(78 days)
Not Found
No
The summary describes a mechanical interbody fusion system and its materials. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is indicated for spinal fusion procedures in patients with symptomatic disc disease, aiming to facilitate fusion, which is a therapeutic intervention.
No
Explanation: The device is an interbody fusion system designed for spinal fusion procedures, acting as an implant to facilitate fusion, not to diagnose a condition.
No
The device description explicitly details physical components made of PEEK, stainless steel, tantalum, and silicone lubricant, which are hardware materials. The device is an implantable interbody fusion system, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Luna 3D Interbody Fusion System is a physical implant designed for surgical insertion into the spine to facilitate fusion. It is a medical device used in vivo (within the body), not in vitro (in a lab setting).
- Intended Use: The intended use clearly describes a surgical procedure for spinal fusion, not a diagnostic test performed on a sample.
Therefore, the Luna 3D Interbody Fusion System falls under the category of a surgical implant or medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Luna 3D Interbody Fusion System consists of the Luna 3D Implant and associated accessories. This system is indicated for spinal fusion procedures in skeletally mature patients with symptomative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to grade I spondylolisthesis or retrolisthesis at the involved level(s). The Luna 3D Interbody Fusion System is to be used with autogenous bone graft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion. Patients receiving the device should have had at least six months of nonoperative treatment prior to receiving the Luna 3D Implant. The Luna 3D Interbody Fusion System is to be used with supplemental fixation.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The Benvenue Luna 3D Interbody Fusion System consists of the Luna 3D Implant and associated accessories set of disposable accessories for use in lumbar fusion procedures to treat degenerative disc disease. The proposed indications for use for the Luna 3D Interbody Fusion System are identical to predicate interbody lumbar cages. The Luna 3D Implant is provided pre-loaded and sterile within a single-use Insertion Tool.
The Luna 3D Implant is available in heights ranging from 8mm to 15mm in 1mm increments. A series of vertically oriented slots allows the device to flex and enables it to be inserted from a straight cannula and then attain a closed, fixed, and circular shape upon being placed into the disc space with a bone graft pocket. Teeth engage the implant into the adjacent endplates.
The Luna 3D Implant is manufactured from polyetheretherketone (PEEK Optima LT-1 or Evonik VESTAKEEP i4R), stainless steel, tantalum, and silicone lubricant (NuSil MED-360).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine, L2-S1
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 comprehensive clinical literature review was conducted to assess any additional safety concern for the use of this device with the use of allograft in the lumbar spine. The review of the literature concluded that there were no additional risks due to the modifications for this device and that the device was substantially equivalent to the predicate devices.
This 510(k) also incorporates a series of minor design changes, including the addition of an 8degree lordotic version of the Luna 3D Implant, expansion of the implant height to 15mm, use of Evonik VESTAKEEP PEEK, and an alternative version of the trial instrument known as the Scout. To evaluate the impact of these changes on product performance, procedural validation and bench verification testing was conducted. The bench testing included static/dynamic compression, static/dynamic shear-compression, and static/dynamic torsion tests per ASTM F2077 as well as subsidence testing per ASTM F2267. The results of these tests confirmed that this design is substantially equivalent to legally marketed predicate devices.
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.
Orthofix FORZA PTC SYSTEM (K152475), Benvenue Medical Luna 360 Interbody Fusion System (K142023)
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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 17, 2016
Benvenue Medical, Inc. % Mr. Justin Eggleton Senior Director, Spine Regulatory Affairs Musculoskeletal Clinical Regulatory Advisers, LLC 1331 H Street NW, 12th Floor Washington, District of Columbia 20005
Re: K162431
Trade/Device Name: Luna 3D Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: August 26, 2016 Received: August 31, 2016
Dear Mr. Eggleton:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Luna 3D Interbody Fusion System
Indications for Use (Describe)
The Luna 3D Interbody Fusion System consists of the Luna 3D Implant and associated accessories. This system is indicated for spinal fusion procedures in skeletally mature patients with symptomative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to grade I spondylolisthesis or retrolisthesis at the involved level(s). The Luna 3D Interbody Fusion System is to be used with autogenous bone graft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion. Patients receiving the device should have had at least six months of nonoperative treatment prior to receiving the Luna 3D Implant. The Luna 3D Interbody Fusion System is to be used with supplemental fixation.
| 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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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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5. 510(k) Summary
| Device Trade Name: | Luna 3D Interbody Fusion System |
|---|---|
| Manufacturer: | Benvenue Medical, Inc. |
| 5403 Betsy Ross Drive | |
| Santa Clara, California 95054 USA | |
| 510(k) Owner: | Jeff Emery |
| Vice President, R&D | |
| Benvenue Medical, Inc. | |
| 5403 Betsy Ross Drive | |
| Santa Clara, California 95054 USA | |
| Telephone: +1 (408) 454-9300 | |
| Application Correspondent: | Mr. Justin Eggleton |
| Senior Director, Spine Regulatory Affairs | |
| Musculoskeletal Clinical Regulatory Advisers, LLC | |
| 1331 H Street NW, 12th Floor | |
| Washington, DC 20005 | |
| Office: 202.552.5800 | |
| jeggleton@mcra.com | |
| Date Prepared: | August 25, 2016 |
| Classifications: | 21 CFR §888.3080: Intervertebral body fusion device |
| Class: | II |
| Product Codes: | MAX |
| Primary Predicate Device: | Orthofix FORZA PTC SYSTEM (K152475) |
Additional Predicate Device: Benvenue Medical Luna 360 Interbody Fusion System (K142023)
Indications for Use:
The Luna 3D Interbody Fusion System consists of the Luna 3D Implant and associated accessories. This system is indicated for spinal fusion procedures in skeletally mature patients with symptomatic degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to grade I spondylolisthesis or retrolisthesis at the involved level(s). The Luna 3D Interbody Fusion System is to be used with autogenous bone graft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion. Patients receiving the device should have had at
4
least six months of nonoperative treatment prior to receiving the Luna 3D Implant. The Luna 3D Interbody Fusion System is to be used with supplemental fixation.
Device Description:
The Benvenue Luna 3D Interbody Fusion System consists of the Luna 3D Implant and associated accessories set of disposable accessories for use in lumbar fusion procedures to treat degenerative disc disease. The proposed indications for use for the Luna 3D Interbody Fusion System are identical to predicate interbody lumbar cages. The Luna 3D Implant is provided pre-loaded and sterile within a single-use Insertion Tool.
The Luna 3D Implant is available in heights ranging from 8mm to 15mm in 1mm increments. A series of vertically oriented slots allows the device to flex and enables it to be inserted from a straight cannula and then attain a closed, fixed, and circular shape upon being placed into the disc space with a bone graft pocket. Teeth engage the implant into the adjacent endplates.
The Luna 3D Implant is manufactured from polyetheretherketone (PEEK Optima LT-1 or Evonik VESTAKEEP i4R), stainless steel, tantalum, and silicone lubricant (NuSil MED-360).
These design features were demonstrated to be equivalent to the predicate devices presented in the next section.
Performance Testing:
A comprehensive clinical literature review was conducted to assess any additional safety concern for the use of this device with the use of allograft in the lumbar spine. The review of the literature concluded that there were no additional risks due to the modifications for this device and that the device was substantially equivalent to the predicate devices.
This 510(k) also incorporates a series of minor design changes, including the addition of an 8degree lordotic version of the Luna 3D Implant, expansion of the implant height to 15mm, use of Evonik VESTAKEEP PEEK, and an alternative version of the trial instrument known as the Scout. To evaluate the impact of these changes on product performance, procedural validation and bench verification testing was conducted. The bench testing included static/dynamic compression, static/dynamic shear-compression, and static/dynamic torsion tests per ASTM F2077 as well as subsidence testing per ASTM F2267. The results of these tests confirmed that this design is substantially equivalent to legally marketed predicate devices.
Substantial Equivalence Summary:
Comparative information presented in the 510(k) supports the substantial equivalence of the Luna 3D Interbody Fusion System to the following predicate devices: Orthofix FORZA PTC SYSTEM (K152475) and Benvenue Medical Luna 360 Interbody Fusion System (K142023). Comparisons were designed to show the indications, intended use, design, and performance are equivalent between the Benvenue Luna 3D Interbody Fusion System and predicate devices.
Conclusion:
The information and performance data demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate devices. This 510(k) was submitted on behalf of the Luna 3D Interbody Fusion System to expand the indications for use to include use with allograft in lumbar interbody fusions. Substantial equivalence was determined in response to sufficient comparisons to a predicate device.