BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000

K041430 · Blease Medical Equipment , Ltd. · BSZ · Oct 7, 2004 · Anesthesiology

Device Facts

• Record ID: K041430
• Device Name: BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000
• Applicant: Blease Medical Equipment , Ltd.
• Product Code: BSZ · Anesthesiology
• Decision Date: Oct 7, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5160
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Blease Frontline Sirius Range, Anaesthesia Machines are 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 a mechanical ventilator, and may be used for the delivery of anaesthetic vapour by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician.

Device Story

Anaesthesia machine for hospital/operating room use; delivers oxygen, air, nitrous oxide, and anaesthetic vapor to patient breathing circuits; supports mechanical ventilation; utilizes dismountable vaporizer. Operated by qualified physicians. Pneumatic systems and ventilator technology derived from predicate devices; cabinet design modified. Provides controlled gas delivery to support patient anesthesia; enables physician-controlled ventilation and gas mixture management.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Anaesthesia gas machine; pneumatic system; mechanical ventilator; dismountable vaporizer; hospital-grade cabinet construction.

Indications for Use

Indicated for hospital and operating room use for delivery of oxygen, air, nitrous oxide, and anaesthetic vapor to patient breathing circuits, with or without mechanical ventilation. Intended for use by qualified physicians.

Regulatory Classification

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. 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).

Predicate Devices

• Blease Frontline Plus (K003251)
• Blease 6200 Ventilator (K982132)

Submission Summary (Full Text)

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OCT 7 - 2004

## 041430 510(K) SUMMARY (as required by 807.92(C))

| Submitter of 510(K): | Blease Medical Equipment Ltd.<br>Deansway, Chesham<br>Bucks, England HP5 2NX<br>Phone [phone]<br>Fax [phone] | | |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|--------------------|
| Contact Person: | Richard Cooke | | |
| Date of Summary: | Thursday, 29 January 2004 | | |
| Trade Name: | Blease Frontline Sirius 2000, 3000 | | |
| Classification Code: | BSZ | | |
| Classification Name: | Anaesthesia Gas Machine | | |
| Predicate Device: | Blease Frontline Plus | Blease 6200 Ventilator | K003251<br>K982132 |
| Device Description/<br>Comparison: | The Frontline Sirius is similar to the cleared<br>Frontline Plus anaesthesia machine and the<br>6200 ventilator. The size and shape of the<br>cabinet are the different, but the pneumatic<br>systems and ventilator are the same. | | |
| Intended Use: | The Blease Frontline Sirius Range,<br>Anaesthesia Machines are intended for use<br>in the hospital environment and operating<br>room. It may be used for the delivery of<br>oxygen, air, and nitrous oxide in a controlled<br>manner to various patient breathing circuits<br>with or without the use of a mechanical<br>ventilator, and may be used for the delivery<br>of anaesthetic vapour by use of a<br>dismountable vaporizer.<br><br>The device is intended for use only by a<br>suitably qualified physician. | | |

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 7 - 2004

Blease Medical Equipment Limited C/O Mr. Arthur J. Ward AJW Technology Consultants, Incorporated 962 Allegro Lane Apollo Beach, Florida 33572

Re: K041430

Ro-11-150
Trade/Device Name: Blease Frontline Sirius Range, Anaesthesia Machine Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: II Product Code: BSZ Dated: September 2, 2004 Received: September 30, 2004

Dear Mr. Ward:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave loviewed young your end 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 mendments, 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 approvisions 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 (1 will), it inches an 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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Please be advised that FDA's issuance of a substantial equivalence determination does not I least that FDA has made a determination that your device complies with other requirements modi that I Dr may Federal statutes and regulations administered by other Federal agencies. or the Act of ally - each as the requirements, including, but not limited to: registration 1 ou must compty with a 807); labeling (21 CFR Part 801); good manufacturing practice and histing (21 er rev or), areality systems (QS) regulation (21 CFR Part 820); and if requirences as bet form 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) rms reter notification. The FDA finding of substantial equivalence of your device to a premaired notified 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), 11 you don't 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 maj overn 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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## Indications for Use

510(k) Number (if known): K041430

Device Name: Blease Frontline Sirius Range, Anaesthesia Machine

Indications for Use:

Blease Frontline Sirius Range, Anaesthesia Machines are intended for use in the hospital Dicase Fromment and operating room. It may be used for the delivery of oxygen, air and eitvronment and operating room er to various patient breathing circuits with or without Introus oxide in a comeoned manner may be used for the delivery of anaesthetic vapour by use of a dismountable vaporizer.

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

Ween
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K041430

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)