(140 days)
The Instratek CMC Cable FIX is a suture button implant designed to stabilize the thumb metacarpal following removal or partial resection of the trapezium. The CMC Cable FIX is an adjunct in the healing process when used in conjunction with a biologic reconstruction of the ligament at the base of the thumb metacarpal for treatment of carpometacarpal (CMC) arthritis and instability.
The Instratek CMC Cable FIX is a suture button implant designed to stabilize the thumb metacarpal following removal or partial resection of the trapezium. The CMC Cable FIX is an adjunct in the healing process when used in conjunction with a biologic reconstruction of the ligament at the base of the thumb metacarpal for treatment of carpometacarpal (CMC) arthritis and instability. The implanted device consists of three (3) components: Plate - 2-hole round - Ti-6Al-4v Plate - 2-hole oblong w/break away guide wire - Ti-6AL-4v #2 Suture - Ultra High Molecular Weight Polyethylene There are 3 accessories required to implant the device: Cannulated Drill Bit - 17-4 Stainless Steel K-wire - 316L Stainless Steel Suture Passer - PTFE tubing
This is a 510(k) premarket notification for a medical device called the "Instratek CMC Cable FIX," a suture button implant. The submission aims to establish substantial equivalence to predicate devices and does not describe a study involving AI or complex statistical analyses of diagnostic performance.
Here's a breakdown of the requested information based on the provided text, outlining why certain sections cannot be completely filled:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Suture Tensile Force (N) | "Comparative Suture Tensile Force (N) vs. Displacement (mm)." was performed. No specific numerical acceptance criteria or performance values are provided in the summary. The "Conclusions" state: "There are no significant differences between the proposed and predicate device; therefore, the proposed device does not raise any questions regarding safety and effectiveness." |
| Displacement (mm) | "Comparative Suture Tensile Force (N) vs. Displacement (mm)." was performed. No specific numerical acceptance criteria or performance values are provided in the summary. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the given text. The submission describes "Comparative Suture Tensile Force (N) vs. Displacement (mm)" testing, which is likely mechanical testing of the device components, not a study on a "test set" of patients or data in the typical sense applied to diagnostic algorithms. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable/not provided. The "test set" described is mechanical testing, not a dataset requiring expert interpretation for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or studies involving human judgment for ground truth establishment. This submission describes mechanical device testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This submission is for a medical device (suture button implant) and focuses on demonstrating substantial equivalence through technological characteristics and mechanical testing, not on comparative effectiveness with human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This submission is for a physical medical implant, not an algorithm or AI-powered device.
7. The Type of Ground Truth Used
The "ground truth" for the testing performed appears to be measured physical properties (suture tensile force and displacement) of the device components under various conditions, likely compared against established benchmarks or the predicate device's performance. It is not expert consensus, pathology, or outcomes data in the usual sense for a diagnostic device.
8. The Sample Size for the Training Set
This information is not applicable/not provided. This submission is for a physical medical implant, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided. As no training set for an algorithm is involved, no ground truth establishment for it is relevant.
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Traditional 510(k)
12
KIII032
SECTION 5. 510(K) SUMMARY
| Submission Correspondentand Owner | Instratek, Inc.4141 Directors Row, Suite HHouston, TX 77092 | AUG 3 1 2011 |
|---|---|---|
| Phone: 281-890-8020Fax: 281-890-8068Email: jeff@instratek.comContact: Mr. Jeff SeaveyVice President | ||
| Date summary prepared:Device trade name:Device common name: | August 15, 2011CMC Cable FIXButton/Suture | |
| Device classification name: | Washer, Bolt Nut, HTN at 21 CFR 888.3030 | |
| Legally marketed device towhich the device issubstantially equivalent: | Arthrex Mini TightRope™ Repair Kit, K090107Michelangelo Bunion System, K091763 (material only) | |
| Description of the device: | The Instratek CMC Cable FIX is a suture button implant designedto stabilize the thumb metacarpal following removal or partialresection of the trapezium. The CMC Cable FIX is an adjunct in thehealing process when used in conjunction with a biologicreconstruction of the ligament at the base of the thumb metacarpalfor treatment of carpometacarpal (CMC) arthritis and instability.The implanted device consists of three (3) components:Plate - 2-hole round - Ti-6Al-4v Plate - 2-hole oblong w/break away guide wire - Ti-6AL-4v #2 Suture - Ultra High Molecular Weight Polyethylene There are 3 accessories required to implant the device:Cannulated Drill Bit - 17-4 Stainless Steel K-wire - 316L Stainless Steel Suture Passer - PTFE tubing | |
| Intended use of the device: | The Instratek CMC Cable FIX is a suture button implant designedto stabilize the thumb metacarpal following removal or partialresection of the trapezium. The CMC Cable FIX is an adjunct in thehealing process when used in conjunction with a biologicreconstruction of the ligament at the base of the thumb metacarpalfor treatment of carpometacarpal (CMC) arthritis and instability. | |
| Technologicalcharacteristics: | The technological characteristics between the predicate andproposed devices are the same. | |
| Testing: | The following testing was performed to demonstrate substantialequivalence.Comparative Suture Tensile Force (N) vs. Displacement(mm). | |
| Conclusions: | There are no significant differences between the proposed andpredicate device; therefore, the proposed device does not raise anyquestions regarding safety and effectiveness.The CMC Cable FIX, as designed, is as safe and effective as thepredicate devices. Comparisons have been made to a legallymarketed predicate device, and the device is determined to besubstantially equivalent to the referenced predicate device currentlyon the market. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Instratek, Inc. % Mr. Jeff Scavey 4141 Director's Row Suite H Houston. Texas 77092
AUG 3 1 2011
Re: K111032
Trade/Device Name: Instratek CMC Cable FIX Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HTN Dated: August 18, 2011 Received: August 18, 2011
Dear Mr. Seavev:
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.
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
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Page 2 - Mr. Jeff Scavey
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/CDRHQffices/ucm1.15809.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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
signature
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 4. INDICATIONS FOR USE STATEMENT
| 510(k) Number: | K111032 |
|---|---|
| Device Name: | CMC Cable Fix |
| Indications for Use: | The Instratek CMC Cable Fix is a suture button implant designed to stabilize the thumb metacarpal following removal or partial resection of the trapezium. The CMC Cable Fix is an adjunct in the healing process when used in conjunction with a biologic reconstruction of the ligament at the base of the thumb metacarpal for treatment of carpometacarpal (CMC) arthritis and instability. |
·
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) (Division of Surgical, Orthopedic, Divisionative Devices
16111032
510(k) Number _
Instratek, Inc
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.