(30 days)
Not Found
No
The summary describes a mechanical spinal implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended to treat tumors and fractures, replace diseased vertebral bodies, and restore the height and biomechanical integrity of the spinal column, which are all therapeutic actions.
No
Explanation: The device is described as a vertebral body replacement device used to treat tumors and fractures, and to restore the height and biomechanical integrity of the spinal column. This indicates a therapeutic or restorative function, not a diagnostic one.
No
The device description clearly states that the TPS-TL Spinal System is composed of physical components (female chamber, male chamber, set screw, bone screws) made from titanium alloy, which are implanted into the spine. This indicates a hardware-based medical device, not a software-only one.
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, tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text clearly describes a surgical implant designed to replace vertebral bodies in the spine. It is a physical device implanted into the body to provide structural support and restore height.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze biological samples or provide diagnostic information. Its function is purely mechanical and structural.
Therefore, based on the provided information, the TPS-TL Spinal System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The TPS-TL Spinal System implants are vertebral body replacement devices intended for use in the thoracic and/or thoracolumbar spine (i.e., T3 to L5). The TPS-TL Spinal System is indicated to replace a diseased vertebral body(ies) 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(ies). The TPS-TL Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The TPS-TL Spinal System 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 (comma separated list FDA assigned to the subject device)
MQP
Device Description
The TPS-TL Spinal System implants function as a single construct that combines an anterior plate and a vertebral body spacer which may be telescopically adjusted in situ to the required height. The TPS-TL Spinal System implants are composed of seven components: one (1) female chamber, one (1) male chamber, one (1) set screw, and four (4) bone screws. The TPS-TL Spinal System implants are made from medical implant grade titanium alloy as described by ASTM F136 (Ti 6Al-4V ELI) and are available for one and two levels.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic and/or thoracolumbar spine (i.e., T3 to L5)
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)
Data regarding the functional performance of the proposed Interpore Cross Telescopic Plate Spacer Thoracolumbar (TPS-TL) Spinal System have been generated. The test data indicates that the proposed Interpore Cross TPS-TL Spinal System meets or exceeds all functional requirements and support its suitability for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JAN 1 7 2002
510(k) SUMMARY
SUBMITTED BY
Lynn Rodarti Manager, Regulatory and Clinical Affairs Interpore Cross International 181 Technology Drive Irvine, California 92618
(949) 453-3200
December 17, 2001
This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR §807.92.
CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME
| Classification Name: | Spinal Vertebral Body Replacement Device |
|---|---|
| Common/Usual Name: | Vertebral Body Replacement Device |
| Product Classification: | Class II |
| Proprietary Name: | Interpore Cross Telescopic Plate Spacer |
| Thoracolumbar (TPS-TL™) Spinal System |
PREDICATE DEVICE
The predicate device is the Interpore Cross Telescopic Plate Spacer Thoracolumbar (TPS-TL) Spinal System which was previously cleared under 510(k) K010989.
INDICATIONS-FOR-USE
The TPS-TL Spinal System implants are vertebral body replacement devices intended for use in the thoracic and/or thoracolumbar spine (i.e., T3 to L5). The TPS-TL Spinal System is indicated to replace a diseased vertebral body(ies) 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(ies). The TPS-TL Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The TPS-TL Spinal System 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 TPS-TL Spinal System implants function as a single construct that combines an anterior plate and a vertebral body spacer which may be telescopically adjusted in situ to the required height. The TPS-TL Spinal System implants are
1
composed of seven components: one (1) female chamber, one (1) male chamber, one (1) set screw, and four (4) bone screws. The TPS-TL Spinal System implants are made from medical implant grade titanium alloy as described by ASTM F136 (Ti 6Al-4V ELI) and are available for one and two levels.
2014145
COMPARISON TO THE PREDICATE DEVICE
The larger Interpore Cross Telescopic Plate Spacer Thoracolumbar (TPS-TL) Spinal System implant is substantially equivalent to the currently available TPS-TL Spinal System implants. All implants are used to treat the same conditions, have the same precautions and contraindications for use, and have equivalent potential for complications associated with the risk of use. In addition, they both represent a basic design concept in terms of safety and effectiveness.
Based on the basic design concept, the use of established well known materials, feature comparisons, mechanical testing, indications for use, preproduction quality assurance planning and engineering analysis, Interpore Cross International believes that sufficient evidence exists to reasonably conclude that this device is substantially equivalent to the existing legally marketed implants.
DISCUSSION OF NONCLINICAL TESTS
Data regarding the functional performance of the proposed Interpore Cross Telescopic Plate Spacer Thoracolumbar (TPS-TL) Spinal System have been generated. The test data indicates that the proposed Interpore Cross TPS-TL Spinal System meets or exceeds all functional requirements and support its suitability for use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 7 2002
Ms. Lynn M. Rodarti Manager, Regulatory and Clinical Affairs Interpore Cross International Irvine, California 92618-2402
Re: K014145
Trade Name: Telescopic Plate Spacer Thoracolumbar (TPS-TL) Spinal System Regulation Number: 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: MQP Dated: December 17, 2001 Received: December 18, 2001
Dear Ms. Rodarti:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.
3
Page 2 & Ms. Lynn Rodarti
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icter will anow you to ough maing of substantial equivalence of your device to a legally premaired predicated 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 and IT you desire specific ad roo for for in vitro diagnostic devices), please contact the Office of additionally 21 CFR Fart 807.10 for his ville in the promotion and advertising of Compliance at (301) 594-1697 - 1657 - 165 - 1639 - 1639. Also, please note the your device, prodo of concerner a by reference to premarket notification" (21CFR Part 807.97). Tegulation ontined, Tribbranding on your responsibilities under the Act may be obtained from the Outcr general mistmation turers, 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/dsma/dsmamain.html
Sincerely yours,
R. Mark N. Mclellan
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
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KO14145 510(k) Number (if known):
Telescopic Plate Spacer Thoracolumbar (TPS-TL) Device Name: Spinal System
Indications-For-Use:
The Interpore Cross Telescopic Plate Spacer Thoracolumbar (TPS-TL) Spinal The Interpore Oross Telecoment devices intended for use in the Cystern inplante are columbar spine (T3 to L5). The TPS-TL Spinal System is indicated to replace a diseased vertebral body(ies) resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal ord treatment of tarnors in Crucific accessful height of a collapsed vertebral body. The and froural trough, and to receive cated for treating fractures of the thoracic and The TPS-TL Spinal System is designed to restore the lumbar spine. fumbal " spine." "The anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.
(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
(Optional Format 1-2-96)
Marlh N melkerson
Division of General, Restorative and Neurological Devices
510(k) Number K014145
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