JULIET® Ti LL Lumbar Interbody Device is indicated for intervertebral body fusion procedures in skeletally mature patients with 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 1 spondylolisthesis or retrolisthesis at the involved level(s). The JULIET® Ti LL Lumbar Interbody Device are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.

Implants with 15-degree lordosis or greater are only indicated from levels L2-L5 and are to be used with at least two integrated fixation screws. The JULIET® Ti LL implants must be used with supplemental internal spinal fixation system that has been cleared by the FDA for use in the lumbosacral spine.

Device Description

Spineart Juliet® Ti LL spinal implants consist of a range of titanium intervertebral body spacers, with various sizes and footprints so as to adapt different patient's conditions. The Juliet® Ti LL spinal implants are made of Titanium alloy Ti6A4V ELI conforming to ASTM F136. The Juliet® TilL spinal implants are additively manufactured and porous structures. The Juliet® Ti LL spinal implants are delivered sterilization). Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device.

The purpose of this submission is to add a new height (10mm) for the hyperlordotic spacers (five footprints) with a lordosis of 15° to the previously cleared Juliet® Ti LL range of devices (K190877, K173702).

The design of the connection interface of the plates and the screws are not modified. The solid, lattice and porous structures are the same. No modifications have been made to the indications for use, materials, manufacturing process, sterilization process.

Previously cleared (K190877, K173702) and added Juliet® Ti LL implants conform to Class II special controls established for Sec 888.3080 Intervertebral body fusion device.

Additionally, the Juliet Ti LL package insert has been updated to describe the conditions under which patients an MR environment.

AI/ML Overview

This document describes a 510(k) premarket notification for the "Juliet® Ti LL Lumbar Interbody Device". The acceptance criteria and supporting studies are focused on demonstrating substantial equivalence to previously cleared predicate devices, primarily K190877 and K173702, following a product line extension to include a new height (10mm) for hyperlordotic spacers with a 15° lordosis.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with numerical performance data in the typical sense of a diagnostic AI device. Instead, the "acceptance criteria" are implied by the demonstration that the modified device (new height) is substantially equivalent to predicates, particularly for the mechanical and MR environment performance. The performance is assessed by confirming that existing predicate device testing covers the new device, and by conducting new MR assessments where applicable.

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance: Does not introduce new worst cases regarding mechanical testing, ensuring safety and effectiveness.	The engineering analysis demonstrated that the Juliet® Ti LL line extension (present submission) does not introduce new worst cases regarding the mechanical testing. Therefore, the tests performed on Juliet® Ti LL predicate devices (K1733702 / K190877) – including static and dynamic axial compression, static and dynamic shear compression, static and dynamic torsion, expulsion, subsidence, and mass loss determination after dynamic testing – are still valid and cover the added cage references. No new mechanical tests were carried out as there is no significant difference between the line extension and predicate devices that would adversely affect use, performance, safety, or effectiveness.
MR Safety and Compatibility: Safe for use in an MR environment.	New assessment against updated MR-related standards was performed. Standards used include: Magnetically induced displacement force (ASTM F2052), Magnetically induced torque (ASTM F2213), MR image artifact (ASTM F2119), Radiofrequency (RF) induced heating (ASTM F2182), Standard practice for marking medical devices for safety in the magnetic resonance environment (ASTM F2503), and Testing and labeling medical devices for safety in the magnetic resonance environment (Guidance for Industry and FDA Staff, October 10, 2023). The package insert has been updated to describe the conditions under which patients can be safe within an MR environment.
Substantial Equivalence: No new safety or effectiveness concerns compared to predicate devices.	The subject Juliet® Ti LL devices are substantially equivalent to the previously cleared Juliet® Ti LL devices (K190877, K173702) with respect to their intended use, indications for use, device description, technological characteristics, and performance.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document focuses on mechanical and MR testing of the device itself, rather than human clinical or imaging data (which would typically have a "test set" and "data provenance").

Mechanical Testing: Performed on physical device samples (the predicate devices). The exact sample size for mechanical tests (e.g., how many devices were tested for compression, shear, etc.) is not specified in the provided text, but it refers to "assemblies (spacer + plate + fixation screws) that passed 5 million cycles."
MR Testing: Performed on physical device samples. No specific sample size is mentioned, but typical MR testing involves a limited number of device samples.
Data Provenance: Not applicable in the context of clinical patient data, as this is a device modification submission based on benchmarking against predicates and engineering analysis, not a new clinical study with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. The submission relies on engineering analysis and testing against established mechanical and material standards (ASTM, USP), rather than expert assessment of a clinical "test set" for ground truth.

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

Not applicable, as there is no clinical "test set" requiring expert adjudication of diagnoses or findings.

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

Not applicable. This is for an intervertebral body fusion device, not an AI-powered diagnostic device, so no MRMC study or AI assistance evaluation was performed.

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

Not applicable. This device is not an algorithm.

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

The "ground truth" here is defined by existing performance standards and the mechanical properties of the device materials and design validated through established testing protocols (e.g., ASTM standards for mechanical properties, USP for endotoxin, ASTM/FDA guidance for MR safety). The comparison is against the performance of the legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

Not applicable. No training set is involved for this device submission.

Summary

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July 18, 2024

Spineart SA Estelle Lefeuvre Regulatory & Market Access Manager 3 Chemin Du Pré-Fleuri Plan Les Ouates, 1228 Switzerland

Re: K241321

Trade/Device Name: Juliet® Ti LL Lumbar Interbody Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD, MAX Dated: May 10, 2024 Received: May 10, 2024

Dear Estelle Lefeuvre:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. 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

Submission Number (if known)

K241321

Device Name

Juliet® Ti LL Lumbar Interbody Device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

ver-The-Counter Use (21 CFR 801 Subpart C)

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K241321 Page 1 of 1

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Prepared on: 2024-07-18

Contact Details

Applicant Name		SPINEART SA

Applicant Address		3 chemin du Pré-Fleuri PLAN LES OUATES 1228 Switzerland
Applicant Contact Telephone		+41 22 570 1203
Applicant Contact		Ms. ESTELLE LEFEUVRE
Applicant Contact Email		elefeuvre@spineart.com
Device Name				21 CFR 807.92(a)(2)
Device Trade Name		Juliet® Ti LL Lumbar Interbody Device
Common Name		Intervertebral body fusion device
Classification Name		Intervertebral Fusion Device With Integrated Fixation, Lumbar
Regulation Number		888.3080
Product Code(s)		OVD, MAX
Legally Marketed Predicate Devices			21 CFR 807.92(a)(3)
Predicate #		Predicate Trade Name (Primary Predicate is listed first)		Product Code
K190877	Juliet® Ti LL			OVD
K173702	Juliet® Ti LL			MAX
Device Description Summary				21 CFR 807.92(a)(4)
Spineart Juliet® Ti LL spinal implants consist of a range of titanium intervertebral body spacers, with

various sizes and footprints so as to adapt different patient's conditions. The Juliet® Ti LL spinal implants are made of Titanium alloy Ti6A4V ELI conforming to ASTM F136. The Juliet® TilL spinal implants are additively manufactured and porous structures. The Juliet® Ti LL spinal implants are delivered sterilization). Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device.

Previously cleared (K190877, K173702) and added Juliet® Ti LL implants conform to Class II special controls established for Sec 888.3080 Intervertebral body fusion device.

Additionally, the Juliet Ti LL package insert has been updated to describe the conditions under which patients an MR environment.

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

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JULIET® Ti LL Lumbar Interbody Device is intervertebral body fusion procedures in skeletally mature patients with 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 1 spondylolisthesis or retrolisthesis at the involved levels). The JULIE™ Ti LL Lumbar Interbody Device are to be used with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral cage.

lmplants with 15-degree lordosis or greater are only indicated from levels L2-L5 and are to be used with at least two integrated fixation screws. The JULIET® Ti LL implants must be used with supplemental internal spinal fixation system that has been cleared by the FDA for use in the lumbosacral spine.

Indications for Use Comparison

The added Juliet® Ti LL interbody spacers subject of this submission for use as the predicate Juliet® Ti LL devices cleared under K190877.

Technological Comparison

The design of the connection interface of the plates and the screws are not modified. The solid, lattice and porous structures are the same. No modifications have been made to the intended use, indications for use, materials, manufacturing process, sterilization process.

Previously cleared (K190877, K173702) and added Juliet® Ti LL implants conform to Class II special controls established for Sec 888.3080 Intervertebral body fusion device.

Additionally, the Juliet Ti LL package insert has been updated to describe the conditions under which patients an be safe within an MR environment.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

The present submission introduces only additional references for the interbody spacer. The interbody spacer interface connection, the plates and the screws are not impacted by the product line extension.

The following non-clinical tests were conducted on Juliet® Ti LL predicate devices (#K173702 / #K190877):

Static and dynamic axial compression (per ASTM F2077)
Static and dynamic shear compression (per ASTM F2077)
Static and dynamic torsion (per ASTM F2077)
Expulsion
Subsidence (per ASTM F2267) and
Mass loss determination after dynamic testing on assemblies (spacer + plate + fixation screws) that passed 5 million cycles. Additionally, axial push out on the fixation screws through the plate were conducted.

The engineering analysis has demonstrated that buliet® Ti LL line extension (present submission) does not introduce new worst cases regarding the mechanical testing, so the tests performed on Juliet® Ti LL predicate devices (K173702 / K19087) are still valid and cover the added cage references.

Standards for MR assessments are the following:

Magnetically induced displacement force (ASTM F2052).
Magnetically induced torque (ASTM F2213).
MR image artifact (ASTM F2119).
Radiofrequency (RF) induced heating (ASTM F2182).
Standard practice for marking medical devices and other items for safety in the magnetic resonance environment (ASTM F2503)
Testing and labeling medical devices for safety in the magnetic resonance environment (Guidance for Industry and FDA Staff, October 10, 2023

There is no significant difference between the Juliet® Ti LL line extension (present submission) and the previously cleared Juliet® Ti LL predicate devices (K173702 / K19087) which would adversely affect the use and performances of the product or raise any issue of safety and effectiveness. Consequently, no new mechanical tests were carried out.

The subject Juliet® Ti LL devices are substantially equivalent to the previously cleared Juliet® Ti LL devices (K190877, K173702) with respect to their intended use, indications for use, device description, technological characteristics, and performance. The information provided in this premarket submission supports substantial equivalence to the predicate devices (K190877, K173702).

21 CFR 807.92(a)(6)

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.