(89 days)
MiniMed Sof-set QR infusion sets, models 115 and 116.
Not Found
No
The device description focuses on the physical components and materials of an infusion set, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
This device is an infusion set designed for drug delivery, which is an accessory to a therapeutic device (the insulin pump), rather than a therapeutic device itself.
No
The device is an infusion administration set designed for the delivery of medicine, not for diagnosing medical conditions.
No
The device description clearly details physical components such as tubing, needles, catheters, hubs, dressings, and connectors, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body ("in vitro").
- Device Function: The MiniMed Sof-set Ultimate QR infusion set is designed for the delivery of medicine into the body (subcutaneously). It's a delivery system, not a diagnostic tool that analyzes samples.
- Intended Use: The intended use clearly states "subcutaneous delivery of medicine." This is a therapeutic function, not a diagnostic one.
The device description further reinforces this by detailing the components involved in the physical process of inserting a catheter and delivering fluid into the subcutaneous tissue.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FPA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous tissue
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.
MiniMed Sof-set QR infusion sets, models 115 and 116.
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
§ 880.5440 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.
0
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.
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.
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.
000009
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Image /page/1/Picture/0 description: The image shows the logo for MiniMed. The logo consists of a black square with white lines that form a wave pattern on the left side. To the right of the square is the word "MiniMed" in a serif font, with a trademark symbol in the upper right corner.
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:
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changes in the shape/configuration of the hub and wings to be flatter and smoother;
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the indwelling catheter is clear instead of white;
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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;
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a change in the adhesive tape: the infusion set will be secured with IV 3000, a product of Smith & Nephew;
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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
4
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)
or
Over-the-Counter Use