(113 days)
Not Found
No
The 510(k) summary describes a mechanical intervertebral body fusion device and its materials, intended use, and performance testing. There is no mention of AI or ML technology in the device description, intended use, or performance studies.
Yes.
The device is an intervertebral body fusion device indicated for treating degenerative disc disease, which falls under the definition of a therapeutic intervention.
No
Explanation: The Rampart One device is an intervertebral body fusion device designed for spinal stabilization and fusion, not for diagnosing medical conditions. It is a therapeutic implant used for treatment rather than diagnosis.
No
The device description clearly states it is an intervertebral body fusion device manufactured from physical materials (PEEK-OPTIMA HA Enhanced, titanium alloy, tantalum) and includes integrated fixation in the form of screws. This indicates a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Rampart One device is an implantable medical device designed for surgical implantation into the lumbar spine to facilitate bone fusion. It is a physical device used in the body, not a test performed on samples from the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or diagnostic purposes. Its function is structural support and promoting fusion.
Therefore, the Rampart One device falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The standard and oblique Rampart One devices are integrated intervertebral body fusion devices indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and had six months non-operative treatment. The standard and oblique Rampart One devices are designed for use with autograft and/or allograft comprised of cancellous bone graft.
The standard Rampart One device may be used with or without supplemental fixation systems cleared by FDA for use in the lumbar spine. When used without supplemental fixation, the standard Rampart One device must be used with four (4) screws.
The oblique Rampart One device must be used with supplemental fixation systems cleared by FDA for use in the lumbar spine.
Product codes
OVD
Device Description
Rampart One implants are intervertebral body fusion devices for use with bone graft in the intervertebral disc space to stabilize spinal segments as an adjunct to fusion. These devices are manufactured from PEEK-OPTIMA HA Enhanced (spacer), titanium alloy (face plate), and tantalum (radiopaque markers) materials. Rampart One devices incorporate integrated fixation in the form of titanium alloy screws. Rampart One devices are provided in standard and oblique configurations. The standard device accommodates four screws and the oblique device accommodates two screws. In each device, the screws are inserted through the anteriorly-located face plate into the adjacent vertebral bodies. Rampart One devices are provided in various heights and lordotic angles and contain a hollow core to receive autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Placement is achieved with an insertion instrument that allows for manipulation of the implant in the intervertebral disc space.
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
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 Testing:
New performance testing was not performed or required to support the modifications for use statement. The initial performance testing conducted for the Rampart One device remains valid and the data obtained provides reasonable assurance of the safety and effectiveness of the Rampart One device when used within the context and limitations of the intended use.
The previously conducted performance testing established conformance to the following:
ASTM F2077 - Static and Dynamic Compression, Subsidence
ASTM 2267 - Axial Pullout
ASTM F543-13 - Static and Dynamic Compression Shear, Anti-Screw Backout, Expulsion
Bacterial Endotoxin Testing (BET) conducted in accordance with ANSI/AAMI FT-72:2011
Clinical Testing:
A review of published clinical data for stand-alone anterior lumbar intervertebral body fusion devices with integrated fixation was provided in support of this application. The published clinical outcomes demonstrate that the use of such devices to treat patients with disc disease, as defined above, poses no new risks to patients. No new components were added to the Rampart One system, nor were any substantive design changes made to the existing devices; therefore, clinical testing was not required or performed to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K163670 Rampart™ One Lumbar Interbody Fusion Device (Spineology Inc.), K150673 SYNFIX™ Evolution Secured Spacer System (Synthes Spine)
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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April 25, 2018
Spineology Inc. Jacqueline Hauge Regulatory Affairs Manager 7800 3rd Street N.. Suite 600 St. Paul, Minnesota 55128
Re: K180002
Trade/Device Name: Rampart™ One Lumbar Interbody Fusion Device Regulation Number: 21 CFR 888,3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: March 23, 2018 Received: March 26, 2018
Dear Ms. Hauge:
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 (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.
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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.
For comprehensive regulatory information about medical devices and radiation-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,
Vincent J. Devlin -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) K180002
Device Name
Rampart™ One Lumbar Interbody Fusion Device
Indications for Use (Describe)
The standard and oblique Rampart One devices are integrated intervertebral body fusion devices indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and had six months non-operative treatment. The standard and oblique Rampart One devices are designed for use with autograft and/or allograft comprised of cancellous bone graft.
The standard Rampart One device may be used with or without supplemental fixation systems cleared by FDA for use in the lumbar spine. When used without supplemental fixation, the standard Rampart One device must be used with four (4) screws.
The oblique Rampart One device must be used with supplemental fixation systems cleared by FDA for use in the lumbar spine.
| 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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510(k) Summary
Inc.)
| Date Prepared: | April 19, 2018 |
|---|---|
| Submitter: | Spineology Inc. |
| 7800 3rd Street North | |
| Suite 600 | |
| Saint Paul, MN 55128 | |
| Establishment Registration Number: 2135156 | |
| Contact Person: | Jacqueline A. Hauge |
| Regulatory Affairs Manager | |
| Phone: 651.256.8534 | |
| Fax: 651.256.8500 | |
| Email: jhauge@spineology.com | |
| Device Name and Classification | |
| Trade Name: | Rampart™ One Lumbar Interbody Fusion Device |
| Common Name: | Intervertebral fusion device with integrated fixation |
| Classification Name: | OVD |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 888.3080 |
| Panel: | Orthopedic |
| Predicate Devices | |
| Primary: | K163670 Rampart™ One Lumbar Interbody Fusion Device (Spineology |
| Additional: | K150673 SYNFIX™ Evolution Secured Spacer System (Synthes Spine) |
Purpose of Submission A.
The purpose of this submission is to expand the indications for use statement to allow the option to use the standard Rampart One implantable device as a stand-alone Anterior Lumbar Interbody Fusion (ALIF) device (without supplemental fixation systems cleared by FDA for use in the lumbar spine).
B. Device Description
Rampart One implants are intervertebral body fusion devices for use with bone graft in the intervertebral disc space to stabilize spinal segments as an adjunct to fusion. These devices are manufactured from PEEK-OPTIMA HA Enhanced (spacer), titanium alloy (face plate), and tantalum (radiopaque markers) materials. Rampart One devices incorporate integrated fixation in the form of titanium alloy screws. Rampart One devices are provided in standard and oblique configurations. The standard device accommodates four screws and the oblique device accommodates two screws. In each device, the screws are inserted through the anteriorly-located face plate into the adjacent vertebral bodies. Rampart One devices are provided in various heights and lordotic angles and contain a hollow core to receive autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Placement is achieved with an insertion instrument that allows for manipulation of the implant in the intervertebral disc space.
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C. Indications for Use
The standard and oblique Rampart One devices are integrated intervertebral body fusion devices indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months non-operative treatment. The standard and oblique Rampart One devices are designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
The standard Rampart One device may be used with or without supplemental fixation using fixation systems cleared by FDA for use in the lumbar spine. When used without supplemental fixation, the standard Rampart One device must be used with four (4) screws.
The oblique Rampart One device must be used with two (2) screws and with supplemental fixation systems cleared by FDA for use in the lumbar spine.
D. Comparison to Predicate Device
There have been no design changes to the standard and oblique Rampart One devices since there last clearance; therefore, when compared to the predicate device, the Rampart One Lumbar Interbody Fusion Device has the same:
- Intended Use
- Indications for Use
- Fundamental Scientific Technology
- Principle of Operation
- Materials ●
- Biocompatibility
- Size Offering
E. Non-Clinical Testing
New performance testing was not performed or required to support the modifications for use statement. The initial performance testing conducted for the Rampart One device remains valid and the data obtained provides reasonable assurance of the safety and effectiveness of the Rampart One device when used within the context and limitations of the intended use.
The previously conducted performance testing established conformance to the following:
ASTM F2077
ASTM 2267
ASTM F543-13
- Static and Dynamic Compression ●
• Subsidence
. Axial Pullout
- Static and Dynamic Compression Shear ●
Anti-Screw Backout
Expulsion Bacterial Endotoxin Testing (BET) conducted in accordance with ANSI/AAMI FT-72:2011
F. Clinical Testing
A review of published clinical data for stand-alone anterior lumbar intervertebral body fusion devices with integrated fixation was provided in support of this application. The published clinical outcomes demonstrate that the use of such devices to treat patients with disc disease, as defined above, poses no new risks to patients. No new components were added to the Rampart One system, nor were any substantive design changes made to the existing devices; therefore, clinical testing was not required or performed to support substantial equivalence.
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G. Conclusion
Based on the indications for use, technological characteristics, comparison to the predicate devices, and supportive literature review, Spineology has demonstrated that the Rampart One Lumbar Interbody Fusion Device is substantially equivalent to the legally marketed predicate device.