(52 days)
No
The summary describes a mechanical orthopedic fixation device and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended to provide fixation during the healing process following a Tarsometatarsal (TMT) injury, which is a therapeutic function.
No
Explanation: The device is an orthopedic fixation device intended for use in fracture repair and soft tissue separations in the midfoot. It is used as an adjunct during the healing process and does not perform any diagnostic function.
No
The device description clearly states it is a "multiple-anchor orthopedic fixation device system" offered in stainless steel and titanium, and includes physical components like anchors, installation tools, Kirschner wire, and drill bit. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, the Akros Scruture Anchor LisFranc Repair Kit is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) for surgical repair of bone and soft tissue in the midfoot. IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a physical implantable device (anchors, wires, drill bits) used during surgery. This is consistent with a surgical orthopedic device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD testing.
Therefore, the Akros Scruture Anchor LisFranc Repair Kit is an orthopedic surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Akros Scruture Anchor LisFranc Repair Kit is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external fixation systems involving plates, with fracture braces and casting. Specifically, the Akros Scruture Anchor LisFranc Repair Kit is intended to provide fixation during the healing process following Tarasometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction).
Product codes
HTN
Device Description
The Akros Scruture Anchor Lisfranc Repair Kit is a multiple-anchor orthopedic fixation device system, offered in both a stainless steel and a titanium version. The system is designed as an adjunct in repair of unstable joints, specifically as a means to provide fixation between the bones of the midfoot during the healing process following a Lisfranc injury. The design of the implant permits placement through any fracture repair plate that can accept a 4.0mm cortical screw conforming to ASTM F543-13. The anchors are provided pre-threaded and pre-loaded on their installation tools in a one-time-use pre-sterilized kit, with the Kirschner wire and drill bit needed for site preparation included.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Midfoot
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
Non-Clinical Testing: Lateral pull-to-failure testing was conducted. Data from simulated use, offset load-to-failure, insertion torque, torque-to-failure, fatigue with pull-to-failure, fretting, pitting corrosion, magnetic resonance, cytotoxicity, and pyrogenicity testing were adopted from the reference device (the Akros FibuLink Syndesmosis Repair System) given the similarity of its design and manufacture. The results of these tests indicate that the performance of the Scruture Anchor device is adequate for its intended use.
Bacterial Endotoxin Testing was performed on the reference device, which is considered worst case, using the Limulus Amebocyte Lysate (LAL) test. Results demonstrated that the reference device meets an 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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April 6, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
Akros Medical Charles Horrell Chief Executive and Co-Founder 3503 Pleasant Green Rd Durham, North Carolina 27705
Re: K200361
Trade/Device Name: Akros Scruture Anchor LisFranc 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: February 10, 2020 Received: February 14, 2020
Dear Mr. Horrell:
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.
for
Jesse Muir, Ph.D. Acting 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Akros Scruture Anchor LisFranc Repair Kit
Indications for Use (Describe)
The Akros Scruture Anchor LisFranc Repair Kit is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external fixation systems involving plates, with fracture braces and casting. Specifically, the Akros Scruture Anchor LisFranc Repair Kit is intended to provide fixation during the healing process following Tarasometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction).
Type of Use (Select one or both, as applicable)
区Prescription Use (Part 21 CFR 801 Subpart D)
□Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
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| 510(k) Summary | |
|---|---|
| Prepared: | February 10th, 2020 |
| Submitter: | Akros Medical |
| 3503 Pleasant Green Rd | |
| Durham, NC 27705 | |
| Contact: | Charles Horrell |
| Chief Executive Officer and Co-Founder | |
| 248.259.5535 | |
| chuck@akrosmedical.com | |
| Proprietary Name: | Akros Scruture Anchor LisFranc Repair Kit |
| Common Name: | Lisfranc Repair Kit |
| Regulation and Class: | 21 CFR 888.3030 Single/multiple component metallic bone |
| fixation appliances and accessories; Class II | |
| Product Code: | 87/HTN |
| Predicate Device: | Arthrex Mini TightRopeTM (K061925) |
| Reference Device: | Akros FibuLinkTM (K162805) |
Device Description:
The Akros Scruture Anchor Lisfranc Repair Kit is a multiple-anchor orthopedic fixation device system, offered in both a stainless steel and a titanium version. The system is designed as an adjunct in repair of unstable joints, specifically as a means to provide fixation between the bones of the midfoot during the healing process following a Lisfranc injury. The design of the implant permits placement through any fracture repair plate that can accept a 4.0mm cortical screw conforming to ASTM F543-13. The anchors are provided pre-threaded and pre-loaded on their installation tools in a one-time-use pre-sterilized kit, with the Kirschner wire and drill bit needed for site preparation included.
4
Intended Use / Indications:
The Akros Scruture Anchor LisFranc Repair Kit is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external fixation systems involving plates, with fracture braces and casting. Specifically, the Akros Scruture Anchor LisFranc Repair Kit is intended to provide fixation during the healing process following Tarasometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a LisFranc injury (Midfoot Reconstruction).
Summary of Technologies/Substantial Equivalence:
The Akros Scruture Anchor Lisfranc Repair Kit is substantially equivalent to the predicate device in terms of its intended use and indications, materials, basic design and mechanical performance. Any noted differences do not raise new types of safety and effectiveness questions, nor are there new technological issues.
Non-Clinical Testing:
Lateral pull-to-failure testing was conducted. Data from simulated use, offset load-to-failure, insertion torque, torque-to-failure, fatigue with pull-to-failure, fretting, pitting corrosion, magnetic resonance, cytotoxicity, and pyrogenicity testing were adopted from the reference device (the Akros FibuLink Syndesmosis Repair System) given the similarity of its design and manufacture. The results of these tests indicate that the performance of the Scruture Anchor device is adequate for its intended use.
Bacterial Endotoxin Testing was performed on the reference device, which is considered worst case, using the Limulus Amebocyte Lysate (LAL) test. Results demonstrated that the reference device meets an endotoxin limit of