(90 days)
The In2Bones IBS-B MIS Beveled Screw System is indicated for the fixation of arthrodesis, osteotomies of long or short bones of the upper and lower limbs appropriate for the size of the device.
The In2Bones IBS-B MIS Beveled Screw System includes screws and surgical instruments intended for fixation of arthrodesis, osteotomies of the long or short bones of the upper and lower limbs. The screws will be offered in neutralization version (fully threaded) and compression version (partially threaded) in 3.3mm, 4.0mm and 6.5mm diameters. The screws are offered sterile single-use and are made from titanium alloy (ASTM F136).
The provided text is a 510(k) summary for the In2Bones IBS-B MIS Beveled Screw System, which is a medical device for bone fixation. It does not contain information about the acceptance criteria or a study proving that the device meets those criteria, particularly in the context of an AI/algorithm-based device as implied by the detailed questions (e.g., number of experts, MRMC study, training set ground truth).
The document focuses on demonstrating substantial equivalence to previously cleared predicate devices, which is a different regulatory pathway than proving performance against specific acceptance criteria for a novel or AI-driven device.
Here's why the requested information cannot be extracted from the provided text:
- Type of Device: The IBS-B MIS Beveled Screw System is a physical implant (screws for bone fixation) made of titanium alloy. It's not an AI or algorithm-based device that would typically have performance metrics like sensitivity, specificity, or require ground truth established by experts or MRMC studies.
- Performance Testing: The document states that "Engineering analysis was utilized to compare the IBS-B MIS Beveled Screw System to the predicate devices to support substantial equivalence with regard to mechanical performance." It also mentions validation "per ISO 11137-2 for gamma sterilization." This refers to mechanical integrity and sterility, not diagnostic or AI-driven performance.
- Substantial Equivalence: The entire submission hinges on showing that the new device is "substantially equivalent" to existing, legally marketed devices in terms of indications, materials, and geometry. This approach generally does not require extensive clinical trials or performance studies with acceptance criteria as would be needed for a de novo or new AI/ML device.
Therefore, I cannot provide the requested table and study details because the provided document does not pertain to an AI/algorithm-based device and focuses on substantial equivalence for a physical medical implant.
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July 27, 2023
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In2Bones USA, LLC Christine Scifert VP, Quality and Regulatory 6000 Poplar Ave, Suite 115 Memphis, Tennessee 38119
Re: K231236
Trade/Device Name: IBS-B MIS Beveled Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: April 26, 2023 Received: April 28, 2023
Dear Christine Scifert:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumava A
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K231236
Device Name IBS-B MIS Beveled Screw System
Indications for Use (Describe)
The In2Bones IBS-B MIS Beveled Screw System is indicated for the fixation of arthrodesis, osteotomies of long or short bones of the upper and lower limbs appropriate for the size of the device.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
IBS-B MIS Beveled Screw System July 25, 2023
| Company: | In2Bones USA, LLC6000 Poplar Ave, Suite 115Memphis, TN 38119901-260-7931 |
|---|---|
| Primary Contact: | Christine Scifert |
| Trade Name: | IBS-B MIS Beveled Screw System |
| Common Name: | Screw, Fixation, Bone |
| Classification: | II |
| Regulation Number: | 888.3040 - Smooth or threaded metallic bone fixation fastener |
| Panel: | 87-Orthopedic |
| Product Code(s): | HWC |
The In2Bones IBS-B MIS Beveled Screw System includes screws and surgical Device Description: instruments intended for fixation of arthrodesis, osteotomies of the long or short bones of the upper and lower limbs. The screws will be offered in neutralization version (fully threaded) and compression version (partially threaded) in 3.3mm, 4.0mm and 6.5mm diameters. The screws are offered sterile single-use and are made from titanium alloy (ASTM F136).
Indications for Use: The In2Bones IBS-B MIS Beveled Screw System is indicated for the fixation of arthrodesis, osteotomies or fractures of long or short bones of the upper and lower limbs appropriate for the size of the device.
Substantial Equivalence: The subject components were demonstrated to be substantially equivalent to the following systems previously cleared by the FDA:
Primary Predicate
- . K131920 - In2Bones SAS Osteosynthesis Screws
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Additional Predicates
The subject IBS-B MIS Beveled Screw System screws are similar geometry to the previously cleared In2Bones SAS IBS Osteosynthesis Screws and is made of titanium alloy (ASTM F136). The IBS-B MIS Beveled Screw System has been demonstrated to be substantially equivalent to the previously cleared devices identified above as the products are similar in indications, materials and geometry.
Performance Testing: Engineering analysis was utilized to compare the IBS-B MIS Beveled Screw System to the predicate devices to support substantial equivalence with regard to mechanical performance. The IBS-B MIS Beveled Screw System was validated per ISO 11137-2 for gamma sterilization.
Conclusion
Based on the test results and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the predicate 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.