(166 days)
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No
The summary describes a bioabsorbable screw for tissue fixation and includes performance testing based on mechanical properties. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes
The device is indicated for "fixation of tissue, including ligament or tendon to bone, or a bone-tendon to bone," which describes a therapeutic action to treat a medical condition or injury.
No
The device, ActivaScrew™ Interference, is described as an implantable screw for fixation of tissue or bone, not for gathering information about a patient's health condition. Its performance studies focus on mechanical properties and degradation, not diagnostic accuracy.
No
The device description explicitly states the product is a physical screw constructed of bioabsorbable material, indicating it is a hardware device, not software.
Based on the provided information, the ActivaScrew™ Interference is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for the fixation of tissue (ligament, tendon, bone-tendon) to bone during surgery. This is a surgical implant used in vivo (within the body).
- Device Description: It's described as a fully threaded screw made of bioabsorbable material, designed to be implanted.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The ActivaScrew™ Interference does not perform any such function.
- Performance Studies: The performance studies focus on mechanical properties (pull-out strength, shear strength) and degradation, which are relevant to an implantable device, not an IVD.
Therefore, the ActivaScrew™ Interference is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
MAI
Device Description
The ActivaScrew™ Interference is constructed of bioabsorbable poly(L-lactide-co-glycolide) (PLGA).
The product family consists of fully threaded ActivaScrew™ Interference, diameters 4 - 10 mm and lengths 10 - 33 mm.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee, shoulder, elbow, ankle, foot and hand/wrist
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
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 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.
Key Metrics
Not Found
Predicate Device(s)
K071464, K010525, K011007, K020043, K041356, K051726, K062980, K072848, K081392
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.
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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
4
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
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Traditional 510(k) Date: March 13th, 2013
F-1 Page