(105 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and structural integrity of the lumbar plate system, with no mention of AI or ML technologies.
Yes.
The device is used in the treatment of spinal instability resulting from various conditions like degenerative disc disease, trauma, and deformities, indicating its role in treating medical conditions.
No.
The device is an implantable plate system used as an adjunct to fusion for treating spinal instability; its function is therapeutic, not diagnostic.
No
The device description explicitly states that the system consists of "an assortment of plates and screws" and "Class I manual surgical instruments and cases," which are physical hardware components. There is no mention of any software component.
Based on the provided information, 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: The Aurora® Anterior Lumbar Plate System is described as an assortment of plates and screws made from titanium alloy, intended for surgical implantation to stabilize the spine. It also includes surgical instruments.
- Intended Use: The intended use is to provide spinal stability as an adjunct to fusion in the treatment of various spinal conditions. This is a surgical intervention, not a diagnostic test performed on a sample.
The device is a surgical implant and associated instruments, which falls under the category of medical devices used for treatment, not diagnosis.
N/A
Intended Use / Indications for Use
The Aurora® Anterior Lumbar Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels as an adjunct to fusion. The AURORA® Anterior Lumbar Plate System is indicated for in the treatment of lumbar and lumbosacral (L1-S1) spinal instability as a result of the following:
- degenerative disc disease (defined as back 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 ●
- failed previous fusion ●
This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
Product codes
KWQ
Device Description
The Aurora® Anterior Lumbar Plate System consists of an assortment of plates and screws. Implant components are available in a variety of sizes to suit the individual patient anatomies. The Aurora® Anterior Lumbar Plate System implants are manufactured from medical grade titanium alloy Ti-6A1-4V per ASTM F136/ISO 5832-3. The Aurora® Anterior Lumbar Plate System also contains Class I manual surgical instruments and cases that are considered exempt from premarket notification.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar and lumbosacral (L1-S1) spinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
The Aurora® Anterior Lumbar Plate System has been tested in the following test modes:
- Static compression bending per ASTM F1717 ●
- Static torsion per ASTM F1717 o
- Dynamic compression bending per ASTM F1717 ●
- Torsional properties per ASTM F543 ●
- Driving torque per ASTM F543
- o Pullout strength per ASTM F543
The results of this non-clinical testing show that the strength of the Aurora® Anterior Lumbar Plate System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
August 5, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Prism Surgical Design Pty Ltd. % Nathan Wright Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K201079
Trade/Device Name: Aurora® Anterior Lumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: July 9, 2020 Received: July 10, 2020
Dear Nathan Wright:
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
1
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 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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/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,
Colin O'Neill, M.B.E. Acting Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | | Form Approved: OMB No. 0910-012
Expiration Date: 06/30/2020
See PRA Statement on last page. |
|-------------------------------------------------------------------------|---------|---------------------------------------------------------------------------------------------------|
| Indications for Use | | |
| 510(k) Number (if known) | K201079 | |
| Device Name | | |
| Aurora® Anterior Lumbar Plate System | | |
| Indications for Use (Describe) | | |
The Aurora® Anterior Lumbar Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels as an adjunct to fusion. The AURORA® Anterior Lumbar Plate System is indicated for in the treatment of lumbar and lumbosacral (L1-S1) spinal instability as a result of the following:
- degenerative disc disease (defined as back 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 ●
- failed previous fusion ●
This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
| 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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3
510(K) SUMMARY
| Submitter's Name: | Prism Surgical Designs Pty Ltd |
|---|---|
| Submitter's Address: | 15/43 Lang Parade |
| Milton, Queensland 4064 Australia | |
| Submitter's Telephone: | +61 7 3720 8882 |
| Contact Person: | Nathan Wright MS |
| Empirical Testing Corp. | |
| 719-351-0248 | |
| nwright@empiricaltech.com | |
| Date Summary was Prepared: | April 21, 2020 |
| Trade or Proprietary Name: | Aurora® Anterior Lumbar Plate System |
| Common or Usual Name: | Spinal Intervertebral body Fixation Orthosis |
| Classification: | Class II per 21 CFR §888.3060 |
| Product Code: | KWQ |
| Classification Panel: | Orthopedic and Rehabilitation Devices |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Aurora® Anterior Lumbar Plate System consists of an assortment of plates and screws. Implant components are available in a variety of sizes to suit the individual patient anatomies. The Aurora® Anterior Lumbar Plate System implants are manufactured from medical grade titanium alloy Ti-6A1-4V per ASTM F136/ISO 5832-3. The Aurora® Anterior Lumbar Plate System also contains Class I manual surgical instruments and cases that are considered exempt from premarket notification.
INDICATIONS FOR USE
The Aurora® Anterior Lumbar Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels as an adjunct to fusion. The AURORA® Anterior Lumbar Plate System is indicated for in the treatment of lumbar and lumbosacral (L1-S1) spinal instability as a result of the following;
- o degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- spondylolisthesis
- trauma (i.e., fracture or dislocation)
- spinal stenosis
- o deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- tumor ●
- o pseudoarthrosis
- failed previous fusion ●
4
This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
TECHNOLOGICAL CHARACTERISTICS
The Aurora® Anterior Lumbar Plate System is comprised of multiple sizes of plates and screws that are inserted the lateral or anterolateral surgical above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels as an adjunct to fusion. The system is designed to provide additional support during fusion. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates:
- Indications for Use ●
- Materials of manufacture ●
- Structural support mechanism ●
- Sizes ●
Table 5-1 Predicate Devices
| 510k Number | Trade or Proprietary or
Model Name | Manufacturer | Predicate
Type |
|-------------|------------------------------------------|----------------------------------|-------------------|
| K052546 | AEGIS Anterior Lumbar
Plate System | DePuy Spine, Inc. | Primary |
| K080429 | Pyramid® Anterior Lumbar
Plate System | Medtronic Sofamor
Danek, Inc. | Additional |
PERFORMANCE DATA
The Aurora® Anterior Lumbar Plate System has been tested in the following test modes:
- Static compression bending per ASTM F1717 ●
- Static torsion per ASTM F1717 o
- Dynamic compression bending per ASTM F1717 ●
- Torsional properties per ASTM F543 ●
- Driving torque per ASTM F543
- o Pullout strength per ASTM F543
The results of this non-clinical testing show that the strength of the Aurora® Anterior Lumbar Plate System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
5
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Aurora® Anterior Lumbar Plate System is substantially equivalent to the predicate device.