(100 days)
No
The device description and performance studies focus on mechanical properties and sterility, with no mention of AI/ML or related concepts.
No.
The device is a suture construct for soft-tissue fixation to bone, which is a structural component for repair, not a device that provides therapy for a disease or condition.
No.
The device is an implant for suture fixation to bone, specifically for meniscal root repair. It is a therapy device, not a diagnostic one.
No
The device description clearly states it is a "suture construct comprised of a polyester sheath with multiple sutures assembled through the sheath," indicating it is a physical implant, not software.
Based on the provided information, the Arthrex SutureLoc™ Implant is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "suture (soft-tissue) fixation to bone in the knee for meniscal root repair." This describes a surgical implant used directly on a patient's body to repair tissue.
- Device Description: The device is described as a "suture construct comprised of a polyester sheath with multiple sutures." This is a physical implant, not a reagent, instrument, or system used to examine specimens from the human body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing specimens (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or calibrators
- Performing tests outside of the body
IVDs are used to perform tests on samples taken from the body to provide information about a person's health status. The Arthrex SutureLoc™ Implant is a surgical device implanted into the body for repair.
N/A
Intended Use / Indications for Use
The Arthrex SutureLoc™ Implant is intended to be used for suture (soft-tissue) fixation to bone in the knee for meniscal root repair.
Product codes
MBI
Device Description
The SutureLoc™ Implant is a suture construct comprised of a polyester sheath with multiple sutures assembled through the sheath.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee
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
Ultimate load testing and cyclic displacement was performed on the subject device to demonstrate that the differences do not negatively impact mechanical strength.
Bacterial endotoxin per USP was conducted to demonstrate that the device meets pyrogen limit specifications.
Packaging testing was conducted to demonstrate shelf-life and confirm the packaging design provides a protective sterile barrier and protects the integrity of the products post sterilization during shipping and handling.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
February 2, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Arthrex Inc. Erikka Edwardsen Regulatory Affairs Principal Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K223284
Trade/Device Name: SutureLocTM Implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: December 23, 2022 Received: December 28, 2022
Dear Ms. Edwardsen:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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.
Sara S. Thompson -S
For
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) K223284
Device Name SutureLoc™ Implant
Indications for Use (Describe)
The Arthrex SutureLoc™ Implant is intended to be used for suture (soft-tissue) fixation to bone in the knee for meniscal root repair.
| 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
510(k) Summary
| Date Prepared | December 23, 2022 |
|---|---|
| 510(k) Number | K223284 |
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Erikka Edwardsen |
| Regulatory Affairs Principal Specialist | |
| 1-239-643-5553, ext. 70422 | |
| rikka.edwardsen@arthrex.com | |
| Name of Device | SutureLoc™ Implant |
| Common Name | Fastener, Fixation, Nondegradable, Soft Tissue |
| Product Code | MBI |
| Classification Name | 21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener. |
| Regulatory Class | II |
| Predicate Device | K173845 Arthrex SwiveLock® Anchors |
| Reference Device | K203268 Arthrex Knotless FiberTak® |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain clearance for |
| the new Arthrex SutureLoc™ Implant. | |
| Device Description | The SutureLoc™ Implant is a suture construct comprised of a polyester sheath |
| with multiple sutures assembled through the sheath. | |
| Indications for Use | The Arthrex SutureLoc™ Implant is intended to be used for suture (soft-tissue) |
| fixation to bone in the knee for meniscal root repair. | |
| Summary of Technological Characteristics | The proposed device has the same intended use and fundamental technology as |
| the predicate and reference devices. The subject device is comprised of multiple | |
| sutures manufactured using the same materials as the Knotless FiberTak® | |
| (K203268) device. The primary differences include the stitching suture and use of | |
| an accessory device to pull the anchor into the bone. | |
| Performance Data | Ultimate load testing and cyclic displacement was performed on the subject |
| device to demonstrate that the differences do not negatively impact mechanical | |
| strength. | |
| Bacterial endotoxin per USP was conducted to demonstrate that the device | |
| meets pyrogen limit specifications. | |
| Packaging testing was conducted to demonstrate shelf-life and confirm the | |
| packaging design provides a protective sterile barrier and protects the integrity of | |
| the products post sterilization during shipping and handling. | |
| Conclusion | The Arthrex SutureLoc™ Implant is substantially equivalent to the predicate |
| devices in which the basic design features, intended use and surgical technique | |
| are the same. Any differences between the subject device and the predicate | |
| devices do not raised questions concerning safety and effectiveness. | |
| Based on the indications for use, technological characteristics, and the summary | |
| of data submitted, Arthrex Inc. has determined that the proposed device is | |
| substantially equivalent to the currently marketed predicate devices. |