PARADIGMPAL, MODEL MMT-7330

K031541 · Minimed, Inc. · LZG · Nov 18, 2003 · General Hospital

Device Facts

• Record ID: K031541
• Device Name: PARADIGMPAL, MODEL MMT-7330
• Applicant: Minimed, Inc.
• Product Code: LZG · General Hospital
• Decision Date: Nov 18, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

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).

Device Story

ParadigmPAL (model 7330) is data transfer software; interfaces with personal computer, Medtronic MiniMed Paradigm insulin infusion pumps (models 512, 712), and hardware models 7304 (ComLink) or HS-3222 (Paradigm Link). Used by patients at home and clinicians in medical offices. Enables programming of insulin basal delivery patterns, delivery rates, and current basal rates. Facilitates bidirectional communication; allows uploading settings to the pump and downloading information from the pump via RF telemetry. Assists healthcare providers in managing insulin therapy; benefits patients by enabling remote or office-based adjustment of pump parameters.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based data transfer system; utilizes RF telemetry for communication with Paradigm insulin pumps (MMT-512). Operates on a personal computer. Connectivity via ComLink or Paradigm Link hardware interfaces.

Indications for Use

Indicated for patients using Medtronic MiniMed Paradigm insulin infusion pumps (models 512 and 712) at home or in a clinical setting to save and adjust pump settings via a personal computer.

Regulatory Classification

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.

Predicate Devices

• Com-Link™ Communication System model 7304
• Com-Link™ Communication System model 7311

Submission Summary (Full Text)

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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; [phone]; [e-mail]

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 [phone]. 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 [phone] or [phone] 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