(170 days)
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Not Found
No
The summary does not mention AI, ML, or any related technologies. The device description focuses on a mechanical infusion system.
Yes
The device is used for the "infusion of medications which are used to control pain," which falls under therapeutic use. Its intended use is to manage and alleviate pain, a direct therapeutic function.
No
The device is described as a driver for the infusion of medications to control pain, which is a treatment function, not a diagnostic one.
No
The device description explicitly mentions a "Driver" and "Cassettes," which are hardware components for drug infusion. The intended use also describes infusion into anatomical sites, which requires physical interaction with the patient, not solely software processing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a "Driver" and "Cassettes" designed for the "infusion of medications" into the body (intravenous, subcutaneous, and epidural routes). This is a drug delivery system, not a diagnostic test performed on a sample outside the body.
- Intended Use: The intended use is for "pain management" through the delivery of pain medications. This is a therapeutic application, not a diagnostic one.
Therefore, the MicroJect Model PCA-1 Driver is a medical device for drug delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The indications for use of the MicroJect Model PCA-1 Driver is in the field of pain management. The Driver and associated, sterile Cassettes have been designed for the infusion of medications which are used to control pain. In addition to use by health care professionals, it is also indicated to be used by the patient for infusion of pain medications on an as-needed basis (patient controlled analgesia). The system is indicated for infusion of pain medications into intravenous, subcutaneous, and epidural access routes from standard drug containers, including flexible solution bags and syringes.
Product codes
MEA
Device Description
MicroJect Infusion Pump, Model PCA-1
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
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Intended User / Care Setting
health care professionals, patient
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): 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.
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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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
JUN 19 1997
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are designed to resemble a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Larry Rigby ·President MicroJet Corporation ------2203 West~Alexander Salt Lake City, Utah 84119
Re : K965222 ક્ MicroJect Model PCA-1 Trade Name: Requlatory Class: II Product Code: MEA Dated: April 11, 1997 Received: April 14, 1997
Dear Mr. Rigby:
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 Requlations, Title 21, Parts 800 to 895. ರ್ಗ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP 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. Rigby
This letter will allow you to begin marketing your device as fire recei wire 510 k) premarket notification. The FDA finding of substantial equivalence of your device to a legally rinang or edicate device results in a classification for your marice 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 at (301) 443-6597.
Sincerely yours,
Susan Runser
XX Timothy A. Ulatowski Director Division of Dental, Infection Control
and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k)Number: K965222
Device Name: MicroJect Infusion Pump, Model PCA-1
Indications For Use:
The indications for use of the MicroJect Model PCA-1 Driver is in the field of pain management. The Driver and associated, sterile Cassettes have been designed for the infusion of medications which are used to control pain. In addition to use by health care professionals, it is also indicated to be used by the patient for infusion of pain medications on an as-needed basis (patient controlled analgesia). The system is indicated for infusion of pain medications into intravenous, subcutaneous, and epidural access routes from standard drug containers, including flexible solution bags and syringes.
Signed:__
Larry Rigby, President MicroJect Corporation 2203 West Alexander Salt Lake City, UT 84119 (801) 956-0033
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rincon
(Division Ston-Off
Division of Dental, infection Control,
and General Hospital Devioce
510(k) Number M63000
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)