(98 days)
No
The device description focuses on materials and mechanical components, and there is no mention of AI, ML, image processing, or data sets for training or testing.
No
The device is an implantable surgical device used to facilitate spinal fusion in patients with degenerative disc disease. While it addresses a medical condition, its primary function is structural support and fusion, not direct therapeutic action like drug delivery or energy emission for treatment.
No
This device is a stand-alone anterior cervical interbody fusion device, used for surgical treatment of degenerative disc disease, not for diagnosing it. The description focuses on its use as an implant and its physical components, not on any diagnostic capabilities.
No
The device description explicitly lists physical components made of PEEK, Tantalum, and Titanium, including a spacer, plate, and screws. This indicates it is a hardware medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion, specifically addressing degenerative disc disease. This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a physical implant made of PEEK, Tantalum, and Titanium, designed to be surgically placed in the cervical spine. This is consistent with a medical device for implantation, not a diagnostic reagent or instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on in vitro testing.
In summary, the Amendia Stand-Alone Cervical System is a surgical implant used for treatment, not a device used for diagnosis outside the body.
N/A
Intended Use / Indications for Use
The Amendia Stand-Alone Cervical System is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Amendia Stand-Alone Cervical implant should be packed with autogenous bone graft and implanted with an anterior approach.
Product codes
OVE
Device Description
The Amendia Stand-Alone Cervical System includes a PEEK spacer component (medical grade Zeniva ZA-500, ASTM F2026) with Tantalum markers (ASTM F560), and a titanium interbody plate and screws (ASTM F136). The spacer component is assembled to the interbody plate and implanted anteriorly. The endplate contacting surfaces of the spacer component include serrations, and the plate component includes two holes for inserting one bone screw in each vertebral body. The plate component also includes a screw lock at each hole. The bone screws are available in a variety of diameters and lengths. The interbody plate components are available in a variety of heights. The spacer components are available in a variety of depths, widths, and heights.
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
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)
Performance testing was not necessary since the Subject and Predicate Devices are identical with regards to intended use, indications for use, materials, manufacturing processes, and performance specifications.
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
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, interconnected design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the profile graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 14, 2016
Amendia, Incorporated Ms. Kristen Allen Senior Regulatory Affairs Specialist 1755 West Oak Parkway Marietta, Georgia 30062
Re: K152972
Trade/Device Name: Amendia Stand-Alone Cervical System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: December 17, 2015 Received: December 21, 2015
Dear Ms. Allen:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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/ResourcesforYou/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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Page 1 of 1
510(k) Number (if known)
Device Name Amendia Stand-Alone Cervical System
Indications for Use (Describe)
The Amendia Stand-Alone Cervical System is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Amendia Stand-Alone Cervical implant should be packed with autogenous bone graft and implanted with an anterior approach.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unl ess it displays a currently valid OMB number."
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Image /page/3/Picture/0 description: The image shows the logo for AMENDIA. The logo consists of the word "AMENDIA" in a sans-serif font, with the "A" in a blue square. Below the word "AMENDIA" is the tagline "creating balanced solutions" in a smaller font.
510(k) Summary
Amendia Stand-Alone Cervical System
| Submitter: | Amendia, Inc.
1755 W. Oak Parkway
Marietta, GA 30062 |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kristen Allen
Sr. Regulatory Affairs Specialist
910-612-4153 (P), 877-420-1213 (F)
kallen@amendia.com (e-mail) |
| Date Prepared: | January 13, 2016 |
| Trade Name: | Amendia Stand-Alone Cervical System |
| Common Name: | Intervertebral Body Fusion Device with Integrated Fixation,
Cervical |
| Device Product Code
and Classification: | OVE, Class II (§888.3080) |
| Primary Predicate: | Zavation Z-Link Cervical System (K141005) |
Device Description:
The Amendia Stand-Alone Cervical System includes a PEEK spacer component (medical grade Zeniva ZA-500, ASTM F2026) with Tantalum markers (ASTM F560), and a titanium interbody plate and screws (ASTM F136). The spacer component is assembled to the interbody plate and implanted anteriorly. The endplate contacting surfaces of the spacer component include serrations, and the plate component includes two holes for inserting one bone screw in each vertebral body. The plate component also includes a screw lock at each hole. The bone screws are available in a variety of diameters and lengths. The interbody plate components are available in a variety of heights. The spacer components are available in a variety of depths, widths, and heights.
Indications and Intended use:
The Amendia Stand-Alone Cervical System is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Amendia Stand-Alone Cervical implant should be packed with autogenous bone graft and implanted with an anterior approach.
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Image /page/4/Picture/0 description: The image contains the logo for AMENDIA. The logo is in blue and features the word "AMENDIA" in a bold, sans-serif font. Below the word "AMENDIA" is the tagline "creating balanced solutions" in a smaller, lighter font. The logo is simple and modern, and the blue color gives it a professional and trustworthy feel.
Summary of Technological Characteristics:
The Amendia Stand-Alone Cervical System is substantially equivalent to predicate devices cleared by FDA for commercial distribution in the United States. The Subject Device was shown to be identical to the predicate device in terms of design, intended use, performance specifications, material specifications, and technological characteristics.
Summary of Performance Testing:
Performance testing was not necessary since the Subject and Predicate Devices are identical with regards to intended use, indications for use, materials, manufacturing processes, and performance specifications.
Conclusion:
Based on the comparison to predicate device, the Amendia Stand-Alone Cervical System has been shown to be substantially equivalent to the legally marketed predicate device.