(267 days)
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No
The document describes a mechanical spinal fixation system and its components, with no mention of software, algorithms, or any technology related to AI or ML. The performance studies are mechanical tests, not algorithmic performance evaluations.
No
A therapeutic device is one that performs a treatment or cures a disease or condition. This device is a posterior spinal fixation device that provides immobilization and stabilization, which is an adjunctive therapy, not a primary treatment.
No
The device is a posterior spinal fixation system, which is an implantable device used to stabilize spinal segments as an adjunct to fusion, not to diagnose medical conditions.
No
The device description explicitly states it consists of physical components like pedicle screws, rods, set screws, and a transverse linking mechanism, all fabricated from titanium alloy. It also mentions specialized instruments for application and removal. This clearly indicates a hardware-based medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Zenius™ Spinal System is a "posterior spinal fixation device" used to "provide immobilization and stabilization of spinal segments as an adjunct to fusion." This describes a surgical implant used in vivo (within the body) to treat structural issues in the spine.
- Device Description: The description details the components of the system (pedicle screws, rods, set screws, etc.) and the materials they are made from (titanium alloy). These are all components of a surgical implant.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body (such as blood, urine, or tissue) to provide information about a person's health. This device does not perform any such tests on bodily samples.
The information provided describes a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The Medyssey Co. Ltd., Zenius™ Spinal System, a posterior spinal fixation device, indicated for skeletally mature patients receiving fusion by autogenous bone graft with removal of the implants after the attainment of a solid fusion and is intended to provide immobilization and stabilization of spinal segments 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).
Product codes
MNI, MNH
Device Description
The Medyssey Co. Ltd., Zenius ™ Spinal System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, set screws, and a transverse (cross) linking mechanism. The Medyssey Co. Ltd., Zenius ™ Spinal System implant components are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available.
Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the Medyssey Co. Ltd., Zenius ™ Spinal System implants.
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
thoracic, lumbar, and sacral spine
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 mechanical testing for both the predicate and the subject included static and fatigue testing performed per ASTM F 1717-04. Testing included: Static Compression Bending; Static Tension Bending; and Static Torsional Testing.
The subject device performed substantially equal or better in the above mentioned testing to that of the predicated devices.
Clinical tests: No clinical tests conducted on either the subject system nor the predicate systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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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510(k) SUMMARY
JUN 2 5 2010
510 (K) Premarket Notification: Medyssey Co. Ltd, Zenius™ Spinal System
1. Submitter/Sponsor:
Medyssey Co. Ltd. Patrick D. Moore, Official US Correspondent 722-3, 4F. Science Tower, Jihaeng-dong, Dongducheon-city, Gyeonggi-do, Korea
Contact person:
Patrick D. Moore Official US Correspondent Medyssey Co. Ltd. 6170 South 380 West, Suite 200. Murray, Utah. 84107 Tel. 801-266-4811, Fax. 801-266-4363; E-Mail: pdmoore@jemospine.com
Date Prepared:
June 25th, 2010
2. Device Name:
| Classification Name: | Pedicle Screw Spinal Fixation System |
|---|---|
| Common/Generic Name: | Pedicle Screw Spinal System |
| Trade Name: | Medyssey Co. Ltd, Zenius TM Spinal System |
3. Device Classification(s):
Class II (88.3390) following Orthopedic and Rehabilitation Device Advisory Review, for the requested indications:
- Spinal Pedicle Screw (MNI) 21 CFR § 888.3070 .
- Spondylolisthesis Spinal Fixation Device System (MNH) 21 CFR § . 888.3070
4. Predicate Device:
U&I Corporation, OPTIMA™ Spinal System – MNI, MNH, KWQ -- (K020279 and K024098) Medyssev Co. Ltd., NOVEL™ Spinal System - MNH, MNI - (K081153)
5. Device Description:
The Medyssey Co. Ltd., Zenius ™ Spinal System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, set screws, and a transverse (cross) linking mechanism. The Medyssey Co. Ltd., Zenius ™ Spinal System implant components are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available.
Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the Medyssey Co. Ltd., Zenius ™ Spinal System implants.
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6. Indications for Use:
The Medyssey Co. Ltd., Zenius™ Spinal System, a posterior spinal fixation device, indicated for skeletally mature patients receiving fusion by autogenous bone graft with removal of the implants after the attainment of a solid fusion and is intended to provide immobilization and stabilization of spinal segments 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).
- Comparison with predicate device: The Medyssey Co. Ltd., Zenius ™ Spinal System is substantially equivalent to the currently marketed U&I Opinal Oystem is oubotantially of Sistem and Medyssey's Co. Ltd., Novel™ Spinal System. When considered for posterior applications, the Medyssey Co. Ltd., Zenius TM Spinal System, the Medyssey's Co. Ltd., Novel™ Spinal System Eld., Londo - Opinal Oys., OPTIMA™ Spinal System worst case constructs consist of a universal housing containing a pre-assembled pedicle screw and set screw. All three systems use vertical rods which are both placed into the housing. The set screws are subsequently tightened onto the rod, providing a completed implant assembly.
The principles of operation for the subject Medyssey Co. Ltd., Zenius™ Spinal System device, and the cited predicate technologies are similar. That is, each of these products employs similar indications for use, contraindications for use, warnings and precautions within labeling. The principles of operation of the subject device are directly equivalent to those of the cited predicates cleared by the Agency and currently being marketed.
Both the subject device and the predicate device were evaluated/tested per established requirements. The mechanical testing for both the predicate and the subject included static and fatigue testing performed per ASTM F 1717-04. Testing included: Static Compression Bending; Static Tension Bending; and Static Torsional Testing.
The subject device performed substantially equal or better in the above mentioned testing to that of the predicated devices.
Clinical tests: No clinical tests conducted on either the subject system nor the predicate systems.
Conclusion: The subject device was evaluated against the predicate devices for all performance, safety & effectiveness requirements and found as substantially equivalent to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest wings and a head.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 2 5 2010
Medyssey Co., Ltd. % Mr. Patrick.D. Moore 6170 South 380 West, Suite 200 Murray, Utah 84107
Re: K093104
Trade/Device Name: Medyssey Co., Ltd. Zenius™ Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH Dated: June 21, 2010 Received: June 21, 2010
Dear Mr. Moore:
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 vour 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 - Mr. Patrick D. Moore
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 n you about open . 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/ReportalProblem/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,
Barbara Bruchid
Mark N. Melker Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K093104
Device Name: Medyssey Co. Ltd., Zenius™ Spinal System
Indications for Use: The Medyssey Co. Ltd., Zenius™ Spinal System, a posterior spinal fixation device, indicated for skeletally mature patients receiving fusion by autogenous bone graft with removal of the implants after the attainment of a solid fusion and is intended to provide immobilization and stabilization of spinal segments 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).
(Per 21 CFR801.109) Prescription Use______________________________________________________________________________________________________________________________________________________________ × OR Over-the-Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Joutish
(Division Sign-Of) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093104
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