(72 days)
Not Found
No
The summary describes a mechanical implant system and its performance testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes.
The device is intended for anterior cervical fixation to treat various medical conditions, including degenerative disc disease, spondylolisthesis, trauma, and spinal stenosis. This directly impacts the structure and function of the human body for medical purposes.
No
Explanation: The provided text describes the Exactech Ambassador™ Cervical Plate System as an implant used for anterior cervical fixation. Its function is to provide stabilization for various spinal conditions, not to diagnose them.
No
The device description explicitly states it consists of bone plates and screws made from titanium alloy, which are hardware components.
No, 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 provided information clearly describes a surgical implant (a cervical plate system) used for fixation in the cervical spine. It is a physical device implanted in the body, not a test performed on a sample outside the body.
The description focuses on the mechanical properties and surgical application of the device, which is characteristic of a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Exactech Ambassador™ Cervical Plate System is intended for anterior cervical fixation (C2-T1) 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, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Product codes
KWQ
Device Description
The Ambassador™ Cervical Plate System consists of a variety of bone plates and screws. Fixation is achieved by inserting bone screws through the openings in the plate into the vertebral bodies of the cervical spine. The Ambassador™ Cervical Plate System implant components are made from titanium alloy such as described by ASTM F136. Plates and screws are provided nonsterile with instructions for sterilization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (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)
The Ambassador™ Cervical Plate System has been tested in the following test modes:
- Static axial compression bending per modified ASTM F1717-13
- Static torsion per modified ASTM F1717-13
- Dynamic axial compression bending fatigue per modified ASTM F1717-13
The results of this non-clinical testing show that the strength of the Ambassador™ Cervical Plate System is sufficient for its intended use and is substantially equivalent to legally marketed 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
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked one behind the other. The faces are rendered in a simple, abstract style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 27, 2015
Exactech, Incoporated % Kenneth C. Maxwell II Regulatory and Quality Specialist Empirical Consulting 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K143576
Trade/Device Name: Exactech Ambassador™ Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: December 16, 2014 Received: December 18, 2014
Dear Mr. Maxwell:
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
1
Page 2 - Mr. Kenneth Maxwell
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K143576
Device Name Exactech Ambassador™
Indications for Use (Describe)
The Exactech Ambassador™ Cervical Plate System is intenor cervical fixation (C2-T1) 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, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e.. scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
| 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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5.510(K) SUMMARY
| Submitter's Name: | Exactech, Inc. |
|---|---|
| Submitter's Address: | 2320 NW 66th Court |
| Gainesville, FL 32658 | |
| Submitter's Telephone: | 352.377.1140 |
| Contact Person: | Kenneth C. Maxwell |
| Empirical Testing Corp. | |
| 719.291.6874 | |
| Date Summary was Prepared: | 20 February 2015 |
| Trade or Proprietary Name: | Exactech Ambassador™ |
| Common or Usual Name: | Anterior Cervical Plate System |
| Classification: | Class II per 21 CFR §888.3060 Spinal Intervertebral Body |
| Fixation Orthosis | |
| Product Code: | KWQ |
| Classification Panel: | Orthopaedic and Rehabilitation Devices Panel |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Ambassador™ Cervical Plate System consists of a variety of bone plates and screws. Fixation is achieved by inserting bone screws through the openings in the plate into the vertebral bodies of the cervical spine. The Ambassador™ Cervical Plate System implant components are made from titanium alloy such as described by ASTM F136. Plates and screws are provided nonsterile with instructions for sterilization.
INDICATIONS FOR USE
The Exactech Ambassador™ Cervical Plate System is intended for anterior cervical fixation (C2-T1) 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, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
TECHNOLOGICAL CHARACTERISTICS
The Ambassador™ Cervical Plate System is made from titanium that conforms to F136. 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 the same between the subject and predicates:
- Indications for Use
- Materials of manufacture
- Structural support mechanism .
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Table 5-1 Predicate Devices
| 510k
Number | Trade or Proprietary or Model Name | Manufacturer | Predicate
Type |
|----------------|-------------------------------------------------|--------------|-------------------|
| K071667 | VECTRA ACP | Synthes | Primary |
| K042798 | C-TEK™ C-Thru Anterior Cervical Plate
System | Interpore | Additional |
| K070891 | Classic ACP System | Altiva® | Additional |
Performance Data
The Ambassador™ Cervical Plate System has been tested in the following test modes:
- Static axial compression bending per modified ASTM F1717-13 .
- . Static torsion per modified ASTM F1717-13
- Dynamic axial compression bending fatigue per modified ASTM F1717-13 ●
The results of this non-clinical testing show that the strength of the Ambassador™ Cervical Plate System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Ambassador™ Cervical Plate System is substantially equivalent to the predicate device.