(138 days)
The Tyche® Pedicle Screw System is a non-cervical, pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S 1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, The Tyche® Pedicle Screw System is 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
The Tyche Pedicle Screw System is made up of muti-axial and standard screws, rods, locking cap, adjustable cross connectors. This system's intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. All components are made from medical grade titanium alloy (Ti-6Al-4V-ELI) by such as ASTM F136. The products are supplied clean and "NON STERILE".
The medical device in question is the Tyche® Pedicle Screw System. The provided text focuses on its 510(k) submission for substantial equivalence, primarily detailing its design, materials, indications for use, and a comparison to predicate devices, rather than an acceptance criteria and study proving performance in the traditional sense of a clinical or software-based diagnostic device.
Therefore, the information for some requested sections, particularly those related to clinical performance, ground truth, and expert evaluation, is not available in the provided document. The performance data discussed is exclusively bench testing.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission for a spinal implant, the "acceptance criteria" are typically defined by recognized standards for mechanical performance, and "device performance" refers to the results of testing against these standards.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ASTM F 1717-04 - Standard Test Method for Spinal Implant Constructs in a Vertebrectomy Model (for static and dynamic axial compression bending test) | Bench testing performed in accordance with this standard.* |
| ASTM F 1717-04 - Standard Test Method for Spinal Implant Constructs in a Vertebrectomy Model (for static torsion test) | Bench testing performed in accordance with this standard.* |
*Note: The document states that testing was "performed in accordance with" ASTM F 1717-04, implying that the device met the requirements of this standard, which defines the acceptance criteria for mechanical performance of such implants. However, the specific quantitative results (e.g., actual load values, cycles survived) are not explicitly detailed in this summary; they are likely in the "mechanical testing report" mentioned in Appendix IV, which is not provided here.
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not explicitly stated regarding the number of devices or constructs tested. The testing was conducted on "the worst case Tyche" pedicle screw system structure."
- Data provenance: Not applicable in the context of clinical data. This refers to bench testing performed on manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for mechanical bench testing is established by the test setup and instrumentation measuring physical properties according to the ASTM standard. This does not involve expert clinical assessment or image interpretation.
4. Adjudication method for the test set
Not applicable. This concept (e.g., 2+1, 3+1) is relevant for studies involving human interpretation or clinical endpoints, not for mechanical bench testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a mechanical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a mechanical implant, not an algorithm.
7. The type of ground truth used
The ground truth for the "performance data" (bench testing) is based on mechanical properties and failure analysis as defined by the ASTM F 1717-04 standard. This standard simulates in-vivo conditions for spinal implants and assesses their structural integrity and strength.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-based device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, no training set is relevant for this type of device.
In summary, the provided 510(k) summary for the Tyche® Pedicle Screw System details its design, materials, indications, and substantial equivalence to predicate devices based on mechanical bench testing against an ASTM standard. It does not include information pertaining to clinical studies, human performance, or AI-related assessments.
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JUN 9 0 2010
510(k) Summary
The following 510(k) summary is being submitted as required by 21 CFR Part 807.92:
Date: 02/08/10
1. Submission information:
- a) Submitter
| Name | Kyungwon Medical Co.,Ltd |
|---|---|
| Address | Suite 601 World Meridian Venture Center, 60-24Gasan-Dong, Geumcheon-Gu, Seoul, Korea 153-801 |
| Phone | +82-2-2113-8693~8 |
| Fax | +82-2-2113-8699 |
| Contact | Ju YunR&D Center/Assistant Manager |
| Website | http://www.kyungwonmedical.com |
b) U.S Agent/Contact Person
13340 E Firestone Blvd. Suite J. Santa Fe Springs, CA 90670 Priscilla Juhee Chung Phone: 562-404-8466 Fax: 562-404-2757 Email : agent.fda@gmail.com
2. Device Identification:
Trade Name: Tyche Pedicle Screw System Common Name: Pedicle screw spinal system Classification Name: Orthosis, Spondyloisthesis Spinal Fixation (21CFR880.3070, Product code MNH, MNI)
3. Substantially Equivalent Predicate Legally Marketed Devices:
The subject Tyche" Pedicle Screw System is substantially equivalent in function, design, composition, labeling, and intended use to:
OPTIMATM Spinal System - K024096
4CIS® SOLAR SPINE SYSTEM - K082453
The substantial equivalence of this device is based on equivalence in intended use. materials, designs and operational principles to the above listed predicate devices.
4. Description:
The Tyche Pedicle Screw System is made up of muti-axial and standard screws, rods, locking cap, adjustable cross connectors. This system's intended to stabilize the
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spinal operative site during the fusion process of a bone graft in the disc space. All components are made from medical grade titanium alloy (Ti-6Al-4V-ELI) by such as ASTM F136. The products are supplied clean and "NON STERILE".
5. Indications for Use:
The Tyche Pedicle Screw System is a non-cervical, pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S 1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, The Tyche® Pedicle Screw System is 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
6. Statement of Technological comparison:
The Tyche" Pedicle Screw System is substantially equivalent to the above listed predicate devices in terms of materials, design, indications for use and operational principles. Based on the provided information in this premarket notification, it can be concluded that the subject device is substantial equivalent to the predicate devices and is safe and effective when used as intended.
7. Performance Date:
Bench testing (static and dynamic axial compression bending test and static torsion test of the worst case Tyche" pedicle screw system structure) as listed in section 2 (appendix IIIbrochure and IV-mechanical testing report) was performed in accordance with ASTM F 1717-04-Standard Test Method for Spinal Implant Constructs in a Vertebrectomy Model.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 3 0 2010
Kyungwon Medical Co., LTD. % Kodent Inc. Ms. Priscilla Juhee Chung 13340 E Firestone Boulevard, Suite J Sante Fe Springs, California 90670
Re: K100373
Trade/Device Name: Tyche® Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: June 23, 2010 Received: June 24, 2010
Dear Ms. Chung:
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
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Page 2 - Ms. Priscilla Juhee Chung
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-rclated 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 yours,
Mark A. Millhesson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K100373
Device Name: Tyche® Pedicle Screw System
Indications For Use:
The Tyche® Pedicle Screw System is a non-cervical, pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S 1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
In addition, The Tyche® Pedicle Screw System is 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).
ion, scoliosis, kyphosis, spinal tumor and
(Division Sign-Off)
(Division of Surgical, Orthopedi and Restorative Devices
510(k) Number K100373
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Status Restricted for
on Sign-C Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of
510(k) Number K100373
§ 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.