(102 days)
No
The device description and performance studies focus on the mechanical properties and intended use of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
This device is an interbody fusion device intended for spinal fusion, acting as an implant to aid in stabilization rather than directly providing a therapeutic effect like treating a disease or symptom.
No
This device is a cervical interbody fusion device, an implant used during surgery to provide stabilization and promote fusion of the cervical spine. Its purpose is therapeutic (fusion), not diagnostic.
No
The device description explicitly states it is a sterile, single-use implant made of PEEK and Tantalum, which are physical materials, not software. The performance studies also focus on the mechanical properties of the physical implant.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Advantage-C PEEK Cervical Interbody Fusion Device is an implant designed for surgical use in the cervical spine to aid in fusion. It is a physical device inserted into the body, not a test performed on a sample outside the body.
The information provided describes a medical device used in a surgical procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
ODP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spinal column, cervical spine, C2 - T1
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The proposed device was subjected to the following performance tests to support the assertion of substantial equivalence:
- 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 x 10^6 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
The subject device demonstrated equivalent mechanical performance to the cited predicate under the same test conditions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
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
1
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)
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.
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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FORM FDA 3881 (6/20)
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Image /page/3/Picture/1 description: The image shows the logo for Intelivation Technologies. The logo features a lightbulb with a brain inside of it on the left side. To the right of the lightbulb is the word "INTELIVATION" in a stylized font. Below that is the word "TECHNOLOGIES" in a smaller font.
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:
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.
- 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
4
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® PEEK
Tantalum Markers | Optima® PEEK
Tantalum Markers | Magnolia® PEEK
Tantalum Markers |
| Sizes | Heights: 6mm - 12mm
Widths: 11mm - 20mm
Lengths: 11mm - 15mm
Parallel (0°) and Lordotic (7°) | Heights: 4mm - 12mm
Widths: 11mm - 20mm
Lengths: 11mm - 15mm
Parallel (0°) and Lordotic (7°) | Heights: 5mm - 12mm
Widths: 14mm - 16mm
Lengths: 12mm - 14mm
Parallel (0°) and Lordotic (6° & 10°) |
| Supplied Sterile? | Yes | No | Yes |
| Sterilization
method | Gamma radiation | N/A | Gamma radiation |
| Intended for
single use? | Yes | Yes | Yes |
| Packaging
Configuration | Tyvek-poly pouch with an outer
shelf carton | Poly bag | Tyvek-poly pouch with an outer
shelf carton |
| Shelf Life | 12 months | >12 months | >12 months |
| Table 1. Table of Substantial Equivalence | |||
|---|---|---|---|
| -- | -- | -- | ------------------------------------------- |
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.
Image /page/4/Picture/9 description: The image shows the logo for Intelivation Technologies. The logo features a lightbulb with a brain inside of it on the left side. To the right of the lightbulb is the company name, "INTELIVATION", in a gradient color from green to blue. Below the company name is the word "TECHNOLOGIES" in a smaller font size.
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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 |
|---|---|---|
| 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 for medical devices | Pass | |
| LAL | ANSI/AAMI ST72:2019, USP, USP, 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
Image /page/5/Picture/15 description: The image shows the logo for Intelivation Technologies. The logo features a lightbulb with a brain inside of it on the left side. To the right of the lightbulb is the company name, "INTELIVATION" in a thin, sans-serif font, with the word "TECHNOLOGIES" in a smaller font below it.