(129 days)
The IN TOUCH Diabetes Management Software System is intended for use in home and clinical settings to aid people with diabetes and health care professionals in the review, analysis, and evaluation of historical blood glucose test results to support effective diabetes management. It is intended for use as an accessory to LifeScan Brand blood glucose monitoring systems with data management capabilities.
The IN TOUCH Diabetes Management Software System is an optional data management software accessory for use with LifeScan Brand blood glucose monitors such as the ONE TOUCH®, SureStep® and FastTake® Meters. When used with one of these meters, IN TOUCH permits the transfer of data from the glucose meter memory into a computer for enhanced data management capability.
The provided text is a 510(k) submission for the IN TOUCH® Diabetes Management Software System. This submission focuses on establishing substantial equivalence to predicate devices for regulatory clearance, rather than presenting a study demonstrating the device meets specific performance-based acceptance criteria through an analytical or clinical validation study.
Therefore, the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not available in the provided document.
The document primarily describes:
- Device Description: An optional data management software accessory for LifeScan blood glucose monitors.
- Intended Use: To aid in the review, analysis, and evaluation of historical blood glucose test results for diabetes management.
- Substantial Equivalence: Claimed against the LifeScan ONE TOUCH® Profile® Diabetes Tracking System and the MediSense® Precision Link™ Blood Glucose Data Management System.
- Regulatory Classification: Unclassified accessory to a blood glucose test system (75CGA) and an exemption for a "calculator/data processing module for clinical use" (862.2100) is discussed, though deemed not entirely applicable due to home use.
In summary, this document does not contain the information requested about acceptance criteria and a study proving the device meets them because it's a 510(k) submission focused on substantial equivalence rather than a detailed performance validation study.
{0}------------------------------------------------
April 29, 1999
TOUCH® Diabetes Management Software System 510(k) Submission
K 984527
510(k) Summary
| Submitter | LifeScan, Inc.1000 Gibraltar DriveMilpitas, CA 95035 |
|---|---|
| Contact Person | Lori D. ConzenSr. Regulatory Affairs SpecialistTel: (408) 942-5606Fax: (408) 942-5906 |
| Date | December 18, 1998 |
| Proprietary Name | IN TOUCH® Diabetes Management Software |
| Common Name | Data Management Software |
| Classification No. and Name | None¹ |
| Regulation No. | None² |
Device Description
The IN TOUCH Diabetes Management Software System is an optional data management software accessory for use with LifeScan Brand blood glucose monitors such as the ONE TOUCH®, SureStep® and FastTake® Meters. When used with one of these meters, IN TOUCH permits the transfer of data from the glucose meter memory into a computer for enhanced data management capability.
1 IN TOUCH is considered an "unclassified" accessory to a blood glucose test system, Classification Number 75CGA, Glucose oxidase, glucose.
2 The device regulation for a "calculator/data processing module for clinical use" (862.2100) exempts such Class I devices from 510(k) Premarket Notification requirements. This regulation is not entirely applicable to IN TOUCH, however, since this exemption only applies to data processors for clinical laboratory use, not home use. The regulation for the parent device (blood glucose monitor - Class II) is 862.1345, "glucose test system."
{1}------------------------------------------------
Intended Use
The IN TOUCH Diabetes Management Software is intended for use in home and clinical settings to aid people with diabetes and their health care professionals in the review, analysis and evaluation of historical blood glucose test results to support effective diabetes management.
Substantial Equivalence
The IN TOUCH Diabetes Management Software System is substantially equivalent to the currently marketed LifeScan ONE TOUCH® Profile® Diabetes Tracking System and the MediSense® Precision Link™ Blood Glucose Data Management System.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three lines representing its wings and tail feathers. The eagle is facing to the right.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 2 9 1999
Ms. Lori D. Conzen Senior Regulatory Affairs Specialist LifeScan, Inc. 1000 Gibraltar Drive Milpitas, California 95035
K984527 Re:
Trade Name: IN TOUCH® Diabetes Management Software Regulatory Class: II Product Code: CGA Dated: April 9, 1999 Received: April 12, 1999
Dear Ms. Conzen:
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 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 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.
{3}------------------------------------------------
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. 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/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
IN TOUCH® Diabetes Management Software System 510(k) Submission
Indications for Use Statement
510(k) Number (if known):
Device Name:
IN TOUCH® Diabetes Management Software System
Indications for Use:
The IN TOUCH Diabetes Management Software System is intended for use in home and clinical settings to aid people with diabetes and health care professionals in the review, analysis, and evaluation of historical blood glucose test results to support effective diabetes management. It is intended for use as an accessory to LifeScan Brand blood glucose monitoring systems with data management capabilities.
Tom Coogle
Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ (per 21 CFR 801.109) OR
Over-the-Counter Use_
(Optional Format 1-2-96)
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.