(191 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and intended use of a physical implant (cervical plating system) and do not mention any software, algorithms, or data processing related to AI/ML.
Yes
Explanation: The device is intended for "temporary stabilization of the anterior spine from C2 to T1 during the development of a cervical spinal fusion in patients with degenerative disc disease, spondylolisthesis, trauma, spinal cord stenosis, deformity, tumors, pseudarthrosis, or failed previous fusions." These indications clearly demonstrate that the device is used to treat or manage a medical condition, qualifying it as a therapeutic device.
No
The device is an anterior cervical plating system designed for fixation and stabilization of the spine, not for diagnosing conditions.
No
The device description explicitly states that the system consists of plates, screws, and associated instruments, which are physical hardware components intended for implantation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description: The provided text clearly describes a system of implants (plates and screws) that are surgically placed inside the body to stabilize the cervical spine.
- Intended Use: The intended use is for "anterior fixation to the cervical spine" and "temporary stabilization of the anterior spine... during the development of a cervical spinal fusion." This is a surgical procedure performed directly on the patient's body.
The device described is a surgical implant used for spinal fixation, not a device used for testing biological samples in a lab.
N/A
Intended Use / Indications for Use
The MIS Anterior Cervical Plating System is intended for anterior fixation to the cervical spine. This system is indicated for use in temporary stabilization of the anterior spine from C2 to T1 during the development of a cervical spinal fusion in patients with:
-
- Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies);
-
- Spondylolisthesis
-
- Trauma (including fractures or dislocations);
-
- Spinal cord stenosis;
-
- Deformity or curvatures (i.e. kyphosis, lordosis and/or scoliosis);
-
- Tumors:
-
- Pseudarthrosis;
-
- Failed previous fusions.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The MIS Anterior Cervical Plating System components are temporary implants that are intended for anterior fixation to the cervical spine during the development of a cervical spinal fusion.
The MIS Anterior Cervical Plating System consists of a variety of sizes of plates, screws, and associated instruments. Fixation is provided by bone screws inserted through the plates and into the vertebral body of the cervical spine using an anterior approach.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine from C2 to 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)
Dynamic Compression as well as Static Compression and Torsion was performed on the MIS Anterior Cervical Plate as described in ASTM 1717, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model. The testing was performed by an independent third party test facility. All mechanical test results are presented in Appendix E.
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.
Nuvasive Helix-Mini ACP (K073275), NEO SL Anterior Cervical Plate (K070285)
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
510(k) Summary
MIS Anterior Cervical Plating System
| Submitted By: | Life Spine, Inc.
2401 W. Hassell Road, Suite 1535
Hoffman Estates, IL 60169
Telephone: 847-884-6117
Fax: 847-884-6118 |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Randy Lewis
Life Spine, Inc.
2401 W. Hassell Road, Suite 1535
Hoffman Estates, IL 60169
Telephone: 847-884-6117
Fax: 847-884-6118 |
| Date Prepared: | November 19th, 2010 |
| Trade Name: | MIS Anterior Cervical Plating System |
| Product Code: | CFR 888.3060 - Spinal Intervertebral Body Fixation
Orthosis
Class II |
| Classification: | KWQ |
| Predicate Device: | Nuvasive Helix-Mini ACP (K073275)
NEO SL Anterior Cervical Plate (K070285) |
Device Description:
The MIS Anterior Cervical Plating System components are temporary implants that are intended for anterior fixation to the cervical spine during the development of a cervical spinal fusion.
The MIS Anterior Cervical Plating System consists of a variety of sizes of plates, screws, and associated instruments. Fixation is provided by bone screws inserted through the plates and into the vertebral body of the cervical spine using an anterior approach.
1
Intended Use of the Device:
The MIS Anterior Cervical Plating System is intended for anterior fixation to the cervical spine. This system is indicated for use in temporary stabilization of the anterior spine from C2 to T1 during the development of a cervical spinal fusion in patients with:
-
- Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies);
-
- Spondylolisthesis
-
- Trauma (including fractures or dislocations);
-
- Spinal cord stenosis;
-
- Deformity or curvatures (i.e. kyphosis, lordosis and/or scoliosis);
-
- Tumors:
-
- Pseudarthrosis;
-
- Failed previous fusions.
Material:
Manufactured from medical grade titanium alloy as described by ASTM F136.
Test Data:
Dynamic Compression as well as Static Compression and Torsion was performed on the MIS Anterior Cervical Plate as described in ASTM 1717, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model. The testing was performed by an independent third party test facility. All mechanical test results are presented in Appendix E.
Testing Conclusions:
The test results demonstrate that the MIS Anterior Cervical Plate is substantially equivalent to the predicate devices, Nuvasive Helix-Mini ACP (K073275) and NEO SL Anterior Cervical Plate (K070285).
Substantial Equivalence:
The MIS Anterior Cervical Plating System is substantially equivalent to previously cleared devices in indications for use, design, function, and materials used.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure, with its wings spread and head turned to the right. The bird is rendered in a simple, bold black line. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN - 1 2011
Life Spine, Inc. % Mr. Randy Lewis 2401 West Hassell Road Suite 1535 Hoffman Estates, Illinois 60169
Re: K103423
Trade/Device Name: MIS Anterior Cervical Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: April 26, 2011 Received: April 27, 201-1
Dear Mr. Lewis:
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
3
Page 2 - Mr. Randy Lewis
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 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
cc
Ds De
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Indications for Use:
K 103423
| Device Name: | MIS Anterior Cervical Plating System |
|---|---|
| -------------- | -------------------------------------- |
The MIS Anterior Cervical Plating System is intended for anterior fixation to the cervical spine. This system is indicated for use in temporary stabilization of the anterior spine from C2 to T1 during the development of a cervical spinal fusion in patients with:
-
- Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies);
-
- Spondylolisthesis
-
- Trauma (including fractures or dislocations);
-
- Spinal cord stenosis;
- ડ. Deformity or curvatures (i.e. kyphosis, lordosis and/or scoliosis);
-
- Tumors;
-
- Pseudarthrosis;
-
- Failed previous fusions.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (DDE) |
|---|
| -------------------------------------------------------- |
Page 1 of 1
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
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KID3423 510/k) Numher