(224 days)
No
The device description and performance studies focus on mechanical properties and material composition, with no mention of AI or ML.
No.
The device is described as providing "fixation as an adjunct to fracture repair hardware during the healing period following an ankle syndesmotic trauma with fracture," which indicates it is a surgical implant for support during healing rather than a device for treating or preventing a disease or condition in a therapeutic sense.
No
The device description indicates it is a surgical implant designed for fixation as an adjunct to fracture repair, and the intended use specifies it provides fixation during the healing period. It does not mention diagnosis of a condition.
No
The device description clearly states it is a sterile, single-use, implant construct composed of physical components like buttons, stainless steel fixation devices, UHMWPE suture tape, polyester suture, and a drill tip passing pin. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, the Smith & Nephew INVISIKNOT Ankle Syndesmosis Repair Kit is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide fixation as an adjunct to fracture repair hardware during the healing period following an ankle syndesmotic trauma with fracture. This describes a surgical implant used in vivo (within the body) for structural support and repair.
- Device Description: The device is described as a sterile, single-use, implant construct composed of buttons, fixation devices, and suture tape. It also includes tools for preparing the bone and passing the implant. These are all components of a surgical device intended for implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
In summary, the device is a surgical implant used for mechanical fixation during fracture healing, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Smith & Nephew INVISIKNOT Ankle Syndesmosis Repair Kit fracture device is indicated to provide fixation as an adjunct to fracture repair hardware during the healing period following an ankle syndesmotic trauma with fracture.
Product codes
HTN
Device Description
Smith & Nephew INVISIKNOT Ankle Syndesmosis Repair Kit is a sterile, single-use, implant construct. The implants are composed of three components: a Plug type lateral button and a medial button, two stainless steel fixation devices and an ultrahigh molecular weight polyethylene (UHMWPE) suture tape. The suture tape has a one-way sliding knot to facilitate reduction. The kit also contains a polyester suture attached to one of the fixation devices to enable passing the medial button from the lateral side to the medial side and a 3.5 mm drill tip passing pin to enable preparation of the fibula and the tibula and the tibia. The eyelet in the passing pin enables delivery of the medial button from the lateral side.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle syndesmosis
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
Mechanical testing to evaluate whether the performance of Smith and Nephew INVISINKOT Ankle Syndesmosis Repair constructs can withstand the expected loading conditions during the healing period following an ankle syndesmosis trauma occurred. Whether the 3.5mm drill tip passing pin required to deploy the implant can withstand use without breaking was also evaluated. Data for after-fatigue displacement and passage of the device from the medial to lateral side demonstrate the INVISIKNOT Ankle Syndesmosis Repair Kit is substantially equivalent to the currently marketed predicate devices.
Bacterial endotoxin testing has been conducted for the subject devices using the LAL Kinetic Chromogenic method. The subject devices have been found to meet the acceptable endotoxin limit of
§ 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.
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June 8, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Smith & Nephew, Inc. Gregory Neal Senior Regulatory Affairs Specialist 150 Minuteman Road Andover, Massachusetts 01810
Re: K162996
Trade/Device Name: INVISIKNOT Ankle Syndesmosis Repair Kit 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: April 28, 2017 Received: May 5, 2017
Dear Mr. Gregory Neal:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 Industry and Consumer Education 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. 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
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 Industry and Consumer Education 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K162996
Device Name INVISIKNOT Ankle Syndesmosis Repair Kit
Indications for Use (Describe)
The Smith & Nephew INVISIKNOT Ankle Syndesmosis Repair Kit fracture device is indicated to provide fixation as an adjunct to fracture repair hardware during the healing period following an ankle syndesmotic trauma with fracture.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K162996 Page 1 of 2
Endoscopy Smith & Nephew 150 Minuteman Road Andover, MA 01810
978 749 1000 978 749 1443 Fax www.smith-nephew.com
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510(k) Summary
| SUBMITTER INFORMATION | CONTACT INFORMATION |
|---|---|
| Smith & Nephew, Inc. | Gregory Neal |
| 150 Minuteman Road | Senior Regulatory Affairs Specialist |
| Andover, MA 01810 | Phone: (508) 337-4120 |
| Fax: (978) 749-1443 |
| DEVICE NAME (UNMODIFIED) | |
|---|---|
| Trade or proprietary name | INVISIKNOT Ankle Syndesmosis Repair Kit |
| Common or usual name | Soft Tissue Fixation Device |
| Classification name | 21 CFR §888.3030 |
| Device Class | Class II |
| Product Code | HTN |
LEGALLY MARKETED PREDICATE DEVICE
The Smith & Nephew INVISIKNOT Ankle Syndesmosis Repair Kit is substantially equivalent in intended use and fundamental scientific technology to the following legally marketed devices in commercial distribution:
| Predicate Device | 510(k) Number | Clearance Date | Predicate Type |
|---|---|---|---|
| Biomet Sport Medicine ToggleLoc System | K083070 | 12/16/2008 | Primary |
| Smith & Nephew ULTRATAPE | K132357 | 10/30/2013 | Reference |
DEVICE DESCRIPTION
Smith & Nephew INVISIKNOT Ankle Syndesmosis Repair Kit is a sterile, single-use, implant construct. The implants are composed of three components: a Plug type lateral button and a medial button, two stainless steel fixation devices and an ultrahigh molecular weight polyethylene (UHMWPE) suture tape. The suture tape has a one-way sliding knot to facilitate reduction. The kit also contains a polyester suture attached to one of the fixation devices to enable passing the medial button from the lateral side to the medial side and a 3.5 mm drill tip passing pin to enable preparation of the fibula and the tibula and the tibia. The eyelet in the passing pin enables delivery of the medial button from the lateral side.
INTENDED USE
The Smith & Nephew INVISIKNOT Ankle Syndesmosis Repair Kit is intended to provide fixation as an adjunct to fracture repair hardware during the healing period following an ankle syndesmotic trauma with fracture.
INDICATIONS FOR USE
The Smith & Nephew INVISIKNOT Ankle Syndesmosis Repair Kit fracture device is indicated to provide fixation as an adjunct to fracture repair hardware during the healing period following an ankle syndesmotic trauma with fracture.
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TECHNOLOGICAL CHARACTERISTICS
Smith & Nephew INVISIKNOT Ankle Syndesmosis Repair Kit is substantially equivalent in intended use and fundamental scientific technology to the legally marketed predicate device (Biomet ToggleLoc (K083070)) and raises no new issues of safety and efficacy. The predicate device shares operating principles - two buttons connected by a flexible material that can be used to reduce a syndesmotic trauma.
SUMMARY OF PERFORMANCE DATA
Mechanical testing to evaluate whether the performance of Smith and Nephew INVISINKOT Ankle Syndesmosis Repair constructs can withstand the expected loading conditions during the healing period following an ankle syndesmosis trauma occurred. Whether the 3.5mm drill tip passing pin required to deploy the implant can withstand use without breaking was also evaluated. Data for after-fatigue displacement and passage of the device from the medial to lateral side demonstrate the INVISIKNOT Ankle Syndesmosis Repair Kit is substantially equivalent to the currently marketed predicate devices.
Bacterial endotoxin testing has been conducted for the subject devices using the LAL Kinetic Chromogenic method. The subject devices have been found to meet the acceptable endotoxin limit of