(166 days)
Not Found
No
The 510(k) summary describes a physical interbody fusion device and surgical instruments, with no mention of software, algorithms, or AI/ML capabilities. The focus is on the material, manufacturing method, dimensions, and performance of the physical components.
Yes
The device is used to treat Degenerative Disc Disease (DDD) by performing intervertebral body fusion, which is a therapeutic intervention.
No
The device is an intervertebral body fusion device (implant) used for treating Degenerative Disc Disease, not for diagnosing it.
No
The device description clearly states it is a titanium alloy interbody cage and includes surgical instruments, indicating it is a physical medical device, not software-only.
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, tissue) to provide information for diagnosis, monitoring, or screening.
- Hexanium® ACIF Function: The Hexanium® ACIF system is an implantable medical device used in surgery to fuse vertebrae in the spine. It is a physical structure placed within the body to provide support and promote bone growth.
- Intended Use: The intended use clearly states it's for "intervertebral body fusion" in patients with Degenerative Disc Disease. This is a surgical treatment, not a diagnostic test performed on a specimen outside the body.
The description focuses on the physical characteristics of the implant, the surgical approach, and the intended patient population for a surgical procedure. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
N/A
"
Intended Use / Indications for Use
The Hexanium® ACIF (Anterior Cervical Interbody Fusion) system is an intervertebral body fusion device indicated for use with autogenous bone graft in skeletally mature patients with Degenerative Disc Disease (DDD) at one level from C3-T1. DDD is defined as discogenic neck pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Patients should have received at least 6 weeks of non-operative treatment with Hexanium® ACIF system. This device has to be filled with autogenous bone graft material. This device is implanted via an anterior approach.
Product codes (comma separated list FDA assigned to the subject device)
OVE
Device Description
The Hexanium® ACIF is a titanium alloy (Ti6Al4V ELI) interbody cage manufactured via an Additive Manufacturing method. The honeycomb structure allows for bone through-growth through the structure of the device as well as providing lateral and vertical bone graft windows in the body of the cage. Hexanium® ACIF is available in 2 sagittal profiles (lordotic 6º and convex 6°), heights of 5-12 mm, and 3 footprints (15x12mm, 17x14mm, and 19x15mm). The Hexanium® ACIF screws are self-drilling and available in lengths of 10, 12, 14, and 16mm and diameters of 3.50 and 3.80mm. Hexanium® ACIF is provided sterile. The Hexanium® ACIF system includes a set of reusable surgical instruments. The purpose of this Special 510(k) application is to propose minor modifications to the currently cleared surgical instruments. There are no modifications being proposed for the implantable components of the system
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
C3-T1 (cervical spine)
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)
Appropriate supportive testing and evaluations were conducted on the Hexanium ACIF surgical instruments to demonstrate that they meet product specifications, pertinent standards, medical community's expectations, and product labeling. These evaluations have shown that the modified instrument configurations meet the same pre-determined functional and performance requirements and external standard requirements as the predicate instruments and are substantially equivalent. The Hexanium ACIF implants are unchanged from the predicate and continue to meet special controls FDA guidance "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" dated June 12, 2007.
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.
Not Found
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.
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Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 14, 2022
SpineVision, S.A.S. % Ms. Nancy Lincé President and CEO Lincé Consulting, LLC 111 Deerwood Road, Suite 200 San Ramon, California 94583
Re: K221578
Trade/Device Name: Hexanium® ACIF Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: October 21, 2022 Received: October 24, 2022
Dear Ms. Lincé:
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
1
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) 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 (QS) 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 -S
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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Indications for Use
510(k) Number (if known) K221578
Device Name Hexanium® ACIF
Indications for Use (Describe)
The Hexanium® ACIF (Anterior Cervical Interbody Fusion) system is an intervertebral body fusion device indicated for use with autogenous bone graft in skeletally mature patients with Degenerative Disc Disease (DDD) at one level from C3-T1. DDD is defined as discogenic neck pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Patients should have received at least 6 weeks of non-operative treatment with Hexanium® ACIF system. This device has to be filled with autogenous bone graft material. This device is implanted via an anterior approach.
| Type of Use (Select one or both, as applicable) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 | and the comments of the comments of the comments of the comments of the comments of |
X Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
| Date Prepared | October 21, 2022 |
|---|---|
| Submitter | SpineVision SAS |
| 10 rue de la Renaissance | |
| Batiment E | |
| 92160 Antony | |
| FRANCE | |
| Submitter Contact | Quang Tran |
| Director, Quality Assurance & Regulatory Affairs | |
| Tel: +33 1 53 33 25 53 | |
| Email: q.tran@spinevision.com | |
| Correspondent | |
| Contact | Nancy Lincé |
| Lincé Consulting, LLC | |
| US Agent | |
| Regulatory Affairs Consultant | |
| Phone: (650) 759-6186 | |
| Email: nlince@linceconsulting.com | |
| Device Name | Hexanium® ACIF |
| Class | Class II |
| Product Code | OVE: Intervertebral Fusion Device with integrated fixation, cervical |
| Classification | 21 CFR 888.3080: Intervertebral body fusion device |
| Device Panel | Orthopedic |
| Primary Predicate | SpineVision SAS Hexanium ACIF (K193000) |
| Device Description | The Hexanium® ACIF is a titanium alloy (Ti6Al4V ELI) interbody cage |
| manufactured via an Additive Manufacturing method. The honeycomb | |
| structure allows for bone through-growth through the structure of the device | |
| as well as providing lateral and vertical bone graft windows in the body of | |
| the cage. Hexanium® ACIF is available in 2 sagittal profiles (lordotic 6º and | |
| convex 6°), heights of 5-12 mm, and 3 footprints (15x12mm, 17x14mm, | |
| and 19x15mm). The Hexanium® ACIF screws are self-drilling and | |
| available in lengths of 10, 12, 14, and 16mm and diameters of 3.50 and | |
| 3.80mm. Hexanium® ACIF is provided sterile. The Hexanium® ACIF | |
| system includes a set of reusable surgical instruments. The purpose of this | |
| Special 510(k) application is to propose minor modifications to the currently | |
| cleared surgical instruments. There are no modifications being proposed for | |
| the implantable components of the system | |
| Indications for Use | The Hexanium® ACIF (Anterior Cervical Interbody Fusion) system is |
| an intervertebral body fusion device indicated for use with autogenous | |
| bone graft in skeletally mature patients with Degenerative Disc Disease | |
| (DDD) at one level from C3-T1. DDD is defined as discogenic neck | |
| pain with degeneration of the disc confirmed by patient history and | |
| radiographic studies. These DDD patients may also have up to Grade I | |
| spondylolisthesis or retrolisthesis at the involved level(s). Patients | |
| should have received at least 6 weeks of non-operative treatment prior | |
| to treatment with Hexanium® ACIF system. This device has to be filled | |
| with autogenous bone graft material. This device is implanted via an | |
| anterior approach. | |
| Performance Data | Appropriate supportive testing and evaluations were conducted on the |
| Hexanium ACIF surgical instruments to demonstrate that they meet | |
| product specifications, pertinent standards, medical community's | |
| expectations, and product labeling. These evaluations have shown that | |
| the modified instrument configurations meet the same pre-determined | |
| functional and performance requirements and external standard | |
| requirements as the predicate instruments and are substantially | |
| equivalent. The Hexanium ACIF implants are unchanged from the | |
| predicate and continue to meet special controls FDA guidance | |
| "Guidance for Industry and FDA Staff – Class II Special Controls | |
| Guidance Document: Intervertebral Body Fusion Device" dated June | |
| 12, 2007. | |
| Clinical | |
| Performance Data | No clinical data has been presented. |
| Substantial | |
| Equivalence | |
| Conclusion | The Hexanium® ACIF is substantially equivalent to the predicate device in |
| terms of intended use, design, mechanical properties, and function. | |
| The Hexanium® ACIF is substantially equivalent to the | |
| predicate device. |
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