(56 days)
Not Found
No
The summary describes a spinal implant made of PEEK material and its intended use for vertebral body replacement. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies mentioned are mechanical testing, not related to algorithmic performance.
Yes
The device is indicated for partial replacement of a diseased vertebral body for the treatment of tumors and fractures and to restore the height of a collapsed vertebral body, which are therapeutic actions.
No
Explanation: The device is indicated for partial replacement of a diseased vertebral body for treating tumors and fractures, and to restore the height of a collapsed vertebral body. It is a surgical implant designed to replace anatomical structures, not to identify or diagnose medical conditions.
No
The device description explicitly states it is adding "PEEK spacers" to an existing system, indicating a physical, hardware component. The intended use also describes a physical implant for vertebral body replacement.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing a diseased or fractured vertebral body in the spine. This is a therapeutic device used in vivo (within the body).
- Device Description: The device is described as a PEEK spacer for the spine, which is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is a physical implant used to treat a condition directly within the body.
N/A
Intended Use / Indications for Use
The ESL® PEEK-OPTIMA® 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 ESL® PEEK-OPTIMA® is also indicated for partial vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The ESL® PEEK-OPTIMA® 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
MQP
Device Description
This Special 510(k) submission is intended to reflect the addition of PEEK spacers to the existing ESL Spine Spacer System.
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
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
EBI® ESL® Spine Spacer System, Interpore Cross International PEEK CAS
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
Page 1 of 1
510(k) Summary EBI® ESL® PEEK-OPTIMA® Spine System
JUN - 8 2006
| Proprietary Name: | ESL® PEEK-OPTIMA® Spine System |
|---|---|
| Common Name: | Vertebral Body Replacement Device |
| Classification Name: | Spinal Intervertebral Fixation Orthosis, 21 |
| CFR §888.3030 | |
| Product Code: | MQP |
| Predicate Device(s): | EBI® ESL® Spine Spacer System |
| Interpore Cross International PEEK CAS | |
| Contact Information: | Jennifer Harakal, Regulatory Affairs Specialist |
| EBI, L.P. | |
| 100 Interpace Parkway | |
| Parsippany, NJ 07054 | |
| Phone: 973-299-9300 x2156 | |
| Date Summary Prepared: | May 15, 2006 |
Indications for Use
The ESL® PEEK-OPTIMA® is indicated for use in the thoracolumbar spine (i.e., T1 to L.5) 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 ESL® PEEK Spine Spacer System is also indicated for partial vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The ESL® PEEK-OPTIMA® 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
This Special 510(k) submission is intended to reflect the addition of PEEK spacers to the existing ESL Spine Spacer System.
Substantial Equivalence
The subject ESL PEEK-OPTIMA Spine System is similar to its predicate devices with respect to intended use and basic design. Mechanical testing demonstrated comparable mechanical properties to the predicate components.
1
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 heads, representing the department's commitment to health, human services, and science. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" written around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 8 2006
EBI, LP % Ms. Jennifer P. Harakal Regulatory Affairs Specialist 100 Interpace Parkway Parsippany, New Jersey 07054
Re: K061016
Trade/Device Name: EBI® ESL® PEEK-OPTIMA® Spine System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: May 17, 2006 Received: May 18, 2006
Dear Ms. Harakal:
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 (OS) 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. Jennifer P. Harakal
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,
Hucker Lemar no
Mark N. Melkerson 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): ﮪ / ○ / ﻁ / ○ / ﻁ / ○ / ﻁ / ○ / ﻁ / ﻁ / ○ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ / ﻁ /
Device Name: EBI® ESL® PEEK-OPTIMA® Spine System
Indications For Use:
The ESL® PEEK-OPTIMA® 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 ESL® PEEK-OPTIMA® is also indicated for partial vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The ESL® PEEK-OPTIMA® 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______________________________________________________________________________________________________________________________________________________________ Use (Part 21 CFR 801 Subpart D AND/OR
Over-The-Counter
(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)
Page 1 of 1
Huber Romer
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K061016