(56 days)
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No
The summary describes a mechanical spinal implant system and does not mention any software, algorithms, or AI/ML capabilities. The performance studies are based on mechanical testing, not algorithmic performance.
Yes
The device is described as providing "immobilization and stabilization of spinal segments" as an "adjunct to fusion in the treatment of various acute and chronic instabilities or deformities," which explicitly indicates it is used for treating a medical condition.
No
The device description clearly states its purpose is to provide "immobilization and stabilization of spinal segments" as an adjunct to fusion. It is an implantable system designed for structural support, not for diagnosing medical conditions.
No
The device description explicitly states the system consists of pedicle screws, spinal rods, and cross connectors, which are physical hardware components implanted into the body.
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. These tests are performed outside of the body.
- Device Description: The FOCUS Pedicle Screw System is described as a system of pedicle screws, rods, and connectors that are implanted into the bones of the spine. This is an implantable medical device used within the body.
- Intended Use: The intended use is to provide immobilization and stabilization of spinal segments as an adjunct to fusion. This is a surgical procedure performed on the patient, not a diagnostic test performed on a sample.
The information provided clearly indicates that this is a surgical implant, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1 to S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion 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 history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
NKB
Device Description
The FOCUS Pedicle Screw System is a spinal system used as an adjunct to fusion, to provide immobilization and stabilization of spinal segments in the non-cervical posterior spine (T1 to S1) of skeletally mature patients. The system consists in pedicle screws implanted into the bones, and capturing spinal rods. The system is stabilized by cross connectors. The device is implanted via a posterior approach.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
non-cervical posterior spine (T1 to S1)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
The following tests were performed to demonstrate safety based on current industry standards:
- . Static compression bending (per ASTM F1717)
- . Dynamic compression bending (per ASTM F1717)
- . Static torsion (per ASTM F1717)
- . Axial pullout (per ASTM F543)
The results of these tests indicate that the FOCUS Pedicle Screw System is substantially equivalent to the predicate devices.
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).
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§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
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Nvision Biomedical Technologies, LLC % Allison Komiyama, Ph.D. Principal Consultant AcKnowledge Regulatory Strategies, LLC 2934 Hawthorn Street San Diego, California 92104
Re: K180458
Trade/Device Name: FOCUS Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw Systems Regulatory Class: Class II Product Code: NKB Dated: February 16, 2018 Received: February 20, 2018
Dear Dr. Komiyama:
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-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) K180458
Device Name FOCUS Pedicle Screw System
Indications for Use (Describe)
The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1 to S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion 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 history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
| 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 K180458
DATE PREPARED
April 16, 2018
MANUFACTURER AND 510(k) OWNER
Nvision Biomedical Technologies, LLC 350 N Loop 1604 E #103, San Antonio, TX 78232, USA Telephone: (210) 545-3713 Official Contact: Diana L. Langham, Director of Regulatory and Corporate Compliance
REPRESENTATIVE/CONSULTANT
Allison C. Komiyama, Ph.D., R.A.C. Lucie Dalet, Ph.D. AcKnowledge Regulatory Strategies, LLC Telephone: +1 (619) 208-7888 Email: akomiyama@acknowledge-rs.com
PROPRIETARY NAME OF SUBJECT DEVICE
FOCUS Pedicle Screw System
COMMON NAME
Thoracolumbosacral Pedicle Screw System
DEVICE CLASSIFICATION
Thoracolumbosacral Pedicle Screw System (21 CFR 888.3070, Product Code NKB, Class II)
PREMARKET REVIEW
ODE/DOD/PSDB Orthopedic
INDICATIONS FOR USE
The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1 to S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion 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 history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, and/ or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
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DEVICE DESCRIPTION
The FOCUS Pedicle Screw System is a spinal system used as an adjunct to fusion, to provide immobilization and stabilization of spinal segments in the non-cervical posterior spine (T1 to S1) of skeletally mature patients. The system consists in pedicle screws implanted into the bones, and capturing spinal rods. The system is stabilized by cross connectors. The device is implanted via a posterior approach.
PREDICATE DEVICE IDENTIFICATION
The FOCUS Pedicle Screw System is substantially equivalent to the following predicates:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate |
|---|---|---|
| K161363 | Arsenal Spinal Fixation System / Alphatec Spine, Inc. | ✓ |
| K101278 | Inertia Pedicle Screw System / Nexxt Spine LLC |
SUMMARY OF NON-CLINICAL TESTING
No FDA performance standards have been established for the FOCUS Pedicle Screw System. The following tests were performed to demonstrate safety based on current industry standards:
- . Static compression bending (per ASTM F1717)
- . Dynamic compression bending (per ASTM F1717)
- . Static torsion (per ASTM F1717)
- . Axial pullout (per ASTM F543)
The results of these tests indicate that the FOCUS Pedicle Screw System is substantially equivalent to the predicate devices.
EQUIVALENCE TO PREDICATE DEVICES
Nvision believes that the FOCUS Pedicle Screw System is substantially equivalent to the predicate devices based on the information summarized here:
The subject device has a similar design, similar dimensions, and uses similar or identical materials as the devices cleared in K101278 and K161363. The subject device has the same intended use as the device cleared in K161363, except that the subject device is not intended to be used in pediatric population. The subject device has similar technological characteristics (polyaxial, cannulated, cortical, self-tapping screws, straight or pre-contoured rods) as the devices cleared in K161363 and K101278. These technological characteristics have undergone testing to ensure the device is as safe and effective as the predicates.
CONCLUSION
Based on the testing performed, including static compression bending, dynamic compression bending, static torsion, and axial pullout, it can be concluded that the subject device does not
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raise new issues of safety or efficacy compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed FOCUS Pedicle Screw System are assessed to be substantially equivalent to the predicate devices.