K Number
K181115
Device Name
CxHA PEEK Cervical IBF System
Manufacturer
Date Cleared
2018-07-16

(80 days)

Product Code
Regulation Number
888.3080
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Innovasis CxHA™ PEEK Cervical IBF System is indicated for cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. This device is to be used in patients who have had six weeks of non-operative treatment. The CxHA device is to be used with supplemental fixation, such as the Innovasis Opteryx® Cervical Plate System. The CxHA device is intended to be used with autograft bone and is to be implanted via an anterior approach.
Device Description
The CxHA PEEK Cervical IBF System is a spinal intervertebral fusion device made from hydroxyapatite infused polyetheretherketone. It is provided in a variety of footprint sizes ranging from 12mm anterior-posterior x 14mm medial-lateral to 16mm anterior-posterior x 19mm medial-lateral. It is provided in heights from 6mm to 12mm in 1mm size increments with 8° lordosis. There is an interior cavity for use with autogenous bone graft material. It has two radiographic marker spheres made from tantalum per ASTM F560.
More Information

No
The device description and intended use are for a physical implant (cervical interbody fusion device) and do not mention any software, algorithms, or data processing capabilities that would involve AI or ML.

Yes
The device is described as an interbody fusion system used in cervical interbody fusion procedures to treat degenerative disc disease, which clearly indicates a therapeutic purpose.

No

The device is described as a spinal intervertebral fusion device, an implant used in surgery, not a tool for diagnosing medical conditions. Its purpose is to facilitate fusion after diagnosis.

No

The device description clearly states it is a physical implant made from hydroxyapatite infused polyetheretherketone with tantalum markers, indicating it is a hardware device.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
  • Device Description and Intended Use: The description clearly states that the Innovasis CxHA™ PEEK Cervical IBF System is an implantable device used in surgical procedures for spinal fusion. It is a physical object inserted into the body.
  • Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is structural support and facilitating bone fusion.

Therefore, based on the provided information, this device falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

The Innovasis CxHA PEEK Cervical IBF System is indicated for cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as discogence pain with degeneration of the disc confirmed by patient history and radiographic studies.

This device is to be used in patients who have had six weeks of non-operative treatment. The CxHA device is to be used with supplemental fixation, such as the Innovasis Optervical Plate System. The CxHA device is intended to be used with autograft bone and is to be implanted via an anterior approach.

Product codes

ODP

Device Description

The CxHA PEEK Cervical IBF System is a spinal intervertebral fusion device made from hydroxyapatite infused polyetheretherketone. It is provided in a variety of footprint sizes ranging from 12mm anterior-posterior x 14mm medial-lateral to 16mm anterior-posterior x 19mm medial-lateral. It is provided in heights from 6mm to 12mm in 1mm size increments with 8° lordosis. There is an interior cavity for use with autogenous bone graft material. It has two radiographic marker spheres made from tantalum per ASTM F560.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Radiographic studies

Anatomical Site

cervical interbody fusion procedures at one level from C2-T1

Indicated Patient Age Range

skeletally mature patients

Intended User / Care Setting

Users of these products are limited to physicians trained in orthopedic surgery. Clinical locations include hospitals and surgery sites equipped to perform spinal surgery.

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)

(Non-clinical)—Performance testing per ASTM F2077-17 for Static Performance Data: Compression, Static Torsion and Dynamic Torsion indicates that the CxHA PEEK Cervical IBF is substantially equivalent to the predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K172674, K122444, K132991

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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 contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left and features a stylized depiction of people. The FDA logo is on the right and consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

Innovasis, Inc. Marshall McCarty Director QA/RA 614 East 3900 South Salt Lake City, Utah 84107

Re: K181115

Trade/Device Name: CxHA™ PEEK Cervical IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: April 27, 2018 Received: April 27, 2018

Dear Marshall McCarty:

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

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

July 16, 2018

1

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 medical devices and radiation-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,

Brent Showalter -S

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

Enclosure

2

Indications for Use

510(k) Number (if known)

K181115

Device Name CxHA™ PEEK Cervical IBF System

Indications for Use (Describe)

The Innovasis CxHA PEEK Cervical IBF System is indicated for cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as discogence pain with degeneration of the disc confirmed by patient history and radiographic studies.

This device is to be used in patients who have had six weeks of non-operative treatment. The CxHA device is to be used with supplemental fixation, such as the Innovasis Optervical Plate System. The CxHA device is intended to be used with autograft bone and is to be implanted via an anterior approach.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

Image /page/3/Picture/1 description: The image shows the logo for Innovasis. The logo is in black and white and features the word "INNOVASIS" in bold, sans-serif font. Below the word "INNOVASIS" is the phrase "INNOVATE / INVOLVE / INVENT" in a smaller, sans-serif font. The logo is simple and modern, and the use of black and white gives it a clean and professional look.

510(k) Summary Report: 5.0

CxHA™ PEEK Cervical IBF System

| Company: | Innovasis, Inc.
614 E. 3900 South
Salt Lake City, UT 84107 |

----------------------------------------------------------------------------

Contact: Marshall McCarty Alternate: Michael Thomas Phone: (801) 261-2236 x8012 (801) 261-2236 x8002 mthomas@innovasis.com mmccarty@innovasis.com

  • CxHA™ PEEK Cervical IBF System Trade Name:
  • Common Name: Intervertebral fusion device with bone graft, cervical
  • Classification: Regulation No.: 21CFR 888.3080 Class 2 Product Code: ODP Review Panel: Orthopedic - ASDB Applicable Standards:
  • Primary Predicate: K172674 Sapphire Cervical Implant System (Sapphire Medical)
  • Additional Predicates:

K122444 Eisertech Cervical Cage (Eisertech, LLC) K132991 C-Box PEEK Cervical IBF (Innovasis, Inc.)

Device Description: CxHA PEEK Cervical IBF System

The CxHA PEEK Cervical IBF System is a spinal intervertebral fusion device made from hydroxyapatite infused polyetheretherketone. It is provided in a variety of footprint sizes ranging from 12mm anterior-posterior x 14mm medial-lateral to 16mm anterior-posterior x 19mm medial-lateral. It is provided in heights from 6mm to 12mm in 1mm size increments with 8° lordosis. There is an interior cavity for use with autogenous bone graft material. It has two radiographic marker spheres made from tantalum per ASTM F560.

  • (Non-clinical)—Performance testing per ASTM F2077-17 for Static Performance Data: Compression, Static Torsion and Dynamic Torsion indicates that

4

CxHA™ PEEK Cervical IBF System

510(k) April 26, 2018

the CxHA PEEK Cervical IBF is substantially equivalent to the predicate device.

The implants are machined from medical grade polyetherether-Materials: ketone infused with hydroxyapatite (Invibio® PEEK Optima® HA Enhanced). The radiographic markers meet ASTM F560 for unalloyed Tantalum.

Intended Use: The CxHA PEEK Cervical IBF device is intended for use in Anterior Cervical Discectomy and Fusion (ACDF) procedures. Users of these products are limited to physicians trained in

orthopedic surgery. Clinical locations include hospitals and surgery sites equipped to perform spinal surgery.

Indications for Use:

The Innovasis CxHA™ PEEK Cervical IBF System is indicated for cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies.

This device is to be used in patients who have had six weeks of non-operative treatment. The CxHA device is to be used with supplemental fixation, such as the Innovasis Opteryx® Cervical Plate System. The CxHA device is intended to be used with autograft bone and is to be implanted via an anterior approach.

Comparison of the Technological Characteristics with Predicate Device:

The Innovasis CxHA PEEK Cervical IBF System has been subjected to risk analysis, engineering analysis and testing to recognized standards and has been shown to be substantially equivalent to the Sapphire Medical Group Cervical Cage (K172674) and the C-Box PEEK Cervical IBF System (K132991) predicates.

  • . Design configurations are substantially equivalent.
  • . Applied mechanical loads are substantially equivalent.
  • Materials used are substantially equivalent.
  • Biocompatibility requirements have been demonstrated.
  • . Manufacturing and processing methods are similar if not identical.
  • . Shelf life is substantially equivalent.
  • Intended Use and Indications for Use are substantially ● equivalent.

5

Image /page/5/Picture/1 description: The image shows the logo for Innovasis. The logo is black and white and features the word "INNOVASIS" in large, bold letters. Below the word "INNOVASIS" is the phrase "INNOVATE / INVOLVE / INVENT" in smaller letters. The logo is simple and modern.

CxHA™ PEEK Cervical IBF System

510(k) April 26, 2018

The design of the predicate K172674 device has been provided to Innovasis by Sapphire Medical Group. The implant dimensions are identical. The instruments are equivalent; Innovasis has added a graft block, bone graft tamp and implant tamp that are not part of the Sapphire system. Three modifications have been made to the implant design when compared to the predicate: The material is Invibio PEEK OPTIMA HA Enhanced, the device is provided sterile and the radiographic markers are tantalum spheres instead of tantalum pins.

  • Conclusion: Performance data and rationales submitted herein demonstrate that the subject CxHA PEEK Cervical IBF device is substantially equivalent to the predicate devices with regard to design, technological characteristics, materials, performance, intended use and indications for use.