(172 days)
The OSTEOTRANS™-OT Pin is intended for fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses or bone grafts, for example in the fixation of apical fragments and cancellous/non-load bearing fragments in the presence of appropriate immobilization.
The OSTEOTRANS™-OT Pins are the sterile, single-use bone pins manufactured from composites of hydroxyapatite and poly-L-lactide (HA/PLLA). Pins are provided with various shapes and sizes typical of other marketed fixation devices. Used properly, in the presence of adequate immobilization, the OSTEOTRANS™-OT Pins maintain accurate alignment of bone fractures and osteotomies.
The provided text is a 510(k) summary for a medical device (OSTEOTRANS™-OT Pin) seeking substantial equivalence to predicate devices. It focuses on device description, intended use, and comparison to existing products, rather than a detailed study proving performance against acceptance criteria in the context of an AI/ML device.
Therefore, the information you've requested regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set information is not present in the provided document.
This document describes a traditional medical device (bioabsorbable bone fixation pin) and its claims of substantial equivalence based on design and material similarities to predicate devices, and performance data demonstrating requisite strength and favorable degradation profile. It does not involve a software algorithm or AI, and therefore the concepts of test sets, ground truth established by experts, MRMC studies, or standalone algorithm performance are not applicable.
The "performance data" mentioned is likely related to bench testing of the pin's mechanical properties and degradation characteristics, not a clinical study with human subjects, or a study of an AI's diagnostic accuracy.
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KO733 || (ps 1/2)
510(k) Summary OSTEOTRANS™-OT Pin
Takiron Co., Ltd.
MAY 13 2008
| Submitter's address: | 3-13 Azuchi-machi 2-chome, Chuo-ku, Osaka541-0052, Japan |
|---|---|
| Contact Person : | Kunihiro HataRegulatory Affairs Specialist7-1-19, Minatojimaminamimachi, Chuo-ku,Kobe, Hyogo, 650-0047, JapanPhone: +81 78 306 2601Fax: +81 78 306 2606 |
| Date prepared: | November 15, 2007 |
| Trade or proprietary name: | OSTEOTRANS™-OT Pin |
| Common or usual name: | Bioabsorbable bone fixation pin |
| Classification name: | Bone fixation pin, Class II |
| Device product code: | HTY - 21 CFR 888.3040 Pin, Fixation, Smooth |
Establishment Registration Number:
Takiron Co., Ltd. has not yet obtained an Establishment Registration Number.
Legally Marketed Predicate Devices:
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- Linvatec Biomaterials Ltd.; SmartPin (K041288)
- Inion Ltd.; Inion OTPSTM Biodegradable Pin (K031712) 2.
- Bionx Implants Ltd .; PLLA Pin (K010983) 3.
Intended Use:
Submitter's name :
The OSTEOTRANS™-OT Pin is intended for fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses or bone grafts, for example in the fixation of apical fragments and cancellous/non-load bearing fragments in the presence of appropriate immobilization.
Device Description:
The OSTEOTRANS™-OT Pins are the sterile, single-use bone pins manufactured from composites of hydroxyapatite and poly-L-lactide (HA/PLLA). Pins are provided with
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various shapes and sizes typical of other marketed fixation devices.
Used properly, in the presence of adequate immobilization, the OSTEOTRANS™-OT Pins maintain accurate alignment of bone fractures and osteotomies.
Summary of Technology:
The OSTEOTRANS™-OT Pin has the same technological characteristics (i.e., design and material) when compared to the predicate devices.
Performance data demonstrate that the OSTEOTRANS™-OT Pin has the requisite strength and favorable degradation profile to provide sufficient and sustained bone fixation for intended uses.
Substantial equivalence
The OSTEOTRANS™-OT Pin is indicated for the same uses and anatomical regions as the predicate devices.
The OSTEOTRANS™-OT Pin has very similar physical design features and functional characteristics as the predicate devices.
Therefore the OSTEOTRANS™-OT Pin is substantially equivalent in design, materials and intended use and principles of operation to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal features an eagle with its wings spread, surrounded by a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is written along the border of the seal.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 13 2008
Takiron Co., LTD c/o Mr. Kunihiro Hata Medical Division 7-1-19, Minatojimaminamimachi, Chuo-Ku, Kobe, Hyogo Japan 650-0047
Re: K073311 Trade/Device Name: OSTEOTRANS™ -OT Pin Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: April 24, 2008 Received: April 24, 2008
Dear Mr. Hata:
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.
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Page 2 - Mr. Kunihiro Hata
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 M. Millerson
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
Applicant: Takiron Co., Ltd. 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: OSTEOTRANS™-OT Pin
Indications For Use:
The OSTEOTRANSTM -OT Pin is intended for fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses or bone grafts, for example in the fixation of apical fragments and cancellous/non-load bearing fragments in the presence of appropriate immobilization.
Prescription Use_ × (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Please do not write below this line on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
Milford S. Fireman
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number.
§ 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.