(59 days)
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No
The document describes a mechanical implant (anterior cervical plate system) and its intended use and performance testing. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is described as an Anterior Cervical Plate System intended for temporary stabilization of the anterior spine during the development of cervical spinal fusion, which addresses various medical conditions like degenerative disk disease, trauma, and tumors. This function indicates a therapeutic intent by supporting spinal healing and stability.
No
Explanation: The Medina ACP System is described as a system for anterior intervertebral screw fixation of the cervical spine, used for temporary stabilization during spinal fusion development. It consists of plates and screws and is indicated for various spinal conditions, but its function is mechanical stabilization, not diagnosis.
No
The device description explicitly states that the Medina ACP System consists of bone plates and screws manufactured from titanium alloy and commercially pure titanium, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The Medina ACP System is a surgical implant (bone plates and screws) intended for anterior intervertebral screw fixation of the cervical spine. It is used in vivo (within the body) to stabilize the spine during fusion.
- Lack of Diagnostic Function: The device does not perform any tests on biological samples to diagnose a condition or provide diagnostic information. Its function is purely mechanical and structural.
Therefore, the Medina ACP System falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Medina ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Medina ACP System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with the following indications:
- Degenerative disk disease (DDD) (defined by neck pain of discogenic origin with o degeneration of the disc confirmed by patient history and radiographic studies)
- Trauma (including fractures)
- o 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 Medina Anterior Cervical Plate System (ACP) System is intended for anterior screw fixation to the cervical spine. The Medina ACP system consists of a variety of shapes and sizes of bone plates and screws. The components are manufactured from titanium alloy (Ti 6Al 4V ELI) per ASTM F136 and commercially pure titanium per ASTM F67. Components of the Medina ACP System should not be used with components from any other system or manufacturer, with exception of the Cage Pins which are to be used only with Alliance Spine's Alamo C or Alamo C-Ti systems. The Medina ACP System components are provided non-sterile. The products need to be steam sterilized by the hospital prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Medina Anterior Cervical Plate System has been tested in the following test modes:
- Static compression bending per ASTM F1717 ●
- Static torsion per ASTM F1717
- Dynamic compression bending per ASTM F1717 ●
The results of this non-clinical testing show that the strength of the Medina Anterior Cervical Plates System is substantially equivalent to legally marketed predicate 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.
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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).
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§ 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
August 6, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below that.
Alliance Partners, LLC % Mr. Nathan Wright Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K201521
Trade/Device Name: Medina Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: June 5, 2020 Received: June 8, 2020
Dear Mr. Wright:
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 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
1
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 mediation-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
Colin O'Neill, M.B.E. Acting Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement on last page. |
|------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| 510(k) Number (if known)
K201521 | |
| Device Name | |
| Medina Anterior Cervical Plate System | |
| Indications for Use (Describe) | |
The Medina ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Medina ACP System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with the following indications:
- Degenerative disk disease (DDD) (defined by neck pain of discogenic origin with o degeneration of the disc confirmed by patient history and radiographic studies)
- Trauma (including fractures)
- o Tumors
- Deformities or curvatures (including kyphosis, lordosis, or scoliosis) ●
- Pseudoarthrosis ●
- Failed previous fusions ●
- Spondylolisthesis ●
- Spinal Stenosis ●
| 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) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
3
| Submitter's Name: | Alliance Partners, LLC |
|---|---|
| Submitter's Address: | 14206 Northbrook Drive |
| San Antonio, Texas 78232 | |
| Submitter's Telephone: | 210-314-2525 |
| Contact Person: | Nathan Wright MS |
| Empirical Testing Corp. | |
| 719-351-0248 | |
| nwright@empiricaltech.com | |
| Date Summary was Prepared: | June 5, 2020 |
| Trade or Proprietary Name: | Medina Anterior Cervical Plate System |
| Common or Usual Name: | Anterior Cervical Plate System |
| Classification: | Class II per 21 CFR §888.3060 |
| Product Code: | KWQ |
| Classification Panel: | Orthopedic and Rehabilitation Devices |
5.510(K) SUMMARY
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Medina Anterior Cervical Plate System (ACP) System is intended for anterior screw fixation to the cervical spine. The Medina ACP system consists of a variety of shapes and sizes of bone plates and screws. The components are manufactured from titanium alloy (Ti 6Al 4V ELI) per ASTM F136 and commercially pure titanium per ASTM F67. Components of the Medina ACP System should not be used with components from any other system or manufacturer, with exception of the Cage Pins which are to be used only with Alliance Spine's Alamo C or Alamo C-Ti systems. The Medina ACP System components are provided non-sterile. The products need to be steam sterilized by the hospital prior to use.
INDICATIONS FOR USE
The Medina ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Medina ACP System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with the following indications:
- Degenerative disk disease (DDD) (defined by neck pain of discogenic origin with ● degeneration of the disc confirmed by patient history and radiographic studies)
- Trauma (including fractures) ●
- Tumors ●
- o Deformities or curvatures (including kyphosis, lordosis, or scoliosis)
- Pseudoarthrosis ●
- Failed previous fusions ●
- Spondylolisthesis ●
- Spinal Stenosis ●
4
TECHNOLOGICAL CHARACTERISTICS
The Medina Anterior Cervical Plate System is made from titanium alloy per ASTM F136 and commercially pure titanium per ASTM F67. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates:
- . Indications for Use
- Materials of manufacture ●
- Structural support mechanism ●
- . Sizes
Table 5-1 Predicate Devices
| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Predicate Type |
|---|---|---|---|
| K141993 | Nakoma ACP | Alliance Partners, LLC | Primary |
| K060025 | Slimplicity Anterior Cervical Plate System | Spinal USA | Additional |
| K091936 | BladeTM Anterior Cervical Plate System | Nexxt Medical, Inc. | Additional |
PERFORMANCE DATA
The Medina Anterior Cervical Plate System has been tested in the following test modes:
- Static compression bending per ASTM F1717 ●
- Static torsion per ASTM F1717
- Dynamic compression bending per ASTM F1717 ●
The results of this non-clinical testing show that the strength of the Medina Anterior Cervical Plates System is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Medina Anterior Cervical Plate System is substantially equivalent to the predicate device.