(52 days)
Not Found
No
The document describes a physical implant made of PEEK and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as a "partial replacement of a diseased vertebral body" and is used to "achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body," as well as "for partial vertebral body replacement for the treatment of fractures." These descriptions indicate it directly treats a medical condition and restores bodily function.
No
The PEEK CAS is an implantable device used to replace diseased or fractured vertebral bodies to restore spinal integrity and decompress neural tissues. It does not perform any diagnostic function.
No
The device description clearly states it is a physical implant constructed of PEEK and includes tantalum markers. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided information clearly describes a surgical implant (a vertebral body replacement) used to treat spinal conditions like tumors and fractures. It is physically implanted into the patient's body.
- Lack of Specimen Analysis: There is no mention of this device analyzing any biological specimens taken from the patient. Its function is structural support and restoration within the spine.
Therefore, based on the provided information, the PEEK CAS is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PEEK CAS is indicated for use in the thoracolumbar spine (i.e., T1 to L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PEEK CAS is also indicated for partial vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The PEEK CAS is designed to restore the biomechanical integrity of the anterior, middle. and posterior spinal column even in the absence of fusion for a prolonged period.
Product codes
MOP, MQP
Device Description
The PEEK CAS is a curved implant constructed of Polyetheretherketone, medical grade (PEEK OPTIMA™ LT1) as described by ASTM F-2026. The pyramidal teeth on the superior and inferior ends resist expulsion in all directions. The device is available in flat or lordotic angles. The device is open in the transverse plane to allow the surgeon to pack the device with bone graft prior to insertion. There are also holes through the anterior-posterior direction to allow for additional bone growth through the device. The tantalum markers used for this product are made to the voluntary standard ASTM F-560. The radiolucent PEEK material allows visualization of the defect site on radiograph to assess bone growth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (i.e., T1 to L5)
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
Not Found
Key Metrics
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
K050861 Page I of I
SUBMITTED BY
Wendy Spielberger, RAC Lead Regulatory and Clinical Affairs Staff Interpore Cross International 181 Technology Drive Irvine, California 92618 (949) 453-3200
Date Prepared: April 4, 2005
CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME
Classification Name: Common/Usual Name: Product Classification: Product Code: Proprietary Name:
Spinal Intervertebral Fixation Orthosis Vertebral Body Replacement Device Class II MOP PEEK CAS
PREDICATE DEVICE
Interpore Cross Expandable PEEK VBR (K040928) Interpore Cross NEXUS (K040168)
INDICATIONS-FOR-USE
The PEEK CAS is indicated for use in the thoracolumbar spine (i.e., TI to L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PEEK CAS is also indicated for partial vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The PEEK CAS is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.
DEVICE DESCRIPTION
The PEEK CAS is a curved implant constructed of Polyetheretherketone, medical grade (PEEK OPTIMA™ LT1) as described by ASTM F-2026. The pyramidal teeth on the superior and inferior ends resist expulsion in all directions. The device is available in flat or lordotic angles. The device is open in the transverse plane to allow the surgeon to pack the device with bone graft prior to insertion. There are also holes through the anterior-posterior direction to allow for additional bone growth through the device. The tantalum markers used for this product are made to the voluntary standard ASTM F-560. The radiolucent PEEK material allows visualization of the defect site on radiograph to assess bone growth.
COMPARISON TO THE PREDICATE DEVICE
Based on the same indications for use, intended use, similarity in materials of construction and equivalent biomechanical performance, the PEEK CAS is considered substantially equivalent to the legally marketed predicate device.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 7 2005
Ms. Wendy Spielberger Lead Regulatory and Clinical Affairs Staff Interpore Cross International 181 Technology Drive Irvine, California 92618-2402
Re: K050861
Trade/Device Name: PEEK (CAS) Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: May 5, 2005 Received: May 6, 2005
Dear Ms. Spielberger:
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.
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.
2
Page 2 - Ms. Wendy Spielberger
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" (21 CFR 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,
A. Hyat Clurdie
C. 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 (if known): K050861
Device Name: PEEK CAS
Indications-For-Use:
The PEEK CAS is indicated for use in the thoracolumbar spine (i.e., T1 to L5) for partial replacement of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The PEEK CAS is also indicated for partial vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The PEEK CAS is designed to restore the biomechanical integrity of the anterior, middle. and posterior spinal column even in the absence of fusion for a prolonged period.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stypt. Burch
Page 1 of 1
(Division Division of General, Restorative. and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________