(68 days)
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.
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.
The device is the MiniMed Com-Station™ (model 7301) and MiniMed Solutions™ software (model 7311). This document does not contain information regarding acceptance criteria or a study proving that the device meets such criteria.
The provided text is a 510(k) Summary and the associated FDA clearance letter. It describes the device, its intended use, and a comparison to a predicate device (Disetronic D-Modem) to establish substantial equivalence. It confirms FDA clearance for marketing based on this substantial equivalence.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text. This type of detailed performance study information is generally found in a separate study report, not typically summarized in the 510(k) summary itself, which focuses on regulatory compliance and substantial equivalence to a predicate device.
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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; (818) 362-5958, 3111; JenniferLy@MiniMed.com
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.
00004
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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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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 .
00008
§ 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).