(81 days)
Not Found
No
The document describes a physical intervertebral body fusion device and its intended use and testing. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes.
The device is intended for "spinal fusion procedures" to treat degenerative disc disease, which involves mitigating a medical condition.
No
This device is an intervertebral body fusion device used for spinal fusion procedures, which is a therapeutic treatment. It does not perform diagnosis.
No
The device description clearly describes a physical implantable device ("intervertebral body fusion device," "interbody cage," "box-shaped with various holes," "exterior of the device has 'teeth'"). The performance studies also describe mechanical testing of a physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Lucent® device is an implantable medical device used in spinal fusion surgery. It is surgically placed within the body to facilitate bone fusion.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens or providing diagnostic information based on such analysis.
Therefore, the Lucent® intervertebral body fusion device falls under the category of a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Lucent® intervertebral body fusion devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) 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).
These devices are 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, and anterior screw and rod systems).
This device is intended to be used with autograft or allogenic bone graft comprised of cancellous 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
The Lucent® device is an intervertebral body fusion device 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 or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine (L2-S1), lumbosacral spine
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)
Non-clinical testing consisted of the following testing performed in accordance with the FDA guidance Class II Special Controls Guidance Document: Intervertebral Body Fusion Device:
- Static and Dynamic Compression Testing per ASTM F 2077-14
- Static and Dynamic Compression Shear Testing per ASTM F 2077-14
All data indicates that the device will perform as intended.
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.
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
§ 888.3080 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
December 10, 2018
Image /page/0/Picture/11 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Spinal Elements, Inc. Ms. Cheryl Allen Regulatory Affairs Manager 3115 Melrose Dr., Suite 200 Carlsbad, California 92010
Re: K182584
Trade/Device Name: Lucent® XP Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: September 20, 2018 Received: September 21, 2018
Dear Ms. Allen:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Melissa Hall -S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182584
Device Name Lucent® XP
Indications for Use (Describe)
Lucent® intervertebral body fusion devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) 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).
These devices are 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, and anterior screw and rod systems).
This device is intended to be used with autograft or allogenic bone graft comprised of cancellous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary Lucent® XP
510(k) Number K182584
I. SUBMITTER
Spinal Elements, Inc. 3115 Melrose Dr., Suite 200 Carlsbad, CA 92010 P. 760-607-0121 F. 760-607-0125
| Contact Information: | Cheryl Allen |
|---|---|
| Regulatory Affairs Manager | |
| Spinal Elements, Inc. | |
| 3115 Melrose Dr., Suite 200 | |
| Carlsbad, CA 92010 | |
| 760-607-1840 | |
| callen@spinalelements.com |
| Date Prepared: | October 29, 2018 |
|---|---|
| ---------------- | ------------------ |
| II. DEVICE | |
|---|---|
| Proprietary Name | Lucent® XP |
| Common Name | Intervertebral Body Fusion Device |
| Device Classification | 21 CFR 888.3080 (Appliance, Fixation Spinal |
| Intervertebral Body) | |
| Proposed Regulatory Class | Class II |
| Device Product Code | MAX |
III. Purpose of this 510k
This Traditional 510(k) seeks clearance for minor modifications to Lucent® XP intervertebral body fusion devices previously cleared under K152011 (10mm footprint), additional sizes (12mm footprint) and an expanded indication for all devices cleared under K152011 to include the use of allogenic bone graft comprised of cancellous and/ or corticancellous bone graft. The new devices have an identical intended use and fundamental scientific technology as the predicate.
IV.DEVICE DESCRIPTION
The Lucent® device is an intervertebral body fusion device 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 or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. The exterior of the device has "teeth" or other generally sharp
4
engagement members on the superior and inferior surfaces to help prevent the device from migrating once it is surgically positioned.
V. INDICATIONS FOR USE
Lucent® intervertebral body fusion devices are intended for spinal fusion procedures at one or two contiguous levels (L2-S1) 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 autograph or allogenic bone graft comprised of cancellous and/or corticancellous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.
VI. SUBSTANTIAL EQUIVALENCE
The subject devices are substantially equivalent in indications for use, surgical technique, design features, manufacturing methods and raw materials to the following predicate devices:
Lucent® devices (K152011): Primary Predicate Lucent® devices (K110632): Additional Predicate Lucent® devices (K170235): Additional Predicate
VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The subject device is identical in manufacturing method, raw material, basic operating principles and fundamental scientific technology to the predicate devices cleared in K152011. The subject devices include modifications to the existing 10mm footprint devices and additional sizes to the Lucent® XP devices. The subject device is seeking clearance for expanded indications for use to include autograph or allogenic bone graft comprised of cancellous and/or corticancellous bone graft. The subject device indications for use are identical to the indications for use as the additional predicate cleared in K170235. The devices will be marketed sterile and non-sterile. The specifications and manufacturing of the titanium coating is identical to that of the predicate devices cleared in K152011. The devices will be marketed with and without a plasma-sprayed porous titanium surface. The modifications do not raise any new issues of safety or effectiveness when compared to the predicate devices.
VIII. PERFORMANCE DATA Biocompatibility Testing
The materials used to manufacture the subject devices as well as the manufacturing processes for the devices seeking clearance are identical as the materials and processes identified in previously cleared K152011 Lucent XP® submission.
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Electrical safety and electromagnetic compatibility (EMC)
No electrical and electromagnetic compatibility testing were performed.
Software Verification and Validation Testing
The device does not contain software. Therefore, no software verification and validation testing were performed.
Mechanical testing
The subject device has the same performance characteristics as the previously cleared predicate device K152011. Non-clinical testing was used to support the decision of substantial equivalence. Non-clinical testing consisted of the following testing performed in accordance with the FDA guidance Class II Special Controls Guidance Document: Intervertebral Body Fusion Device:
- Static and Dynamic Compression Testing per ASTM F 2077-14
- Static and Dynamic Compression Shear Testing per ASTM F 2077-14 o
All data indicates that the device will perform as intended.
Animal Study
No animal studies were performed.
Clinical Studies
No clinical studies were performed.
VIIII. CONCLUSIONS
Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject device has been shown to be substantially equivalent to the aforementioned predicate devices cleared by FDA for commercial distribution in the United States.