(22 days)
Not Found
No
The 510(k) summary describes a mechanical vertebral body replacement device made of titanium alloy. There is no mention of software, algorithms, image processing, AI, DNN, or ML. The performance studies are mechanical tests, not related to AI/ML performance metrics.
Yes
The device is described as a vertebral body replacement device intended to restore biomechanical integrity to the spine following trauma or tumor removal, which directly addresses a health condition.
No
The device, Cadence and Fortitude, is described as a vertebral body replacement device, which is an implant used to restore biomechanical integrity after a vertebrectomy. Its function is to replace a resected or excised vertebral body due to tumor or trauma, not to diagnose a condition.
No
The device description explicitly states that Cadence and Fortitude are crafted from titanium alloy and are physical implants intended for surgical placement, indicating they are hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that Cadence and Fortitude are implantable devices intended to replace vertebral bodies in the spine. They are used in the body, not to test samples from the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information based on laboratory tests.
- Using reagents or assays.
Therefore, Cadence and Fortitude are medical devices, specifically implants, but they do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Cadence and Fortitude are vertebral body replacement devices that are intended for use in the thoracic and/or thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with bone graft.
Product codes
MOP
Device Description
Cadence™ is a hollow device with texture on two opposing flat sides. The device is crafted titanium alloy (ASTM F136) and is offered in a tapered style of various sizes.
Fortitude™ is a hollow device with texture on two opposing flat sides. The device is crafted from titanium alloy (ASTM F136) and is offered in straight and tapered styles of various sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic and/or thoracolumbar spine (T3 - L5)
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)
Mechanical Testing: Mechanical testing demonstrated that Cadence™ and Fortitude™ exhibit the functional requirements to support their use as vertebral body replacements under normal physiologic loads in the spine.
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.
0
AUG 1 2 2003
Page 1 of 1
510(K) Summary
| Submitted By: | Lisa Peterson
Regulatory Affairs Specialist
Spinal Concepts, Inc.
5301 Riata Park Court, Bldg. F
Austin, TX 78727
512-918-2700
June 19, 2003 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | Spinal Concepts Inc. CadenceTM and FortitudeTM |
| Classification Name: | Vertebral Body Replacement |
Product Code: MOP
Vertebral Body Replacement
Predicate Devices: Cadence™ and Fortitude™ are substantially equivalent to the Interpore Cross GEO™ Structure, which was cleared as an oval shaped configuration on August 3, 2001 (K010530) and as a rectangular shaped configuration on February 6, 2002 (K020048), and to the DePuy AcroMed Stackable Cage™ System cleared on July 26, 2000 (K001340).
Device Description: Cadence™ is a hollow device with texture on two opposing flat sides. The device is crafted titanium alloy (ASTM F136) and is offered in a tapered style of various sizes.
Fortitude™ is a hollow device with texture on two opposing flat sides. The device is crafted from titanium alloy (ASTM F136) and is offered in straight and tapered styles of various sizes.
Intended Use: Cadence and Fortitude are vertebral body replacement devices that are intended for use in the thoracic and/or thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with bone graft.
Mechanical Testing: Mechanical testing demonstrated that Cadence™ and Fortitude™ exhibit the functional requirements to support their use as vertebral body replacements under normal physiologic loads in the spine.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an abstract image of a bird-like figure with three lines forming the body and two wavy lines forming the legs. There is a small star above the bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 2 2003
Ms. Lisa Peterson Regulatory Affairs Specialist Spinal Concepts Incorporated 5301 Riata Park Court, Bldg. F Austin, Texas 78727
K031914 Trade Name: Cadence™ and Fortitude™ VBR Systems Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MOP Dated: June 19, 2003 Received: June 26, 2003
Dear Ms. Peterson:
Re:
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.
2
Page 2 - Ms. Lisa Peterson
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. 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,
Celia M. Witten, Ph.D., M.D.
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
3
INDICATIONS FOR USE STATEMENT
Page 1 of 1
KO31 914 510(k) Number (if known):
Device Name:
Spinal Concepts, Inc. Cadence™ and Fortitude™
Indications for Use:
Cadence and Fortitude are vertebral body replacement devices that are intended for use in the thoracic and/or thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with bone graft.
(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: (Optional Format 1-2-96)
Dision of General, Restorative and Neurolog
) Number /C0319/4