The Medtronic MiniMed Sof-site infusion sets are indicated for the subcutaneous infusion of medicine, including insulin, from a Medtronic MiniMed infusion pump.

Device Description

The Medtronic MiniMed Sof-site infusion sets, models MMT-358S6. MMT-358M6. MMT-358L6. MMT-358S9. MMT-358M9. and MMT-358L9, are infusion administration sets that connect to a Medtronic MiniMed medication reservoir. The infusion sets attach to the medication reservoir by means of a female Luer connector. Fluid is administered through multi-layer tubing to an indwelling catheter. The indwelling catheter is introduced into the subcutaneous tissue by means of a removable introducer needle. The introducer needle is housed in a plastic needle hub and protected by a plastic needle guard. The needle guard is removed before insertion. The indwelling catheter is affixed to a plastic base unit. The plastic base unit functions as a site for connection and disconnection. The adhesive patch is integral to the base and is used to secure the unit to the user.

AI/ML Overview

This document describes the Medtronic MiniMed Sof-site Infusion Sets and their 510(k) premarket notification (K030137). However, the provided text does not contain any information regarding specific acceptance criteria, device performance metrics, or a study detailing how the device met such criteria.

The document is a 510(k) summary and the FDA's clearance letter, which primarily focus on:

Device Description and Intended Use: Explains what the device is and what it's used for (subcutaneous insulin infusion).
Predicate Device Comparison: States that the modified device has similar materials and features to predicate devices, with the exception of the at-site connection mechanism, which is deemed not to affect safety or effectiveness.
Substantial Equivalence: The FDA's determination that the new device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance: This information is not present.
Sample size used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method for the test set: Not mentioned.
If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned, and generally not applicable to infusion sets in this context.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned, and not applicable as this is a physical medical device, not an AI algorithm.
The type of ground truth used: Not applicable in the way you're likely thinking (e.g., pathology for AI). Compliance with standards and in-vitro/in-vivo testing would typically be used for such products, but details are not provided.
The sample size for the training set: Not applicable and not mentioned.
How the ground truth for the training set was established: Not applicable and not mentioned.

The document essentially states that the new device is considered safe and effective because it is substantially equivalent to existing, predicate devices, and a specific modification to the connection mechanism does not impact this equivalence. There is no detailed study methodology or performance data provided in this particular excerpt.

Summary

{0}------------------------------------------------

Avail Medical Products, Inc., Premarket Notification - 510(k), Sof-site Infusion Set, Models MMT-358S6, MMT-358M6, MMT-358L6, MMT-358S9, MMT-358M9, MMT-358L9 KO30137 Page 10 of 173

Section C. 510(k) Summary

Submitter: Avail Medical Products, Inc. 201 Main Street, Suite 1600 Fort Worth, Texas 76102

FEB 1 9 2003

Contact: Courtland Imel (972) 929-4800

Name of Device: Medtronic® MiniMed® Sof-site

Predicate Device: Maersk Medical Quick-set®, model Contour, and Medtronic® MiniMed® Sof-set® Ultimate® OR® infusion sets, models MMT-315 and MMT-316.

Description of the New Device: The Medtronic MiniMed Sof-site infusion sets, models MMT-358S6. MMT-358M6. MMT-358L6. MMT-358S9. MMT-358M9. and MMT-358L9, are infusion administration sets that connect to a Medtronic MiniMed medication reservoir.

The infusion sets attach to the medication reservoir by means of a female Luer connector. Fluid is administered through multi-layer tubing to an indwelling catheter. The indwelling catheter is introduced into the subcutaneous tissue by means of a removable introducer needle. The introducer needle is housed in a plastic needle hub and protected by a plastic needle guard. The needle guard is removed before insertion. The indwelling catheter is affixed to a plastic base unit. The plastic base unit functions as a site for connection and disconnection. The adhesive patch is integral to the base and is used to secure the unit to the user.

Intended Use of the New Device: The Medtronic MiniMed Sof-site infusion sets, models MMT-358S6, MMT-358M6, MMT-358L6, MMT-358S9, MMT-358M9, and MMT-358L9, are intended for the subcutaneous infusion of medicine, including insulin, from a external infusion pump. The set is not intended nor indicated for use with blood.

Comparison of the Technological Features of the New Device and Predicate Devices The modified device and the lawfully marketed predicate devices contain similar materials of construction. Features of the modified device are comparable to those of the predicate devices with the exception of the at-site connection mechanism. The modified mechanism does not require specific alignment for attachment to the site as is currently required in the predicate devices. This modification does not affect the safety or effectiveness of the device.

Signed,

Courtland Imel

Manager, Quality Avail Medical Products, Inc.

@MiniMed, Quick-setter, Quick-set, Soft-set Ultimate QR, Soft-set, and QR are Registered Trademarks of Medtronic MiniMed TMParadigm, Quick Release, Ultimate, and Sof-site are Trademarks of Medtronic MiniMed Inc.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is written in a simple, sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 9 2003

Mr. Courtland Imel Quality Manager Avail Medical Products 8300 Esters Road, Suite 930 Irving, Texas 75063

Re: K030137

Trade/Device Name: Medtronic MiniMed Sof-site Infusion Sets, Models MMT-358S6, MMT-358M6, MMT-358L6, MMT-358S9, MMT-358M9, and MMT-358L9 Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: January 13, 2003 Received: January 14, 2003

Dear Mr. Imel:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{2}------------------------------------------------

Page 2 - Mr. Imel

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Susan Runner

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Avail Medical Products, Inc., Premarket Notification - 510(k), Sof-site Infusion Set, Models MMT-358S6, MMT-358M6, MMT-358L6, MMT-358S9, MMT-358M9, MMT-358L9 Page 12 of 173

INDICATIONS FOR USE

510(k) Number:

Device Name: Medtronic MiniMed Sof-site infusion sets, models MMT-358S6, MMT-358M6, MMT-358L6, MMT-358S9, MMT-358M9, and MMT-358L9 The Medtronic MiniMed Sof-site infusion sets are indicated Indications for Use:

for the subcutaneous infusion of medicine, including insulin, from a Medtronic MiniMed infusion pump.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use √
(Per 21 CFR 801.109)

Over-the-Counter Use

Tatian Cuciente

ivision of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number. K030137

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.