(41 days)
Not Found
No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is implanted to promote fusion and treat various spinal conditions, indicating a direct therapeutic purpose.
No
This device is a spinal system (plates, screws, rods, etc.) intended for promoting fusion of the cervical spine, not for diagnosing medical conditions. The "Intended Use" section clearly lists conditions it treats, not conditions it diagnoses.
No
The device description explicitly lists numerous hardware components (plates, nuts, bone screws, rods, etc.) and describes their physical use in surgical procedures. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Summit Occipito-Cervico-Thoracic (OCT) Spinal System is a collection of implants (plates, screws, rods, cables, etc.) designed to be surgically implanted into the spine to promote fusion and provide stability.
- Intended Use: The intended use clearly describes a surgical procedure to stabilize and fuse the cervical and occipito-cervico-thoracic spine for various conditions like spondylolisthesis, spinal stenosis, and fractures. This is a therapeutic intervention, not a diagnostic test performed on a sample.
The device is a surgical implant used for treatment, not for diagnosing a condition by analyzing a biological sample.
N/A
Intended Use / Indications for Use
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Summit Occipito-Cervico-Thoracic (OCT) Spinal System is indicated 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 atlantoaxial 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 Summit OCT Spinal System allows for wire/cable attachment to the posterior cervical spine.
The Summit OCT System can also be linked to the ISOLA, TiMX, Monarch 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)
MNI, KWP
Device Description
The Summit OCT Spinal System consists of plates, nuts, bone screws, rods, transverse rod connectors, cable connectors, dual wedding band and axial connectors, set screws, minipolyaxial screws and Songer Cables. For occipitocervicothoracic fusion, the transition rod is bent and cut to the appropriate length. The occipital plate is fixed to the occiput with bone screws and the transition rod is attached to the plate by a locking mechanism. This locking mechanism consists of a bolt and a washer which are free to rotate and translate along a slot in the occipital plates. The rod loads from the top and is fixed and locked into place with a mini outer nut. Sub-axially, cable connectors are fixed to the transition rod and attached to the spine via sublaminar cabling looped through the cable connectors. The end of the construct is stabilized with polyaxial screws and mini outer nuts to the upper thoracic spine, as required.
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), occiput, 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)
Biomechanical testing, including static and dynamic construct axial compression bending and static construct torsion, were conducted.
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.
Summit OCT Spinal System (K002733, K010681), Synthes CerviFix System (K001864)
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
| X.
| 510 (k) Summary | NOV 0 7 2001 |
|---|---|
| SUBMITTER: | DePuy AcroMed™, Inc. |
| 325 Paramount Drive | |
| Raynham, MA 02780 | |
| CONTACT PERSON: | Karen F. Jurczak |
| DATE PREPARED: | September 26, 2001 |
| CLASSIFICATION NAME: | Appliance, Fixation, Spinal Interlaminal |
| Orthosis, Spinal Pedicle Fixation | |
| PROPRIETARY NAME: | Summit OCT Spinal System |
| PREDICATE DEVICES: | Summit OCT Spinal System (K002733, K010681) |
| Synthes CerviFix System (K001864) | |
| INTENDED USE: | When intended to promote fusion of the cervical spine and |
| occipito-cervico-thoracic junction (occiput-T3), the Summit | |
| Occipito-Cervico-Thoracic (OCT) Spinal System is | |
| indicated 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 atlantoaxial 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 Summit OCT Spinal System allows for wire/cable attachment to the posterior cervical spine.
・・・・・
PY2
KU13222
1
The Summit OCT System can also be linked to the ISOLA, TiMX, Monarch and MOSS Miami Systems using the dual wedding band and axial connectors, and via dual diameter rods.
Manufactured from ASTM F-136 implant grade titanium MATERIALS: alloy.
The Summit OCT Spinal System consists of plates, nuts, DEVICE DESCRIPTION: bone screws, rods, transverse rod connectors, cable connectors, dual wedding band and axial connectors, set screws, minipolyaxial screws and Songer Cables. For occipitocervicothoracic fusion, the transition rod is bent and cut to the appropriate length. The occipital plate is fixed to the occiput with bone screws and the transition rod is attached to the plate by a locking mechanism. This locking mechanism consists of a bolt and a washer which are free to rotate and translate along a slot in the occipital plates. The rod loads from the top and is fixed and locked into place with a mini outer nut. Sub-axially, cable connectors are fixed to the transition rod and attached to the spine via sublaminar cabling looped through the cable connectors. The end of the construct is stabilized with polyaxial screws and mini outer nuts to the upper thoracic spine, as required.
The Summit OCT System can also be linked to the ISOLA, TiMX, and MOSS Miami Systems using the dual wedding bands and axial connectors, and via dual diameter rods.
PERFORMANCE Biomechanical testing, including static and dynamic DATA: construct axial compression bending and static construct torsion, were conducted.
$\mathbb{K}013222\ P^{4/2}$
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus, featuring a triple-stranded helix or staff with a serpent-like form wrapped around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 7 2001
Mr. Frank Maas Manager, Regulatory Affairs DePuy Acromed, Inc. 325 Paramount Drive Raynham, Massachusetts 02767
K013222 Re:
Trade/Device Name: Summit Occipito-Cervico-Thoracic (OCT) Spinal System Regulatory Number: 21 CFR 888.3070, 21 CFR 888.3050 Regulation Name: Pedicle Screw Spinal System, Spinal Interlaminal Fixation Orthosis Regulatory Class: II Product Code: MNI, KWP Dated: September 26, 2001 Received: September 27, 2001
Dear Mr. Maas:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Frank Maas
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its tollfree number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use III.
| 510(k) Number (if known): | K013222 |
|---|---|
| NOV 0 7 2001 |
Summit OCT Spinal System Device Name:
Indications For Use:
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Summit Occipito-Cervico-Thoracic (OCT) Spinal System is indicated 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 Summit OCT Spinal System allows for wire/cable attachment to the posterior cervical spine.
The Summit OCT System can also be linked to the ISOLA, TiMX, Monarch and MOSS Miami Systems using the dual wedding band and axial connectors, and via dual diameter rods.
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use: | X |
|---|---|
| (Per 21 CFR 801.109) | OR Over-The-Counter Use: |
| DePuy AcroMed, Inc. Special 510(k) | (Division Sign-Off)
Division of General, Restorative and Neurological Devices | Page 4 |
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