(53 days)
The Medtronic MiniMed Paradigm Reservoir MMT-332 is indicated for the subcutaneous infusion of medication, including insulin, from the Paradigm family of infusion pumps and infusion sets. The reservoir is not indicated for use with blood.
The Medtronic MiniMed Paradigm™ Reservoir Model MMT-332 is a disposable, single use medication container intended for use with the Mediconic MiniMed external micro infusion pumps. The reservoir shall be packaged together with a plunger rod and a transfer guard for use in filling the reservoir from a medication vial.
The provided text describes a 510(k) premarket notification for the Modtronic MiniMod Paradigm™ Reservoir MMT-332. This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical study results with specific acceptance criteria and performance metrics typically found in efficacy studies.
Therefore, many of the requested details about acceptance criteria, study design, ground truth, and expert involvement are not present in this type of regulatory submission. The 510(k) summary primarily addresses the device's description, intended use, and comparison to its predicate.
Here's a breakdown based on the provided text, indicating where information is present and where it is absent for your specific questions:
1. A table of acceptance criteria and the reported device performance
This information is not present in the 510(k) summary. A 510(k) for this type of device typically relies on demonstrating that the new device does not raise new questions of safety and effectiveness compared to a legally marketed predicate, often through bench testing and, in some cases, limited animal or human use data without specific "acceptance criteria" and "reported device performance" in the way one might expect for a diagnostic or AI-driven device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present. The submission does not detail a "test set" in the context of clinical performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not present. The concept of "ground truth" established by experts for a test set is not applicable to this type of device submission as described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present. Adjudication methods are not relevant to this type of regulatory submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not present. An MRMC study is not relevant to this type of device (a medication reservoir) and its 510(k) submission. There is no AI component mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not present. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not present. "Ground truth" in the context of performance accuracy is not discussed for this device.
8. The sample size for the training set
This information is not present. There is no "training set" in the context of this device.
9. How the ground truth for the training set was established
This information is not present. There is no "training set" or "ground truth" discussed for this device.
Summary of the K032005 Submission:
- Device Name: Medtronic MiniMed Paradigm™ Reservoir Model MMT-332
- Predicate Device: Medtronic MiniMed Paradigm™ Reservoir Model MMT-326
- Key Modification: Differences in "volume, filling mechanism, and infusion set connector" compared to the predicate.
- Regulatory Focus: To demonstrate that these modifications have "no untoward effect on the safety and effectiveness of the device" and that the new device is "substantially equivalent" to the predicate. This is a common approach for 510(k) submissions, where direct comparative clinical trials for novel performance criteria are usually not required unless new questions of safety or effectiveness are raised.
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Modtronic MiniMod Premarket Notification - 510(k) Paradigm™ Reservoir MMT-332 AUG 2 2 2003
Section C. 510(k) Summary
In accordance with the requirements of SMDA 1990, and 21 CFR 807.92, a 510(k) Summary follows:
Submitter: Medironic MiniMed 18000 Devonsbire Street Northridge California 9132.5
Contact: Mirielle Mengotto (818) 576-4112
Name of Device: Mcdtronic MiniMed Paradigm™ Reservoir Model MMT-332
Predicate Device: Medtronic MiniMed Paradigm™ Reservoir Model MMT-326
Description of the Device: The Medtronic MiniMed Paradigm Reservoir Model MMT-332 is a disposable, single use medication container intended for use with the Mediconic MiniMed external micro infusion pumps. The reservoir shall be packaged together with a plunger rod and a transfer guard for use in filling the reservoir from a medication vial.
The modifications which are the subject of this premarker notification have no untoward effect on the safety and offectiveness of the device.
Intended Use of the Device: The Meditoric MiniMed Paradigm Reservoir MMT-332 is indicated for the subcutaneous infusion of medication, insulin, from the Paradigm family of infusion pumps and infusion sets. The reservoir is not indicated for use with blood
Comparison of the Technological Features of the New and Predicate Devices: The new device is substantially equivalent to the lawfully marketed predicate device. They differ in volume, filling mechanism, and infusion set connector.
1 Or
Gerda Resch Manager Regulatory Affairs Medtronic MiniMed
Date
CONFIDENTIAL
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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 an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 2 2003
Ms. Mirielle Mengotto Senior Regulatory Affairs Specialist Medtronic MiniMed 18000 Devonshire Street Northridge, California 91325-1219
Re: K032005
Trade/Device Name: Medtronic MiniMed Paradigm Reservoir MMT-332 Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: June 26, 2003 Received: June 30, 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.
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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 mr rketed 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 yours,
Susan Runner
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
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Medtronic MiniMed Premarket Notification - 510(k) Paradigm™ Reservoir MMT-332
INDICATIONS FOR USE
510(k) Number:
Device Name:
Medtronic MiniMed Paradigm Reservoir MMT-332
Indications for Use:
The Medtronic MiniMed Paradigm Reservoir MMT-332 is indicated for the subcutaneous infusion of medication, including insulin, from the Paradigm family of infusion pumps and infusion sets. The reservoir is not indicated for use with blood.
Patricia Cascente
(Division Sign-Off Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:_
Concurrence of CDRH, Office of Device Evaluation (ODE) .
Prescription Use (Per 21 CFR 801.109)
or
Over-the-Counter Use
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).