(64 days)
Medtronic® MiniMed® Paradigm™ Quick-set™, models MMT-396, MMT-397, MMT-398, and MMT-399 and Medtronic® MiniMed® Paradigm™ Sof-set™ ! . ! timate™ QR® infusion sets, models MMT-317 and MMT-318
Not Found
No
The device description and intended use clearly describe a mechanical infusion set for delivering medication, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
Yes
The "Intended Use / Indications for Use" section states that the device is "indicated for the subcutaneous infusion of medicine, including insulin," which directly relates to the treatment of a medical condition.
No
The device is described as an infusion set for administering medicine, specifically insulin, subcutaneously. Its purpose is to deliver medication, not to diagnose a condition.
No
The device description clearly details physical components such as tubing, catheters, needles, hubs, guards, and adhesive patches, indicating it is a hardware device, not software-only.
Based on the provided information, the Medtronic MiniMed Paradigm Sof-site infusion sets are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the "subcutaneous infusion of medicine, including insulin." This describes a device used to deliver medication directly into the body, not to perform tests on samples taken from the body.
- Device Description: The description details components like tubing, catheters, needles, and adhesive patches, all of which are consistent with a device for delivering substances into the body. There is no mention of reagents, test strips, or any components used for analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Testing biological samples (blood, urine, tissue, etc.)
- Analyzing biomarkers or other substances in samples
- Providing diagnostic information
Therefore, the Medtronic MiniMed Paradigm Sof-site infusion sets are a medical device used for drug delivery, not an IVD.
N/A
Intended Use / Indications for Use
The Medtronic MiniMed Paradigm Sof-site, model: MMT-359S6, MMT-359M6, MMT-359L6, MMT-359S9, MMT-359M9, and MMT-359L9, are intended for the subcutaneous infusion of medicine, including insulin, from a Medtronic MiniMed infusion pump. The set is not intended nor indicated for use with blood.
The Medtronic MiniMed Paradigm Sof-site infusion sets are indicated for the subcutaneous infusion of medicine, including insulin, from a Medtronic MiniMed infusion pump.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The Medtronic MiniMed Paradigm Sof-site infusion sets, models MMT-359S6, MMT-359M6, MMT-359L6, MMT-359S9, MMT-359M9, and MMT-359L9, are infusion administration sets that connect to a Medtronic MiniMed medication reservoir.
The infusion sets attach to the medication reservoir by means of a proprietary connecter. Fluid is administered through multi-layer tubing to an indwelling catheter. The indwelling catheter is introduced into the subcutaneous tissue of the user 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. The adhesive patch is integral to the base and is used to secure the unit 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.
Medtronic® MiniMed® Paradigm™ Quick-set™, models MMT-396, MMT-397, MMT-398, and MMT-399 and Medtronic® MiniMed® Paradigm™ Sof-set™ ! . ! timate™ QR® infusion sets, models MMT-317 and MMT-318
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
Avail Medical Products, Inc., Premarket Notification - 510(k), Paradigm Set, Models MMT-359S6, MMT-359M6, MMT-359L6, MMT-359S9, MMT-359M9, MMT-359L9 Page 10 of 177
Section C. 510(k) Summary
Submitter: Avail Medical Products, Inc. 201 Main Street. Suite 1600 Fort Worth, Texas 76102
Contact: Courtland Imel (972) 929-4800
Name of Device: Medtronic® MiniMed® Paradigm® Sof-site
Predicate Device: Medtronic® MiniMed® Paradigm™ Quick-set™, models MMT-396, MMT-397, MMT-398, and MMT-399 and Medtronic® MiniMed® Paradigm™ Sof-set™ ! . ! timate™ QR® infusion sets, models MMT-317 and MMT-318
Description of the New Device: The Medtronic MiniMed Paradigm Sof-site infusion sets, models MMT-359S6, MMT-359M6, MMT-359L6, MMT-359S9, MMT-359M9, and MMT-359L9, are infusion administration sets that connect to a Medtronic MiniMed medication reservoir.
The infusion sets attach to the medication reservoir by means of a proprietary connecter. Fluid is administered through multi-layer tubing to an indwelling catheter. The indwelling catheter is introduced into the subcutaneous tissue of the user 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. 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 Paradigm Sof-site, model: MMT-359S6, MMT-359M6, MMT-359L6, MMT-359S9, MMT-359M9, and MMT-359L9, are intended for the subcutaneous infusion of medicine, including insulin, from a Medtronic MiniMed 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 distal connect mechanism. The modified mechanism does not require specific alignment 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
Courtland Imel Manager, Quality Avail Medical Products, Inc.
@MiniMed, Quick-setter, Quick-set, Soft-set Utimate QR, Soft-set, and OR are Registered Trademarks of Meduronic MiniMed TMParadigm, Ouick Release, Ultimate, and Sof-site are Trademarks of Medtronic MiniMed.
MAR 2 0 2003
CONFIDENTIAL
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three profiles facing right, resembling a bird or a symbol of human connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 0 2003
Ms. Carroll Councilman Avail Medical Products, Incorporated 1900 Carnegie Avenue Santa Ana, California 92705
Re: K030149
Trade/Device Name: Medtronic MiniMed Paradigm Sof-site Infusion Sets, Models MMT359S6, MMT359M6, MMT359L6, MMT359S9, MMT359M9 and MMT359L9 Regulation Number: 880.5440 Regulation Name: Intravascular Administrative Set Regulatory Class: II Product Code: FPA Dated: January 14, 2003 Received: January 15, 2003
Dear Ms. Councilman:
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 mav, 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. Councilman
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 (QS) 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 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), Paradigm Set, Models MMT-359S6, MMT-359M6, MMT-359L6, MMT-359S9, MMT-359M9, MMT-359L9 Page 12 of 177
K030/49
INDICATIONS FOR USE
510(k) Number:
| Device Name: | Medtronic MiniMed Paradigm Sof-site infusion sets, models
MMT359S6, MMT359M6, MMT359L6, MMT359S9,
MMT359M9, and MMT359L9 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | The Medtronic MiniMed Paradigm Sof-site infusion sets are
indicated 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)
or
Over-the-Counter Use __________
Patrice Crescent
Division Sign-Off) sion of Anesthesiology, General Hospital, on Control Dental Devices
CONFIDENTIAL
510(k) Number. 6030
Page 12