(105 days)
Not Found
No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML components.
Yes.
The device is indicated for promoting fusion of the cervical spine and occipito-cervico-thoracic junction in conditions such as spondylolisthesis, spinal stenosis, and fractures, which are therapeutic medical conditions.
No
The provided text describes a spinal system (Summit Occipito-Cervico-Thoracic (OCT) Spinal System) intended for surgical fusion of the spine to treat various conditions. It explicitly states its purpose is to "promote fusion" and describes its components for implantation, not for diagnosing conditions.
No
The device description explicitly lists numerous hardware components (rods, plates, screws, etc.) and describes their physical assembly and function in spinal fusion. There is no mention of software as a component or the primary function of the device.
Based on the provided information, 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 (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The description clearly states that the Summit OCT Spinal System consists of implants (rods, plates, screws, cables, etc.) designed to be surgically implanted to stabilize and promote fusion of the spine.
- Intended Use: The intended use is to promote fusion of the cervical spine and occipito-cervico-thoracic junction for various spinal conditions. This is a surgical intervention, not a diagnostic test performed on samples.
The device is a surgical implant, not a diagnostic tool that analyzes biological samples.
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.
Product codes (comma separated list FDA assigned to the subject device)
KWP, MNI
Device Description
The Summit OCT Spinal System consists of rods, plates, nuts, bolts, washers, bone screws, transverse rod connectors, cable 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), 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 axial slippage, static torsion slippage, static and dynamic construct axial compression bending and static and dynamic 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.
K965221, K982322, K984377, K990965, K991089, K994187, 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
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
| IX. 510(k) Summary | DEC 1 5 2000 |
|---|---|
| SUBMITTER: | DePuy AcroMed™, Inc. |
| 325 Paramount Drive | |
| Raynham, MA 02780 | |
| CONTACT PERSON: | Karen F. Jurczak |
| DATE PREPARED: | November 27, 2000 |
| CLASSIFICATION NAME: | Appliance, Fixation, Spinal Interlaminal |
| Orthosis, Spinal Pedicle Fixation | |
| PROPRIETARY NAME: | Summit Occipito-Cervico-Thoracic (OCT) Spinal System |
| PREDICATE DEVICES: | Ransford Cervical Fixation System (K965221) |
| Synthes CerviFix System (K982322, K984377, K990965, | |
| K991089, K994187, 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.
: : -------
1
MATERIALS:
DEVICE DESCRIPTION:
Manufactured from ASTM F-136 implant grade titanium alloy.
The Summit OCT Spinal System consists of rods, plates, nuts, bolts, washers, bone screws, transverse rod connectors, cable 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.
PERFORMANCE DATA:
Biomechanical testing, including static axial slippage, static torsion slippage, static and dynamic construct axial compression bending and static and dynamic construct torsion, were conducted.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 of three abstract human figures.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 5 2000
Mr. Frank Maas Regulatory Affairs Manager DePuy AcroMed 325 Paramount Drive Raynham, Massachusetts 02767-0350
Re: K002733
Trade Name: Summit Occipito-Cervico-Thoracic (OCT) Spinal System Regulatory Class: II Product Codes: KWP and MNI Dated: November 21, 2000 Received: November 22, 2000
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 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). 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 requirements, 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.
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.
3
Page 2 - Mr. Frank Maas
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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Mark A. Milkerner
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
4
IV. Indications for Use
510(k) Number (if known): K002733
Summit Occipito-Cervical-Thoracic (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 t
- 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.
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use:
Use: (Per 21 CFR 801.109)
DePuy AcroMed, Inc. K002733 - Indications for Use
_ OR Over-The-Counter
Mark N. Millikan
Division of General 510(k) Number