(52 days)
Not Found
No
The description explicitly states the device is "manually operated" and "spring-loaded," with no mention of AI, ML, or any computational processing.
No.
This device is an insertion system for infusion sets, designed to make the insertion process simpler and less uncomfortable. It does not provide any therapeutic effect itself but rather aids in the delivery of a separate therapeutic agent (which would be infused via the Sof-set or Sof-set QR infusion sets).
No
Explanation: The device is described as an "infusion set insertion system" intended to simplify and reduce discomfort during the insertion of infusion sets. It helps improve consistency of insertion. There is no mention of it being used to diagnose any condition or disease.
No
The device description explicitly states it is a "manually operated, spring-loaded injection device," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to facilitate the insertion of infusion sets into the subcutaneous tissue. This is a physical process performed on the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description clearly states it's a "manually operated, spring-loaded injection device" used for inserting infusion sets. This aligns with a medical device used for administering something into the body, not for diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The MiniMed Sof-serter infusion set insertion system is intended to help make insertion of a Sof-set or Sof-set OR infusion set simpler and with minimal discomfort. Use of the device may improve the user's consistency of infusion set insertion.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
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 infirstration sets, the Sof-set® and Sof-set QR® infusion sets manufactured by MiniMed Inc. The device is contraindicated for use with other infusion sets.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
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.
AutoJect® 2 injection device (K945660)
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).
Not Found
§ 880.6920 Syringe needle introducer.
(a)
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.(b)
Classification. Class II (performance standards).
0
Premarket [510(k)] Notification MiniMed® Sof-serter™ Model 300
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 infirstration 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 OR 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 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,
2-5-97 date
Don Selvey Regulatory Affairs MiniMed Inc.
@MiniMed, Sof-set and QR are Registered Trademarks of MiniMed Inc. 145of-Seter is a Trademark of MiniMed Inc. @ AutoJect 2 is a Registered Trademark of Owen Mumford, Inc