(31 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 described as a 'Spinal System' intended for 'stabilization as an adjunct to fusion' for various spinal conditions, indicating its direct role in treating a medical condition.
No
The device is a spinal fixation system designed to provide stabilization and immobilization of spinal segments as an adjunct to fusion. It is a surgical implant, not a tool for diagnosing medical conditions.
No
The device description explicitly states it is a "multiple component, posterior (cervical-thoracic) spinal fixation system which consists of pedicle screws, rods, locking set screws, hooks, and rod connectors," and is made of physical materials (Ti6A14V Eli and Cobalt Chrome). This indicates it is a hardware-based medical device, not software-only.
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 and Intended Use: The Caspian OCT/miniMesa/miniDenali Spinal System is a surgical implant designed to provide stabilization and fusion of the spine. It is a physical device used within the body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or diagnostic testing.
Therefore, the Caspian OCT/miniMesa/miniDenali Spinal System falls under the category of a surgical implant or medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Caspian OCT/miniMesa/miniDenali Spinal System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) when used with autograft or allograft and is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies), spondylolisthesis, spinal stenosis, fracture/dislocation, revision of previous cervical spine surgery, tumors, atlantoaxial fracture with instability, occipitocervical dislocation.
The occipital bone screws are limited to occipital fixation only.
The rod and hook components are intended for use in the cervical/upper thoracic (C1-T3) spine. The pedicle screws are limited to placement in T1-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.
The Caspian OCT/miniMesa/miniDenali Spinal System can also be linked to the Range Spinal System using the 3.5mm/5.5mm rod connectors or transitional rods.
Product codes
KWP
Device Description
The Caspian Spinal System is a top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system which consists of pedicle screws, rods, locking set screws, hooks, and rod connectors. Additional hooks are being added to the system.
Materials: The devices are manufactured from Ti6A14V Eli and Cobalt Chrome per ASTM and ISO standards.
Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of spinal segments of the cervical and thoracic (TI-T3) spine.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
cervical spine, occipito-cervico-thoracic junction (occiput-T3), cervical/upper thoracic (C1-T3) spine, T1-T3
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The subject components were compared to the existing components of the K2M Caspian OCT Spinal System were determined not to represent worst case for the system for mechanical testing.
The design features and sizing of the subject devices were also compared to predicate devices including components of the K2M Caspian System and of Depuy Mountaineer and found to be substantially the same as these systems. It is manufactured from the same materials and is indicated for the same intended uses as these systems.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
113654
JAN 1 2 2012
510(k) Summary for the Caspian OCT Spinal System
This 510(k) summary for the Caspian Spinal System is provided as required per Section 513(i)(3) of the Food, Drug and Cosmetic Act.
1. Submitter :
K2M, Inc. 751 Miller Drive SE Leesburg, VA 20175 Telephone: 703-777-3155 Date Prepared: 01/11/12
Contact Person :
Nancy Giezen Manager Regulatory Affairs
| 2. Tradename: | Caspian OCT Spinal System |
|---|---|
| Common Name: | Spinal Fixation System |
| Classification Name: | Spinal Interlaminal Fixation Orthosis (21CFR 888.3050) |
| Device Product Code: | KWP |
| Regulatory Class: | Class II |
3. Predicate or legally marketed devices which are substantially equivalent:
4. Description of the device:
The Caspian Spinal System is a top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system which consists of pedicle screws, rods, locking set screws, hooks, and rod connectors. Additional hooks are being added to the system.
Materials: The devices are manufactured from Ti6A14V Eli and Cobalt Chrome per ASTM and ISO standards.
Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of spinal segments of the cervical and thoracic (TI-T3) spine.
5. Intended Use:
The Caspian OCT/miniMesalminiDenali Spinal System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) when used with autograft or allograft and is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies), spondylolisthesis, spinal stenosis, fracture/dislocation, revision of previous cervical spine surgery, tumors, atlantoaxial fracture with instability, occipitocervical dislocation.
The occipital bone screws are limited to occipital fixation only.
The rod and hook components are intended for use in the cervical/upper thoracic (C1-T3) spine. The pedicle screws are limited to placement in T1-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.
The Caspian OCT/miniMesa/miniDenali Spinal System can also be linked to the Range Spinal System using the 3.5mm/5.5mm rod connectors or transitional rods.
6. Comparison of the technological characteristics of the device to predicate and legally marketed devices : The subject components were compared to the existing components of the K2M Caspian OCT Spinal System were determined not to represent worst case for the system for mechanical testing ..
P 1 of 2
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The design features and sizing of the subject devices were also compared to predicate devices including components of the K2M Caspian System and of Depuy Mountaineer and found to be substantially the same as these systems. It is manufactured from the same materials and is indicated for the same intended uses as these systems.
There are no significant differences between the subject implants and other devices currently being marketed. They are substantially equivalent to these other devices in design, function, material and intended use.
Pg 2 of 2
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle or bird symbol, with three thick, curved lines representing the wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 12 2012
K2M, Inc. % Ms. Nancy Giezen Manager, Regulatory Affairs 751 Miller Drive, SE Leesburg, Virginia 20175
Re: K113654
Trade/Device Name: Caspian OCT Spinal System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: December 9, 2011 Received: December 13, 2011
Dear Ms. Giezen:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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Page 2 – Ms. Nancy Giezen
or any Federal statutes and regulations administered by other Federal agencies. You must or any is with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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113654
Indications for Use
510(k) Number (if known): K113654
Device Name: Caspian OCT Spinal System
Indications for Use:
The Caspian OCT/miniMesa/miniDenali Spinal System is intended to provide stabilization as an adjunct to fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3) when used with autograft or allograft and is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies), spondylolisthesis, spinal stenosis, fracture/dislocation, revision of previous cervical spine surgery, tumors, atlantoaxial fracture with instability, occipitocervical dislocation.
The occipital bone screws are limited to occipital fixation only.
The rod and hook components are intended for use in the cervical/upper thoracic (C1-T3) spine. The pedicle screws are limited to placement in T1-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.
The Caspian OCT/miniMesa/miniDenali Spinal System can also be linked to the Range Spinal System using the 3.5mm/5.5mm rod connectors or transitional rods.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-the-counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS-LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Diy sion Sign-Off) Diffision of Surgical, Orthopedic, and Restorative Devices
K 113654 510(k) Number_