(71 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and fixation capabilities of a physical implant (bone plates and screws), with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device addresses various medical conditions such as Degenerative Disc Disease, Spondylolisthesis, Trauma, Spinal Stenosis, Deformities, Tumor, Pseudoarthrosis, and failed previous fusion by providing anterior cervical fixation, which is a therapeutic intervention.
No
Explanation: The device, the SeaSpine Cabo ACP (Anterior Cervical Plate) System, is described as a system for anterior cervical fixation (C2-T1) using bone plates and screws. Its purpose is to physically stabilize the spine for various indications. There is no mention of it being used to detect, monitor, or diagnose medical conditions.
No
The device description explicitly states it consists of bone plates and screws made from titanium alloy, which are hardware components.
No, 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, tissue) to provide information about a person's health.
- Device Description: The SeaSpine Cabo ACP System is described as a system of bone plates and screws made from titanium alloy. It is surgically implanted into the cervical spine.
- Intended Use: The intended use is for anterior cervical fixation for various spinal conditions. This is a surgical procedure, not a diagnostic test performed on a sample.
The device is a surgical implant used to stabilize the spine, not a tool for analyzing biological samples to diagnose a condition.
N/A
Intended Use / Indications for Use
The SeaSpine Cabo ACP (Anterior Cervical Plate) System is intended for anterior cervical fixation (C2-T1) for the following indications:
· Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
- · Spondylolisthesis,
- · Trauma (i.e., fracture or dislocation),
- · Spinal Stenosis,
- · Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis).
- · Tumor,
- · Pseudoarthrosis,
- and failed previous fusion
Product codes
KWQ
Device Description
The SeaSpine Cabo ACP (Anterior Cervical Plate) System consists of a variety of bone plates and screws. Fixation is achieved by inserting bone screws through the openings in the plate into the vertebral bodies of the cervical spine. The Cabo plates include locking pins that cover the heads of the bone screws to reduce the potential for screw back-out. The locking pins come preassembled to the plate. The Cabo ACP (Anterior Cervical Plate) System implant components are made from titanium alloy per ASTM F136. Associated instruments are available to facilitate the implantation of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
C2-T1
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)
The SeaSpine Cabo ACP (Anterior Cervical Plate) System demonstrated equivalent performance to the predicate system through engineering analysis of static axial compression and torsion, and dynamic axial compression per ASTM F1717.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
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January 24, 2018
SeaSpine Orthopedics Corporation Gina Flores Sr. Regulatory Specialist 5770 Armada Drive Carlsbad, California 92008
Re: K173521
Trade/Device Name: SeaSpine Cabo ACP (Anterior Cervical Plate) System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: November 27, 2017 Received: November 28, 2017
Dear Ms. Flores:
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 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
SeaSpine Cabo ACP (Anterior Cervical Plate) System
Indications for Use (Describe)
The SeaSpine Cabo ACP (Anterior Cervical Plate) System is intended for anterior cervical fixation (C2-T1) for the following indications:
· Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
- · Spondylolisthesis,
- · Trauma (i.e., fracture or dislocation),
- · Spinal Stenosis,
- · Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis).
- · Tumor,
- · Pseudoarthrosis,
- · and failed previous fusion
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image contains the logo for SeaSpine. The logo consists of a stylized graphic of three curved lines in shades of blue, resembling waves or a spine. To the right of the graphic is the company name, "SeaSpine," in orange, with a small trademark symbol next to it. The text is in a sans-serif font and appears to be the primary element of the logo.
510(k) Summary
Contact Details
| Applicant Name: | SeaSpine Orthopedics Corporation | |
|---|---|---|
| Address: | 5770 Armada Drive, Carlsbad CA | |
| Phone number: | (760) 216-5136 | |
| Fax number: | (760) 683-6874 | |
| Contact person: | Gina Flores, Sr. Regulatory Specialist | |
| Email address: | gina.flores@seaspine.com | |
| Date Prepared: | January 10, 2018 |
Device Name
| Trade Name: | SeaSpine Cabo ACP (Anterior Cervical Plate) System |
|---|---|
| Common Name: | Cervical Plate |
| Classification Name: | Spinal intervertebral body fixation orthosis |
| Classification: | 21 CFR 888.3060 |
| Class: | II |
| Product Code: | KWQ |
Legally Marketed Predicate Device
| 510(k)
Number | Product
Code | Trade Name | Manufacturer |
|------------------|-----------------|----------------------------------|-----------------------|
| K142060 | KWQ | Transom Cervical Plate
System | Neurostructures, Inc. |
Device Description
The SeaSpine Cabo ACP (Anterior Cervical Plate) System consists of a variety of bone plates and screws. Fixation is achieved by inserting bone screws through the openings in the plate into the vertebral bodies of the cervical spine. The Cabo plates include locking pins that cover the heads of the bone screws to reduce the potential for screw back-out. The locking pins come preassembled to the plate. The Cabo ACP (Anterior Cervical Plate) System implant components are made from titanium alloy per ASTM F136. Associated instruments are available to facilitate the implantation of the device.
4
SeaSpine
Intended Use/Indications for Use
The SeaSpine Cabo ACP (Anterior Cervical Plate) System is intended for anterior cervical fixation (C2-T1) for the following indications:
- . Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
- . Spondylolisthesis.
- Trauma (i.e., fracture or dislocation), ●
- Spinal Stenosis,
- Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- Tumor,
- Pseudoarthrosis, ●
- and failed previous fusion.
Summary of Technological Characteristics
The SeaSpine Cabo ACP (Anterior Cervical Plate) System is equivalent to the cited predicate device in regard to components, device description, intended use/indications for use, technological characteristics (operating principle, design, materials, sterility, manufacturing, etc.) and performance (mechanical).
Non-Clinical Testing
The SeaSpine Cabo ACP (Anterior Cervical Plate) System demonstrated equivalent performance to the predicate system through engineering analysis of static axial compression and torsion, and dynamic axial compression per ASTM F1717.
Clinical Testing
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
Conclusions
The submitted data demonstrate that the SeaSpine Cabo ACP (Anterior Cervical Plate) System is substantially equivalent to the cited legally marketed predicate device.