(358 days)
Not Found
No
The summary describes a physical implant (interbody cage and screws) and its mechanical properties. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
Yes
The device is used to treat Degenerative Disc Disease, which makes it a therapeutic device.
No
This device is an intervertebral body fusion device (an implantable cage) used for spinal fusion, not for diagnosing medical conditions. Its purpose is to mechanically support the spine and promote bone growth, not to identify or measure a disease or condition.
No
The device description clearly states it is a titanium alloy interbody cage and includes details about its physical dimensions and associated screws, indicating it is a physical implant, not software.
No, 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 (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Hexanium® ACIF Function: The Hexanium® ACIF system is an implantable surgical device. It is designed to be surgically placed inside the body to facilitate bone fusion in the spine. It does not perform any diagnostic tests on bodily samples.
The provided text clearly describes a physical implant used in surgery, not a diagnostic test performed in a lab.
N/A
Intended Use / Indications for Use
The Hexanium® ACIF (Anterior Cervical Interbody Fusion) system is 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
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 6° 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.
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)
The following non-clinical tests were conducted: static and dynamic axial compression, static and dynamic shear compression, static and dynamic torsion testing according to ASTM F2077, subsidence testing according to ASTM F2267, and expulsion testing. Results demonstrate comparable mechanical properties to the predicate device.
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.
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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.
October 20, 2020
SpineVision SAS % Sevrina Ciucci US Agent/Regulatory Affairs Consultant Lince Consulting, LLC 111 Deerwood Road, Suite 200 San Ramon, California 94583
Re: K193000
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: September 14, 2020 Received: September 15, 2020
Dear Sevrina Ciucci:
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,
for
Brent Showalter, Ph.D. Acting 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
Page 1 of 1
510(k) Number (if known) K193000
Device Name Hexanium ACIF
Indications for Use (Describe)
The Hexanium ACIF (Anterior Cervical Interbody Fusion) system is 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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510K SUMMARY
K193000
Page 1 of 2
| Date Prepared | October 19, 2020 |
|---|---|
| Submitter | SpineVision SAS |
| 10 rue de la Renaissance | |
| Batiment E | |
| 92160 Antony | |
| FRANCE | |
| Submitter Contact | Anaëlle Gallego |
| QA and RA Manager | |
| Tel: +33 1 53 33 25 25 | |
| Fax: +33 1 72 69 00 30 | |
| Email: a.gallego@spinevision.com | |
| Correspondent | Sevrina Ciucci |
| Contact | Lincé Consulting, LLC |
| US Agent | |
| Regulatory Affairs Consultant | |
| Phone: (408) 316-4837 | |
| Email: sciucci@linceconsulting.com | |
| Alternate Contact: | |
| Nancy Lincé | |
| Lincé Consulting, LLC | |
| US Agent | |
| Clinical and 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 | K190546 Nexxt Matrixx Stand Alone Cervical System, Nexxt Spine |
| Additional | K141314 SCARLET® AC-T Secured Anterior Cervical Cage, SPINEART |
| Predicate | |
| 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 6° 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. | |
| Indications for Use | The Hexanium® ACIF (Anterior Cervical Interbody Fusion) system is |
| 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 | The following non-clinical tests were conducted: static and dynamic axial |
| compression, static and dynamic shear compression, static and dynamic | |
| torsion testing according to ASTM F2077, subsidence testing according to | |
| ASTM F2267, and expulsion testing. Results demonstrate comparable | |
| mechanical properties to the predicate device. | |
| Clinical | |
| Performance Data | No clinical data has been presented. |
| Substantial | |
| Equivalence | The Hexanium® ACIF is substantially equivalent to the primary predicate |
| device in terms of intended use, design, mechanical properties, and | |
| function. | |
| Conclusion | The Hexanium® ACIF is substantially equivalent to the |
| predicate device |
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