MINIMED SOF-SET ULTIMATE QR INFUSION SET MODELS 315 AND 316 by MEDTRONIC MINIMED

The MiniMed Sof-set Ultimate QR infusion set is indicated for the subcutaneous delivery of medicine, including insulin, from an external infusion pump.

Device Description

The MiniMed Sof-set Ultimate QR infusion sets, models 315 and 316, are infusion administration sets, connecting to a medicine reservoir proximally, and inserted in the subcutaneous tissue of a user distally by means of an introducer needle. The reservoir to which the infusion set attaches proximally is inserted into an external infusion pump, such as the MiniMed 507 insulin pump.

The administration set attaches to the reservoir syringe by means of a female Luer connector, and subcutaneously in the user through an indwelling catheter made of FEP Teflon. The tubing is made of polyvinyl chloride (PVC) with a polyolefin liner. This configuration of PVC and polyolefin has been trademarked by MiniMed as Polyfin.

The 24 gauge indwelling catheter is introduced into the subcutaneous tissue by a removable 26 gauge introducer needle made of 304 stainless steel. The needle, indwelling catheter, and tubing share a common hub. The hub incorporates a winged configuration to facilitate handling of the administration set during insertion and stability following insertion.

On the skin-contact side of the wings, around the Teflon catheter, is an antibacterial dressing. Additionally, an adhesive dressing covers the wings of the administration set, securing the subcutaneous catheter and infusion line to the user.

AI/ML Overview

This 510(k) premarket notification for the MiniMed Sof-set Ultimate QR infusion set does not contain specific acceptance criteria or a detailed study proving the device meets acceptance criteria in the way typically expected for a software or AI-driven medical device.

The document is a submission for a modified physical device (an infusion set for insulin delivery), not a diagnostic algorithm or a device relying on complex data analysis and ground truth establishment. Therefore, many of the requested categories in your prompt (like "number of experts," "adjudication method," "MRMC study," "training set size") are not applicable to this type of regulatory submission.

The "study" referenced in this document implicitly refers to the comparison of the new device to its predicate device and the general safety and effectiveness standards for such devices. The "acceptance criteria" are whether the modifications ensure the device remains safe and effective for its intended use, and importantly, whether it is "substantially equivalent" to the predicate device.

Here's an attempt to answer your questions based on the provided text, while also highlighting why some are not applicable:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implicit)	Reported Device Performance (Implicit)
Substantial Equivalence: The new device (Sof-set Ultimate QR) must be substantially equivalent to the predicate device (Sof-set QR) in terms of safety and effectiveness for its intended use.	The FDA 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 modifications "do not affect the safety or effectiveness of the device."
Intended Use: The device must be suitable for the subcutaneous infusion of medicine, including insulin, from an external infusion pump.	The device's intended use is precisely stated as: "subcutaneous delivery of medicine, including insulin, from an external infusion pump." This aligns with the predicate.
Materials Compatibility & Safety: Materials used must be safe for patient contact and compatible with the infused medicine.	"Both devices are made of substantially similar materials." (PVC, polyolefin, FEP Teflon, stainless steel). The specific change to higher density polyethylene in the tubing inner layer is mentioned as resulting in a "more sensitive occlusion alarm," implying an improvement in safety rather than degradation.
Functionality (e.g., occlusion detection): The device should function reliably, potentially with improved safety features.	The higher density polyethylene in the inner layer of the tubing reportedly "has resulted in a more sensitive occlusion alarm, which will be promoted by MiniMed." This indicates an improvement in a safety-critical function.
Biocompatibility: Materials in contact with the body must be biocompatible.	"On the skin-contact side of the wings, around the Teflon catheter, is an antibacterial dressing." This suggests existing measures for biocompatibility and infection control.

2. Sample size used for the test set and the data provenance

Sample Size: Not specified in the provided text. For physical device modifications like this, testing typically involves bench testing, limited animal studies (if applicable), and potentially human factors testing, but the numerical details are not provided. There is no "test set" in the sense of a dataset for an algorithm.
Data Provenance: Not explicitly stated. The submission is from MiniMed Inc. in the USA. The implied testing would likely be internal to the manufacturer or conducted by contract research organizations.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This is a physical device modification, not an AI or diagnostic algorithm requiring expert "ground truth" establishment for data annotation. Expert input would relate to engineering, clinical safety, and regulatory compliance.

4. Adjudication method for the test set

Not Applicable. See point 3.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is not an AI or imaging diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable in the traditional sense. The "ground truth" for a physical device like this is its ability to perform its intended function safely and effectively, as demonstrated through engineering testing, biocompatibility assessments, and clinical performance data (often compared to a predicate device). The ultimate "ground truth" in regulatory terms is that the device is "substantially equivalent" to a legally marketed predicate device, meaning it doesn't raise new questions of safety or effectiveness.

8. The sample size for the training set

Not Applicable. This is not an AI or machine learning device requiring a training set.

9. How the ground truth for the training set was established

Not Applicable. See point 8.

Summary of Device and Regulatory Context (Based on the text):

This 510(k) submission describes minor modifications to an existing insulin infusion set. The core argument for regulatory clearance is substantial equivalence to an already marketed predicate device. The changes are largely focused on manufacturing improvements, hub configuration, adhesive, and tubing material, with one noted improvement being a "more sensitive occlusion alarm." The FDA's letter confirms their agreement that the device is substantially equivalent, allowing it to be marketed.

What would constitute "proof" in this context are internal engineering tests (e.g., tensile strength of materials, flow rate, occlusion detection sensitivity testing, biocompatibility studies, sterilization validation) which are typically summarized and submitted to the FDA but not detailed in this public-facing 510(k) summary. The "acceptance criteria" are implicitly met if these tests demonstrate that the modifications haven't negatively impacted safety or effectiveness, and in some cases, have improved them (like the occlusion alarm).

Summary

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MiniMed Inc. Premarket Notification - 510(k) Sof-set Ultimate QR infusion set, models 315 and 316

Part E. 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/t).

Name of Device: MiniMed® Sof-set® Ultimate QR® infusion sets, models 315 and 316.

Predicate Device: MiniMed Sof-set QR infusion sets, models 115 and 116.

Description of the New Device: The MiniMed Sof-set Ultimate QR infusion sets, models 315 and 316, are infusion administration sets, connecting to a medicine reservoir proximally, and inserted in the subcutaneous tissue of a user distally by means of an introducer needle. The reservoir to which the infusion set attaches proximally is inserted into an external infusion pump, such as the MiniMed 507 insulin pump.

Intended Use of the New Device: The MiniMed Sof-set Ultimate QR is intended for the subcutaneous infusion of medicine, including insulin, from an external infusion pump. The set is not intended nor indicated for use with blood or blood products.

®MiniMed, Sof-set, and QR are registered trademarks of MiniMed Inc.

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MiniMed Inc. Premarket Notification - 510(k) Sof-set Ultimate QR infusion set, models 315 and 316

Comparison of the Technological Features of the New Device and Predicate Device: The modified devices are substantially similar to the lawfully marketed predicate devices. Both are intended for subcutaneous delivery insulin or other appropriately labeled medicines from an infusion pump to the pump user. Both sets attach proximally to a reservoir by means of a Luer connector, and insert distally into the device user's subcutaneous tissues with a removable stainless steel needle and flexible catheter. Both devices are made of substantially similar materials.

Several differences exist between the new and predicate device:

changes in the shape/configuration of the hub and wings to be flatter and smoother;
the indwelling catheter is clear instead of white;
a change in the adhesive tab to be slightly longer and rotated 90°, facilitating tab removal prior to insertion and use with an auto inserter device;
a change in the adhesive tape: the infusion set will be secured with IV 3000, a product of Smith & Nephew;
a change in the polyethylene plastic in the inner layer of the tubing, from low density to a higher density. This has resulted in a more sensitive occlusion alarm, which will be promoted by MiniMed.

These modifications do not affect the safety or effectiveness of the device.

Signed,

Don Selvey 10-27-97
date

Regulatory Affairs MiniMed Inc.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized eagle emblem. The eagle is depicted with its head facing left and its wings spread, creating a sense of strength and protection. The overall design is simple and professional, reflecting the department's role in promoting the health and well-being of the nation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 1998

Mr. Don Selvey Requlatory Affairs MiniMed® Incorporated 12744 San Fernando Road Sylmar, California 91342

K974163 Re: MiniMed® Sof-set® Ultimate QR® infusion Trade Name: sets, models 315 and 316 Regulatory Class: II Product Code: FPA Dated: October 27, 1997 Received: November 5, 1997

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 aqainst 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 Requlations, Title 21, Parts 800 to 895 .... A ... ................................................................................................................... substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

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Page 2 - Mr. Selvey

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 requlations.

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 diaqnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Directd Division of Dental, Infection Control and General Hospital Devices 10000000 Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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MiniMed Inc. Premarket Notification - 510(k) Sof-set Ultimate QR infusion set, models 315 and 316

INDICATIONS FOR USE

510(k) Number:

MiniMed Sof-set Ultimate QR infusion sets, models 315 Device Name: and 316. Indications for Use: The MiniMed Sof-set Ultimate QR infusion set is indicated for the subcutaneous delivery of medicine, including insulin, from an external infusion pump.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patrick Cassinite

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number 的

Prescription Use (Per 21 CFR 801.109)

Over-the-Counter Use

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.