(100 days)
The Penlon Prima Anaesthesia Machine is intended to provide controlled concentrations and flows of anaesthesia gases into a patient breathing system, from where the anaesthesia ventilator and breathing circuit will deliver this fresh gas to the patient.
The Penlon Prima Anaesthesia Machine is designed to deliver a combination of medical gases and volatile anaesthetic agents to a breathing system.
The Prima Anaesthesia Machine is a continuous flow anaesthesia gas delivery device that enables the anesthetist to deliver mixtures of oxygen, air, nitrous oxide and volatile anaesthetic agents to a patient. Although the device has no direct contact with the patient it has an important role to play in a system that delivers anaesthesia gases to a patient.
The device comprises a trolley, a gas delivery system, gas control system. safety systems and facilities to mount and interface other modules of an anaesthesia delivery system, e.g. ventilators, vaporizers, absorbers plus other accessories. The design of the device conforms to all relevant national and international standards covering the safety of anesthesia systems.
This FDA submission focuses on a modification to an Anesthesia Machine, not an AI/ML powered device. Therefore, the typical acceptance criteria and study designs associated with AI/ML device approval (which involve metrics like sensitivity, specificity, reader studies, etc.) are not applicable here.
The document describes a Special 510(k) for a device modification, which emphasizes demonstrating that the modified device is substantially equivalent to a legally marketed predicate device. The information provided is primarily administrative and descriptive, outlining the device's function, intended use, and technological characteristics. There is no mention of a study involving clinical performance metrics, reader studies, or explicit acceptance criteria in the format you've requested for an AI/ML device.
Here's why the requested information cannot be fully provided based on the given document:
- No AI/ML Component: The device is an "Anaesthesia Machine," a hardware medical device. There's no indication of any AI or machine learning algorithms involved.
- Focus on Substantial Equivalence: For this type of device modification submission, the "study" is often a demonstration through engineering analysis, design documentation, and testing (e.g., electrical safety, mechanical integrity, gas delivery accuracy) that the modified device performs as intended and is as safe and effective as the predicate. These are typically internal validation activities, not public "studies" with performance metrics like those for diagnostic AI.
- Lack of Specific Quantitative Performance Data: The document does not contain tables of performance metrics (like sensitivity, specificity, AUC), sample sizes for test sets, expert ground truth establishment, or details about reader studies.
If this were an AI/ML powered device submission, the requested information would be crucial. However, for a traditional hardware device modification, the content of the provided 510(k) summary is typical.
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JUL 2 8 2005
Section 12 Appendix 12-1 Prima Anaesthesia Machine Special 510(k): Device Modification
510(k) Summary
(in accordance with 21 CFR 807.87(h) and 21 CFR 807.92)
1. Submitter's name and address: Penlon Limited Abingdon Science Park
Barton Lane Abinadon Oxfordshire POX14 3PH n K.
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- Submitter's telephone number and fax number: Tel: 011 44 1235 547000 Fax: 011 44 1235 547041
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- Contact person: Mr. Alan Green - Technical Director
- Date this 510(k) summary prepared: 4. March 28, 2006
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- Trade/proprietary name of the device: Prima Anaesthesia Machine
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- Classification name and number of the device: Gas Machine for Anaesthesia 21CFR 868,5160
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- Legally marketed predicate devices to which substantial equivalence is claimed:
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- Penlon Limited AM1000 Anaesthesia Machine FDA 510(k) No. K844008 Approval to market this device given by FDA on March 12, 1985 FDA Device Classification: Class 2 FDA Regulation Number: 21CFR 868.5160 FDA Classification Code: BSZ
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- Bear Medical Systems, Inc. AM1000 Anaesthesia Machine FDA 510(k) No. K864590 Approval to market this device given by FDA on May 4, 1987 FDA Device Classification: Class 2
- FDA Regulation Number: 21CFR 868.5160
- FDA Classification Code: BSZ
Appendix 12-1 Page 1 of 2
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Section 12 Appendix 12-1 Prima Anaesthesia Machine Special 510(k): Device Modification
510(k) Summary (continued)
(in accordance with 21 CFR 807.87(h) and 21 CFR 807.92)
8. Description of the device that is the subject of this premarket notification:
The Prima Anaesthesia Machine is a continuous flow anaesthesia gas delivery device that enables the anesthetist to deliver mixtures of oxygen, air, nitrous oxide and volatile anaesthetic agents to a patient. Although the device has no direct contact with the patient it has an important role to play in a system that delivers anaesthesia gases to a patient.
த். Intended use and indication for use:
The Prima Anaesthesia Machine is intended to provide controlled concentrations and flows of anaesthesia gases into a patient breathing system, from where the anaesthesia ventilator and breathing circuit will deliver this fresh gas to the patient.
The machine is intended for use by health care providers, i.e. Physicians, Nurses and Technicians for use with patients during general anaesthesia in suitably equipped operating rooms.
The Prima Anaesthesia Machine is a prescription device and the labelling indicates this.
10. Technological characteristics:
The device comprises a trolley, a gas delivery system, gas control system. safety systems and facilities to mount and interface other modules of an anaesthesia delivery system, e.g. ventilators, vaporizers, absorbers plus other accessories. The design of the device conforms to all relevant national and international standards covering the safety of anesthesia systems.
Different versions of the Prima Anaesthesia Machine exist for the delivery of anaesthetics in differing locations and sizes of operating rooms e.g. in hospitals, surgery centers and doctors offices. All versions utilize the same component modules, method of construction and safety devices hence simplifying the servicing operations and minimizing the maintenance requirements of the medical center.
This concludes the 510(k) Summary.
Appendix 12-1 Page 2 of 2
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 6 2006
Penlon Limited C/O Mr. Barry Pearce Shotwell & Carr, Incorporated 25 Barker Close Fishbourne Chickester, UNITED KINGDOM P0188BJ
Re: K061102
Trade/Device Name: Penlon Prima Anaesthesia Machine Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: II Product Code: BSZ Dated: July 6, 2006 Received: July 10, 2006
Dear Mr. Pearce:
This letter corrects our substantially equivalent letter of July 28, 2006.
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 (PMA). You may, therefore, market the device, subject to the general controls 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 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. Pearce
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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), please contact the Office of Compliance at (240) 276-0120. 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. Division 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): K061102
Device Name: Penlon Prima Anaesthesia Machine
Indications for Use:
The Penlon Prima Anaesthesia Machine is designed to deliver a combination of medical gases and volatile anaesthetic agents to a breathing system.
Over-The-Counter Use _ NO YES Prescription Use _ Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Page 1 of 1
: Number
§ 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).