(210 days)
No
The summary describes a physical implant and surgical instruments, with no mention of AI/ML terms or image processing.
Yes
The device is a lumbar interbody fusion system designed for spinal fusion, which is a therapeutic intervention for degenerative disc disease.
No
Explanation: The provided text describes a surgical implant system for lumbar spinal fusion, not a device used to identify a medical condition or disease. Its purpose is treatment, not diagnosis.
No
The device description explicitly states that the system consists of instruments and Titanium Alloy implants, which are physical 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: The provided text describes a surgical implant (Lumbar Interbody Fusion System) made of titanium alloy, intended to be surgically placed in the lumbar spine to facilitate bone fusion.
- Intended Use: The intended use is for intervertebral body fusion in the lumbar spine, a surgical procedure.
- No Mention of Samples or Testing: There is no mention of the device being used to test samples from the body or provide diagnostic information.
This device is a surgical implant used in a therapeutic procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This system is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
Product codes
MAX
Device Description
The Lumbar Interbody Fusion System consists of instruments and Titanium Alloy (Ti-6Al-4V per ASTM F136) implants which will be offered in twenty-four (24) size configurations to accommodate individual patient anatomy. The implants are designed to facilitate a specific surgical technique, the Oblique Lateral Lumbar approach (OLLIF). The implants are single use and the system is provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine, from L2 to 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)
Static and dynamic axial compression following ASTM F2077-14. Subsidence was tested following ASTM F2267-04. The above listed pre-clinical testing on the Subject device indicate that the Lumbar Interbody Fusion System is substantially equivalent to the 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
§ 888.3080 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/0 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Advanced Research Medical, LLC % James A. Dunning Principal OPC Services, LLC 537 N. Spencer Mesa, Arizona 85203
Re: K173947
Trade/Device Name: Lumbar Interbody Fusion System (OLLIF) Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: June 20, 2018 Received: June 28, 2018
Dear James A. Dunning:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
July 25, 2018
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Page 2 - James A. Dunning
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Brent Showalter -S
for 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) K173947
Device Name Lumbar Interbody Fusion System (OLLIF)
Indications for Use (Describe)
This system is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate 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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Lumbar Interbody Fusion System (OLLIF) Premarket Notification 510(k) Summary
| DATE PREPARED | 07/18/2018 |
|---|---|
| MANUFACTURER | Advanced Research Medical, LLC |
| 1519 Highway 13 East | |
| Burnsville, MN 55337 | |
| CONTACT PERSON | John D Siegel |
| CEO | |
| 610-457-5324 | |
| John.siegel@amwspine.com | |
| PANEL CODE | Orthopaedics/87 |
| CLASSIFICATION NAME | MAX 888.3080 - Intervertebral Fusion Device with |
| Bone Graft, Lumbar | |
| CLASS | Class II |
| COMMON NAME | Intervertebral Body Fusion Device, Lumbar (MAX) |
| TRADE NAME | Lumbar Interbody Fusion System (OLLIF) |
| PRIMARY PREDICATE DEVICE | Python Interbody Fusion Device, Eminent Spine |
| (K090064) | |
| REFERENCE PREDICATE DEVICE | Buttress (Fang) Plate System, Eminent Spine |
| (K090415) |
DEVICE DESCRIPTION
The Lumbar Interbody Fusion System consists of instruments and Titanium Alloy (Ti-6Al-4V per ASTM F136) implants which will be offered in twenty-four (24) size configurations to accommodate individual patient anatomy. The implants are designed to facilitate a specific surgical technique, the Oblique Lateral Lumbar approach (OLLIF). The implants are single use and the system is provided non-sterile.
INDICATIONS and INTENDED USE
Intervertebral Body Fusion Device:
This system is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
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TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
Documentation was provided to demonstrate that the Subject Lumbar Interbody Fusion System is substantially equivalent to the predicate devices: Python Interbody Fusion Device (K090064) and Buttress (Fang) Plate System (K090415). The Subject devices are substantially equivalent to the predicate device in intended use, indications for use, materials, technological characteristics, and labelling.
PERFORMANCE DATA
Static and dynamic axial compression following ASTM F2077-14. Subsidence was tested following ASTM F2267-04. The above listed pre-clinical testing on the Subject device indicate that the Lumbar Interbody Fusion System is substantially equivalent to the predicate devices.
CONCLUSION
The Lumbar Interbody Fusion System and its predicate(s) have the same intended use, to provide mechanical stability in the lumbar disc space to facilitate biologic fusion. The indications for use of the Subject device are identical to those of the predicate device. Minor differences between the Subject and predicate devices do not raise any new questions of safety or efficacy. Bench testing demonstrated that the differences do not adversely impact device mechanical performance. Based on the intended use, indications for use, technological characteristics, and comparison to the predicate devices, the Lumbar Interbody Fusion System has been shown to be substantially equivalent to legally marketed predicate devices.