(163 days)
Not Found
Not Found
No
The device description and intended use focus on mechanical components for spinal fusion and do not mention any software, algorithms, or data processing capabilities indicative of AI/ML.
Yes.
The device is indicated for promoting fusion of the cervical spine and occipito-cervico-thoracic junction for conditions such as DDD, spondylolisthesis, spinal stenosis, fracture/dislocation, and tumors, which are therapeutic interventions.
No
The device description indicates that the Interpore Cross International ICI Occipito-Cervico-Thoracic (OCT) Rod and Plate System is a titanium system composed of rods, bone screws, hooks, set screws, nuts, cross connectors, and plates, which are components used in surgical procedures to promote fusion. The "Intended Use / Indications for Use" section lists conditions that the system is used to treat, not diagnose.
No
The device description clearly states it is a titanium system composed of physical components like rods, bone screws, hooks, etc., indicating it is a hardware-based medical device.
Based on the provided text, 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 description clearly states that the Interpore Cross International ICI Occipito-Cervico-Thoracic (OCT) Rod and Plate System is a system of physical implants (rods, screws, plates, etc.) used for surgical fusion of the spine.
- Intended Use: The intended use is to promote fusion of the cervical spine and occipito-cervico-thoracic junction, addressing structural issues like DDD, spondylolisthesis, fractures, etc. This is a surgical intervention, not a diagnostic test performed on a sample.
The device is a surgical implant used for treatment, not a diagnostic tool used to analyze 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 Interpore Cross International ICI Occipito-Cervico-Thoracic (OCT) Rod and Plate 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.
Product codes (comma separated list FDA assigned to the subject device)
KWP
Device Description
The Interpore Cross International ICI Occipito-Cervico-Thoracic (OCT) Rod and Plate System is a titanium system composed of rods, bone screws, hooks, set screws, nuts, cross connectors, and plates. For occipito-cervico-thoracic fusion, the occipital plate is fixed to the occiput with bone screws. The pre-bent rod is cut to the appropriate length. Bone screws are placed in the thoracic spine (T1-T3) and hooks are placed in the cervical spine. The rod is inserted and the construct is locked with screws and nuts. Cross connectors can be added to the construct.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine and occipito-cervico-thoracic junction (occiput-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)
Not Found
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.
The predicate device is the Summit Occipito-Cervico-Thoracic (OCT) Spinal System
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
510(k) SUMMARY
K022048 Page 1 of 2
SUBMITTED BY
Lynn Rodarti Manager, Regulatory and Clinical Affairs Interpore Cross International 181 Technology Drive Irvine, California 92618 (949) 453-3200
DEC 0 4 2002
June 18, 2002
This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR §807.92.
CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME
| Classification Name: | Appliance, Fixation, Spinal Interlaminal Orthosis |
|---|---|
| Common/Usual Name: | Spinal Interlaminal Orthosis Fixation |
| Product Classification: | Class 11 |
| Proprietary Name: | ICI (Occipito-Cervio-Thoracic (OCT) Rod and Plate System) |
PREDICATE DEVICE
The predicate device is the Summit Occipito-Cervico-Thoracic (OCT) Spinal System that is currently manufactured and distributed by DePuy AcroMedTM, Inc.
INDICATIONS-FOR-USE
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Interpore Cross International ICI Occipito-Cervico-Thoracic (OCT) Rod and Plate 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.
1
DEVICE DESCRIPTION
KO22048 Page 2 of 2
The Interpore Cross International ICI Occipito-Cervico-Thoracic (OCT) Rod and Plate System is a titanium system composed of rods, bone screws, hooks, set screws, nuts, cross connectors, and plates. For occipito-cervico-thoracic fusion, the occipital plate is fixed to the occiput with bone screws. The pre-bent rod is cut to the appropriate length. Bone screws are placed in the thoracic spine (T1-T3) and hooks are placed in the cervical spine. The rod is inserted and the construct is locked with screws and nuts. Cross connectors can be added to the construct.
COMPARISON TO THE PREDICATE DEVICE
The ICI OCT Rod and Plate System is similar in design to the Summit OCT Spinal System. They are both intended for the same use, specifically, to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3). Both are made from the same material, titanium. Based on this information, the ICI OCT Rod and Plate System is substantially equivalent to the Summit OCT Spinal System.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
ood and Drug Administrat 200 Corporate Boulevard Rockville MD 20850
Wendy Spielberger Senior Regulatory Affairs Associate Interpore Cross International 181 Technology Drive Irvine, California 92618-2402
Re: K022048
Trade/Device Name: OCT Rod and Plate System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: September 4, 2002 Received: September 5, 2002
Dear Ms. Spielberger:
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. Wendy Spielberger
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 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
lo Mark N Millers
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
510(k) Number (if known): | 0 2 2 04
Interpore Cross International (ICI) Occipito-Cervico-Thoracic Device Name: (OCT) Rod and Plate System . . . . . . . .
Indications-For-Use:
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Interpore Cross International (ICI) Occipito-Cervico-Thoracic (OCT) Rod and Plate 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.
(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
(Optional Format 1-2-96) |
| ------------------------------------------ | ---- | -------------------------------------------------- |
|---|
for Mark n Milham
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K022048 |
|---|---|
| --------------- | --------- |