(166 days)
The ActivaScrew™ Interference is indicated for fixation of tissue, including ligament or tendon to bone, or a bone-tendon to bone in the presence of appropriate immobilization / controlled mobilization. Interference fixation is intended for surgeries of knee, shoulder, elbow, ankle, foot and hand/wrist.
The product family consists of fully threaded ActivaScrew™ Interference, diameters 4 - 10 mm and lengths 10 - 33 mm. The ActivaScrew™ Interference is constructed of bioabsorbable poly(L-lactide-co-glycolide) (PLGA).
Here's an analysis of the provided text regarding the Bioretec ActivaScrew™ Interference, focusing on the acceptance criteria and the study that proves the device meets them:
Disclaimer: The provided text is a 510(k) summary for a medical device. 510(k) submissions primarily demonstrate substantial equivalence to existing legally marketed devices, rather than establishing de novo safety and effectiveness through extensive clinical trials as would be required for a PMA. Therefore, the "acceptance criteria" discussed here relate to demonstrating equivalence rather than clinical performance targets. Similarly, the "study" refers to non-clinical testing for equivalence.
Acceptance Criteria and Reported Device Performance
The Bioretec ActivaScrew™ Interference sought clearance by demonstrating substantial equivalence to predicate devices. The acceptance criteria were implicitly met by showing that the new device performs "substantially similar" to the predicates in specific mechanical tests.
| Acceptance Criteria Category | Reported Device Performance (Compared to Predicates) |
|---|---|
| Intended Use | Same (fixation of tissue, including ligament or tendon to bone, or a bone-tendon to bone in the presence of appropriate immobilization / controlled mobilization; interference fixation for knee, shoulder, elbow, ankle, foot, hand/wrist surgeries) |
| Principles of Operation | Same |
| Design Characteristics | Very similar (fully threaded, diameters 4-10mm, lengths 10-33mm) |
| Material | Same as previously cleared ActivaScrew™ (poly(L-lactide-co-glycolide) (PLGA)) |
| Mechanical Properties | Sufficient for indications, substantially similar to predicates (demonstrated through pull-out testing, shear strength testing) |
| Degradation Properties | Substantially similar to predicates (demonstrated through inherent viscosity and dimensional stability testing) |
The study (non-clinical testing) did not raise "any new questions of safety or effectiveness of the ActivaScrew™ Interference and demonstrates that the ActivaScrew™ Interference performs mechanically in a manner substantially similar to the tested predicate device."
Study Details
Given this is a 510(k) submission focusing on substantial equivalence, the "study" described is a series of non-clinical, in vitro tests comparing the new device to predicate devices. It is not a clinical study with human patients, nor a study involving AI.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document does not specify the exact sample sizes (number of screws or test repetitions) for each non-clinical test (pull-out, shear strength, inherent viscosity, dimensional stability).
- The data provenance is not explicitly stated beyond being "non-clinical tests and in vitro testing." Given the manufacturer (Bioretec Ltd.) is based in Finland, the testing likely occurred in Finland or by a contract lab; however, this is not confirmed in the text. These are prospective tests conducted specifically for this submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- This question is not applicable to this submission. "Ground truth" in the context of clinical disease detection or diagnosis, and the involvement of experts for adjudication, are concepts relevant to diagnostic device performance studies (e.g., for AI/ML devices). This submission is for a physical orthopedic implant and relies on engineering and material science standards and comparative mechanical testing, not expert interpretation of clinical data for a "ground truth" diagnosis.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable. See point 2.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This is not applicable. This is not an AI/ML device, nor a diagnostic device requiring human reader interpretation. No MRMC study was conducted.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable. This is not an algorithm or AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- This is not applicable in the traditional sense for diagnostic performance. For this device, the "ground truth" for demonstrating equivalence largely relies on established engineering principles, material science properties, and direct mechanical comparison to physically identical predicate devices against specified performance metrics (e.g., force to failure, material degradation rate). The "truth" is the measured physical property.
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The sample size for the training set:
- This is not applicable. There is no "training set" as this is not an AI/ML device.
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How the ground truth for the training set was established:
- This is not applicable. There is no "training set" or "ground truth" for one in this context.
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G 510(k) SUMMARY ·
For the Bioretec ActivaScrew™ Interference
MANUFACTURER .
Bioretec Ltd. Hermiankatu 22, Modulight Building FI-33720 Tampere FINLAND
Contact person: Ms. Minna Räsänen Quality and Regulatory Affairs Manager Direct: +358 20 778 9509 Mobile: +358 40 868 1606 Fax: +358 3 317 0225 E-mail: Minna.Rasanen@bioretec.com
Date prepared: March 13", 2013
DEVICE NAME
Trade Name: Bioretec ActivaScrew™ Interference
Common Name: Biodegradable interference screw
AUG 2 8 2013
DEVICE CLASSIFICATION AND PRODUCT CODE
Product Code: MAI
Regulation Number: 21 CFR 888.3030
Device Classification Name: Single/multiple component metallic bone fixation appliances and accessories
Classification Panel: Orthopedic
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PREDICATE DEVICES
- Inion Hexalon™ Biodegradable ACL/PCL Screw (K071464) 1.
- Arthrex Bio-Tenodesis™ Screw from Tenodesis™ Screw Family (K010525, K011007, 2. K020043, K041356, K051726)
DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION
The ActivaScrew™ Interference is indicated for fixation of tissue, including ligament or tendon to bone, or a bone-tendon to bone in the presence of appropriate immobilization / controlled mobilization. Interference fixation is intended for surgeries of knee, shoulder, elbow, ankle, foot and hand/wrist.
The product family consists of fully threaded ActivaScrew™ Interference, diameters 4 - 10 mm and lengths 10 - 33 mm.
The ActivaScrew™ Interference is constructed of bioabsorbable poly(L-lactide-co-glycolide) (PLGA).
SUBSTANTIAL EQUIVALENCE TO MARKETED PRODUCTS
The ActivaScrew™ Interference bioabsorbable screw is substantially equivalent to biodegradable screws, intended for similar indications, which have been cleared through a 510(k) pre-market notification pathway.
The Bioretec ActivaScrew™ Interference has the same intended use and principles of operation, and very similar design characteristic as the predicate devices Inion Hexalon™ Biodegradable ACL/PCL Screw (K071464) and Arthrex Bio-Tenodesis™ Screw from Tenodesis™ Screw Family (K010525, K011007, K020043, K041356, K051726). The material of the ActivaScrew™ Interference is the same as the material of the previously cleared ActivaScrew™ (K062980, K072848, K081392).
The performance of the ActivaScrew™ Interference was compared to the predicate devices by pull-out testing, shear strength testing, inherent viscosity and dimensional stability testing.
These test results also verify that the performance of ActivaScrew™ Interference is sufficient for its indications, and that the device is substantially similar to its predicates with regard to its mechanical properties, and long term degradation properties. This performance testing does not raise any new questions of safety or effectiveness of the ActivaScrew™ Interference and demonstrates that the ActivaScrew™ Interference performs mechanically in a manner
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K130716 (3/3)
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substantially similar to the tested predicate device. Thus, non-clinical tests and in vitro testing determined that the ActivaScrew™ Interference has substantially similar performance as compared to its predicate devices.
:
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 28, 2013
Biorectec Limited Ms. Mari Ruotsalainen Quality and Regulatory Affairs Manager Hermiankatu 22, Modulight Building FI-33720 Tampere Finland
Re: K130716
Trade/Device Name: Bioretec ActivaScrew 131 Interference 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: July 5, 2013 Received: July 5, 2013
Dear Ms. Ruotsalainen:
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. listing of r ne general ochariting 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 docs 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
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CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industrv/default.htm. 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/Reportal?roblem/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/Industrs/default.htm.
Sincercly yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedie Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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F Indications for Use Statement
Submitter: Bioretec Ltd. K130716 510(k) Number: ActivaScrew™ Interference Device Name:
Indications for Use:
The ActivaScrew™ Interference is indicated for fixation of tissue, including ligament or tendon to bone, or a bone-tendon to bone in the presence of appropriate immobilization / controlled mobilization. Interference fixation is intended for surgeries of knee, shoulder, elbow, ankle, foot and hand/wrist.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
Page 2_of_1
Traditional 510(k) Date: March 13th, 2013
F-1 Page
§ 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.