(57 days)
MMT-365, MMT-366
Not Found
No
The 510(k) summary describes a disposable infusion set and does not mention any AI or ML components or functionalities.
No.
The document describes an infusion set, which is a delivery device for medicine, not a device that directly provides therapy itself.
No
The device is an infusion set used for delivering medicine, not for diagnosing conditions.
No
The device description explicitly states it is a "disposable single-use infusion set," which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "subcutaneous infusion of medicine, including insulin". This is a therapeutic delivery function, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is an "infusion set" used with an "external microinfusion pump". This further reinforces its role in delivering substances into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples like blood, urine, or tissue, which are typical for IVDs. The intended use explicitly states "The set is not intended for use with blood."
Therefore, the Medtronic MiniMed Paradigm Polyfin QR MMT-312L and MMT-312S are medical devices for drug delivery, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Medtronic MiniMed Paradigm Polyfin QR MMT-312L and MMT-312S are intended for the subcutaneous infusion of medicine, including insulin, from a Medtronic MiniMed Paradigm infusion pump. The set is not intended for use with blood.
Product codes
FPA
Device Description
The Paradigm Polyfin QR MMT-312L and MMT-312S are disposable single-use infusion set intended for use with Medtronic MiniMed external microinfusion pumps.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous
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)
Polyfin™ QR® with Wings Infusion set, Model MMT-365 and MMT-366
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
AUG 1 9 2003
Medtronic MiniMed Inc. Premarket Notification-510 (k) Medtronic MiniMed Paradigm Polyfin QR Model MMT-312L/ 312S Infusion set
SECTION C. 510(k) Summary
In accordance with the requirements of SMDA 1990, and 21 CFR 807.92, this 510(k) Summary is provided:
Submitter: Medtronic MiniMed, 18000 Devonshire St., Northridge, CA 91325
Contact: Mirielle Mengotto (818) 576-4112
Name of Device: Medtronic MiniMed Paradigm™ Polyfin® QR® Infusion set, Model MMT-312L and MMT-312S
Predicate Device: Polyfin™ QR® with Wings Infusion set, Model MMT-365 and MMT-366
Description of the Device: The Paradigm Polyfin QR MMT-312L and MMT-312S are disposable single-use infusion set intended for use with Medtronic MiniMed external microinfusion pumps.
Intended Use of the Device: The Medtronic MiniMed Paradigm Polyfin QR MMT-312L and MMT-312S are intended for the subcutaneous infusion of medicine, including insulin, from a Medtronic MiniMed Paradigm infusion pump. The set is not intended for use with blood.
Comparison of the Technological Features of the New Device and Predicate Device: The new and predicate devices have similar materials and basic design. The new devices include a proprietary connector for connection to a Paradigm reservoir whereas the predicate devices use a standard luer connection.
Amor
Gerda Resch Manager, Regulatory Affairs Medtronic MiniMed
8/13/03
Date
R nd QR are Registered Trademarks of Medtronic MiniMed
1
Image /page/1/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the border of the circle. In the center of the seal is an abstract image of an eagle.
AUG 1 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Mirielle Mengotto Senior Regulatory Affairs Specialist Medtronic MiniMed 18000 Devonshire Street Northridge, California 91325-1219
Re: K031917
Trade/Device Name: Medtronic MiniMed Paradigm™ Polyfin® QR ® Model MMT-312L and MMT-312S Infusion Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: June 20, 2003 Received: June 24, 2003
Dear Ms. Mengotto:
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 - Ms. Mengotto
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 vours.
Susan Runne
Susan Runner, DDDS, 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
INDICATIONS FOR USE
510(k) Number:
Medtronic MiniMed Paradigm™ Polyfin® QR® Model Device Name: MMT-312L and MMT-312S Infusion set
The Medtronic MiniMed Paradigm Polyfin QR MMT-312L Indications for Use: and MMT-312S are intended for the subcutaneous infusion of medicine, including insulin, from a Medtronic MiniMed Paradigm infusion pump. The set is not intended for use with blood.
Patricia Crescent
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: KD31917
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
or
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________