QUICK-SERTER, MODEL 395

K992300 · Medtronic Minimed · KZH · Jul 29, 1999 · General Hospital

Device Facts

• Record ID: K992300
• Device Name: QUICK-SERTER, MODEL 395
• Applicant: Medtronic Minimed
• Product Code: KZH · General Hospital
• Decision Date: Jul 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6920
• Device Class: Class 2

Intended Use

The Quick-serter infusion set insertion system (Quickserter), model 395, is indicated for use as an aid for insertion of the Maersk Medical A/S Contour infusion sets.

Device Story

The MiniMed Quick-serter (Model 395) is a manually operated, spring-loaded insertion device designed to assist in the placement of Maersk Medical A/S Contour infusion sets. The device functions by having the user load an infusion set into a carrier, compress an internal metal spring, and trigger the mechanism to insert the set. It is intended to simplify the insertion process, minimize discomfort, and improve consistency of placement. The device is used by the patient or clinician; it is contraindicated for use with any infusion sets other than the specified Contour models.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manually operated, spring-loaded insertion device. Materials: plastic housing with metal springs. Dimensions/form factor: handheld. Connectivity: none. Sterilization: not specified. Software: none. Energy source: mechanical (spring-driven).

Indications for Use

Indicated for use as an aid for the insertion of Maersk Medical A/S Contour infusion sets. No specific patient population, age, or gender restrictions are stated.

Regulatory Classification

Identification

A syringe needle introducer is a device that uses a spring-loaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface.

Predicate Devices

• MiniMed Sof-serter infusion set insertion system

Submission Summary (Full Text)

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MiniMed Inc. Premarket [510(k)] Notification MiniMed® Quick-serter™ Model 395

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## Part C. 510(k) Summary

Submitter: MiniMed® Inc. 12744 San Fernando Rd., Sylmar, California 91342

Contact: Don Selvey, Regulatory Affairs [phone], ext. 3011; [phone] (v/f)

Name of Device: MiniMed Quick-serter™ infusion set insertion system

Predicate Device: MiniMed Sof-serter™ infusion set insertion system

Description of the New Device: The MiniMed Quick-serter is a manually operated, spring-loaded infusion set insertion device. It is similar in features and intended use to the MiniMed Sof-serter infusion set insertion system. The device has been designed for use exclusively with the Maersk Medical A/S Contour infusion sets. The device is contraindicated for use with other infusion sets.

Intended Use of the New Device: The MiniMed Quick-serter infusion system is intended to help make insertion of the Contour infusion sets simpler and with minimal discomfort. Use of the device may improve the user's consistency of infusion set insertion.

Comparison of the Technological Features of the New Device and Predicate Device: Technologically, both insertion devices are spring-driven devices that require the user to load the infusion set into a carrier, compress a spring, then activate the device by depressing the release or trigger buttons. Both devices are made of plastic with metal springs. The differences between the new device and the predicate device are limited to differences required for compatibility with the specific infusion set to be inserted. These modifications do not affect the safety or effectiveness of the device.

Signed,

Don Selvey 7-6-99
date

Senior Regulatory Affairs Specialist Department of Clinical Research and Regulatory Affairs MiniMed Inc.

@MiniMed is a Registered Trademarks of MiniMed Inc. "Sof-serter and Quick-serter are Trademarks of MiniMed Inc.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 29 1999

Mr. Don Selvey Senior Regulatory Affairs Specialist Department of Clinical and Regulatory Affairs MiniMed® Technologies, Incorporated 12744 San Fernando Road Sylmar, California 91342

K992300 Re :

MiniMed® Quick-serter™ Infusion Set Trade Name: Insertion System, Model 395 Requlatory Class: II Product Code: KZH Dated: July 7, 1999 Received: July 8, 1999

Dear Mr. Selvey:

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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ಕ 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.

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Page 2 - Mr. Selvey

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.

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 [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 [phone] or at its internet address "http://www.fda/gov/cdrh/dsmamain.html".

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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MiniMed Inc. Premarket [510(k)] Notification MiniMed® Quick-serter™ Model 395

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## INDICATIONS FOR USE

510(k) Number:

Device Name:

MiniMed Quick-serter infusion set insertion system

Indications for Use:

The Quick-serter infusion set insertion system (Quickserter), model 395, is indicated for use as an aid for insertion of the Maersk Medical A/S Contour infusion sets.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) or

Over-the-Counter Use

Thola Hubbard for Pat Cuicci

510(k) Numb

000007