(107 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and structural integrity of the spinal fixation system components, with no mention of AI or ML.
Yes
The device is indicated as an adjunct to fusion for treating various spinal conditions, implying it is used to correct or alleviate a health problem, which is the definition of a therapeutic device.
No
Explanation: The device is described as a "spinal fixation system" used as an "adjunct to fusion" of vertebrae. It consists of hardware like screws, rods, and connectors. Its intended use is for treatment, not for diagnosing conditions.
No
The device description explicitly states it is a "multiple component, top-loading, posterior spinal fixation system which consists of pedicle screws, rods, cross-connectors, and locking cap set screws," all made from titanium alloy. This clearly indicates a hardware-based medical device, not a software-only one.
Based on the provided information, the Palladian™ Lumbar Pedicle Screw System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used to stabilize the spine during fusion. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as a system of physical components (screws, rods, etc.) made of titanium alloy, designed for surgical implantation. This aligns with a surgical device, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (blood, tissue, etc.) from the human body, which is the defining characteristic of an IVD.
Therefore, the Palladian™ Lumbar Pedicle Screw System is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The use of the Palladian™ Lumbar Pedicle Screw System is indicated as an adjunct to fusion of the L5-S1 vertebra for the treatment of; degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformity, or curvature (i.e., scoliosis, kyphosis, and lordosis), tumor, stenosis, pseudoarthrosis, and previous failed fusion.
The Palladian™ Lumbar Pedicle Screw System is a non-cervical spinal fixation system, and intended for use with autograft and/or allograft. Pedicle screw fixation is limited to skeletally mature patients.
Product codes
NKB, MNI, MNH, KWP
Device Description
The Palladian™ Lumbar Pedicle Screw System is a multiple component, top-loading, posterior spinal fixation system which consists of pedicle screws, rods, cross-connectors, and locking cap set screws. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All components are made from titanium alloy described by such standards as ASTM F136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L5-S1 vertebra
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
The Palladian™ Lumbar Pedicle Screw System has been tested in the following test modes:
- Static axial compression bending per ASTM F1717-13
- Static torsion per ASTM F1717-13 ●
- Dynamic axial compression bending fatigue per ASTM F1717-13 ●
The results of this non-clinical testing show that the strength of the Palladian™ Lumbar Pedicle Screw System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K000236, K103490, K033901, K955348, K081080, K020279, K051971, K024096, K102870
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract image of what appears to be a family.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 25, 2015
Neurostructures, Incorporated % Meredith L. May, MS, RAC Empirical Consulting, LLC 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K143230
Trade/Device Name: Palladian™ Lumbar Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH, KWP Dated: January 19, 2015 Received: January 22, 2015
Dear Ms. May:
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
1
Page 2 - Meredith L. May, MS, RAC
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education 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 vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE STATEMENT
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K143230 Device Name Palladian™ Lumbar Pedicle Screw System Indications for Use (Describe)
The use of the Palladian™ Lumbar Pedicle Screw System is indicated as an adjunct to fusion of the L5-S1 vertebra for the treatment of; degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformity, or curvature (i.e., scoliosis, kyphosis, and lordosis), tumor, stenosis, pseudoarthrosis, and previous failed fusion.
The Palladian™ Lumbar Pedicle Screw System is a non-cervical spinal fixation system, and intended for use with autograft and/or allograft. Pedicle screw fixation is limited to skeletally mature patients.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D) PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
PSC Publishing Services (301) 443-6740 E.P.
3
510(K) SUMMARY
| Submitter's Name: | Neurostructures, Inc. |
|---|---|
| Submitter's Address: | 16 Technology Dr. Suite 165 |
| Irvine, CA 92618 | |
| Submitter's Telephone: | 800.352.6103 |
| Contact Person: | Meredith L. May MS, RAC |
| Empirical Consulting LLC | |
| 719.337.7579 | |
| Date Summary was Prepared: | February 24, 2015 |
| Trade or Proprietary Name: | Palladian™ Lumbar Pedicle Screw System |
| Common or Usual Name: | Orthosis, Spinal Pedicle Fixation |
| Orthosis, Spondylolisthesis Spinal Fixation | |
| Orthosis, Spinal Pedicle Fixation, For Degenerative Disc | |
| Disease | |
| Appliance, Fixation, Spinal Interlaminal | |
| Classification: | Class III per 21 CFR §888.3070 |
| Product Code: | NKB, MNI, MNH, KWP |
| Classification Panel: | 87 Orthopedics Panel |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Palladian™ Lumbar Pedicle Screw System is a multiple component, top-loading, posterior spinal fixation system which consists of pedicle screws, rods, cross-connectors, and locking cap set screws. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All components are made from titanium alloy described by such standards as ASTM F136.
INDICATIONS FOR USE
The use of the Palladian™ Lumbar Pedicle Screw System is indicated as an adjunct to fusion of the L5-S1 vertebra for the treatment of; degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformity, or curvature (i.e., scoliosis, kyphosis, and lordosis), tumor, stenosis, pseudoarthrosis, and previous failed fusion.
The Palladian™ Lumbar Pedicle Screw System is a non-cervical spinal fixation system, and intended for use with autograft and/or allograft. Pedicle screw fixation is limited to skeletally mature patients.
The indications for use for the Palladian™ Lumbar Pedicle Screw System is similar to that of the predicate devices listed in Table 5-1.
4
TECHNOLOGICAL CHARACTERISTICS
The intended use and technological features of the Palladian™ Lumbar Pedicle Screw System do not substantially differ from the legally marketed predicate devices. The predicate devices and the Palladian™ Lumbar Pedicle Screw System are designed for posterior stabilization to provide immobilization and stabilization of spinal segments as an adjunct to fusion. The primary predicate for this submission is the Interpore Synergy VLS Open.
| 510k Number | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| K000236 | Synergy VLS Open | Interpore |
| K103490, K033901, K955348 | Moss Miami Titanium | DePuy Spine Inc. |
| K081080 | TSRH | Medtronic |
| K020279, K051971, K024096 | OPTIMA™ | U&I Corporation |
| K102870 | Spine Proliant Screw System | Exactech |
Table 5-1 Predicate Devices
PERFORMANCE DATA
The Palladian™ Lumbar Pedicle Screw System has been tested in the following test modes:
- Static axial compression bending per ASTM F1717-13
- Static torsion per ASTM F1717-13 ●
- Dynamic axial compression bending fatigue per ASTM F1717-13 ●
The results of this non-clinical testing show that the strength of the Palladian™ Lumbar Pedicle Screw System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Palladian™ Lumbar Pedicle Screw System is substantially equivalent to the predicate device.