(118 days)
No
The summary describes a mechanical interbody fusion system and its materials, with no mention of AI or ML in its function, design, or testing.
Yes
The device is used for spinal fusion procedures to treat symptomatic degenerative disc disease, which involves medically repairing or alleviating a disease or injury.
No
The device is an interbody fusion system designed for spinal fusion procedures, specifically to treat degenerative disc disease. It is an implantable device used during treatment, not to diagnose a condition.
No
The device description clearly states it is an implant and associated accessories made from physical materials (PEEK, stainless steel, tantalum, silicone lubricant). It also describes mechanical testing and cadaveric testing, which are relevant to hardware devices, not software-only devices.
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 and Intended Use: The Luna 360 Interbody Fusion System is a surgical implant designed to be placed within the spine (L2-S1) to facilitate bone fusion in patients with degenerative disc disease. It is a physical device used in vivo (within the body) during a surgical procedure.
- Lack of Diagnostic Function: The description does not mention any function related to analyzing biological samples or providing diagnostic information. Its purpose is structural support and promoting fusion.
Therefore, the Luna 360 Interbody Fusion System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Luna 360 Interbody Fusion System consists of the Luna 360 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 360 System is to be used with autogenous bone graft. Patients receiving the device should have had at least six months of nonoperative treatment prior to receiving the Luna 360 Implant. The Luna 360 System is to be used with supplemental fixation.
Product codes
MAX
Device Description
The Benvenue Luna 360 System consists of the Luna 360 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 360 System are identical to predicate interbody lumbar cages. The Luna 360 Implant is provided pre-loaded and sterile within a single-use Insertion Tool.
The Luna 360 Implant is available in heights ranging from 8mm to 13mm 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 360 Implant is manufactured from polyetheretherketone (PEEK Optima LT-1), 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2-S1 (lumbar 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
Non-clinical tests performed included static/dynamic compression, static/dynamic shearcompression, and static/dynamic torsion testing per ASTM F2077, static subsidence (ASTM F2267), and expulsion testing (ASTM Draft Standard F-04.25.02.02). Additional cadaveric testing has been performed to validate the surgical technique. MR Compatibility testing was performed to demonstrate MR safety. The results of the performed tests demonstrated that the Luna Interbody System is substantially equivalent to legally marketed predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K130254, K092901, K082310, K122967, K071724, K112095, K093669
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked one behind the other, representing people. The faces are rendered in a simple, abstract style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 20, 2014
Benvenue Medical, Incorporated % Ms. Cindy Domecus Principal Domecus Consulting Servics LLC 1171 Barroilhet Drive Hillsborough, California 94010
Re: K142023
Trade/Device Name: Luna 360 Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: October 22, 2014 Received: October 23, 2014
Dear Ms. Domecus:
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
1
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 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/Resourcesfor You/Industry/default.htm. 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 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 yours,
Mark N. Melkerson -S
Mark N. Melkerson Director. Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K142023
Device Name
Benvenue Medical, Inc. Luna 360 Interbody Fusion System
Indications for Use (Describe)
The Luna 360 Interbody Fusion System consists of the Luna 360 Implant and associated accessories. This system is indicated for spinal fusion procedures in skeletally mature patients with symptomatic degenerative dise disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degenerations of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to grade I snoondsylolisthesis or retrolisthesis at the involved level(s). The Luna 360 Interbody Fusion System is to be used with autogenous bonsitissis. Patients receiving the device should have had at least six months of nonoperative treatment prior to receiving books Lona 360 Implant. The Luna 360 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
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 360 Interbody System |
|---|---|
| Manufacturer: | Benvenue Medical, Inc. |
| 3052 Bunker Hill Lane, Suite 120 | |
| Santa Clara, California 95054 USA | |
| 510(k) Owner: | Barbara S. Lindsay |
| Vice President, Clinical and Regulatory Affairs | |
| Benvenue Medical, Inc. | |
| 3052 Bunker Hill Lane, Suite 120 | |
| Santa Clara, California 95054 USA | |
| Telephone: +1 (408) 454-9300 | |
| Application Correspondent: | Cindy Domecus, R.A.C. (US & EU) |
| Principal | |
| Domecus Consulting Services LLC | |
| Consultant to Benvenue Medical, Inc. | |
| Office: 650-343-4813 | |
| Fax: 650-343-7811 | |
| domecusconsulting@comcast.net | |
| Date Prepared: | November 18, 2014 |
| Classifications: | 21 CFR §888.3080: Intervertebral body fusion device |
| Class: | II |
| Product Codes: | MAX |
Indications for Use:
The Luna 360 System consists of the Luna 360 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 360 System is to be used with autogenous bone graft. Patients receiving the device should have had at least six months of nonoperative treatment prior to receiving the Luna 360 Implant. The Luna 360 System is to be used with supplemental fixation.
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Device Description:
The Benvenue Luna 360 System consists of the Luna 360 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 360 System are identical to predicate interbody lumbar cages. The Luna 360 Implant is provided pre-loaded and sterile within a single-use Insertion Tool.
The Luna 360 Implant is available in heights ranging from 8mm to 13mm 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 360 Implant is manufactured from polyetheretherketone (PEEK Optima LT-1), 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.
Predicate Device Comparison:
Comparative information presented in the 510(k) supports the substantial equivalence of the Luna Interbody System to the primary predicate of the NLT Prow Fusion (K130254) and other predicates, including R Tree Innovations Epicage (K092901), SeaSpine Hollywood (K082310), Spinal Elements Lucent (K122967, K071724) and CoAlign Innovations AccuLIF TL-PEEK Cage (K112095 and K093669). Comparisons were designed to show the indications, intended use, design, and performance are equivalent between the Benvenue Luna 360 System and predicate devices.
Performance Testing:
The non-clinical tests performed included static/dynamic compression, static/dynamic shearcompression, and static/dynamic torsion testing per ASTM F2077, static subsidence (ASTM F2267), and expulsion testing (ASTM Draft Standard F-04.25.02.02). The results of the performed tests demonstrated that the Luna Interbody System is substantially equivalent to legally marketed predicate devices. Additional cadaveric testing has been performed to validate the surgical technique. MR Compatibility testing was performed to demonstrate MR safety.
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.