(48 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and safety of a physical implant system for spinal fusion. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is a medical implant intended to promote cervical fusion and provide temporary resistance to movement, which directly treats conditions like degenerative disc disease, trauma, and spinal stenosis.
No
The device is a CervAlign Anterior Cervical Plate System, intended for fixation and promotion of cervical fusion. It is a surgical implant, not a diagnostic tool.
No
The device description clearly states it is a system of physical implants (screws and plates) made of titanium alloy, along with instrumentation for insertion and removal. This is a hardware-based medical device.
Based on the provided information, 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.
- Device Description: The CervAlign Anterior Cervical Plate System is a surgical implant designed to provide structural support and promote fusion in the cervical spine. It is a physical device implanted into the body.
- Intended Use: The intended use is for anterior cervical fixation for various spinal conditions. This involves surgical intervention and the placement of a physical implant, not the analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of biomarkers, or any other activities typically associated with IVDs.
Therefore, the CervAlign Anterior Cervical Plate System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CervAlign Anterior Cervical Plate System is intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
KWO
Device Description
The CervAlign Anterior Cervical Plate System is designed to promote cervical fusion by providing temporary resistance to flexion, extension, lateral bending, and axial rotation with strength and stiffness in the cervical spine (C2-C7). The system includes implants of various sizes of screws and plates to accommodate varying patient anatomies. The plates have integrated cover-style locking mechanisms that actuate to cover each screw. Implants are manufactured from titanium alloy, Ti-6Al-4V ELI (ASTM F136). The implants are supplied with instrumentation necessary to facilitate the insertion and removal. The implants and instruments are provided non-sterile and must be sterilized before use. Sterilization cases and trays are provided to facilitate proper sterilization and storage.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (C2-C7)
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 showed that the mechanical strength of the subject system is equivalent to or better than predicate devices and is therefore sufficient for the intended use.
Mechanical Testing:
Locking Mechanism Retention
There is no impact to the following non-clinical performance data that was included in cleared submission K183060. This testing is not included in the subject submission:
Mechanical Testing ASTM F1717-18 static and dynamic compression bending ASTM F1717-18 static torsion
MR Safety Evaluation determined the devices are MR Conditional via the following standards: ASTM F2052-15, “Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment” ASTM F2213-17, “Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment” ASTM F2182-19e2, “Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging” ASTM F2119-07 (Reapproved 2013), “Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants” ASTM F2503-20 “Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment”
Packaging and sterilization testing and evaluations ISO 10993-1 Biological safety evaluation
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
§ 888.3060 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA acronym is in a blue square, and the full name is in blue text. The seal features an emblem with a staff and serpent, symbolizing healing and medicine.
Pioneer Surgical Technology, Inc. Jaclyn Holli Sr. Specialist, Regulatory Affairs 375 River Park Circle Marquette, Michigan 49855
Re: K211408
Trade/Device Name: Cerv Align ® Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWO Dated: May 5, 2021 Received: May 6, 2021
Dear Jaclyn Holli:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
June 23, 2021
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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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
K211408
Device Name CervAlign® Anterior Cervical Plate System
Indications for Use (Describe)
The CervAlign Anterior Cervical Plate System is intended for anterior cervical fixation (C2-C7) for the following conditions: degenerative disc disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion.
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) Summary
As required by 21 CFR 807.92
| Company: | Pioneer Surgical Technology, Inc.
375 River Park Circle
Marquette, MI 49855, USA
Phone: +1-906-226-9909
Fax: +1-906-226-4443 |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter/Contact: | Jaclyn Holli
Sr. Specialist, Regulatory Affairs
Pioneer Surgical Technology, Inc.
jholli@rtix.com |
| Date Prepared | May 5, 2021 |
| Proprietary Name | CervAlign® Anterior Cervical Plate System |
| Common Name | Anterior Cervical Plate System |
| Classification | Class II; 21 CFR 888.3060 (Product Code KWQ - Appliance, Fixation,
Spinal Intervertebral Body) Spinal Intervertebral Body Fixation Orthosis |
| Panel | Orthopedic Device Panel |
| Predicate Device | CervAlign Anterior Cervical Plate System (K183060 cleared January 17,
2019) - Pioneer Surgical Technology, Inc. |
| Device Description | The CervAlign Anterior Cervical Plate System is designed to promote
cervical fusion by providing temporary resistance to flexion, extension,
lateral bending, and axial rotation with strength and stiffness in the
cervical spine (C2-C7). The system includes implants of various sizes of
screws and plates to accommodate varying patient anatomies. The plates
have integrated cover-style locking mechanisms that actuate to cover
each screw. Implants are manufactured from titanium alloy, Ti-6Al-4V
ELI (ASTM F136). The implants are supplied with instrumentation
necessary to facilitate the insertion and removal.
The implants and instruments are provided non-sterile and must be
sterilized before use. Sterilization cases and trays are provided to
facilitate proper sterilization and storage. |
| Indications for Use | The CervAlign Anterior Cervical Plate System is intended for anterior
cervical fixation (C2-C7) for the following conditions: degenerative disc
disease (DDD) defined as neck pain of discogenic origin with
degeneration of the disc confirmed by history and radiographic studies,
spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis,
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
tumor, pseudarthrosis, and failed previous fusion. |
| Non-clinical
Performance Data | Performance testing showed that the mechanical strength of the subject
system is equivalent to or better than predicate devices and is therefore
sufficient for the intended use.
Mechanical Testing:
Locking Mechanism Retention
●
There is no impact to the following non-clinical performance data that
was included in cleared submission K183060. This testing is not included
in the subject submission: |
| | Mechanical Testing ASTM F1717-18 static and dynamic compression bending ASTM F1717-18 static torsion MR Safety Evaluation determined the devices are MR Conditional via the following standards: ASTM F2052-15, “Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment” ASTM F2213-17, “Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment” ASTM F2182-19e2, “Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging” ASTM F2119-07 (Reapproved 2013), “Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants” ASTM F2503-20 “Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment” Packaging and sterilization testing and evaluations ISO 10993-1 Biological safety evaluation |
| Clinical Performance Data | No clinical performance data was required for a determination of substantial equivalence. |
| Summary of Technological Characteristics: | The subject system has the same or similar fundamental technology (technological characteristics, indications for use, material, principles of operation, overall implant geometry and size options, and anatomical location of use) as the predicate. |
| Substantial Equivalence | The supporting evidence in this submission is sufficient to justify the substantial equivalence of the subject CervAlign Anterior Cervical Plate System as compared to the predicate device referenced. |
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