(189 days)
No
The description focuses on the mechanical design and materials of a spinal plate system, with no mention of AI or ML capabilities.
Yes
The device is intended to treat various medical conditions of the cervical spine, such as degenerative disc disease, trauma, spinal stenosis, and tumors, which are therapeutic interventions.
No
This device is a surgical implant (anterior cervical vertebrae plate system) used for spinal fixation, not for diagnosing medical conditions.
No
The device description clearly states it consists of plates and locking screws made of titanium alloy, 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 perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The provided text describes a surgical implant (plates and screws) intended for fixation of the cervical spine. This is a physical device implanted within the body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly states the device is for "anterior screw fixation of the cervical spine" for various conditions affecting the spine. This is a surgical procedure, not a diagnostic test.
The device described is a surgical implant used for structural support and stabilization of the spine.
N/A
Intended Use / Indications for Use
The Olsen Medical Dynamic and Semiconstrained Plates are intended for anterior screw fixation of the cervical spine (C2 to C7) for the following indications: degenerative disc disease (neck pain of discogenic origin with degeneration of the disc, confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis and tumors (primary and metastatic), deformities or curvatures (i.e., scoliosis, kyphosis, and lordosis), pseudoarthrosis and failed previous fusions.
Product codes
KWO, KWQ
Device Description
The Olsen Medical Anterior Cervical Vertebrae Plate System consists of plates and locking screws. The plate attaches to the anterior portion of the vertebral body of the cervical spine (levels C2 to C7).
The Olsen Medical Dynamic and Semiconstrained Plate Systems each come in lengths ranging from 23mm to 109mm. All of the plates, regardless of the length, are 16mm and 19mm wide at the cephalad and caudal ends of the plate, respectively. The Dynamic Plates have slots to receive the screws and the Semiconstrained Plates have round holes to receive the screws. All other plate dimensions are the same. Both plates each have tack holes and drill guide holes at the cephalad and caudal ends of the plate. Both plates are curved both in the longitudinal and lateral planes.
The implants of these systems are manufactured from medical grade titanium alloy Ti6 Al4 V meeting the requirements of ASTM F136 or ASTM 1472.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2 to 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)
Testing for substantial equivalence to the Synthes CSPL Variable Angle device is done per ASTM 1717 in accordance with FDA Guidance for Spinal System 510(k)s, May 3, 2004.
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
510(k) Summary
SUBMITTED BY
Doug Mc Whorter Olsen Medical 3001 W Kentucky Street Louisville, KY 40211
Date Submitted: July 20, 2004
CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME
Trade/Proprietary Name: Common/Usual Name: Device Product Code: Classification:
Olsen Medical Anterior Cervical Vertebrae Plate System Cervical Plating Instrumentation KWO 888.3060 Spinal Intervertebral Body Fixation Orthosis
PREDICATE DEVICE
Classification Name:
Synthes CSKP Variable Angle Cervical Plate Locking System (K031276)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92
DEVICE DESCRIPTION AND MATERIALS OF CONSTRUCTION
The Olsen Medical Anterior Cervical Vertebrae Plate System consists of plates and locking screws. The plate attaches to the anterior portion of the vertebral body of the cervical spine (levels C2 to C7).
The Olsen Medical Dynamic and Semiconstrained Plate Systems each come in lengths ranging from 23mm to 109mm. All of the plates, regardless of the length, are 16mm and 19mm wide at the cephalad and caudal ends of the plate, respectively. The Dynamic Plates have slots to receive the screws and the Semiconstrained Plates have round holes to receive the screws. All other plate dimensions are the same. Both plates each have tack holes and drill guide holes at the cephalad and caudal ends of the plate. Both plates are curved both in the longitudinal and lateral planes.
The implants of these systems are manufactured from medical grade titanium alloy Ti6 Al4 V meeting the requirements of ASTM F136 or ASTM 1472.
1
INDICATIONS FOR USE
The Olsen Medical Dynamic and Semiconstrained Plates are intended for anterior screw fixation of the cervical spine (C2 to C7) for the following indications: degenerative disc disease (neck pain of discogenic origin with degeneration of the disc, confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis and tumors (primary and metastatic), deformities or curvatures (i.e., scoliosis, kyphosis, and lordosis), pseudoarthrosis and failed previous fusions.
PERFORMANCE DATA
Testing for substantial equivalence to the Synthes CSPL Variable Angle device is done per ASTM 1717 in accordance with FDA Guidance for Spinal System 510(k)s, May 3, 2004.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an emblem of an abstract bird-like figure, which is the symbol of the Department of Health & Human Services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 7 2005
Mr. Larry D. Potts Olsen Medical 3001 West Kentucky Street Louisville, Kentucky 40211
Re: K042073
Trade/Device Name: Anterior Cervical Vertebrae Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: January 13, 2004 Received: January 13, 2004
Dear Mr. Potts:
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.
3
Page 2 - Mr. Larry D. Potts
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. 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 (240) 276-0120. 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/industry/support/index.html.
Sincerely yours.
Mark H. Milken
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
4
Indications for Use:
510(k) Number (if known): K042073
Device Name:
Indications For Use:
Page 1 of 1
Olsen Medical Anterior Cervical Vertebrae Plate System The Olsen Medical Dynamic and Semiconstrained Plates are
intended for anterior screw fixation of the cervical spine (C2 to C7) for the following indications: degenerative disc disease (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis and tumors (primary and metastatic), deformities or curvatures (i.e., scoliosis, kyphosis, and lordosis), pseudoarthrosis and failed previous fusions.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Melkeson
and New
K042073
510(k) Number