(44 days)
Not Found
No
The summary describes a mechanical spinal implant system and its components, with no mention of software, algorithms, or any technology related to AI or ML. The performance studies focus on mechanical testing against predicate devices.
Yes
The device is indicated for the temporary stabilization of the anterior spine to aid in the development of cervical spinal fusions for various medical conditions, which constitutes a therapeutic purpose.
No
The device is described as a "fixation device" intended for "temporary stabilization of the anterior spine." Its purpose is to physically support the spine, not to identify or diagnose medical conditions.
No
The device description explicitly states it is a "fixation device consisting of a variety of sizes of cervical plates, locking tabs, fixed and variable angle bone screws, and associated instruments," all of which are physical hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for the temporary stabilization of the anterior spine during spinal fusions. This is a therapeutic device used in vivo (within the body).
- Device Description: The description details physical components like plates, screws, and instruments made from titanium alloy. These are physical implants and surgical tools.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
"This system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (i.e., fractures or dislocation), 3) tumors, 4) spinal stenosis, 5) spondylolisthesis, 6)deformity or curvatures (i.e., kyphosis and/or lordosis, or scoliosis), 7) pseudoarthrosis, and/or 8) failed previous fusions.
WARNING: THIS DEVICE IS NOT INTENDED FOR SCREW ATTACHMENT TO THE POSTERIOR WANNINGS (PEDICLES) OF THE CERVICAL, THORACIC, OR LUMBAR SPINE."
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
"The Verteview Anterior Cervical Plate System is a fixation device consisting of a variety of sizes of cervical places, locking tabs, fixod and variable angle bone screws, and associated instruments. Fixation is provided by bone serews moorted into the vertebral body of the cervical spine using the in antenor approad. The screws have various diameters. All components are supplied clean not sterile.
The Verteview Anterior Cervical Plate System implant components are made from titanium alloy interested with titanium anodization per AMS (Aerospace Material Specification) 2488 Type II. Bone screws are subjected to a color anodizing process to differentiate the screw type and diameter."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine
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)
"Testing in accordance with ASTM F1717-04 "Standard Test Methods for Spinal Implant Contructs in a Venebrecto Mode of the Vertenew Anterior CSLP System demonstrates that the device is substantially equivalent to the Oynthos Opine Anterior Cervical Plate System (K010003, concurrence date January 31, 2001.)"
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.
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
§ 888.3060 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 2005
OSDSS88
//
510(k) Premarket Notification Submission -Verteview Anterior Cervical Plate System
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
DEVICE INFORMATION
| Date Prepared: | March 7, 2005 |
|---|---|
| Submitter Name/Address: | Innovative Spinal Design, LLC |
| 1115 Jupiter Park Drive #4 | |
| Jupiter, FL 33458 | |
| Contact: | Leigh Cowden |
| Telephone Number: | 561.741.1108 |
| Fax Number: | 561.741.1870 |
| Email: | leigh@innovativespinaldesign.com |
| Device Trade Name: | Verteview Anterior Cervical Plate System |
| Common Name: | |
| Regulatory Number: | |
| Classification: | |
| Product Code: | Spinal Intervertebral Body Fixation Orthosis, Anterior Cervical Plate System |
| 888.3060 | |
| Class II | |
| KWQ |
SUMMARY INTENDED USES/INDICATIONS
This system is indicated for use in the temporary stabilization of the anterior spine during the I his system is final fusions in the tomatients with 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (i.e., fractures or dislocation), 3) tumors, 4) spinal stenosis, 5) spondylolisthesis, 6)deformity or curvatures (i.e., kyphosis and/or lordosis, or scoliosis), 7) pseudoarthrosis, and/or 8) failed previous fusions.
WARNING: THIS DEVICE IS NOT INTENDED FOR SCREW ATTACHMENT TO THE POSTERIOR WANNINGS (PEDICLES) OF THE CERVICAL, THORACIC, OR LUMBAR SPINE.
SUMMARY DEVICE DESCRIPTION
SUMMAN i DEVICE System is a fixation device consisting of a variety of a variety of sizes of The veltew / menor our fiate your variable angle bone screws, and associated instruments. cervical places, locking tabs, fixod and Terred into the vertebral body of the cervical spine using the Frixation is provided by bone serews moorted into the released and and the many of the in antenor approad. The screws have various diameters. All components are supplied clean not sterile.
The Verteview Anterior Cervical Plate System implant components are made from titanium alloy The Verteview Antenor Ocenour nato eyeten interested with titanium anodization per AMS (Aerospace Material Specification) 2488 Type II. Bone screws are subjected to a color anodizing process to differentiate the screw type and diameter.
EQUIVALENT DEVICE
EQUIVALENT DEVIOE
Testing in accordance with ASTM F1717-04 "Standard Test Methods for Spinal Implant Contructs in a Testing in accordance with : Verteview Anterior Cervical Plate System demonstrates that the device venebreconty Moder of the Vertenew Anterior CSLP System (K030866, concurrence date Is sustantially equivalent to the Oynthos Opine Anterior Cervical Plate System (K010003, concurrence date January 31, 2001.)
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird.
Public Health Service
APR 2 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Leigh Cowden CEO Innovative Spinal Design, LLC 1555 Jupiter Park Drive, Suite 4 Jupiter, Florida 33458
Re: K050588
Trade/Device Name: Verteview Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: March 7, 2005 Received: March 9, 2005
Dear Ms. Cowden:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becternined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorosale) to tegans actment date of the Medical Device Amendments, or to commerce provide that have been reclassified in accordance with the provisions of the Federal Food. Drug. de vices mat have been receire approval of a premarket approval application (PMA). and Cosmetic Act (71ct) that ac novice, subject to the general controls provisions of the Act. The I ou may, mercere, mailer are a Act include requirements for annual registration, listing of general controls provisions of the rice, 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 If your device is classified (500 abor of the Existing major regulations affecting your device can may be subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Outseenents concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that I Dri 3 localited on the vice complies with other requirements of the Act that IDA has made a decormination an administered by other Federal agencies. You must or any receral statutes and regulations and adming, but not limited to: registration and listing (21 comply with an the Act 3 requirements, morading, worder of the requirements as se CTN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 -- Ms. Leigh Cowden
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin maneting your arrantial equivalence of your device to a legally premarket nothication: "The PDA midning of backannal or p
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 If you desire specific advice for your do not our called on our and the regulation entitled, and contact the Office of Comphance at (210) 21 0 0 0 0 0 0 0 0 0 0 0 may obtain other IMISoraniumly by reference to premaibilities under the Act from the Division of Small general information on your responsionnes Assistance at its toll-free number (800) 638-2041 or and Manufacturers, International and Consultation of the consideration of the many in the saltml.
Sincerely yours,
Stypt Rhodes
Miriam Provost, Ph.D. Acting 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: K050588
Device Name: Verteview Anterior Cervical Plate System
Indications for Use: This system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (i.e., fractures or the use committentures, 4) spinal stenosis, 5) spondylolisthesis, 6)deformity or curvatures (i.e., kyphosis and/or lordosis, or scoliosis), 7) pseudoarthrosis, and/or 8) failed previous fusions.
warning: This device is not intended for Screw atTACHMENT TO THE POSTERIOR WANNING: THIS DEVISE IS THE CERVICAL, THORACIC, OR LUMBAR SPINE.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stupt Cluorlu
tern). Restorative. Division of Ge and Neurologial Devices
KOSO588 510(k) Number_