(111 days)
No
The summary describes a physical implant and associated instrumentation for spinal fusion, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is intended to stabilize a cervical spinal segment to promote fusion, which restricts motion and decreases pain caused by degenerative disc disease (DDD). This aligns with the definition of a therapeutic device as it treats a medical condition.
No
Explanation: This device is an intervertebral body fusion device designed for treatment, specifically to stabilize a cervical spinal segment and promote fusion. It is not used for diagnosing medical conditions.
No
The device description clearly states it is an intervertebral body fusion (IBF) device made from titanium alloy with associated instrumentation, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The Innovasis HAtetracell™-C Titanium Cervical IBF System is a physical implant designed to be surgically placed in the cervical spine to promote bone fusion. It is a medical device used in vivo (within the body), not in vitro (outside the body).
- Intended Use: The intended use is for cervical interbody fusion procedures, which is a surgical intervention, not a diagnostic test performed on a specimen.
Therefore, the description clearly indicates a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Innovasis HAtetracel™ -C Titanium Cervical IBF System is 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 had six weeks of non-operative treatment. The HAtetracell™-C device is to be used with supplemental fixation, such as the Innovasis Oryx® Cervical Plate System. The HAtetracell™-C device is intended to be used with autogenous and/or allogeneic bone graft comcellous, cortical, and/or corticocancellous bone and is to be implanted via an anterior approach.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
The HAtetracell™-C Titanium Cervical IBF System is an intervertebral body fusion (IBF) device with associated instrumentation, used with bone graft material, intended to stabilize a cervical spinal segment to promote fusion which restricts motion and decreases pain. The HAtetracel™ -C Titanium Cervical IBF System is implanted via an Anterior Cervical Discectomy and Fusion (ACDF) surgical aproach. The HAtetracel™ - C implants are an additive mane from titanium alloy Ti-6Al-4V ELI per ASTM F3001 and are coated with a hydroxyapatite HAnano surface. The trabecular structures on the endplate contact surfaces , micro-, and nanofeatures that are designed to mimic cortical and cacellous bone to help facilitate intervertebral fusion. The HAtetracell™-C implant 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 the open lattice structure is designed to radiographic signature. The implant is available in multiple size options to match vertebral anatomy and is designed to restore height in the cervical spinal column during the fusion process. Implants are supplied sterile. Reusable instruments to support the surgery are provided with the implants in sterilization trays.
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
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 FDA Guidance for Cervical Intervertebral Body Fusion Devices, Class II Special Controls Guidance Document: Intervertebral Body Fusion Device (issued June 2007) recommends the following testing:
Static and dynamic torsion testing per ASTM F2077
Static and dynamic axial compression testing per ASTM F2077
Static and dynamic compression shear testing per ASTM F2077
Static subsidence testing per ASTM F2267
Particulate analysis after dynamic testing per ASTM F1877
Static expulsion testing performed per recommendation in above guidance special controls document.
Abrasive resistance testing per ASTM F1978
All testing performed met the acceptance criteria when compared with the predicate device and/or FDA clear. The subject device is demonstrated to be as safe, as effective, and performs as well or better than the predicate device.
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
October 17, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Innovasis, Inc. Michael Thomas Director Regulatory Affairs 614 E 3900 South Salt Lake City, Utah 84107
Re: K231899
Trade/Device Name: HAtetracell™-C Titanium Cervical IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: October 16, 2023 Received: October 16, 2023
Dear Michael Thomas:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Katherine D. Kavlock -S
for
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
2
Indications for Use
Submission Number (if known)
Device Name
HAtetracell™-C Titanium Cervical IBF System
Indications for Use (Describe)
The Innovasis HAtetracell™-C Titanium 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 HAtetracell™-C device is to be used with supplemental fixation, such as the Innovasis Oryx® Cervical Plate System. The HAtetracell™-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.
Type of Use (Select one or both, as applicable)
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
510(k) Summary
Prepared on: 2023-09-26
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | Innovasis, Inc |
|---|---|
| Applicant Address | 614 E 3900 S Salt Lake City UT 84107 United States |
| Applicant Contact Telephone | (801) 261-2236 |
| Applicant Contact | Mr. Michael Thomas |
| Applicant Contact Email | mthomas@innovasis.com |
Device Name 21 CFR 807.92(a)(2)
| Device Trade Name | HAtetracell™-C Titanium Cervical IBF System |
|---|---|
| Common Name | Intervertebral body fusion device |
| Classification Name | Intervertebral Fusion Device With Bone Graft, Cervical |
| Regulation Number | 888.3080 |
| Product Code | ODP |
Legally Marketed Predicate Devices 4. Correct the html representation of the form. Make sure that the output is a valid JSON. Do not include any extra text outside of the JSON string. Do not generate any comments inside the json block. Do not generate any control token (such as
and
) at any places. If a user requests multiple JSON, always return a single parseable JSON array. Do not include any extra text outside of the JSON string. When producing JSON you must follow the schema provided in the context. The schema is as follows: {## Device Description Summary
The HAtetracell™-C Titanium Cervical IBF System is an intervertebral body fusion (IBF) device with associated instrumentation, used with bone graft material, intended to stabilize a cervical spinal segment to promote fusion which restricts motion and decreases pain. The HAtetracel™ -C Titanium Cervical IBF System is implanted via an Anterior Cervical Discectomy and Fusion (ACDF) surgical aproach. The HAtetracel™ - C implants are an additive mane from titanium alloy Ti-6Al-4V ELI per ASTM F3001 and are coated with a hydroxyapatite HAnano surface. The trabecular structures on the endplate contact surfaces , micro-, and nanofeatures that are designed to mimic cortical and cacellous bone to help facilitate intervertebral fusion. The HAtetracell™-C implant 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 the open lattice structure is designed to radiographic signature. The implant is available in multiple size options to match vertebral anatomy and is designed to restore height in the cervical spinal column during the fusion process. Implants are supplied sterile. Reusable instruments to support the surgery are provided with the implants in sterilization trays.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(4)
The Innovasis HAtetracel™ -C Titanium Cervical IBF System is 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 had six weeks of non-operative treatment. The HAtetracell™-C device is to be used with supplemental fixation, such as the Innovasis Oryx® Cervical Plate System. The HAtetracell™-C device is intended to be used with autogenous and/or allogeneic bone graft comcellous, cortical, and/or corticocancellous bone and is to be implanted via an anterior approach.
4
Indications for Use Comparison
The subject device has substantially equivalent indications for use as predicate device K220875 (HAcancellous PEEK Cervical IBF System).
Technological Comparison
The subject device has substantially equivalent technological characteristics (i.e., design, material, chemical composition, principle of operation) as predicate device K220875 (HAcancellous PEEK-Cervical IBF System) and reference device K201614 (TxTiHA IBF System).
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The FDA Guidance for Cervical Intervertebral Body Fusion Devices, Class II Special Controls Guidance Document: Intervertebral Body Fusion Device (issued June 2007) recommends the following testing:
Static and dynamic torsion testing per ASTM F2077
Static and dynamic axial compression testing per ASTM F2077
Static and dynamic compression shear testing per ASTM F2077
Static subsidence testing per ASTM F2267
Particulate analysis after dynamic testing per ASTM F1877
Static expulsion testing performed per recommendation in above guidance special controls document.
Abrasive resistance testing per ASTM F1978
N/A - no clinical data were necessary.
All testing performed met the acceptance criteria when compared with the predicate device and/or FDA clear. The subject device is demonstrated to be as safe, as effective, and performs as well or better than the predicate device.
21 CFR 807.92(a)(6)