The Luna XD Ti Interbody Fusion System consists of the Luna XD Ti 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 XD Ti Interbody Fusion is to be used with autogenous bone graft and/or allogence bone graft composed of cancellous bone graft to facilitate fusion. Patients receiving the device should have had at least six months of nonoperative treatment prior to receiving the Luna XD Ti Implant. The Luna XD Ti Interbody Fusion System is to be used with supplemental fixation.

Device Description

The Benvenue Luna XD Ti Interbody Fusion System consists of the Luna XD Ti 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 XD Ti Interbody Fusion System are identical to the primary predicate device. The Luna XD Ti Implant is provided pre-loaded and sterile within a single-use Insertion Tool.

The Luna XD Ti Implant is an assembly of three (3) PEEK components referred to as the Top, Middle and Bottom, similar to the Luna 3D Gen2. Additionally, a Nitinol Spine is inserted into the middle component to retain its normally closed shape configuration. And finally, the outer top and bottom surfaces of the implant XD Ti have a commercially pure (Cp) Ti metallic powder. The final components have radiopaque tantalum markers for fluoroscopic visibility.

The outer surfaces of the Top and Bottom components have teeth in addition to the already rough surface created by the Ti coating, which are designed to enhance the implant's resistance to expulsion. Upon insertion of the outer components, the middle component is inserted to expanded into its ultimate height. The central cavity of the implant accommodates placement of autogenous bone graft and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft through a graft window.

The Luna XD Ti Implant is manufactured from polyetheretherketone (Evonik VESTAKEEP i4R; ASTM F2026), Nitinol (nickel titanium alloy; ASTM F2063), tantalum (ASTM F560) and commercially pure (Cp) Ti metallic powder coating layer (ASTM F 1580).

The Luna XD Ti Implant is available in heights ranging from 10mm to 14mm with 2mm increments and a 6° lordotic angle and from 12mm with 2mm increments and a 12° lordotic angle. 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. In addition, the outer top and bottom surfaces of the implant XD Ti have a commercially pure (Cp) Ti metallic powder conforming to ASTM F1580 with a specified grain size and morphology. This additional titanium coating offers initial stability due to increased surface roughness and possibly also long-term stability due to bony ingrowth created from osteoconductive microenvironment on the device surface.

The Luna XD Ti Implant that is the subject of this 510(k) is manufactured from polyetheretherketone (Evonik VESTAKEEP i4R; ASTM F2026), Nitinol (nickel titanium alloy; ASTM F2063), tantalum (ASTM F560) and commercially pure (Cp) Ti metallic powder coating layer (ASTM F 1580). This 510(k) is submitted in support of the additional surface coating to an existing Device cleared under K183560.

AI/ML Overview

The extract provided describes the Luna XD Ti Interbody Fusion System, which is an intervertebral body fusion device. The document is an FDA 510(k) premarket notification summary.

Based on the provided text, the device is not an AI/ML powered device. The information focuses on mechanical testing, material properties, and sterilization, comparing the device to a predicate device. Therefore, several of the requested categories related to AI/ML device performance, such as 'number of experts used to establish ground truth', 'adjudication method', 'MRMC study' and 'standalone algorithm performance' are not applicable to this submission.

Here is the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (from predicate device comparison)	Reported Device Performance (Luna XD Ti Interbody Fusion System)
Mechanical performance (Axial Compression, Torsion, Compression-Shear) at same load as predicate device	Comparable to predicate device; coating process does not impact mechanical performance. Runout testing successfully completed.
Coating thickness, porosity, and surface roughness characterized per ASTM F1854 standards	Characterized and deemed substantially equivalent to predicate based on the overall submission.
Shear Strength (ASTM F1160)	Conducted on modified surface (coupons); not explicitly stated if it met a specific numerical criterion but the overall conclusion is substantial equivalence.
Static Shear Strength (ASTM F-1044)	Conducted on modified surface (coupons); not explicitly stated if it met a specific numerical criterion but the overall conclusion is substantial equivalence.
Tensile Strength (ASTM F-1147)	Conducted on modified surface (coupons); not explicitly stated if it met a specific numerical criterion but the overall conclusion is substantial equivalence.
Abrasion Resistance (ASTM 1978-99)	Conducted on modified surface (coupons); not explicitly stated if it met a specific numerical criterion but the overall conclusion is substantial equivalence.
Debris Analysis (ASTM F1877)	Conducted on the Luna XD Ti PEEK implant coated with commercially pure Titanium following testing per ASTM F2077 and after implantation. Results "demonstrate that the devices are substantially equivalent to the predicate devices."
Sterility Assurance Level	10^-6 sterility assurance level (Gamma radiation for sterilization of components)
Indications for Use, Intended Use, Design	Identical to primary predicate device.
Overall safety and effectiveness	Device is "as safe, as effective, and performs as well as or better than the primary predicate device."

2. Sample size used for the test set and the data provenance:

The document primarily describes mechanical and material testing based on ASTM standards. It does not mention human subject studies or a "test set" in the context of clinical data for AI/ML performance. The "testing" refers to bench testing of the device and its materials.
No information on "data provenance" (country of origin, retrospective/prospective) is provided as it's not a clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This is a medical device (interbody fusion system) of the mechanical type, not an AI/ML diagnostic or prognostic tool. Therefore, "ground truth" as related to expert interpretation of data is not relevant here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For mechanical and material performance, the "ground truth" is established by adherence to recognized ASTM and other relevant standards for material properties, mechanical integrity, and biocompatibility, as well as comparison to the performance of a legally marketed predicate device. The ultimate "ground truth" for substantial equivalence lies in demonstrating that the modified device performs similarly or better than the predicate device in relevant bench tests.

8. The sample size for the training set:

Not Applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established:

Not Applicable. See point 8.

Summary

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July 2, 2020

Benvenue Medical, Inc. % Justin Eggleton Vice President, Spine Regulatory Affairs MCRA. LLC 1050 K Street NW, Suite 1000 Washington, District of Columbia 20001

Re: K193172

Trade/Device Name: Luna XD Ti Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: June 3, 2020 Received: June 3, 2020

Dear Justin 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. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Brent Showalter, Ph.D. Acting Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193172

Device Name Luna XD Ti Interbody Fusion System

Indications for Use (Describe)

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 4

Device Trade Name:	Luna XD Ti Interbody Fusion System
Manufacturer:	Benvenue Medical, Inc.5403 Betsy Ross DriveSanta Clara, California 95054 USA
Contact:	Laurent SchallerCTO and FounderBenvenue Medical, Inc.5403 Betsy Ross DriveSanta Clara, California 95054 USA
Prepared by:	Mr. Justin EggletonVice President, Spine Regulatory AffairsMCRA, LLC1050 K Street NW, Suite 1000Washington, DC 20001jeggleton@mcra.com
Date Prepared:	November 15, 2019
Classifications:	21 CFR §888.3080, Intervertebral body fusion device
Class:	II
Product Codes:	MAX
Primary Predicate:	The subject devices are substantially equivalent to thefollowing primary predicate device.

Manufacturer	Device Name	K Number
Benvenue Medical	Luna 3D Interbody Fusion System	K183560

In addition to the primary predicate device, additional Additional Predicates: predicate devices cited in this 510(k) are presented in the following table.

Manufacturer	Device Name	K-Number
Exatech	Octane Straight IFD, Ti Coated	K150152

Table 7: Additional Predicate Devic

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Device Description:

Indications for Use:

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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 XD Ti 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 XD Ti Implant. The Luna XD Ti Interbody Fusion System is to be used with supplemental fixation.

Performance Testing Summary:

Mechanical testing was completed by confirmation testing of runouts in Axial Compression, Torsion, and Compression-Shear at the same load as predicate device to ensure that the coating process does not impact mechanical performance and leverage of the predicate data as the failure modes across all mechanical tests is identical in this regard. Coating thickness, porosity, and surface roughness were characterized according to ASTM F1854 standards. Additional testing of the modified surface (on coupons) were conducted per the following Standards: ASTM F1160 Shear Strength; ASTM F-1044 Static Shear Strength: ASTM F-1147 Tensile Strength and ASTM 1978-99 Abrasion Resistance.

In addition, Debris Analysis per ASTM F1877 was conducted on the Luna XD Ti PEEK implant coated with commercially pure Titanium following testing per ASTM F2077 as well as following implantation testing. The results demonstrate that the devices are substantially equivalent to the predicate devices.

Sterilization, Shelf Life, Cleaning and Pyrogenicity:

The components of the Luna XD Ti Interbody Fusion System are provided sterile. Gamma radiation is utilized for sterilization of the components. All sterile components have a 10° sterility assurance level. The Luna XD Ti Accessories are provided non-sterile in a sterilization instrument tray (LUN6310) and are the same as previously presented in the predicate device (K183560).

Substantial Equivalence Summary:

Comparative information presented in the 510(k) supports the substantial equivalence of the Luna XD Ti Interbody Fusion System to the primary predicate device. Comparisons were designed to show the indications, intended use, design, and performance are equivalent between the Benvenue Luna XD Ti Interbody Fusion System and primary predicate device.

Conclusion:

The information and performance data demonstrate that the device is as safe, as effective, and performs as well as or better than the primary predicate device. This 510(k) was submitted on behalf of the Luna XD Ti Interbody Fusion System in support of the additional surface coating to an existing Device cleared under K183560. Substantial equivalence was determined in response to sufficient comparisons to the primary predicate device.

Regulation Number and Section

§ 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.