Who is the manufacturer of MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300?

Medtronic Minimed filed the 510(k) submission for MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300 (K970479).

What is the FDA product code for MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300?

KZH. It is classified under 21 CFR 880.6920 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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)

Related Devices

K160860 — MiniMed Quick-serter · Medtronic Minimed · Sep 22, 2016
K163400 — Orbit Inserter · Ypsomed AG · Jul 26, 2017
K122837 — AUTOJECT 2 FOR GLASSY SYRINGE · Owen Mumford, Ltd. · Oct 15, 2012
K993385 — AUTOJET 2 (NON-FIXED NEEDLE TYPE) · Owen Mumford USA, Inc. · Nov 10, 1999
K063146 — ACCU-CHEK LINKASSIST · Disetronic Medical Systems AG · Nov 27, 2006

Submission Summary (Full Text)

{0} 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 (818) 362-5958, 3011; (520) 527-0107 (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, ![img-0.jpeg](img-0.jpeg) ©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 000019