(115 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a physical fixation device, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a "fixation device" intended for "fixation of bone or soft tissue to bone" and for "distributing suture tension," which are functions of mechanical support rather than active therapy.
No
Explanation: The device description states that the SECURE-LOCK is a "fixation device" intended for "fixation of bone or soft tissue to bone." This indicates a therapeutic or reparative function, not a diagnostic one. Diagnostic devices are used to identify or determine the nature of a disease or condition.
No
The device description clearly outlines physical components made of polyester, ultrahigh molecular weight polyethylene, and titanium alloy, indicating it is a hardware device. The performance studies also focus on mechanical properties and biocompatibility of these materials.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "fixation of bone or soft tissue to bone" and is used as a "fixation device, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair". This describes a surgical implant used in vivo (within the body) during a procedure.
- Device Description: The description details a physical implantable device made of polyester, polyethylene, and titanium alloy, designed to be placed within a bone tunnel. This is consistent with a surgical implant, not a diagnostic test performed in vitro (outside the body).
- Performance Studies: The performance studies focus on mechanical properties (tensile strength, fatigue), biocompatibility, and pyrogenicity. These are relevant tests for an implantable device, not for an IVD which would focus on analytical and clinical performance related to detecting substances or conditions in biological samples.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The SECURE-LOCK device is a surgical tool and implant used directly on the patient's anatomy during a repair procedure.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HTY, GAT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone, soft tissue, ligament, tendon, Anterior Cruciate Ligament (ACL), Posterior Cruciate Ligament (PCL)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- 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 , and meets the pyrogen specification limits for this test.
Key Results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Arthrex ACL Tightrope (K112990)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
XTREME-LOOP (K191053), SECURE-LOOP (K151601)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
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 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
2
| 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)
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.
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
3
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
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510(k) Summary
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
4
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
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.
Intended Use
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.
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
5
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 , 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 Tensile Strength -
- 6-469 USP-NF M99650 02 01 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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