(312 days)
Not Found
No
The document describes a physical implantable device (a spinal cage system) and its intended use. There is no mention of software, algorithms, data processing, or any terms related to AI/ML. The performance studies section refers to a literature analysis of clinical data, not the performance of an AI/ML algorithm.
Yes.
The device is indicated for replacing a diseased vertebral body, treating tumors, achieving decompression of spinal cord and neural tissues, restoring height of a collapsed vertebral body, and treating fractures, all of which are therapeutic interventions.
No
The provided text describes the Bengal® Stackable Cage System as a device designed to replace vertebral bodies and restore spinal column integrity. Its intended use is for treatment and restoration, not for diagnosing conditions.
No
The device description clearly indicates it is a physical implant made of polymer/carbon-fiber composite, designed to be surgically implanted in the spine. It is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Bengal® Stackable Cage System is a surgical implant designed to replace or support vertebral bodies in the spine. Its function is mechanical and structural, not diagnostic. It is used in vivo (within the body) during surgery, not in vitro (in a lab setting) on patient samples.
The text clearly describes a surgical implant used for structural support and reconstruction of the spine, which falls under the category of a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Bengal® Stackable Cage System is indicated for use in the thoracolumbar spine (i.e. T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Bengal® Stackable Cage System is also indicated for treating fractures of the thoracic and lumbar spine. The Bengal® Stackable Cage System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The Bengal® Stackable Cage System is intended for use with supplemental internal fixation.
The Bengal® Stackable Cage System is also indicated for use in the cervical spine (C3-C7 vertebral bodies for the standard and large VBR implant) in skeletally mature patients for partial or total replacement of a diseased, collapsed, damaged, or unstable vertebral body due to tumor, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues. The Bengal® Stackable Cage System for use in the cervical spine is designed to restore the integrity of spinal column even in the absence of fusion for a limited time period, in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with the surgeon's bone graft material of choice. The Bengal® Stackable Cage System is intended for use with supplemental internal fixation. When used at more than two levels in the cervical spine, supplemental fixation should include posterior fixation that has been cleared by FDA.
Product codes (comma separated list FDA assigned to the subject device)
PLR, MQP
Device Description
The Bengal Stackable Cage System is a VBR Spinal System designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period, as well as for treating fractures of the thoracic and lumbar spine.
The structure of the polymer/carbon-fiber composite implants has been shown to support anticipated loads with a modulus of elasticity approximating that of cortical bone. The implants have ridges or teeth in both the anterior-posterior and medial-lateral directions, which resist rotation and migration. The polymer/carbon-fiber composite implants have cavities to accept packing of bone graft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
thoracolumbar spine (i.e. T1-L5), cervical spine (C3-C7 vertebral bodies)
Indicated Patient Age Range
skeletally mature patients
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A literature analysis of published clinical data is provided to support the modified indication for use. The clinical outcomes demonstrate that interbody fusion devices similar to the subject devices are as safe and effective as the primary predicate devices and the additional predicate devices for the modification for use. No additional testing was required as the technological characteristics are consistent and or similar with those of the primary predicate device and the additional predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.
December 20, 2019
Medos International SARL % Karin McDonough Regulatory Affairs Specialist DePuy Synthes Spine 325 Paramount Drive Raynham, Massachusetts 02767
Re: K190284
Trade/Device Name: Bengal® Stackable Cage System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: PLR, MQP Dated: November 19, 2019 Received: November 20, 2019
Dear Karin McDonough:
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
1
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,
Brent L. Showalter, PhD Assistant Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190284
Device Name Bengal® Stackable Cage System
Indications for Use (Describe)
The Bengal® Stackable Cage System is indicated for use in the thoracolumbar spine (i.e. T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Bengal® Stackable Cage System is also indicated for treating fractures of the thoracic and lumbar spine. The Bengal® Stackable Cage System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The Bengal® Stackable Cage System is intended for use with supplemental internal fixation.
The Bengal® Stackable Cage System is also indicated for use in the cervical spine (C3-C7 vertebral bodies for the standard and large VBR implant) in skeletally mature patients for partial or total replacement of a diseased, collapsed, damaged, or unstable vertebral body due to tumor, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues. The Bengal® Stackable Cage System for use in the cervical spine is designed to restore the integrity of spinal column even in the absence of fusion for a limited time period, in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with the surgeon's bone graft material of choice. The Bengal® Stackable Cage System is intended for use with supplemental internal fixation. When used at more than two levels in the cervical spine, supplemental fixation should include posterior fixation that has been cleared by FDA.
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
A. Submitter Information
| 510(k) Sponsor: | DePuy Synthes Spine
325 Paramount Drive
Raynham, MA 02767 |
|-----------------|------------------------------------------------------------------------------------|
| Contact Person: | Karin McDonough
DePuy Synthes Spine
325 Paramount Drive
Raynham, MA 02767 |
| Telephone: | (508) 977-3851 |
| Fax: | (508) 828-3797 |
| Email: | kmcdono3@its.jnj.com |
B. Date Prepared December 20, 2019
C. Subject Device Name
| Trade/Proprietary Names: | Bengal® Stackable Cage System |
|---|---|
| Common/Usual Names: | Spinal Intervertebral Body Fixation Orthosis |
| Classification Names: | Class II |
| Spinal Intervertebral Body Fixation Orthosis | |
| Per 21 CFR 888.3060 | |
| Product codes: | PLR, MQP |
Primary Predicate Device Name D.
| Trade/Proprietary Names: | Modulift Vertebral Body Replacement (VBR) System
(K172032) |
|--------------------------|-----------------------------------------------------------------------------|
| Common/Usual Names: | Spinal Vertebral Body Replacement Device Cervical |
| Classification Names: | Class II
Spinal Intervertebral Body Fixation Orthosis
21 CFR 888.3060 |
| Product codes: | PLR |
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K190284 Page 2 of 4
E. Additional Predicate Device Name
| Trade/Proprietary Names: | Bengal Stackable Cage System (K073649, K140759) |
|---|---|
| Common/Usual Names: | Spinal Intervertebral Body Fixation Orthosis |
| Classification Names: | Intervertebral Fusion Device with Bone Graft, |
| Lumbar Per 21 CFR 888.3080 | |
| Product codes: | MAX, MQP |
F. Submission Purpose
The purpose of this submission is to seek clearance to expand the indication for use for Bengal Stackable Cage System to include the cervical spine (C3-C7).
G. Device Description
The Bengal Stackable Cage System is a VBR Spinal System designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period, as well as for treating fractures of the thoracic and lumbar spine.
The structure of the polymer/carbon-fiber composite implants has been shown to support anticipated loads with a modulus of elasticity approximating that of cortical bone. The implants have ridges or teeth in both the anterior-posterior and medial-lateral directions, which resist rotation and migration. The polymer/carbon-fiber composite implants have cavities to accept packing of bone graft.
H. Indications for Use
The Bengal® Stackable Cage System is indicated for use in the thoracolumbar spine (i.e. T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
The Bengal® Stackable Cage System is also indicated for treating fractures of the thoracic and lumbar spine.
The Bengal® Stackable Cage System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.
The Bengal® Stackable Cage System is intended for use with supplemental internal fixation.
The Bengal® Stackable Cage System is also indicated for use in the cervical spine (C3-C7 vertebral bodies for the standard and large VBR implant) in skeletally mature patients for partial or total replacement of a diseased, collapsed, damaged, or unstable vertebral
5
body due to tumor, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues. The Bengal® Stackable Cage System for use in the cervical spine is designed to restore the integrity of spinal column even in the absence of fusion for a limited time period, in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with the surgeon's bone graft material of choice.
The Bengal® Stackable Cage System is intended for use with supplemental internal fixation. When used at more than two levels in the cervical spine, supplemental fixation should include posterior fixation that has been cleared by FDA.
I. Summary of Similarities and Differences in Technological Characteristics, Performance, and Intended Use
The technological characteristics of the subject Bengal Stackable Cage System remain unchanged from their currently marketed predicate version in their design, material, performance, and intended use.
J. Materials
The materials of the subject implants remain unchanged from that of the previously cleared implants.
The Bengal Stackable Cage System implants are made of a polymer/carbon-fiber The polymer/carbon-fiber composite is made from PEEK Optima composite. LT1DA30 which complies with ASTM F2026-12, USP Class VI and ISO 10993-1. The Bengal cages have a tantalum ball per ASTM-F560 and a nut component made from titanium alloy, same as the screws, Ti-6Al-4V per ASTM F136.
The accessories are all class I instruments made from stainless steel, silicone and polypropylene (or polyprolylux) a material that complies with ASTM D4101 for extruded polypropylene.
K. Performance Data
A literature analysis of published clinical data is provided to support the modified indication for use. The clinical outcomes demonstrate that interbody fusion devices similar to the subject devices are as safe and effective as the primary predicate devices and the additional predicate devices for the modification for use. No additional testing was required as the technological characteristics are consistent and or similar with those of the primary predicate device and the additional predicate device.
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L. Conclusion
The substantial equivalence justification provided in this submission demonstrates that device is equivalent to the safety and effectiveness of the predicate the subject devices. The intended use and technological characteristics are consistent and/or similar with those of both the primary predicate device and the additional predicate devices.