(118 days)
No
The summary describes a mechanical spinal fusion device and its testing, with no mention of AI or ML.
Yes
The device is described as an "ALIF device" intended for "spinal fusion procedures" to treat "degenerative disc disease," which clearly indicates it is a therapeutic device designed to treat a medical condition.
No
The device description indicates it is a two-part ALIF device intended for spinal fusion procedures with an integral anterior plate for fixation, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states that the FBC 921™ is a two-part ALIF device consisting of physical components made of titanium alloy, including top and bottom components, an integral anterior plate, and screws. It also mentions surgical instruments. This indicates a hardware-based medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "spinal fusion procedures" and is used with bone graft in skeletally mature patients with degenerative disc disease. This describes a surgical implant used directly within the body for a therapeutic purpose.
- Device Description: The description details a physical implant made of titanium alloy, designed to be anchored to vertebrae. This is consistent with a surgical device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing information for diagnosis. The device's function is structural support and fusion promotion.
- Performance Studies: The performance studies focus on mechanical properties, biocompatibility, and equivalence to other surgical implants. They do not involve clinical trials evaluating diagnostic accuracy.
In summary, the FBC 921™ is a surgical implant used for spinal fusion, which falls under the category of medical devices, but not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The FBC 921™ is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spiral surgery at the involved spinal level(s) and may have up to Grade 1 spondylolisthesis at the involved level(s). This device is intended to be used with posterior supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
Product codes (comma separated list FDA assigned to the subject device)
OVD
Device Description
The FBC 921™ is a two-part ALIF device consisting of top and bottom components with an integral anterior plate to allow additional fixation. Both the bottom and the top components come in three footprints. The top component comes in three footprints and one size. It has a starting lordosis of 9 degrees. Lordosis for each assembly is adjustable between 9 and 21 degrees. The bottom component includes the height variation. It comes in the three footprints and four heights (8, 10, 12, and 14mm). The device is anchored to the superior and inferior vertebra using three Ø5.5 variable angle screws. The top and bottom components are made of titanium alloy (Ti-6Al-4V) additively manufactured from biocompatible titanium alloy (Ti-6Al-4V) using powder per ASTM F3001 which are then machined to their final geometry. Screws are made from an implant grade titanium alloy (Ti6Al4V ELI) meeting the requirements of ASTM F136. The FBC 921™ is a single-use device delivered sterile (gamma sterilization) and supplied with surgical instruments (reusable - provided non-sterile).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spinal levels from L2-S1
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)
Nonclinical testing was performed to demonstrate that the FBC 921™ is substantially equivalent to other predicate devices. The characterization of the chemical composition, mechanical and metallographic properties was performed in accordance with ASTM F2924-14 and ASTM E8/E8M. Mechanical testing in compliance with: FDA's "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" was performed for the FBC 921™. The following mechanical tests were performed: Static and dynamic axial compression (per ASTM F2077), Static and dynamic shear compression (per ASTM F2077), Static torsion (per ASTM F2077), subsidence (per ASTM F2267) and expulsion (per internal protocol). The characteristics of any particulate wear debris (per ASTM F1877) generated during the mechanical test were carried out using SEM/EDS (scanning electron microscopy/energy dispersive spectrometry) techniques. Microscopic analysis was conducted of parts following dynamic testing to assess contact at all three intended areas of contact: (1) on the front of the column with the locking screw, (2) on the back of the column with the top, and (3) posteriorly. A pressure film study was conducted to evaluate contact between the top and bottom components at different lordotic angles. Lastly, assessment of the potential for locking screw loosening was conducted. In addition, dynamic testing in torsion (axial rotation) was performed to +/- 4Nm for 1 million cycles. The result of these studies shows that the FBC 921™ meets or exceeds the performance of the predicate devices and does not introduce any new risks. Therefore, the FBC 921™ is substantially equivalent to the predicate devices. Bacterial endotoxin testing per USP 39 NF 34 (2016) for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / 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.
Lanx Fusion System manufactured by Lanx, LLC (K102738), Lanx Fusion System manufactured by Lanx, LLC (K123767), Infix Anterior Lumbar System manufactured by Zimmer Spine, INC (K132790), 4WEB Spinal Implant Products manufactured by 4WEB, INC (K112316, K142112), Alif Interfixated System manufactured by Nuvasive, INC (K151214), Synfix Evolution Secured Spacer System manufactured by Synthes (USA) (K150673)
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.
Pyramid Anterior Plate Fixation System manufactured by Medtronic Sofamor Danek, INC (K013665)
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
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FBC Device ApS Finn Christensen, M.D., Ph.D. CEO Viengevej 100 Risskov, 8240 Dk
Re: K180695
Trade/Device Name: FBC 921™ (ALIF) Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: June 7, 2018 Received: June 8, 2018
Dear Dr. Christensen:
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 (QS) regulation (21 CFR Part 820);
July 12, 2018
1
Page 2 - Dr. Finn Christensen
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-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,
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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) K180695
Device Name FBC 921™ (ALIF)
Indications for Use (Describe)
The FBC 921™ is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spiral surgery at the involved spinal level(s) and may have up to Grade 1 spondylolisthesis at the involved level(s). This device is intended to be used with posterior supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
| 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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3
Traditional 510k FBC 921™ (ALIF)
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510(k) SUMMARY
| Submitted by | FBC Device Aps
Viengevej 100
DK-8240 Risskov
DENMARK |
|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contacts | Pr. Finn Bjarke Christensen MD, PhD (CEO) Phone +45 2344 2012 e-mail
finn@fbcdevice.com ; Dr Bruce ROBIE PhD (COO) Phone +1.201.757.1581, +45 4078
3167(when in Europe) e-mail bruce@fbcdevice.com Regulatory contact : Dr Isabelle
DRUBAIX PhD (Idée Consulting) idrubaix@nordnet.fr |
| Date Prepared | July 11, 2018 |
| Common Name | Intervertebral body fusion device |
| Trade Name | FBC 921™ (ALIF) |
| Classification Name | Intervertebral Fusion Device with Integrated Fixation, Lumbar |
| Class | II |
| Product Code | OVD |
| CFR section | 888.3080 |
| Device panel | ORTHOPEDIC |
| Legally marketed
predicate devices | Primary predicate: Lanx Fusion System manufactured by Lanx, LLC (K102738)
Additional predicates: Lanx Fusion System manufactured by Lanx, LLC (K123767); Infix
Anterior Lumbar System manufactured by Zimmer Spine, INC (K132790); 4WEB Spinal
Implant Products manufactured by 4WEB, INC (K112316, K142112); Alif Interfixated
System manufactured by Nuvasive, INC (K151214); Synfix Evolution Secured Spacer
System manufactured by Synthes (USA) (K150673)
Reference Device: Pyramid Anterior Plate Fixation System manufactured by Medtronic
Sofamor Danek, INC (K013665) |
| Indications for use | The FBC 921™ is intended for spinal fusion procedures to be used with autogenous bone
graft in skeletally mature patients with degenerative disc disease ("DDD ") at one or two
contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with
degeneration of the disc confirmed by history and radiographic studies. These patients
should have had six months of non-operative treatment. These DDD patients may have
had a previous non-fusion spinal surgery at the involved spinal level(s) and may have up
to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is
intended to be used with posterior supplemental spinal fixation systems that have been
cleared for use in the lumbosacral spine. |
| Description of the device | The FBC 921™ is a two-part ALIF device consisting of top and bottom components with an integral anterior plate to allow additional fixation. Both the bottom and the top components come in three footprints. The top component comes in three footprints and one size. It has a starting lordosis of 9 degrees. Lordosis for each assembly is adjustable between 9 and 21 degrees. The bottom component includes the height variation. It comes in the three footprints and four heights (8, 10, 12, and 14mm). The device is anchored to the superior and inferior vertebra using three Ø5.5 variable angle screws. The top and bottom components are made of titanium alloy (Ti-6Al-4V) additively manufactured from biocompatible titanium alloy (Ti-6Al-4V) using powder per ASTM F3001 which are then machined to their final geometry. Screws are made from an implant grade titanium alloy (Ti6Al4V ELI) meeting the requirements of ASTM F136. The FBC 921™ is a single-use device delivered sterile (gamma sterilization) and supplied with surgical instruments (reusable - provided non-sterile). |
| Technological
characteristics compared
to the predicate devices | As was established in this submission, the FBC 921™ is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. FBC 921™ was shown to be substantially equivalent and have the same or similar technological characteristics to its predicate devices through comparison in areas including intended use, indications for use, function, material composition and manufacturing process, design, range of sizes and mechanical performance. |
| Non-clinical performance
data | Nonclinical testing was performed to demonstrate that the FBC 921™ is substantially equivalent to other predicate devices.
The characterization of the chemical composition, mechanical and metallographic properties was performed in accordance with ASTM F2924-14 and ASTM E8/E8M. Mechanical testing in compliance with: FDA's "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" was performed for the FBC 921™. The following mechanical tests were performed: Static and dynamic axial compression (per ASTM F2077), Static and dynamic shear compression (per ASTM F2077), Static torsion (per ASTM F2077), subsidence (per ASTM F2267) and expulsion (per internal protocol). The characteristics of any particulate wear debris (per ASTM F1877) generated during the mechanical test were carried out using SEM/EDS (scanning electron microscopy/energy dispersive spectrometry) techniques. Microscopic analysis was conducted of parts following dynamic testing to assess contact at all three intended areas of contact: (1) on the front of the column with the locking screw, (2) on the back of the column with the top, and (3) posteriorly. A pressure film study was conducted to evaluate contact between the top and bottom components at different lordotic angles. Lastly, assessment of the potential for locking screw loosening was conducted. In addition, dynamic testing in torsion (axial rotation) was performed to +/- 4Nm for 1 million cycles.
The result of these studies shows that the FBC 921™ meets or exceeds the performance of the predicate devices and does not introduce any new risks. Therefore, the FBC 921™ is substantially equivalent to the predicate devices. Bacterial endotoxin testing per USP 39 NF 34 (2016) for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device. |
| Conclusion | Based on the design features, technological characteristics, feature comparisons, indications for use, and non-clinical performance testing, the FBC 921™ has demonstrated substantial equivalence to the identified predicate devices. |
4