The Impress SFS System is indicated for general orthopaedic repair procedures. The Impress SFS System is also intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures.

Device Description

The Impress SFS System is cable system which includes components such as cables and which are manufactured from stainless steel. These components are used together to address the indications as outlined in the next section. The implantable components in the Impress SFS System are provided sterile as indicated on the outer carton label.

AI/ML Overview

This document is a 510(k) premarket notification for the Impress SFS System, a bone fixation cerclage device. It aims to demonstrate substantial equivalence to previously cleared predicate devices, not to establish novel performance through a clinical study with acceptance criteria in the typical sense for AI/software devices.

Therefore, many of the requested elements for describing acceptance criteria and a study to prove device performance are not applicable to this type of submission. This device is a physical orthopedic implant, not an AI or software device.

Here's an attempt to answer the questions based on the provided document, noting when a question is not applicable:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Measured Performance Aspect)	Reported Device Performance (Impress SFS System)	Comparison / Conclusion
Stop Strength	Confirmed to be equivalent to predicate devices	Meets equivalence to predicate devices
Washer Locking Strength	Confirmed to be equivalent to predicate devices	Meets equivalence to predicate devices
Cable Strength	Confirmed to be equivalent to predicate devices	Meets equivalence to predicate devices
Endotoxin Requirements	Met	Meets pyrogenicity standards
Material Composition	Same as predicate devices	Equivalent materials
Sizes and Designs	Similar to predicate devices	Equivalent sizes and designs
Intended Use	Same as predicate devices	Equivalent indications for use
Sterility	Provided sterile as indicated on label	Standard for implantable devices

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable in the context of a clinical study or AI model validation. The document describes mechanical testing and pyrogen testing performed on the device itself.
The exact sample sizes for these tests (e.g., number of cables tested for strength) are not specified in the provided summary.
Data provenance (country of origin, retrospective/prospective) is not relevant for this type of mechanical and material testing described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This submission relies on engineering standards and comparisons, not on expert ground truth for interpretation of outputs like an AI device would. The "ground truth" here is established by engineering specifications and comparative test results against predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No expert adjudication method is described or relevant for mechanical testing of a physical device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a physical orthopedic implant, not an AI or diagnostic software device, so no MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical orthopedic implant, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Mechanical and material property standards/specifications and performance data from legally marketed predicate devices are the "ground truth" for demonstrating equivalence. The device's performance characteristics (stop strength, washer locking strength, cable strength) were compared directly to those of the predicate devices. Pyrogenicity was confirmed against established endotoxin requirements.

8. The sample size for the training set

Not applicable. This submission relates to a physical medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable. No training set exists for this type of device submission.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains 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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue.

September 14, 2018

Cable Fix Medical LLC % Janet Akil Senior Project Manager I M Squared Associates, Inc 575 Eighth Avenue, Suite 1212 New York, New York 10018

Re: K173910

Trade/Device Name: Impress SFS System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone Fixation Cerclage Regulatory Class: Class II Product Code: JDQ Dated: August 13, 2018 Received: August 14, 2018

Dear Janet Akil:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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

510(k) Number (if known) K173910

Device Name Impress SFS System

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image contains the logo for Cablefix. The logo consists of a stylized letter "C" made up of blue lines, with a green horizontal line running through the middle. To the right of the symbol is the word "cablefix" in a sans-serif font, also in blue. The logo is clean and modern, with a focus on simplicity and readability.

510(k) Summary:	K173910
Sponsor:	Cable Fix Medical LLC1050 Getwell Rd. S.Hernando, MS 386324246
Phone:	901-552-8088
Contact:	Carey Bryant
Date Prepared:	September 7, 2018
Trade Name:	Impress SFS System
Common Name:	Orthopedic cable system
Classification:	888.3010 Bone fixation cerclage
Product Code:	JDQ/Orthopedics, Class II
Predicate Devices:	Orthopedic Cable System, Smith & Nephew (K031162)Kirschner Wires (K-Wires), Steinmann Pins and Orthopedic CableSystem, Synthes (K960385, K953777)TightRope Syndesmosis Device, Arthrex (K043248)

Description of Device:

Indications for Use:

{4}------------------------------------------------

Technological Characteristics:

The technological characteristics for the Impress SFS System are the same as the characteristics of the predicate devices. The components are manufactured in similar sizes and designs as the predicate devices. In addition, the components Impress SFS System are manufactured from the same materials as the predicate devices.

Mechanical testing (stop strength, washer locking strength and cable strength) confirmed that the device is equivalent to predicate devices and pyrogen testing confirmed that the endotoxin requirements have been met.

Substantial Equivalence

The design features of the Impress SFS System are substantially equivalent to the design features of other predicate devices previously cleared for market. The methods used to establish equivalence are based on the comparison of the intended use, product technical characteristics and performance characteristics (stop strength, washer locking strength and cable strength). All comparisons confirmed that the Impress SFS System is substantially equivalent to the predicate devices. The safety, effectiveness, and performance of the Impress SFS System are adequately supported by the substantial equivalence information, material information and analysis data provided within this Premarket Notification. Therefore, it is concluded that the Impress SFS System is substantially equivalent to the noted predicate devices.

Conclusions

While the Impress SFS System is not identical to the predicate devices, any differences that may exist do not significantly affect device safety and effectiveness. In addition, the differences do not add new or increased risks and complications. Therefore, it is concluded that the Impress SFS System is substantially equivalent to the predicate devices as outlined previously and should not render the subject device NSE.

Regulation Number and Section

§ 888.3010 Bone fixation cerclage.

(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.