(143 days)
The Sof-set and Polyfin families of infusion sets are indicated for the subcutaneous infusion of medication, including insulin, from a Medtronic MiniMed infusion pump and reservoir.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "Polyfin Infusion Set" and related models. It explicitly states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices.
A 510(k) clearance evaluates substantial equivalence, meaning the new device is as safe and effective as a legally marketed predicate device. This process does not typically involve detailed studies to establish new acceptance criteria or quantify device performance against specific metrics in the way a PMA (Premarket Approval) or a clinical trial for a novel device would. The provided text does not contain the acceptance criteria or a study that proves the device meets specific acceptance criteria as you've requested.
The information you are asking for, such as sample size, ground truth establishment, expert qualifications, and specific performance metrics, is usually found in detailed scientific reports, clinical trial summaries, or design validation documents that are submitted to the FDA as part of the 510(k) but are not typically included in the public-facing clearance letter itself.
Therefore,Based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets those criteria because this information is not present. The document is an FDA 510(k) clearance letter, which confirms substantial equivalence to a predicate device, rather than providing detailed performance data against new acceptance criteria.
The information you've requested typically comes from the technical documentation and studies submitted to the FDA, which are not included in this summary letter.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Mark Faillace Senior Director, Regulatory Affairs and Product Reporting Medtronic MiniMed JUL - 9 2010 18000 Devonshire Street Northridge, California, 91325-1219
Re: K100432
Trade/Device Name: Polyfin Infusion Set, Models MMT-165, MMT-365, MMT-366. MMT-312S Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA, FPK Dated: July 2, 2010 Received: July 6, 2010
Dear Mr. Faillace:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. ﻨﻴﺔ
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Page 2- Mr. Faillace
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH /CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K100432
Device Name: Polyfin QR Infusion Set (Model MMT-165, MMT-365), Paradigm Polyfin QR Infusion Set (Model MMT-312L), Sof-set Ultimate QR Infusion Set (MMT-315, MMT-316), Sof-set Micro QR Infusion Set (MMT-320, MMT-321), Paradigm Sof-set Ultimate QR Infusion Set (MMT-317, MMT-318), Paradigm Sofset Micro QR Infusion Set (Model MMT-324, MMT-325)
Indications For Use: The Sof-set and Polyfin families of infusion sets are indicated for the subcutaneous infusion of medication, including insulin, from a Medtronic MiniMed infusion pump and reservoir.
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 (QDE)
(Division Sign-Citt) // Division of Anesthesiology, General Hospital mection Control, Dental Devices
510(k) Number:
§ 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.