(446 days)
Not Found
Not Found
No
The provided text does not contain any mention of AI, ML, deep learning, or related concepts. The description focuses on the device's function as a patient-controlled analgesia device for drug delivery.
Yes
The device is intended to deliver analgesic medications to patients for pain management, which is a therapeutic purpose.
No
Explanation: The device is intended for delivering analgesic medications, not for diagnosing conditions. It is a treatment device, not a diagnostic one.
No
The device description is not found, but the intended use clearly describes a device for delivering analgesic medications through IV and epidural routes, which inherently involves hardware components for drug delivery.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a means of delivering analgesic medications to patients through intravenous and epidural routes. This is a therapeutic function, not a diagnostic one.
- Lack of Diagnostic Activity: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Device Description (Not Found): While the description is missing, the intended use clearly points away from an IVD.
- Other Sections: The absence of information about image processing, AI/ML, imaging modality, anatomical site, training/test sets, performance studies, and key metrics further supports that this is not a diagnostic device.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This device is designed to administer medication.
N/A
Intended Use / Indications for Use
Go Medical Patient Controlled Analgesia Devices, if properly used, are intended to provide a safe and effective means of delivering various analgesic medications to in-patients and out-patients, on both an acute and/or chronic basis. This can be peformed through intravenous (IV) and epidural routes of administration. The device will be available only by prescription and will carry the following legend: "Caution : Federal Law restricts this device to sale by or on the order of a physician". (21 CFR 801.109(b)(1))
Product codes
MEA
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
in-patients and out-patients, prescription only by physician order
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
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 features a stylized caduceus, which is a symbol of medicine, with three lines representing the staff and two snakes intertwined around it. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
APR 2 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. George O'Neal Henning Enterprises Europe S.R.L. 25 Shann Street Floreat Park Perth AUSTRALIA 6014
Re: K020421
Trade/Device Name: Go Medical Patient Controlled Analgesia Devices (PCA) Devices Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEA Dated: February 12, 2003 Received: February 24, 2003
Dear Dr. O' Neil:
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 application (PMA). 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 vour device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting vour 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.
1
Page 2 - Dr. O' Neil
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 begin 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 (301) 594-4618. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Rumer
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE STATEMENT
510 (k) Number:
wmo RU20421 To be Assoned
Trade Name:
Go Medical PCA Devices
Indications For Use:
Go Medical Patient Controlled Analgesia Devices, if properly used, are intended to provide a safe and effective means of delivering various analgesic medications to in-patients and out-patients, on both an acute and/or chronic basis. This can be peformed through intravenous (IV) and epidural routes of administration. The device will be available only by prescription and will carry the following legend: "Caution : Federal Law restricts this device to sale by or on the order of a physician". (21 CFR 801.109(b)(1))
Patricia Quixote
(Division Sign Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental De
510(k) Number: K220421