(94 days)
Not Found
No
The summary describes an expansion of size offerings for a spinal fixation system and does not mention any AI or ML components.
Yes
The device is described as a spinal system intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction, treating conditions like neck pain, spondylolisthesis, spinal stenosis, and fractures, which are all therapeutic interventions.
No
The document describes a spinal system (MOUNTAINEER OCT Spinal System) used for surgical fixation and fusion, not for diagnosing medical conditions.
No
The device description explicitly states it is an expansion of a spinal system and includes manual surgical instruments and cases, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description and intended use clearly state that this device is a spinal system (screws, rods, cables) used for surgical implantation to promote fusion of the spine. This is a surgical implant, not a device used for testing samples outside the body.
- Lack of IVD Characteristics: The document does not mention any testing of biological samples, analysis of biomarkers, or diagnostic procedures performed on samples.
Therefore, based on the provided information, the MOUNTAINEER OCT Spinal System is a surgical implant device, not an In Vitro Diagnostic.
N/A
Intended Use / 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 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 minipolyaxial 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™ and MOSS® MIAMI™ Systems using the dual wedding band and axial connectors, and via dual diameter rods.
Product codes (comma separated list FDA assigned to the subject device)
KWP, MNI, MNH
Device Description
Expansion of the size offering of MOUNTAINEER OCT Spinal System Minipolyaxial Screws.
The MOUNTAINEER OCT Spinal System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine, occipito-cervico-thoracic junction (occiput – T3), upper thoracic spine (T1-T3)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data were submitted to characterize the additional components of the MOUNTAINEER OCT Spinal System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
MOUNTAINEER OCT Spinal System (K041203, K042508), SUMMIT OCT Spinal System (K002733, K010681, K013222, K022190, K030103)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
IX. 510(k) Summary
长080828
| SUBMITTER: | DePuy Spine, Inc.
325 Paramount Drive
Raynham, MA 02780 | JUN 27 2008 |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| CONTACT PERSON: | Lisa A. Gilman | |
| CONTACT TELEPHONE: | (508) 880-8100 | |
| DATE PREPARED: | June 19, 2008 | |
| CLASSIFICATION NAME: | Appliance, Fixation, Spinal Interlaminal
§888.3050 | |
| | Orthosis, Spinal Pedicle Fixation
§888.3070 | |
| CLASSIFICATION PANEL NAME: | Orthopedics | |
| FDA PANEL NUMBER: | 87 | |
| PRODUCT CODE: | KWP, MNI, MNH | |
| PROPRIETARY NAME: | MOUNTAINEER OCT Spinal System | |
| PREDICATE DEVICES: | MOUNTAINEER OCT Spinal System (K041203,
K042508) | |
| | SUMMIT OCT Spinal System (K002733, K010681,
K013222, K022190, K030103) | |
| DEVICE DESCRIPTION: | Expansion of the size offering of MOUNTAINEER OCT
Spinal System Minipolyaxial Screws.
The MOUNTAINEER OCT Spinal System also contains
Class 1 manual surgical instruments and cases that are
considered exempt from premarket notification. | |
Page 1 of 2
·
1
INTENDED 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 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 minipolyaxial 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™ and MOSS® MIAMI™ Systems using the dual wedding band and axial connectors, and via dual diameter rods.
MATERIALS:
PERFORMANCE DATA:
Manufactured from ASTM F-136 implant grade titanium alloy.
Performance data were submitted to characterize the additional components of the MOUNTAINEER OCT Spinal System.
DePuy Spine, Inc. Special 510K
2
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 with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The text is in all capital letters and is written in a simple, sans-serif font. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DePuy Spine, Inc. % Ms. Lisa Gilman 325 Paramount Drive Raynham, MA 02767
JUN 2-7 2008
Dear Ms. Gilman:
Re: K080828
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: MNH, MNI, KWP Dated: June 12, 2008 Received: June 17, 2008
Dear Ms. Gilman:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
3
Page 2 – Ms. Lisa Gilman
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Mulhearn
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
lll. Indications for Use
510(k) Number (if known):
Modified MOUNTAINEER™ OCT Spinal System Components Device Name:
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 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 minipolyaxial 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™ and MOSS® MIAMI™ Systems using the dual wedding band and axial connectors, and via dual diameter rods.
| 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-CON R PAGE IF NEEDED)
Concurrence of CDRH, Offic
510(k) Number
DePuy Spine, Inc. Special 510K