spacelabs Healthcare Limited C/O Mr. Thomas Kroenke Speed to Market, Incorporated PO Box 3018 Nederland, Colorado 80466

MAR - 2 2011

Re: K101850

Trade/Device Name: Spacelabs BleaseSirius Anesthesia Workstation Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: February 18, 2011 Received: February 22, 2011

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. Kroenke

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 (OS) 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,

Anthony V. aver

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

Enclosure

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#### Indications for Use

| 510(k) Number (if known): | K101850 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Spacelabs BleaseSirius Anesthesia Workstation |
| Indications for Use: | The Spacelabs BleaseSirius Anesthesia Workstation is intended<br>for use in the hospital environment and operating room. It may<br>be used for the delivery of oxygen, air and nitrous oxide in a<br>controlled manner to various patient breathing circuits with or<br>without the use of mechanical ventilator, and may be used for the<br>delivery of anesthetic vapor by use of a dismountable vaporizer.<br><br>The device is intended for use only by a suitably qualified<br>physician. |

X Prescription Use (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)

ce of Device Evaluation (ODE)

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Control Coursel, Dental Devices Division of Antosthools - 1999
Infection Control, Dental Devices

510(k) Number: K101850