(56 days)
The Tiger Cannulated Screw System is indicated for fixation of fractures, non-unions, arthrodeses, and osteotomies of bones appropriate for the size of the device.
The Tiger Cannulated Screw System is a headed and headless, cannulated, self-drilling, self-tapping screw system for the management of bone orthopedic osteotomies and trauma. The system consists of Ø2.0-Ø7.0 mm screws and washers, and the necessary instruments to facilitate the placement of these implants. The purpose of this submission is to add Ø5.5 mm and Ø7.0 mm headed cannulated screws to the Tiger Cannulated Screw System and to modify the indications for use statement for previously cleared devices (K081510 / K112737).
This document is a 510(k) premarket notification for the "Tiger Cannulated Screw System". It primarily discusses the substantial equivalence of this device to previously marketed predicate devices rather than presenting a study demonstrating the device meets specific acceptance criteria in a clinical or AI-related context.
Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) regarding AI-specific study details, ground truth, expert involvement, and sample sizes for training/test sets are not applicable to this document as it pertains to a traditional medical device (bone screws) and not an AI/ML device.
However, I can extract information related to non-clinical testing and the comparison to predicate devices, which serve as the "acceptance criteria" for this type of submission.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (from Non-clinical Test Summary) | Reported Device Performance |
|---|---|
| ASTM F543-07 requirements for: | The results of these evaluations indicate that the Tiger Cannulated Screws are equivalent to predicate devices. |
| - Torque to Failure | (Implicitly met standards of predicate devices / ASTM F543-07) |
| - Axial Pullout Strength | (Implicitly met standards of predicate devices / ASTM F543-07) |
| - Axial Pull Through Strength | (Implicitly met standards of predicate devices / ASTM F543-07) |
| - Driving/Insertion and Removal Torque | (Implicitly met standards of predicate devices / ASTM F543-07) |
| Conclusion of Equivalence: | The Ø5.5 mm and Ø7.0 mm Tiger Cannulated Screws and Washers are equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use. |
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 for this type of device. The non-clinical tests (ASTM F543-07) involve mechanical testing of the screws, not data from human patients or a test set in the AI sense. The number of screws tested for each mechanical property would typically be specified in the full test report, but it's not detailed in this 510(k) 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. This submission relies on engineering and material standards for mechanical properties rather than expert clinical assessment of patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This refers to methods for resolving discrepancies in expert labeling of AI datasets, which is not relevant here.
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. This is a mechanical device, not an AI-assisted diagnostic or therapeutic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a surgical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical tests, the "ground truth" or reference standard would be the defined specifications and performance characteristics of the predicate devices and the requirements of the ASTM F543-07 standard.
8. The sample size for the training set:
- Not applicable. There is no training set as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set for this type of device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, and they are connected by a flowing line.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 14, 2016
Trilliant Surgical, LTD % J.D. Webb President The OrthoMedix Group 1001 Oakwood Boulevard Round Rock, Texas 78681
Re: K153338
Trade/Device Name: Tiger Cannulated 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: November 13, 2015 Received: November 19, 2015
Dear Mr. Webb:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Tiger Cannulated Screw System
Indications for Use (Describe)
The Tiger Cannulated Screw System is indicated for fixation of fractures, non-unions, arthrodeses, and osteotomies of bones 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)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary:
| Date Prepared | November 13, 2015 |
|---|---|
| Submitted By | Trilliant Surgical, LTD6721 Portwest Dr,Suite 160Houston, TX 77024713-388-6055 Telejolson@trilliantsurgical.com |
| Contact | J.D. Webb1001 Oakwood BlvdRound Rock, TX 78681512-388-0199 Telee-mail: jdwebb@orthomedix.net |
| Trade Name | Tiger Cannulated Screw System |
| Common Name | Bone screws |
| Classification Name | Smooth & threaded metallic bone fixation fasteners |
| Class | II |
| Product Code | HWC |
| CFR Section | 21 CFR section 888.3040 |
| Device Panel | Orthopedic |
| Primary PredicateDevice | Tiger Cannulated Screw System - K081510 / K112737 |
| Secondary PredicateDevices | Synthes Cannulated Screws - K962011 / K963172 / K963192 / K021556Osteomed ExtremiFix Cannulated Screw System - K063298 / K151021 |
| Device Description | The Tiger Cannulated Screw System is a headed and headless, cannulated,self-drilling, self-tapping screw system for the management of bone orthopedicosteotomies and trauma. The system consists of Ø2.0-Ø7.0 mm screws andwashers, and the necessary instruments to facilitate the placement of theseimplants.The purpose of this submission is to add Ø5.5 mm and Ø7.0 mm headedcannulated screws to the Tiger Cannulated Screw System and to modify theindications for use statement for previously cleared devices (K081510 /K112737). |
| Materials | Titanium alloy, Ti-6Al-4V (ASTM F136) |
| SubstantialEquivalence Claimedto Predicate Devices | The Ø5.5 mm and Ø7.0 mm Tiger Cannulated Screws and Washers aresubstantially equivalent to the predicate devices in terms of intended use, design,materials used, mechanical safety and performances. |
| Indications for Use | The Tiger Cannulated Screw System is indicated for fixation of fractures, non-unions, arthrodeses, and osteotomies of bones appropriate for the size of thedevice. |
| Non-clinical TestSummary | The following analyses were conducted:ASTM F543-07• Torque to Failure• Axial Pullout Strength• Axial Pull Through Strength• Driving/Insertion and Removal TorqueThe results of these evaluations indicate that the Tiger Cannulated Screws areequivalent to predicate devices. |
| Clinical Test Summary | No clinical studies were performed |
| Conclusions: Non-clinical and Clinical | Trilliant Surgical considers the Ø5.5 mm and Ø7.0 mm Tiger Cannulated Screwsand Washers to be equivalent to the predicate devices listed above. Thisconclusion is based upon the devices' similarities in principles of operation,technology, materials and indications for use |
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
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510(k) Summary:
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
§ 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.