(64 days)
The SBi Titanium Threaded Pin is indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.
The SBi Titanium Threaded Pin consists of a set of titanium threaded pins for internal fixation. Each threaded pin has a machined groove that provides a "break-away" capability. The devices are supplied non-sterile and are available in various sizes diameters and lengths.
The provided text is a 510(k) summary for the SBi Titanium Threaded Pin, seeking clearance from the FDA. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study of device performance against specific acceptance criteria. Therefore, the information required to answer most of your questions is not typically found in this kind of regulatory submission.
Specifically, the document does not contain information about:
- A table of acceptance criteria and reported device performance.
- Sample sizes for a test set, data provenance, or details on retrospective/prospective studies.
- Number or qualifications of experts used to establish ground truth for a test set.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
- Standalone algorithm performance studies.
- The type of ground truth used (e.g., pathology, outcomes data).
- Sample size for a training set.
- How ground truth for a training set was established.
The 510(k) process primarily relies on demonstrating that a new device is as safe and effective as another legally marketed device (the predicate device) and that it has the same technological characteristics or has different technological characteristics but does not raise new questions of safety and effectiveness. This is typically achieved through comparisons of materials, design, indications for use, and often bench testing to confirm mechanical properties, rather than clinical studies with ground truth established by experts.
Summary of available information from the provided text:
- Device Name: SBi Titanium Threaded Pin
- Manufacturer: Small Bone Innovations International, SA
- Intended Use: The SBi Titanium Threaded Pin is indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.
- Material: Ti-6Al-4V per ISO 5832-3
- Regulation Number: 21 CFR 888.3040 (Smooth or threaded metallic bone fixation fastener)
- Regulatory Class: Class II
- Product Code: JDW
- Substantial Equivalence: Documentation is provided which demonstrates the SBi Titanium Threaded Pin to be substantially equivalent to other legally marketed devices.
To answer your initial request directly, the document explicitly states: "Documentation is provided which demonstrates the SBi Titanium Threaded Pin to be substantially equivalent to other legally marketed devices." This statement is the "study" that proves the device meets the "acceptance criteria" of substantial equivalence required for 510(k) clearance. However, the details of that "documentation" (e.g., bench tests, materials safety data, design comparisons) are not provided in this summary. There is no performance data in the traditional sense of diagnostic accuracy or clinical outcomes presented here, as it's not a clinical trial summary.
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510(k) Summary
| Manufacturer: | Small Bone Innovations International, SAZ.A. Les BruyeresPeronnas France 01960 | AUG - 8 2007 |
|---|---|---|
| Submitted By: | Small Bone Innovations1380 South Pennsylvania AvenueMorrisville, PA 19067 | |
| Proprietary Name: | SBi Titanium Threaded Pin | |
| Classification name: | Class II, 888.3040 - Smooth or threaded metallic bonefixation fastener | |
| Common/Usual Name: | Pin, Fixation, Threaded | |
| Product Code: | JDW | |
| Substantial Equivalence: | Documentation is provided which demonstrates the SBiTitanium Threaded Pin to be substantially equivalent toother legally marketed devices. | |
| Device Description: | The SBi Titanium Threaded Pin consists of a set oftitanium threaded pins for internal fixation. Each threadedpin has a machined groove that provides a "break-away"capability. The devices are supplied non-sterile and areavailable in various sizes diameters and lengths. | |
| Intended Use: | The SBi Titanium Threaded Pin is indicated for bonereconstruction, osteotomy, arthrodesis, joint fusion, fracturerepair, and fracture fixation of bones appropriate for thesize of the device. | |
| Material: | The implants are made from Ti-6Al-4V per ISO 5832-3 |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized lines representing its wings or feathers.
AUG - 8 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Small Bone Innovations, Inc. % Mr. Robert Hoehn Regulatory Associate Musculoskeletal Clinical Regulatory Advisers, LLC 505 Park Avenue, 14th Floor New York, New York 10022
K071540 Re:
Trade/Device Name: SBi Titanium Threaded Pin Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: JDW Dated: May 25, 2007 Received: June 5, 2007
Dear Mr. Hoehn:
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. Robert Hoehn
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 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,
Barbara Buchur
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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071540
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Indications for Use
510(k) Number:
Device Name: SBi Titanium Threaded Pin
Indications For Use:
The SBi Titanium Threaded Pin is indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Barbara Buehrn
(Division of General, Restorative, and Neurological Devices
510(k) Number K070540
§ 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.