(56 days)
No
The description focuses on the material properties and mechanical function of a bioabsorbable pin and a disposable applicator. There is no mention of AI or ML.
No.
The device is used for fixation of bone fractures and osteotomies, not for treating or curing a disease.
No
The ActivaPin™ is indicated for fixation of bone fractures, osteotomies, arthrodeses, and osteochondral fractures, which signifies a therapeutic rather than a diagnostic purpose.
No
The device description clearly states it is a physical pin made of bioabsorbable material and includes a disposable pin applicator with a K-wire, indicating it is a hardware device used for bone fixation.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures". This is a surgical procedure performed directly on the body, not a test performed on a sample taken from the body.
- Device Description: The device is a bioabsorbable pin made of PLGA, designed to be implanted into bone. This is a physical implant, not a reagent or instrument used to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
The device is clearly a surgical implant used for orthopedic fixation.
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 modified ActivaPin™ is identical to the currently cleared device except for the modification. The only modification to the initial 510(k) K061164 to be cleared is adding a Disposable Pin Applicator with K-wire for installation of ActivaPin™ and revising labeling accordingly. The change does not affect the intended use or alter the fundamental scientific technology of the device.
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 decrade in vivo by hvdrolysis into alpha-hydroxy acids that are metabolized by the body. As the operated bone fracture or osteotomy gains strength during healing, the ActivaPin"1" 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 and 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Microbiological testing determined that the ActivaPin™ and the ActivaPin™ Disposable Pin Applicator with K-wire instrument set has substantially similar performance as compared to its predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
K071863 page '1 of 2
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G
SPECIAL 510(k) SUMMARY
AUG 3 1 2007
For the modification to Bioretec ActivaPin™ (K061164)
MANUFACTURER
Bioretec Ltd. Hermiankatu 22, Modulight Building FI-33720 Tampere FINLAND
Contact person:
Ms. Mari Ruotsalainen Quality Manager Phone: +358 20 778 9514 Fax: +358 3 317 0225 Mari Ruotsalainen@bioretec.com
Date prepared: June 28th, 2007
DEVICE NAME
Trade Names: Bioretec ActivaPin™, NexFix™ RFS Pin (Resorbable Fixation System) Common Name: Pin, Fixation
ESTABLISHMENT REGISTRATION NUMBER
Bioretec Ltd. has been submitted the Establishment Registration form and is waiting for an Establishment Registration Number.
DEVICE CLASSIFICATION AND PRODUCT CODE
Device Classification Name: Pin, Fixation, Smooth Classification Panel: Orthopedic Regulation Number: 21 CFR 888.3040 Product Code: HTY
PREDICATE DEVICES
Bioretec ActivaPin™ (K061164)
Special 510(k): Device Modification, Date: June 28th, 2007
G-1 Page
1
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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 three curved shapes that resemble stylized leaves or abstract forms, arranged in a cluster. The logo is black against a white background.
DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION
The modified ActivaPin™ is identical to the currently cleared device except for the modification. The only modification to the initial 510(k) K061164 to be cleared is adding a Disposable Pin Applicator with K-wire for installation of ActivaPin™ and revising labeling accordingly. The change does not affect the intended use or alter the fundamental scientific technology of the device.
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 decrade in vivo by hvdrolysis into alpha-hydroxy acids that are metabolized by the body. As the operated bone fracture or osteotomy gains strength during healing, the ActivaPin"1" 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™ Bioabsorbable Pin and its instrumentation is substantially equivalent to the ActivaPin™ cited as predicate device above.
The Bioretec ActivaPin" with its modified instrumentation has the same intended use, principles of operation and technological characteristic as the predicate device. Adding a Disposable Pin Applicator with K-wire for installation of ActivaPin™ and revising labeling accordingly does not raise any questions of safety and effectiveness.
Microbiological testing determined that the ActivaPin™ and the ActivaPin™ Disposable Pin Applicator with K-wire instrument set has substantially similar performance as compared to its predicate devices.
Special 510(k): Device Modification, Date: June 28th, 2007
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle.
AUG 3 1 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Bioretec Ltd. % Ms. Mari Ruotsalainen Quality Manager Hermiankatu 22, Modulight Building FI-33720 Tampere FINLAND
Re: K071863
Trade/Device Name: Bioretec ActivaPin™ Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: August 1, 2007 Received: August 3, 2007
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 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.
3
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" (21 CFR Part 807,97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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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F Indications for Use Statement
Submitter: 510(k) Number:
Device Name:
Bioretec Ltd.
K07186
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 ___ x (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)
Clerbau Brelup
(Division Sig Division of General, Restorative, and Neurological Devices
510(k) Number K071863
Special 510(k): Device Modification, Date: June 28th, 2007
Page 4 of 4
F-1 Page