MEDTRONIC MINIMED COMLINK, HARDWARE MODEL 7304 & SOFTWARE MODEL 7311

K021974 · Minimed, Inc. · MRZ · Aug 6, 2002 · General Hospital

Device Facts

• Record ID: K021974
• Device Name: MEDTRONIC MINIMED COMLINK, HARDWARE MODEL 7304 & SOFTWARE MODEL 7311
• Applicant: Minimed, Inc.
• Product Code: MRZ · General Hospital
• Decision Date: Aug 6, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2

Intended Use

The Medtronic MiniMed ComLink (model 7304) and model 7311 software are intended for use by patients at home and clinicians in a medical office setting to communicate with devices that utilize Paradigm pump compatible RF telemetry (i.e. MMT-511). MMT-7304 is intended for use in downloading device information when commanded by MMT-7311 operating on a PC and MMT-7304 is connected in line with the PC's serial port.

Device Story

Data transfer system comprising RF transceiver hardware (model 7304) and software (model 7311). Device receives RF telemetry signals from compatible infusion pumps (MMT-511); converts RF signals into RS-232 compatible electrical pulses; transmits data to a personal computer via serial port. Used by patients at home and clinicians in medical offices. Enables downloading of pump device information for review; facilitates clinical decision-making by providing access to pump data; benefits patients by allowing remote data management and monitoring.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Hardware: RF transceiver in plastic housing with RS-232 serial port. Connectivity: RF telemetry to pump, serial connection to PC. Power: Indirectly powered by PC. Software: Model 7311 for command and control of data download.

Indications for Use

Indicated for patients at home and clinicians in medical office settings to communicate with Paradigm pump compatible RF telemetry devices (e.g., MMT-511) for data downloading.

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-Station™ Communication System

Submission Summary (Full Text)

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AUG 0 6 2002

Medtronic MiniMed Premarket Notification - 510(k) Medtronic MiniMed ComLink™ Communication System

K 021974

## 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]

Medtronic MiniMed ComLink, model 7304, and Medtronic MiniMed Solutions™ Name Of Device: software, model 7311

Predicate Device: Com-Station™ Communication System

Description Of The Device: The Medtronic MiniMed Communication System is a data transfer system consisting of a hardware component designated by Medtronic MiniMed model number 7304 and a software component designated by model number 7311.

The system is designed for use with Medtronic MiniMed infusion pump (model 511). The hardware component of the ComLink consists of a radio-frequency (RF) transceiver enclosed in a plastic housing and one female RS-232 compatible serial communications port. Data is downloaded via RF telemetry to transfer data from the pump to a personal computer. The Converts RF signals into RS-232 compatible electrical pulses, which are sent through a serial port to the PC.

Intended Use Of The Device: The Medtronic MiniMed ComLink (model 7304) and model 7311 software are intended for use by patients at home and clinicians in a medical office setting to communicate with devices that utilize Paradigm pump compatible RF telemetry (i.e. MMT-511). MMT-7304 is intended for use in downloading device information when commanded by MMT-7311 operating on a PC and MMT-7304 is connected in line with the PC's serial port.

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 differences are that the Com-Station System transfers data via Infa-Red (IR) while the ComLink Communication System utilizes RF signals, the Com-Station derives its power from an electrical outlet whereas the ComLink is indirectly powered by PC, the ComLink does not have a cradle, and finally can only download pump information from pumps with RF telemetry.

Gerda Resch, RAC Manager, Regulatory Affairs Medtronic MiniMed

Date

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 0 6 2002

Ms. Gerda Resch Manager, Regulatory Affairs Medtronic MiniMed 18000 Devonshire Street Northridge, California 91325

Re: K021974

Trade/Device Name: Medtronic MiniMed ComLink™ Communication System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MRZ Dated: June 15, 2002 Received: June 17, 2002

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 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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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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

Timothy A. Ulatowski 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

K021974 510(k) Number:

Device Name: Medtronic MiniMed ComLink Model 7304 and software Model 7311

Indications For Use: For use by patients at home and clinicians in a medical office setting to communicate with devices that utilize Paradigm pump compatible RF telemetry (i.e. MMT-511). MMT-7304 is intended for use in downloading device information when commanded by MMT-7311 operating on a PC and MMT-7304 is connected in line with the PC's serial port.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) or

Over-the-Counter Use _ X

Patricia Cucente
(Division Sign-Off)

on of Anesthesiology, General Hospital, ction Control. D ntal Devices

510(k) Number: K021974

CONFIDENTIAL

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