The Advantage-C PEEK Cervical Interbody Fusion Device is a cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disease (DDD) with / without radicular symptoms at one level from C2 - T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Advantage-C PEEK Cervical Interbody Fusion Device is intended for use with supplemental fixation systems and with autogenous bone graft.. The Advantage-C PEEK Cervical Interbody Fusion Device is supplied sterile and is intended for one-time use.

Device Description

The proposed Intelivation Advantage-C Cervical Interbody Fusion Device is a sterile, single use implant grade polyetheretherketone (PEEK; ASTM F2026) device and Tantalum (ASTM F560), available in varied footprints and heights, designed for supplemental stabilization of the cervical spinal column in anterior cervical discectomy and fusion (ACDF) procedures. The device is intended for spinal fusion procedures at one level in skeletally mature patients with degenerative disc disease (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. The implant should be used with supplemental spinal fixation systems and with autogenous bone graft.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Advantage-C PEEK Cervical Interbody Fusion Device." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical efficacy studies typically required for a new device. Therefore, the information provided for acceptance criteria and studies will be geared towards non-clinical performance and biological compatibility.

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

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

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

Requirement	Acceptance Criteria (Implicit)	Reported Device Performance
Subsidence Testing (ASTM F2267-04)	Characterization of subsidence as defined in ASTM F2267-04	"Subsidence characterization as defined in ASTM F2267-04" (Implies successful characterization, but explicit "Pass" not stated)
Monotonic Compressive and Torsional Strength (ASTM F2077-11)	Yield and/or ultimate force and moment characterization as defined in ASTM F2077-11	PASS
Dynamic Compressive and Torsional Strength (ASTM F2077-11)	Maximum runout (5x10^6 cycles) force or overall fatigue resistance as defined in ASTM F2077-11	PASS
Compressive and Torsional Wear Particle Analysis (ASTM F1877-16)	Wear particle size, shape, and distribution within the reported range of PEEK wear particles as defined in ASTM F1877-16	PASS
Sterilization Validation (ISO/AAMI/ANSI 11137-1:2006)	Sterilization of health care products. Radiation. Requirements for development, validation and routine control of a sterilization process. (Implicit: achieve SAL of 10^-6)	Pass (An SAL of 10^-6 is explicitly mentioned in the text for the method employed)
LAL (Endotoxin) (ANSI/AAMI ST72:2019, USP<161>, USP<85>, EP 2.6.14 and JP 4.01)	Meet specified standards for endotoxin levels	Pass
Biocompatibility (ISO 10993-1:2018)	Demonstrate device is safe for permanent contact (>30 days) implantation	Established for the predicate device (Refer to MAF #2735)

Notes on Acceptance Criteria: For some tests (like subsidence), a "characterization" is performed, implying that the results are within expected limits for the material and design, even if an explicit "Pass" is not stated in the summary. The core acceptance criterion for a 510(k) is often "substantial equivalence" to a predicate device, which these non-clinical tests help to demonstrate.

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

Sample Size for Test Set: Not explicitly stated for any of the non-clinical tests. The document refers to "the proposed device" and "this testing" which implies standard sample sizes for each test method as per the referenced ASTM and ISO standards would have been used, but specific numbers are not given.
Data Provenance: The studies are non-clinical (laboratory tests). No country of origin is mentioned for the data, but the submitter is Intelivation, LLC, based in Saint Simons Island, Georgia, USA. The studies are prospective in the sense that they were conducted specifically for this submission.

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

This question is not applicable to the non-clinical performance and sterilization tests described. Ground truth, in the clinical sense, is not established for these types of engineering and material property tests. The "ground truth" for these tests is defined by the objective measurement criteria and methodologies specified in the referenced ASTM and ISO standards.

4. Adjudication method for the test set:

Not applicable. The tests are objective, laboratory-based physical and chemical evaluations following standardized protocols. There is no human adjudication process involved as there would be with clinical image interpretation or diagnosis.

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 device is a physical interbody fusion implant, not an AI-assisted diagnostic or therapeutic tool. No MRMC study was conducted or is relevant for this product.

6. 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 or software.

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" is based on the objective measurements and performance specifications defined by the referenced industry standards (ASTM, ISO). For example, for strength tests, the ground truth is the measured yield/ultimate force or fatigue resistance compared against a predefined standard. For wear particle analysis, it's the measured size, shape, and distribution. For sterilization, it's the achievement of a specific sterility assurance level (SAL).

8. The sample size for the training set:

Not applicable. There is no concept of a "training set" for physical medical device performance testing in this context. The manufacturing process and quality control would involve internal testing, but not a "training set" in the machine learning sense.

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

Not applicable, as there is no "training set" for these non-clinical tests.

Summary

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August 24, 2021

Intelivation, LLC Jack Griffis Regulatory Affairs 70 Gruber Lane Saint Simons Island, Georgia 31522

Re: K211501

Trade/Device Name: Advantage-C PEEK Cervical Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: July 23, 2021 Received: July 26, 2021

Dear Jack Griffis:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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,

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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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K211501

Device Name

Advantage-C PEEK Cervical Interbody Fusion Device

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (6/20)

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510(k) Summary

510(k) Number: K211501

July 23″d, 2021 Date Submitted:

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

A. Submitter: Intelivation, LLC 70 Gruber Lane Saint Simons Island, GA 31522 912-434-2780
B. Company Contact: Jack Griffis Regulatory Affairs (404) 583-6889 (direct) jackgriffisiii@gmail.com
C. Device Information: Trade Name: Advantage-C PEEK Cervical Interbody Fusion Device Intervertebral Fusion Device, Cervical Common Name:
D. Classification: Intervertebral Fusion Device 21 CFR §888.3080 (ODP) Class II
E. Predicate Device:

Zimmer-Biomet Vista®-S PEEK Cervical Cage System, K111983 (Primary) Zimmer-Biomet Vista®-S PEEK Cervical Cage System, K133784

F. Reference Predicate Device: Zavation Interbody Fusion System (IBF), K162206
G. Physical Description:

H. Indications for Use: The Advantage-C Cervical Interbody Fusion Device is a cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with / without radicular symptoms at one level from C2 – T1. DDD is

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defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Advantage-C Cervical Interbody Fusion Device is intended for use with supplemental fixation systems and with autogenous bone graft. The Advantage-C Cervical Interbody Fusion Device is implanted via an anterior approach.

l. Comparison to Predicate Device:
The Intelivation Advantage-C PEEK Cervical Interbody Fusion Device is substantially equivalent with respect to intended use and technological characteristics to the Zimmer Vista-S, cleared under K111983 & 133784 and the Zavation Interbody Fusion (IBF) System cleared under K162206. These devices all operate under the same principle of operation and with a similar form factor (PEEK cage with graft window and superior and inferior features to resist expulsion). The devices differ in geometry only, and that the proposed Advantage-C device is provided packaged and pre-sterilized via gamma irradiation. Intelivation asserts that any differences between the Advantage-C and the predicate devices do not affect safety or efficacy.

Parameter	Advantage-C(Intelivation Proposed)	Zimmer Vista-S(Predicate; K111983 & K133784)	Zavation IBF System(Reference Predicate, K162206)
Manufacturer	Intelivation LLC	Zimmer	Zavation
510(k) Number	Unassigned	K111983 & K133784	K162206
Product Code	ODP	ODP	ODP
Material	Magnolia® PEEKTantalum Markers	Optima® PEEKTantalum Markers	Magnolia® PEEKTantalum Markers
Sizes	Heights: 6mm - 12mmWidths: 11mm - 20mmLengths: 11mm - 15mmParallel (0°) and Lordotic (7°)	Heights: 4mm - 12mmWidths: 11mm - 20mmLengths: 11mm - 15mmParallel (0°) and Lordotic (7°)	Heights: 5mm - 12mmWidths: 14mm - 16mmLengths: 12mm - 14mmParallel (0°) and Lordotic (6° & 10°)
Supplied Sterile?	Yes	No	Yes
Sterilizationmethod	Gamma radiation	N/A	Gamma radiation
Intended forsingle use?	Yes	Yes	Yes
PackagingConfiguration	Tyvek-poly pouch with an outershelf carton	Poly bag	Tyvek-poly pouch with an outershelf carton
Shelf Life	12 months	>12 months	>12 months

			Table 1. Table of Substantial Equivalence
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In addition, the proposed device was subjected to the following performance tests to support the assertion of substantial equivalence:

J. Summary of Non-Clinical Tests:
Product characterization using known standards and/or clinically relevant acceptance criteria was performed on the proposed device. A summary of this testing is provided in Table 2 below.

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Table 2. Non-Clinical Testing Information

Requirement
Subsidence Testing:◦ Subsidence characterization as defined in ASTM F2267-04
Monotonic Compressive and Torsional Strength:◦ Yield and/or ultimate force and moment characterization as defined in ASTM F2077-11 - PASS
Dynamic Compressive and Torsional Strength:◦ Maximum runout ( $5\times10^6$ cycles) force or overall fatigue resistance as defined in ASTM F2077-11 - PASS
Compressive and Torsional Wear Particle Analysis:◦ Wear particle size, shape, and distribution within the reported range of PEEK wear particles as defined in ASTM F1877-16 - PASS

K. Biocompatibility Testing:
Biocompatibility of the predicate device has been established in accordance with ISO 10993-1:2018 – Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process to demonstrate that the device is safe for permanent contact (>30 days) implantation. Refer to MAF #2735.
L. Sterilization:
The method employed to ensure a sterility assurance level of 10th of the proposed device is provided in Table 3. The sterilization process is identical to the reference predicate device.

Test	Test Method Summary	Results
Sterilizationvalidation	ISO/AAMI/ANSI 11137-1:2006 Sterilization of health care products. Radiation. Requirementsfor development, validation and routine control of a sterilization process for medical devices	Pass
LAL	ANSI/AAMI ST72:2019, USP<161>, USP<85>, EP 2.6.14 and JP 4.01	Pass

Table 3. Sterilization Information

M. Clinical Studies:

No human studies were necessary to prove the safety and efficacy of the device.

N. Conclusion:
The subject device demonstrated equivalent mechanical performance to the cited predicate under the same test conditions.

Jack Griffis Regulatory Affairs (404) 583-6889 (direct) jackgriffisiii@gmail.com

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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.