(54 days)
Not Found
No
The description focuses on the material properties and mechanical function of a bioabsorbable screw, with no mention of AI or ML.
No
The device is used for fixation of bone, which is a supportive and reparative function, not a therapeutic one that treats specific diseases or conditions.
No
The device, ActivaScrew™, is indicated for fixation of bone fractures, osteotomies, arthrodeses, bone grafts, and osteochondral fractures. It is a bioabsorbable screw used to physically stabilize bone and does not provide any diagnostic information.
No
The device description clearly describes a physical, bioabsorbable screw made of PLGA material, intended for surgical implantation. This is a hardware device, not software.
Based on the provided information, the ActivaScrew™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- ActivaScrew™ Function: The ActivaScrew™ is an implantable device used for the fixation of bone fractures, osteotomies, etc., within the body. It is a surgical implant, not a diagnostic tool that analyzes biological samples.
The description clearly states its use in surgical procedures for bone fixation and its bioabsorption within the body. This aligns with the definition of a medical device used for treatment or support within the body, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper extremity, ankle and foot
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)
Non-clinical tests and in vitro -testing determined that the ActivaScrew™ has substantially similar performance as compared to its predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows the logo for bioretec. The logo consists of a stylized graphic above the word "bioretec". The graphic is composed of three curved shapes that resemble a stylized leaf or wing. The word "bioretec" is written in a lowercase sans-serif font.
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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Image /page/1/Picture/0 description: The image shows the logo for Bioretec. The logo consists of a stylized, curved shape that resembles a wing or a wave. Below the symbol, the word "bioretec" is written in lowercase letters.
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.
2
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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Image /page/4/Picture/0 description: The image shows the logo for Bioretec. The logo consists of the word "bioretec" in lowercase letters, with a stylized graphic above it. The graphic is composed of three curved lines that resemble a stylized leaf or wing. The lines are thicker at the top and taper towards the bottom, creating a sense of movement or growth.
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