(30 days)
Not Found
No
The description focuses on the mechanical components and materials of a spinal implant system, with no mention of software, algorithms, or data processing capabilities that would indicate AI/ML.
Yes
This device, a pedicle screw system, is intended to provide correction, immobilization, and stabilization of spinal segments as an adjunct to fusion for various spinal conditions, which directly addresses medical conditions and aims to improve health.
No
The device description indicates that the LEUCADIA™ MIS Pedicle Screw System is an implant intended to provide correction, immobilization, and stabilization of spinal segments as an adjunct to fusion. It is a treatment device, not one that diagnoses conditions.
No
The device description explicitly details hardware components (rods, cannulated screws, guidewire) made of titanium alloy, indicating it is a physical implant system, not software only.
Based on the provided information, the LEUCADIA™ MIS Pedicle Screw System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a surgical implant system used in vivo (within the body) as an adjunct to fusion for various spinal conditions. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a system of rods and screws made of titanium alloy, designed to be implanted into the spine. This is consistent with a surgical device, not an IVD.
- Lack of IVD characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory tests.
Therefore, the LEUCADIA™ MIS Pedicle Screw System is a surgical implant device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The LEUCADIA™ MIS Pedicle Screw System is intended to be used as an adjunct to fusion using autograft or allograft in posterior, non-cervical fixation for the following conditions: 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; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumors; pseudarthrosis; and/or failed previous fusion.
Product codes
NKB, KWP, KWQ, MNI, MNH
Device Description
The Leucadia™ MIS Pedicle Screw System is intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space.
The Leucadia™ MIS Pedicle Screw System consists of a variety of rods and cannulated screws, which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case. Multi-axial implant screws are supplied in 5mm, 6mm, and 7mm diameter sizes. All sizes are able to receive 5.5mm connecting rods only. The ø1.7mm cannulation allows the screws to be implanted over a guidewire in a "mini open" or minimally invasive procedure. The Leucadia™ MIS Pedicle Screw System implant components are fabricated from medical grade titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or equivalent.
The Leucadia™ MIS Pedicle Screw System is a temporary implant system, intended to be removed after solid fusion has occurred. Leucadia™ MIS Pedicle Screw System implant components should not be used with components from any other system or manufacturer. As with all orthopedic implants, Leucadia™ MIS Pedicle Screw System components should not be reused.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior, non-cervical fixation (thoracic, lumbar and/or sacral space)
Indicated Patient Age Range
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biomechanical tests per ASTM F1717-10 (Static Compression Bending, Static Torsion, and Dynamic Compression Bending) as well as the Screw Pullout Tests per ASTM F543-07 have been performed. The test results were equivalent to the predicate device and/or other similar implants and are sufficient for in vivo loading.
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
§ 888.3070 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
长川2931
NOV - 2 2011
510(k) Summary
| Contact: | Mr. Hartmut Loch
Vice President, Regulatory Affairs & Quality Assurance
Phygen, LLC.
2301 Dupont Drive, Suite 510
Irvine CA 92612
Tel: 1-949-752-7885 x 117 - Fax: 1-949-752-7886 | |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Date Prepared: | September 30, 2011 | |
| Trade name: | LEUCADIA™ MIS Pedicle Screw System | |
| Common name: | Spinal Fixation System | |
| Classification
name: | § 888.3070 - Orthosis, Spinal Pedicle Fixation, For Degenerative Disc
Disease
§ 888.3050 - Appliance, Fixation, Spinal Interlaminal
§ 888.3060 - Spinal Intervertebral Body Fixation Orthosis
§ 888.3070 - Pedicle Screw Spinal System
§ 888.3070 - Pedicle Screw Spinal System
All Orthopedic Device Panel 87 | (NKB) - Class III
(KWP) - Class II
(KWQ) - Class II
(MNI) - Class II
(MNH) - Class II |
| Product Code (s): | NKB, KWP, KWQ, MNI, & MNH | |
| Device Description
and Characteristics: | The Leucadia™ MIS Pedicle Screw System is intended to help provide
correction, immobilization and stabilization of spinal segments as an adjunct
to fusion of the thoracic, lumbar and/or sacral space.
The Leucadia™ MIS Pedicle Screw System consists of a variety of rods and
cannulated screws, which can be rigidly locked into a variety of
configurations, with each construct being tailor made for the individual case.
Multi-axial implant screws are supplied in 5mm, 6mm, and 7mm diameter
sizes. All sizes are able to receive 5.5mm connecting rods only. The
ø1.7mm cannulation allows the screws to be implanted over a guidewire in a
"mini open" or minimally invasive procedure. The Leucadia™ MIS Pedicle
Screw System implant components are fabricated from medical grade
titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 or equivalent.
The Leucadia™ MIS Pedicle Screw System is a temporary implant system,
intended to be removed after solid fusion has occurred. Leucadia™ MIS
Pedicle Screw System implant components should not be used with
components from any other system or manufacturer. As with all orthopedic
implants, Leucadia™ MIS Pedicle Screw System components should not be
reused. | |
| Equivalence: | The modified LEUCADIA™ MIS Pedicle Screw System is substantially
equivalent to the LEUCADIA™ Pedicle Screw System (K110588 – S/E May
25, 2011), which is manufactured and marketed by Phygen, LLC. | |
Page 1 of 2
1
The LEUCADIA™ MIS Pedicle Screw System is intended to be used as an Indications: adiunct to fusion using autograft or allograft in posterior, non-cervical fixation for the following conditions: 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; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumors; pseudarthrosis; and/or failed previous fusion.
Biomechanical tests per ASTM F1717-10 (Static Compression Bending, Performance data: Static Torsion, and Dynamic Compression Bending) as well as the Screw Pullout Tests per ASTM F543-07 have been performed. The test results were equivalent to the predicate device and/or other similar implants and are sufficient for in vivo loading.
Page 2 of 2
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV 2 2011
Phygen, LLC % Mr. Hartmut Loch Vice President, Regulatory Affairs and Quality Assurance 2301 Dupont Drive, Suite 510 Irvine, California 92612
Re: K112931
Trade/Device Name: LEUCADIA™ MIS 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, KWQ Dated: September 30, 2011 Received: October 03, 2011
Dear Mr. Loch:
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.
3
Page 2 – Mr. Hartmut Loch
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 (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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Sincerely yours,
Eunel Keith
for Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
LEUCADIA™ MIS Pedicle Screw System Device Name(s):
Indications for Use:
The LEUCADIA™ MIS Pedicle Screw System is intended to be used as an adjunct to fusion using autograft or allograft in posterior, non-cervical fixation for the following conditions:
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; curvatures (i.e. scoliosis, kyphosis and/or lordosis); tumor pseudarthrosis; and/or failed previous fusion.
AND/OR Over-The-Counter-Use Prescription Use × (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tonath Ar
(Division Sign-Off) (Division Sigh-Ord), Orthopedic, Division of Surgical and Restorative Devices
510(k) Number_KII2131