(41 days)
No
The summary describes a mechanical spinal fixation device and its associated instruments. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies are bench tests evaluating mechanical properties.
Yes
The device is described as a "temporary fixation device until fusion is achieved" for treating spine instability, which directly addresses a medical condition and aims to improve patient health.
No
Explanation: The device is described as a "temporary fixation device until fusion is achieved," indicating it is a treatment device, not a diagnostic one.
No
The device description explicitly states it consists of physical components (titanium alloy plates and screws) and is intended for surgical implantation. It also mentions instruments and a tray, further indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for stabilizing the spine in cases of instability due to various conditions like fracture, tumor, or degenerative disc disease. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as a rigid plate and screws made of titanium alloy, designed to be surgically implanted. This is consistent with a medical device used for treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the AccuFit® Lateral Plate System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AccuFit® Lateral Plate System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (TI-LS) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiosy, scollosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The AccuFit® Lateral 2-Hole Plate consists of non-sterile, single use, titanium alloy (Ti-6AI-4V ELI per ASTM F136) rigid plates and screws of varying sizes. The plate attaches by means of screws to the lateral portion of the vertebral body. The AccuFit® Lateral 2-Hole Plate (Subject Device) will be implanted using the instruments cleared with the AccuFit® Lateral Plate System (K162211), however a new inserter and tray will be introduced to the system that is to be used with the AccuFit® Lateral 2-Hole Plate (Subject Device). The AccuFit® Lateral 2-Hole Plate is to be provided non-sterile. They require sterilization prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar (TI-LS) spine, lumbar and lumbosacral (L1-S1) spine
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)
Performance Testing Summary:
The testing of the AccuFit® Lateral 2-Hole Plate includes:
- Static Compression Bending per ASTM F1717
- Static Torsion per ASTM F1717
- Dynamic Compression Bending per ASTM F1717
The bench testing demonstrates that the performance characteristics of the AccuFit® Lateral 2-Hole Plate is equivalent to those of other legally marketed spinal intervertebral body fixation orthoses.
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.
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
March 16, 2022
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Precision Spine, Inc. % Lisa Ferrara, PhD Technical Director Element Materials Technology 3701 Port Union Road Farfield, Ohio 45014
Re: K220324
Trade/Device Name: AccuFit Lateral 2-Hole Plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: February 3, 2022 Received: February 3, 2022
Dear Lisa Ferrara:
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/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 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,
Colin O'Neill, M.B.E. 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
Indications for Use
510(k) Number (if known) K220324
Device Name AccuFit® Lateral Plate System
Indications for Use (Describe)
The AccuFit® Lateral Plate System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (TI-LS) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiosy, scollosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X 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 | |
|---|---|
| Device Trade Name: | AccuFit® Lateral 2-Hole Plate |
| Manufacturer: | Precision Spine, Inc. |
| 2050 Executive Dr. | |
| Pearl, Mississippi 39208 | |
| United States | |
| Contact: | Mr. Michael Dawson |
| VP of Regulatory Affairs / General Counsel | |
| 601-420-4244 | |
| Precision Spine | |
| Mike.dawson@precisionspineinc.com | |
| Prepared By: | Dr. Lisa Ferrara |
| Technical Director | |
| Element Materials Technology | |
| 3701 Port Union Road | |
| Fairfield, OH 45014 | |
| lisa.ferrara@element.com | |
| Date Prepared: | February 3, 2022 |
| Classification: | 21 CFR §888.3060, Spinal intervertebral body fixation |
| orthosis | |
| Class: | II |
| Product Codes: | KWQ |
Indications for Use:
The AccuFit® Lateral Plate System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine
4
instability as a result of fracture (including dislocation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.
Device Description:
The AccuFit® Lateral 2-Hole Plate consists of non-sterile, single use, titanium alloy (Ti-6AI-4V ELI per ASTM F136) rigid plates and screws of varying sizes. The plate attaches by means of screws to the lateral portion of the vertebral body. The AccuFit® Lateral 2-Hole Plate (Subject Device) will be implanted using the instruments cleared with the AccuFit® Lateral Plate System (K162211), however a new inserter and tray will be introduced to the system that is to be used with the AccuFit® Lateral 2-Hole Plate (Subject Device). The AccuFit® Lateral 2-Hole Plate is to be provided non-sterile. They require sterilization prior to use.
Primary Predicate Devices:
The AccuFit® Lateral 2-Hole Plate is substantially equivalent in device indications, design and performance to the following primary predicate device.
- AccuFit® Lateral Plate System. Precision Spine. K162211 ●
Additional Predicate Devices:
The following additional predicate device is presented to further demonstrate substantial equivalence since this device contributes incremental benefit to the substantial equivalence profile with the device indications, design, mechanical performance, and clinical performance:
- . LITe® Plate System, Stryker, K150449
Performance Testing Summary:
The testing of the AccuFit® Lateral 2-Hole Plate includes:
- Static Compression Bending per ASTM F1717
- Static Torsion per ASTM F1717 ●
- . Dynamic Compression Bending per ASTM F1717
Comparison of Technological Characteristics:
The AccuFit® Lateral 2-Hole Plate has the same indications for use, materials, and similar design features as compared to the predicate devices. The bench testing demonstrates that the performance characteristics of the AccuFit® Lateral 2-Hole Plate is equivalent to those of other legally marketed spinal intervertebral body fixation orthoses, and therefore supports a determination of Substantial Equivalence for the proposed indications for use. Any differences between the subject and predicate devices would not render the device NSE, affect the safety or effectiveness, or raise different questions of safety and effectiveness.
5
Substantial Equivalence
The subject device was demonstrated to be substantially equivalent to the predicate cited in the passage above with respect to indications, design, function and performance.
Conclusion:
The AccuFit® Lateral 2-Hole Plate is substantially equivalent to the cited predicate device with respect to indications for use, design, function, and performance.