(140 days)
No
The description focuses on a mechanical implant and surgical accessories, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to stabilize the thumb metacarpal and assist in the healing process for carpometacarpal (CMC) arthritis and instability, which are therapeutic functions.
No
The device is described as an implant designed to stabilize the thumb metacarpal and aid in the healing process, not to identify or diagnose a condition.
No
The device description clearly outlines physical components (implant, plates, suture, drill bit, K-wire, suture passer) made of specific materials, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Instratek CMC Cable FIX is an implantable surgical device designed to stabilize a bone (thumb metacarpal) and assist in ligament reconstruction. It is physically placed within the patient's body.
- Intended Use: The intended use is to provide mechanical support and aid in the healing process of a musculoskeletal issue (CMC arthritis and instability). It does not involve testing samples from the body to diagnose or monitor a condition.
The description clearly indicates a surgical implant used for structural support and healing, which falls under the category of medical devices, but not specifically in vitro diagnostics.
N/A
Intended Use / 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.
Product codes
HTN
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thumb metacarpal, base of the thumb metacarpal
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
The following testing was performed to demonstrate substantial equivalence. Comparative Suture Tensile Force (N) vs. Displacement (mm).
Key Metrics
Not Found
Predicate Device(s)
Arthrex Mini TightRope™ Repair Kit, K090107
Reference Device(s)
Michelangelo Bunion System, K091763
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Traditional 510(k)
12
KIII032
SECTION 5. 510(K) SUMMARY
| Submission Correspondent
and Owner | Instratek, Inc.
4141 Directors Row, Suite H
Houston, TX 77092 | AUG 3 1 2011 |
|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| | Phone: 281-890-8020
Fax: 281-890-8068
Email: jeff@instratek.com
Contact: Mr. Jeff Seavey
Vice President | |
| Date summary prepared:
Device trade name:
Device common name: | August 15, 2011
CMC Cable FIX
Button/Suture | |
| Device classification name: | Washer, Bolt Nut, HTN at 21 CFR 888.3030 | |
| Legally marketed device to
which the device is
substantially equivalent: | Arthrex Mini TightRope™ Repair Kit, K090107
Michelangelo Bunion System, K091763 (material only) | |
| Description of the device: | 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 | |
| Intended use of the device: | 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. | |
| Technological
characteristics: | The technological characteristics between the predicate and
proposed devices are the same. | |
| Testing: | The following testing was performed to demonstrate substantial
equivalence.
Comparative Suture Tensile Force (N) vs. Displacement
(mm). | |
| Conclusions: | There are no significant differences between the proposed and
predicate device; therefore, the proposed device does not raise any
questions regarding safety and effectiveness.
The CMC Cable FIX, as designed, is as safe and effective as the
predicate devices. Comparisons have been made to a legally
marketed predicate device, and the device is determined to be
substantially equivalent to the referenced predicate device currently
on the market. | |
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2
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
3
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
4
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