(137 days)
The EXPEDIUM Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: 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; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
The EXPEDIUM Spine System is a 5.5mm and 6.35mm rod based system offered in both titanium and stainless steel. Both systems consist of the following: Monoaxial Screws, Polyaxial Screws, Reduction screws, Reduction hooks, Hooks, Extended Tab Implants, Sacral Extenders, Lateral connectors, Washers.
The proposed addition to the EXPEDIUM Spine System is a 5.5 and 6.35mm rod and plate offset system offered in both titanium and stainless steel. The EXPEDIUM Spine System will also include the following: Fixed Bolts, Polyaxial Bolts, Closed screws, Slotted connectors, Plates, Nuts, Washers, Drop-entry connectors, Modular cross connectors, Transverse rod connectors, Wires.
These additional components are available in various geometries and sizes to accommodate patient anatomy. They will be provided non-sterile and sterile.
The provided document is a 510(k) premarket notification for additions to the EXPEDIUM® Spine System. This document describes a medical device (spinal implant components) and its substantial equivalence to previously cleared predicate devices, rather than a diagnostic device or AI/ML-driven system. Therefore, many of the requested criteria such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable to this type of submission.
However, I can extract the acceptance criteria and the "study" (in this case, mechanical testing) that demonstrates the device meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Static compression bending | The acceptance criteria was/were met (as per ASTM F1717-04 standard). | Met |
| Static torsion | The acceptance criteria was/were met (as per ASTM F1717-04 standard). | Met |
| Dynamic compression bending | The acceptance criteria was/were met (as per ASTM F1717-04 standard). | Met |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not specified in terms of number of samples, but the "test set" refers to the new components of the EXPEDIUM Spine System (closed screws, fixed bolts, polyaxial bolts, cross connectors, nuts, washers, wires, and plates) that underwent mechanical testing.
- Data Provenance: The tests were conducted according to ASTM F1717-04 standard, which is an international standard. The submission is from Medos International Sárl, located in Switzerland, with a contact person in the US.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a mechanical device, and "ground truth" is established by adherence to engineering performance standards (ASTM F1717-04) rather than expert consensus on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Mechanical testing results are objective measurements against a standard, not subject to adjudication.
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 is a physical spinal implant system, not a diagnostic or AI-assisted system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a physical spinal implant system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device is based on established mechanical engineering performance standards, specifically ASTM F1717-04, for spinal implant constructs in a vertebrectomy model.
8. The sample size for the training set:
Not applicable. This is a physical device, not an AI/ML system.
9. How the ground truth for the training set was established:
Not applicable. This is a physical device, not an AI/ML system.
In summary, the study proving the device meets its acceptance criteria involved nonclinical mechanical testing (Static compression bending, Static torsion, Dynamic compression bending) in accordance with the ASTM F1717-04 standard. The acceptance criteria for these tests were simply "the acceptance criteria was/were met" as defined by that standard. No clinical testing was performed for this 510(k) submission. The submission relies on substantial equivalence to predicate devices and the successful completion of these mechanical tests to demonstrate safety and effectiveness.
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| 5. 510(K) SUMMARY | AUG 31 2010 |
|---|---|
| Submitter: | Medos International SárlChemin-Blanc 38Le Locle, CH-NE 2400, Switzerland |
| Contact Person: | Daphney GermainRegulatory Affairs AssociateDePuy Spine, Inc.Voice: (508) 880-8395Fax: (508) 828-3797E-Mail: dgermain@its.jnj.com |
| Date Prepared: | August 16, 2010 |
| Device Class: | Class III |
| Tradename: | EXPEDIUM® Spine System |
| Common Name: | Appliance, Fixation, Spinal Interlaminal;Orthosis, Spondyloisthesis Spinal Fixation;Orthosis, Spinal Pedicle Fixation;Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease |
| Classification Name: | Spinal interlaminar fixation orthosisper 21 CFR §888.3050Spinal intervertebral body fixation orthosisper 21 CFR §888.3060Pedicle screw spinal fixationper 21 CFR §888.3070 |
| Classification Panel: | Orthopedics |
| FDA Panel Number: | 87 |
| Product Code(s): | NKB, KWQ, KWP, MNH, MNI |
| Proprietary Name: | EXPEDIUM® Spine System |
| Device Description: | The EXPEDIUM Spine System is a 5.5mm and 6.35mm rod basedsystem offered in both titanium and stainless steel. Both systemsconsist of the following:Monoaxial ScrewsPolyaxial Screws |
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- . Reduction screws
- . Reduction hooks
- Hooks .
- Extended Tab Implants .
- Sacral Extenders .
- Lateral connectors .
- Washers .
The proposed addition to the EXPEDIUM Spine System is a 5.5 and 6.35mm rod and plate offset system offered in both titanium and stainless steel. The EXPEDIUM Spine System will also include the following:
- Fixed Bolts ●
- . Polyaxial Bolts
- Closed screws .
- Slotted connectors .
- Plates .
- . Nuts
- . Washers
- . Drop-entry connectors
- . Modular cross connectors
- Transverse rod connectors .
- . Wires
These additional components are available in various geometries and sizes to accommodate patient anatomy. They will be provided non-sterile and sterile.
The EXPEDIUM Spine System is intended to provide Intended Use: immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: 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; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
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| Materials: | Manufactured from ASTM F138 implant grade stainless steel,ASTM F136 implant grade titanium alloy, and ASTM F 562implant grade cobalt-nickel-chromium-molybdenum alloy. |
|---|---|
| Predicate Devices: | EXPEDIUM Spine System - K092473, K090230, K080313K062174, and K071495ISOLA System - K013441, K010972, and K980485MONARCH Spine System - K024348 and K010576VSP System - K984350TIMX System – K981274 |
| Summary ofTechnologicalDifferences: | The purpose of this submission is to obtain market clearance forthe proposed additional components to the EXPEDIUM 5.5mmand 6.35mm Spine Systems which consist of closed screws, fixedbolts, polyaxial bolts, cross connectors, nuts, washers, wires, andplates. These proposed components have the same designcharacteristics, performance, intended use, and packaging as thepredicate devices. The key differences between the subject andpredicate devices are:The addition of various sizes of closed screws, fixed bolts,polyaxial bolts, cross connectors, nuts, washers, wires, andplates. The availability of sterile components. |
| Nonclinical TestSummary: | The following mechanical tests were conducted:Static compression bending in accordance with ASTMF1717-04 test standard Standard Test Methods for SpinalImplant Constructs in a Vertebrectomy Model. Theacceptance criteria was/were met. Static torsion in accordance with ASTM F1717-04 teststandard Standard Test Methods for Spinal ImplantConstructs in a Vertebrectomy Model. The acceptancecriteria was/were met. Dynamic compression bending in accordance with ASTMF1717-04 test standard Standard Test Methods for SpinalImplant Constructs in a Vertebrectomy Model. Theacceptance criteria was/were met. |
| Clinical TestSummary: | No clinical tests were performed. |
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Traditional 510(k) Submission – Additions to the EXPEDIUM® 5.5mm & 6.35mm Spine Systems
.
Conclusion:
Based on the predicate comparison and testing, the subject additions to the EXPEDIUM 5.5mm and 6.35mm Spine Systems are substantially equivalent to the predicate devices.
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Image /page/4/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-like 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
Medos International Sarl % DePuy Spine, Inc. Ms. Daphney Germain Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767
AUG 3 1 2010
Re: K101070
K101070
Trade/Device Name: EXPEDIUM® Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Regulatory Chass!" B, MNH, MNI, KWQ, KWP Dated: August 16, 2010 Received: August 17, 2010
Dear Ms. Germain:
We have reviewed your Section 510(k) premarket notification of intent to market the device
ting indication in the charge is and the device is whetantially equivalent (for the We have reviewed your Section > IV(K) premium in the minuted (for the indications
referenced above and have determined the device is substantially equivalent in interstate referenced above and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to legally market predical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food, Drug, commerce prior to May 28, 1976, the enactment use of the Federal Food, Drug, Drug,
devices that have been reclassified in accordance with the provisions of the Federal Food, devices that have been reclassined in accordance will and proval application
and Cosmetic Act (Act) that do not require approval of a premarket approval application and Cosmetic Act (Act) that do not require approvation to the general controls provisions of the
(PMA). You may, therefore, market the device, subject to the general control (PMA). You may, therefore, market the device, suchie menual registration,
Act. The general controls provisions of the Act include requirements for annual misbrandin Act. The general controls provisions of the Act Include Lequintini Son against misbranding
listing of devices, good manufacturing practice, labeling, and prohibitions agains listing of devices, good manufacturing practice, labelion related to contract liability
and adulteration. Please note: CDRH does not evaluate information related ing. and adulteration. Please note: CDRH does not evaluate information on the misleading.
warranties. We remind you; however, that device labeling must be truthful and not mis
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) into eimer class if (optents of control your device can be
may be subject to additional controls. Existing major regulations affecti may be subject to additional controls. Existing major regardent of the Soles of Anaddition, FDA may
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In found in the Code of Federal Regulations, This ETF and Collection
publish further announcements concerning your device in the Federal Register.
{5}------------------------------------------------
Page 2 - Ms. Daphney Germain
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s Issualic of a subscribes with other requirements of the Act
that FDA has made a determination that your device only - Econoles, You must that FDA has made a delerimiation and Jour and Journer Federal agencies. You must or any Federal statures and regulations administers or registration and listing (21
comply with all the Act's requirements, including, but not setting of medical comply with all the Act S requirements, includes reporting (to ording of medical CFR Part 807); labeling (21 CFR Pall 801); pood manufacturing practice requirements as set
device-related adverse events) (21 CFR 803); good manufacturing practice requiremen device-related adverse events) (21 CFR 803); good fif applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the elect forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
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
r (1580), please (1) (1) = ================================================ If you desire specific advice for your device of var adolfices/ucm115809.htm for any for for for for for for for the go to http://www.ida.gov/Aboult12/0CentersOries/Office of Compliance. Also, please
the Center for Devices and Radiological Health's (CDBH's) Office of Compliance. (21CFR Par the Center for Devices and Radional realling by reference to oremarket notification" (21CFR Part
note the regulation entitled, "Misbranding by reference under the MDR regulat note the regulation entitled, " Misoraliung by reference to premiers" CFR Part 803), please go to
CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of http://www.ida.gov/Micdicalles/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the You may obtain other general informational and Consumer Assistance at its toll-free number Division of Small Manazzone of its Internet address (800) 038-2041 01 (501) 770-7100 01 at the researcesfor You/Industry/default.htm.
Sincerely yours,
Carlare Buelu
Mark N. Melkers Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Traditional 510(k) Submission - Additions to the EXPEDIUM® 5.5mm & 6.35mm Spine Systems
INDICATIONS FOR USE STATEMENT 4.
510(k) Number (if known): K101070
AUG 31 2010
10/070
Device Name: EXPEDIUM® Spine System
Indications For Use:
The EXPEDIUM Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
The EXPEDIUM Spine System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: 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 failed previous fusion in skeletally mature patients.
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 THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KI01070 510(k) Number_
§ 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.