(63 days)
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.
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.
The provided text describes the 510(k) summary for the ACCU-CHEK® FlexLink Plus infusion set and the optional ACCU-CHEK® LinkAssist Plus insertion device. Based on the document, here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics like sensitivity, specificity, accuracy, or specific failure rates. Instead, the acceptance criteria appear to be met through demonstrating functional equivalence to a predicate device and successful completion of functional and human factors testing, implying performance within expected parameters for such devices.
Therefore, the table below reflects the qualitative acceptance criteria and the summary of the performance as reported:
| Acceptance Criteria Category | Specific Criteria / Test | Reported Device Performance |
|---|---|---|
| Functional Equivalence (Infusion Set) | Same intended use as predicate device | Met (ACCU-CHEK® FlexLink Plus has same intended use as ACCU-CHEK® Ultraflex infusion set) |
| Same storage conditions | Met | |
| Same luer connector | Met | |
| Same operating conditions | Met | |
| Flexible catheter and needle for insertion | Met | |
| Separate extension tubing with detachable connector | Met | |
| Adhesive patch for securement | Met | |
| Requires introducer needle removal prior to infusion | Met | |
| Incorporates needle protection feature (automatic retraction) | Met | |
| Functional Equivalence (Insertion Device) | Same intended use as predicate device | Met (ACCU-CHEK® LinkAssist Plus has same intended use as ACCU-CHEK® LinkAssist insertion device) |
| Same storage conditions | Met | |
| Same operating conditions | Met | |
| Same general functionality | Met | |
| Overall dimensions (slightly wider and longer than predicate) | Acceptable (not presented as a failure) | |
| Safety catch mechanism (incorporated in device base) | Acceptable (not presented as a failure) | |
| Functional Testing (In vitro) | Functioned according to specifications | Met (Results indicated device functioned according to specifications) |
| Biocompatibility Testing | Materials used are biocompatible | Met (Materials used in devices are biocompatible) |
| Human Factors Usability Testing | Customer requirements met | Met (Evaluations determined customer requirements were met) |
| Primary operating function operated as intended | Met (Primary operating function operated as intended) | |
| No needle stick injuries reported (unintentional ejection) | Met (No needle stick injuries reported) | |
| Overall Conclusion | Considered acceptable for human use | Met (Based on study results, product is considered acceptable for human use) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a numerical sample size for the functional testing or the human factors usability testing. It mentions "individuals who participated in the evaluation included patients who routinely use an insulin pump and infusion set," but no specific number is provided.
- Data Provenance: The studies were prospective. The human factors usability testing involved individuals participating in evaluations, implying it was conducted specifically for this device submission. The in vitro functional and biocompatibility testing similarly suggests newly generated data for the device. The country of origin of the data is not explicitly stated, but the submitter is Disetronic Medical Systems AG in Switzerland, and the US contact is Roche Diagnostics in Indianapolis, Indiana. The studies would likely have been conducted according to international standards (e.g., ISO) and possibly in relevant regions (e.g., Europe, US).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not applicable/not specified. For this type of device (infusion sets and insertion devices), the "ground truth" is typically established by engineering specifications, regulatory standards, and clinical user experience rather than expert consensus on diagnostic images or pathology. The human factors usability testing involved patients who routinely use such devices, serving as the user population for evaluating intended use.
- Qualifications of Experts: Not applicable in the traditional sense for diagnostic accuracy. The "experts" involved would be regulatory specialists, engineers, and potentially clinicians involved in setting the performance specifications, but their numbers and specific qualifications are not detailed. For the human factors testing, the "experts" were the intended users themselves (patients), providing user experience validation.
4. Adjudication Method for the Test Set
- Adjudication method: Not applicable. Adjudication methods like "2+1" or "3+1" are typically used in studies involving subjective interpretation (e.g., image reading) where differences in expert opinions need to be resolved. For functional and usability testing of a medical device like an infusion set, the "ground truth" is determined by objective performance against specifications and direct user feedback, not by adjudicating conflicting expert interpretations.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices often involving AI algorithms, comparing human reader performance with and without AI assistance. The ACCU-CHEK® FlexLink Plus and LinkAssist Plus are mechanical devices for insulin infusion, not diagnostic imaging tools, and do not incorporate AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a mechanical infusion set and insertion device. It does not involve algorithms or AI, so there is no "standalone" algorithm performance to evaluate. The device's function is inherently "human-in-the-loop" as it requires user operation and insulin pump interface.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission was established through a combination of:
- Engineering Specifications and Design Requirements: For functional testing (e.g., luer connector compatibility, needle retraction mechanism, operating conditions).
- Biocompatibility Standards: For material testing.
- Predicate Device Performance: Demonstrating substantial equivalence to a legally marketed predicate device (ACCU-CHEK® Ultraflex infusion set and ACCU-CHEK® LinkAssist insertion device) served as a primary "ground truth" for device design and expected performance.
- User Feedback and Usability Standards: For human factors testing, the "ground truth" was whether the device met "customer requirements" and "primary operating functions" as assessed by target patients, and whether it operated safely (e.g., no needle stick injuries).
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device does not use machine learning or AI, so there is no concept of a "training set" in the context of data used to train an algorithm. The development of the device would have involved internal design, prototyping, and iterative testing, but not an AI training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no AI training set. The "ground truth" during the device's development would have been based on engineering principles, regulatory requirements, intended use specifications, and potentially patient and healthcare professional feedback, guiding the design and testing phases.
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MAY 1 4 2010
| 510(k) Summary | |
|---|---|
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. |
| Submitter | Submitted by:Disetronic Medical Systems AGKirchbergstrasse 190, PostfachCH-3401 Burgdorf, Switzerland |
| United States Contact Person:Scott ThielRoche Diagnostics9115 Hague RoadIndianapolis, Indiana 46250317-521-3362scott.thiel@roche.comDate Prepared: April 12, 2010 | |
| Device name | Proprietary name: ACCU-CHEK® FlexLink Plus infusion setCommon name: subcutaneous infusion setClassification name: intravascular administration setProduct Code: FPAProprietary name: ACCU-CHEK® LinkAssist Plus insertion deviceCommon name: infusion set insertion deviceClassification name: syringe needle introducerProduct Code: KZH |
| Predicatedevice | We claim substantial equivalence to the current legally marketed ACCU-CHEK® Ultraflex infusion set and ACCU-CHEK® LinkAssist insertion device. |
Continued on next page
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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 |
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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
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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.
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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.
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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 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
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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
§ 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).