(45 days)
Not Found
No
The description focuses on the mechanical properties and design of a physical implant (anterior cervical plate and screws) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies described are mechanical tests.
No
The device is an anterior cervical plate fixation system intended for temporary stabilization, not a therapeutic device designed to cure or treat disease itself.
No
The Manta Ray™ ACP System is described as an anterior cervical plate intended for temporary stabilization, not for diagnosing medical conditions. It is a fixation system, used in treatment rather than diagnosis.
No
The device description explicitly states it is an anterior cervical plate fixation system consisting of plates and screws made from titanium alloy, which are hardware components.
Based on the provided information, the Manta Ray™ ACP System 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.
- Manta Ray™ ACP System Description: The description clearly states that the Manta Ray™ ACP System is an anterior cervical plate fixation system consisting of plates and screws. These are implantable medical devices used for the temporary stabilization of the cervical spine.
- Intended Use: The intended use is for stabilizing the cervical spine due to various conditions, which is a surgical procedure involving the implantation of a device, not a diagnostic test performed on a sample.
Therefore, the Manta Ray™ ACP System falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Manta Ray™ ACP System is an anterior cervical plate that is intended for temporary stabilization of the cervical spine from C2-C7 due to the following indications: Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Spondylolisthesis, Trauma (i.e. fracture/dislocation), Tumor, Spinal stenosis, Deformity (i.e. scoliosis, kyphosis and/or lordosis), Pseudoarthrosis, Failed previous fusion.
The Manta Ray™ ACP System is an anterior cervical plate that is intended for temporary stabilization of the cervical spine from C2-C7 due to the following indications: Degenerative Disc Disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) Spondylolisthesis Trauma (i.e. fracture/dislocation) Tumor Spinal stenosis Deformity (i.e. scoliosis, kyphosis and/or lordosis) Pseudoarthrosis Failed previous fusion
Product codes
KWQ
Device Description
The Manta Ray™ ACP System is an anterior cervical plate fixation system. The system consists of a number of plates and screws. The plates feature a normal lordotic curvature as well as a transverse plane curvature for anatomic fit and are available in a variety of lengths for one to four level configurations. Screws are available in fixed and variable angle styles to create rigid or semi-rigid constructs as well as multiple lengths to fit individual patient pathologies. All implants are machined from implant grade titanium alloy, Ti-6Al-4V (ELI) per ASTM F-136.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine from C2-C7
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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
Static and fatigue testing was performed to characterize the stiffness, strength and fatigue life of Manta Ray™ ACP System
Key Metrics
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.
0
APR 2 5 2008
510(k) Summary (21 CFR Part 807.92)
A. Submitter Information
| Submitter's Name: | Theken Spine, LLC |
|---|---|
| Address: | 1800 Triplett Blvd. |
| Akron, Ohio 44306 | |
| Telephone Number: | 330-475-8600 |
| Fax Number: | 330-773-7697 |
| Contact Person: | Dale Davison |
| Date Prepared: | 03 March 2008 |
| Trade Name: | Manta Ray™ Anterior Cervical Plate (ACP) System |
| Common Name: | Anterior Spinal Fixation System |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis (per 21 CFR 888.3060) |
| Device Classification: | Class II (per 21 CFR 888.3060) |
| Panel: Orthopedic, Product Code: KWQ, Panel Code: 87 | |
| Material Composition: | Implant grade Titanium Alloy (Ti-6Al-4V ELI) per ASTM F136 |
| Device Description: | The Manta Ray™ ACP System is an anterior cervical plate fixation system. The system consists of a number of plates and screws. The plates feature a normal lordotic curvature as well as a transverse plane curvature for anatomic fit and are available in a variety of lengths for one to four level configurations. Screws are available in fixed and variable angle styles to create rigid or semi-rigid constructs as well as multiple lengths to fit individual patient pathologies. All implants are machined from implant grade titanium alloy, Ti-6Al-4V (ELI) per ASTM F-136. |
| Intended Use: | The Manta Ray™ ACP System is an anterior cervical plate that is intended for temporary stabilization of the cervical spine from C2-C7 due to the following indications: Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Spondylolisthesis, Trauma (i.e. fracture/dislocation), Tumor, Spinal stenosis, Deformity (i.e. scoliosis, kyphosis and/or lordosis), Pseudoarthrosis, Failed previous fusion |
| Performance Data: | Static and fatigue testing was performed to characterize the stiffness, strength and fatigue life of Manta Ray™ ACP System |
| Predicate Device: | X-Spine Systems - Spider Cervical Plating System (K052292 - October 21, 2005) |
| Theken Surgical, LLC - Tether™ ACFS (K010466 - May 16, 2001) |
C. Substantial Equivalence
Theken Spine, LLC believes that the Manta Ray™ ACP System is substantially equivalent to Theren Spine, ELO believes that the Mana Ray - Stablishment of equivalence is based on the same
other legally marketed predicate devices. Establishment of equivalence is be other legally marketed predicate devices. Establishment dies in design concept, the use of Infications and contrainuleations for use as woll as emilantical testing and engineering analysis.
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is black and white and appears to be a scanned image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 5 2008
Theken Spine % Mr. Dale Davison Vice President of Engineering 1800 Triplett Blvd Akron, OH 44306
K080690 Re: Trade/Device Name: Manta Ray™ Anterior Cervical Plate (ACP) System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: March 3, 2008 Received: March 11, 2007
Dear Mr. Davison:
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.
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Page 2 - Mr. Dale Davison
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K080690
Device Name: Manta Ray ACP System
Indications For Use:
The Manta Ray™ ACP System is an anterior cervical plate that is intended for t ne manta + (a) = + (a) = + (a) = + (a) = = ) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =
- Degenerative Disc Disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- Spondylolisthesis
- Trauma (i.e. fracture/dislocation)
- Tumor
- Spinal stenosis
- Deformity (i.e. scoliosis, kyphosis and/or lordosis)
- Pseudoarthrosis
- Failed previous fusion
AND/OR × Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Division of General, Restorative, and Neurological Devices
510(k) Number K080610