(53 days)
No
The summary describes a mechanical implant (anterior cervical plate system) and its intended use, with no mention of software, algorithms, image processing, AI, ML, or related concepts. The performance studies focus on mechanical testing.
Yes
The device is described as an anterior cervical plating system intended for use in anterior cervical decompression and fusion (ACDF) surgery to treat conditions such as degenerative disc disease, spondylolisthesis, and trauma, clearly indicating a therapeutic purpose.
No
This device is a cervical plating system used for temporary stabilization of the anterior spine during fusion, and is not described as being used for diagnosis.
No
The device description explicitly states that the system includes cervical plates, screws, and various instrumentation, which are physical hardware components.
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 the "temporary stabilization of the anterior spine during the development of fusion" in patients with specific spinal conditions. This is a surgical implant used in vivo (within the body) to provide structural support.
- Device Description: The device is described as an "anterior cervical plating system" consisting of "cervical plates, screws, and various instrumentation." These are physical implants and surgical tools.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
It is intended that this device, in any system configuration, be removed after the development of solid fusion mass of spinal segments in skeletally mature patients.
The NEXT GENERATION™ Anterior Cervical Plate system is intended for use in anterior cervical decompression and fusion (ACDF) surgery (C2-C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of fusion in patients with the following conditions:
- degenerative disc disease(DDD) (defined as back pain of discogenic origin with I degeneration of the disc confirmed by history and radiographic studies)
- 트 spondylolisthesis
- trauma (i.e., fracture or dislocation) . ■
- 에 spinal stenosis
- pseudoarthrosis 예
- 트 tumor
- and failed previous fusion.
Product codes
KWQ
Device Description
The NEXT GENERATION™ Anterior Cervical Plating System is an anterior cervical plating system intended for use in anterior cervical decompression and fusion (ACDF) surgery (C2-C7). The subject components of this submission are cervical plates, screws, and various instrumentation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior 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)
Mechanical and dynamic testing of the cervical plate system was performed. The test results demonstrate that the mechanical performance of the NEXT GENERATION™ Anterior Cervical Plating System is substantially equivalent to the predicate devices.
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 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
Alphatec Spine NEXT GENERATION™ Cervical Plate System
510(k) Number K07068/
510(k) SUMMARY
NEXT GENERATION™ Anterior Cervical Plating System 510(k) SUMMARY March 2007
MAY - 4 2007
| Company: | Alphatec Spine, Inc.
2051 Palomar Airport Road#100
Carlsbad, CA 92011 USA
Telephone: (760) 431-9286
Fax: (760) 431-9132 |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Paula Morgan, Director of Regulatory Affairs |
| Trade/Proprietary Name: | NEXT GENERATION™ Anterior Cervical Plating System |
| Common Name: | Anterior Cervical plate System |
| Classification Name: | Spinal Intervertebral body fixation Orthosis (888.3060) |
Product Description:
The NEXT GENERATION™ Anterior Cervical Plating System is an anterior cervical plating system intended for use in anterior cervical decompression and fusion (ACDF) surgery (C2-C7). The subject components of this submission are cervical plates, screws, and various instrumentation.
Indications for Use:
It is intended that this device, in any system configuration, be removed after the development of solid fusion mass of spinal segments in skeletally mature patients.
The NEXT GENERATION™ Anterior Cervical Plate system is intended for use in anterior cervical decompression and fusion (ACDF) surgery (C2-C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of fusion in patients with the following conditions:
- degenerative disc disease(DDD) (defined as back pain of discogenic origin with degeneration . of the disc confirmed by history and radiographic studies)
- 트 spondvlolisthesis
- . trauma (i.e., fracture or dislocation)
- 지 spinal stenosis
- 트 tumor
- 미 pseudoarthrosis
- 체 and failed previous fusion.
Confidential and Proprietary
1
Substantial Equivalence:
The NEXT GENERATION™ Anterior Cervical Plating System is substantially equivalent to the following predicate devices:
| Trade/Proprietary Name | Manufacturer | Clearance |
|---|---|---|
| CSLP | Synthes Spine | K000536 |
| Stella | Scient'x | K042317 |
Performance Data:
Mechanical and dynamic testing of the cervical plate system was performed. The test results demonstrate that the mechanical performance of the NEXT GENERATION™ Anterior Cervical Plating System is substantially equivalent to the predicate devices.
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 features a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Alphatec Spine, Inc. % Ms. Paula Morgan Director of Regulatory Affairs & Compliance 2051 Palomar Airport Road, Suite 100 Carlsbad, California 92011
MAY - 4 2007
Re: K070681
Trade Name: NEXT GENERATION™ Anterior Cervical Plate System Regulation Number(s): 21 CFR 888.3060 Regulation Names: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: April 20, 2007 Received: April 25, 2007
Dear Ms. Morgan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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 (PMA) application. You may, therefore, market the device, subject to the general controls (1 mil) appliethe Act and the limitations described below. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
3
Page 2 - Ms. Paula Morgan
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address: http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Harbaye Muehlup
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: NEXT GENERATION™ Anterior Cervical Plating System
Indications for Use:
It is intended that this device, in any system configuration, be removed after the development of solid fusion mass of spinal segments in skeletally mature patients.
The NEXT GENERATION™ Anterior Cervical Plate system is intended for use in anterior cervical decompression and fusion (ACDF) surgery (C2-C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of fusion in patients with the following conditions:
- degenerative disc disease(DDD) (defined as back pain of discogenic origin with I degeneration of the disc confirmed by history and radiographic studies)
- 트 spondylolisthesis
- trauma (i.e., fracture or dislocation) . ■
- 에 spinal stenosis
- pseudoarthrosis 예
- 트 tumor
- and failed previous fusion.
Prescription Use (Per 21 CFR 801.109) OR
Over-The Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Oarlare Buend
Division of General, Restorative, and Neurological Devices
Confidential and Propriatio(k) Number_
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