(162 days)
Not Found
No
The device description and performance studies focus solely on the mechanical properties and design of a physical implant, with no mention of software, algorithms, or data processing.
Yes
The device is described as an "anterior screw fixation to the cervical spine (C2-C7) for immobilization and stabilization as an adjunct to fusion" designed to treat various medical conditions such as "Degenerative disc disease (DDD)", "Fracture", and "Tumors". These functions directly address health conditions to restore a patient's health, which aligns with the definition of a therapeutic device.
No
The device description indicates that the Cervical Plate is an implant used for immobilization and stabilization as an adjunct to fusion, not for diagnosing conditions. Its purpose is to treat conditions like degenerative disc disease, not to identify them.
No
The device description clearly states it is a "spinal internal fixation device made from titanium alloy" and describes physical components like plates, screws, and locking mechanisms. This indicates it is a 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 that 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 in vivo (within the body) to treat specific spinal conditions.
- Device Description: The description details a physical implant made of titanium alloy, including plates, screws, and locking mechanisms. This is consistent with a surgical device, not a diagnostic test performed in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory tests.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to mechanically stabilize the spine.
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 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).
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Cervical Plate spinal internal fixation device made from titanium alloy (all components are made from ASTM F-136). It is provided in a variety of sizes ranging from 20mm to 110mm in length, and accommodating fusion of one to four levels of the cervical spine. Two screws may be affixed to each vertebral body associated with the spinal fusion.
All plates, regardless of length have a nominal thickness of 1.85mm and width of 18mm. Screws are provided in 4:0mm and 4.5mm diameters and in fixed and variable angle styles.
Screws are prevented from backing out of the plate by attaching a separate locking mechanism. The mechanism is either a lock washer, consisting of a set screw attached to a washer, or a lock cover, which is a solid screw whose head captures both bone screws at the level of application.
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)
The Cervical Plate was tested by the methods described in ASTM F1717, including static axial compression, dynamic axial compression, and static torsion. Mechanical performance in each tested mode was equivalent or superior to previously marketed devices.
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
LI13170
510(k) Summary (April 5, 2012):
| Company: | Eisertech, LLC
San Diego, California 92103 | APR - 6 2012 |
|----------------------|------------------------------------------------------------|--------------|
| Contact: | Lukas Eisermann
lukas@eisertech.com
888-262-2817x101 | |
| Trade Name: | Cervical Plate | |
| Common Name: | Anterior Cervical Plate | |
| Classification Name: | Anterior cervical system | |
| Regulation Number: | 888.3060 | |
| Product Code: | KWQ | |
Substantial Equivalence
Eisertech, LLC believes that the Eisertech, LLC Cervical Plate is substantially equivalent to the Blackstone Medical, Inc. Anterior Cervical Plate System (K974885) and the Synthes CSLP System (K926453).
Description of device
The Cervical Plate spinal internal fixation device made from titanium alloy (all components are made from ASTM F-136). It is provided in a variety of sizes ranging from 20mm to 110mm in length, and accommodating fusion of one to four levels of the cervical spine. Two screws may be affixed to each vertebral body associated with the spinal fusion.
All plates, regardless of length have a nominal thickness of 1.85mm and width of 18mm. Screws are provided in 4:0mm and 4.5mm diameters and in fixed and variable angle styles.
Screws are prevented from backing out of the plate by attaching a separate locking mechanism. The mechanism is either a lock washer, consisting of a set screw attached to a washer, or a lock cover, which is a solid screw whose head captures both bone screws at the level of application.
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).
Pg lodz
1
-
Spondylolisthesis
-
Fracture
-
Spinal stenosis
-
Tumors (primary and metastatic)
-
Failed previous fusions
-
Pseudoarthrosis
-
Deformity (i.e. kyphosis, lordosis, and/or scoliosis).
Description of device design requirements
The Cervical Plate must stabilize the spine while fusion occurs. It must keep the fused vertebrae in their intended alignment.
Identification of the risk analysis method
Risks were qualitatively summarized and addressed by quantitatively analyzing specific in-vivo device performance requirements. The biomechanical loads that the device is expected to be subjected to were described and used as design input criteria. Test results relative to those loading conditions (e.g. design output data) were compared to the design input criteria. The device output data showed performance meeting or exceeding the design input requirements for all conditions.
Discussion of the device characteristics
The Cervical Plate is an anterior cervical spinal plate intended to be used in cervical spinal fusion surgery. It provides internal fixation to the spine and protects the bone graft from excessive loads so that bone healing can occur.
Description of the performance aspects
The Cervical Plate was tested by the methods described in ASTM F1717, including static axial compression, dynamic axial compression, and static torsion. Mechanical performance in each tested mode was equivalent or superior to previously marketed devices.
Comparison of Technological Similarities or Differences to Predicate Devices
The Cervical Plate utilizes the same basic technology as its predicate. Both systems are titanium alloy plates of similar size and shape. Both plate systems provide fixed and variable angle screws of 4.0 and 4.5mm diameter. The plates have similar thicknesses, widths, general geometry, and mechanical performance.
Reliance on standards
Standards relevant to the methods in which the testing was conducted were relied upon. This includes ASTM F1717. However, no performance standard exists for anterior cervical spinal plates.
Pg 1 of 2
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Eistertech, LLC % Mr. Lukas Eisermann CEO 2555 Front Street San Diego, California 92103
APR - 6 2012
Re: K113170
Trade/Device Name: Cervical Plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: March 1, 2012 Received: March 2, 2012
Dear Mr. Eisermann:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Lukas Eisermann
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark M. Millerson
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): KII 3170
Cervical Plate Device Name:
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).
× Prescription Use (Part 21 CFR 801 Subpart D)
90
AND/OR
Over-the-counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
| (Division Sign-Off) | |
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| Division of Surgical, Orthopedic, and Restorative Devices |
| Page | of |
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| 510(k) Number | K113170 |