(54 days)
The ActivaScrew™ is indicated for fixation of bone fractures, osteotomies, arthrodeses, bone grafts and osteochondral fractures of upper extremity, ankle and foot in the presence of appropriate immobilization.
The ActivaScrew™ is indicated for fixation of bone fractures, osteotomies, arthrodeses, bone grafts and osteochondral fractures of upper extremity, ankle and foot in the presence of appropriate immobilization. Screws are available as fully and partially threaded in several different sizes, including diameters of 2.0 – 4.5 mm and lengths of 10 – 90 mm. The ActivaScrew™ is made of the completely bioabsorbable poly(L-lactide-co-glycolide) (PLGA) material, and they degrade in vivo by hydrolysis into alpha-hydroxy acids that are metabolized by the body. As the operated bone fracture or osteotomy gains strength during healing, the ActivaScrew™ gradually loses its strength, however, maintaining its function at least 8 weeks. Bioabsorption takes place approximately within two years thus eliminating the need for implant removal surgery.
The Bioretec ActivaScrew™ received 510(k) clearance based on substantial equivalence to predicate devices, namely the Inion OTPS™ Biodegradable Fixation System (K030900) and the Bioretec ActivaPin™ (K061164). The clearance did not provide acceptance criteria and directly reported device performance metrics in the same way clinical studies do for novel devices. Instead, the focus was on demonstrating that the ActivaScrew™ has substantially similar performance to its predicates through non-clinical and in-vitro testing.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state specific acceptance criteria in terms of numerical thresholds for device performance. Instead, the acceptance was based on demonstrating "substantial equivalence" to predicate devices. This typically means the device performs within the expected range for its class and intended use, and any differences do not raise new questions of safety or effectiveness.
Therefore, a direct table of acceptance criteria vs. statistical device performance is not available in this 510(k) summary. The summary states:
| Performance Aspect | Reported Device Performance |
|---|---|
| Mechanical Performance | "substantially similar performance as compared to its predicate devices" through "Non-clinical tests and in vitro -testing" |
| Material Degradation | Degradation in vivo by hydrolysis into alpha-hydroxy acids, metabolized by the body. Gradual loss of strength, maintaining function for at least 8 weeks. Bioabsorption within approximately two years. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "non-clinical tests and in vitro -testing."
- Sample Size: The specific sample sizes for these tests are not provided in the 510(k) summary.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given it's non-clinical/in-vitro testing, it would generally be considered laboratory-based performance rather than human data.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not applicable to this 510(k) summary. The substantial equivalence determination for this device relies on non-clinical and in-vitro testing, not on clinical data requiring expert consensus or ground truth derived from expert review.
4. Adjudication Method:
This information is not applicable as the clearance was based on non-clinical and in-vitro testing, not on clinical studies requiring adjudication of outcomes or diagnoses.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was mentioned or performed as part of this 510(k) submission. No effect size of human reader improvement with/without AI assistance is provided. This type of study is not typically required for a Class II device like a bone fixation screw based on substantial equivalence to existing predicates.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):
This information is not applicable. The Bioretec ActivaScrew™ is a physical medical device (a bone fixation screw), not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm or "human-in-the-loop performance" does not apply.
7. Type of Ground Truth Used:
For the non-clinical and in-vitro testing, the "ground truth" would likely be derived from:
- Material specifications and established testing standards: Performance metrics (e.g., tensile strength, bending strength, degradation rate) would be compared against expected values or regulatory standards for similar implant materials and designs.
- Performance of predicate devices: The "ground truth" for comparison would be the known mechanical and degradation characteristics of the predicate devices.
8. Sample Size for the Training Set:
This information is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI algorithms. The design and manufacturing process would involve material characterization and engineering validation, not data training.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for this type of device.
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G 510(k) SUMMARY
For the Bioretec ActivaScrew™
MANUFACTURER
Bioretec Ltd. Hermiankatu 22, Modulight Building FI-33720 Tampere FINLAND
Contact person: Ms. Mari Ruotsalainen Quality Manager Phone: +358 20 778 9514 +358 3 317 0225 Fax: Mari. Ruotsalainen@bioretec.com
Date prepared: September 27th, 2006
DEVICE NAME
Trade Name: Bioretec ActivaScrew™ Common Name: Bone, Fixation, Screw
ESTABLISHMENT REGISTRATION NUMBER
Bioretec Ltd. will register following FDA clearance.
DEVICE CLASSIFICATION AND PRODUCT CODE
Device Classification Name: Screw, Fixation, Bone Classification Panel: Orthopedic Regulation Number: 21 CFR 888.3040 Product Code: HWC
PREDICATE DEVICES
DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION
The ActivaScrew™ is indicated for fixation of bone fractures, osteotomies, arthrodeses, bone grafts and osteochondral fractures of upper extremity, ankle and foot in the presence of
Traditional 510(k) Date: September 27th, 2006
NOW 2 2 2006
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appropriate immobilization. Screws are available as fully and partially threaded in several different sizes, including diameters of 2.0 – 4.5 mm and lengths of 10 – 90 mm.
The ActivaScrew™ is made of the completely bioabsorbable poly(L-lactide-co-glycolide) (PLGA) material, and they degrade in vivo by hydrolysis into alpha-hydroxy acids that are metabolized by the body. As the operated bone fracture or osteotomy gains strength during healing, the ActivaScrew™ gradually loses its strength, however, maintaining its function at least 8 weeks. Bioabsorption takes place approximately within two years thus eliminating the need for implant removal surgery.
EQUIVALENCE TO MARKETED PRODUCTS
The ActivaScrew™ bioabsorbable screw is substantially equivalent to biodegradable screws, intended for similar indications, which have received 510(k) clearance.
The Bioretec ActivaScrew™ has the same intended use and principles of operation, and very similar design characteristic as the predicate device INION OTPS™ Biodegradable Fixation System screw implants (K030900). The material of the ActivaScrew™ is same as the material of the previously cleared ActivaPin™ (K061164). Any differences between ActivaScrew™ and these predicate devices do not raise any questions of safety and effectiveness.
Non-clinical tests and in vitro -testing determined that the ActivaScrew™ has substantially similar performance as compared to its predicate devices.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Bioretec Ltd. % Ms. Mari Ruotsalainen Quality Manger l·lermiankatu 22, Modulight Building FI-33720 Tampere Finland
NOV 2 2 2006
Re: K062980
Trade/Device Name: ActivaScrewTM Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: September 27, 2006 Received: September 29, 2006
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 devices, good manufacturing practice, 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 may be subject to such additional controls. Existing major regulations affecting your devire 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 af 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); 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.
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Page 2 – Ms. Mari Ruotsalainen
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a 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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Claban buene
PV MXM
Mark N. Melkers Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement F
Submitter: Bioretec Ltd. 510(k) Number: ActivaScrew™ Device Name:
Indications for Use:
The ActivaScrew™ is indicated for fixation of bone fractures, osteotomies, arthrodeses, bone grafts and osteochondral fractures of upper extremity, ankle and foot in the presence of appropriate immobilization.
Contraindications:
-
Fractures and osteotomies of diaphyseal bone (except those in the hand and foot).
-
Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient's co-operation cannot be guaranteed.
Prescription Use _ ×
AND/OR
Over-The-Counter Use _
(Part 21 CFR 801 Subpart D)
(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)
Seibare Brechtdor nem
ion Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K062980
Traditional 510(k) Date: September 27th, 2006
§ 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.