The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Renovis S128 ALIF System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The Renovis S128 ALIF System is a stand-alone device and is intended to be used with the cover plate and screws provided and requires no additional supplementary fixation. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided. Should the physician choose to use fewer than the four screws provided, additional supplemental fixation cleared by the FDA for use in the lumbar spine must be used. Supplemental fixation, cleared by the FDA for use in the lumbosacral spine, must be used with implants ≥20°.

Device Description

The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System is FDA cleared as K131122 and K140106 (sterile implants). This application describes additional cages offerings (new lengths, widths, and lordosis) and a packaging change.

The S128 ALIF System includes cages of a variety of lengths, widths, heights, and lordosis to suit the individual pathology and anatomical conditions of the patient. The different shape of the footprint allows for different surgical approaches for insertion. S128 ALIF System cages are standalone for devices <20° when implanted with the coverplate and screws. Implants are offered in Ti6A14V and PEEK with Tantalum marker pins. Titanium cages are additively manufactured then machined to the final cage dimensions. PEEK implants are manufactured using traditional methods.

The Ti6Al4V conforms to the chemical and mechanical requirements of ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications
The PEEK is compliant with ASTM F2026-17 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications.The Tantalum is compliant with ASTM F560-17 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications.

The S128 ALIF System cages that are the subject of this application are gamma sterilized.

The system also includes instruments to allow for implant determination, trialing and disc preparation. Instruments are manufactured from stainless steel in compliance with ASTM A564/M564-13e1 Standard Specification for Hot-Rolled and Cold-Finished Age-Hardening Stainless Steel Bars and Shapes.

AI/ML Overview

This document describes the FDA's decision regarding the Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System and focuses on its substantial equivalence to previously cleared devices rather than a study about AI performance. Therefore, many of the requested categories are not applicable.

Here's the information extracted and interpreted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical "acceptance criteria" table with specific performance metrics for an AI device. Instead, it focuses on demonstrating substantial equivalence for a medical implant (ALIF System) by meeting established standards and performing tests relevant to its physical properties and function.

Acceptance Criteria (Demonstrated Equivalence through)	Reported Device Performance (Successful Testing)
Functional Equivalence: Same Indications for Use	The modified cages (new lengths, widths, and lordosis) and packaging change have the same Indications for Use as the K140106 predicate cages.
Material Equivalence: Manufactured from same materials	The device is manufactured from the same materials as the predicate devices: Ti6Al4V (conforms to ASTM F136-13), PEEK (compliant with ASTM F2026-17), and Tantalum (compliant with ASTM F560-17). Instruments are stainless steel (compliant with ASTM A564/M564-13e1).
Process Equivalence: Same manufacturing processes	The device uses the same manufacturing processes as the predicate devices. Titanium cages are additively manufactured then machined. PEEK implants are manufactured using traditional methods.
Sterilization Equivalence: Same gamma sterilization	The device is gamma sterilized, the same as the K140106 predicate cages. Complies with AAMI/ANSI/ISO 11137-2:2013 and AAMI/ANSI/ISO 11137-1:2006/(R)2010.
Mechanical Performance: Dynamic Shear Compression strength	Successful Dynamic Shear Compression strength testing was performed per ASTM F2077-14.
Mechanical Performance: Expulsion testing	Successful Expulsion testing was performed.
Risk Management: Assessed for risk under Design Controls	All changes were assessed for risk and successfully tested under Design Controls.
Biocompatibility: Biological evaluation	Complies with AAMI/ANSI/ISO 10993-1:2009/(R)2013 Biological Evaluation Of Medical Devices.
Endotoxin Testing: AAMI/ANSI ST72 standard	Complies with AAMI/ANSI ST72:2011/(R)2016 Bacterial Endotoxins Test Methods.
Additional Standards Compliance:	Complies with ISO 17665-1 (Sterilization Of Health Care Products Moist Heat) and "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Intervertebral Body Fusion Device, June 2007."

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

Sample Size for Test Set: Not applicable. This document describes the substantial equivalence of a physical medical implant (ALIF System) based on engineering tests, not a software device or AI algorithm evaluated on a data test set. The "tests" mentioned (Dynamic Shear Compression, Expulsion) refer to physical testing of the device itself.
Data Provenance: Not applicable for an AI or software study. The data is generated from physical material and mechanical testing of the device components.

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

Not applicable. Ground truth, in the context of expert consensus, is not relevant for this type of device submission. The "ground truth" for the device's physical properties is established by adherence to ASTM standards and validated engineering test methods performed by qualified laboratories.

4. Adjudication method for the test set:

Not applicable. There is no human expert adjudication of test results in the sense of consensus on medical images or diagnoses for this device. The physical tests are governed by standardized protocols.

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 submission is for a physical medical implant, not an AI or software device that would involve human readers or AI assistance.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

The "ground truth" for this medical device's performance is based on established engineering standards and validated physical test methods. For example, ASTM F2077-14 for intervertebral body fusion devices sets the benchmark for acceptable mechanical performance. Material composition adherence to ASTM F136-13, F2026-17, F560-17, and A564/M564-13e1 provides the "ground truth" for material specifications. Sterilization validation using AAMI/ANSI/ISO standards establishes the "ground truth" for sterility.

8. The sample size for the training set:

Not applicable. This is not an AI or machine learning device 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 type of device.

Summary

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Renovis Surgical Technologies Inc. % Sharyn Orton Senior Consultant MEDIcept. Inc. 200 Homer Ave Ashland, Massachusetts 01721

June 14, 2018

Re: K180502

Trade/Device Name: S128 Anterior Lumbar Interbody Fusion (ALIF) System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: May 15, 2018 Received: May 16, 2018

Dear Dr. Orton:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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Page 2 - Dr. Sharyn Orton

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 2018.06.14 12:57:33 -04'00"

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) K180502

Device Name

S128 Anterior Lumbar Interbody Fusion (ALIF) 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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Traditional 510(k) Summary as required by 21 CFR 807.92(a) K180502

A) Submitted by:	Renovis Surgical Technologies Inc.1901 W. Lugonia Ave, Ste 340Redlands, CA 92374Phone: 909-557-2360Fax: 909-307-8571
Official Contact:	Anthony DeBenedictisVice President of Quality Assurance
Consultant:	Sharyn Orton, Ph.D.MEDIcept, Inc.200 Homer AveAshland, MA 01721
B) Classification Name:	Intervertebral Fusion Device, Lumbar
Common Name:	Intervertebral body fusion device
Proprietary Name:	Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System
Device Class:	Class II
Regulationsand Product Code:	21 CFR 888.3080OVD
Classification panel:	Orthopedic
C) Predicates:	Primary: K140106 Renovis S128 Anterior Lumbar InterbodyFusion (ALIF) SystemK131122 Renovis S128 Anterior Lumbar Interbody Fusion (ALIF)System
D) Date Prepared:	June 12, 2018

E) Device Description:

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The Ti6Al4V conforms to the chemical and mechanical requirements of ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications
The PEEK is compliant with ASTM F2026-17 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications.The Tantalum is compliant with ASTM F560-17 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications.

The S128 ALIF System cages that are the subject of this application are gamma sterilized.

F) Intended Use/Indications For Use:
The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Renovis S128 ALIF System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six months of non-operative treatment. The Renovis S128 ALIF System is a stand-alone device and is intended to be used with the cover plate and screws provided and requires no additional supplementary fixation. The anterior cover plate must be utilized whenever the device is implanted using the bone screws provided. Should the physician choose to use fewer than the four screws provided, additional supplemental fixation cleared by the FDA for use in the lumbar spine must be used. Supplemental fixation, cleared by the FDA for use in the lumbosacral spine, must be used with implants ≥20°.
G) Substantial Equivalence Comparison and Discussion
The modified cages have the same Indications for Use, are manufactured from the same materials using the same manufacturing processes, and are gamma sterilized the same as the K140106 predicate cages. The new cages are different sizes and lordosis from the predicate cages.

The manufacturing change was validated.

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The new changes were assessed for risk and tested under Design Controls. Successful testing included:

Dynamic Shear Compression strength testing per ASTM F2077-14 .
Expulsion testing ●

Conclusion: Testing demonstrated that the new S128 ALIF System cages are substantially equivalent to the FDA cleared predicate S128 ALIF System cages.

H) Compliance with Design Controls

All changes were assessed for risk and successfully tested under Design Controls.

I) Compliance with Standards or FDA Guidance

The Renovis S128 ALIF System complies with the following:

ASTM F2077-14: Test Methods For Intervertebral Body Fusion Devices ●
AAMI/ANSI ST72:2011/(R)2016 Bacterial Endotoxins Test Methods, Routine ● Monitoring, And Alternatives To Batch Testing
AAMI/ANSI/ISO 11137-2:2013 Sterilization Of Health Care Products Radiation -● Part 2: Establishing The Sterilization Dose
AAMI/ANSI/ISO 11137-1:2006/(R)2010 Sterilization of Health Care Products -● Radiation - Part 1: Requirements for Development, Validation and Routine Control Of A Sterilization Process For Medical Devices [Including: Amendment 1 (2013)]
AAMI/ANSI/ISO 10993-1:2009/(R)2013 Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within a Risk Management Process
ISO 17665-1 1st Edition 2006-08-15 Sterilization Of Health Care Products Moist ● Heat - Part 1: Requirements For The Development, Validation And Routine Control Of A Sterilization Process For Medical Devices
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Intervertebral Body Fusion Device, June 2007

Conclusion

There are no new or different issues of safety or effectiveness associated with the new cages or packaging when compared to a predicate device. Testing, where applicable, was verified under Design Controls and found to be acceptable.

The new S128 ALIF System cages are substantially equivalent to the predicate cages.

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.