The Lifescan FastTake® Adapter is an accessory to the Lifescan FastTake® Blood Glucose Meter. It provides a communication link between the FastTake® Meter and the Lifescan ONE TOUCH® Interface cable, neither of which is included. The FastTake Adapter is intended to be used for data transfer between a FastTake® Meter and a personal computer.

Device Description

The FastTake" Adapter is an accessory to the FastTake Blood Glucose Meter. lt provides a communication link between the FastTake Meter and the ONE TOUCH® cable, neither of which is included with the Adapter. The FastTake Adapter is intended to be used for data transfer between a FastTake Meter and a personal computer.

AI/ML Overview

The provided 510(k) summary for the FastTake® Adapter does not contain detailed acceptance criteria or a specific study that proves the device meets such criteria in a quantitative manner. This submission focuses on demonstrating substantial equivalence to a predicate device, the Precision Link™ Communications Box.

Here's an analysis of the information provided, trying to extract what's available for each requested point:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Reliable communication between a PC and the FastTake Blood Glucose Meter	Software and hardware verification and validation tests demonstrate that the FastTake Adapter provides reliable communication between a PC and the FastTake Blood Glucose Meter.

Note: The document is limited in providing specific, measurable acceptance criteria (e.g., success rate of data transfer, error rate, speed of transfer) and instead offers a general statement about "reliable communication" being demonstrated through verification and validation tests.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a "test set" in the context of a clinical study or a dataset with labeled ground truth. The "verification and validation tests" mentioned are likely product-level hardware and software testing, not a study involving patient data. Therefore, details regarding sample size, country of origin, or retrospective/prospective nature of data are not provided.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

As there is no mention of a "test set" involving expert-labeled ground truth, this information is not applicable/not provided.

4. Adjudication Method for the Test Set:

Since a test set requiring adjudication by experts is not described, this information is not applicable/not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No MRMC study is mentioned. This device is a communication adapter, not an AI or diagnostic device that would typically involve human readers. Therefore, this is not applicable/not provided.

6. If a Standalone (Algorithm Only) Performance Study Was Done:

The document indicates "Software and hardware verification and validation tests" were performed, which implies standalone testing of the device's functionality. However, specific details about the methodology, metrics, or results of these tests beyond the general statement of "reliable communication" are not provided. The device itself is described as "microprocessor controlled communication devices," implying an "algorithm" (firmware/software) controls its function, and this would have been tested in a standalone manner during verification and validation.

7. The Type of Ground Truth Used:

For the "reliable communication" claim, the ground truth would likely be defined by successful data transfer operations as per the device's specifications (e.g., data transmitted equals data received, correct data formatting). This would be established through engineering and software testing protocols, not clinical outcomes or pathology. Specifics are not provided.

8. The Sample Size for the Training Set:

This device is not an AI/machine learning model that typically requires a "training set" of data in the sense of supervised learning. Its functionality is based on established communication protocols and hardware/software design. Therefore, a "training set" in this context is not applicable/not provided.

9. How the Ground Truth for the Training Set Was Established:

As there is no training set described, this information is not applicable/not provided.

In summary:

This 510(k) submission for the FastTake® Adapter is for a Class I accessory device, and its approval relies on demonstrating substantial equivalence to a predicate device (the Precision Link™ Communications Box) with "the same technological characteristics" and "the same intended use." The performance data is limited to a general statement that "Software and hardware verification and validation tests demonstrate that the FastTake Adapter provides reliable communication." This level of detail is typical for such a device classification and regulatory pathway at the time of approval (1998), where the focus is on functional equivalence rather than extensive clinical efficacy studies with detailed statistical metrics as would be expected for more complex diagnostic or therapeutic devices, especially AI-driven ones.

Summary

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1983468

DEC 17 1998

Section 5 510(k) SUMMARY (Summary of Safety and Effectiveness)

Submitted by:

Betty J. Lane Director of Quality and Regulatory Affairs Selfcare, Inc. 200 Prospect Street Waltham, MA 02453-3457 USA Phone: (781) 647-3900 Fax: (781) 647-3939

Contact Person:

Betty Lane Phone (781) 647-3900 x144

Summary Prepared:

September 30, 1998

Name of the device:

FastTake® Adapter

Classification name(s):

The FastTake Adapter is a Class I accessory device classified as a calculator/data processing module for clinical use (21 CFR § 862.2100). As it can also be used in the home by a layperson, it is not exempt from premarket notification (21 CFR § 862.9(a)).

Classification of predicate device(s):

The FastTake Adapter is not materially different from the predicate device, the Precision Link™ Communications Box, a component of the Precision Link™ Blood Glucose Data Management System. The predicate device is manufactured by Medisense, Inc and was cleared for use in the United States by K952279. The Precision Link™ System, which is classified as a data management system, is comprised of five separate components: data management software, communications box, an AC power adapter, communications cable, and an RS-232 cable. It is the Precision Link™ Communications Box that the FastTake Adapter is analogous to. Whereas K952279 covered all components of the Precision Link™ Data Management System, this premarket notification covers only the communication link component (i.e. the FastTake Adapter).

Description of the device/intended use(s):

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Statement of How the Technological Characteristics of the Device Compare to the Predicate device:

The technological characteristics are the same as both devices are micoprocessor controlled communication devices, thus have the same safety and effectiveness. They have the same intended use, i.e. communication between a PC and a glucose meter.

Summary of Performance Data:

Software and hardware verification and validation tests demonstrate that the FastTake Adapter provides reliable communication between a PC and the FastTake Blood Glucose Meter.

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Image /page/2/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines suggesting hair or movement.

DEC 17 1998

Ms. Betty J. Lane Director of Quality and Requlatory Affairs Selfcare, Inc. 200 Prospect Street Waltham, Massachusetts 02453-3457

Re : K983468 FastTake® Adapter Trade Name: Requlatory Class: I Product Code: JQP Dated: September 30, 1998 Received: October 1, 1998

Dear Ms. Lane:

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 Requlations, 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 Failure to comply with the GMP regulation may result in assumptions. requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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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 Butman

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

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Indications for Use Statement

510(k) Number (if known): K983468

Lifescan FastTake® Adapter Device Name:

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K983468

Prescription Use (Per 21 CFR 801.019) OR

Over-The-Counter Use ✓

51.0(k) Notification FastTake Adapter

Regulation Number and Section

§ 862.2100 Calculator/data processing module for clinical use.

(a)
Identification. A calculator/data processing module for clinical use is an electronic device intended to process laboratory data.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.