(47 days)
Not Found
No
The summary describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as an implant system for anterior screw fixation of the cervical spine to provide stabilization as an adjunct to cervical fusion for various medical conditions, indicating a therapeutic purpose.
No
The device description indicates it is an implant system (plate and screw components) for stabilization and fusion of the cervical spine, not for diagnosing conditions.
No
The device description explicitly states that the system comprises "plate and screw components," which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "anterior screw fixation of the cervical spine (C2-C7)" and "provide stabilization as an adjunct to cervical fusion." This describes a surgical implant used in vivo (within the body) to treat a physical condition.
- Device Description: The description details "plate and screw components," which are physical implants.
- 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 treatment.
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
The Intuitive Anterior Cervical System is intended for anterior screw fixation of the cervical spine (C2-C7). These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system are: degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.
WARNING: The Intuitive Anterior Cervical System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
Product codes
KWQ
Device Description
The Intuitive Anterior Cervical System comprises plate and screw components in a variety of sizes and lengths. Three styles of plate, including fixed, variable and corpectomy, are available. Primary, self-drilling primary and rescue screws are 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)
Static compression bending and torsion, and dynamic compression bending were performed according to ASTM F1717 on a worst-case, cervical plate construct. The mechanical test results demonstrated that Intuitive performs as well as the predicate device.
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
8. 510(k) Summary
| FEB 15 2011 | |
|---|---|
| Date: | 29 December 2010 |
| Sponsor: | Precision Surgery Limited |
| 2700 W. 9th Ave, Suite 120 | |
| Oshkosh, WI 54904 | |
| Phone 920-223-0547 | |
| Fax 920-223-0551 | |
| Contact Person: | Kamaljit S. Paul, MD |
| Proposed Trade | |
| Name: | Intuitive Anterior Cervical System |
| Device Classification | Class II |
| Classification Name: | Spinal intervertebral body fixation orthosis |
| Regulation: | 888.3060 |
| Device Product | |
| Code: | KWQ |
| Device Description: | The Intuitive Anterior Cervical System comprises plate and screw |
| components in a variety of sizes and lengths. Three styles of plate, | |
| including fixed, variable and corpectomy, are available. Primary, self- | |
| drilling primary and rescue screws are offered. | |
| Intended Use: | The Intuitive Anterior Cervical System is intended for anterior screw |
| fixation of the cervical spine (C2-C7). These implants have been | |
| designed to provide stabilization as an adjunct to cervical fusion. | |
| Indications for the use of this implant system are: degenerative disc | |
| disease defined as neck pain of discogenic origin with the | |
| degeneration of the disc confirmed by history and radiographic | |
| studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, | |
| pseudarthrosis or failed previous fusion. | |
| WARNING: The Intuitive Anterior Cervical System is not intended for | |
| screw attachment or fixation to the posterior elements (pedicles) of | |
| the cervical, thoracic or lumbar spine. | |
| Materials: | The Intuitive Anterior Cervical System components are manufactured |
| from titanium alloy (Ti-6Al-4V per ASTM F136). The screw-retaining | |
| central rail is manufactured from nickel titanium alloy (NiTi per ASTM | |
| F2063). | |
| Predicate Device: | Fixed, Variable & Corpectomy Cervical Plate System |
| (K032815/K073708) |
.
1
| Technological
Characteristics: | The Intuitive Anterior Cervical System identical to the predicate
Fixed, Variable & Corpectomy Cervical Plate System, only the
system name has changed. Therefore, the system possesses the
same technological characteristics as the predicate. These include:
• intended use (as described above),
• design (plate-based fixation system having self-tapping screws in
various sizes),
• material (titanium alloy) and
• sizes (plate and screw sizes are the same as those offered by
the predicate system).
The fundamental scientific technology of Intuitive is the same as the
previously cleared device. |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data: | Static compression bending and torsion, and dynamic compression
bending were performed according to ASTM F1717 on a worst-case,
cervical plate construct. The mechanical test results demonstrated
that Intuitive performs as well as the predicate device. |
| Conclusion: | The Intuitive Anterior Cervical System is substantially equivalent to
the devices referenced above and is therefore safe and effective for
its intended use. |
、
·
.
.
..
.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the circumference of the circle. Inside the circle is a stylized image of an eagle or other bird with outstretched wings, depicted in a minimalist, flowing style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Precision Surgery, Ltd. % BackRoads Consulting, Inc. Karen E. Warden. Ph.D. 8202 Sherman Road Chesterland, Ohio 44026
FEB 1 5 201
Re: K103838
Trade/Device Name: Intuitive Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: K WQ Dated: December 29, 2010 Received: December 30, 2010
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
3
Page 2 - Karen E. Warden, Ph.D.
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.
A.J. B. n. Ata
per
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
7. Indications for Use Statement
510(k) Number: K103838
Device Name: Intuitive Anterior Cervical System
Indications for Use:
The Intuitive Anterior Cervical System is intended for anterior screw fixation of the cervical spine (C2-C7). These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system are: degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.
WARNING: The Intuitive Anterior Cervical System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-the-Counter Use
(21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K103838 510(k) Number_________________________________________________________________________________________________________________________________________________________________