(186 days)
The Medtronic MiniMed ParadigmPAL (model 7330) is intended for use by patients at home and clinicians in a medical office setting in programming insulin basal delivery patterns, insulin delivery rates and current basal rates in effect on the pump. It is intended to communicate with devices that utilize Paradigm pump compatible RF telemetry (i.e. MMT-512).
The Medtronic MiniMed ParadigmPAL (model 7330) is intended for use by patients at home and clinicians in a medical office setting as a tool to save and adjust Medtronic MiniMed Paradigm pump settings using a personal computer.
The Medtronic MiniMed ParadigmPAL is data transfer software designated by Medtronic MiniMed to interface with hardware models 7304 (ComLink) and HS-3222 (Paradigm Link); personal computer and a Paradigm insulin infusion pump.
The ParadigmPAL system is designed for use with Medtronic MiniMed infusion pumps (model 512 and model 712).
The provided text is a 510(k) summary for the Medtronic MiniMed ParadigmPAL, model 7330, and related FDA correspondence. It does not contain information about acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert involvement that would typically be found in a detailed study report. The document primarily focuses on establishing substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information based on the given text. The K031541 filing is a submission demonstrating equivalence rather than a study with performance metrics against pre-defined acceptance criteria.
To elaborate, the document states:
- Device Description: The ParadigmPAL is data transfer software designed to interface with specific hardware models, personal computers, and Paradigm insulin infusion pumps.
- Intended Use: For patients at home and clinicians in a medical office setting to "program insulin basal delivery patterns, insulin delivery rates and current basal rates in effect on the pump" and "communicate with devices that utilize Paradigm pump compatible RF telemetry."
- Comparison to Predicate: The key difference from the predicate device (Com-Link™ Communication System) is the ParadigmPAL's ability to "upload of information to the pump" in addition to downloading the information, which the predicate device could only do.
- FDA Determination: The FDA letter states that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to market under general controls.
This is a regulatory pathway that largely relies on demonstrating that the new device is as safe and effective as a legally marketed device, often without requiring new clinical performance studies if the technological characteristics and intended use are very similar.
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NOV 1 8 2003
K03/54/
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 Street Northridge, CA 91325
Contact: Gerda Resch, Regulatory Affairs; (818) 576-4198; gerda.resch@medtronic.com
Name Of Device: Medtronic MiniMed ParadigmPAL, model 7330,
Predicate Device: Com-Link™ Communication System model 7304 and model 7311
Description Of The Device: The Medtronic MiniMed ParadigmPAL is data transfer software designated by Medtronic MiniMed to interface with hardware models 7304 (ComLink) and HS-3222 (Paradigm Link); personal computer and a Paradigm insulin infusion pump.
The ParadigmPAL system is designed for use with Medtronic MiniMed infusion pumps (model 512 and model 712).
Intended Use Of The Device: The Medtronic MiniMed ParadigmPAL (model 7330) is intended for use by patients at home and clinicians in a medical office setting in programming insulin basal delivery patterns, insulin delivery rates and current basal rates in effect on the pump. It is intended to communicate with devices that utilize Paradigm pump compatible RF telemetry (i.e. MMT-512).
Comparison Of The Technological Features Of The New Device And Predicate Device: The technological features of the new device do not differ significantly from the predicate device. The minor difference is that the software will permit both the upload of information to the punnp through a Medtronic MiniMed ComLink or Paradigm Link glucose meter. The Com-Link Communication System software only permits download of information from the pump and does not allow the user to upload setting to the pump.
Vum
Gerda Resdh, RAC Manager, Regulatory Affairs Medtronic MiniMed
5-15-23
Date
000004
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle.
Public Health Service
NOV 1 8 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtronic MiniMed. Incorporated Ms. Gerda Resch Manager. Regulatory Affairs 18000 Devonshire Street Northridge, California 91325-1219
Re: K031541
Trade/Device Name: ParadigmPAL, Model MMT-7330 Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: October 20, 2003 Received: October 22, 2003
Dear Ms. Resch:
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 vour 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. Resch
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 yours,
Chuls
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
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Medtronic MiniMod Premarket Notification - 510(k) Medtronic MiniMcd ParadigmPAI ™
INDICATIONS FOR USE
510(k) Number:
Device Name: Medtronic MiniMed ParadigmPAL model 7330
Indications For Use: The Medtronic MiniMed ParadigmPAL (model 7330) is intended for use by patients at home and clinicians in a medical office setting as a tool to save and adjust Medtronic MiniMed Paradigm pump settings using a personal computer.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
(Per 21 CFR 801.109)
or
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
Patricio Cucurella
siology, General Hospital.
510(k) Number: K631541
CONFIDENTIAL
§ 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).