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.

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.

AI/ML Overview

Regarding the Rampart™ One Lumbar Interbody Fusion Device and its K180002 submission for expanded indications of use, the document states that no new performance or clinical testing was performed or required. Therefore, there are no specific new acceptance criteria or studies associated with this particular submission that prove new performance.

The document instead refers to previously conducted performance testing for the Rampart One device and a review of published clinical data for similar stand-alone devices.

Here's a breakdown based on the provided text, focusing on what is mentioned or not mentioned:

1. Table of Acceptance Criteria and Reported Device Performance

Since new performance testing was not conducted for this specific submission, there isn't a table of new acceptance criteria and device performance. The document states that the initial performance testing for the Rampart One device remains valid. That initial testing established conformance to the following standards:

Acceptance Criteria (Standards Conformed To)	Reported Device Performance
ASTM F2077 - Static and Dynamic Compression	Conformed
ASTM 2267 - Subsidence	Conformed
ASTM F543-13 - Axial Pullout	Conformed
Static and Dynamic Compression Shear	Conformed
Anti-Screw Backout	Conformed
Expulsion	Conformed
ANSI/AAMI FT-72:2011 - Bacterial Endotoxin Testing (BET)	Conformed

Note: The specific quantitative performance metrics (e.g., specific load values, displacement limits) for "conformed" are not provided in this summary but would have been part of the original K163670 submission's testing report.

2. Sample Size Used for the Test Set and Data Provenance

For Performance Testing: The sample sizes used for the initial performance testing (referenced but not detailed here) are not specified in this document. These would have been documented in the original K163670 submission.
For Clinical Data (Review): The document mentions a "review of published clinical data," which implies data collected retrospectively or prospectively from various studies. No specific sample size or data provenance (e.g., country of origin) is given for this review, as it refers to a compilation of existing literature rather than a new, specific clinical study associated with this submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable to this submission, as no new clinical test set was created or evaluated in a way that required an independent expert panel for ground truth establishment. The clinical evaluation relied on a review of existing published literature.

4. Adjudication Method for the Test Set

This information is not applicable, as no new clinical test set requiring adjudication was performed for this submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done for this submission. The submission states that "clinical testing was not required or performed to support substantial equivalence."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This question is not applicable as the device is a physical medical implant, not an algorithm or AI software, and therefore "standalone performance" in that context does not apply.

7. Type of Ground Truth Used

For Performance Testing: The ground truth for the engineering performance tests (e.g., compression, pullout) is the physical properties and mechanical behavior of the device under specified testing conditions, as measured against the limits set by the ASTM standards.
For Clinical Data Review: The "ground truth" for the clinical evaluation was derived from published clinical outcomes related to similar stand-alone anterior lumbar intervertebral body fusion devices with integrated fixation. This essentially means the consensus findings and results reported in established medical literature.

8. Sample Size for the Training Set

This is not applicable as the device is a physical implant and does not involve a "training set" in the context of an algorithm or AI model.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as the device is a physical implant and does not involve a "training set" in the context of an algorithm or AI model.

Summary

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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 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)
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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 NorthSuite 600Saint Paul, MN 55128Establishment Registration Number: 2135156
Contact Person:	Jacqueline A. HaugeRegulatory Affairs ManagerPhone: 651.256.8534Fax: 651.256.8500Email: 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

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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.

Regulation Number and Section

§ 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.