BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000

{0}------------------------------------------------ SEP 2 2 2005 K051629 ## 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 | | |------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------| | | Phone<br>Fax | +44 1494784422<br>+44 1494 791497 | | Contact Person: | Richard Cooke | | | Date of Summary: | Monday, 19 September 2005 | | | Trade Name: | Blease Frontline Sirius 2000, 3000 | | | Classification Code: | BSZ | | | Classification Name: | Anaesthesia Gas Machine | | | Predicate Device: | Blease Frontline Sirius | K041430 | | Device Description/<br>Comparison: | The Frontline Sirius with 8700 ventilator is<br>similar to the cleared Frontline Sirius<br>anaesthesia machine with the 6200<br>ventilator. The size and shape of the<br>cabinet are identical, but the pneumatic<br>systems are the same. The ventilator user<br>interface is now graphical with colour LCD<br>and Trak wheel control. | | | 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>The device is intended for use only by a<br>suitably qualified physician. | | {1}------------------------------------------------ Test and Validation The system has been validated by testing to all relevant US standards covering operation, Safety, EMC. Full performance testing and validation to r an perioduct, software, manufacturing the Bloads proog specification has been carried out with satisfactory results using traceable calibrated test equipment. {2}------------------------------------------------ Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three bars representing the human services aspect. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. ## SEP 2 2 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Blease USA, Incorporated C/O Mr. Arthur J. Ward AJW Technology Consultants, Incorporated 962 Allegro Lane Apollo Beach, Florida 33572 Re: K051629 K051629 Trade/Device Name: Blease Frontline Sirius Range Anaesthesia Machines Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: II Product Code: BSZ Dated: September 8, 2005 Received: September 12, 2005 Dear Mr. Ward: We have reviewed your Section 510(k) premarket notification of intent to market the device to We nave reviewed your Section 910(to) production is substantially equivalent (for the devices may referenced above and have decemmed the active marketed predicate devices marketed in indications for use stated in the enclosure) to legally marketed profita Medical Device indications for use stated in the cholorary to regional date of the Medical Device interstate commerce prior to way 20, 1970, are child in accordance with the provisions of Amendments, of to devices that have obsition that do not require approval of a premarket the agencel the Federal Food, Drug, and Cosmetic Fee (10) ... market the device, subject to the general approval application (1 Mr.). I ou . The general controls provisions of the Act include controls provisions of the rea. "The genting of devices, good manufacturing practice, requirements for animons against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see above) into controls. Existing major regulations affecting (PMA), it may be subject to such additions, Title 21, Parts 800 to 898. In the Federal your device can be found in the Couc of Pecessaring your device in the Federal Register. {3}------------------------------------------------ Page 2 - Mr. Ward Please be advised that FDA's issuance of a substantial equivalence determination does not Piease be advised that IDA 3 issualled of a basedan is a complies with other requirements mean that FDA has made a decommances and regulations administered by other Federal agencies. of the Act of any Federal statutes and regulations, but not limited to: registration You must comply with an the Hotel Ing (21 CFR Part 801); good manufacturing practice and ilsung (21 CFR Part 807), labeling (20 mg (QS) regulation (21 CFR Part 820); and if requirements as set forth in the quality bjections (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) This letter will anow you to begin maileding 7 bastantial equivalence of your device to a premarket notification. The PDF miding of cassification 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), If you desire specific advice for your de at (240) 276-0120. Also, please note the regulation please contact inc Office or Somphanes and (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Division of Shares (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Clive Shin, Liz, Ph.D. 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 {4}------------------------------------------------ 510(k) Number (if known):K051629 DEVICE NAME: Blease Frontline Sirius Range Anaesthesia Machines INDICATIONS FOR USE: The Blease Frontline Sirius Range, Anaesthesia Machines are intended for use in The Blease Frontine Sinus Runge, Andeshell in may be used for the delivery of the nospital enviroriment and operating room. It in they so arous patient breathing oxygen, air, and nitrous oxide in a controlled mannel to verod for the oxygen, alr, and hitrous oxide in a control mannel ator, and may be used for the circults with of without the ass of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician. ## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign Off) Division of, Anesthesiology , General Hospital, Infection Control and Dental Devices | Prescription Use | YES | OR | Over The Counter - | |------------------|--------------------------|----|--------------------| | Use | (Optional Format 1-2-96) | | | (Per 21 CFR 801.109) (Division Sign Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | 510(k) Number: | K051629 | |----------------|---------| |----------------|---------|