(42 days)
Not Found
No
The description focuses on mechanical components and spring-loaded mechanisms for inserting an infusion set, with no mention of AI, ML, image processing, or data-driven decision-making.
No
The device is an insertion aid for infusion sets, it does not directly treat or diagnose a disease or condition.
No
The device description clearly states its purpose as an "insertion aid for automatic application of the Accu-Chek infusion sets," enabling the "introduction of the infusion set cannula into the subcutaneous fatty tissue." This function is therapeutic, facilitating the delivery of a substance (via infusion sets), rather than diagnostic, which involves identifying a disease or condition.
No
The device description explicitly states it is made of plastic and stainless steel components and has spring-loaded mechanisms, indicating it is a physical hardware device.
Based on the provided information, the Accu-Chek LinkAssist is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the placement of infusion sets into subcutaneous tissue. This is a physical action performed on the body, not a test performed on a sample taken from the body.
- Device Description: The description details a mechanical device for insertion, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of detecting diseases, conditions, or states of health through in vitro examination.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Accu-Chek LinkAssist's function is purely mechanical and related to drug delivery, not diagnosis.
N/A
Intended Use / Indications for Use
The Accu-Chek LinkAssist is an insertion device, which is intended specifically for placement of compatible Accu-Chek infusion sets.
Product codes
KZH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous fatty tissue
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
Performance and functional testing of the Accu-Chek LinkAssist have been verified and validated and no new issues were raised regarding safety and effectiveness.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 Road |
| Indianapolis, IN 46250 | |
| Contact: | Scott Thiel |
| Regulatory Affairs Program Manager | |
| Phone: | (800) 428-5074 X 13362 |
| Fax: | (317) 521-2324 |
| E Mail: | scott.thiel@roche.com |
| Submission Sponsor: | Disetronic Medical Systems AG |
| Kirchbergstrasse 190, Postfach | |
| CH-3401 Burgdorf | |
| Switzerland | |
| 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:
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.
Intended Use:
The Accu-Chek LinkAssist is an insertion device, which is intended specifically for placement of compatible Accu-Chek infusion sets.
1
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.
2
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.
3
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
4
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
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