(72 days)
No
The description focuses on the mechanical design and materials of a spinal implant system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for the temporary stabilization of the anterior spine and is indicated for conditions such as degenerative disc disease, trauma, tumors, and deformity, which directly treat or alleviate a disease or condition.
No.
This device is an anterior cervical plate system intended for spinal fixation and stabilization during fusion, not for diagnosing medical conditions.
No
The device description clearly outlines physical components made of Ti-6AI-4V ELI, including plates and screws, and describes mechanical testing performed on these physical components. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The FloSpine PANAMA™ Anterior Cervical Plate System is a physical implant (plates and screws) designed to be surgically placed in the cervical spine. It is a medical device used in vivo (within the body) for structural support and stabilization.
- Intended Use: The intended use clearly describes the device's function in stabilizing the spine during fusion, not for analyzing biological samples.
The information provided describes a surgical implant, not a diagnostic test.
N/A
Intended Use / Indications for Use
The FloSpine PANAMA™ Anterior Cervical Plate System is intended for anterior cervical screw fixation of the cervical spine at levels C2-T1. The System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative discase (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis), or scoliosis), pseudoarthrosis, and/or failed previous fusions.
Product codes
KWQ
Device Description
The PANAMA™ Anterior Cervical Plate System is an anterior cervical spine fixation system that provides cervical spine fixation for intervertebral disk replacement procedures. The PANAMA™ ACP System is designed to stabilize and facilitate fusion in intervertebral disk replacement surgeries.
The PANAMA™ Anterior Cervical Plate (ACP) System consists of cervical plates that are 2.25 mm thick, 16 mm wide, and length options between 18 and 110 mm (end-to-end length) to accommodate 1 to 5 levels of fusion between C2 and T1. The PANAMA ACP System includes fixed and variable angle screws with 4.0mm and 4.5mm diameters and length options between 12mm and 20mm with self-tapping and self-drilling options. The screws and plates are made from Ti-6AI-4V ELI conforming to ASTM F-136.
The plates and screws of the PANAMA™ ACP System include a primary and secondary mechanism to mitigate screw backout. The primary mechanism consists of a cover plate that is rotated in-situ that partially covers the screw. The secondary mechanism consists of a number of radial teeth on the screw head and mating grooves on the underside of the cover plate. In the event that the screws start to back out, the teeth and grooves will engage, thereby preventing further counter-clockwise rotation of the screw. The screws in the system have a threaded hole at the bottom of the drive to provide easy insertion and positioning during surgery. The PANAMA™ ACP System of implants and instruments is provided clean and non-sterile in one sterilization case.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine at levels C2-T1
Indicated Patient Age Range
Not Found
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)
Performance testing of the PANAMA™ ACP System was performed per ASTM F1717 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model". Testing included static axial compression bend testing, dynamic axial compression testing, and static torsion testing. The testing verified achievement of the acceptance criteria for the subject device. The following tests were performed:
-
- Static axial compression bending testing per ASTM 1717-18.
-
- Static torsion testing per ASTM 1717-18.
-
- Dynamic compression bend testing per ASTM 1717-18.
The results of testing demonstrated the subject device to possess similar strength and mechanical performance characteristics as the predicate devices.
The PANAMA™ ACP System of implants and instruments are provided clean, not sterile to the end user in a single tray and case system. Sterility of the subject device system was verified for a SAL of 10^-6 per AAMI TIR12-2004, ISO 17664-2004.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
April 7, 2021
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 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.
FloSpine % Robert Poggie President BioVera, Inc. 65 Promenade Saint Louis Notre-Dame-de-L'lle-Perrot, QC J7V7P2 Canada
Re: K210182
Trade/Device Name: PANAMA™ Anterior Cervical Plate (ACP) System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: January 21, 2021 Received: January 25, 2021
Dear Robert Poggie:
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 (0S) 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,
Anne D. Talley - $S_{for}$
Colin O'Neill, M.B.E. 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) K210182
Device Name
PANAMATM Anterior Cervical Plate (ACP) System
Indications for Use (Describe)
The FloSpine PANAMA™ Anterior Cervical Plate System is intended for anterior cervical screw fixation of the cervical spine at levels C2-T1. The System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative discase (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis), or scoliosis), pseudoarthrosis, and/or failed previous fusions.
| 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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510(k) SUMMARIES
In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following is a summary of safety and effectiveness of the PANAMA™ Anterior Cervical Plate System.
A. SUBMITTERS INFORMATION
| Submitter Name: | BioVera, Inc. |
|---|---|
| Submitter Address: | 65 Promenade Saint-Louis, NDIP, Québec, J7V 7P2, CANADA |
| Contact Person: | Robert A. Poggie, PhD |
| Phone Number: | 514-901-0796 |
| Fax Number: | 514-901-0796 |
| Date of Submission: | January 21, 2021 |
B. DEVICE IDENTIFICATION & MANUFACTURER
| Manufacturer Name: | FloSpine, LLC |
|---|---|
| Manufacturer Address: | 3651 FAU Blvd, Suite 400, Boca Raton, FL 33431 USA |
| Registration Number: | 3010125671 |
| Contact Name: | Peter Harris |
| Title: | President / CEO |
| Device Trade Name: | PANAMATM Anterior Cervical Plate (ACP) System |
| Device Common Name: | Appliance, fixation, spinal intervertebral body |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis |
| Classification Code: | KWQ |
| Classification Panel: | Orthopedic |
| Regulation Number: | 21 CFR sections 888.3060 |
C1. PRIMARY PREDICATE DEVICE
K060442 K2M - Pyrenees Cervical Plate System C2. ADDITIONAL PREDICATE DEVICE K022344 Zimmer/Centerpulse - Trinica Select Anterior Cervical Plate C3. REFERENCE DEVICE K141850 FloSpine Canaveral Pedicle Screw System
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D. DEVICE DESCRIPTION
The PANAMA™ Anterior Cervical Plate System is an anterior cervical spine fixation system that provides cervical spine fixation for intervertebral disk replacement procedures. The PANAMA™ ACP System is designed to stabilize and facilitate fusion in intervertebral disk replacement surgeries.
The PANAMA™ Anterior Cervical Plate (ACP) System consists of cervical plates that are 2.25 mm thick, 16 mm wide, and length options between 18 and 110 mm (end-toend length) to accommodate 1 to 5 levels of fusion between C2 and T1. The PANAMA ACP System includes fixed and variable angle screws with 4.0mm and 4.5mm diameters and length options between 12mm and 20mm with self-tapping and self-drilling options. The screws and plates are made from Ti-6AI-4V ELI conforming to ASTM F-136.
The plates and screws of the PANAMA™ ACP System include a primary and secondary mechanism to mitigate screw backout. The primary mechanism consists of a cover plate that is rotated in-situ that partially covers the screw. The secondary mechanism consists of a number of radial teeth on the screw head and mating grooves on the underside of the cover plate. In the event that the screws start to back out, the teeth and grooves will engage, thereby preventing further counter-clockwise rotation of the screw. The screws in the system have a threaded hole at the bottom of the drive to provide easy insertion and positioning during surgery. The PANAMA™ ACP System of implants and instruments is provided clean and non-sterile in one sterilization case.
E. INDICATIONS FOR USE
The FloSpine PANAMA™ Anterior Cervical Plate System is intended for anterior cervical screw fixation of the cervical spine at levels C2-T1. The System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions.
F. TECHNOLOGICAL CHARACTERISTICS, COMPARISON TO PREDICATE DEVICE
FloSpine PANAMA™ Anterior Cervical Plate (ACP) System has similar The technological characteristics as the predicate devices, including the materials, design, function, range of sizes, manufacturing processes, surgical techniques, and intended use. The minor differences in design and sizing options do not present new issues of
5
safety and effectiveness. Specifically, the following characteristics are the same or similar for the subject and predicate devices:
- The subject and predicate device K022344 are made of Ti6AI4V (ASTM F136) .
- . The subject and predicate device K060442 are indicated for anterior cervical fixation for 1 through 5 levels.
- The subject and predicate device K022344 are indicated for levels C2 T1. .
- The subject and predicate devices include fixed and variable angle screws and . self-tapping and self-drilling screws.
- The biomechanical performance characteristics of the subject and predicate . devices were assessed and determined acceptable per ASTM F1717.
G. PERFORMANCE DATA
Performance testing of the PANAMA™ ACP System was performed per ASTM F1717 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model". Testing included static axial compression bend testing, dynamic axial compression testing, and static torsion testing. The testing verified achievement of the acceptance criteria for the subject device. The following tests were performed:
-
- Static axial compression bending testing per ASTM 1717-18.
-
- Static torsion testing per ASTM 1717-18.
-
- Dynamic compression bend testing per ASTM 1717-18.
The results of testing demonstrated the subject device to possess similar strength and mechanical performance characteristics as the predicate devices.
The PANAMA™ ACP System of implants and instruments are provided clean, not sterile to the end user in a single tray and case system. Sterility of the subject device system was verified for a SAL of 10-6 per AAMI TIR12-2004, ISO 17664-2004.
H. CONCLUSIONS
The data presented in these 510(k) notifications show the FloSpine PANAMA™ Anterior Cervical Plate (ACP) System to be substantially equivalent to the cited legally marketed predicate and reference devices.