(156 days)
Not Found
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 suggest the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes
The device is described as "implants" designed to "provide stabilization as an adjunct to cervical fusion" for various spinal conditions, indicating it is used to treat or alleviate a disease or injury.
No
The device is described as an implant system for screw fixation of the cervical spine, designed to provide stabilization as an adjunct to cervical fusion. Its intended use is to treat various spinal conditions, which makes it a therapeutic or stabilization device, not a diagnostic one.
No
The device description explicitly states that the system includes "plates and screw components," which are physical hardware implants.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device description: The provided text describes a surgical implant system (plates and screws) intended for anterior screw fixation of the cervical spine. This is a physical device implanted in the body, not a test performed on a sample outside the body.
- Intended Use: The intended use is to provide stabilization as an adjunct to cervical fusion, which is a surgical procedure.
Therefore, based on the provided information, the Precision Surgery Limited Variable and Fixed Cervical Plate System is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Precision Surgery Limited Variable and Fixed Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degeneralive 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.
Product codes
KWQ
Device Description
The Precision Surgery Limited Variable and Fixed Cervical Plate System includes plates and screw components. There are three types of plates available, two variable and one fixed. Primary and rescue screws are available.
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
Prescription Use
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
FEB 1 2 2004
- 31
Attachment VIII 510(k) Summary
| Sponsor: | Precision Surgery Limited
318 Pheasant Court
Fond du Lac, WI 54935
Phone: 920.223.0547, Fax: 920.223.0551 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact
Person: | Kamaljit S. Paul, MD |
| Proprietary
Trade Name: | Precision Surgery Limited Variable and Fixed Cervical Plate System |
| Device
Description: | The Precision Surgery Limited Variable and Fixed Cervical Plate System
includes plates and screw components. There are three types of plates available,
two variable and one fixed. Primary and rescue screws are available. |
| Intended Use: | The Precision Surgery Limited Variable and Fixed Cervical Plate System is
intended for anterior screw fixation of the cervical spine. These implants have
been designed to provide stabilization as an adjunct to cervical fusion.
Indications for the use of this implant system include 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 Precision Surgery Limited Variable and Fixed Cervical Plate
System is not intended for screw attachment or fixation to the posterior elements
(pedicles) of the cervical, thoracic or lumbar spine. |
| Materials: | The Precision Surgery Limited Variable and Fixed Cervical Plate components
are manufactured from titanium alloy (ASTM F136). |
| Substantial
Equivalence: | Documentation was provided which demonstrated the Variable and Fixed
Cervical Plate System to be substantially equivalent to previously cleared
devices. The substantial equivalence is based upon equivalence in indications
for use, anatomic sites, performance and material of manufacture. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 2004
Precision Surgery Limited C/o Ms. Karen E. Warden, MEBE 8202 Sherman Road Chesterland, Ohio 44026
Re: K032815
Trade/Device Name: Variable and Fixed Cervical Plates Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: December 29, 3003 Received: January 6, 2004
Dear Ms. 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.
If your device is classified (sec above) into either class II (Special Controls) or class HI (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 fiederal Register.
Please be advised that I'DA'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. Karen E. Warden, MEBE
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 antial equivalence of your device to a logally premarket notification. The PDA midnig of substanted by and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (11 CFR Part 801). phcase If you desire specific advice for your de new case. Also, please note the regulation enitled. comaci the Office of Comphaned at (537) eart 807.97). You may obtain "Misbranding by reference to premance notifications of the Act from the Division of Small other general information on your responsents at its toll-free number (800) 638-2041 or Manufacturers, International and Consumer Pressurer Pressuredth/dsma/dsmamain.html
Sincerely yours,
L. Mark McMullerson
Celia M. Witten, Ph.D., M.D. Director Division of Gencral, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
iofl
Indications for Use Attachment III
510(k) Number:
Device Name: Variable and Fixed Cervical Plates
Indications for Use:
The Precision Surgery Limited Variable and Fixed Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degeneralive 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 Precision Surgery Limited Variable and Fixed Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
for Mark A. Miller
Division of General, I astorative. and Neurological Devices
510(k) Number K032815
(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 Use ____________