(86 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a suture/button implant, with no mention of AI or ML technologies.
Yes
The device is intended to "supplement repair or during healing of ligament injuries or deficiencies of the extremities" and "to provide fixation during the healing process in syndesmotic trauma," which are therapeutic applications.
No
The device is an implantable suture button system used to provide fixation during the healing process of ligament injuries or deficiencies, not to diagnose them.
No
The device description clearly states it is an "implantable device" made of physical materials (stainless steel and UHMWPE) and includes "ancillary instruments to aid in insertion." This indicates 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 or tissue, to detect diseases, conditions, or infections.
- Device Description: The TriMed Ripcord device is an implantable surgical device made of metal and suture material. It is used to physically support and stabilize ligaments during healing.
- Intended Use: The intended use is to "supplement repair or during healing of ligament injuries or deficiencies of the extremities" and "as an adjunct in combination with compatible TriMed fixation implants to provide fixation during the healing process in syndesmotic trauma". This describes a surgical intervention, not a diagnostic test performed on a sample.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's condition.
The device is a surgical implant used for mechanical support and fixation, which falls under the category of medical devices, but not specifically in vitro diagnostics.
N/A
Intended Use / Indications for Use
TriMed RipCord devices are intended for use to supplement repair or during healing of ligament injuries or deficiencies of the extremities.
The TriMed RipCord device is indicated to be used as an adjunct in combination with compatible TriMed fixation implants to provide fixation during the healing process in syndesmotic trauma, such as fixation of syndesmosis disruptions in connection with Weber B and C ankle fractures.
Product codes
HTN
Device Description
The TriMed RipCord Suture Button implant (RipCord Device) is a non-bioabsorbable suture/button implantable device used as an aid for the treatment of ligament injuries, deficiencies, or reconstruction. The TriMed RipCord Suture Button Implant comprises of, a far side 316L stainlesssteel Button, near side 316L stainless-steel button, and ultra-high molecular weight polyethene (UHMWPE) braided suture. The implantable device is packaged with various ancillary instruments to aid in insertion. The implantable devices and various ancillary instruments are provided sterile and are single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
extremities, syndesmotic trauma, ankle
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)
The TriMed RipCord Device implants were tested for the following:
- Cyclic endurance
- Static load displacement
- Pull through needle testing
- Cyclical shear endurance
- Bacterial Endotoxins Test (BET) per ANSI/AAMI ST72: 2019 and USP
- Cytotoxicity, Sensitization and Irritation testing in accordance with ISO 10993-1:2018
The submitted mechanical testing data demonstrates that the cyclic fatigue, maximum static loading, needle pull through, and cyclical shear of the subject device is substantially equivalent to that of the predicate device for the desired indications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
June 1, 2022
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. Next to the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
TriMed, Inc. % David Anderson Principle Consultant Tech2Med, LLC 6450 Old Darby TRL NE Ada, Michigan 49301
Re: K220650
Trade/Device Name: TriMed Ripcord Device 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: March 4, 2022 Received: March 7, 2022
Dear David Anderson:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220650
Device Name TriMed RipCord Device
Indications for Use (Describe)
TriMed Ripcord devices are intended for use to supplement repair or during healing of ligament injuries or deficiencies of the extremities.
The TriMed RipCord device is indicated to be used as an adjunct in combination with compatible TriMed fixation implants to provide fixation during the healing process in syndesmotic trauma, such as fixation of syndesmosis disruptions in connection with Weber B and C ankle fractures.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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K220650
510(K) SUMMARY
| (a)(1). Submitted By: | TriMed, Inc.
27533 Avenue Hopkins
Santa Clarita, CA 91355
United States of America |
|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| Contact Person: | David Anderson
Principle Regulatory Consultant
Office - (574) 377-0111
Fax - (661) 254-8485 |
| Date: | May 19, 2021 |
| (a)(2). Proprietary Name: | TriMed RipCord Device |
| Common Name(s): | Button / Suture |
| Classification Name: | 21 CFR 888.3030: Single/multiple component metallic bone
fixation appliances and accessories. |
| Regulatory Class: | II |
| Product Codes: | HTN |
| (a)(3). Predicate Device: | Primary Predicate
K130033 - ToggleLoc System (ToggleLoc with Ziptight),
Biomet (USA) (Primary) |
| Other Predicate Device(s)
K201522 – Arthrex Syndesmosis TightRope XP Buttress Plate
Implant System, Arthrex Inc. (USA) | |
(a)(4). Device Description
The TriMed RipCord Suture Button implant (RipCord Device) is a non-bioabsorbable suture/button implantable device used as an aid for the treatment of ligament injuries, deficiencies, or reconstruction. The TriMed RipCord Suture Button Implant comprises of, a far side 316L stainlesssteel Button, near side 316L stainless-steel button, and ultra-high molecular weight polyethene (UHMWPE) braided suture. The implantable device is packaged with various ancillary instruments to aid in insertion. The implantable devices and various ancillary instruments are provided sterile and are single use.
4
Image /page/4/Picture/0 description: The image shows the logo for TriMed, which is in blue. Underneath the logo is the text "K220650" in black. The logo consists of a stylized letter "T" and the word "TriMed".
(a)(5). Indications for Use
TriMed RipCord devices are intended for use to supplement repair or reconstruction during healing of ligament injuries or deficiencies of the extremities.
The TriMed RipCord device is indicated to be used as an adjunct in combination with compatible TriMed fixation implants to provide fixation during the healing process in syndesmotic trauma, such as fixation of syndesmosis disruptions in connection with Weber B and C ankle fractures.
(a)(6). Technological Characterizes
The subject TriMed RipCord Device is similar to the predicate devices in material, size, packaging. sterility, and has similar indications for use.
(b)(1). Substantial Equivalence: - Non-Clinical Evidence Performance Data
The TriMed RipCord Device implants were tested for the following:
- Cyclic endurance
- Static load displacement
- Pull through needle testing ●
- Cyclical shear endurance
- Bacterial Endotoxins Test (BET) per ANSI/AAMI ST72: 2019 and USP ●
- Cytotoxicity, Sensitization and Irritation testing in accordance with ISO 10993-1:2018 ●
(b)(2). Substantial Equivalence: - Clinical Evidence
Clinical testing was not necessary for the determination of substantial equivalence.
(b)(3). Substantial Equivalence - Conclusions
The TriMed RipCord Device is substantially equivalent to the predicate device in which the basic design features and intended uses are the same. Any differences between the proposed device and the predicate device are considered minor and do not raise different questions concerning safety or effectiveness.
The submitted mechanical testing data demonstrates that the cyclic fatigue, maximum static loading, needle pull through, and cyclical shear of the subject device is substantially equivalent to that of the predicate device for the desired indications.
Based on the indications for use, technological characteristics, and the summary of data submitted, TriMed Inc. has determined that the proposed device is substantially equivalent to the currently marketed predicate device.