MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300

K970479 · Medtronic Minimed · KZH · Mar 31, 1997 · General Hospital

Device Facts

• Record ID: K970479
• Device Name: MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300
• Applicant: Medtronic Minimed
• Product Code: KZH · General Hospital
• Decision Date: Mar 31, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6920
• Device Class: Class 2

Intended Use

The MiniMed Sof-serter infusion set insertion system is intended to help make insertion of a Sof-set or Sof-set QR infusion set simpler and with minimal discomfort. Use of the device may improve the user's consistency of infusion set insertion.

Device Story

Manually operated, spring-loaded injection device; facilitates insertion of MiniMed Sof-set or Sof-set QR subcutaneous infusion sets. User loads infusion set into carrier; compresses spring; activates via release button. Used by patients or clinicians to simplify insertion and improve consistency. Reduces discomfort during needle/cannula placement. Device is mechanical; no electronic or software components.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Plastic housing; metal springs. Spring-loaded, manually operated mechanical insertion mechanism. Dimensions/form factor specific to MiniMed Sof-set/Sof-set QR infusion sets. Non-sterile device (intended for use with sterile infusion sets).

Indications for Use

Indicated for patients requiring subcutaneous infusion set insertion using MiniMed Sof-set or Sof-set QR infusion sets. Contraindicated for use with infusion sets other than the specified MiniMed models.

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

• AutoJect® 2 injection device (K945660)

Submission Summary (Full Text)

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K970479

Premarket [510(k)] Notification
MiniMed® Sof-serter™ Model 300
MiniMed Inc.

MAR 31 1997

# Part I. 510(k) Summary

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

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

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

Predicate Device: AutoJect® 2 injection device (K945660).

Description of the New Device: The MiniMed Sof-serter infusion set insertion system is a manually operated, spring-loaded injection device. It is similar to most syringe needle introducer devices currently marketed; however, this device is used to insert two specific subcutaneous infusion administration sets, the Sof-set® and Sof-set QR® infusion sets manufactured by MiniMed Inc. The device is contraindicated for use with other infusion sets.

Intended Use of the New Device: The MiniMed Sof-serter infusion set insertion system is intended to help make insertion of a Sof-set or Sof-set QR infusion set 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 devices are spring-driven devices that require the user to load the infusion set or syringe into a carrier, compress a spring or springs, then activate the device by depressing a release button. Both devices are made of plastic, with metal springs. The differences between the new device and the predicate device involve primarily the type of hypodermic needle introduced by the device. The Sof-serter introduces a subcutaneous infusion set needle and cannula, while the AutoJect 2 introduces a needle attached to an insulin syringe, and simultaneously delivers the insulin. These modifications do not affect the safety or effectiveness of the device.

Signed,


©MiniMed, Sof-set and QR are Registered Trademarks of MiniMed Inc. ™Sof-Serter is a Trademark of MiniMed Inc. ©AutoJect 2 is a Registered Trademark of Owen Mumford, Inc

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