(95 days)
Not Found
No
The document describes a standard anesthesia machine with a mechanical ventilator and a graphical user interface. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies.
No
The device is an anesthesia machine used for controlled delivery of gases and anesthetic vapor, and is not designed to directly treat a medical condition.
No
This device is an anesthesia machine used for delivering gases and anesthetic vapor, not for diagnosing medical conditions. Its purpose is to deliver controlled substances for medical procedures, not to identify diseases or conditions.
No
The device description explicitly mentions a physical cabinet, pneumatic systems, and a graphical user interface with a color LCD and Trak wheel control, indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an anaesthesia machine used for delivering gases and anaesthetic vapour to patients in a hospital setting. This is a therapeutic and life-support function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the mechanical and pneumatic aspects of the anaesthesia machine and its user interface. There is no mention of analyzing biological samples or performing diagnostic tests.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, the Blease Frontline Sirius Range, Anaesthesia Machines, as described, falls under the category of a medical device used for patient care and treatment, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
BSZ
Device Description
The Frontline Sirius with 8700 ventilator is similar to the cleared Frontline Sirius anaesthesia machine with the 6200 ventilator. The size and shape of the cabinet are identical, but the pneumatic systems are the same. The ventilator user interface is now graphical with colour LCD and Trak wheel control.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
suitably qualified physician, hospital environment and operating room
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5160 Gas machine for anesthesia or analgesia.
(a)
Gas machine for anesthesia —(1)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.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. 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).(2)
Classification. Class II (performance standards).
0
SEP 2 2 2005
510(K) SUMMARY (as required by 807.92(C))
| Submitter of 510(K): | Blease Medical Equipment Ltd.
Deansway, Chesham
Bucks, England HP5 2NX | |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| | Phone
Fax | +44 1494784422
+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/
Comparison: | The Frontline Sirius with 8700 ventilator is
similar to the cleared Frontline Sirius
anaesthesia machine with the 6200
ventilator. The size and shape of the
cabinet are identical, but the pneumatic
systems are the same. The ventilator user
interface is now graphical with colour LCD
and Trak wheel control. | |
| 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. | |
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 |
|---|---|
| ---------------- | --------- |