(107 days)
Not Found
No
The device description focuses on the mechanical components (plates, screws, instrumentation) and their material and design features. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are based on mechanical testing, not algorithmic performance.
Yes.
The device is intended for temporary stabilization of the anterior spine during the development of cervical spine fusion, which is used to treat various medical conditions like degenerative disk disease, trauma, tumors, and deformities. These applications align with the definition of a therapeutic device as they are used to treat or manage a disease or condition.
No
The device description clearly states it is a surgical implant designed for "anterior intervertebral screw fixation of the cervical spine" and "support and structural stability" during spinal fusion surgery. It is a therapy device, not a diagnostic one.
No
The device description explicitly states it consists of plates and screws made of titanium alloy, which are hardware components.
Based on the provided information, the Nakoma ACP System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "anterior intervertebral screw fixation of the cervical spine" and "temporary stabilization of the anterior spine during the development of cervical spine fusion." This describes a surgical implant used directly on a patient's body.
- Device Description: The description details plates and screws made of titanium alloy, designed for surgical implantation.
- 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 compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. The Nakoma ACP System is an in vivo (inside the body) surgical implant.
N/A
Intended Use / Indications for Use
The Nakoma ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Nakoma ACP System is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusion in patents with the following indications:
• Degenerative Disk Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• Trauma (including fractures)
• Tumors
• Deformities or curvatures (including kyphosis, lordosis or scoliosis)
• Pseudoarthrosis
• Failed previous fusions
• Spondylolisthesis
• Spinal Stenosis
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Nakoma Anterior Cervical Plating (ACP) system is used for spinal fusion surgery to provide support and structural stability. The system consists of a variety of plates and screws, all of which are manufactured from titanium alloy per ASTM F136. Instrumentation necessary for proper implantation is also included.
The plates are available in a range of lengths in Levels 1-5 and feature windows to aid in visualization and locking clips to assist in screw retention. The screws are available in multiple lengths and diameters, feature self-tapping and self-drilling designs and are able to be placed on-axis and at various angles (15° medial/lateral, 10° cephalad/caudal).
The purpose of this submission is to gain initial marketing authorization in the United States.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine at levels C2-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)
Non-clinical testing: Testing in accordance with ASTM F1717 (i.e., static compression, static torsion, dynamic compression) was conducted and the subject devices were found to perform equivalently to the predicates.
Clinical testing: Clinical testing was not required to demonstrate substantial equivalence in this premarket notification.
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
Image /page/0/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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 6, 2014
Alliance Partners, LLC % Ms. Kellen Hills Quality & Regulatory Consultant Orchid Design 4600 East Shelby Drive Memphis, Tennessee 38118
Re: K141993
Trade/Device Name: Nakoma ACP System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: August 8, 2014 Received: August 11, 2014
Dear Ms. Hills:
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
1
Page 2 - Ms. Kellen Hills
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K141993
Device Name Nakoma ACP system
Indications for Use (Describe)
| spine fusion in patents with the following indications: |
|---|
| --------------------------------------------------------- |
| • Degenerative Disk Disease | (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) |
|---|---|
| • Trauma | (including fractures) |
| • Tumors | |
| • Deformities or curvatures | (including kyphosis, lordosis or scoliosis) |
| • Pseudoarthrosis | |
| • Failed previous fusions | |
| • Spondylolisthesis | |
| • Spinal Stenosis |
The Nakoma ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Nakoma ACP System is indicated for temporary stabilization of the auting the development of cervical
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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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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| (a)(1) | Submitted By: | Alliance Partners, LLC |
|---|---|---|
| 14206 Northbrook Dr. | ||
| San Antonio, TX 78232 | ||
| Phone: | 210-314-2525 | |
| Fax: | 210-314-2524 | |
| Date: | November 6, 2014 | |
| Contact Persons | ||
| Primary: | Kellen Hills (Orchid Design Consulting) | |
| Secondary: | Frank Morris (Alliance Partners, LLC) | |
| (a)(2) | Proprietary Name: | Nakoma ACP |
| Common Name: | Anterior Cervical Plate | |
| Classification Name and Reference: | 21CFR 888.3060 - Spinal intervertebral body | |
| fixation orthosis | ||
| Product Code: | KWQ | |
| (a)(3) | Predicate Devices: |
Device Description: (a)(4)
The Nakoma Anterior Cervical Plating (ACP) system is used for spinal fusion surgery to provide support and structural stability. The system consists of a variety of plates and screws, all of which are manufactured from titanium alloy per ASTM F136. Instrumentation necessary for proper implantation is also included.
The plates are available in a range of lengths in Levels 1-5 and feature windows to aid in visualization and locking clips to assist in screw retention. The screws are available in multiple lengths and diameters, feature self-tapping and self-drilling designs and are able to be placed on-axis and at various angles (15° medial/lateral, 10° cephalad/caudal).
The purpose of this submission is to gain initial marketing authorization in the United States.
(a)(5) Indications for Use:
The Nakoma ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Nakoma ACP System is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusion in patents with the following indications:
- Degenerative Disk Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- Trauma (including fractures)
- Tumors
- Deformities or curvatures (including kyphosis, lordosis or scoliosis)
- · Pseudoarthrosis
- Failed previous fusions
- Spondylolisthesis
4
- Spinal Stenosis
- (a)(6) Comparison of Technological Characteristics:
- The fundamental scientific technology, materials of construction and mechanism of operation is the same between the subject Nakoma ACP and predicate Regent ACP device. Both are intervertebral fusion devices, designed to provide support and stabilization in order to achieve fusion between adjacent vertebrae. Both subject and predicate devices are made from titanium alloy and incorporate retention clips and multiple screw options. Both subject and predicate devices offer plates and screws in comparable size ranges. Both devices utilize instrumentation common to spinal fusion surgery.
Additionally, Aesculap's QUINTEX system was used as a dimensional predicate for the Level 5 plates of the subject Nakoma ACP system.
- (b)(1) Non-clinical testing:
Testing in accordance with ASTM F1717 (i.e., static compression, static torsion, dynamic compression) was conducted and the subject devices were found to perform equivalently to the predicates.
(b)(2) Clinical testing:
Clinical testing was not required to demonstrate substantial equivalence in this premarket notification.
(b)(3) Conclusions:
Based on the information provided in this premarket notification and the details specified in FDA guidance "Spinal System 510(k)s", we believe that the subject Nakoma ACP system is as safe, as effective, and performs as well as or better than the predicate devices.