(87 days)
No
The summary describes a bioabsorbable interference screw for ligament reconstruction and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is used to fix ligament grafts during knee anterior cruciate ligament reconstruction, which is a therapeutic procedure to restore knee function.
No
The device description clearly states its purpose as an implantable screw for fixing grafts in ligament surgery, specifically for knee anterior cruciate ligament reconstructions. It is a therapy device, not a diagnostic one.
No
The device description clearly states that the devices are "bioabsorbable interference screws" and "implantable screw devices," indicating they are physical hardware components, 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 "knee anterior cruciate ligament reconstruction in ligamentoplasty procedures." This is a surgical procedure performed on the body, not a test performed on a sample taken from the body.
- Device Description: The device is described as "bioabsorbable interference screws used in ligament surgery" and "implantable screw devices in long term contact with bone and tissue grafts." This clearly indicates a device that is implanted into the body during surgery.
- IVD Definition: In Vitro Diagnostics are tests performed on samples (like blood, urine, tissue) taken from the human body to provide information about a person's health. This device does not perform any such testing.
The device is a surgical implant used to fix grafts during knee ligament reconstruction.
N/A
Intended Use / Indications for Use
EUROSCREW® NG and EUROSCREW® TCP NG screws are indicated in knee anterior cruciate ligament reconstruction in ligamentoplasty procedures.
Product codes
MAI
Device Description
Teknimed's EUROSCREW® NG and EUROSCREW® TCP NG are bioabsorbable interference screws used in ligament surgery specifically designed for fixation of both bone-tendon-bone and soft tissue grafts. The screws are suitable and designed for ligamentoplasty surgical procedures specifically for knee anterior cruciate ligament reconstructions. Both are implantable screw devices in long term contact with bone and tissue grafts. Teknimed's EUROSCREW® NG and EUROSCREW® TCP NG are implant devices that are utilized in a surgical setting with a qualified healthcare professional (i.e., surgeons).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgical setting with a qualified healthcare professional (i.e., surgeons).
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)
Performance Testing: Both the subject devices, EUROSCREW® NG and EUROSCREW® TCP NG, were tested for torsion, torque (insertion) and pull-out as per ASTM F 2502, and for In Vitro Degradation as per ISO 13781. The company also performed Insertion Validation and Association screwdriver-screw tests to assess screw insertion criteria. Performance test reports confirmed that the difference between the predicate (LIGAFIX Interference Screw (K122228)) and subject devices, EUROSCREW® NG and TCP NG, do not raise any new questions of safety or effectiveness.
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
Teknimed % Barry E Sands President and Founder RQMIS, Inc. 110 Haverhill Rd., Suite 524 Amesbury, Massachusetts 01913
Re: K230394
Trade/Device Name: Euroscrew® NG; Euroscrew® TCP NG Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: MAI, Dated: February 14, 2023 Received: February 14, 2023
Dear Barry Sands:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Yu-chieh Chiu - Digitally signed by Yu-chieh
Chiu-s Chiu -S Date: 2023.05.12 13:43:23 S -04'00
Yu-Chieh Chiu, Ph.D. Acting Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230394
Device Name EUROSCREW® NG EUROSCREW® TCP NG
Indications for Use (Describe)
EUROSCREW® NG and EUROSCREW® NG TCP screws are indicated in knee anterior cruciate ligament reconstruction in ligamentoplasty procedures.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
Submitter information
| Date Prepared per 21 CFR
| 807.92(a)(1) | May 11, 2023 |
|---|---|
| Applicant/Manufacturer | Teknimed |
| 11-12 rue Apollo | |
| Z.I. Montredon | |
| L'Union | |
| 31240, France | |
| Primary Contact | Barry Sands |
| President and Founder, RQMIS | |
| Phone: (978) 358-7307 | |
| Email: regulatorysubmissions@rqmis.com | |
| Device information | |
| Trade Name of Subject Device | EUROSCREW® NG & EUROSCREW® TCP NG |
| Common Name | Fastener, Fixation, Biodegradable, Soft Tissue |
| Device class | Class II |
MAI
Device Description
Product Code
Regulation Number
Predicate Device:
Teknimed's EUROSCREW® NG and EUROSCREW® TCP NG are bioabsorbable interference screws used in ligament surgery specifically designed for fixation of both bone-tendon-bone and soft tissue grafts. The screws are suitable and designed for ligamentoplasty surgical procedures specifically for knee anterior cruciate ligament reconstructions. Both are implantable screw devices in long term contact with bone and tissue grafts. Teknimed's EUROSCREW® NG and
888.3030 Single/multiple component metallic bone
Fixation appliances and accessories
LIGAFIX Interference Screw (K122228)
4
EUROSCREW® TCP NG are implant devices that are utilized in a surgical setting with a qualified healthcare professional (i.e., surgeons).
Indications for Use
EUROSCREW® NG and EUROSCREW® TCP NG screws are indicated in knee anterior cruciate ligament reconstruction in ligamentoplasty procedures.
Intended Use
EUROSCREW® NG and EUROSCREW® TCP NG are intended for attaching ligaments or tendons to bone in orthopaedic surgical procedures.
Intended Use/Indication for Use - Comparison of the Subject Devices with Predicate Device
The subject devices, EUROSCREW® NG and TCP NG, have equivalent intended use, indications for use, material composition to the predicate device, LIGAFIX Interference Screw (K122228).
Technological Characteristics - Comparison with the Predicate Device, LIGAFIX Interference Screw (K122228)
The technological characteristics comparison demonstrated that the subject devices, EUROSCREW® NG and EUROSCREW® TCP NG, are equivalent to the previously cleared predicate device in terms of intended uses, designs, materials, and operational principles.
Basis of Substantial Equivalence
The substantial equivalence of both subject devices was determined per the FDA guidance document, "The 510(k) program: evaluating substantial equivalence in premarket Notification [510(k]]." Comparison with the predicate device (K12228) does not raise new questions of safety and effectiveness. The analysis of the technological characteristics, which include design, material composition and other device features, as defined in section 513(i)(1)(B) of the FD&C Act and 21 CFR 807.100(b)(2) (ii)(A), demonstrated that EUROSCREW® NG and EUROSCREW® TCP NG are substantially equivalent to the identified predicate device, LIGAFIX Interference Screw (K122228).
Sterilization
EUROSCREW® NG and TCP NG will be supplied sterile. EUROSCREW® NG and EUROSCREW® TCP NG are delivered in double sterile packaging. Both subject devices are sterilized by ethylene oxide and are provided sterile for single patient use. The sterilizations are performed per ISO 11135-1 and ISO 10993-7 FDA recognized consensus standards. The sterilization validation demonstrated that both subject devices are effective at all points of load and achieve a sterility assurance level (SAL) of 10-6.
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Biocompatibility
Biocompatibility testing was performed on both Teknimed subject devices, and the test results demonstrated that EUROSCREW® NG and EUROSCREW® TCP NG are biocompatible. Biocompatibility of both devices were evaluated according to the FDA guidance document entitled, Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing within a Risk Management Process" issued on September 4, 2020. Based on this FDA guidance document, both the subject devices are considered implants which come in permanent contact (>30 days) with bone and tissue of the patient's body.
Performance Testing
Both the subject devices, EUROSCREW® NG and EUROSCREW® TCP NG, were tested for torsion, torque (insertion) and pull-out as per ASTM F 2502, and for In Vitro Degradation as per ISO 13781. The company also performed Insertion Validation and Association screwdriver-screw tests to assess screw insertion criteria. Performance test reports confirmed that the difference between the predicate (LIGAFIX Interference Screw (K122228)) and subject devices, EUROSCREW® NG and TCP NG, do not raise any new questions of safety or effectiveness. Therefore, both subject devices are substantially equivalent to the predicate device identified throughout this submission.
| Device
Characteristics | Subject Devices | Predicate Device | Substantial
Equivalence
Discussion |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Products | EUROSCREW® NG
and TCP NG | LIGAFIX Interference Screw
(30/70) | N/A |
| Applicant | Teknimed | SBM | N/A |
| 510(k)
Number | K230394 | K122228 | N/A |
| Classification | Class II | Class II | Identical |
| Classification
Name | 888.3030
Single/multiple
component
metallic bone
Fixation appliances
and accessories | 888.3030 Single/multiple
component metallic bone
Fixation appliances and
accessories | Identical |
| Product Code | MAI | MAI | Identical |
| Indications for use | EUROSCREW® NG
and EUROSCREW®
TCP NG screws are
indicated in knee
anterior cruciate
ligament
reconstruction in
ligamentoplasty
procedures. | LIGAFIX/ComposiTCP is a
cannulated; sterile, single
use, resorbable interference
bone screw made of a
mixture of tri calcium
phosphate (beta-TCP) and
Poly Lactic Acid (PLA)
designed for' the
interference fixation of
grafts in anterior cruciate
ligament reconstruction. | Equivalent
Both Subject devices
and the predicate
device have equivalent
Indications for use. |
| Sterile | Ethylene Oxide
(EtO) | Unknown | Equivalent
Both Subject devices
meet ISO 10993-7
specification. The
Sterilization tests'
results for both subject
devices passed, and
reports are attached in
the original 510(K)
body. |
| Material | Euroscrew NG: Poly
Lactic Acid (PLA)
&
Euroscrew TCP NG
Tri calcium
phosphate (beta-
TCP) and Poly Lactic
Acid (PLA) | Tri calcium phosphate
(beta-TCP) and Poly Lactic
Acid (PLA) | Equivalent
Both subject devices
and the predicate
devices have
equivalent materials.
Both Subject devices
and the predicate
devices meet ASTM
F2502 specifications. |
| Available sizes | Ø 6 mm L 20 mm
Ø 7 mm L 24 mm
Ø 8 mm L 24 mm
Ø 9 mm L 24 mm
Ø 7 mm L 30 mm
Ø 8 mm L 30 mm
Ø 9 mm L 30 mm
Ø 10 mm L 30 mm
Ø 11 mm L 35 mm | Flat head
Ø 10 mm - L 30 mm
Ø 10 mm - L 35 mm
Ø 11 mm - L 30 mm
Ø 11 mm - L 35 mm
Round head
Ø 6 mm - L 20 mm
Ø 7 mm - L 20 mm
Ø 7 mm - L 25 mm
Ø 7 mm - L 30 mm
Ø 8 mm - L 20 mm
Ø 8 mm - L 25 mm
Ø 8 mm - L 30 mm | Equivalent
Size range is
equivalent to the
Predicate device. |
| | | | |
| | | Ø 8 mm - L 35 mm | |
| | | Ø 9 mm - L 20 mm | |
| | | Ø 9 mm - L 25 mm | |
| | | Ø 9 mm - L 30 mm | |
| | | Ø 9 mm - L 35 mm | |
| | | Ø 10 mm - L 25 mm | |
| | | Ø 10 mm - L 30 mm | |
| | | Ø 10 mm - L 33 mm | |
| | | Ø 10 mm - L 35 mm | |
| How Supplied | Resorbable
interference bone
screw, Single use
only | Resorbable
interference bone screw,
Single use only | Identical |
| Biocompatible | ISO 10993-1 | Biocompatible | Equivalent
Both Subject and
predicate devices
testing
protocols/reports for
the screws meet ISO
10993 specification. All
tests' results for the
subject device passed
and reports are
attached in the original
510(K) body |
Table 1: Substantial Equivalence Comparison Table between EUROSCREW®NG and TCP NG (Subject Devices) with LIGAFIX® Interference Screw (K122228)
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Substantial Equivalence Conclusion
EUROSCREW® NG and EUROSCREW® TCP NG have equivalent intended use, material comparison, design, operational principle and equivalent technological characteristics as the predicate device (K122228). The non-clinical performance test reports support the safety, effectiveness and performance of the subject devices and demonstrate that any difference in technological characteristics and material composition do not rase any new questions of safety and effectiveness. Therefore, EUROSCREW® NG and EUROSCREW® TCP NG are substantially equivalent to the identified predicate device, LIGAFIX Interference Screw (K122228).