SOF-SET MICRO QR INFUSION SET, MODELS 320 AND 321 by MEDTRONIC MINIMED

The MiniMed Sof-set Micro QR infusion sets, models 320 and 321. are infusion administration sets, connected to a medication 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 a MiniMed infusion pump.

The administration set attaches to the reservoir by means of a female Luer connector, and subcutaneously in the user through an indwelling catheter made of Fluorinated Ethylene Propylene (FEP). 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 indwelling catheter and tubing share a common hub through which the introducer needle fits. The hub incorporates a winged configuration with an adhesive patch to facilitate handling of the administration set during insertion and stability following insertion. An adhesive dressing covers the wings and hub of the administration set, securing the subcutaneous catheter and infusion line to the user.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device (MiniMed Sof-set Micro QR infusion sets) and does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, MiniMed Sof-set Ultimate™ QR infusion sets.

Here's what can be inferred from the document regarding the device and its comparison, even though it doesn't fit the requested format of acceptance criteria and performance study:

1. Acceptance Criteria and Reported Device Performance:

The document does not list specific acceptance criteria or report performance metrics in a quantitative manner. Instead, it claims "These modifications do not affect the safety or effectiveness of the device."

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. No performance test set is described. The comparison is based on design modifications and materials.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

Not applicable. No ground truth establishment by experts for a test set is described.

4. Adjudication Method for the Test Set:

Not applicable. No test set or adjudication method is described.

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 a medical device (infusion set), not an AI-powered diagnostic or assistive technology. No MRMC study was conducted.

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

Not applicable. This is a medical device (infusion set), not an algorithm.

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

Not applicable. The submission relies on demonstrating substantial equivalence through comparison of design, materials, manufacturing processes, and intended use with a legally marketed predicate device, rather than a new clinical study with a defined ground truth.

8. The Sample Size for the Training Set:

Not applicable. This is a medical device (infusion set), not an algorithm or AI model that requires a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable. As above, this is not an AI/algorithm-based device requiring a training set.

Summary of what the document does provide:

New Device Name: MiniMed Sof-set Micro QR infusion sets, models 320 and 321.
Predicate Device Name: MiniMed Sof-set Ultimate™ QR infusion sets, models 315 and 316.
Intended Use: Subcutaneous infusion of medicine, including insulin, from an external infusion pump.
Key Differences from Predicate Device:
- Shorter catheter (6mm vs 9mm).
- Shorter introducer needle (shortened by 3mm).
- Larger adhesive patch.
- Modified wing radius.
Claim for Substantial Equivalence: "The modified device is substantially similar to the lawfully marketed predicate device. Both are intended for subcutaneous delivery of insulin or other appropriately labeled medication 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 tissue with a removable stainless steel needle and flexible catheter. The materials and manufacturing processes are the same for the modified and predicate devices. ... These modifications do not affect the safety or effectiveness of the device."

This document is a regulatory submission for a physical medical device, not an AI or algorithm-based product, which explains the absence of the requested AI-centric study details.

Summary

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SEP 3 1999

Part C. 510(k) Summary

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

Contact: Don Selvey, Regulatory Affairs (818) 362-5958, 3011; (480) 704-8070 (v/f)

Name of Device: MiniMed Sof-set Micro QR® infusion sets, models 320 and 321

Predicate Device: MiniMed Sof-set Ultimate™ QR infusion sets, models 315 and 316

Description of the New Device: The MiniMed Sof-set Micro QR infusion sets, models 320 and 321. are infusion administration sets, connected to a medication 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 a MiniMed infusion pump.

Intended Use of the New Device: The MiniMed Sof-set Micro 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.

Comparison of the Technological Features of the New Device and Predicate Device: The modified device is substantially similar to the lawfully marketed predicate device. Both are intended for subcutaneous delivery of insulin or other appropriately labeled medication 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 tissue with a removable stainless steel needle and flexible catheter. The materials and manufacturing processes are the same for the modified and predicate devices.

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@MiniMed, Polyfin, Sof-set, and QR are registered trademarks of MiniMed Inc. TMUltimate and Micro are Trademarks of MiniMed Inc.

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Image /page/1/Picture/1 description: The image shows the logo for MiniMed. The logo consists of a black square with white curved lines inside, followed by the word "MiniMed" in a bold, serif font. There is a trademark symbol to the upper right of the word "Med".

Several differences exist between the new and predicate device:

1. The new device has a 6 mm long catheter instead of the current 9 mm version.
1. The introducer needle has been shortened by 3 mm.
1. The adhesive patch beneath the stabilizing wings has been increased in size to cover the entire underside of the wings.
1. The underside of the wing has been modified with a smoother radius to facilitate attachment of the larger adhesive patch.

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

Signed,

Dan Solvou 6-9-99
date

Don Selvey date Senior Regulatory Affairs Specialist Department of Clinical and Regulatory Affairs MiniMed Inc.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 3 1999

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

K991979 Re : Trade Name: Sof-Set Mirco QR Infusion Sets, Models 320 and 321 Requlatory Class: II Product Code: FPA Dated: June 9, 1999 Received: June 14, 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 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 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Selvey

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 (301) 594-4692. 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

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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INDICATIONS FOR USE

Ka991979

510(k) Number:

Device Name:

MiniMed Sof-set Micro QR infusion sets, models 320 and 321.

Indications for Use:

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

Concurrence of CIDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K991979

Over-the Counter Use

Prescription Use √
(Per 21 CFR 801.109)

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Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

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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.