(119 days)
No
The summary describes a mechanical pedicle screw system and does not mention any AI/ML components or related performance metrics.
Yes
The device is described as providing "immobilization and stabilization" to treat "instabilities or deformities of the thoracic, lumbar, and sacral spine," which are therapeutic actions.
No
The Aversion Pedicle Screw System is a surgical implant designed for spinal fixation and stabilization, not for diagnosing medical conditions.
No
The device description explicitly lists hardware components (straight and curved rods, polyaxial pedicle screws, and crosslink connectors) and describes mechanical performance testing of these components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Aversion Pedicle Screw System is a surgical implant used for spinal fixation. It is physically implanted into the patient's body to provide structural support.
- Lack of Specimen Analysis: The provided information does not mention any analysis of biological specimens. The device's function is mechanical stabilization of the spine.
Therefore, based on the provided information, the Aversion Pedicle Screw System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Aversion Pedicle Screw System is intended for posterior, noncervical (T1-S1) pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to fusion for 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, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion
Product codes
MNI, MNH
Device Description
The Aversion Pedicle Screw System consists of straight and curved rods, polyaxial pedicle screws and crosslink connectors. These are available in a variety of sizes to accommodate differing patient anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior, noncervical (T1-S1) pedicle
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
Static compression bending and torsion, and dynamic compression bending tests were performed according to ASTM F1717 on the worst case Aversion screw. In addition, pullout testing according to ASTM F543 was performed on the worst case Aversion screw.
The mechanical test results demonstrate that the Aversion Pedicle Screw System performance is substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
CD HORIZON® (K031655/K041460), Moss® Miami (K992168/K022623), Synergy™ VLS (K950099/K974749), Viper™2 (K090648)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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| 510(k) Summary | JAN 27 2014 |
|---|---|
| Date: | 27 September 2013 |
| Sponsor: | K7 LLC |
| 54 Moonrise Way | |
| Henderson, NV 89074 | |
| Phone: 817.219.4441 | |
| Facsimile: 817.326.5524 | |
| Contact Person: | Michael D. Smith, Manager |
| Trade Names: | Aversion Pedicle Screw System |
| Device Classification | Class II |
| Classification Name: | Pedicle screw spinal system |
| Regulation: | 888.3070 |
| Device Product | |
| Code: | MNI/MNH |
| Device Description: | The Aversion Pedicle Screw System consists of straight and curved |
| rods, polyaxial pedicle screws and crosslink connectors. These are | |
| available in a variety of sizes to accommodate differing patient | |
| anatomy. | |
| Intended Use: | The Aversion Pedicle Screw System is intended for posterior, |
| noncervical (T1-S1) pedicle fixation to provide immobilization and | |
| stabilization in skeletally mature patients as an adjunct to fusion for | |
| 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, spinal stenosis, scoliosis, kyphosis, | |
| lordosis, spinal tumor, pseudarthrosis and failed previous fusion | |
| Materials: | The Aversion Pedicle Screw System is manufactured from titanium |
| alloy (Ti-6Al-4V ELI) as described by ASTM F136. | |
| Predicate Devices: | CD HORIZON® (K031655/K041460) |
| Moss® Miami (K992168/K022623) | |
| Synergy™ VLS (K950099/K974749) | |
| Viper™2 (K090648) | |
| Performance Data: | Static compression bending and torsion, and dynamic compression |
| bending tests were performed according to ASTM F1717 on the | |
| worst case Aversion screw. In addition, pullout testing according to | |
| ASTM F543 was performed on the worst case Aversion screw. | |
| The mechanical test results demonstrate that the Aversion Pedicle | |
| Screw System performance is substantially equivalent to the | |
| predicate devices. |
,
.
1
Technological Characteristics:
The Aversion Pedicle Screw System components possess the same technological characteristics as the predicate devices. These include:
- basic design (rod-based pedicle screw fixation system), .
- material (titanium alloy), .
- anatomic location (non-cervical spine) and .
- sizes (widths, lengths and heights are within the range(s) . offered by the predicate systems).
Technological characteristics which are different have been supported with descriptive information and/or performance data.
In comparison to the predicate devices, the Aversion Pedicle Screw System has
- the same intended use (as described above), .
- the same technological characteristics or different without raising . safety and effectiveness issues (as described above)
Therefore the Aversion Pedicle Screw System can be found substantially equivalent to the predicate devices.
Conclusion:
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 27, 2014
K7. LLC % Karen E. Warden, Ph.D. BackRoads Consulting, Incorporated P.O. Box 566 Chesterland, Ohio 44026-0566
Re: K133103
Trade/Device Name: Aversion Pedicle Screw System Regulation Number: 21 CFR.888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH Dated: January 20, 2014 Received: January 22, 2014
Dear Dr. Warden:
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 todevices 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 that i Dri has intatutes and regulations administered by other Federal agencies. You must or any veith 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Dr. Karen E. Warden
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number: K133103
Device Name: Aversion Pedicle Screw System
Indications for Use:
The Aversion Pedicle Screw System is intended for posterior, noncervical (T1-S1) pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to fusion for 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, spinal stenosis, scoliosis, kyphosis, spinal tumor, pseudarthrosis and failed previous fusion.
Prescription Use X OR Over-the-Counter Use_
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Zane W.N/yatt -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K133103