(17 days)
Not Found
No
The summary describes a physical implant (a screw) and its intended use in orthopedic surgery. There is no mention of software, algorithms, or data processing that would indicate the presence of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No
The device is a screw designed for fixation of tendon grafts during ACL and PCL reconstructions, which is a supportive role in a surgical procedure, not a direct therapeutic action on a disease or condition itself.
No
The device is described as a screw designed for fixation of tendon grafts during ACL and PCL reconstructions, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly states it is a screw made out of PEEK and used with a tape, indicating it is a physical implantable device, not software.
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 in the body.
- Device Description: The device is a screw made of PEEK, designed to be implanted.
- 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 outside the body to analyze samples. This device is an implantable surgical device.
N/A
Intended Use / Indications for Use
The CoLS® PEEK 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)
HWC
Device Description
The CoLS® PEEK is a screw made out of PEEK (Poly-Ether-Ketone) and used with the tape of TLS® fixation system agreed by FDA K080974. To standardize CoLS® range, the TLS® tape will be called CoLS® tape.
The difference between CoLS® screw made out of PEEK and TLS® screw made out of titanium is only the raw material.
The CoLS® PEEK 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 and 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)
The CoLS® PEEK was tested according to ASTM F543-07. The test performed in ASTM F543 was the insertion torque test. After the testing was completed, it was determined that the CoLS® PEEK performances were substantially equivalent to those of the selected predicate devices.
Risks to health have been addressed through the specified materials, processing controls, quality assurance and compliance to the Medical Device Good Manufacturing Practices Regulations.
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
Product code: HWC : screw, fixation, bone Regulation: 21 CFR 888.3040 Class: II
l
5-4. Predicate/ Legally Marketed Devices :
Information on devices to which substantial equivalence is claimed:
| Manufacturer: | Fournitures Hospitalières Industrie |
|---|---|
| Device Trade Name: | TLS Fixation System |
| 510 (K): | K080974 |
| Manufacturer: | Smith & Nephew, Inc. |
| Device Trade Name: | BIOSURE® SYNC Smith & Nephew PEEK |
| Interference Screws | |
| 510 (K): | K083226 |
1
Fournitures Hospitalières industrie
5-5. Device Description:
The CoLS® PEEK is a screw made out of PEEK (Poly-Ether-Ketone) and used with the tape of TLS® fixation system agreed by FDA K080974. To standardize CoLS® range, the TLS® tape will be called CoLS® tape.
The difference between CoLS® screw made out of PEEK and TLS® screw made out of titanium is only the raw material.
The CoLS® PEEK is intended to be implanted using the dedicated instrumentation supplied by the manufacturer.
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® PEEK 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.
5-7. Comparison of Technological Characteristics:
The CoLS® PEEK and the above selected predicate devices have the same intended use and substantial similar indications for use and share the following similarities:
- they are made out of the same material: PEEK, -
- they are available in similar ranges of sizes, -
5-8. Performances:
The CoLS® PEEK was tested according to ASTM F543-07. The test performed in ASTM F543 was the insertion torque test. After the testing was completed, it was determined that the CoLS® PEEK performances were substantially equivalent to those of the selected predicate devices.
Risks to health have been addressed through the specified materials, processing controls, quality assurance and compliance to the Medical Device Good Manufacturing Practices Regulations.
: 2 of 3
$
2
Fournitures Hospitalières industrie
Kr13591
CoLS® PEEK Traditional 510(k) Premarket Notification
5-9. Conclusion:
Following the examination of all the above mentioned information, we believe that the CoLS® PEEK is substantially equivalent to the selected predicate devices in terms of material, ranges of sizes, intended use, performances, safety and effectiveness.
p. 3 of 3
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Image /page/3/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract image of an eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Fournitures Hospitalières Industrie % Mr. Franck Hunt General Manager 6 Rue Nobel, Z.I. de Kernèvez 29000 Quimper France
DEC 2 2 2011
Re: K113591
Trade/Device Name: CoLS® PEEK Regulation Number: 21 CFR 888.3040 . Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: November 24, 2011 Received: December 5, 2011
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
4
Page 2 - Mr. Franck Hunt
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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/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,
for Delle
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
4. Indications for Use
510(k) Number (if known): _ K // 359 l
Device Name:
CoLS® PEEK
This device is composed of fixation screw made out of PEEK.
Indications for Use: The CoLS® PEEK 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)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1
(Division Sign-Off) Division of Surgical, Orthopedic. and Restorative Devices
| 510(k) Number | K113591 |
|---|---|
| --------------- | --------- |