The Sypher Spacer System is a standalone intervertebral body fusion system for use in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use with autogenous and/or allogenic bone graft (composed of cancellous and/or corticocancellous bone) at one or two contiguous levels of the lumbar spine (L2-S1) for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Supplemental fixation is required whenever fewer than 3 bone screws are utilized.

Device Description

The Sypher Spacer System is a standalone intervertebral body fusion system intended for the lumbar spine. The Sypher Spacer System implants include cylinder shaped blocks manufactured from PEEK-OPTIMA™ LT1 conforming to ASTM F2026, tantalum markers conforming to ASTM F560, titanium alloy self-tapping, self-drilling bone screws conforming to ASTM F136, and titanium alloy cage lock assemblies conforming to ASTM F136.

The implants are available in a variety of footprints. heights, and lordotic angles. The device features a hollow center to accommodate autogenous and/or allogenic bone graft (composed of cancellous and/or corticocancellous bone). The implants have integrated anterior screw holes to allow for medial placement of screws, and a titanium alloy cage lock assembly for securing the screws in place. The superior and inferior surfaces of the implant have a pattern of teeth to prevent movement.

AI/ML Overview

This document is a 510(k) summary for the Sypher Spacer System, an intervertebral body fusion device. It primarily focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and mechanical testing. As such, the document does not contain the detailed information typically found in an AI/ML device submission regarding acceptance criteria, performance studies involving human readers, or detailed ground truth establishment.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent:

Acceptance Criteria and Study Details for the Sypher Spacer System

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Testing:	Static Compression (ASTM F2077): Performance not explicitly stated (results deemed sufficient for substantial equivalence)
Static compression per ASTM F2077	Static Shear Compression (ASTM F2077): Performance not explicitly stated (results deemed sufficient for substantial equivalence)
Static shear compression per ASTM F2077	Expulsion Testing (ASTM Draft Standard F-04.25.02.02): Performance not explicitly stated (results deemed sufficient for substantial equivalence)
Expulsion testing per ASTM Draft Standard F-04.25.02.02	Finite Element Analysis (FEA): Results deemed sufficient for substantial equivalence
Finite Element Analysis (FEA)

Explanation: The document states that "Substantial Equivalence is supported by the results of mechanical testing and Finite Element Analysis (FEA)." However, it does not provide the specific acceptance criteria thresholds or the quantitative results from these tests. It only lists the types of tests performed.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The document describes mechanical testing of a medical device (intervertebral spacer), not an AI/ML diagnostic or predictive tool that would utilize a "test set" in the context of data. The mechanical tests would typically involve a certain number of manufactured units, but this sample size is not disclosed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable/provided. The device is a physical implant, and its performance is assessed through mechanical testing against standards, not by an expert review of a "test set" of patient data for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert labeling of data, which is not relevant to the mechanical testing of a physical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

This information is not applicable/provided. An MRMC study is relevant for AI-powered diagnostic tools to assess the impact on human reader performance. This document describes a physical medical implant, not an AI system.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is not applicable/provided. The device is a physical intervertebral spacer. It does not have an "algorithm-only" performance as it is not an AI/ML software.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by engineering standards and specifications for mechanical properties and biocompatibility, as evidenced by the mention of ASTM standards (e.g., ASTM F2077, ASTM F560, ASTM F136). The device's design also ensures it can accommodate autogenous and/or allogenic bone graft (composed of cancellous and/or corticocancellous bone) for fusion.

8. The Sample Size for the Training Set

This information is not applicable/provided. The device is a physical implant and does not involve a "training set" in the context of AI/ML models.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/provided. As above, there is no "training set" for this type of device. The design and manufacturing process would adhere to established quality systems and design controls rather than data-driven ground truth establishment.

Summary of what the document does provide:

Device Type: Intervertebral body fusion system (Sypher Spacer System).
Regulatory Status: 510(k) clearance (K181337) based on substantial equivalence.
Predicate Devices: Biogennix Sypher Spacer System (K141798) as primary, Zimmer Biomet Solitaire (K081395, K081501) and Zimmer Biomet ROI-A® ALIF Cage System (K153495) as reference predicates.
Performance Study: Mechanical testing including static compression, static shear compression (both per ASTM F2077), expulsion testing (per ASTM Draft Standard F-04.25.02.02), and Finite Element Analysis (FEA).
Conclusion: The device demonstrated substantial equivalence based on indications for use, technological characteristics, and comparison with predicate devices supported by mechanical testing and FEA.

The provided document is a 510(k) summary for a traditional medical device (implant), not an AI/ML-powered device. Therefore, many of the requested criteria related to AI/ML device validation are not present or applicable.

Summary

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September 18, 2018

Biogennix, LLC % Daniel Johnson Regulatory Engineer JALEX Medical, LLC. 30311 Clemens Rd. Suite 5D Westlake, Ohio 44145

Re: K181337

Trade/Device Name: Sypher Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, OVD Dated: August 21, 2018 Received: August 22, 2018

Dear Mr. Johnson:

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

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Melissa Hall -S

For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181337

Device Name Sypher Spacer 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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K181337 510(k) Summary

Submitted By:	Biogennix, LLC18007 Sky Park Circle, Suite FIrvine, CA 92614
Date:	08/21/2018
Contact Person:	Daniel Johnson, Regulatory Engineer
Contact Telephone:	(440) 541-0060
Contact Fax:	(440) 933-7839
Device Trade Name:	Sypher Spacer System
Device Common Name:	Intervertebral Fusion Device
Device Classification Name:	Intervertebral Fusion Device With Bone Graft, LumbarIntervertebral Fusion Device With Integrated Fixation, Lumba
Regulation Number:	21 CFR 888.3080
Device Classification:	Class II
Product Code:	MAX, OVD
Primary Predicate:	Biogennix Sypher Spacer System (K141798)The predicate device has never been subjected to a recall
Reference Predicates:	Zimmer Biomet Solitaire (K081395, K081501)Zimmer Biomet ROI-A® ALIF Cage System (K153495)

Device Description:

Indications For Use:

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Image /page/4/Picture/0 description: The image shows the word "BIOGENNiX" in a stylized, bold, sans-serif font. The letters are all capitalized and connected, with rounded corners. The "X" has a swoosh extending from the bottom left to the top right, adding a dynamic element to the logo. The overall design is modern and sleek.

Summary of Technological Characteristics:

The Sypher Spacer System and the predicates have similar intended use and fundamental scientific technology. All devices compare similarly in:

Design features
Intended use ●
Materials
Dimensions
Function

Mechanical Testing:

Substantial Equivalence is supported by the results of mechanical testing and Finite Element Analysis (FEA). The mechanical testing performed includes static compression per ASTM F2077, static shear compression per ASTM F2077, and expulsion testing per ASTM Draft Standard F-04.25.02.02.

Conclusion:

Based on the indications for use, technological characteristics, and comparison with the predicate devices, 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.