(28 days)
The indications for use for the modified devices described in this submission are the same as those for the MOUNTAINEER OCT Spinal System. The indications are as follows:
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput - T3), the MOUNTAINEER Occipito-Cervical-Thoracic (OCT) Spinal System is intended for:
- ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- spondylolisthesis
- spinal stenosis
- fracture/dislocation
- atlanto/axial fracture with instability
- occipitocervical dislocation
- revision of previous cervical spine surgery
- tumors
The occipital bone screws are limited to occipital fixation only.
The use of the monoaxial and polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
The Songer Cable System, to be used with the MOUNTAINEER OCT Spinal System, allows for wire/cable attachment to the posterior cervical spine.
The MOUNTAINEER OCT Spinal System can also be linked to the ISOLA®, TiMX®, MONARCH®, EXPEDIUM®, VIPER® and MOSS® MIAMI® Systems using the dual wedding band and axial connectors, and via dual diameter rods.
Addition of the 3.5mm diameter monoaxial screw to the existing MOUNTAINEER® OCT Spinal System. This system also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
The KIO3100 submission describes the addition of a 3.5mm diameter monoaxial screw to the existing MOUNTAINEER® OCT Spinal System. The device's performance is demonstrated through non-clinical mechanical testing, comparing it to predicate devices. This is a medical device, not an AI/ML device, so many of the requested categories are not applicable.
Here's the breakdown of the available information:
- A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| Static cantilever beam in accordance with ASTM F1798 | Testing conducted and results supported substantial equivalence. The submission implies that the new components meet the same performance standards as the predicate devices under these conditions. Specific numerical results are not provided in the summary, but the conclusion states "Based on the predicate comparison and testing, the subject MOUNTAINEER® OCT Spinal System is device substantially equivalent to the predicate device." |
| Static axial slip in accordance with ASTM F1798 | Testing conducted and results supported substantial equivalence. The submission implies that the new components meet the same performance standards as the predicate devices under these conditions. |
| Dynamic cantilever beam in accordance with ASTM F1798 | Testing conducted and results supported substantial equivalence. The submission implies that the new components meet the same performance standards as the predicate devices under these conditions. |
| Intended Use, Design Characteristics, Materials, Performance, and Packaging (comparison to predicate devices) | The proposed components "have the same intended use, design characteristics, materials, performance, and packaging as the predicate devices." |
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided. The study involved non-clinical mechanical testing, not clinical human subject data. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. This is a mechanical device, and "ground truth" as it applies to AI/ML or diagnostic studies is not relevant here. The ground truth for mechanical testing is established by the ASTM standards themselves and the physical measurements obtained. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is a mechanical device. -
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 mechanical device. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical device. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For mechanical testing, the "ground truth" is defined by the physical properties measured under standardized ASTM test methods (ASTM F1798 in this case) and the established performance characteristics of the predicate devices. -
The sample size for the training set
Not applicable. This is a mechanical device, not an AI/ML system requiring a training set. -
How the ground truth for the training set was established
Not applicable.
{0}------------------------------------------------
KIO3100
NOV 1 7 2010
IX. 510(k) Summary
| SUBMITTER: | DePuy Spine, Inc.325 Paramount DriveRaynham, MA 02780 |
|---|---|
| ------------ | --------------------------------------------------------------- |
- Eugene Bang CONTACT PERSON: Regulatory Affairs Associate Voice: 508-977-3966 508-828-3797 Fax: Email: ebang@its.jnj.com
DATE PREPARED: October 11, 2010
CLASSIFICATION NAME: Appliance, Fixation, Spinal Interlaminal Orthosis, Spinal Pedicle Fixation
REGULATION NUMBER: 888.3050, 888.3070
CLASSIFICATION
人人 : 在线
上一篇:
上一篇:
上一篇:
Orthopedics PANEL NAME:
FDA PANEL NUMBER: 87
KWP, MNI PRODUCT CODE:
PROPRIETARY NAME: MOUNTAINEER® OCT Spinal System
MOUNTAINEER® OCT Spinal System PREDICATE DEVICES: (K080828, K041203)
Addition of the 3.5mm diameter monoaxial screw to the DEVICE DESCRIPTION: existing MOUNTAINEER® OCT Spinal System.
This system also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
The indications for use for the modified devices described in INTENDED USE: this submission are the same as those for the MOUNTAINEER OCT Spinal System. The indications are as follows:
{1}------------------------------------------------
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput - T3), the MOUNTAINEER Occipito-Cervical-Thoracic (OCT) Spinal System is intended for:
- ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
- · spondylolisthesis
- · spinal stenosis
- · fracture/dislocation
- · atlanto/axial fracture with instability
- · occipitocervical dislocation
- · revision of previous cervical spine surgery
- · tumors
The occipital bone screws are limited to occipital fixation only.
The use of the monoaxial and polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
The Songer Cable System, to be used with the MOUNTAINEER OCT Spinal System, allows for wire/cable attachment to the posterior cervical spine.
The MOUNTAINEER OCT Spinal System can also be linked to the ISOLA®, TiMX®, MONARCH®, EXPEDIUM®, VIPER® and MOSS® MIAMI® Systems using the dual wedding band and axial connectors, and via dual diameter rods.
MATERIALS:
Manufactured from ASTM F-136 implant grade titanium alloy.
{2}------------------------------------------------
SUMMARY OF TECHNOLOGICAL DIFFERENCES:
The purpose of this submission is to obtain market clearance proposed additional components to the for the MOUNTAINEER® OCT System which consists of monoaxial screws. These proposed components have the same intended use, design characteristics, materials, performance, and packaging as the predicate devices. The kev differences between the subject and predicate devices are:
- The length reduction on overall head height. .
- The non-threaded shank diameter is increased to . provide additional shank strength.
NON-CLINICAL TEST SUMMARY:
The following mechanical tests were conducted:
- . Static cantilever beam in accordance with ASTM F1798 "Standard Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spine Arthrodesis Implants".
- Static axial slip in accordance with ASTM F1798 . "Standard Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spine Arthrodesis Implants".
- Dynamic cantilever beam in accordance with ASTM . F1798 "Standard Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spine Arthrodesis Implants".
CONCLUSION:
Based on the predicate comparison and testing, the subject Svstem is MOUNTAINEER® OCT Spinal device substantially equivalent to the predicate device.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DePuy Spine, Inc. % Mr. Eugene Bang Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02780
2010 NOV
Re: K103100
Trade/Device Name: MOUNTAINEER® OCT Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, KWP Dated: October 11, 2010 Received: October 20, 2010
Dear Mr. Bang:
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
{4}------------------------------------------------
Page 2 - Mr. Eugene Bang
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/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark A. Millman
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
III. Indications for Use
510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________
Device Name: MOUNTAINEER® OCT Spinal System
NOV 1 7 2010
Indications For Use:
The indications for use for the modified devices described in this submission are the same as those for the MOUNTAINEER OCT Spinal System. The indications are as follows:
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput - T3), the MOUNTAINEER Occipito-Cervical-Thoracic (OCT) Spinal System is intended for:
- ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by patient o history and radiographic studies)
- . spondylolisthesis
- spinal stenosis o
- o fracture/dislocation
- atlanto/axial fracture with instability 0
- occipitocervical dislocation o
- revision of previous cervical spine surgery �
- tumors .
The occipital bone screws are limited to occipital fixation only.
The use of the monoaxial and polyaxial screws is limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
The Songer Cable System, to be used with the MOUNTAINEER OCT Spinal System, allows for wire/cable attachment to the posterior cervical spine.
The MOUNTAINEER OCT Spinal System can also be linked to the ISOLA®. TiMX®. MONARCH®, EXPEDIUM®, VIPER® and MOSS® MIAMI® Systems using the dual wedding band and axial connectors, and via dual diameter rods.
Prescription Use (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
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.