(358 days)
Not Found
No
The device description and intended use focus on mechanical fixation components (screws, tape, suture) and surgical accessories. There is no mention of software, data processing, or any terms related to AI/ML.
Yes.
The device is used for the fixation of tendon grafts during ACL and PCL reconstructions, which are surgical procedures to repair damaged ligaments, indicating a therapeutic purpose.
No
The device is a CoLS® Fixation System used for fixing tendon grafts during ACL and PCL reconstructions, which is a therapeutic function, not diagnostic.
No
The device description explicitly lists hardware components such as screws, tape, and surgical instruments, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation of tendon grafts during orthopedic surgical procedures (ACL and PCL reconstructions). This is a surgical implant used directly on the patient's body.
- Device Description: The device is described as an implantable system (screw and tape) used for surgical fixation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MBI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femur, tibia
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)
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.
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.
Not Found
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
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.
1
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):
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.
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.
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have the same design.
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use the same operating principle,
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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. -
2
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.
3
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
4
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
5
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:
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.
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