(63 days)
Not Found
Not Found
No
The summary describes a mechanical infusion set and an insertion device. There is no mention of AI, ML, or any computational decision-making or data analysis that would suggest the use of these technologies. The testing described is functional and usability testing, not performance evaluation of an algorithm.
Yes
The device, an infusion set, is used for the subcutaneous infusion of insulin for patients with insulin-dependent diabetes mellitus, which is a therapeutic treatment.
No
The device is an infusion set and insertion aid for administering insulin, not for diagnosing a condition.
No
The device description clearly states it is an "infusion set" and an "insertion device," which are physical hardware components used for delivering insulin.
Based on the provided information, the ACCU-CHEK® FlexLink Plus and ACCU-CHEK® LinkAssist Plus devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use is for the subcutaneous infusion of insulin and the insertion of the infusion set. This is a direct interaction with the patient's body for therapeutic delivery, not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description focuses on the physical components and their function in delivering insulin into the subcutaneous tissue. There is no mention of analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, or other bodily fluids.
- Providing diagnostic information.
- Performing tests on specimens outside the body.
These devices are classified as medical devices for drug delivery and insertion, not for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
ACCU-CHEK® FlexLink Plus is an infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps.
ACCU-CHEK® LinkAssist Plus is an insertion device, which is intended specifically for placement of compatible ACCU-CHEK® FlexLink Plus infusion sets.
Product codes (comma separated list FDA assigned to the subject device)
FPA, KZH, FRN
Device Description
The ACCU-CHEK® FlexLink Plus is a disconnectable infusion set with soft cannula perpendicular to the adhesive, for transfusion of insulin into the subcutaneous tissue. The unit is designed to interface with commercially available insulin infusion pumps with suitable connections. The insulin infusion pump systems are designed to control the delivery of insulin as prescribed by a health care professional. The system (infusion set, insulin infusion pump, and insulin) is indicated for patients with insulin dependent diabetes mellitus.
The ACCU-CHEK® LinkAssist Plus is an insertion aid for automatic application of ACCU-CHEK® infusion sets equipped with a compatible adapter. The ACCU-CHEK® LinkAssist device is non-invasive, non-sterile and intended for multiple uses by the same patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
patients with insulin dependent diabetes mellitus.
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)
- Study type: Functional Testing. Key results: The results of the testing conducted indicate the ACCU-CHEK® FlexLink Plus infusion set and the optional ACCU-CHEK® LinkAssist Plus insertion device functioned according to specifications and the materials used in the devices are biocompatible.
- Study type: Human factors usability testing. Key results: The design validation of ACCU-CHEK® FlexLink Plus & ACCU-CHEK® LinkAssist Plus confirmed that the devices fulfill its intended use, customer requirements and primary operating functions.
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.
Not Found
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).
0
KUUZOY
····
; .
ﺑ
MAY 1 4 2010
| 510(k) Summary | |
|---|---|
| Introduction | According to the requirements of 21 CFR 807.92, the following information |
| provides sufficient detail to understand the basis for a determination of | |
| substantial equivalence. | |
| Submitter | Submitted by: |
| Disetronic Medical Systems AG | |
| Kirchbergstrasse 190, Postfach | |
| CH-3401 Burgdorf, Switzerland | |
| United States Contact Person: | |
| Scott Thiel | |
| Roche Diagnostics | |
| 9115 Hague Road | |
| Indianapolis, Indiana 46250 | |
| 317-521-3362 | |
| scott.thiel@roche.com | |
| Date Prepared: April 12, 2010 | |
| Device name | Proprietary name: ACCU-CHEK® FlexLink Plus infusion set |
| Common name: subcutaneous infusion set | |
| Classification name: intravascular administration set | |
| Product Code: FPA |
Proprietary name: ACCU-CHEK® LinkAssist Plus insertion device
Common name: infusion set insertion device
Classification name: syringe needle introducer
Product Code: KZH |
| Predicate
device | We claim substantial equivalence to the current legally marketed ACCU-
CHEK® Ultraflex infusion set and ACCU-CHEK® LinkAssist insertion device. |
Continued on next page
1
510(k) Summary, Continued
| Device description | The ACCU-CHEK® FlexLink Plus is a disconnectable infusion set with soft cannula perpendicular to the adhesive, for transfusion of insulin into the subcutaneous tissue. The unit is designed to interface with commercially available insulin infusion pumps with suitable connections. The insulin infusion pump systems are designed to control the delivery of insulin as prescribed by a health care professional. The system (infusion set, insulin infusion pump, and insulin) is indicated for patients with insulin dependent diabetes mellitus. |
|---|---|
| The ACCU-CHEK® LinkAssist Plus is an insertion aid for automatic application of ACCU-CHEK® infusion sets equipped with a compatible adapter. The ACCU-CHEK® LinkAssist device is non-invasive, non-sterile and intended for multiple uses by the same patient. | |
| Intended use | ACCU-CHEK® FlexLink Plus is an infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps. |
| ACCU-CHEK® LinkAssist Plus is an insertion device, which is intended specifically for placement of compatible ACCU-CHEK® FlexLink Plus infusion sets. | |
| Continued on next page |
2
510(k) Summary, Continued
The ACCU-CHEK® FlexLink Plus infusion set was compared to the ACCU-Device CHEK® Ultraflex infusion set. The ACCU-CHEK® FlexLink Plus is Comparisons substantially equivalent to this product by having the same intended use, same storage conditions, same luer connector, same operating conditions, a flexible catheter and needle for insertion into the subcutaneous tissue and separate extension tubing with detachable connector. Both sets have an adhesive patch that secures the headset to the skin. Prior to infusion, both sets require removal of the introducer needle. The ACCU-CHEK® FlexLink Plus incorporates a needle protection feature that retracts the needle automatically following insertion of the needle and cannula. The optional ACCU-CHEK® LinkAssist Plus insertion device was compared to the optional ACCU-CHEK® LinkAssist insertion device. The ACCU-CHEK® FlexLink Plus is substantially equivalent to this product by having the same intended use, same storage conditions, same operating conditions, and same general functionality. The overall dimensions of the ACCU-CHEK® FlexLink Plus are slightly wider and longer than the ACCU-CHEK® FlexLink device. Both devices include a safety catch; the ACCU-CHEK® FlexLink Plus incorporates the safety catch in the base of the device
such that it is depressed when placing the device into position on the body.
Continued on next page
3
510(k) Summary, Continued
Summary of Functional Testing:
In vitro functional testing of the ACCU-CHEK® FlexLink Plus infusion set and the optional ACCU-CHEK® LinkAssist Plus insertion device was conducted. Biocompatibility testing was performed on the materials used in both devices.
Clinical Studies:
Human clinical studies were not deemed necessary to evaluate the safety or effectiveness of the ACCU-CHEK® FlexLink Plus infusion set or the optional ACCU-CHEK® LinkAssist Plus insertion device.
System validation testing included human factors usability testing of the customer requirements and primary operating function of the ACCU-CHEK® FlexLink Plus infusion set and the optional ACCU-CHEK® LinkAssist Plus insertion device. Individuals who participated in the evaluation included patients who routinely use an insulin pump and infusion set. The usability evaluations determined the customer requirements were met and that the primary operating function operated as intended. No needle stick injuries were reported associated with unintentional ejection.
Study Conclusions
Studies
Functional Testing:
The results of the testing conducted indicate the ACCU-CHEK® FlexLink Plus infusion set and the optional ACCU-CHEK® LinkAssist Plus insertion device functioned according to specifications and the materials used in the devices are biocompatible.
Human factors usability testing:
The design validation of ACCU-CHEK® FlexLink Plus & ACCU-CHEK® LinkAssist Plus confirmed that the devices fulfill its intended use, customer requirements and primary operating functions.
Based upon these results, the product is considered acceptable for human use.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Disetronic Medical System AG C/O Mr. Scott Thiel Regulatory Affairs Program Manager Roshe Diagnostics 9115 Hague Road Indianapolis, Indiana 46250-0457
MAY 1 4 2010
Re: K100704
Trade/Device Name: ACCU-CHEK® FlexLink Plus infusion set with optional ACCU- CHEK® LinkAssist Plus insertion device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FRN Dated: April 14, 2010 Received: April 16, 2010
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
5
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 requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use Statement
510(k) Number (if known): K100704
Device Name: ACCU-CHEK® FlexLink Plus infusion set with optional ACCU-CHEK® LinkAssist Plus insertion device
Indications for Use:
ACCU-CHEK® FlexLink Plus is an infusion set for the subcutaneous infusion of insulin administered with micro dosage insulin pumps.
ACCU-CHEK® LinkAssist Plus is an insertion device, which is intended specifically for placement of compatible ACCU-CHEK® FlexLink Plus infusion sets.
Prescription Use_ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(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 Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K100704