(167 days)
No
The document describes a spinal implant made of PEEK with tantalum markers and mentions a system for minimally invasive surgery, but there is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is indicated for vertebral body replacement, intervertebral fusion, and treating spinal fractures, all of which are interventions intended to treat a disease or injury, restoring function or alleviating symptoms.
No
The device is an implantable surgical system used for vertebral body replacement and intervertebral fusion, not for diagnosing medical conditions.
No
The device description explicitly states the device is constructed of medical grade Polyetheretherketone (PEEK) with tantalum radiographic markers, indicating it is a physical implant, not software.
Based on the provided information, the ESL® Spinal System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- ESL® Spinal System Function: The description clearly states that the ESL® Spinal System is a physical implant made of PEEK with tantalum markers. Its intended use is for vertebral body replacement and intervertebral fusion within the spine. It is a surgical implant designed to provide structural support and facilitate fusion, not to analyze biological samples.
The information provided describes a surgical implant used directly within the body, which falls under the category of a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ESL® Spinal System is indicated for vertebral body replacement and intervertebral fusion. When used for vertebral body replacement, the ESL® Spinal System is indicated for use in the thoracolumbar spine (i.e., T1- 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® Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The ESL® 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 of time.
As an intervertebral body fusion device, the ESL® Spinal System is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
The ESL® Spinal System is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The ESL® Spinal System may also be implanted using the Accuvision System to amount the surgeon with a minimally invasive approach for posterolateral spinal survery.
Product codes (comma separated list FDA assigned to the subject device)
MAX, MQP
Device Description
The ESL® Spinal System is a device constructed medical grade Polyetheretherketone (PEEK) with tantalum radiographic markers for spinal applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (i.e., T1- L5), lumbar spine from L2 to S1
Indicated Patient Age Range
skeletally mature
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)
Based upon the mechanical testing, ESL Spinal System is substantially equivalent for its intended use to other spacers currently on the market.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
Image /page/0/Picture/1 description: The image shows the logo for Biomet Spine. The word "BIOMET" is in large, bold, sans-serif font, with each letter outlined in black. Below the word "BIOMET" is the word "SPINE" in a smaller, sans-serif font, also outlined in black. The logo is simple and clean, with a focus on the company name.
510(k) Summary
| Preparation Date: | January 28, 2010 | |
|---|---|---|
| Applicant/Sponsor: | Biomet Spine | |
| 100 Interpace Parkway | ||
| Parsippany, NJ 07054 | ||
| Contact Person: | Vivian Kelly | |
| Phone: 973-299-9300 | ||
| Fax: 973-257-0232 | FEB - 4 2010 | |
| Trade name: | ESL® Spinal System | |
| Common Name: | Non-cervical spinal spacer | |
| Classification Name: | Intervertebral fusion device, 21 CFR §888.3080 | |
| Spinal Intervertebral Body Fixation Orthosis, 21 CFR § 888.3060 | ||
| Device Panel/Product Code: | Orthopedic MAX & MQP |
Device Description:
The ESL® Spinal System is a device constructed medical grade Polyetheretherketone (PEEK) with tantalum radiographic markers for spinal applications.
Indications for Use:
The ESL® Spinal System is indicated for vertebral body replacement and intervertebral fusion. When used for vertebral body replacement, the ESL® Spinal System is indicated for use in the thoracolumbar spine (i.e., T1- 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 Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The ESL® 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 of time.
As an intervertebral body fusion device, the ESL® Spinal System is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment.
The ESL® Spinal System is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The ESL® Spinal System may also be implanted using the Accu Vision System to provide the surgeon with a minimally invasive approach for posterior or posterolateral spinal surgery.
Summary of Technologies:
The technological characteristics (material, design and sizing) of the ESL® Spinal Spacer is the same as, or similar to, the predicate devices.
Substantial Equivalence:
The ESL Spinal System is substantially equivalent to its predicate devices with respect to intended use and indications, technological characteristics, and principles of operation and do not present any new issues of safety or effectiveness. An example of a predicate intervertebral body fusion device distributed for the similar indications includes the Expandable PEEK Implant (K040928 and the ESL® Spinal System (K061016) has similar design features. Based upon the mechanical testing, ESL Spinal System is substantially equivalent for its intended use to other spacers currently on the market.
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Vivian Kelly, MS, RAC Regulatory Affairs Project Manager Biomet Spine 100 Interpace Parkway Parsippany, NJ 07054
FEB - 4 2010
Re: K092574
Trade/Device Name: EBI ESL Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, MQP Dated: January 28, 2010 Received: January 29, 2010
Dear Ms. Kelly:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
2
Page 2 - Vivian Kelly, MS, RAC
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Barbara Buell
Mark N. Melke Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K092574
Device Name: ESL® Spinal System
Indications for Use:
The ESL® Spinal System is indicated for vertebral body replacement and intervertebral fusion. When used for vertebral body replacement, the ESL® Spinal System is indicated for use in the thoracolumbar spine (i.e., T1- 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® Spinal System is also indicated for treating fractures of the thoracic and lumbar spine. The ESL® 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 of time.
As an intervertebral body fusion device, the ESL® Spinal System is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
The ESL® Spinal System is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The ESL® Spinal System may also be implanted using the Accuvision System to amount the surgeon with a minimally invasive approach for posterolateral spinal survery.
Prescription Use X (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)
 Division of Surgical, Orthopedic, and Restorative Devices
K092574 510(k) Number_
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