(84 days)
Not Found
Not Found
No
The device description focuses solely on the mechanical components of an infusion set (tubing, connectors, needle, adhesive) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is an infusion set indicated for the subcutaneous infusion of medicine, including insulin, from an external infusion pump, which is a therapeutic function.
No
The device is described as an "infusion administration set" used for the "subcutaneous infusion of medicine". Its function 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, 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 describes a device used in vivo (within the body) for delivering medication.
- Device Description: The description details a system for delivering fluid into the subcutaneous tissue using a catheter and needle. This is a delivery system, not a diagnostic test performed on samples in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic purposes. This device is used to administer a substance into the body.
N/A
Intended Use / Indications for Use
The Medtronic MiniMed® Leapfrog II Infusion Sct, models MMT-801S1, MMT-801L1, MMT-801L2, MMT-801L2, MMT-803S1, MMT-803L1. MMT-80352, and MMT-803L2 are 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.
Product codes (comma separated list FDA assigned to the subject device)
FPK
Device Description
The Medtronic MiniMed® Leapfrog II Infusion Sct. models MMT-801S1, MMT-801L1, MMT-801L2, MMT-801L2, MMT-803S1, MMT-803L1, MMT-803S2, and MMT-803L2, are single use infusion administration sets intended for use with an external infusion pump, such as the Medtronic MiniMed® infusion pump.
The infusion administration set attaches proximally to a medication reservoir by means of a female Luer connector and is inserted into the subcutancous tissue of the user distally through an indwelling catheter made of Fluorinated Ethylene (FEP). 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutancous 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.
Unomedical A/S (formerly Maersk Medical), model Contour Infusion Set (Quick-set®), and Avail Medical Products Inc., Sof-Site™ Infusion Set, models MMT-358S6, MMT-358M6, MMT-358L6, MMT-358S9, MMT-358M9, and MMT-358L9.
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
52431/
NOV 2 9 2005
Medtronic MiniMed Inc. Premarket Notification -- 510(k)
く
Medronic MiniMed Leapfrog II Infusion Sets, Models MMT-80151, MMT-80152, MMT-801L2, MMT-801L2, MMT-803S1, MMT-803S1, MMT-803L1, MMT-803S2, and MMT-803L2
SECTION C. 510(k) Summary
In accordance with the requirements of SMDA 1990, and CFR 807.92, the 510(k) Summary is provided.
Submitter: Medtronic MiniMed 18000 Devonshire St. Northridge, CA 91325
Contact: Jodic Rogers (818) 576-5708
Name of Device: Medtronic MiniMed® Leapfrog II Infusion Sct
Predicate Device: Unomedical A/S (formerly Maersk Medical), model Contour Infusion Set (Quick-set®), and Avail Medical Products Inc., Sof-Site™ Infusion Set, models MMT-358S6, MMT-358M6, MMT-358L6, MMT-358S9, MMT-358M9, and MMT-358L9.
Description of the New Device: The Medtronic MiniMed® Leapfrog II Infusion Sct. models MMT-801S1, MMT-801L1, MMT-801L2, MMT-801L2, MMT-803S1, MMT-803L1, MMT-803S2, and MMT-803L2, are single use infusion administration sets intended for use with an external infusion pump, such as the Medtronic MiniMed® infusion pump.
The infusion administration set attaches proximally to a medication reservoir by means of a female Luer connector and is inserted into the subcutancous tissue of the user distally through an indwelling catheter made of Fluorinated Ethylene (FEP). 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® Leapfrog II Infusion Sct, models MMT-801S1, MMT-801L1, MMT-801L2, MMT-801L2, MMT-803S1, MMT-803L1. MMT-80352, and MMT-803L2 are 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.
@MiniMed, and Quick-set are Registered Trademarks of Meduonic MiniMed IM Sof-site is a Trademark of Medtronic MiniMed
1
Medtronic MiniMed Inc. Premarket Notification - 510(k) I Moducano MiniMed Leapfrog II Infusion Sets, Models MMT-801 St, MMT-801S2, MMT-801L2, MMT-801S2, MMT-801S2, MMT-803L1, MMT-803S2, and MMT-803L2
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 modified attachment mechanism that offers multiple alignments and locking sites for the attachment to the site connection. This modification does not affect the safety or effectiveness of the device.
Signed.
ib Fullone
Mark Faillace, Sr. Director Regulatory Affairs and Product Reporting
@MiniMed, and Quick-set, are Registerod Trademarks of Medtronic MiniMed ** Sof-site is a Trademark of Medtronic MiniMed
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its head facing left and three horizontal lines above it, representing the agency's commitment to health and human services. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
NOV 2 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jodie Rogers, B.S. Regulatory Affairs Specialist Medtronic MiniMed 18000 Devonshire Street Northridge, California 91325-1219
Re: K052431
Trade/Device Name: Medtronic MiniMed Leapfrog II Infusion Set, Models MMT-801S1, MT-801L1, MMT-801S2, MMT-801L2, MMT-803S1, MMT-803L1, MMT-803S2 and MMT-803L2 Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPK Dated: September 2, 2005 Received: September 6, 2005
Dear Ms. Rogers:
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.
3
Page 2 - Ms. Rogers
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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), n Jase contact the Office of Compliance at (240) 276-0115. 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/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Medtronic MiniMed Inc. Premarket Notification - 510(k) Medronic MiniMed LeapIrog II Infusion Sets, Models MMT-801S1, MMT-801S2, MMT-801L2, MMT-801L2, MMT-803S1, MMT-803L1, MMT-803S2, and MMT-803L2
INDICATIONS FOR USE
11052431 510(k) Number:
Medtronic MiniMed Leapfrog II Infusion Set, models MMT-Device Name: 801SI, MMT-801LI, MMT-801S2, MMT-801L2, MMT-803S1, MMT-803L1, MMT-803S2. and MMT-803L2
The Medtronic MiniMed Leapfrog II Infusion Set is Indications for Use: indicated for the subcutaneous infusion of medicine, including insulin, from a Medtronic MiniMed infusion pump.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ques
ivision Sign-Off)
Mision of Anesthesiciology, General Hospital,
Mision Oratcal, Dental Devices
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