(447 days)
The Cannulated Compression Device System is indicated for fracture fixation of small and long bones. The system is not intended for spinal use.
The Cannulated Compression Device System is used to aid in the alignment and stabilization of bone fractures. The system consists of the following parts:
- A cannulated compression device body with distal threads for bone engagement and distal portals that allow passage of deployable integral anchors to achieve stabilization distally within the bone. The anchors may be retracted for removal of the device if and when it is necessary. The device will be provided in a pre-assembled condition with the deployable anchors and a distal end cap already installed. The device will be available in a variety of lengths.
- A compression nut will be provided separately in various configurations, including both threaded and non-threaded versions. The compression nut has a proximal head and internal threads. The proximal head engages the bone fragment. The internal threads allow engagement to the cannulated compression device body. As the compression nut is tightened onto the device body compression is achieved across the bone fragments. The rate of compression varies based on the proximal head configuration selected.
ODi-NA will manufacture the implants from implant grade titanium allov (Ti-6AL-4V-ELI) per ASTM F136. The implants will be offered in both sterile (steam) and non-sterile packaging configurations and are intended for single-use.
The provided text is a 510(k) summary for the Cannulated Compression Device System. It describes the device, its indications for use, and a comparison to predicate devices, along with performance data. However, it does not contain the information required to fill in the table and answer all the questions about acceptance criteria and a study proving a device meets them, particularly in the context of an AI/ML algorithm.
This document describes a physical medical device (cannulated compression device for bone fracture fixation), not an AI/ML algorithm or software. Therefore, many of the requested fields are not applicable to the content provided (e.g., sample size for training set, number of experts for ground truth, MRMC study, standalone algorithm performance).
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from F543-17 & F1264-16) | Reported Device Performance |
|---|---|
| Torsional strength (per ASTM F543-17, Annex A1) | Evaluated |
| Driving torque (per ASTM F543-17, Annex A2) | Evaluated |
| Pullout strength (per ASTM F543-17, Annex A3) | Evaluated |
| Static bend strength (per ASTM F1264-16, Annex A1) | Evaluated |
| Dynamic bend strength (per ASTM F1264-16, Annex A4) | Evaluated |
| Endotoxin limit (20.0 USP Endotoxin Units per device, per ANSI/AAMI ST72) | Meet specified endotoxin limit |
| Compression features performance (comparative to predicate) | Comparatively tested |
Note: The document states that the device was "evaluated" and "tested" against these standards and criteria, and that it "meets the specified endotoxin limit." Specific numerical results of these evaluations and tests are not provided in this summary. The "acceptance criteria" here refers to the standards used for mechanical and biological testing of the physical hardware, not the performance of an AI/ML system.
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. The study described is for a physical medical device, involving mechanical and biological testing according to ASTM standards. There is no "test set" in the context of software/AI data, nor "data provenance." The tests would involve physical samples of the device and biological samples for pyrogen testing.
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. This information is relevant for AI/ML studies where human experts establish ground truth for image interpretation or diagnosis. For a physical device, ground truth is established by measured physical properties or biochemical assays against established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. Adjudication methods are used in AI/ML studies to resolve disagreements among human experts when establishing ground truth. This is not relevant for the mechanical and biological testing of a physical device.
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
- Not applicable / Not provided. MRMC studies are specific to evaluating AI/ML systems, particularly in medical imaging, to compare human performance with and without AI assistance. This document describes a physical bone fixation device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable / Not provided. This pertains to the performance of an AI/ML algorithm without human intervention. The device in question is a physical surgical implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the mechanical tests (torsional strength, driving torque, pullout strength, bend strength), the "ground truth" would be the measured physical properties of the device, compared against the specifications defined by the ASTM standards (F543-17 and F1264-16).
- For the pyrogen testing, the "ground truth" is the measured endotoxin level compared against the specified limit of 20.0 USP Endotoxin Units per device, as per ANSI/AAMI ST72 using the Limulus amebocyte lysate (LAL) test.
8. The sample size for the training set
- Not applicable / Not provided. This is relevant for AI/ML algorithms.
9. How the ground truth for the training set was established
- Not applicable / Not provided. This is relevant for AI/ML algorithms.
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April 13, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Orthopedic Designs North America, Inc. Robin Wilson Quality Manager 5912 Breckridge Parkway, Suite F Tampa, Florida 33610
Re: K210146
Trade/Device Name: Cannulated Compression Device System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: October 12, 2021 Received: October 13, 2021
Dear Robin Wilson:
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, 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) K210146
Device Name Cannulated Compression Device System
Indications for Use (Describe)
The Cannulated Compression Device System is indicated for fracture fixation of small and long bones. The system is not intended for spinal use.
| 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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510(k) SUMMARY
Image /page/3/Picture/1 description: The image shows the logo for Orthopedic Designs North America, Inc. The logo consists of a large, stylized "i" inside a circle, followed by the letters "ODI" in a sans-serif font. Below the letters, the words "ORTHOPEDIC DESIGNS NORTH AMERICA, INC." are printed in a smaller font. The logo is a dark blue color.
Date of Preparation:
April 12, 2022
Company Name / Contact:
Company: Orthopedic Designs North America, Inc. (ODI-NA) 5912 Breckenridge Parkway Suite F Tampa, FL 33610
Contact:
Robin Wilson Phone: (813) 443-4905 Fax: (888) 632-8047
Device Identification:
Proprietary Name: Common Used Name: Classification Name: Classification Reference: Classification Panel: Device Product Code: Proposed Regulatory Class:
Cannulated Compression Device System Non-Spinal Metallic Bone Screw Screw, Fixation, Bone 21 CFR § 888.3040 87 - Orthopedic Devices HWC Class II
Predicate Devices:
- Stryker® Asnis® III Cannulated Screw System Primary: (K000080)
- Synthes® (USA) 6.5 mm Cannulated Screw (K021932) Additional: Synthes® (USA) 4.5 and 6.5 mm Headless Compression Screws (K080943)
Device Description:
The Cannulated Compression Device System is used to aid in the alignment and stabilization of bone fractures. The system consists of the following parts:
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- . A cannulated compression device body with distal threads for bone engagement and distal portals that allow passage of deployable integral anchors to achieve stabilization distally within the bone. The anchors may be retracted for removal of the device if and when it is necessary. The device will be provided in a pre-assembled condition with the deployable anchors and a distal end cap already installed. The device will be available in a variety of lengths.
- A compression nut will be provided separately in various configurations, ● including both threaded and non-threaded versions. The compression nut has a proximal head and internal threads. The proximal head engages the bone fragment. The internal threads allow engagement to the cannulated compression device body. As the compression nut is tightened onto the device body compression is achieved across the bone fragments. The rate of compression varies based on the proximal head configuration selected.
ODi-NA will manufacture the implants from implant grade titanium allov (Ti-6AL-4V-ELI) per ASTM F136. The implants will be offered in both sterile (steam) and non-sterile packaging configurations and are intended for single-use.
Indications for Use:
The Cannulated Compression Device System is indicated for fracture fixation of small and long bones. The system is not intended for spinal use.
Substantial Equivalence Information:
Orthopedic Designs North America, Inc. believes the Cannulated Compression Device System is substantially equivalent to the products described herein with respect to indications for use, device design, materials, method of manufacture and method of sterilization. The following technological differences exist between the subject and predicate devices:
- The predicate devices obtain fixation through distal threads alone. ● The subject device, while having distal threads, offers integral, deployable and retractable anchors to enhance fixation.
- The predicate devices offer a singular head design for each . system. The subject device offers multiple head designs which allow the surgeon to choose the appropriate head design for the operation being performed.
Performance Data:
The subject devices were evaluated for their torsional strength, driving torque, and pullout strength per Annex A1, Annex A2, and Annex A3 of ASTM F543-17. The subject devices were evaluated for their static and dynamic bend strength per Annex A1 and Annex A4 of ASTM F1264-16.
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The compression features of the subject device were comparatively tested against a predicate device.
Pyrogen testing was performed in accordance with ANSI/AAMI ST72 and confirmed the implants meet the specified endotoxin limit of 20.0 USP Endotoxin Units per device using the Limulus amebocyte lysate (LAL) test.
Conclusion:
The totality of data collected through comprehensive performance testing has successfully demonstrated the Cannulated Compression Device System is substantially equivalent to the previously cleared predicate devices currently marketed for the same intended use.
§ 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.