The CoLS® Fixation System is designed for the fixation of tendons graft to the femur and tibia during orthopedic surgical procedures for Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) reconstructions.

Device Description

The CoLS® Fixation System is composed of the following elements: The CoLS® tendon anchoring screw, implantable device, used for the fixation of the CoLS® tendon anchoring tape to the bone. The CoLS® tendon anchoring tape, it is a non absorbable surgical suture, used for the ACL and PCL reconstruction, to which the tendon graft is attached. This implantable tendon anchoring tape is used with accessories non implantable: tape support, passing wire and scalpel blade. The CoLS® Fixation System is provided sterile and it is intended to be implanted using the dedicated instrumentation supplied by the manufacturer.

AI/ML Overview

Here's an analysis of the provided text regarding the CoLS® Fixation System, focusing on acceptance criteria and the study conducted.

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. Therefore, the "study" described is a comparison of characteristics and performance rather than a full efficacy clinical trial.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Tensile Strength (measured on Fixation System)	"Tensile strength on the Fixation System" was compared to the predicate device. It was determined that "the Fixation System performances were substantially equivalent to the selected predicate device."
Biocompatibility (of final finished material)	"Biocompatibility of the final finished material" was compared to the predicate device. It was determined that "the Fixation System performances were substantially equivalent to the selected predicate device."
Material	Same material (titanium alloy and polyethylene terephtalate) as the predicate device.
Design	Same design as the predicate device.
Operating Principle	Same operating principle as the predicate device.
Sterilization Method	Same sterilization method (Gamma radiation) as the predicate device.
Indication for Use	Same indication for use (fixation of tendon grafts to femur and tibia for ACL/PCL reconstructions) as the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in the context of a dedicated clinical or pre-clinical study with specific sample sizes for tensile strength or biocompatibility. Instead, the "tests were performed" to compare the new device to the predicate. This suggests laboratory testing rather than a patient-based test set.

Sample Size: Not explicitly stated. The document refers to "tests were performed" but does not give the number of samples used for tensile strength or biocompatibility testing.
Data Provenance: The tests were performed as part of a 510(k) submission from Fournitures Hospitalières Industrie, a French company. The nature of the tests (tensile strength, biocompatibility) implies laboratory testing, which is generally retrospective in the sense that the device has already been designed and manufactured when these comparative tests are conducted.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable to this 510(k) submission. The "ground truth" for demonstrating substantial equivalence here relies on direct comparative testing of physical characteristics (tensile strength, biocompatibility, material, design, etc.) against a legally marketed predicate device, rather than expert interpretation of data like images or patient outcomes.

4. Adjudication Method for the Test Set

This information is not applicable to this 510(k) submission. Adjudication methods (like 2+1, 3+1) are typically used in studies involving expert review of ambiguous cases or outcomes, such as in diagnostic imaging or clinical trials. The described "tests" are laboratory-based comparisons of physical and material properties.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study assesses how AI impacts human reader performance, usually in diagnostic scenarios. This 510(k) is for a physical medical device (fixation system) and does not involve AI or human interpretation of outputs.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone algorithm performance study was not done. This 510(k) is for a physical medical device and does not involve a diagnostic algorithm.

7. Type of Ground Truth Used

The "ground truth" for this substantial equivalence determination is established by:

Comparative Laboratory Testing Data: Tensile strength and biocompatibility data from the novel device were compared directly to the predicate device.
Direct Comparison of Device Characteristics: Material composition, design, operating principle, sterilization method, and indications for use were directly compared to the predicate device.

There is no "expert consensus," "pathology," or "outcomes data" in the typical sense used for diagnostic or treatment efficacy studies, as the core of this submission is device equivalence based on physical and functional characteristics.

8. Sample Size for the Training Set

This information is not applicable. This is a submission for a physical medical device, not an AI or machine learning model. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for an AI/ML model.

Summary

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K120740 (1/3)

Fournitures Hospitalières industrie

CoLS® Fixation System Special 510(k) Premarket Notification

510(k) Summary of Safety and Effectiveness 5. 5 2013 MAR This summary of 510(k) safety and effectiveness information is being submitted in accordance to the requirements of SDMA 1990 and 21 CFR 807.92. Date prepared: February 27th 2012 The assigned 510(k) number is: 5-1. Applicant: Fournitures Hospitalières industrie 6 Rue Nobel, Z.I. de Kernévez 29000 QUIMPER - FRANCE Tel: (+33) 2.98.55.68.95 Fax: (+33) 2.98.53.42.13 5-2. Company Contact: Franck HUNT, General Manager Tel: (+33) 2.98.55.68.95 5-3. Product : CoLS® Fixation System Trade name: Common name: Fixation screw and non absorbable surgical suture Classification: Class II Product code: MBI Smooth or threaded metallic bone fixation fastener Regulation: 21 CFR 888.3040

5-4. Predicate/ Legally Marketed Device:

Manufacturer:	Fournitures Hospitalières Industrie
Device Trade Name:	TLS® Fixation System
510 (K):	K080974

5-5. Device Description:

The CoLS® Fixation System is composed of the following elements:

The CoLS® tendon anchoring screw, implantable device, used for the fixation of the CoLS® tendon anchoring tape to the bone.

The CoLS® tendon anchoring tape, it is a non absorbable surgical suture, used for the ACL and PCL reconstruction, to which the tendon graft is attached.

This implantable tendon anchoring tape is used with accessories non implantable: tape support, passing wire and scalpel blade.

The CoLS® Fixation System is provided sterile and it is intended to be implanted using the dedicated instrumentation supplied by the manufacturer.

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5-6. Indications for Use/ Intended Use:

As stated in the Indications for Use section and on the product related labeling (instructions for use and commercial documents):

This is the same intended use as previously cleared for the TLS® Fixation System K080974

The intended use of the medical device, as described in its labeling, has not changed as a result of the modification

Therefore, no changes to the labels or instructions for use have occurred. We simply add another package to the currently existing.

5-7. Comparison of Technological Characteristics:

The CoLS® tendon anchoring screw and the CoLS® tendon anchoring tape have the same intended use and substantial similar indications for use as the predicate device.

made out of the same material: titanium alloy and polyethylene terephtalate.
have the same design.
use the same operating principle,
have the same method of sterilization: Gamma radiation.

5-8. Performances:

Tests were performed to compare the tensile strength on the Fixation System and also the biocompatibility of the final finished material. After the tests were completed, it was determined that the Fixation System performances were substantially equivalent to the selected predicate device.

Risks to health have been addressed through the specified materials, processing controls, quality assurance and compliance to the Medical Device Good Manufacturing Practices Regulations.

5-9. Substantial Equivalence:

The modified CoLS® Fixation System has the following similarities to the predicate device previously cleared 510(k):

the same indication for use l
the same material
the same design
the same operating principle, ・
the same sterilization method: Gamma radiation. -

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In summary, the CoLS® Fixation System described in this submission is substantially equivalent to the predicate device TLS® Fixation System.

5-10. Conclusion:

Following the examination of all the above mentioned information, we believe that the CoLS® Fixation System is substantially equivalent to the selected predicate device in terms of intended use, material, design, operating principle, sterilization, performance, safety and effectiveness.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 5, 2013

Fournitures Hospitalières Industrie % Mr. Franck Hunt General Manager 6 Rue Nobel, Z.I. de Kernévez 29000 Quimper - France

Re: K120740

Trade/Device Name: CoLS® Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: February 19, 2013 Received: February 25, 2013

Dear Mr. Hunt:

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. Iisting 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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Page 2 - Mr. Franck Hunt

forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled; "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.

Erin ה eith

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Fournitures Hospitalières industrie

4. Indications for Use

510(k) Number (if known): K120740

Device Name:

CoLS® Fixation System

This device is composed of the following elements:

The CoLS® tendon anchoring screw
The CoLS® tendon anchoring tape

Indications for Use:

Prescription Use: Yes (Part 21 CFR 801 Subpart D) AND/OR

Over the counter Use: No (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Concurrence of CDRH, Office of Device Evaluation (ODE) Page __ of ____________________________________________________________________________________________________________

Casey L. Hanley, Ph

Division of Orthopaedic Devices

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.