The Accu-Chek LinkAssist is an insertion aid for automatic application of the Accu-Chek infusion sets with compatible adapter. It permits introduction of the infusion set cannula into the subcutaneous fatty tissue.

The Accu-Chek LinkAssist is made of plastic and stainless steel components and has spring loaded mechanisms. The device is non-invasive, non-sterile and intended for multiple uses by the same patient. The connection between the Accu-Chek LinkAssist device and the infusion set is established by means of a compatible sterile adapter.

AI/ML Overview

This 510(k) submission for the Accu-Chek LinkAssist, K063146, does not contain the detailed information required to fulfill your request regarding acceptance criteria and a study proving device performance.

Here's why and what information is available:

The document explicitly states: "Performance and functional testing of the Accu-Chek LinkAssist have been verified and validated and no new issues were raised regarding safety and effectiveness." However, it does not provide the specific acceptance criteria, the study design, or the results of this testing.

Therefore, I cannot populate the table or answer the specific questions about sample size, ground truth, expert involvement, or comparative effectiveness.

Information that can be extracted from the provided text:

510(k) Summary for Accu-Chek LinkAssist (K063146)

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Not specified in the document	"Performance and functional testing of the Accu-Chek LinkAssist have been verified and validated and no new issues were raised regarding safety and effectiveness."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size (Test Set): Not specified.
Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable as no specific human expert evaluation in performance testing is described for establishing ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not specified.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a mechanical insertion aid, not an AI or imaging diagnostic device that would involve human "readers."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This device is a standalone mechanical device. Its performance testing would be focused on its mechanical function, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not specified. For a mechanical device, ground truth would typically refer to objective measurements of its function (e.g., proper insertion depth, force, ease of use).

8. The sample size for the training set:

Not applicable. This is a mechanical device, not a machine learning model that requires a "training set."

9. How the ground truth for the training set was established:

Not applicable.

Summary

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Disetronic Medical Systems AG Traditional 510(k) Premarket Submission Accu-Chek LinkAssist

Ko63146

510(k) SUMMARY

NOV 2 1 2006
Submission Correspondent:	Roche Diagnostics
Address:	9115 Hague RoadIndianapolis, IN 46250
Contact:	Scott ThielRegulatory Affairs Program Manager
Phone:	(800) 428-5074 X 13362
Fax:	(317) 521-2324
E Mail:	scott.thiel@roche.com
Submission Sponsor:	Disetronic Medical Systems AGKirchbergstrasse 190, PostfachCH-3401 BurgdorfSwitzerland
Date Prepared:	October 12, 2006
Trade Name:	Accu-Chek LinkAssist
Common Name:	Spring loaded insertion device
Classification:	Introducer, syringe needle
Regulation #:	21 CFR 880.6920; Class II device
Product Code	KZH

Description:

Intended Use:

The Accu-Chek LinkAssist is an insertion device, which is intended specifically for placement of compatible Accu-Chek infusion sets.

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Disetronic Medical Systems AG Traditional 510(k) Premarket Submission Accu-Chek LinkAssist

Predicate Devices:

The Accu-Chek LinkAssist is substantially equivalent to the following predicate devices:

Sof-Serter by Medtronic Minimed; 510(k) number K970479 .
Quick-Serter by Medtronic Minimed, 510(k) number K992300 .

Safety and Effectiveness:

The Accu-Chek LinkAssist device and the predicate devices, Sof-Serter and Quick-Serter, have the same intended use and are for multiple uses with dedicated infusion sets. All devices are made of plastics and metal springs and have similar method of operations which employ spring loaded mechanisms.

Performance and functional testing of the Accu-Chek LinkAssist have been verified and validated and no new issues were raised regarding safety and effectiveness.

Summary and Conclusion Regarding Substantial Equivalence:

By definition, a device is substantially equivalent when the device has the same intended use and the same technological characteristics as the predicate device, or has the same intended use and different technological characteristics, but it can be demonstrated that the device is as safe and effective as the predicate device and the new device does not raise different questions regarding safety and effectiveness as compared to the predicate device.

The Accu-Chek LinkAssist has the same indications for use and has similar method of operations, which employ spring loaded mechanisms as the above predicate devices. Based on the design equivalency and the testing performed, we have determined that the Accu-Chek LinkAssist is substantially equivalent to the predicate device(s) currently on the market.

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Image /page/2/Picture/11 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes forming its body and wing. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 27 2006

Disetronic Medical Systems AG C/O Mr. Scott Thiel Regulatory Affairs Program Manager Roche Diagnostics -9115 Hague Road Indianapolis, Indiana 46250

Re: K063146

Trade/Device Name: Accu-Chek LinkAssist Regulation Number: 21 CFR 880.6920 Regulation Name: Syringe Needle Introducer Regulatory Class: II Product Code: KZH Dated: October 12, 2006 Received: October 16, 2006

Dear Mr. Thiel:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Thiel

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other on our mot of the Act or any Federal statutes and regulations administered by other Federal gencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.0 regulario may obtain other general information on your responsibilities under the Act 6vr.77). Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Chiu Lin, Ph.D Director Division of Anesthesiology, General Hospital, Infection Control and Dental 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): ____________________________________________________________________________________________________________________________________________________

Device Name: Accu-Chek LinkAssist

The Accu-Chek LinkAssist is an insertion device, which is intended specifically for placement of compatible Accu-Chek infusion sets.

Prescription Use _X (Per 21 CFR 801.109) OR

Over the Counter Use__________________________________________________________________________________________________________________________________________________________

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

Clues

1 11-2 11 of Anesthesiology, General Hospital, Control, Dental Device

Page 1 of 1

Regulation Number and Section

§ 880.6920 Syringe needle introducer.

(a)
Identification. A syringe needle introducer is a device that uses a spring-loaded mechanism to drive a hypodermic needle into a patient to a predetermined depth below the skin surface.(b)
Classification. Class II (performance standards).