MICROJECT MODEL PCA-1

K965222 · Microject, Inc. · MEB · Jun 19, 1997 · General Hospital

Device Facts

• Record ID: K965222
• Device Name: MICROJECT MODEL PCA-1
• Applicant: Microject, Inc.
• Product Code: MEB · General Hospital
• Decision Date: Jun 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

MicroJect Model PCA-1 is an infusion pump for pain management; delivers medication via intravenous, subcutaneous, or epidural routes. System comprises a driver unit and sterile cassettes; accepts standard drug containers including flexible bags and syringes. Operated by healthcare professionals or patients for patient-controlled analgesia (PCA). Device automates medication delivery to provide pain relief; enables patient self-administration on an as-needed basis. Clinical utility involves precise infusion control to manage pain levels; benefits include improved patient comfort and simplified analgesic delivery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Infusion pump system; includes driver unit and sterile cassettes. Supports intravenous, subcutaneous, and epidural delivery. Compatible with standard drug containers, flexible bags, and syringes. Mechanical/electromechanical infusion mechanism.

Indications for Use

Indicated for pain management in patients requiring infusion of pain medications. Suitable for use by healthcare professionals or patients for patient-controlled analgesia (PCA). Indicated for intravenous, subcutaneous, and epidural administration from standard drug containers, bags, or syringes.

Regulatory Classification

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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
* Trade Name: MicroJect Model PCA-1
Regulatory 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 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.

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Page 2 - Mr. Rigby

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone].

Sincerely yours,

Timothy A. Ulatowski
Director
Division of Dental, Infection Control and General Hospital Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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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
[phone]

(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 Dental, Infection Control,
and General Hospital Devices
510(k) Number K965222

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use
(Optional Format 1-2-96)