(15 days)
Not Found
No
The provided text describes a physical medical device (an interbody fusion system) and its materials, dimensions, and intended use. There is no mention of software, algorithms, data processing, or any terms related to AI or ML.
Yes
The device is used for intervertebral body fusion procedures to treat degenerative disc disease and spondylolisthesis, which are conditions requiring therapeutic intervention.
No
The device is an interbody fusion system used for surgical implantation, not for diagnosing medical conditions.
No
The device description clearly details physical components made of titanium and PEEK, indicating it is a hardware medical device, not software-only.
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, such as blood, urine, or tissue, to provide information about a person's health.
- Device Description: The OPTIMUS Anterior Lumbar Interbody Fusion (ALIF) System is a surgical implant designed to be placed inside the body to fuse vertebrae. It is a physical device used in a surgical procedure, not a test performed on a sample outside the body.
- Intended Use: The intended use is for intervertebral body fusion procedures, which is a surgical intervention, not a diagnostic test.
Therefore, based on the provided information, the OPTIMUS Anterior Lumbar Interbody Fusion (ALIF) System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The OPTIMUS Anterior Lumbar Interbody Fusion (ALIF) System is indicated for intervertebral body fusion procedures at one or two contiguous levels (L2-Sl) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis at the involved levels. The patient should be skeletally mature and have had six months of non-operative treatment.
The OPTIMUS Anterior Lumbar Interbody Fusion (ALIF) System is a stand-alone system intended to be used with bone screws, autogenous bone graft and requires no additional supplementary fixations. One device is used per intervertebral space.
Product codes (comma separated list FDA assigned to the subject device)
OVD
Device Description
The Optimus Anterior Lumbar Interbody Fusion (ALIF) system is a zero profile stand-alone interbody that combines the benefits of an anterior fixation plate and fusion device. Optimus is a modular design that consists of a center fixation plate, lordotic end caps and three bone screws for anterior fixation and stability. The bone screws thread into the fixation plate and pass through the superior and inferior openings of the end caps to fixate the implant with the adjacent vertebral bodies.
OPTIMUS is available in a variety of heights (9-13mm posterior), angles (6 to 14 degrees) and two footprints to accommodate variations in patient anatomy. The fixation plates are manufactured from Titanium (ASTM F136), and the end caps are available in PEEK (ASTM F2026) and titanium (Ti-6Al-4V, ASTM F136), and are plasma sprayed with CPtitanium (ASTM F1580). The bone screws manufactured from Titanium (ASTM F136) are Ø5mm and are available in lengths from 24 to 32mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Discogenic origin (L2-S1)
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)
Cleaning and steam sterilizations were performed to verify method suitability.
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
§ 888.3080 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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 18, 2016
Amendia, Incorporated % Kristen Allen Senior Regulatory Affairs Specialist 1755 West Oak Parkway Marietta, Georgia 30062
Re: K160291
Trade/Device Name: Optimus ALIF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: February 1, 2016 Received: February 3, 2016
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 Part 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" (21 CFR 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
2
Indications for Use
510(k) Number (if known)
K160291
Device Name Optimus ALIF System
Indications for Use (Describe)
The OPTIMUS Anterior Lumbar Interbody Fusion (ALIF) System is indicated for intervertebral body fusion procedures at one or two contiguous levels (L2-Sl) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis at the involved levels. The patient should be skeletally mature and have had six months of non-operative treatment.
The OPTIMUS Anterior Lumbar Interbody Fusion (ALIF) System is a stand-alone system intended to be used with bone screws, autogenous bone graft and requires no additional supplementary fixations. One device is used per intervertebral space.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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 shows the logo for AMENDIA. The logo is in blue and consists of the word "AMENDIA" in a sans-serif font. To the left of the word is a blue square with the letter "A" in white. Below the word "AMENDIA" is the tagline "creating balanced solutions" in a smaller, lighter blue font.
510(k) Summary Optimus
| 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) |
Date Prepared: February 7, 2016
Trade Name: Optimus ALIF System
Device Product Code OVD, 888.3080, Class II, Intervertebral body fusion device and Classification:
kallen@amendia.com (e-mail)
Primary Predicate Device: Optimus ALIF System (K132596)
Purpose of Submission: This special 510(k) is intended to gain clearance for a modification to the Optimus Stand-Alone ALIF System, specifically for the trial distractor instrument.
Device Description:
The Optimus Anterior Lumbar Interbody Fusion (ALIF) system is a zero profile stand-alone interbody that combines the benefits of an anterior fixation plate and fusion device. Optimus is a modular design that consists of a center fixation plate, lordotic end caps and three bone screws for anterior fixation and stability. The bone screws thread into the fixation plate and pass through the superior and inferior openings of the end caps to fixate the implant with the adjacent vertebral bodies.
OPTIMUS is available in a variety of heights (9-13mm posterior), angles (6 to 14 degrees) and two footprints to accommodate variations in patient anatomy. The fixation plates are manufactured from Titanium (ASTM F136), and the end caps are available in PEEK (ASTM F2026) and titanium (Ti-6Al-4V, ASTM F136), and are plasma sprayed with CPtitanium (ASTM F1580). The bone screws manufactured from Titanium (ASTM F136) are Ø5mm and are available in lengths from 24 to 32mm.
Indications and Intended use:
The OPTIMUS Anterior Lumbar Interbody Fusion (ALIF) System is indicated for intervertebral body fusion procedures at one or two contiguous levels (L2-SI) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with deqeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis at
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the involved levels. The patient should be skeletally mature and have had six months of non-operative treatment.
The OPTIMUS Anterior Lumbar Interbody Fusion (ALIF) System is a stand-alone system intended to be used with bone screws, autogenous bone graft and requires no additional supplementary fixations. One device is used per intervertebral space.
Summary of Technological Characteristics:
There are no changes being proposed for the Subject Device with respect to intended use, design, material composition, and function. The only change being proposed for the currently marketed device is a change in sterilization status for the Trial Distractor instrument (Class I).
Summary of Performance Testing:
Cleaning and steam sterilizations were performed to verify method suitability.
Conclusion:
Based on comparison to the predicate device, the Subject Device has been shown to be substantially equivalent.