(85 days)
Not Found
No
The 510(k) summary describes a mechanical implant system and its instruments, with no mention of software, algorithms, or any technology related to AI or ML. The performance studies are mechanical tests, not related to data analysis or image processing.
Yes
The device is described as an Anterior Cervical Plate System intended for cervical fixation to treat various medical conditions like degenerative disc disease, trauma, and spinal stenosis, which are therapeutic interventions.
No
The device is described as an "Anterior Cervical Plate System" intended for "anterior cervical fixation." It is a surgical implant used to stabilize the spine, not to identify or determine a disease or condition. Its purpose is therapeutic/restorative, not diagnostic.
No
The device description explicitly states that the system consists of bone plates, screws, and instruments made from titanium alloy and stainless steels, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The ChoiceSpine Boomerang™ Anterior Cervical Plate System is a surgical implant intended for anterior cervical fixation. It is a physical device used to stabilize the spine, not to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or diagnostic testing. It focuses on the mechanical function of the plate and screws for spinal stabilization.
Therefore, based on the provided information, the ChoiceSpine Boomerang™ Anterior Cervical Plate System is a surgical implant/device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KWO
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
C2-T1
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing (static and dynamic compression bending and static torsion) per ASTM F1717-18 was performed to demonstrate that the ChoiceSpine Boomerang™ Anterior Cervical Plate system is substantially equivalent to its predicate devices. The test results indicate that the pre-defined acceptance criteria were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K030866, K143576, K030500, K982443, K083562
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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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
1
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
2
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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3
7. 510(k) Summary
| Date: | February 4, 2019 |
|---|---|
| Sponsor: | ChoiceSpine, LP |
| 400 Erin Drive | |
| Knoxville, TN 37919 | |
| Phone: | 865-246-3333 |
| Fax: | 865-246-3334 |
| Contact Person: | Kim Finch, Director of Regulatory Affairs |
| Proposed Proprietary | |
| Trade Name: | Boomerang™ Anterior Cervical Plate System |
| Product Class: | Class II |
| Classification Name: | |
| Device Product Code: | 888.3060 - Spinal Intervertebral Body Fixation Orthosis |
| KWQ | |
| Purpose of | |
| Submission: | The purpose of this submission is to gain clearance for a new anterior cervical plate |
| and screw system. | |
| Device Description: | 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. | |
| Indications for Use: | 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. | |
| Summary of the | |
| Technological | |
| Characteristics | As established in this submission, equivalency of the ChoiceSpine Boomerang™ |
| Anterior Cervical Plate system to its predicate devices is based on similarities in the | |
| indications for/intended use, design, product offering, materials used and levels of | |
| attachment. | |
| Summary of the | |
| Performance Data: | Mechanical testing (static and dynamic compression bending and static torsion) per |
| ASTM F1717-18 was performed to demonstrate that the ChoiceSpine | |
| Boomerang™ Anterior Cervical Plate system is substantially equivalent to its | |
| predicate devices. The test results indicate that the pre-defined acceptance | |
| criteria were met. |
4
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 Cervical | ||
| Stablization System (K982443) | ||
| Stryker Spine – Aviator Plate (K083562) |