The Novel III Spinal System is a 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 Novel Spinal 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).

Device Description

The Novel ///TM Spinal Fixation and Adjustable Bridge System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, set screws, and a transverse (cross) linking mechanism. The Novel /// ™ Spinal Fixation and Adjustable Bridge System implant components are fabricated from titanium allov (Ti-6Al-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 Novel ////™ Spinal Fixation and Adjustable Bridge System implants.

AI/ML Overview

This 510(k) summary does not contain information related to an AI/ML device. The submission is for a medical device (spinal fixation system) and its modified sterilization trays, not a software algorithm that performs diagnostic or prognostic functions.

Therefore, many of the requested items (e.g., acceptance criteria for AI performance, sample size for test/training sets, expert ground truth, MRMC studies) are not applicable to this document.

Here's an analysis based on the information provided in the 510(k) summary, focusing on the device modification mentioned:

Acceptance Criteria and Study for Novel III™ Spinal Fixation and Adjustable Bridge System (Modified Sterilization Trays)

This 510(k) submission primarily concerns a "Special 510(k): Device Modification" related to redesigning custom sterilization trays for the Novel III™ Spinal Fixation and Adjustable Bridge System. The core spinal fixation device itself has already been cleared (predicates K081153 and K103147).

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria and reported device performance are focused on the sterilization process for the redesigned trays, not on the clinical performance of the spinal system or an AI/ML algorithm.

Acceptance Criteria Category	Specific Criterion	Reported Performance / Outcome
Sterilization Validation	Achieve a Sterility Assurance Level (SAL) equal to at least 1 x 10⁻⁶	Validation satisfactorily performed on the redesigned sterilization trays.
Mechanical Testing (of the implant)	Conformance to ASTM F 1717-04 (Static Compression, Tension, Torsion Bending)	Performed on the subject/predicate device. (Note: Not for the new trays themselves, as trays are not worst-case and don't require this specific testing)
Material Conformance (of the implant)	Titanium alloy (Ti-6Al-4V ELI) conforms to ASTM F 136	Stated that implant components conform to ASTM F 136.
Substantial Equivalence	Device is substantially equivalent to predicate devices	Determined by FDA (letter) and stated in submission.

2. Sample Size and Data Provenance

Test Set Sample Size:
- For the sterilization validation, the sample size is not explicitly stated in the summary, but it would typically involve a statistically relevant number of sterilization cycles and biological indicator tests. The summary just states it was "satisfactorily performed."
- For mechanical testing of the implant, the sample size is not specified but would follow ASTM F 1717-04 guidelines.
Data Provenance: The data provenance for the tests performed (sterilization validation, mechanical testing) is not specified beyond being generated by Medyssey Co. Ltd. There is no mention of country of origin or whether it was retrospective or prospective, as these terms are relevant for clinical studies, not typically for device performance testing like sterilization or mechanical strength.

3. Number of Experts and Qualifications for Ground Truth Establishment

This item is not applicable as the submission does not involve an AI/ML algorithm or a diagnostic/prognostic device that requires expert ground truth establishment from clinical images or data. The ground truth for sterilization is a defined SAL, established through validated laboratory procedures.

4. Adjudication Method for the Test Set

This item is not applicable. The type of testing performed (sterilization validation, mechanical testing) does not involve human readers or adjudication processes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This item is not applicable. No MRMC study was performed as this is not an AI/ML device, nor is it a diagnostic imaging device where human reader performance would be the primary endpoint. The submission explicitly states: "Clinical tests: No clinical tests conducted on either the subject system nor the predicate system."

6. Standalone Performance (Algorithm Only)

This item is not applicable as there is no algorithm or software component for standalone performance evaluation in this 510(k) submission.

7. Type of Ground Truth Used

For Sterilization Validation: The ground truth is the Sterility Assurance Level (SAL), which is a quantitative measure (1 x 10⁻⁶), established through specific, validated laboratory methods involving biological indicators and physical parameters of the sterilization cycle.
For Mechanical Testing: The ground truth is the performance specifications defined by the ASTM F 1717-04 standard.
For Substantial Equivalence: The ground truth is the characteristics and performance of the predicate devices and the regulatory standard for equivalence.

8. Sample Size for the Training Set

This item is not applicable. There is no "training set" as this is not an AI/ML device.

9. How the Ground Truth for the Training Set was Established

This item is not applicable as there is no training set.

Summary

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510(k) SUMMARY

"Special 510 (K): Device Modification" Premarket Notification: Novel III Spinal Fixation and Adjustable Bridge System

1. Submitter/Sponsor:

Medvssey 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 801-266-4811, Fax. 801-266-4363; E-Mail: pdmoore@jemospine.com Tel.

Date Prepared:

June 8, 2011

2. Device Name:

Pedicle Screw Spinal System Classification Name: Common/Generic Name: Pedicle Screw Spinal System Novel III TM Spinal Fixation and Adjustable Bridge Trade Name: System

3. Device Classification(s):

Spinal Pedicle Screw (MNI, MNH) 21 CFR § 888.3070 .

4. Predicate Device:

Medyssey Co., Ltd., Nove/TM Spinal System - (K081153) Medyssey Co., Ltd., Novel " Spinal Fixation and Adjustable Bridge System -(K103147)

5. Device Description:

Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the Novel ////™ Spinal Fixation and Adjustable Bridge System implants.

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6. Intended Use:

In addition, the Novel Spinal System is intended to provide immobilization and stabilization of spinal seqments 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).

Comparison with predicate device: The Novel ///™ Spinal System is substantially equivalent to the currently marketed Nover™ Spinal System and the Novel M. Spinal Fixation and Adjustable Bridge System. When considered for anterior applications, both the Novel ///TM Spinal Fixation and Adjustable Bridge System and the cited predicates worst case constructs consist of the same universal housing containing the same pre-assembled pedicle screw and set screw. Both systems use the same vertical rods which are both placed into the housing. The same set screws are subsequently tightened onto the rod, providing a completed implant assembly.

The principles of operation for the subject Novel ///™ Spinal Fixation and Adiustable Bridge System device, and the cited predicate technologies are same. That is, each of these products employs the same 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.

The design and development process of the manufacturer of subject system and Predicate system conforms to 21 CFR part 820, quality systems.

The subject device was evaluated/tested per established requirements.

The subject/predicate device underwent mechanical testing included Static Compression Bending; Static Tension Bending; and Static Torsional Testing. All testing performed per ASTM F 1717-04. However, the sole purpose of the submission is the clearance of the redesign of the custom sterilization trays, therefore the new modified custom dedicated sterilization tray(s) (are not worst case) and therefore not subject to ASTM F 1717-04 additional testing. However, a new Sterilization Validation according to AAMI ST77 and AAMI ST79 quidelines to achieve a degree of Sterility Assurance Level (SAL) equal to at least 1 x 10 x ; is required, and was satisfactorily preformed on the re-designed

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sterilization trays; the validation summary is presented within the body of this submission. Clinical tests: No clinical tests conducted on either the subject system nor the predicate system.

Conclusion: The subject device was evaluated against the predicate device for all performance, safety & effectiveness requirements and found as substantially equivalent to the predicate device.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

JUN - 8 2011

Medyssey Co., Ltd. % Mr. Patrick Moore 6170 South 380 West, Suite 200 Murray, Utah 84107

Re: K110284

Trade/Device Name: Novel III™ Spinal Fixation and Adjustable Bridge System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI. MNH Dated: May 04, 2011 Received: May 09, 2011

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 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 - Mr. Patrick 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 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.

ely yours,

For Blo Th

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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"Special 510(k): Device Modification" Number (if known):

Device Name: Novel III™ Spinal Fixation and Adjustable Bridge System

Indications for Use: The Novel III Spinal System is a 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 araft 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 Novel Spinal System is intended to provide immobilization and stabilization of spinal segments in skelefally 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).

Prescription Use	X
OR Over-the-Counter Use

(Per 21 CFR 801.109)

(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)

(Division Sign-Off) Division of Surgical, Orthopedic, and Blestorative Devices

KI10284 510(k) Number_

Regulation Number and Section

§ 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.