(30 days)
The devices of Bloretec ActivaPin™ Product Group including ActivaPin™ Fusion, ActivaNail™ Conical, ActivaNail™ Flat and ActivaPin™ HT are indicated for fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures in the presence of appropriate immobilization.
The modified ActivaPin™ Product Group is identical to the currently cleared device expect for the modification. The modification of the initial ActivaPin™ Product group 510(k) (K080879) adds one trade name; Biorelec ActivaPin™ HT in the AclivaPin™ Product Group. That device has a small modification to ActivaPin™ Fusion; the instrument accepting hole is made on the both ends instead of one end of the device to enable insertions. The labeling will be revised accordingly.
Bioretec ActivaPin™ Product Group covers Bioretec's bioabsorbable devices AclivaPin™, ActivaPin™ Fusion, ActivaPin™ HT, ActivaNail™ Conical and ActivaNail™ Flat.
The Bioretec ActivaPin™ products do not differ significantly or at all in purpose, design, materials, function or any other feature related to safety and effectiveness. ActivaPin™ HT is almost identical with a predicate device and the other devices of Bioretec's ActivaPin™ Product Group. ActivaPin141 HT is the same kind of device as ActivaPin™ Fusion, but it's both ends have an instrument accepting hole. The diameter of ActivaPin™ HT is 1,5 mm and the lengths are 20 - 70 mm.
The devices of Bioretec ActivaPin™ Product Group are indicated for fixation of bone fractures, osteotomies, arthrodeses and osleochondral fractures in the presence of appropriate immobilization.
The Bioretec ActivaPin™ Product Group devices are made of completely bioabsorbable poly(L-lactide-co-glycolide) (PLGA), and they degrade in vivo by hydrolysis into alphahydroxy acids that are metabolized by the body. As the operated bone fracture or osteotomy gains strength during healing, the Bioretec ActivaPin™ products gradually loses their strength, however, maintaining their function at least 8 weeks. Bioabsorption lakes place within approximately two years thus eliminating the need for implant removal surgery.
This document is a 510(k) summary for a Special 510(k) submission, focusing on a modification to an already cleared medical device, the Bioretec ActivaPin™ Product Group. As such, the purpose of this submission is to demonstrate substantial equivalence to previously cleared devices, rather than to present a de novo study with acceptance criteria and a detailed study report for new device performance.
Therefore, many of the requested items (e.g., specific acceptance criteria, detailed study results proving the device meets those criteria, expert ground truth establishment, MRMC studies, standalone performance, training set details) are not applicable or not present in the provided document. The submission relies on the prior clearance of the predicate devices for performance, safety, and effectiveness.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. This is a Special 510(k) for a modification (adding a new trade name and a minor design change) to an already cleared device. The "acceptance criteria" here implicitly refer to demonstrating substantial equivalence to the predicate devices, not to a new performance study against specific metrics. The document states: "The modified ActivaPin™ Product Group is identical to the currently cleared device expect for the modification. ... The Bioretec ActivaPin™ products do not differ significantly or at all in purpose, design, materials, function or any other feature related to safety and effectiveness."
2. Sample size used for the test set and the data provenance
Not applicable. No new clinical or performance test set data is presented for this Special 510(k) in the provided summary. The substantial equivalence argument relies on the existing clearances and the minimal nature of the modification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment for a test set is discussed in this Special 510(k) summary.
4. Adjudication method for the test set
Not applicable. No test set or adjudication method is discussed.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a bioabsorbable fixation pin, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical fixation pin, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No new ground truth is established for this Special 510(k) submission. The safety and effectiveness are supported by the substantial equivalence to predicate devices, which would have had their performance and safety established through prior studies (not detailed in this document). The device itself (a bioabsorbable pin) is evaluated based on its mechanical properties, biocompatibility, and degradation characteristics, often through bench testing and sometimes animal or clinical studies for initial clearance.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device.
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K133950 (pg 1/3)
JAN 2 2 2014
bioretec
Special 510(k) SUMMARY ਰ
For the modification to Bioretec ActivaPin™ Product Group
MANUFACTURER
Bioretec Ltd. Hermiankatu 22, Modulight Building F1-33720 Tampere FINLAND
Contact person:
Ms. Minna Räsänen Quality and Regulatory Affairs Manager Direct: +358 20 778 9509 Mobile: +358 40 868 1606 Fax: +358 3 317 0225 E-mail: Minna Rasanen@bioretec.com
Date prepared: December 19", 2013
DEVICE NAME
Bioretec ActivaPin™ Trade Name:
Bioretec ActivaPin™ Fusion
Bioretec ActivaNail ™ Conical
Bioretec ActivaNail™ Flat
Bioretec ActivaPin™ HT
Common Name: Pin, Fixation
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), Bioretec ActivaPin™ Product Group (K080879)
Special 510(k) Date: December 19th, 2013
G-1 Page
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DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION
The modified ActivaPin™ Product Group is identical to the currently cleared device expect for the modification. The modification of the initial ActivaPin™ Product group 510(k) (K080879) adds one trade name; Biorelec ActivaPin™ HT in the AclivaPin™ Product Group. That device has a small modification to ActivaPin™ Fusion; the instrument accepting hole is made on the both ends instead of one end of the device to enable insertions. The labeling will be revised accordingly.
Bioretec ActivaPin™ Product Group covers Bioretec's bioabsorbable devices AclivaPin™, ActivaPin™ Fusion, ActivaPin™ HT, ActivaNail™ Conical and ActivaNail™ Flat.
The Bioretec ActivaPin™ products do not differ significantly or at all in purpose, design, materials, function or any other feature related to safety and effectiveness. ActivaPin™ HT is almost identical with a predicate device and the other devices of Bioretec's ActivaPin™ Product Group. ActivaPin141 HT is the same kind of device as ActivaPin™ Fusion, but it's both ends have an instrument accepting hole. The diameter of ActivaPin™ HT is 1,5 mm and the lengths are 20 - 70 mm.
The devices of Bioretec ActivaPin™ Product Group are indicated for fixation of bone fractures, osteotomies, arthrodeses and osleochondral fractures in the presence of appropriate immobilization.
The Bioretec ActivaPin™ Product Group devices are made of completely bioabsorbable poly(L-lactide-co-glycolide) (PLGA), and they degrade in vivo by hydrolysis into alphahydroxy acids that are metabolized by the body. As the operated bone fracture or osteotomy gains strength during healing, the Bioretec ActivaPin™ products gradually loses their strength, however, maintaining their function at least 8 weeks. Bioabsorption lakes place within approximately two years thus eliminating the need for implant removal surgery.
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K133950 (pg 3/3)
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EQUIVALENCE TO MARKETED PRODUCTS
The devices of modified Bioretec ActivaPin™ Product Group are substantially equivalent to the previously cleared Bioretec ActivaPin™ (K061164) and Bioretec ActivaPin™ Product Group (K080879).
The modified Bioretec ActivaPin™ products have the same intended use and principles of operation, and also the same technological characteristic and performance as the previously cleared Bioretec ActivaPin™ (K061164) and Bioretec ActivaPin ™ Product Group (K080879). Any differences between modified Bioretec ActivaPin™ products and predicate device do not raise any questions of safety and effectiveness.
Special 510(k) Date: December 19th, 2013
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 22, 2014
Bioretec Limited Ms. Minna Räsänen Quality and Regulatory Affairs Manager Hermiankatu 22, Modulight Building FI-33720 Tampere Finland
Re: K133950
Trade/Device Name: ActivaPin™ Product Group (ActivaPin™, ActivaPin™ Fusion, ActivaNail™ Conical, ActivaNail™ Flat, ActivaPin™ HT) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: December 19, 2013 Received: December 23, 2013
Dear Ms. Räsänen:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical
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Page 2 - Ms. Minna Räsänen
.
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Ronald##Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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bioretec
F Indications for Use Statement
| Submitter: | Bioretec Ltd. |
|---|---|
| 510(k) Number: | K133950 |
| Device Name: | ActivaPin™ Product Group |
| ActivaPin™ | |
| ActivaPin™ Fusion | |
| ActivaNail™ Conical | |
| ActivaNail™ Flat | |
| ActivaPin™ HT |
Indications for Use:
The devices of Bloretec ActivaPin™ Product Group including ActivaPin™ Fusion, ActivaNail™ Conical, ActivaNail™ Flat and ActivaPin™ HT are indicated for fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures in the presence of appropriate immobilization.
Contraindications:
..
-
High-load bearing applications
-
Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient's co-operation 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)
Page __ of _
Elizabet简必压rank -S
Division of Orthopedic Devices
§ 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.