(85 days)
The ChoiceSpine Boomerang™ Anterior Cervical Plate System is intended for anterior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
WARNING: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
The ChoiceSpine Boomerang™ Anterior Cervical Plate system is intended for anterior screw fixation to the cervical spine. The system consists of a variety of bone plates and screws made from titanium alloy (T-6Al-4V ELI) per ASTM F136 and a set of instruments made from stainless steels (455, 465 and 17-4) per ASTM A564 and ASTM F899. The system components are provided non-sterile and must be steam sterilized by the user prior to use.
Here's a breakdown of the acceptance criteria and study information for the ChoiceSpine Boomerang™ Anterior Cervical Plate System based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary indicates that mechanical testing was performed according to ASTM F1717-18. While specific numerical acceptance criteria (e.g., maximum deflection, fatigue cycles) are not detailed in the provided text, the summary states:
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Pre-defined acceptance criteria were met. | The test results indicate that the pre-defined acceptance criteria were met. |
| Substantially equivalent to predicate devices based on mechanical testing. | Demonstrated substantial equivalence to predicate devices. |
Missing Information: The document states "pre-defined acceptance criteria were met" but does not specify what those criteria are (e.g., specific load tolerances, cycles to failure, deflection limits per ASTM F1717-18). To fully answer this, one would need to consult the full ASTM F1717-18 standard and the original test report.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document mentions "mechanical testing" was performed but does not quantify the number of plates or screws tested.
- Data Provenance: Not specified. Mechanical testing is typically conducted in a laboratory setting, not with human patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This question is not applicable to this type of device submission. Mechanical testing of an implantable device does not typically involve human experts to establish "ground truth" in the same way clinical studies or diagnostic AI algorithms do. The "ground truth" here is the physical performance and material properties of the device as measured by engineering tests.
4. Adjudication Method for the Test Set
Not applicable. Mechanical testing outcomes are typically measured directly by equipment and analyzed by engineers, not adjudicated by experts in a consensus process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document does not describe an MRMC comparative effectiveness study. This type of study is typically used for diagnostic devices with human readers, not for spinal implants.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The "standalone" performance here refers to the device itself performing according to its design specifications through mechanical tests, without human interaction influencing the performance of the device itself. There is no algorithm being tested in this context.
7. The Type of Ground Truth Used
The ground truth used for this submission is mechanical performance data according to a recognized standard (ASTM F1717-18). This includes measurements of static and dynamic compression bending and static torsion, compared against design specifications and predicate device performance.
8. The Sample Size for the Training Set
Not applicable. This device is a physical implant, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
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May 1, 2019
ChoiceSpine, LP Ms. Kim Finch Director of Regulatory Affairs 400 Erin Drive Knoxville, Tennessee 37919
Re: K190227
Trade/Device Name: Boomerang™ Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: February 1, 2019 Received: February 5, 2019
Dear Ms. Finch:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for CAPT Raquel Peat, PhD, MPH, USPHS Director Office of Health Technology 6 Office of Product Evaluation and Ouality 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)
K190227
Device Name
Boomerang™Anterior Cervical Plate System
Indications for Use (Describe)
The ChoiceSpine Boomerang™ Anterior Cervical Plate System is intended for anterior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, tracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), turnor, pseudoarthrosis, and failed previous fusion.
WARNING. This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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7. 510(k) Summary
| Date: | February 4, 2019 |
|---|---|
| Sponsor: | ChoiceSpine, LP400 Erin DriveKnoxville, TN 37919 |
| Phone: | 865-246-3333 |
| Fax: | 865-246-3334 |
| Contact Person: | Kim Finch, Director of Regulatory Affairs |
| Proposed ProprietaryTrade Name: | Boomerang™ Anterior Cervical Plate System |
| Product Class: | Class II |
| Classification Name:Device Product Code: | 888.3060 - Spinal Intervertebral Body Fixation OrthosisKWQ |
| Purpose ofSubmission: | The purpose of this submission is to gain clearance for a new anterior cervical plateand screw system. |
| Device Description: | The ChoiceSpine Boomerang™ Anterior Cervical Plate system is intended for anteriorscrew fixation to the cervical spine. The system consists of a variety of bone platesand screws made from titanium alloy (T-6Al-4V ELI) per ASTM F136 and a set ofinstruments made from stainless steels (455, 465 and 17-4) per ASTM A564 and ASTMF899. The system components are provided non-sterile and must be steam sterilizedby the user prior to use. |
| Indications for Use: | The ChoiceSpine Boomerang™ Anterior Cervical Plate system is intended for anteriorcervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD)(defined as neck pain of discogenic origin with degeneration of the disc confirmed byhistory and radiographic studies), spondylolisthesis, trauma (i.e., fracture ordislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/orlordosis), tumor, pseudoarthrosis, and failed previous fusion. |
| WARNING: This device is not intended for screw attachment or fixation to theposterior elements (pedicles) of the cervical, thoracic or lumbar spine. | |
| Summary of theTechnologicalCharacteristics | As established in this submission, equivalency of the ChoiceSpine Boomerang™Anterior Cervical Plate system to its predicate devices is based on similarities in theindications for/intended use, design, product offering, materials used and levels ofattachment. |
| Summary of thePerformance Data: | Mechanical testing (static and dynamic compression bending and static torsion) perASTM F1717-18 was performed to demonstrate that the ChoiceSpineBoomerang™ Anterior Cervical Plate system is substantially equivalent to itspredicate devices. The test results indicate that the pre-defined acceptancecriteria were met. |
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The ChoiceSpine Boomerang™ Anterior Cervical Plate system has the same Conclusion: indications, technological characteristics, and principles of operation as its predicates of traditional design. The proposed design differs from its predicates in that only one screw is required to be placed in each adjacent vertebral body as opposed to two. Despite this difference, the mechanical testing results and predicate data provided in Attachment 4 further demonstrate substantial equivalence to the predicate devices.
| Predicate Devices: | Primary predicate: | DePuy Synthes Anterior CSLP System (K030866) |
|---|---|---|
| Additional Predicates: | ChoiceSpine Ambassador™ (K143576) | |
| Eurosurgical, SA ORIA Zenith (K030500) | ||
| DePuy Motech AcroMed – DOC™ Ventral CervicalStablization System (K982443) | ||
| Stryker Spine – Aviator Plate (K083562) |
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.