(76 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and safety of a physical implant system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for anterior cervical fixation to promote cervical fusion for various medical conditions, indicating a therapeutic purpose to treat or alleviate a medical condition.
No
The device description clearly states its purpose is 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)." This indicates a therapeutic, supportive function, not a diagnostic one. There is no mention of it being used to detect, diagnose, or monitor a medical condition.
No
The device description explicitly states it includes implants (screws and plates) made of titanium alloy and necessary instrumentation, which are physical hardware components.
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.
- Device Description: The provided text describes a surgical implant (an anterior cervical plate system) used for spinal fixation. It is a physical device implanted into the body during surgery.
- Intended Use: The intended use clearly states it's for "anterior cervical fixation" for various spinal conditions. This is a surgical procedure, not a diagnostic test performed on a sample.
The device is a therapeutic device used to treat a condition, not a diagnostic device used to identify or monitor a condition through testing of bodily samples.
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, kyphosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion.
Product codes
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 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)
The following nonclinical tests were submitted and relied on in this premarket notification submission for a determination of substantial equivalence. Testing identified in this summary has all passed acceptance criteria established by the predicate device, where applicable. 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:
ASTM F1717-18 static and dynamic compression bending ASTM F1717-18 static torsion Locking Mechanism Retention Other modes of mechanical testing were evaluated via an engineering rationale, but not required nor completed for a determination of substantial equivalence.
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 F2182-11a, “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"
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
§ 888.3060 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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
January 17, 2019
Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) Ms. Jaclyn Holli Specialist, Regulatory Affairs 375 River Park Circle Marquette, Michigan 49855
Re: K183060
Trade/Device Name: CervAlign™ 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: November 1. 2018 Received: November 2, 2018
Dear Ms. 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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-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.
Ronald P. Jean -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
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.
DBA RTI Surgical, Inc.
375 River Park Circle
Marquette, MI 49855 USA
Phone: (906) 226-9909
Fax: (906) 225-5868
Prepared: November 1, 2018 |
|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter/Contact: | Jaclyn Holli
Specialist, Regulatory Affairs
RTI Surgical, Inc.
jholli@rtix.com
(906) 226-9909 ext. 5647 |
| Trade 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) |
| Panel: | Orthopedic Device Panel |
| Predicates: | Primary Predicate:
Pioneer Aspect Anterior Cervical Plate System (K130427
cleared 6/5/2013)- Pioneer Surgical Technology, Inc.
Additional Predicate:
Pioneer Anterior Cervical Plate System (PACP) (K083663
cleared 2/25/2009)- Pioneer Surgical Technology, Inc. |
| 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 |
| | 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. |
| 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 predicates. |
| Discussion of
Supporting Non-
Clinical Testing: | The following nonclinical tests were submitted and relied
on in this premarket notification submission for a
determination of substantial equivalence. Testing
identified in this summary has all passed acceptance
criteria established by the predicate device, where
applicable. 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:
ASTM F1717-18 static and dynamic compression
bending ASTM F1717-18 static torsion Locking Mechanism Retention Other modes of mechanical testing were evaluated via an
engineering rationale, but not required nor completed for a
determination of substantial equivalence. |
| | 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 F2182-11a, “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" |
| Conclusion: | 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 devices referenced. |
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