(95 days)
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.
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.
The provided document is a 510(k) summary for a medical device, the Blease Frontline Sirius Range Anaesthesia Machines. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the specific information required to answer your questions about acceptance criteria and a study proving those criteria are met for the following reasons:
- Focus of 510(k) Summary: A 510(k) summary primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, not on detailing a comprehensive study with acceptance criteria for a new device's performance. It often refers to compliance with standards rather than specific performance metrics.
- Nature of the Device: Anesthesia machines are complex integrated systems. Their "performance" is typically assessed against recognized industry standards (e.g., ISO, IEC) for aspects like gas delivery accuracy, pressure regulation, alarm functions, and safety, rather than through a single "study" with statistical endpoints like those for a diagnostic AI device.
Therefore, many of your specific questions cannot be answered from the provided text. I will indicate where the information is available and where it is not.
Acceptance Criteria and Study for Blease Frontline Sirius Range Anaesthesia Machines
The provided document, a 510(k) summary, indicates compliance with relevant standards rather than presenting a performance study with specific acceptance criteria in the format requested for AI/diagnostic devices. The core of the submission is to demonstrate substantial equivalence to a predicate device (Blease Frontline Sirius with 6200 ventilator) for an updated version (Blease Frontline Sirius with 8700 ventilator).
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as specific numerical acceptance criteria. The document states: "The system has been validated by testing to all relevant US standards covering operation, Safety, EMC." | The document states: "Full performance testing and validation to... product, software, manufacturing... specification has been carried out with satisfactory results using traceable calibrated test equipment." |
| Implicitly, the device must meet the performance and safety requirements outlined in the specified "relevant US standards." | The "satisfactory results" indicate that the device met these standards and specifications. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The testing refers to "performance testing," which typically involves bench testing against engineering specifications and relevant standards, not a "test set" in the context of diagnostic or AI studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. "Ground truth" in the context of an anesthesia machine's performance would relate to its ability to accurately deliver gases and maintain patient safety according to established medical and engineering principles, often validated through direct measurement against calibrated instruments, rather than expert consensus on diagnostic images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which is not the primary mode of validation for an anesthesia machine's core functional performance.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no indication of an MRMC study being performed. This type of study is completely inappropriate for an anesthesia gas machine, which is a physical device delivering therapeutics, not a diagnostic imaging or AI system that aids human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to this device. An anesthesia machine is not an algorithm; it is a physical and mechanical device with integrated software. Its performance is always "standalone" in the sense that it operates according to its design, delivering gas and monitoring, but it requires a human operator (a "suitably qualified physician" as stated in the intended use) for clinical application and management.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for an anesthesia machine's performance is adherence to established engineering specifications, recognized industry standards (e.g., ISO, IEC for medical electrical equipment, gas delivery systems), and the principles of safe and effective medical gas delivery. This is typically established through:
- Bench testing: Direct measurement of gas flow, pressure, concentration, alarm thresholds, etc., using calibrated reference equipment.
- Compliance with standards: Demonstrating that the device meets the pass/fail criteria defined in relevant national and international medical device standards.
8. The sample size for the training set
This information is not provided and is not applicable to this type of device. "Training set" refers to data used to train machine learning algorithms. The Blease Frontline Sirius Range Anaesthesia Machine is not an AI/ML product in the sense that it would require a training set; it's a conventional medical device.
9. How the ground truth for the training set was established
This information is not provided and is not applicable for the reasons stated above.
{0}------------------------------------------------
SEP 2 2 2005
510(K) SUMMARY (as required by 807.92(C))
| Submitter of 510(K): | Blease Medical Equipment Ltd.Deansway, CheshamBucks, England HP5 2NX | |
|---|---|---|
| PhoneFax | +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 issimilar to the cleared Frontline Siriusanaesthesia machine with the 6200ventilator. The size and shape of thecabinet are identical, but the pneumaticsystems are the same. The ventilator userinterface is now graphical with colour LCDand Trak wheel control. | |
| Intended Use: | The Blease Frontline Sirius Range,Anaesthesia Machines are intended for usein the hospital environment and operatingroom. It may be used for the delivery ofoxygen, air, and nitrous oxide in a controlledmanner to various patient breathing circuitswith or without the use of a mechanicalventilator, and may be used for the deliveryof anaesthetic vapour by use of adismountable vaporizer.The device is intended for use only by asuitably 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 |
|---|---|
| ---------------- | --------- |
§ 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).