When used as an intervertebral fusion device, the TETRIS™ ST devices are intended for use at one level in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment. The devices are intended for use with a supplemental internal fixation system and with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

Device Description

The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6AI-4V). Each device is available in a single footprint, with multiple heights and angulations.

The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 - S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.

AI/ML Overview

Here's an analysis based on the provided document, addressing the acceptance criteria and study information.

This document describes a 510(k) submission for an intervertebral body fusion device (Signus Tetris™ ST / Tetris™ R ST). For such devices, clinical studies and AI/human reader performance studies are generally not required for clearance, especially when the submission focuses on manufacturing process changes for a previously cleared product. The emphasis is on non-clinical (mechanical) testing to demonstrate substantial equivalence to a predicate device.

Therefore, many of the requested points, particularly those related to clinical studies, AI performance, and human reader studies, will be answered as "not applicable" or "no clinical testing was performed" based on the provided text.

Acceptance Criteria and Device Performance

For this specific device (intervertebral body fusion device), the "acceptance criteria" are primarily related to mechanical performance demonstrating equivalency to a predicate device, rather than diagnostic accuracy or AI performance.

Acceptance Criteria (Non-Clinical)	Reported Device Performance (Non-Clinical)
Compliance with ASTM F2077 Standard Test Methods for Intervertebral Body Fusion Devices (Static and Dynamic testing)	"The test results demonstrated that the subject device complies with ASTM F2077 Standard Test Methods for Intervertebral Body Fusion Devices by performing static and dynamic testing."
Static subsidence testing per ASTM F2267-22	"Static subsidence testing per ASTM F2267-22... were performed."
Static expulsion testing	"...static expulsion testing were performed."
Demonstrated substantial equivalence to predicate device in terms of safety and effectiveness	"Based on the indications for use, technological characteristics, and comparison with the predicate device, the subject device has demonstrated substantial equivalence."

Study Information

Sample size used for the test set and the data provenance:
- Test Set (for clinical or AI performance): Not applicable. Clinical testing was not performed to support this 510(k) submission. Mechanical testing involves samples of the device itself (e.g., a certain number of implants) to perform the specified ASTM tests, but the document does not specify the exact number of physical samples used for mechanical testing.
- Data Provenance: Not applicable for clinical data. The mechanical testing would have been conducted by the manufacturer (SIGNUS Medizintechnik GmbH) or their designated testing facility.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical test set requiring expert ground truth was used for this 510(k) submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set requiring adjudication was used.
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 device is an implantable medical device, not an AI diagnostic or assistance tool. No MRMC comparative effectiveness study was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is an implantable medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for clinical ground truth. For mechanical testing, the "ground truth" is adherence to established industry standards (ASTM standards) and comparison of performance metrics (e.g., stiffness, displacement) against the predicate device.
The sample size for the training set:
- Not applicable. There is no AI component that requires a training set.
How the ground truth for the training set was established:
- Not applicable. There is no AI component or training set.

Summary

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Image /page/0/Picture/0 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size, also in blue.

September 11, 2024

SIGNUS Medizintechnik GmbH % Chhavy Tep-Cullison Regulatory Affairs Specialist JALEX Medical, LLC 27865 Clemens Road, Suite 3 Westlake, Ohio 44145

Re: K241438

Trade/Device Name: Signus Tetris™ ST; Signus Tetris™ R ST Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: August 20, 2024 Received: August 20, 2024

Dear Chhavy Tep-Cullison:

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.

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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).

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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-regulatory

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assistance/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,

Brent Showalter -S

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

510(k) Number (if known) K241438

Device Name SIGNUS TETRISTM ST; SIGNUS TETRISTM R ST

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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Image /page/4/Picture/1 description: The image shows the logo for SIGNUS. The logo features a stylized letter "S" in gray and red, followed by the word "SIGNUS" in black, bold letters. Below "SIGNUS" is the tagline "The Spine Sign" in a smaller, less bold font, underlined with a thin red line.

Special 510(k) Submission -TETRIS™ ST/TETRIS™ R ST System 510(k) Summary

	510(k) Summary
Applicant:	SIGNUS Medizintechnik GmbHIndustriestrasse 2D-63755 Alzenau, GERMANY
Date:	09/05/2024
Applicant Contact:	Antje Schmidt, Regulatory Affairs Managera.schmidt@signus.com
Contact Person:	Chhavy Tep-CullisonRegulatory Affairs Specialist, JALEX Medical
Contact Email:	ccullison@jalexmedical.com
Contact Telephone:	(440) 320-4338
Contact Fax:	(440) 933-7839
Regulation Number:	21 CFR 888.3080
Classification Product Code:	MAX
Device Trade Name:	TETRIS™ ST, TETRIS™ R ST
Common Name:	Intervertebral body fusion device
Device Classification Name:	Intervertebral fusion device with bone graft, lumbar
Device Class:	II
Reviewing Panel:	Orthopedic
Primary Predicate Device:	K122317 - SIGNUS TETRISTM II
Additional Predicates:	K123758 – SIGNUS TASMIN® RK141405 – SIGNUS MOBIS™ II ST

Device Description:

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Image /page/5/Picture/1 description: The image contains the logo for SIGNUS. The logo features a stylized gray shape with red accents on the left side. To the right of the shape, the word "SIGNUS" is written in bold, black letters. Below "SIGNUS", the phrase "The Spine Sign" is written in a smaller font size, with a line above and below the phrase.

Special 510(k) Submission -TETRIS™ ST/TETRIS™ R ST System 510(k) Summary

Indications for Use and Intended Use:

Description of Modifications:

The TETRIS™ ST and TETRIS™ R ST system is an updated version of a legally marketed previous generation of the device to expand the TETRIS™ product line. The purpose of this submission is for SIGNUS Medizintechnik GmbH to obtain clearance for the manufacturing process change to include additive manufacturing. There are no changes to material or sterilization parameters.

Summary of Technological Characteristics:

The subject TETRIS™ ST and TETRIS™ R ST have the same intended use and indications for use as the predicate system. The technological characteristics of the subject system are similar to those of the predicate, and that any differences do not impact safety or effectiveness.

Performance Testing - Non-Clinical:

Mechanical testing was conducted to verify that the subject device was substantially equivalent to the predicate device. The test results demonstrated that the subject device complies with ASTM F2077 Standard Test Methods for Intervertebral Body Fusion Devices by performing static and dynamic testing. Static subsidence testing per ASTM F2267-22 and static expulsion testing were performed.

Performance Testing - Clinical:

Clinical testing was not applicable to support a substantial equivalence determination for the subject device.

Conclusion:

Based on the indications for use, technological characteristics, and comparison with the predicate device, the subject device has demonstrated substantial equivalence.

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.