(233 days)
Not Found
No
The document describes a physical implant device for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for intervertebral body spinal fusion procedures to treat degenerative disc disease, aiming to provide structural stability and alleviate pain, which are therapeutic interventions.
No
The device is an interbody fusion device, indicated for spinal fusion procedures by providing structural stability and maintaining disc space distraction. It treats a condition rather than diagnosing it.
No
The device description clearly states that the device is comprised of sterile, single-use implants fabricated from PEEK or Titanium alloy, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Amendia Lumbar Interbody Fusion Devices are implants designed to be surgically placed within the body to provide structural support and facilitate bone fusion in the spine.
- Intended Use: The intended use is for surgical procedures to treat degenerative disc disease by fusing vertebrae.
- No Specimen Analysis: The device itself does not analyze any biological specimens. While patient history and radios (radiographic studies) are used for diagnosis, the device's function is mechanical and structural, not diagnostic based on in vitro analysis.
Therefore, based on the provided information, the Amendia Lumbar Interbody Fusion Devices are not IVDs. They are surgical implants.
N/A
Intended Use / Indications for Use
The Amendia Lumbar Interbody Fusion Devices are indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. These DDD patients may also have up to Grade I spondylolisthesis at the involved level. Amendia Lumbar Interbody Fusion Devices are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The Amendia Interbody Fusion Devices are used to provide structural stability and maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. They are designed to be used in conjunction with supplemental spinal fixation instrumentation. The Subject Amendia Interbody Fusion Devices (LLIF and OLLIF) are multiple component systems comprised of sterile, single-use implants, designed to treat the lumbar spine.
The Subject Amendia Interbody Fusion System lumbar (LLIF and OLLIF) implants are fabricated from PEEK (ASTM F2026) with tantalum (ASTM F560) x-ray markers, or Titanium alloy (Ti6Al4V ELI, ASTM F136). The Amendia Interbody Fusion System implants are available in a range of sizes and shapes, and are designed to accommodate variations in surgical approach and patient anatomy. Each cage has a hollow center to allow placement of autograft. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2-S1 (lumbar spine)
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)
Non-clinical mechanical testing for the Subject Device was performed on the worst case subject device. Testing included static and dynamic axial compression and compression shear (ASTM F2077), subsidence (ASTM F2267), and expulsion testing. Performance testing demonstrated the Subject Device is substantially equivalent to the predicate device.
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.
K081614, K141665, K151472, K151322, K132700, K122989, K080281
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
§ 888.3080 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 and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other, representing health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 6, 2016
Amendia, Incorporated Ms. Kristen Allen Senior Regulatory Affairs Specialist 1755 West Oak Parkway Marietta, Georgia 30062
Re: K151310
Trade/Device Name: Amendia Interbody Fusion Devices Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: December 7, 2015 Received: December 8, 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/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,
Lori A. Wiggins -S
for 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)
K151310
Device Name Amendia Interbody Fusion Devices
Indications for Use (Describe)
The Amendia Lumbar Interbody Fusion Devices are indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. These DDD patients may also have up to Grade I spondylolisthesis at the involved level. Amendia Lumbar Interbody Fusion Devices are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
Type of Use (Select one or both, as applicable)
| ý Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image is a logo for Amendia. The logo features the word "AMENDIA" in a bold, sans-serif font, with the "A" in a blue square. Below the word "AMENDIA" is the tagline "creating balanced solutions" in a smaller, lighter font. The overall design is clean and modern.
510(k) Summary
Amendia Interbody Fusion Devices
| 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 5, 2016 | |
| Trade Name: | Amendia Interbody Fusion Devices | |
| Common Name: | Intervertebral body fusion device | |
| Device Product Code
and Classification: | MAX, 888.3080, Class II, Intervertebral Fusion
Device with Bone Graft, Lumbar | |
| Primary Predicate Device: | Zeus Intervertebral Fusion Devices (K081614) | |
| Additional Predicate Devices: | Nuvasive CoRoent System (K141665, K151472)
Amendia IBFD (K151322)
Medtronic Perimeter Interbody Fusion Device (K132700)
Biomet Lateral Spacer System (K122989)
Custom Spine Pathway (K080281) | |
Purpose of Submission: This 510(k) is intended to add additional LLIF (lateral) and OLLIF (obligue) implant models to the family of lumbar implants originally cleared in K081614.
Device Description:
The Amendia Interbody Fusion Devices are used to provide structural stability and maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. They are designed to be used in conjunction with supplemental spinal fixation instrumentation. The Subject Amendia Interbody Fusion Devices (LLIF and OLLIF) are multiple component systems comprised of sterile, single-use implants, designed to treat the lumbar spine.
The Subject Amendia Interbody Fusion System lumbar (LLIF and OLLIF) implants are fabricated from PEEK (ASTM F2026) with tantalum (ASTM F560) x-ray markers, or Titanium alloy (Ti6Al4V ELI, ASTM F136). The Amendia Interbody Fusion System implants are available in a range of sizes and shapes, and are designed to accommodate variations in surgical approach and patient anatomy. Each cage has a hollow center to allow placement of autograft. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion.
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Image /page/4/Picture/0 description: The image shows the logo for AMENDIA. The logo is in blue and consists of the word "AMENDIA" in a sans-serif font. The "A" is in a square. Below the word "AMENDIA" is the tagline "creating balanced solutions" in a smaller font.
Indications and Intended use:
The Amendia Lumbar Interbody Fusion Devices are indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiquous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. Amendia Lumbar Interbody Fusion Devices are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Summary of Technological Characteristics:
The subject devices are substantially equivalent to the predicate devices as well as other similar devices cleared by FDA for commercial distribution in the United States. The Subject Device was shown to have the same technological characteristics as its predicate devices through comparison of characteristics including design, intended use, material composition, and function, Both the subject and predicate lumbar devices are interbody devices designed to contain graff material and facilitate fusion between two vertebral bodies in the lumbar region of the spine.
Summary of Performance Testing:
Non-clinical mechanical testing for the Subject Device was performed on the worst case subject device. Testing included static and dynamic axial compression and compression shear (ASTM F2077), subsidence (ASTM F2267), and expulsion testing. Performance testing demonstrated the Subject Device is substantially equivalent to the predicate device.
Conclusion:
Based on the comparison to predicate devices, the Subject Device has been shown to be substantially equivalent to legally marketed predicate devices.