(151 days)
Not Found
No
The device description and performance studies focus on mechanical properties and equivalence to predicate devices, with no mention of AI/ML or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML algorithms.
No.
The device is an anterior cervical plate and screw system intended for fixation, which is a structural support device rather than one that treats or cures a disease.
No
The device description indicates ASCOT® is an "anterior cervical plate and screw system" used for fixation in the spine, and the indications for use describe conditions for which the device is implanted to treat, not to diagnose.
No
The device description explicitly states that ASCOT® is an anterior cervical plate and screw system, which are physical 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 examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- ASCOT® Description: The provided information clearly describes ASCOT® as an anterior cervical plate and screw system intended for surgical implantation to fix the cervical spine. This is a surgical implant, not a device used to test bodily specimens.
- Intended Use: The intended use describes the conditions for which the device is used in the body (degenerative disc disease, trauma, etc.), not for analyzing samples outside the body.
- Device Description: The description focuses on the physical components of the implant (plates, screws).
- Performance Studies: The performance studies mentioned are mechanical tests on the device itself, not studies on the accuracy of diagnostic results from analyzing biological samples.
Therefore, based on the provided information, ASCOT® is a surgical implant and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ASCOT® is intended for anterior cervical fixation (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis and failed previous fusion.
Product codes
KWQ
Device Description
ASCOT® is an anterior cervical plate and screw system. Plates offered in a variety of sizes to accommodate anatomic requirements. Fixed and variable angle screws are available in numerous length/diameter combinations. In addition, a center graft screw is offered.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (C2-C7)
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 of the worst case ASCOT® was performed according to ASTM F1717 and included static and dynamic compression bending and static torsion. The mechanical test results demonstrate that the ASCOT® device performance is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K043082, K080815, K051815, K062110, K042544
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
K132310 page 1 of 2
.
| 510(k) Summary | DEC 2 3 2013 | |
|---|---|---|
| Date: | 24 July 2013 | |
| Sponsor: | SIGNUS Medizintechnik GmbH | |
| Industriestrasse 2 | ||
| D-63755 Alzenau, GERMANY | ||
| Tel. + 49 (0) 6023 9166-136 | ||
| Fax + 49 (0) 6023 9166-161 | ||
| Url: http://www.signus-med.de | ||
| Contact Person: | Joachim Schneider, Quality Management/Regulatory Affairs | |
| Trade Names: | ASCOT® | |
| Device Classification | Class II | |
| Common Name: | Anterior cervical plate system | |
| Classification Name: | Appliance, fixation, spinal intervertebral body | |
| Regulation: | 888.3060 | |
| Device Product | ||
| Code: | KWQ | |
| Device Description: | ASCOT® is an anterior cervical plate and screw system. Plates | |
| offered in a variety of sizes to accommodate anatomic requirements. | ||
| Fixed and variable angle screws are available in numerous | ||
| length/diameter combinations. In addition, a center graft screw is | ||
| offered. | ||
| Intended Use: | ASCOT® is intended for anterior cervical fixation (C2-C7) for the | |
| following indications: degenerative disc disease (as defined by neck | ||
| pain of discogenic origin with degeneration of the disc confirmed by | ||
| patient history and radiographic studies), spondylolisthesis, trauma | ||
| (i.e., fracture or dislocation), spinal stenosis, deformities or | ||
| curvatures (i.e., scoliosis, kyphosis and/or lordosis), tumor, | ||
| pseudarthrosis and failed previous fusion. | ||
| Materials: | The ASCOT® implant components are manufactured from titanium | |
| alloy (Ti-6Al-4V ELI) as described by ASTM F136. | ||
| Predicate Devices: | TOSCA® (K043082) | |
| TOSCA® II (K080815) | ||
| VERTEBRON SCP™ (K051815 & K062110) | ||
| Uniplate™ (K042544) | ||
| Performance Data: | Mechanical testing of the worst case ASCOT® was performed | |
| according to ASTM F1717 and included static and dynamic | ||
| compression bending and static torsion. | ||
| The mechanical test results demonstrate that the ASCOT® device | ||
| performance is substantially equivalent to the predicate devices. |
.
.
1
K132310 page 2 of 2
Technological Characteristics:
ASCOT® possesses the same technological characteristics as the predicate devices. These include:
- . performance (as described above),
- . basic design (plate and screw system),
- . material (titanium alloy), and
- sizes (component dimensions are within the ranges offered . by the predicates).
Therefore the fundamental scientific technology of the ASCOT® device is the same as previously cleared devices.
Conclusion:
The ASCOT® devices possess the same intended use and technological characteristics as the predicate devices. Therefore the ASCOT® is substantially equivalent for its intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, which is a symbol often associated with healthcare. The image is in black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 23, 2013
SIGNUS Medizintechnik GmbH % Karen E. Warden, Ph.D. BackRoads Consulting, Incorporated 8202 Sherman Road Chesterland, Ohio 44026
Re: Ki32310
Trade/Device Name: ASCOT® Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: November 13, 2013 Received: November 19, 2013
Dear Dr. Warden:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Karen E. Warden, Ph.D.
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/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,
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 7 - Indications for Use Statement
510(k) Number: K132310
Device Name: ASCOT®
Indications for Use:
らいくなり、
ASCOT® is intended for anterior cervical fixation (C2-C7) for the following indications: degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis), turnor, pseudarthrosis and failed previous fusion.
Prescription Use _ X _ OR Over-the-Counter Use_
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ Division of Orthopedio Devices