(161 days)
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No
The summary describes a device for administering anesthetic gases with no mention of AI or ML capabilities.
No.
The device administers anaesthetic agents to induce and maintain anaesthesia, which is a supportive function during medical procedures, rather than directly treating a disease or therapeutic condition.
No
The device provides continuous gas inhalation for anesthesia and facilitates the control and administration of gas mixtures. It is not described as detecting, monitoring, or analyzing physiological parameters for diagnostic purposes.
No
The device description clearly states it is an "Anaesthesia Induction Unit" which provides "continuous gas inhalation" and facilitates the "control and administration of operator selected gas mixtures". This indicates a physical device with hardware components for gas delivery and control, not a software-only device.
Based on the provided text, the Hawk Anaesthesia Induction Unit is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The description of the Hawk Anaesthesia Induction Unit clearly states its purpose is to provide continuous gas inhalation for patients during anaesthesia induction. It directly interacts with the patient's respiratory system, not with in vitro specimens.
The device's function and intended use fall under the category of a therapeutic or life support device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Hawk Anaesthesia Induction Unit is a medical device for providing continuous gas inhalation for adults and children above 5 kg body weight. It facilitates the control and administration of operator selected gas mixtures with anaesthetic agents. The anaesthetic agents are accurately dispensed by a suitable anaesthetic vaporiser, of the type specified, which may be safely and securely attached to the modular backbar.
The Hawk provides safe and accurate gas flows to maintain patient respiration during induction of anaesthesia. It is specified for use with an oxygen monitor and other suitable monitoring, these monitors are specified in the operator's manual.
The Hawk may be safely used with magnetic resonance imaging systems (MRJ) as it is MRI compatible.
It is recommended that pre-use checks and preparation is done by suitably qualified technicians, and that the device is used only by trained and qualified physicians. The device is used in the induction room, operating room, recovery room or similar surgical environments.
Product codes
73 BSZ
Device Description
The MIE Hawk Anaesthesia Induction Unit
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
adults and children above 5 kg body weight
Intended User / Care Setting
suitably qualified technicians, and ... trained and qualified physicians. The device is used in the induction room, operating room, recovery room or similar surgical environments.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, facing to the right. The eagle is composed of multiple lines, giving it a modern and abstract appearance. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", arranged in a circular fashion around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 3 1998
Mr. .Henry Marshall Medical Industrial Equipment Ltd. Falcon Road, Sowton Industrial Estate Exeter, Devon, EX2 7NA ENGLAND
Re: K981845 Hawk™ Anaesthesia Induction Unit Requlatory Class: II (two) Product Code: 73 BSZ Dated: October 9, 1998 Received: October 13, 1998
Dear Mr. Marshall:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. Henry Marshall
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Sincerely yours,
Thomas J. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
ﺎ ﻓ
Enclosure
2
510(k) Number (if known):
Device name: The MIE Hawk Anaesthesia Induction Unit
Indications For Use:
The Hawk Anaesthesia Induction Unit is a medical device for providing continuous gas inhalation for adults and children above 5 kg body weight. It facilitates the control and administration of operator selected gas mixtures with anaesthetic agents . The anaesthetic agents are accurately dispensed by a suitable anaesthetic vaporiser, of the type specified, which may be safely and securely attached to the modular backbar.
The Hawk provides safe and accurate gas flows to maintain patient respiration during induction of anaesthesia. It is specified for use with an oxygen monitor and other suitable monitoring, these monitors are specified in the operator's manual.
The Hawk may be safely used with magnetic resonance imaging systems (MRJ) as it is MRI compatible.
It is recommended that pre-use checks and preparation is done by suitably qualified technicians, and that the device is used only by trained and qualified physicians. The device is used in the induction room, operating room, recovery room or similar surgical environments.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark Kranier
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K981845
Image /page/2/Picture/11 description: The image shows the words "Prescription Use" with a check mark above the word "Use". Underneath the words "Prescription Use" is the text "(Per 21 CFR 801.109)". The check mark indicates that the prescription use is selected. The text is black and the background is white.
Over The Counter Use
(Optional Format 1-2-96)