(71 days)
The ActivaPin™ is indicated for fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures in the presence of appropriate immobilization.
The 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.
The provided document is a 510(k) summary for the Bioretec ActivaPin™. It describes the device, its intended use, and its equivalence to predicate devices. However, the document does not contain any information about acceptance criteria or specific studies proving the device meets those criteria, as typically found in clinical trials or performance testing reports.
Instead, the submission focuses on demonstrating substantial equivalence to already marketed devices (Inion OTPSTM Biodegradable Pin and Bionx Implants Inc., SmartPin™ PDX, PLGA Pin) through non-clinical tests and in vitro-testing. This type of submission relies on comparing the new device's characteristics and performance to those of legally marketed predicate devices, rather than conducting new clinical studies or setting explicit acceptance criteria for novel performance claims.
Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported device performance, nor can I answer questions about sample sizes, ground truth establishment, expert adjudication, or MRMC studies, as these details are not present in the provided 510(k) summary.
The document states: "Non-clinical tests and In vitro-testing determined that the ActivaPin™ has substantially similar performance as compared to its predicate devices." This is the core of the proof of meeting acceptance criteria, which in this context means "being substantially equivalent to predicate devices."
In summary, based only on the provided text:
- Acceptance Criteria and Reported Device Performance: Not explicitly stated as numerical criteria or specific performance values. The acceptance criterion is "substantial equivalence" to predicate devices, which was determined through non-clinical and in vitro testing.
- Sample size for the test set and data provenance: No information provided. The testing was non-clinical and in vitro, not on human subjects.
- Number of experts used to establish the ground truth for the test set and qualifications: Not applicable, as there was no human-based ground truth establishment described for a test set.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned or conducted.
- Standalone (algorithm only without human-in-the-loop performance) study: Not applicable, as this is a physical medical device, not an algorithm.
- Type of ground truth used: Not applicable in the traditional sense of clinical studies. The "ground truth" for the equivalence assessment was the performance of the predicate devices.
- Sample size for the training set: Not applicable, as this is not a machine learning algorithm; it's a physical device.
- How the ground truth for the training set was established: Not applicable.
The 510(k) process for this device relies on demonstrating that it is as safe and effective as a legally marketed device through comparison, rather than establishing de novo performance metrics with new clinical data.
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K061164 page 1 of 2
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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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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.
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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
§ 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.