(132 days)
No
The summary describes a mechanical intervertebral body fusion device made of standard materials, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as an "integrated intervertebral body fusion device" indicated for patients with degenerative disc disease, which aims to fuse spinal segments and stabilize them as an adjunct to fusion. This indicates a therapeutic intent to treat a medical condition.
No.
The provided text describes the Rampart One device as an "intervertebral body fusion device" designed to stabilize spinal segments and aid fusion, not to diagnose medical conditions.
No
The device description explicitly states that the Rampart One implants are manufactured from physical materials (PEEK-OPTIMA HA Enhanced, titanium alloy, tantalum) and incorporate integrated fixation in the form of titanium alloy screws. This indicates a physical hardware device, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "integrated intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine." This describes a surgical implant used to fuse vertebrae, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details the materials and design of a physical implant (spacer, face plate, screws) intended for surgical insertion into the spine. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the Rampart One device is a surgical implant, not an IVD.
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 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 and are intended for use with supplemental fixations 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 allov 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)
The following mechanical testing was conducted in accordance with FDA's Class II Special Controls Guidance Document: Intervertebral Fusion Device (2007) and applicable American Society for Testing and Materials (ASTM) standards:
ASTM F2077:
• Static and Dynamic Compression
• Static and Dynamic Compression Shear
ASTM F2267:
• Subsidence
ASTM F543-13:
• Axial Pullout
• Static and Dynamic Compression Shear
Anti-Screw Backout Expulsion Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K153082, K111880, K160906, K150321, K072253, K163543
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 8, 2017
Spineology Inc. Jacqueline A. Hauge Regulatory Affairs Manager 7800 3rd Street N., Suite 600 Saint Paul, Minnesota 55128
Re: K163670
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: April 10, 2017 Received: April 11, 2017
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
1
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,
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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K163670 Page 1 of 1
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 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 and are intended for use with supplemental fixations systems cleared by FDA for use in the lumbar spine.
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/1 description: The image shows the word "Spineology" in a bold, sans-serif font. To the right of the word is a purple graphic that looks like a cluster of dots arranged in a circular pattern. The logo appears to be for a company or organization named Spineology.
| Date Prepared: | May 3, 2017 |
|---|---|
| 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: 651.256.8505 | |
| Email: jhauge@spineology.com |
Device Name and Classification
| Trade Name: | Rampart One Lumbar Interbody Fusion Device |
|---|---|
| Common Name: | Intervertebral fusion device with integrated fixation |
| Product Codes: | OVD |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 888.3080 |
| Panel: | Orthopedic |
| Predicate Devices | ||
|---|---|---|
| Primary: | K153082 | Rampart A Lumbar Interbody Fusion Device (Spineology Inc.) |
| Additional: | K111880 | Rampart P Lumbar Interbody Fusion Device (Spineology Inc.) |
| K160906 | Rampart A, O, T Lumbar Interbody Fusion Devices (Spineology Inc.) | |
| K150321 | EVOS Lumbar Interbody Fusion Device (Cutting Edge Spine, LLC) | |
| K072253 | SynFix LR (Synthes Spine) | |
| K163543 | Durango Stand-Alone ALIF System (Biomet Spine) |
I. Purpose
The purpose of this premarket notification is to obtain initial 510(k) clearance of Spineology's Rampart One Lumbar Interbody Fusion Device.
II. Submission History
There have been no prior submissions submitted to FDA for the Rampart One Lumbar Interbody Fusion Device.
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III. 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 allov 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.
IV. 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 and are intended for use with supplemental fixation systems cleared by FDA for use in the lumbar spine.
V. Comparison to Predicate
When compared to the predicate devices, Rampart One Lumbar Interbody Fusion Device has the same or similar:
- Intended Use ●
- . Indications for Use
- . Fundamental Scientific Technology
- Principle of Operation
- Biological Safety ●
- Base Materials
- . Size Offering
VI. Non-Clinical Testing
The following mechanical testing was conducted in accordance with FDA's Class II Special Controls Guidance Document: Intervertebral Fusion Device (2007) and applicable American Society for Testing and Materials (ASTM) standards:
| ASTM F2077 | ASTM F2267 | ASTM F543-13 |
|---|---|---|
| • Static and Dynamic Compression | ||
| • Static and Dynamic Compression Shear | • Subsidence | • Axial Pullout |
- . Static and Dynamic Compression Shear
Anti-Screw Backout Expulsion Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.
VII. Conclusion
Spineology has demonstrated that the Rampart One Lumbar Interbody Fusion Device is substantially equivalent to the predicate devices.