The SECURE-LOCK is indicated for fixation of bone or soft tissue to bone, and is intended as a fixation device, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair such as Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) Repair and Reconstruction.

Device Description

The SECURE-LOCK fixation device consists of a sterile and non-absorbable polyester and ultrahigh molecular weight polyethylene blended braid that forms a loop on a titanium alloy button. The button sits on the cortex over the exit to a bone tunnel, suspending the loop inside the tunnel to provide secure, strong fixation for ligament repair and reconstruction. The SECURE-LOCK fixation device is supplied with polyester sutures that are used to assemble and deliver the device.

AI/ML Overview

The provided text describes the 510(k) summary for the SECURE-LOCK device, a suspensory fixation device for ACL/PCL repair and reconstruction. It outlines the device's characteristics, intended use, and performance data to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative table format with corresponding "reported device performance" values for clinical efficacy. Instead, it lists various performance tests conducted to demonstrate the device's mechanical properties, safety, and substantial equivalence to a predicate device. The conclusion states that the device provides "appropriate mechanical properties and is relatively safe for its use."

However, based on the tests conducted, we can infer performance areas:

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Properties
Implant Tensile Strength (Sufficient for fixation)	Tested (result reported as demonstrating "appropriate mechanical properties")
Implant Fatigue (Durability over time)	Tested (result reported as demonstrating "appropriate mechanical properties")
Pulling Suture Tensile Strength (Sufficient for delivery)	Tested (result reported as demonstrating "appropriate mechanical properties")
Suture Diameter (Meeting manufacturing specifications)	Measured (result reported as demonstrating "appropriate mechanical properties")
Biocompatibility & Safety
Biocompatibility (No adverse biological reactions)	Tested in accordance with ISO 10993-1 (Implied to meet standards for safety)
Pyrogenicity (Absence of fever-inducing substances)	Bacterial endotoxin testing performed on representative devices (XTREME-LOOP and SECURE-LOOP) using Limulus Amoebocyte Lysate (LAL) method. Results met FDA requirements of < 20 EU/Device. Tested for rabbit material-mediated pyrogenicity in line with USP <151> and meets specification limits. Final product batch release testing for endotoxins will be carried out on the subject device in accordance with ANSI/AAMI ST72:2019.
MRI Compatibility (Safe for use in MR environment)	Tested (Implied to meet standards for safety in an MR environment)
Functional Equivalence
Performance in Simulated Use Conditions (Effective function)	Formal assessment of the SECURE-LOCK design in simulated use conditions (Implied satisfactory performance)
Characterization of UHMWPE (Material integrity)	Tested (Implied to meet standards for material integrity)
Substantial Equivalence to Predicate (Overall safety/efficacy)	Concluded to be substantially equivalent to the Arthrex ACL Tightrope (K112990), with differences being minor and not raising safety/effectiveness concerns.

Study Details

The document describes performance testing rather than a clinical study with a test set of human subjects. The assessment is based on bench testing of the device itself and its materials.

Sample size used for the test set and the data provenance: Not applicable in the context of a clinical test set. The "test set" here refers to physical devices and materials undergoing various laboratory tests (tensile strength, fatigue, etc.). There is no mention of the specific number of devices tested for each performance test, but it is implied that representative samples were used. Data provenance is internal laboratory testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical and material properties is established by recognized engineering and material science standards and measurement techniques, not expert consensus in the diagnostic sense.
Adjudication method for the test set: Not applicable for device performance testing against established standards. Results are compared directly to pre-defined specification limits or industry standards (e.g., ISO, USP, ANSI/AAMI).
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a device 510(k) submission focused on demonstrating substantial equivalence through bench testing and material characterization, not a comparative clinical effectiveness study involving human readers or patient outcomes, especially not in the context of AI.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is a medical device (fixation implant), not a software algorithm or AI device.
The type of ground truth used:
- Mechanical Performance: Engineering specifications, industry standards (e.g., for tensile strength, fatigue, suture properties).
- Biocompatibility: ISO 10993-1 standards.
- Pyrogenicity: FDA requirements (< 20 EU/Device) and USP <151> specification limits.
- MRI Compatibility: Recognized standards for safety in MR environments.
The sample size for the training set: Not applicable. There is no training set as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable.

Summary

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July 22, 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 includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Xiros Ltd. Steve Curran Compliance Director Springfield House Lane, Whitehouse Lane Leeds, West Yorkshire LS17 7UE United Kingdom

Re: K220906

Trade/Device Name: SECURE-LOCK Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY, GAT Dated: June 16, 2022 Received: June 21, 2022

Dear Steve Curran:

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

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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 medical devices and radiation-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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

510(k) Number (if known) K220906

Device Name

SECURE-LOCK

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)

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023

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FORM FDA 3881 (6/20)

PSC Publishing Services (101) 443-6740 ESF

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Ltd. Springfield Hou
Whitehouse La
Leeds
LS19 7UF
UK

Tel. +44 (0) 113 238 7200
Fax. +44 (0) 113 238 7201

enquiries@xiros.co.uk
www.xiros.co.uk

Image /page/3/Picture/3 description: The image shows a logo for Xiros. The logo features the word "XIROS" in bold, sans-serif font, placed inside a rounded, rectangular shape. The shape is colored in a teal or dark green hue. To the right of the rounded rectangle, there is a white, stylized branching shape, possibly representing a network or connection. The background is a light gray or muted green color.

510(k) Summary

K220906

In accordance with 21 CFR 807.92, the following information constitutes a 510(k) summary for SECURE-LOCK, Suspensory Fixation Device for ACL/PCL.

Submitter Information

Xiros Ltd 510(k) Submitter: Address: Springfield House Whitehouse Lane Leeds LS19 7UE UK Telephone: +44 (0)113 238 7200 Fax: +44 (0)113 2387201 Contact (primary correspondent) Name: Dr. Steve Curran Title: Compliance Director Email: CFS@xiros.co.uk Date summary was prepared: July 22, 2022

Device Identification

Name of device: Trade Name: Model number(s):

Common Name:

Classification: Regulation and Classification Name:

Classification Panel: Product Code:

Pin, Fixation, Smooth / Suture, nonabsorbable, synthetic, polyethylene Class II 21 CFR 888.3040 Smooth or threaded metallic bone fixation fastener 21 CFR 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture Orthopedic HTY/ GAT

Purpose of Submission

The purpose of this submission is to obtain clearance for a new orthopedic fixation device for use in the fixation of bone to bone and soft tissue to bone.

SECURE-LOCK SECURE-LOCK

102-1377

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Predicate Device Information

The SECURE-LOCK Suspensory Fixation Device for ACL/PCL described in this submission is substantially equivalent to the following predicate device:

Arthrex ACL Tightrope (K112990) -

Reference Device

XTREME-LOOP (K191053) The device uses identical Titanium alloy and -UHMWPE materials, an identical Flipping suture and the same sterilization process to the SECURE-LOCK.
-SECURE-LOOP (K151601) - The device uses identical Polyester materials in the suture components (Implant Loop, Pulling and Flipping sutures) and the same sterilization process to the SECURE-LOCK.

Device Description

Intended Use

Comparison of Technological Characteristics with the Predicate Device

The SECURE-LOCK has the same basic principles of operation as the predicate device. They both consist of an implantable, titanium alloy button that sits on the exit to a bone tunnel on the cortex, suspending a non-absorbable loop inside a tunnel to provide secure, strong fixation for ligament repair/reconstruction. Both devices utilize sutures to deliver the implant into the body with the only difference being the number of sutures used. Both devices utilize the same core materials, with only minor differences in the material composition of each device component. Any differences are considered minor and do not raise questions concerning safety and effectiveness.

Performance Data

The following performance testing has been completed for the SECURE-LOCK:

Implant Tensile Strength Tests ●
Implant Fatigue Tests ●
Pulling Suture Tensile Strength Tests ●
Suture Diameter Measurements and Tensile Strength
Formal assessment of the SECURE-LOCK design in simulated use conditions
MRI Compatibility
Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE)
Biocompatibility testing in accordance with ISO 10993-1

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Bacterial endotoxin testing was performed on representative devices, the XTREME-LOOP (K191053) and SECURE-LOOP (K151601) that, together, are identical in materials, formulation, sterilization process and manufacturing facilities to the subject device implantable components. The devices have been tested for pyrogenicity using the Limulus Amoebocyte Lysate (LAL) method in line with the requirements of ANSI/AAMI ST72. The devices were found to have a result that met the FDA requirements of < 20 EU/Device. Final product batch release testing for endotoxins will be carried out on the subject device in accordance with ANSI/AAMI ST72:2019. In addition, the SECURE-LOCK has been tested for rabbit materialmediated pyrogenicity in line with USP <151>, and meets the pyrogen specification limits for this test.

These tests have been conducted in accordance with the following Guidance documents and applicable FDA recognized consensus standards, relevant to the device:

Surgical Sutures Class II Special Controls Guidance Document for Industry and FDA -Staff
Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in -Orthopedic Devices
Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) -Environment
6-467 USP-NF M80200 04 01 Nonabsorbable Surgical Suture -
6-468 USP-NF M99670 02 01 <881> Tensile Strength -
6-469 USP-NF M99650 02 01 <861> Sutures Diameter -
Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices -Part-1": Evaluation and Testing within a risk management process

Conclusion

The intended use of SECURE-LOCK is substantially equivalent to the predicate, Arthrex ACL Tightrope. SECURE-LOCK has the same basic principles of operation and core materials as the predicate. Any differences identified between the subject and predicate device are minor and do not present safety and effectiveness concerns.

The performance testing results demonstrate that the SECURE-LOCK provides appropriate mechanical properties and is relatively safe for its use in the fixation of bone to bone and soft tissue to bone. The performance data benefit/risk analysis concluded that the differences encountered do not affect the safety and efficacy of the new device in relation to the predicate.

The SECURE-LOCK device is substantially equivalent to the Arthrex ACL Tightrope (K112990) for use in fixation of bone to bone and soft tissue to bone.

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Regulation Number and Section

§ 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.