(367 days)
Not Found
No
The device description and intended use clearly define a physical, bioabsorbable interference screw for ACL reconstruction. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device is an interference screw used for fixation of grafts in ACL reconstruction. It is an implantable device used to support the biological healing process, but it does not directly administer therapy or provide a therapeutic effect itself.
No
Explanation: The device, the BIO-EUROLIG® screw, is described as an interference screw intended for fixations in ACL reconstruction. Its function is to provide physical support and fixation, not to diagnose a condition or disease.
No
The device description clearly states it is a bioabsorbable interference screw made of Poly-Lactid Acid (PLA), which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide interference fixations of bone-tendon-bone and soft tissue grafts in ACL reconstruction. This is a surgical procedure performed on the body, not a test performed on samples taken from the body.
- Device Description: The device is a bioabsorbable interference screw used for fixation within the body. This is a medical device used for treatment, not for diagnosis.
- Lack of IVD characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) or any diagnostic purpose.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The Bio-Eurolig® screw is intended to provide interference fixations of bone-tendon-bone and soft tissue grafts in ACL reconstruction through arthroscopy or arthrotomy.
Product codes
HWC
Device Description
The Bio-Eurolig® screw is a bioabsorbable interference screw made of Poly-Lactid Acid (PLA) and available in 3 diameters (7, 8 and 9mm) and in 2 lengths (25 and 30). They are delivered sterile and are single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone-tendon-bone
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)
Risk to health have been addressed through the specified materials, processing controls, quality assurance and compliance to the Medical Device Good Manufacturing Practices Regulations. Testing were performed to characterize the functionality, durability and safety of the Bio-Eurolig® screws.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JUN 2, 4, 2004
K031939 Page 122
510 (K) SUMMARY – BIO-EUROLIG® SCREW
| Submitter name: | Fournitures Hospitalières Industrie |
|---|---|
| Submitter adress: | 6 Rue Nobel, Z.I. de Kernevez |
| QUIMPER, France 29000 | |
| Contact person: | C.QUENDEZ |
| Phone Number: | 33.2.98.55.68.95 |
| Fax Number: | 33.2.98.53.42.13 |
| Date prepared: | May 28, 2003 |
| Device Trade Name: | BIO-EUROLIG® SCREW |
| Device common name: | Bioabsorbable Interference Screw |
| Classification name: | Bone Fixation Screw |
| Predicate Devices: | BIO RCI |
| Smith & Nephew | |
| K 992396 | |
| BIO Screw | |
| Linvatec | |
| K 973758 | |
| ARTHREX Bio-Interference Screw | |
| Arthrex | |
| K 971358 | |
| Device description: | The Bio-Eurolig® screw is a bioabsorbable interference screw made of |
| Poly-Lactid Acid (PLA) and available in 3 diameters (7, 8 and 9mm) | |
| and in 2 lengths (25 and 30). They are delivered sterile and are single | |
| use. | |
| Intended use: | The Bio-Eurolig® screw is intended to provide interference fixations of |
| bone-tendon-bone and soft tissue grafts in ACL reconstruction through | |
| arthroscopy or arthrotomy. |
1
| Performance Data: | Risk to health have been addressed through the specified materials,
Processing controls, quality assurance and compliance to the Medical
Device Good Manufacturing Practices Regulations. Testing were
performed to characterize the functionality, durability and safety of the
Bio-Eurolig® screws. |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | The Bio-Eurolig® Screws are substantially equivalent to predicate
devices in terms of intended use, safety, and effectiveness. |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines representing its wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 2004
Mr. M. Philippe Schweblin President du Directoire Fournitures Hospitaliéres Industrie ZI de Kernevez – 6 rue Nobel 29000 Quimper France
Re: K031939 Trade/Device Name: Bio-Eurolig® Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: March 25, 2004 Received: March 29, 2004
Dear Mr. Schweblin:
We have reviewed your Section 510(k) premarket notification of intent to market the indicati we nave reviewed your becamed the device is substantially equivalent (for the indications ferenced above and have actoring active marketed predicate devices marketed in interstate for use stated in the enclosure) to regard actual date of the Medical Device Amendments, or to commerce prior to May 20, 1978, the excordance with the provisions of the Federal Food. Drug, devices mat nave tech recuire approval of a premarket approval application (PMA). and Cosmetic Act (7101) that do not required to the general controls provisions of the Act. The 1 ou may, therefore, market of the Act include requirements for annual registration, listing of general controls provisions of mactice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (500 a0070) ins tExisting major regulations affecting your device can a may be subject to such additional combines, Title 21, Parts 800 to 898. In addition, FDA may oublish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that i Dri 3 issualles complies with other requirements of the Act that I DA has made a active and regulations administered by other Federal agencies. You must of any I cochar statutes und regulations, including, but not limited to: registration and listing (21 Comply with an the Her 800 manufacturing practice requirements as set CI K Fart 607); adoning (2) (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality of course (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 – Mr. M. Philippe Schweblin
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow yourse overnment of substantial equivalence of your device to a legally premarket notineation: "The classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific acriver 181 ) 394-4639. Also, please note the regulation entitled, Collider the Office of Come to premarket notification" (21CFR Part 807.97) you may obtain. IMISoranding by reference to premiesponsibilities under the Act may be obtained from the Oincl general information on your International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark N. Adkison
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510 K Number (if known):
BIO-EUROLIG® screw
Device Name:
Indications For Use:
The BIO-EUROLIG® screw is intended to provide interference fixations of bone-tendonbone and soft tissue grafts in ACL reconstruction through arthroscopy or arthrotomy.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH | Office of Device Evaluation |
|---|---|
| --------------------- | ----------------------------- |
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
| 510(k) Number | K031939 |
|---|---|
| Prescription Use (Per 21 CFR 801.109) | Yes |
| Over-The-Counter Use | No |
(Optional Format 1-2-96)