(154 days)
Not Found
No
The summary describes a physical medical device (an interbody fusion system) made of specific materials with a particular design for spinal fusion. There is no mention of software, algorithms, data processing, or any technology that would typically involve AI or ML. The performance studies focus on mechanical properties and equivalence to predicate devices, not algorithmic performance.
Yes
The device is indicated for cervical interbody fusion procedures to treat degenerative disc disease, which involves mitigating pain and promoting fusion, thereby acting as a therapeutic intervention.
No
The device is an implantable medical device used for cervical interbody fusion procedures, not for diagnosis. While radiographic studies are used to confirm degenerative disc disease, the device itself is a treatment, not a diagnostic tool.
No
The device description clearly indicates it is a physical implant made from PEEK material with specific structural features and is intended for surgical implantation. It also mentions reusable instruments. This is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the Innovasis HAcancellous PEEK-C Porous HA PEEK Cervical IBF System is an implantable device used for cervical interbody fusion procedures. It is a physical implant designed to stabilize the spine and promote bone fusion.
- Intended Use: The intended use is for surgical implantation in the cervical spine to treat degenerative disc disease. This is a surgical procedure, not a diagnostic test performed on a sample outside the body.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze biological samples or provide diagnostic information.
Therefore, this device falls under the category of a surgical implant or medical device used in a surgical procedure, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Innovasis HAcancellous PEEK-C Porous HA 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 HAcancellous PEEK-C device is to be used with supplemental fixation, such as the Innovasis Oryx® Cervical Plate System. The HAcancellous PEEK-C device is intended to be used with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone and is to be implanted via an anterior approach.
Product codes
ODP
Device Description
The HAcancellous™ PEEK-C Porous HA PEEK Cervical IBF System is for Anterior Cervical Discectomy and Fusion (ACDF). The implant is available in multiple size options to match vertebral anatomy and is intended to stabilize a cervical spinal segment to promote fusion which restricts motion and decreases pain.
The HAcancellous PEEK-C Implants are made from Invibio® PEEK-OPTIMA® HA Enhanced and include Pore Matrix™ Technology. Hydroxyapatite (HA) is fully integrated throughout the implant, including the porous layers. The HAcancellous PEEK-C Implant is made from PEEK which has a modulus of elasticity similar to human vertebral bone. The Porous Layers on the endplate contact surfaces and along the vertical walls of the graft window utilize Pore Matrix Technology, a geometry that unlike smooth PEEK, is designed to mimic anatomical cancellous bone, with interconnected spherical pores. The surface porosity is designed to promote cell signaling, on-growth, in-growth, and fusion. The HAcancellous PEEK-C Implant may provide an increased opportunity for bone ingrowth and for achieving early integration. In vitro performance or animal studies may not be representative of clinical performance. The HAcancellous PEEK-C lmplant features a tapered nose to aid in insertion and protect the porous layer during insertion, a graft cavity to provide volume for bone graft, and is radiolucent allowing assessment of the fusion process, while three tantalum spheres enable implant visualization during the surgical procedure. The implants come in 7 heights, 6-12mm in 1mm increments and 8 Footprints with an 8° lordotic angle. Reusable instruments to support ACDF surgeries are provided with the implants in sterilization sets. Innovasis implants are designed and validated for use with these instruments described in the Surgical Technique Guide. Usage of any instrumentation outside of the validated design intent is considered off-label use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine, 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)
Performance Data: The mechanical performance and fatigue endurance of the HAcancellous PEEK-C implants was conducted in accordance with ASTM F2077, "Test Methods for Intervertebral Body Fusion Devices", ASTM F2267, "Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Devices under Static Axial Compression". The ASTM F2077 standard is designed for testing intervertebral body fusion devices and is followed to assess the static and dynamic strength and fatigue endurance of the interbody fusion device in compression, compression-shear, and torsional loading paradigms. The device was also evaluated in expulsion and simulated insertion. The Innovasis HAcancellous PEEK-C cervical interbody fusion device exhibited substantially equivalent characteristics to previously cleared predicate devices and FDA published data for strength, stiffness, and cyclic endurance in all planes of spinal loading.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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 logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 26, 2022
Innovasis, Inc. Marshall McCarty Director, QA/RA 614 East 3900 South Salt Lake City, Utah 84107
Re: K220875
Trade/Device Name: HAcancellous™ PEEK-C Porous HA PEEK Cervical IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: July 22, 2022 Received: July 25, 2022
Dear Mr. 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. 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220875
Device Name
HAcancellous™ PEEK-C Porous HA PEEK Cervical IBF System
Indications for Use (Describe)
The Innovasis HAcancellous PEEK-C Porous HA 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 weatment. The HAcancellous PEEK-C device is to be used with supplemental fixation, such as the Innovasis Oryx® Cervical Plate System. The HAcancellous PEEK-C device is intended to be used with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone and is to be implanted via an anterior approach.
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/0 description: The image shows the logo for Innovasis. The logo is black and white and features the word "INNOVASIS" in a 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.
510(k) Summary Report:
HAcancellous™ PEEK-C Porous HA PEEK Cervical IBF System
Company: Innovasis, Inc. 614 East 3900 South Salt Lake City, UT 84107
- Contact: Marshall C. McCarty Phone: (801) 261-2236 x8012 mmccarty@innovasis.com
Trade Name: HAcancellous™ PEEK-C Porous HA PEEK Cervical IBF System
- Common Name: Intervertebral fusion device with bone graft, Cervical
- Classification: Requlation No.: 21CFR 888.3080 Class 2 Product Code: ODP Review Panel: 87 - Orthopedic
- Innovasis CxHA® PEEK Cervical IBF System Primary Predicate: K181115 This predicate has not been subject to a design-related recall.
- Additional Predicate: K173030 Nuvasive Cohere Cervical IBF
- Device Description: The HAcancellous™ PEEK-C Porous HA PEEK Cervical IBF System is for Anterior Cervical Discectomy and Fusion (ACDF). The implant is available in multiple size options to match vertebral anatomy and is intended to stabilize a cervical spinal segment to promote fusion which restricts motion and decreases pain.
The HAcancellous PEEK-C Implants are made from Invibio® PEEK-OPTIMA® HA Enhanced1 and include Pore Matrix™M Technology2. Hydroxyapatite (HA) is fully integrated throughout the implant, including the porous layers. The HAcancellous PEEK-C Implant is made from PEEK which has a modulus of elasticity similar to human vertebral bone. The Porous Layers on the endplate contact surfaces and along the vertical walls of the graft window utilize Pore Matrix Technology, a geometry that unlike smooth PEEK, is designed to mimic anatomical cancellous bone, with interconnected spherical pores. The surface porosity is designed to promote cell signaling, on-growth, in-growth, and
1 Invibio® and PEEK-OPTIMA® are registered trademarks of Invibio Limited. All rights reserved.
2 Pore Matrix Technology by Pore Matrix, LLC. California, USA
4
Image /page/4/Picture/0 description: The image shows the logo for Innovasis. The logo is black and consists of the word "INNOVASIS" in all caps. Below the logo is the phrase "INNOVATE / INVOLVE / INVENT". The logo is simple and modern.
Auqust 25, 2022 Page 2 of 4
fusion. The HAcancellous PEEK-C Implant may provide an increased opportunity for bone ingrowth and for achieving early integration3. In vitro performance or animal studies may not be representative of clinical performance. The HAcancellous PEEK-C lmplant features a tapered nose to aid in insertion and protect the porous layer during insertion, a graft cavity to provide volume for bone graft, and is radiolucent allowing assessment of the fusion process, while three tantalum spheres enable implant visualization during the surgical procedure. The implants come in 7 heights, 6-12mm in 1mm increments and 8 Footprints with an 8° lordotic angle. Reusable instruments to support ACDF surgeries are provided with the implants in sterilization sets. Innovasis implants are designed and validated for use with these instruments described in the Surgical Technique Guide. Usage of any instrumentation outside of the validated design intent is considered off-label use. Performance Data: The mechanical performance and fatigue endurance of the HAcancellous PEEK-C implants was conducted in accordance with ASTM F2077, "Test Methods for Intervertebral Body Fusion Devices", ASTM F2267, "Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Devices under Static Axial Compression". The ASTM F2077 standard is designed for testing intervertebral body fusion devices and is followed to assess the static and dynamic strength and fatigue endurance of the interbody fusion device in compression, compression-shear, and torsional loading paradigms. The device was also evaluated in expulsion and simulated insertion. The Innovasis HAcancellous PEEK-C cervical interbody fusion device exhibited substantially equivalent characteristics to previously cleared predicate devices and FDA published data for strength, stiffness, and cyclic endurance in all planes of spinal loading. Materials: The HAcancellous PEEK-C implants are manufactured from Invibio® PEEK-OPTIMA® HA Enhanced polyetheretherketone with hydroxyapatite. HA is a naturally occurring mineral in bone and is
3 University of New South Wales – Surgical & Orthopaedic Research Laboratories – In-vivo evaluation of PEEK and surface modified PEEK in an ovine model. Note: this study was conducted on standard PEEK, not PEEK-OPTIMA® HA Enhanced from Invibio". The porous structure for the HAcancellous PEEK-C device has been modified from the one used for this study with the intent to increase pore interconnectivity and optimize pore size for bone in-growth.
5
Image /page/5/Picture/0 description: The image shows the logo for Innovasis. The logo is black and features the word "INNOVASIS" in all caps. Below the word is the phrase "INNOVATE / INVOLVE / INVENT" also in all caps.
widely used in the orthopedic field. The radiographic markers meet ASTM F560 for unalloyed Tantalum.
The HAcancellous PEEK-C instruments/accessories are machined from Surgical Stainless Steel per ASTM F899. The HAcancellous PEEK-C rasps are coated with Titanium Nitride.
The HAcancellous PEEK-C sterilization sets are comprised of Anodized 5052 Aluminum and have components made of Nylon, Silicone, Stainless Steel, and RADEL per ASTM D6394 SP031.
- Intended Use: The Innovasis HAcancellous™ PEEK-C Porous HA PEEK Cervical IBF System is an intervertebral body fusion (IBF) device with associated instrumentation, used with bone graft material. The device is intended to stabilize a cervical spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain. Users of these products are limited to physicians trained in orthopedic surqery. Clinical locations include hospitals and surgery sites equipped to perform spinal surgery.
Indications for Use: The Innovasis HAcancellous PEEK-C Porous HA 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 HAcancellous PEEK-C device is to be used with supplemental fixation, such as the Innovasis Oryx® Cervical Plate System. The HAcancellous PEEK-C device is intended to be used with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone and is to be implanted via an anterior approach.
Comparison of Technological Characteristics with the Predicate Devices:
The HAcancellous PEEK-C Porous HA 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 predicate devices, K181115, Innovasis CxHA® PEEK Cervical IBF System and K173030, Nuvasive Cohere Cervical IBF.
- -Technology is substantially equivalent.
- Design and implant sizes are substantially equivalent.
- Mechanical strength is substantially equivalent.
6
Image /page/6/Picture/0 description: The image shows the logo for Innovasis. The logo is black and features the word "INNOVASIS" in all capital letters. Below the word is the phrase "INNOVATE / INVOLVE / INVENT" also in black.
- Indications for use are substantially equivalent. ।
- । Materials (biocompatibility profile) are substantially equivalent.
- Conclusion: The overall technology characteristics and mechanical performance data lead to the conclusion that the subject device is substantially equivalent to legally marketed predicate devices.