(446 days)
Not Found
No
The document describes a physical intervertebral body fusion device made of titanium or PEEK, with no mention of software, algorithms, or any AI/ML related terms or functionalities. The performance studies are mechanical tests of the device's physical properties.
Yes
The device description and intended use clearly state that it is an intervertebral body fusion device used in spinal fusion procedures to treat degenerative disc disease, which are medical treatments for a disease or condition.
No
The device is an intervertebral body fusion device used in spinal fusion procedures. It is a treatment device, not a diagnostic one. Its purpose is to physically fuse vertebrae, not to identify or diagnose a condition. The text mentions "degeneration of the disc confirmed by history and radiographic studies" as part of DDD, indicating that diagnosis occurs prior to the use of this device.
No
The device description clearly states it is an intervertebral body fusion device manufactured from titanium or PEEK-Optima®, which are physical materials, not software. The performance studies also focus on mechanical testing of the physical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The device is described as an intervertebral body fusion device made of titanium or PEEK, designed to be surgically implanted. This is consistent with a medical device, not an IVD.
- Lack of IVD characteristics: There is no mention of analyzing biological samples, reagents, or providing diagnostic information based on in vitro testing.
The device is a medical device intended for surgical implantation to treat degenerative disc disease.
N/A
Intended Use / Indications for Use
Lucent® and Lucent Magnum® are intervertebral body fusion devices intended for spinal fusion procedures at one or two contiguous levels (T1-L5) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).
This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
This product is an intervertebral body fusion device, manufactured from titanium (Ti-6Al-4V) or PEEK-Optima®, for use in lumbar spinal surgery. It may also be referred to as an interbody device or interbody cage. The device is generally box-shaped with various holes throughout its design to allow for the placement of autograft. The exterior of the device has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the device from migrating once it is surgically positioned. This modification seeks clearance for the addition of PEEK devices coated with a plasma-sprayed titanium coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal fusion procedures at one or two contiguous levels (T1-L5)
Indicated Patient Age Range
skeletally mature patients
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)
A comparison of the data to mechanical testing performance results of the previously cleared Lucent system devices indicates that the additional Lucent devices have the capability to perform at least as well the Lucent device.
Testing performed includes:
- Static Compression Testing as per ASTM F2077 .
- . Static Torsion Testing as per ASTM F2077
- . Static Compression-Shear Testing as per ASTM F2077
- Dynamic Compression Testing as per ASTM 2077 .
- Subsidence Testing as per ASTM F2267 ●
- . Wear Characterization as per ASTM F1877, ASTM F2025-06
Coating Characterization testing was performed using coupons.
- Coating Characterization -Static and Dynamic Shear per ASTM F1044 .
- Coating Characterization Static Tension per ASTM F1147 .
All data indicates that the device will perform as intended.
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).
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§ 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
Spinal Elements, Inc. Premarket Notification - Lucent" Intervertebral Body Fusion Device
510(k) Summary Lucent® and Lucent Magnum®
510(k) Number K110632
MAY 2 3 2012
| Manufacturer Identification | |
|---|---|
| Submitted by: | Spinal Elements, Inc. |
| 2744 Loker Ave. W., Suite 100 | |
| Carlsbad, CA 92010 | |
| 760-607-0121 | |
| Contact Information: | Benjamin A. Kimball |
| Regulatory Affairs Manager | |
| Spinal Elements, Inc. | |
| 2744 Loker Ave. W., Suite 100 | |
| Carlsbad, CA 92010 | |
| 760-607-1816 | |
| Bkimball@spinalelements.com | |
| Date Prepared: | March 03, 2011 |
| Proprietary Name | Lucent® and Lucent Magnum® |
| Common Name | Intervertebral Body Fusion Device |
| Device Classification | 21 CFR 888.3080 (Intervertebral Body Fusion Device |
| Proposed Regulatory Class | Class II |
| Device Product Code | MAX |
Purpose of this Special 510(k)
This Special 510(k) seeks clearance for a modification to a current system.
Device Description
This product is an intervertebral body fusion device, manufactured from titanium (Ti-6Al-4V) or PEEK-Optima®, for use in lumbar spinal surgery. It may also be referred to as an interbody device or interbody cage. The device is generally box-shaped with various holes throughout its design to allow for the placement of autograft. The exterior of the device has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the device from migrating once it is surgically positioned. This modification seeks clearance for the addition of PEEK devices coated with a plasma-sprayed titanium coating.
Intended Use of the Device
Lucent® and Lucent Magnum® are intervertebral body fusion devices intended for spinal fusion procedures at one or two contiguous levels (T1-L5) in skeletally mature patients
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1
with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).
This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.
Predicates
The Lucent intervertebral body fusion device is substantially equivalent to the following cleared devices in indications for use, design, function, and materials used.
Performance Data
A comparison of the data to mechanical testing performance results of the previously cleared Lucent system devices indicates that the additional Lucent devices have the capability to perform at least as well the Lucent device.
Testing performed includes:
- Static Compression Testing as per ASTM F2077 .
- . Static Torsion Testing as per ASTM F2077
- . Static Compression-Shear Testing as per ASTM F2077
- Dynamic Compression Testing as per ASTM 2077 .
- Subsidence Testing as per ASTM F2267 ●
- . Wear Characterization as per ASTM F1877, ASTM F2025-06
Coating Characterization testing was performed using coupons.
- Coating Characterization -Static and Dynamic Shear per ASTM F1044 .
- Coating Characterization Static Tension per ASTM F1147 .
All data indicates that the device will perform as intended.
Substantial Equivalence
The Lucent intervertebral body fusion device was shown to be substantially equivalent previously cleared devices in indications for use, design, function, and materials used.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling a human figure with outstretched arms, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Spinal Elements Inc. % Benjamin A. Kimball Regulatory Affairs Manager 2744 Loker Ave. W., Suite 100 Carlsbad, California 92010
MAY 2 3 2012
Re: K110632
Trade/Device Name: Lucent® and Lucent Magnum® Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: May 14, 2012 Received: May 15, 2012
Dear Mr. Kimball:
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
3
Page 2 - Mr. Kimball
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 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.
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,
Mark N. Melkerson
Director
Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) K: 110632
Device Name: Lucent®
Indications for Use:
Lucent® and Lucent Magnum® are intervertebral body fusion devices intended for spinal fusion procedures at one or two contiguous levels (T1-L5) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).
This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.
Prescription Use × (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)
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(Division Sign-Off) Diysson of Surgical, Orthopedic, and Restorative Devices
510(k) Number ..
KII0632