(23 days)
The indications for use for the modified devices described in this submission are the same as those for the Summit OCT Spinal System (K022190). The indications are as follows:
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput -T3), the Summit 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 Summit OCT Spinal System, allows for wire/cable attachment to the posterior cervical spine.
The Summit OCT Spinal 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.
The Summit OCT Spinal System Minipolyaxial Screws are designed to accept a 3.0mm rod and are available in various sizes and geometries.
The Summit OCT Spinal System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
Manufactured from ASTM F-136 implant grade titanium alloy.
The provided text is a 510(k) summary for a medical device (Summit OCT Spinal System Minipolyaxial Screws) and contains regulatory information, indications for use, and a description of the device. However, it does not contain any information about acceptance criteria, detailed study designs, or performance data beyond a general statement that "Performance data were submitted to characterize the modified Summit OCT Spinal System minipolyaxial screws."
Therefore, I cannot provide the requested information from the given text.
To answer your questions, I would need a document that includes:
- Specific acceptance criteria (e.g., tensile strength, fatigue life, torsional stability thresholds).
- Details of mechanical or other performance studies.
- Results of those studies demonstrating compliance with the acceptance criteria.
- Information on human reader studies or ground truth establishment if this were an AI/image-based device, which it is not.
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K030103 p 1/2
IX. 510(k) Summary
FEB 0 5 2003
| SUBMITTER: | DePuy AcroMed, Inc. |
|---|---|
| 325 Paramount Drive | |
| Raynham, MA 02780 |
Lisa A. Gilman CONTACT PERSON:
DATE PREPARED: January 10, 2003
CLASSIFICATION NAME: Appliance, Fixation, Spinal Interlaminal Orthosis, Spinal Pedicle Fixation
PROPRIETARY NAME: Summit OCT Spinal System Minipolyaxial Screws
Summit OCT Spinal System (K002733, K010681, PREDICATE DEVICES: K013222, K022190)
DEVICE DESCRIPTION: The Summit OCT Spinal System Minipolyaxial Screws are designed to accept a 3.0mm rod and are available in various sizes and geometries.
The Summit OCT Spinal 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 INTENDED USE: described in this submission are the same as those for the Summit OCT Spinal System (K022190). The indications are as follows:
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput -T3), the Summit 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
{1}------------------------------------------------
- · 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 Spinal 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 MATERIALS: titanium alloy.
PERFORMANCE DATA:
Performance data were submitted to characterize the modified Summit OCT Spinal System minipolyaxial screws.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
FEB 0 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lisa A. Gilman Regulatory Affairs Associate DePuy Acromed, Inc. 325 Paramount Drive Raynham, Massachusetts 02767
Re: K030103
Trade/Device Name: Summit Occipito-Cervico-Thoracic (OCT) Spinal System Regulation Number: 21 CFR 888.3070, 21 CFR 888.3050 Regulation Name: Pedicle Screw Spinal System, Spinal Interlaminal Fixation Orthosis Regulatory Class: Class II Product Code: MNI, KWP Dated: January 10, 2003 Received: January 13, 2003
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 A. 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 vour 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark n Milkman
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
III. Indications for Use
510(k) Number (if known): KO30 |03
Modified Summit OCT Spinal System Minipolyaxial Screws Device Name:
Indications For Use:
The indications for use for the modified devices described in this submission are the same as those for the Summit OCT Spinal System (K022190). The indications are as follows:
When intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (occiput - T3), the Summit Occipito-Cervical-Thoracic (OCT) Spinal System is intended for:
- ddd (neck pain of discoqenic origin with deqeneration 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 Spinal 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: (Per 21 CFR 801.109)
OR Over-The-Counter Use:
(Per 21 CFR 801.109)
OR Over-The-Counter Use:
DePuy AcroMed, Inc. Special 510K
N/A