(328 days)
Not Found
Not Found
No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
Yes
The device is described as an "anagelsia gas machine" used for "nitrous oxide/oxygen sedation systems," indicating its purpose is to provide pain relief and sedation, which are therapeutic actions.
No
Explanation: This device is for delivering a mixture of nitrous oxide and oxygen gases for sedation, which is a therapeutic function, not a diagnostic one.
No
The device description clearly indicates it is a physical "anagelsia gas machine" used for delivering gas mixtures, which is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver a mixture of nitrous oxide and oxygen gases to a patient for sedation. This is a therapeutic and procedural use, not a diagnostic one.
- Lack of Diagnostic Activity: IVD devices are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such examination of specimens.
- Device Description (Not Found): While the description is missing, the intended use clearly points away from diagnostic activity.
- Other Sections: The absence of information related to image processing, AI/ML, imaging modalities, anatomical sites, training/test sets, performance studies, and key metrics further supports that this is not a diagnostic device. These sections are typically relevant for devices that analyze data or images for diagnostic purposes.
In summary, the primary function of this device is the delivery of gases for sedation, which falls under the category of therapeutic or procedural medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
This anagelsia gas machine is to be used in nitrous oxide/oxygen sedation systems for the delivery to a patient a mixture of nitrous oxide and oxygen gases where the maximum nitrous oxide concentration is 70%.
Product codes
73 ELI
Device Description
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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
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Rockville MD 20857
DEC I 0 1997
Mr. James R. Moore Technical Medical Products, Inc. 2020 West Melinda Lane Phoenix, Arizona 85027
Re : K970163 Model 20 Alpha MX Gas Machine for Analgesia and Model 30 Ultra PC Gas Machine for Analgesia Regulatory Class: II (two) Product Code: 73 ELI Dated: September 12, 1997 Received: September 15, 1997
Dear Mr. Moore:
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 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). 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 regulation (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 requlation 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. James R. Moore
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 regulation 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/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number if Known: K970163
Device Name:
Classification Name - Gas machine for analgesia
Trade Name
Alpha MX Anage sia gas machine Model 20
Ultra PC Anagersia gas machine Model 30
Indications for Use:
This anagelsia gas machine is to be used in nitrous oxide/oxygen sedation systems for the delivery to a patient a mixture of nitrous oxide and oxygen gases where the maximum nitrous oxide concentration is 70%.
(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 Cardiovascular, Respiratory, and Neurological Devices | |
|---|---|
| 510(k) Number | K970163 |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-the-Counter-Use | |
|---|---|---|---|
| --------------------------------------- | -- | ---- | ---------------------- |