(71 days)
Not Found
No
The summary describes a bioabsorbable pin for bone fixation and does not mention any software, algorithms, or data processing that would suggest the use of AI/ML.
No
The device is used for bone fixation, which is a supportive function during the healing process, not a direct therapeutic treatment of a disease or condition itself.
No
The device description indicates it is a bioabsorbable pin for fixation of bone fractures and osteotomies, not for diagnosis.
No
The device description clearly states the ActivaPin™ is a physical pin made of bioabsorbable material, intended for bone fixation. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of the ActivaPin™ is for the fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures. This is a therapeutic and structural function performed within the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used outside the body (in vitro).
- Device Description: The description clearly states the device is a bioabsorbable pin that degrades in vivo (within the body) and is used for bone fixation.
The ActivaPin™ is a medical device used for surgical intervention and support within the body, not for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for Use
The ActivaPin™ is indicated for fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures in the presence of appropriate immobilization.
Product codes
HTY
Device Description
The ActivaPin™ is indicated for fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures in the presence of appropriate immobilization. Pins are available in several different dimensions, including diameters of 1.5 – 3.2 mm and lengths of 20 – 70 mm.
ActivaPin™ is made of completely bioabsorbable poly(L-lactide-co-glycolide) (PLGA), 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 ActivaPin™ gradually loses its strength, however, maintaining its function at least 8 weeks. Bioabsorption takes place 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
bone fractures, osteotomies, arthrodeses, osteochondral fractures.
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
Non-clinical tests and In vitro-testing determined that the ActivaPin™ has substantially similar performance as compared to its predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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K061164 page 1 of 2
Image /page/0/Picture/1 description: The image shows the logo for Bioretec. The logo consists of a stylized, abstract symbol above the word "bioretec" in lowercase letters. The symbol is composed of two curved shapes that resemble stylized wings or leaves, positioned diagonally above the text.
JUL - 6 2006
510(k) SUMMARY G
For the Bioretec ActivaPin™
MANUFACTURER
Bioretec Ltd. Hermiankatu 22, Modulight Building F1-33720 Tampere FINLAND
Contact person:
Ms. Mari Ruotsalainen Quality Manager Phone: +358 20 778 9514 Fax: +358 3 317 0225 Mari.Ruotsalainen@bioretec.com
Secondary Contact:
Jonathan S. Kahan Hogan & Hartson L.L.P. Phone: 202-637-3638 202-637-5910 Fax: jskahan@hhlaw.com
Date prepared: April 25th, 2006
DEVICE NAME
Trade Name: Bioretec ActivaPin™ Common Name: Pin, Fixation
ESTABLISHMENT REGISTRATION NUMBER
Bioretec Ltd. has not yet obtained an Establishment Registration Number. Bioretec Ltd. will register following the FDA clearance.
DEVICE CLASSIFICATION AND PRODUCT CODE
Device Classification Name: Pin, Fixation, Smooth Classification Panel: Orthopedic Regulation Number: 21 CFR 888.3040 Product Code: HTY
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page 2 of 2
Image /page/1/Picture/1 description: The image shows the logo for bioretec. The logo consists of a stylized graphic above the word "bioretec" in lowercase letters. The graphic is composed of two curved shapes that resemble stylized leaves or wings, with the left shape being a solid black and the right shape having a textured or shaded appearance.
PREDICATE DEVICES
- Inion OTPSTM Biodegradable Pin (K031712, K050275) 2. Bionx Implants Inc., SmartPin™ PDX, PLGA Pin (K003659)
DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION
The ActivaPin™ is indicated for fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures in the presence of appropriate immobilization. Pins are available in several different dimensions, including diameters of 1.5 – 3.2 mm and lengths of 20 – 70 mm.
ActivaPin™ is made of completely bioabsorbable poly(L-lactide-co-glycolide) (PLGA), 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 ActivaPin™ gradually loses its strength, however, maintaining its function at least 8 weeks. Bioabsorption takes place within two years thus eliminating the need for implant removal surgery.
EQUIVALENCE TO MARKETED PRODUCTS
The ActivaPin"M Bioabsorbable Pin is substantially equivalent to those the biodegradable pins cited as predicate devices above.
The Bioretec ActivaPin™ has the same intended use and principles of operation, and very similar technological characteristic as the predicate devices. Any differences between ActivaPin™ and predicate devices do not raise any questions of safety and effectiveness.
Non-clinical tests and In vitro-testing determined that the ActivaPin™ has substantially similar performance as compared to its predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, U.S.A." around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 6 2006
Bioretec Ltd. Ms. Mari Ruotsalainen Quality Manager Hermiankatu 22, Modulight Building FI-33720 Tampere FINLAND
Re: K061164
Trade/Device Name: ActivaPin™ Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: April 25, 2006 Received: April 26, 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 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
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Page 2 - Ms. Mari Ruotsalainen
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. 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 logally marketed predicate device results in a classification for your device and thus, perrorits your clevice 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" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Swall Manufacturers, International and Consumer Assistance at its toll-free number (800) 633-2041 or 240-276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
faraz Anchip
Mark N. Melkerson 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: Device Name: ActivaPin ™
Indications for Use:
The ActivaPin™ is indicated for fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures in the presence of appropriate immobilization.
Contraindications:
-
Fractures and osteotomies of diaphyseal bone.
-
Fractures and osteotomies in weight bearing cancellous bone.
-
Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient cooperation cannot be guaranteed.
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)
510(k) Number
No Neurological Devices Districts of to to General, Restorative, (HO-ugig noisiviti)
Division of Ger and Neurological Dev
510(k) Number K00114
Traditional 510(k) Date: April 25th, 2006