MINIMED COM-STATION, HARDWARE-7301; SOFTWARE-7311

K993012 · Medtronic Minimed · LZG · Nov 15, 1999 · General Hospital

Device Facts

• Record ID: K993012
• Device Name: MINIMED COM-STATION, HARDWARE-7301; SOFTWARE-7311
• Applicant: Medtronic Minimed
• Product Code: LZG · General Hospital
• Decision Date: Nov 15, 1999
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2

Intended Use

The MiniMed Com-Station Communication System is intended for use as an accessory to certain MiniMed infusion purps and LifeScan and Roche blood glucose meters to transmit and display stored data from device memory banks to a user's or physician's personal computer.

Device Story

MiniMed Com-Station (model 7301) and MiniMed Solutions software (model 7311) function as data transfer system. Hardware is cradle-like unit with Infra-Red (IR) ports; receives data from MiniMed infusion pumps via IR; includes serial port for connection to blood glucose meters. Device converts IR pulses into RS-232 compatible electrical pulses; transmits data to personal computer. Used by patients or physicians to display stored memory bank data. Facilitates data management and review of infusion and glucose history; aids clinical decision-making regarding therapy adjustments.

Clinical Evidence

bench testing only

Technological Characteristics

Hardware: cradle-like unit (approx. 6"x6"x3"). Connectivity: Infra-Red (IR) input from pumps, RS-232 serial output to PC, serial port for glucose meter connection. Energy source: electrical. Software: MiniMed Solutions (model 7311) for data display.

Indications for Use

Indicated for use as an accessory to MiniMed infusion pumps (models 507, 507C, 508) and LifeScan (One Touch) and Roche (Accu-Chek) blood glucose meters to transmit and display stored data from device memory banks.

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

• Disetronic D-Modem

Submission Summary (Full Text)

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NOV I 5 1999

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## 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: MiniMed® Inc. 12744 San Fernando Rd., Sylmar, California 91342

Contact: Jennifer Lyons, Regulatory Affairs; [phone], 3111; [e-mail]

Name of Device: MiniMed Com-Station™, model 7301, and MiniMed Solutions™ software, model 7311

Predicate Device: Disetronic D-Modem

Description of the Device: The MiniMed Com-Station Communication System is a data transfer system consisting of a hardware component designated by MiniMed model number 7301 and a software component designated by model number 7311 .

The system is designed for use with MiniMed infusion pumps (models 507, 507C, and 508) and certain popular blood glucose meters (LifeScan® One Touch®; Roche Accu-Chek™). The hardware component of the Com-Station is a cradle-like unit approximately 6" wide by 6" deep by 3" tall, with Infra-Red ports to transfer data electronically from the pump to a personal computer. The Com-Station converts Infra-Red (IR) pulses into RS-232 compatible electrical pulses which are sent through a serial port to the PC. The Com-Station also includes a serial port which allows connection to compatible blood glucose meters.

Intended Use of the Device: The MiniMed Com-Station Communication System is intended for use as an accessory to certain MiniMed infusion purps and LifeScan and Roche blood glucose meters to transmit and display stored data from device memory banks to a user's or physician's personal computer.

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 devices have similar materials, product design, and energy source.

Jennifer Lyons 9-7-99
Jennifer Lyons date

Jennifer Lyons Regulatory Affairs Specialist Regulatory Affairs MiniMed Inc.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 5 1999

Ms. Jennifer Lyons Requlatory Affairs Specialist Regulatory Affairs MiniMed® Technoloqies, Inc. 12744 San Fernando Rd. Sylmar, California 91342

Re : K993012

> MiniMed® Com-Station™ Communication System Trade Name: Requlatory Class: II Product Code: LZG Dated: September 7, 1999 Received: September 8, 1999

Dear Ms. Lyons:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 requlation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

510(k) Number:

Device Name: MiniMed Com-Station Model 7301, and software model 7311

The MiniMed Com-Station Communication System is indicated for use Indications for Use: as an accessory to MiniMed infusion pumps (models 507, 507C, and 508), and LifeScan (One Touch) and Roche (Accu-Chek) blood glucose meters to transmit and display data from device memory banks.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

or

Over-the-Counter Use _ X

Patricia Cicenti

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital De 510(k) Number .

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