(68 days)
Disetronic D-Modem
Not Found
No
The description focuses on data transfer and conversion between devices and a personal computer, with no mention of AI or ML algorithms for analysis or interpretation.
No.
The device is described as a "data transfer system" intended to transmit and display stored data from medical devices to a computer, which is an accessory function, not a direct therapeutic intervention.
No
This device is a data transfer system that transmits and displays stored data; it does not perform diagnosis.
No
The device description explicitly states that the system consists of both a hardware component (model number 7301) and a software component (model number 7311). The hardware component is described as a physical cradle-like unit with Infra-Red ports and a serial port.
Based on the provided information, the MiniMed Com-Station Communication System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to transmit and display stored data from infusion pumps and blood glucose meters to a computer. It does not perform any diagnostic testing or analysis of biological samples.
- Device Description: The device description clearly states it's a "data transfer system" that converts and transmits data. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The description doesn't mention any reagents, assays, or procedures for analyzing blood, urine, or other biological materials, which are hallmarks of IVD devices.
The MiniMed Com-Station is an accessory used to manage data generated by other devices (infusion pumps and blood glucose meters), but it does not perform the diagnostic function itself.
N/A
Intended Use / Indications for Use
The MiniMed Com-Station Communication System is indicated 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.
Product codes (comma separated list FDA assigned to the subject device)
LZG
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Disetronic D-Modem
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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NOV I 5 1999
Image /page/0/Picture/2 description: The image shows the logo for MiniMed. Below the logo is the text 'K993012'. The logo consists of a black square with white curved lines on the left and the word 'MiniMed' in black font on the right.
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.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and body.
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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Page 2 - Ms. Lyons
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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Image /page/3/Picture/1 description: The image shows the logo for MiniMed. The logo consists of a black square on the left with a white waveform design inside. To the right of the square is the word "MiniMed" in a bold, serif typeface, with a registered trademark symbol next to the "d".
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