(28 days)
Not Found
No
The device description and intended use are purely mechanical, describing a physical implant for surgical fixation. There is no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for fixation during the healing process of hematoma distraction arthroplasty, and provides stabilization, which indicates a therapeutic purpose.
No
The device is described as a fixation post, distribution bridge, or for distributing suture tension during surgical procedures, specifically for CMC joint arthroplasty. Its function is to provide stabilization and fixation, not to diagnose medical conditions.
No
The device description explicitly states it consists of physical components: two stainless steel buttons and a strand of FiberWire. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical fixation within the body (bone-to-bone, soft-tissue-to-bone, suspension of the thumb metacarpal). This is an in vivo application.
- Device Description: The description of stainless steel buttons and suture material aligns with surgical implants, not diagnostic reagents or instruments used to analyze samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory tests.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used for mechanical support and fixation during healing.
N/A
Intended Use / Indications for Use
The Arthrex CMC Mini TightRope, when used for fixation of bone-to-bone or soft-tissue-tobone, is intended as a fixation post, distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, the Arthrex CMC Mini TightRope is indicated for Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the suspension of the thumb metacarpal during the healing process of hematoma distraction arthroplasty by providing stabilization at the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.
Product codes (comma separated list FDA assigned to the subject device)
HTN
Device Description
The Arthrex CMC Mini TightRope consists of two oblong stainless steel buttons and a single strand of #2 FiberWire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Carpal Metacarpal (CMC) joint, base of the first and second 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
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
§ 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
:
Arthrex Special. 510(K): ARTHREX CMC MINI TIGHTROPE
MAR 1 0 2014
| Date Summary Prepared | 06 FEBRUARY 2014 |
|---|---|
| Manufacturer/ | |
| Distributor/ | |
| Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | Nancy Hoft |
| Regulatory Affairs Specialist | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239/643-5553, ext.71113 | |
| Fax: 239/598-5508 | |
| Email: Nancy.Hoft@arthrex.com | |
| Trade Name | CMC Mini TightRope |
| Common Name | Button / Anchor / Suture |
| Product Code, | |
| Classification Name, CFR | HTN - Single/multiple component metallic bone fixation appliances and |
| accessories -888.3030 | |
| Predicate Device | Mini TightRope, K133275 |
| Purpose of Submission | This special 510(k) premarket notification is submitted to obtain clearance for the |
| CMC Mini TightRope line extension. | |
| Device Description | The Arthrex CMC Mini TightRope consists of two oblong stainless steel buttons |
| and a single strand of #2 FiberWire. | |
| Intended Use | The Arthrex CMC Mini TightRope, when used for fixation of bone-to-bone or soft |
| tissue-to-bone, is intended as a fixation post, distribution bridge, or for | |
| distributing suture tension over areas of ligament or tendon repair. Specifically, | |
| the Arthrex CMC Mini TightRope is indicated for Carpal Metacarpal (CMC) joint | |
| arthroplasty as an adjunct in the suspension of the thumb metacarpal during the | |
| healing process of hematoma distraction arthroplasty by providing stabilization at | |
| the base of the first and second metacarpal when the trapezium has been excised | |
| due to osteoarthritis. | |
| Substantial | |
| Equivalence Summary | The Arthrex CMC Mini TightRope is substantially equivalent to the Arthrex |
| Implant System, Mini TightRope. Any differences between the CMC Mini | |
| TightRope and this predicate are considered minor and do not raise questions | |
| concerning safety and effectiveness. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
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March 10, 2014
Arthrex, Inc. Ms. Nancy Hoft Regulatory Affairs Specialist 1370 Creekside Blvd. Naples, Florida 34108-1945
Re: K140328
Trade/Device Name: CMC Mini TightRope Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HTN Dated: February 6, 2014 Received: February 10, 2014
Dear Ms. Hoft:
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 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
2
Page 2 - Ms. Nancy Hoft
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 yours,
Lori A. Wiggins
- for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Arthrex SPECIAL 510(K): ARTHREX CMC MINI TIGHTROPE
2.5 INDICATIONS FOR USE
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K140328
Device Name
CMC Mini TightRope
Indications for Use (Describe)
The Arthrex CMC Mini TightRope, when used for fixation of bone-to-bone or soft-tissue-tobone, is intended as a fixation post, distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, the Arthrex CMC Mini TightRope is indicated for Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the suspension of the thumb metacarpal during the healing process of hematoma distraction arthroplasty by providing stabilization at the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.
Type of Use (Select one or both, as applicable)
Ø Prescription Use (Part 21 CFR 801 Subpart D)
O Over-The-Counter Use (21 CFR 801 Subpart C)
Please do not write below this line - continue on a separate page if needed.
国际游戏 | again | 亚游官网 | 亚洲官网 | 亚 FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Casey Li Hanley P. niof Orthopedic Devices Divisio
FORM FDA 3881 (9/13)
on 2 1013 64 147
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