(45 days)
Not Found
No
The summary describes a mechanical implant system and associated instrumentation, with no mention of software, algorithms, or AI/ML capabilities. The performance studies are mechanical tests.
Yes
The device is described as a system intended to provide "additional support during fusion" and "temporary stabilization and augment of a solid spinal fusion" for various spinal conditions, indicating it directly treats or alleviates a medical condition.
No
The device is a lumbar plate system intended to provide support during spinal fusion for various conditions, not to diagnose them.
No
The device description explicitly states that the system consists of plates and screws manufactured from titanium alloy and associated manual general surgical instrumentation, indicating it is a hardware-based medical device.
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: The Raven Lumbar Plate System is described as an anterior/anterolateral/lateral plate system consisting of plates and screws made of titanium alloy, used in spinal surgery.
- Intended Use: The intended use is to provide support during spinal fusion in skeletally mature patients for various spinal conditions. This is a surgical implant, not a diagnostic test performed on a sample.
The description clearly indicates a surgical implant used within the body to provide structural support, which is fundamentally different from an in vitro diagnostic device that analyzes samples outside the body.
N/A
Intended Use / Indications for Use
The Raven Lumbar Plate System Anterior and Lateral Plates are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the thoracic and thoracolumbar (TI-LS) spine or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
· Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);
- · Pseudoarthrosis;
- · Spondylolysis;
- · Spondylolisthesis:
- · Spinal stenosis;
- Tumors;
- · Trauma (i.e. Fractures or Dislocation);
- · Deformities (i.e. Scoliosis, Kyphosis or Lordosis);
- Failed Previous Fusion
The Raven Lumbar Plate System Buttress Plate is intended to stabilize the allograft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.
Product codes (comma separated list FDA assigned to the subject device)
KWO
Device Description
Raven Lumbar Plate System is an anterior/anterolateral/lateral plate system that may be used in the thoracic, lumbar, and sacral spine (T1-S1). Raven Lumbar Plate System consists of plates and screws manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, as well as associated manual general surgical instrumentation. The implants are available in a variety of sizes to accommodate various patient anatomies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic and thoracolumbar (T1-L5) spine or lumbar and lumbosacral (L1-S1) spine, T1-S1
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Risk analysis was performed to demonstrate that the Raven Lumbar Plate System is substantially equivalent to its predicate devices. The risk analysis determined that the predefined acceptance criteria associated with the following mechanical testing was met:
• Static and dynamic compression testing per ASTM F1717-15
• Static torsion testing per ASTM F1717-15
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.
K150449, K121791, K171538, K061482, K120092
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.
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January 3, 2019
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, featuring a stylized eagle. To the right of the HHS logo is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Choice Spine, LP Kim Finch Director of Regulatory Affairs 400 Erin Drive Knoxville, Tennessee 37919
Re: K183214
Trade/Device Name: Raven Lumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWO Dated: November 16, 2018 Received: November 19, 2018
Dear Kim 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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,
Colin O'neill -S
for MNM
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183214
Device Name Raven Lumbar Plate System
Indications for Use (Describe)
The Raven Lumbar Plate System Anterior and Lateral Plates are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the thoracic and thoracolumbar (TI-LS) spine or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
· Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);
- · Pseudoarthrosis;
- · Spondylolysis;
- · Spondylolisthesis:
- · Spinal stenosis;
- Tumors;
- · Trauma (i.e. Fractures or Dislocation);
- · Deformities (i.e. Scoliosis, Kyphosis or Lordosis);
- Failed Previous Fusion
The Raven Lumbar Plate System Buttress Plate is intended to stabilize the allograft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.
| 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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7. 510(k) Summary
| Date: | November 16, 2018 |
|---|---|
| Sponsor: | Choice Spine, LP |
| 400 Erin Drive | |
| Knoxville, TN 37919 | |
| Phone: | 865-246-3333 |
| Fax: | 865-246-3334 |
| Contact Person: | Kim Finch, Manager of Regulatory Affairs |
| Proposed Proprietary | |
| Trade Name: | Raven Lumbar Plate System |
| Product Class: | Class II |
| Classification Name: | Raven Lumbar Plate System: |
| • 888.3060 - Spinal Intervertebral Body Fixation Orthosis | |
| Device Product Code: | Raven Lumbar Plate System: |
| • KWQ | |
| Purpose of | |
| Submission: | The purpose of this submission is to gain clearance for the new Raven Lumbar Plate |
| System. | |
| Device Description: | Raven Lumbar Plate System is an anterior/anterolateral/lateral plate system that |
| may be used in the thoracic, lumbar, and sacral spine (T1-S1). Raven Lumbar Plate | |
| System consists of plates and screws manufactured from titanium alloy (Ti-6Al-4V | |
| ELI) per ASTM F136, as well as associated manual general surgical instrumentation. | |
| The implants are available in a variety of sizes to accommodate various patient | |
| anatomies. | |
| Indications for Use: | The Raven Lumbar Plate System Anterior and Lateral Plates are indicated for |
| use via a lateral or anterolateral surgical approach above the bifurcation of the | |
| great vessels in the treatment of the thoracic and thoracolumbar (T1-L5) spine | |
| or via an anterior approach below the bifurcation of the great vessels in the | |
| treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to | |
| provide additional support during fusion in skeletally mature patients in the | |
| treatment of the following acute and chronic instabilities or deformities: | |
| • Degenerative Disc Disease (defined as back pain of discogenic origin with | |
| degeneration of the disc confirmed by patient history and radiographic | |
| studies); | |
| • Pseudoarthrosis; | |
| • Spondylolysis; | |
| • Spondylolisthesis; | |
| • Spinal stenosis; | |
| • Tumors; | |
| • Trauma (i.e. Fractures or Dislocation); | |
| • Deformities (i.e. Scoliosis, Kyphosis or Lordosis); | |
| • Failed Previous Fusion | |
| The Raven Lumbar Plate System Buttress Plate is intended to stabilize the | |
| allograft or autograft at one level (T1-S1) as an aid to spinal fusion and to | |
| provide temporary stabilization and augment development of a solid spinal | |
| fusion. It may be used alone or with other anterior, anterolateral, or posterior | |
| spinal systems made of compatible materials. This device is not intended for | |
| load bearing applications. | |
| Summary of the | |
| Technological | |
| Characteristics: | As established in this submission, the Raven Lumbar Plate System is |
| substantially equivalent and has similar technological characteristics to its | |
| predicate devices through comparison in areas including intended use, | |
| material composition, principles of operation, and design. | |
| Summary of the | |
| Performance Data: | Risk analysis was performed to demonstrate that the Raven Lumbar Plate |
| System is substantially equivalent to its predicate devices. The risk analysis | |
| determined that the predefined acceptance criteria associated with the | |
| following mechanical testing was met: | |
| • Static and dynamic compression testing per ASTM F1717-15 | |
| • Static torsion testing per ASTM F1717-15 | |
| Conclusion: | The Raven Lumbar Plate System has similar indications, technological |
| characteristics, and principles of operation as its predicates. The risk analysis | |
| performed demonstrates that any minor differences do not impact device | |
| performance a compared to the predicates. The Raven Lumbar Plate System | |
| was shown to be substantially equivalent to its predicate devices. | |
| Predicate Device: | Primary predicate: Stryker Spine LITe® Plate System (K150449), |
| Additional Predicate: Corelink, LLC Zou Anterior Lumbar Plate System | |
| (K121791), and Meditech Spine, LLC Cure™ Lumbar Plate System (K171538), | |
| Altiva Corporation, Altes Anterior Buttress Plating System (K061482), Globus, | |
| Plymouth Thoracolumbar Plate System (K120092). |
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