(123 days)
The PROSTEP™ TBI™ (Tailor's Bunion Implant) system is indicated for the fixation of 5th metatarsal osteotomies made in the correction of Tailor's Bunion.
The PROSTEP™ TBI™ (Tailors Bunion Implant) System is intended for use in bone reconstruction and osteotomy of the fifth metatarsal. The implants are provided sterile and consist of one MIS Bunion implant and one ORTHOLOC 3Di screw. Based on patient anatomy and surgeon's needs, different component sizes can be selected.
This is a 510(k) premarket notification for a medical device (PROSTEP™ TBI™ System), which typically establishes substantial equivalence to a predicate device rather than conducting extensive clinical studies with acceptance criteria and performance metrics in the same way a de novo or PMA submission might. Therefore, many of the requested categories related to clinical performance and AI algorithm evaluation may not be directly applicable or explicitly detailed in this type of submission.
Based on the provided document, here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
The document describes non-clinical evidence (construct fatigue testing and bacterial endotoxin testing) to support substantial equivalence. It does not provide specific acceptance criteria or reported performance in a table format for clinical device performance in terms of diagnostic accuracy or reader improvement metrics, as the device is an implant and not an AI-driven diagnostic tool.
For the non-clinical testing, the document states: "The subject was evaluated to the predicate through construct fatigue testing to support the safety and effectiveness of the subject device system. Additionally, bacterial endotoxin testing was done on a representative part." While these tests would have internal acceptance criteria (e.g., fatigue cycles survived, endotoxin limits), those specific criteria and detailed results are not provided in this summary. The conclusion is simply that the testing "shows no new worst case" and supports substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is not an AI diagnostic device, so there is no "test set" of clinical images or patient data in the typical sense for evaluating algorithm performance. The "testing" mentioned is mechanical (fatigue) and biocompatibility (endotoxin) on the device itself.
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, as there is no test set for clinical performance evaluation requiring expert ground truth in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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, an MRMC study was not done. This is not an AI diagnostic device. The submission explicitly states under "SUBSTANTIAL EQUIVALENCE - CLINICAL EVIDENCE": "N/A."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This is not an AI diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable for clinical performance. For the described non-clinical testing, the "ground truth" would be established engineering standards and biocompatibility requirements.
8. The sample size for the training set
Not applicable. This is not an AI device, so there is no training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable.
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August 13, 2019
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Wright Medical Technology, Inc. Michael Mullins Regulatory Affairs Specialist 1023 Cherry Road Memphis, Tennessee 38117
Re: K190970
Trade/Device Name: PROSTEP TBI System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: July 11, 2019 Received: July 12, 2019
Dear Michael Mullins:
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,
Shumaya Ali, MPH 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) K190970
Device Name PROSTEP™ TBI™ (Tailors Bunion Implant) System
Indications for Use (Describe)
The PROSTEP™ TBT™ (Tailor's Bunion Implant) system is indicated for the fixation of 5th metatarsal osteotomies made in the correction of Tailor's Bunion.
| Type of Use (Select one or both, as applicable) | |
|---|---|
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Headquarters Wright Medical Technology, Inc.
1023 Cherry Road Memphis, TN 38117
901 867 9971 mt.com
510(k) SUMMARY
In accordance with the Food and Drug Administration rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the PROSTEP™ TBI™ (Tailors Bunion Implant) System.
(a)(1) MANUFACTURER IDENTIFICATION
Submitted By:
Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117
Date:
July 11, 2019
Contact Person:
Michael Mullins Regulatory Affairs Specialist II Office: (901) 867-4142 Fax: (901) 867-4190
(a)(2) SUBJECT DEVICE INFORMATION
| Proprietary Name: | PROSTEP™ TBI™ (Tailors Bunion Implant) System |
|---|---|
| Common Name: | Plate, Fixation, Bone / Screw, Fixation, Bone |
| Classification Name & Reference: | 21 CFR 888.3030 / 21 CFR 888.3040 – Class II |
| Device Product Code & Panel: | HRS / HWC - Orthopedic |
(a)(3) PREDICATE DEVICE INFORMATION
Wright Compression Screw System (primary) WMT Implantable K-Wires (secondary) ORTHOLOC® 3Di Small Bones Plating System (secondary) K082320 K132895 K163039
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(a)(4) DEVICE DESCRIPTON
The PROSTEP™ TBI™ (Tailors Bunion Implant) System is intended for use in bone reconstruction and osteotomy of the fifth metatarsal. The implants are provided sterile and consist of one MIS Bunion implant and one ORTHOLOC 3Di screw. Based on patient anatomy and surgeon's needs, different component sizes can be selected.
(a)(5) INTENDED USE
The PROSTEP™ TBI™ (Tailor's Bunion Implant) system is indicated for the fixation of 5th metatarsal osteotomies made in the correction of Tailor's Bunion.
(a)(6) TECHNOLOGICAL CHARACTERISTICS COMPARISON
The subject device is a construct that uses cleared components and a new component to address first metatarsal hallux valgus. The subject devices intended use/indications for use is contained within the predicate. Table 1 below shows a comparison of technological characteristics. The principles of operation of the subject uses screw and intramedullary fixation where the predicate uses screw fixation. The subject and predicate have same materials and use similar internal fixation methods. Both subject and predicate use screws to achieve fixation in fifth metatarsal osteotomies.
| SUBJECT | PREDICATE (primary) | ||
|---|---|---|---|
| Tailor's Bunion System | Wright Compression Screws –K082320 | ||
| Material | ASTM F136 (Titanium Alloy) | ASTM F136 (Titanium Alloy) | |
| Tailor's Bunion: Small, Medium,Large | |||
| Implant | ORTHOLOC 3Di Screw (K163039-reference predicate): | Diameter: 2.0mmLength: 10-24mm | |
| Diameter: 2.4 mmLength: 12mm |
Table 1 Subject vs Predicate Technological Comparison
(b)(1) SUBSTANTIAL EQUIVALENCE - NON-CLINICAL EVIDENCE
The subject was evaluated to the predicate through construct fatigue testing to support the safety and effectiveness of the subject device system. Additionally, bacterial endotoxin testing was done on a representative part.
(b)(2) SUBSTANTIAL EQUIVALENCE - CLINICAL EVIDENCE N/A
(b)(3) SUBSTANTIAL EQUIVALENCE - CONCLUSIONS
The design characteristics of the subject device do not raise any new types of questions of safety or effectiveness and testing shows no new worst case. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate and are substantially equivalent.
§ 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.