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.

Device Description

The Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System is cleared under K131122. The SI28 ALIF implants (cages) are to be used with the bone screws and anterior cover plate assembly and requires no additional supplementary fixation systems. The Renovis S128 ALIF System implants are available in a variety of sizes (widths, height, depths, and bone screw sizes; see below) to suit the individual pathology and anatomical conditions of the patient. The implants are manufactured from PEEK or additively manufactured and machined Titanium. The bone screws and cover plate assembly are both manufactured from Titanium alloy. The PEEK markers are manufactured from Tantalum.

This Special 510(k) Premarket Notification is submitted for the additional offering of gamma sterilized S128 implants (PEEK cages; titanium cages, screws and cover plates).

AI/ML Overview

This document is a 510(k) Special Premarket Notification for the Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System, focusing on the addition of gamma sterilization for its implants. It primarily addresses the safety and effectiveness of the sterilization method and its impact on the device's materials, rather than a clinical study of the device's performance in patients.

Therefore, the requested information focusing on clinical performance metrics, sample sizes for test/training sets, expert ground truth, and comparative effectiveness with AI is not directly applicable to this specific regulatory submission. This is because the submission is about a manufacturing change (sterilization method) to an already cleared device (K131122), not a new device or a clinical outcome study.

However, I can extract the information relevant to the performance data for the sterilization process, which is the core of this submission.

Acceptance Criteria and Reported Device Performance (for Gamma Sterilization)

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Sterility Assurance	Sterilization validated to a sterility assurance level (SAL) of 10⁻⁶ by selecting and substantiating a 25 kGy dose using the VDmax 25 method, according to ISO 11137-1.	Implants are sterilized by ⁶⁰Gamma irradiation validated to a sterility assurance level (SAL) of 10⁻⁶ by selecting and substantiating a 25 kGy dose by the VDmax 25 method, according to ISO 11137-1.
Material Compatibility (Titanium)	Titanium alloy components are not negatively affected by gamma sterilization and/or aging.	Titanium alloy components are not affected by gamma sterilization and/or aging.
Material Compatibility (PEEK)	After an average dose of 200 kGy and accelerated aging (simulating 10+ years), PEEK components should not show any significant difference compared to untreated PEEK.	PEEK components were tested to an average dose of 200 kGy and underwent accelerated aging to simulate 10 or more years. After aging, the samples were tested, and the results did not show any significant difference between untreated PEEK and gamma treated and aged PEEK.
Packaging Sterility Maintenance	Packaging validated to maintain sterility for 3 years, complying with ISO 11607-2 (accelerated aging simulation per ASTM F1980-07 and real-time aging) and performance following distribution per ISTA 2A.	Packaging has been validated to maintain sterility for 3 years in compliance with ISO 11607-2, demonstrates compliance with accelerated aging simulation per ASTM F1980-07 and real-time aging; and performance following distribution per ISTA 2A.

Regarding the other requested information:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This document does not describe a clinical test set with human subjects. The "test set" here refers to material samples (Titanium and PEEK) and packaging subjected to sterilization and aging simulations. The sample sizes for these material tests are not explicitly stated but are part of standard validation protocols for ISO 11137-1 and internal Renovis testing.
- Data provenance is from internal testing and validation performed by Renovis Surgical Technologies, Inc. and its sterilization/packaging validation partners. No country of origin for clinical data is applicable.
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):
- Not applicable as this is not a clinical study involving human expert interpretation of medical images or outcomes. Ground truth for material testing is based on established materials science and engineering principles and validated sterilization/packaging standards by qualified engineers and scientists.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for subjective assessments (like image interpretation) where there might be disagreement among experts. Material and sterilization testing follows objective, quantifiable methods against pre-defined specifications.
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 about a medical device (surgical implant) and a manufacturing process change (sterilization), not an AI-powered diagnostic tool or image analysis software.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable for the same reason as above.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this submission is based on established international and national standards for medical device sterilization (ISO 11137-1, ANSI/AAMI/ISO 11137-2), packaging (ISO11607-2, ASTM F1980-07), and material specifications (ASTM F2026, ASTM F136, ASTM F 560-08). This is objective, measurable data comparing post-sterilization/aging material properties to baseline and specified requirements.
The sample size for the training set:
- Not applicable. There is no machine learning or AI training set described in this document.
How the ground truth for the training set was established:
- Not applicable.

Summary

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ORENOVIS

MAR 2 7 2014

Special 510(k) Summary as required by 21 CFR 807.92(a) K140106

Renovis Surgical Technologies, Inc. A ) Submitted by: 1901 W. Lugonia Ave, Ste 340 Redlands, CA 92374 Phone: 909-557-2360 Fax: 909-307-8571
Official Contact: Anthony DeBenedictis Vice President of Quality Assurance
Sharyn Orton, Ph,D. Consultant: MEDIcept, Inc. 200 Homer Ave Ashland, MA 01721

February 28, 2014 Date:

Device Name:	Intervertebral Fusion Device With Bone Graft, Lumbar
Common Name:	Intervertebral body fusion device
Proprietary Name:	S128 Anterior Lumbar Interbody Fusion (ALIF) System
Device Class:	Class II – 888.3080
Regulation and Product code:	888.3080, OVD - Intervertebral body fusion device

Classification panel: Orthopedic

C) Predicates:

K131122 Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System .

D) Device Description:

The Renovis $128 Anterior Lumbar Interbody Fusion (ALIF) System is cleared under K131122. The SI28 ALIF implants (cages) are to be used with the bone screws and anterior cover plate assembly and requires no additional supplementary fixation systems. The Renovis S128 ALIF System implants are available in a variety of sizes (widths, height, depths, and bone screw sizes; see below) to suit the individual pathology and anatomical conditions of the patient. The implants are manufactured from PEEK or additively manufactured and machined Titanium. The bone screws and cover plate

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assembly are both manufactured from Titanium alloy. The PEEK markers are manufactured from Tantalum.

This Special 510(k) Premarket Notification is submitted for the additional offering of gamma sterilized S128 implants (PEEK cages; titanium cages, screws and cover plates).

E) Indications For Use:

Patients should be skeletally mature and have at least six months of non-operative treatment.

	RenovisS128 ALIF System	RenovisS128 ALIF SystemK131122
Product code	OVD
Implant Material(cages, cover plate, andscrews)	PEEK (ZA-500) per ASTM F2026Titanium alloy Ti-6Al-4V per ASTM F136
PEEK marker material	Tantalum per ASTM F 560-08
Dimensions (mm)
A/P	26, 28, 30
M/L	30, 34, 38
H	11 - 21
Lordosis	7°, 12°
Number of screws	4
Screw Diameter (mm)	4.5, 5.
Screw Length (mm)	20, 25, 30, 35
Cover plate (mm)	8.3 x 22
Provided sterile?	Yes - gamma	No

F) Substantial Equivalence Comparison and Discussion

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Conclusion

Based upon the same intended use, design, function, technology, and materials, the Renovis SI28 ALIF System is substantially equivalent to the predicate devices and does not raise new issues of safety or effectiveness.

G) Performance Data

Implants are sterilized by 60 Gamma irradiation validated to a sterility assurance level (SAL) of 10th by selecting and substantiating a 25 kGy dose by the VDmax 35 method, according to ISO 11137-1. Titanium alloy components are not affected by gamma sterilization and/or aging. PEEK components were tested to an average dose of 200kGy and underwent accelerated aging to simulated 10 or more years. After aging the samples were tested, and the results did not show any significant difference between untreated PEEK and gamma treated and aged PEEK.

Packaging has been validated to maintain sterility for 3 years in compliance with ISO 11607-2 demonstrates compliance with accelerated aging simulation per ASTM F1980-7 and real time aging; and performance following distribution per ISTA 2A.

Conclusion

Gamma sterilization does not have a negative effect on Renovis S128 ALIF System implants.

H) Compliance with Design Controls

The results of design validation support that the Renovis S128 ALIF System is substantially equivalent to the predicate device and the offering of gamma irradiated implant components does not raise new issues of safety or effectiveness.

I) Compliance with Consensus Standards and FDA Guidance

Standards - Renovis complies with:

ASTM F2026 Standard Specification for PEEK Polymers for Surgical Implant . Applications
ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI . (Extra Low Interstitial) Alloy for Surgical Implant Applications, and
ASTM F 560-08, Standard Specification for Unalloyed Tantalum for Surgical Implant . Applications
. ISO 11137-1: 2006; Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ANSI/AAMI/ISO 11137-2:2006 Sterilization of health care products -- Radiation -- Part . 2: Establishing the sterilization dose
ISO11607-2: 2006 Packaging for terminally sterilized medical devices -- Part 2: . Validation requirements for forming, sealing and assembly processes
ASTM F1980-07: 2007 Standard Guide for Accelerated Aging of Sterile Barrier Systems . for Medical Devices

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ASTM D4169:2009 Standard Practice for Performance Testing of Shipping Containers . and Systems
ISTA 2A, 2011 Partial-Simulation Performance Test Procedure: Packaged Products . 150lb (68 kg) or Less

FDA guidance:

Updated 510(k) Sterility Review Guidance K90-1; Guidance for Industry and FDA, . August 2002
. Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Intervertebral Body Fusion Device, October 2007
Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA . Review Guidance, April 1996
Guidance for Industry and FDA Staff Spinal System 510(k)'s, May 2004 (for labeling . language)

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 27, 2014

Renovis Surgical Technologies, Incorporated % Sharyn Orton, Ph.D. MEDIcept, Incorporated 200 Homer Avenue Ashland, Massachusetts 01721

Re: K140106

Trade/Device Name: Renovis 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: March 5, 2014 Received: March 7, 2014

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 – Sharvn Orton. Ph.D.

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address -

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Ronald P. Jean -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 Statement

510(k) Number (if known): K140106

Device Name: Renovis S128 Anterior Lumbar Interbody Fusion (ALIF) System

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 I 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.

Prescription Use______________________________________________________________________________________________________________________________________________________________ (21 CFR 801, Subpart D)

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY) NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton E. Dmitriev, PhD

Division of Orthopedic Devices

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.