(89 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on mechanical properties and surgical technique, with no mention of AI or ML.
No
Explanation: A therapeutic device is used to treat a disease or condition. This device is used for fixation of tendons and ligaments during orthopedic reconstruction procedures, which is a structural support function rather than a direct treatment of a disease or condition.
No
The device description indicates it is used for "fixation of tendons and ligaments during orthopedic reconstruction procedures," which is a treatment or support function, not a diagnostic one.
No
The device description clearly states it is a physical device consisting of a polyester loop and a titanium alloy button used for surgical fixation.
Based on the provided information, the SECURE-LOOP device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fixation of tendons and ligaments during orthopedic reconstruction procedures". This is a surgical procedure performed in vivo (within the living body).
- Device Description: The device is a physical implant used to secure tissues within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health. The SECURE-LOOP does not perform this function.
Therefore, the SECURE-LOOP is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SECURE-LOOP is used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as anterior cruciate ligament (ACL) reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The SECURE-LOOP fixation device consists of a polyester continuous loop captured on a titanium alloy button. The button sits on the exit to a bone tunnel on the cortex, suspending the continuous loop inside the tunnel to provide secure, strong fixation for ligament reconstruction. The SECURE-LOOP fixation device is supplied with sutures that are used to pull the graft assembly into place and then flip the button allowing ligament reconstruction to be performed arthroscopically.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 SECURE-LOOP when tested against the Endobutton Continuous Loop (K980155) for stiffness, tensile strength, cyclic fatigue testing, and functional testing, was determined to be substantially equivalent. The testing demonstrated that the differences between the new device and the predicate device do not raise any new issues of safety and efficacy. 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.
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.
No reference devices were used in this submission.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 9, 2015
Xiros, Limited Stephen Seed Regulatory Manager Springfield House Whitehouse Lane Leeds LS19 7UE England
Re: K151601
Trade/Device Name: SECURE-LOOP Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: June 2, 2015 Received: June 12, 2015
Dear Mr. Seed:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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forth in 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 yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K151601
Device Name SECURE-LOOP
Indications for Use (Describe)
The SECURE-LOOP is used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as anterior cruciate ligament (ACL) 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)
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Image /page/3/Picture/0 description: The image shows the word "XIROS" in gray, enclosed in a gray, rounded shape. The shape resembles a pill or capsule with a small extension on the right side. The text is in a simple, sans-serif font and is centrally aligned within the shape. The background is plain white.
SECTION 5. 510(k) SUMMARY
In accordance with 21 CFR 807.92, the following information constitutes Xiros Ltd. 510(k) summary for the SECURE-LOOP.
I.SUBMITTER INFORMATION
| Submitter`s Name: | Xiros Limited |
|---|---|
| Address: | Springfield House |
| Whitehouse Lane | |
| Leeds LS19 7UE | |
| England | |
| Telephone Number: | +44 (0)1132387200 |
| Fax Number: | +44 (0)113 2387201 |
| Contact Person: | Stephen Seed (Regulatory Affairs Manager) |
| Date: | 01.09.2015 |
| 510(K) number: | K151601 |
II. DEVICE IDENTIFICATION
| Name of Device: | SECURE-LOOP |
|---|---|
| Trade Name: | SECURE-LOOP |
| Common or usual name: | Suture retention device; Surgical Button, Polyester Surgical |
| Suture, ACL suspension fixation. | |
| Classification Name: | Fastener, fixation, non-degradable soft tissue |
| Regulatory Class: | Class II |
| Product Code: | MBI |
| Regulation: | 888.3040 |
| Panel: | Orthopaedic |
III. PREDICATE DEVICE
Smith & Nephew, Inc , Endobutton Continuos Loop (ECL) K980155. This predicate has not been subject to a design related recall. No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
The SECURE-LOOP fixation device consists of a polyester continuous loop captured on a titanium alloy button. The button sits on the exit to a bone tunnel on the cortex, suspending the continuous loop inside the tunnel to provide secure, strong fixation for ligament reconstruction. The SECURE-LOOP fixation device is supplied with sutures that are used to pull the graft
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Image /page/4/Picture/0 description: The image shows a logo with the word "XIROS" in a rounded rectangle. The text is in a bold, sans-serif font and appears to be gray. The rectangle has rounded corners and a double-line border. A horizontal line extends from the right side of the rectangle.
assembly into place and then flip the button allowing ligament reconstruction to be performed arthroscopically.
V. INDICATIONS FOR USE
The SECURE-LOOP fixation device is used for fixation of tendons and ligaments during orthopaedic reconstruction procedures such as anterior cruciate ligament (ACL) reconstruction.
VI. COMPARISIONS OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The SECURE-LOOP has the same technological characteristics as the predicate Endobutton Continuous Loop device, with respect to intended use, labelling, material composition, chemical formulation, design, design tolerances, functionality and use the same manufacturing methods.
VII. PERFORMANCE DATA
The SECURE-LOOP when tested against the Endobutton Continuous Loop (K980155) for stiffness, tensile strength, cyclic fatigue testing, and functional testing, was determined to be substantially equivalent. The testing demonstrated that the differences between the new device and the predicate device do not raise any new issues of safety and efficacy. 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.
Summary: Based on the pre-clinical testing performance, the SECURE-LOOP is found to have a safety and effectiveness profile that is similar to the predicate device.
VIII.CONCLUSION
The SECURE-LOOP is composed of the same material and has the same design as the predicate device. It is manufactured in the same manner and uses the same methods of that used to manufacture the predicate device.
Testing performed demonstrate that the SECURE-LOOP is substantially equivalent to the Smith &Nephew Endobutton CL fixation device.
Xiros therefore conclude the SECURE-LOOP is substantially equivalent to the Smith & Nephew Endobutton CL fixation device.