(97 days)
The SBi TwistoFIX is indicated for bone reconstruction, osteotomy, fracture repair, and fracture fixation of bones appropriate for the size of the device.
The SBi TwistoFIX System consists of a set of titanium bone screws for internal fixation. The screws are machined on the end of a drill shank which inserts into a driver. After insertion of the screw into the bone, the drill shank twists off and breaks cleanly from the screw head. The devices are supplied non-sterile and are available in various sizes diameters and lengths.
Based on the provided text, the SBi TwistoFIX is a medical device, specifically a bone fixation fastener. The 510(k) summary focuses on demonstrating "substantial equivalence" to existing legally marketed devices, rather than establishing performance against specific acceptance criteria through a formal study with a test set.
Therefore, many of the requested details, such as specific performance metrics, sample sizes, expert qualifications, ground truth establishment, and comparative effectiveness studies, are not applicable or not explicitly detailed in this type of regulatory submission for substantial equivalence.
Here's a breakdown of the information that can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The primary acceptance criterion for a 510(k) submission is to demonstrate "substantial equivalence" to a predicate device. This means showing that the new device is as safe and effective as a legally marketed device that does not require PMA.
- Reported Device Performance: Instead of performance against specific acceptance criteria, the submission likely focused on comparing the SBi TwistoFIX's design, materials, and intended use as being similar to predicate devices. The document directly states: "Documentation is provided which demonstrated the SBi TwistoFIX to be substantially equivalent to other legally marketed devices."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided: In a substantial equivalence filing for a physical implant like this, there isn't typically a "test set" in the sense of a clinical trial or a dataset for an AI algorithm. The evaluation is based on engineering principles, material properties, and comparison to existing devices. Biomedical testing (e.g., mechanical strength, fatigue) would have been performed, but the sample sizes and specific provenance for such engineering tests are not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable / Not Provided: As there is no "test set" in the context of an AI or diagnostic device, there are no experts establishing ground truth for such a set. The "experts" involved would be regulatory reviewers at the FDA and engineers/scientists at Small Bone Innovations who would evaluate the technical aspects and equivalence claims.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided: This concept is relevant for clinical studies or AI model evaluation. It does not apply to a 510(k) submission demonstrating substantial equivalence for a bone screw.
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
- No: This is a physical bone screw, not an AI-assisted diagnostic tool. An MRMC study is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No: This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided: For substantial equivalence, the "ground truth" isn't outcomes data or expert consensus on diagnosis. Instead, it refers to established engineering standards (e.g., ISO 5832-3 for material properties), biomechanical testing acceptance criteria (which are not detailed here but would be part of the full submission), and the safe and effective history of the predicate devices.
8. The sample size for the training set
- Not Applicable / Not Provided: This device is a physical bone screw, not a machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided: See point 8.
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510(k) Summary
SEP 1 0 2007
| Manufacturer: | Small Bone Innovations International, SAZ.A. Les BruyeresPeronnas France 01960 |
|---|---|
| Submitted By: | Small Bone Innovations1380 South Pennsylvania AvenueMorrisville, PA 19067 |
| Proprietary Name: | SBi TwistoFIX |
| Classification name: | Class II, 888.3040 - Smooth or threaded metallic bonefixation fastener |
| Common/Usual Name: | Screw, Fixation, Bone |
| Product Code: | HWC |
| Substantial Equivalence: | Documentation is provided which demonstrated the SBiTwistoFIX to be substantially equivalent to other legallymarketed devices. |
| Device Description: | The SBi TwistoFIX System consists of a set of titaniumbone screws for internal fixation. The screws aremachined on the end of a drill shank which inserts into adriver. After insertion of the screw into the bone, the drillshank twists off and breaks cleanly from the screw head.The devices are supplied non-sterile and are available invarious sizes diameters and lengths. |
| Intended Use: | The SBi TwistoFIX is indicated for bone reconstruction,osteotomy, fracture repair, and fracture fixation of bonesappropriate for the size 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 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. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three curved lines that suggest the shape of a bird in flight. The image is in black and white.
SEP 1 0 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) % Small Bone Innovations International, SA Mr. Robert Hoehn Regulatory Associate 1380 S. Pennsylvania Avenue Morrisville, PA 19067
Re: K071541
Trade/Device Name: SBI TwistoFIX Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: September 5, 2007 Received: September 7, 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 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.
Jaubere Bueher
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
510(k) Number:
Device Name: SBi TwistoFIX
Indications For Use:
The SBi TwistoFIX is indicated for bone reconstruction, osteotomy, 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 Buchro
Division of General, Restorative. and Neurological Devices
510(k) Number K071541
§ 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.