(87 days)
Not Found
No
The 510(k) summary describes a mechanical spinal implant and surgical instruments, with no mention of AI or ML capabilities. The changes described relate to material options and surface treatment for the instruments.
Yes
The device is intended for the immobilization and stabilization of the cervical spine as an adjunct to fusion for various conditions like degenerative disc disease, fractures, and tumors, which are therapeutic interventions.
No
The device is a cervical plate, which is an implant used for stabilization and fusion of the cervical spine. While it is indicated for conditions that require diagnosis (e.g., degenerative disc disease, fracture), the device itself is a treatment device, not a diagnostic tool used to identify or monitor these conditions.
No
The device description explicitly states it is a "spinal internal fixation device" and includes "instrumentation to facilitate implantation," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "anterior screw fixation to the cervical spine (C2-C7) for immobilization and stabilization as an adjunct to fusion." This describes a surgical implant used directly on the patient's body for structural support.
- Device Description: The description details a "spinal internal fixation device" and associated "instrumentation to facilitate implantation." This further confirms it's a physical device used in surgery.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such testing.
The device is a surgical implant and associated instruments, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
The Cervical Plate is intended for anterior screw fixation to the cervical spine (C2-C7) for immobilization and stabilization as an adjunct to fusion in skeletally mature patients for the following indications:
-Degenerative disc disease (DDD, defined as neck pain of discogenic origin with degenertion of the disc confirmed by history and radiographic studies)
-Spondylolisthesis
- -Fracture
-Spinal stenosis
-Tumors (primary and metastatic)
-Failed previous fusions
-Pseudoarthrosis
-Deformity (i.e. kyphosis, lordosis, and/or scoliosis).
Product codes (comma separated list FDA assigned to the subject device)
KWO
Device Description
The Eisertech, LLC. Cervical Plate (K113170) is a spinal internal fixation device which is provided in a variety of sizes ranging from 20mm in length. The device is designed to accommodate fusion of one to four levels of the cervical spine. Two screws may be affixed to each vertebral body associated with the spinal fusion. Instrumentation to facilitate implantation of the cervical plate is included with the device. This instrumentation is the subject of the present Traditional 510(k) submission. Specifically, the present Traditional 510(k) submission seeks to add two additional base material options as well as a surface treatment to all previously cleared instruments for use with the cervical plate system. The purpose of the surface treatment is to add scratch resistance and hydrophobicity to the instruments. There are no changes to the implants and the surface treatment is not being applied to the implants.
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
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)
Biocompatibility Testing was performed to ensure that the addition of a surface treatment to all previously cleared instruments for use with the cervical plate system does not negatively impact biocompatibility of the instruments. Additionally, ball on flat wear testing, instrumented indentation testing, and corrosion resistance testing was performed to demonstrate that the coating provides additional wear/corrosion resistance to the instruments.
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.
Eisertech,LLC Cervical Plate (K113170)
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
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May 31, 2019
EiserTech, LLC % Dawn Norman Executive VP MRC-X, LLC 6075 Poplar Ave Memphis, Tennessee 38119
Re: K190565
Trade/Device Name: Cervical Plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWO Dated: February 22, 2019 Received: March 5, 2019
Dear Dawn Norman:
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
1
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) 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 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 CAPT Raquel Peat, PhD, MPH, USPHS Director 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) K190565
Device Name Cervical Plate
Indications for Use (Describe)
The Cervical Plate is intended for anterior screw fixation to the cervical spine (C2-C7) for immobilization and stabilization as an adjunct to fusion in skeletally mature patients for the following indications:
-Degenerative disc disease (DDD, defined as neck pain of discogenic origin with degenertion of the disc confirmed by history and radiographic studies)
-Spondylolisthesis
- -Fracture
-Spinal stenosis
-Tumors (primary and metastatic)
-Failed previous fusions
-Pseudoarthrosis
-Deformity (i.e. kyphosis, lordosis, and/or scoliosis).
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Cervical Plate February 22, 2019
| Company: | Eistertech, LLC
9988 Hibert Street Suite 302
San Diego, CA 92131 |
|---------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Establishment
Registration: | 3009381326 |
| Primary Contact: | Dawn Norman
Phone: 618-604-3064 |
| Company Contact: | Lukas Eisermann
Phone: 888-262-2817 |
| Trade Name: | Cervical Plate |
| Common Name: | Anterior Cervical Plate |
| Classification: | Class II |
| Regulation Number: 21 CFR 888.3060 Spinal Intervertebral Body Fixation Orthosis | |
| Panel: | 87- Orthopedic |
| Product Code: | KWQ |
| Primary Predicate
Device: | Eisertech,LLC Cervical Plate (K113170) |
Device Description:
The Eisertech, LLC. Cervical Plate (K113170) is a spinal internal fixation device which is provided in a variety of sizes ranging from 20mm in length. The device is designed to accommodate fusion of one to four levels of the cervical spine. Two screws may be affixed to each vertebral body associated with the spinal fusion. Instrumentation to facilitate implantation of the cervical plate is included with the device. This instrumentation is the subject of the present Traditional 510(k) submission. Specifically, the present Traditional 510(k) submission seeks to add two additional base material options as well as a surface treatment to all previously cleared instruments for use with the cervical plate system. The purpose of the surface treatment is to add scratch resistance and hydrophobicity to the instruments. There are no changes to the implants and the surface treatment is not being applied to the implants.
4
Indications for Use:
The Cervical Plate is intended for anterior screw fixation to the cervical spine (C2-C7) for immobilization and stabilization as an adjunct to fusion in skeletally mature patients for the following indications:
-Degenerative disc disease (DDD, defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
- Spondylolisthesis
- Fracture
- Spinal stenosis
- Tumors (primary and metastatic)
- Failed previous fusions
- Pseudoarthrosis
- Deformity (i.e. kyphosis, lordosis, and/or scoliosis).
Substantial Equivalence:
The subject Cervical Plate components are substantially equivalent to the following Primary Predicate device:
Eisertech, LLC Cervical Plate: K113170
The subject components are similar to the predicate devices in terms of indications, geometry, and materials. Biocompatibility and wear testing have confirmed that the addition of a surface treatment to all previously cleared instruments for use with the cervical plate system does not negatively impact the performance of the instruments. Thus, it can be concluded that the subject devices raise no new questions of safety and effectiveness and are substantially equivalent to the predicate devices.
Performance Testing:
Biocompatibility Testing was performed to ensure that the addition of a surface treatment to all previously cleared instruments for use with the cervical plate system does not negatively impact biocompatibility of the instruments. Additionally, ball on flat wear testing, instrumented indentation testing, and corrosion resistance testing was performed to demonstrate that the coating provides additional wear/corrosion resistance to the instruments.
Conclusion:
There are no substantial differences between the Cervical Plate and the predicate device with respect to intended use and technological characteristics, including basic design, base materials of manufacture, mechanical properties, and intended effect.
Therefore, the Cervical Plate can be found substantially equivalent to the cited predicate, as it does not raise new questions of safety and effectiveness.