(97 days)
Rampart-T implants are 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 six months of non-operative treatment.
Rampart-T implants are designed for use with autograft to facilitate fusion and are intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.
The Spineology Rampart™-T Interbody Fusion implant is a tapered version of the predicate Spineology PEEK Crescent implant. The subject and predicate devices are composed of PEEK -OPTIMA® LT1 (polyetheretherketone). The subject device and the primary predicate are both manufactured as a curved (crescent) shape and contain two areas for the placement of autograft. Additionally, the subject and predicate devices contain tantalum alloy markers to assist in device placement through intraoperative imaging. The devices all have a toothed fish-scale style antibackout design on the surfaces that interface with the vertebral body endplates. The subject device is tapered at its leading end for ease of initial implantation and will maintain the same 6 degree lordotic angle to accommodate a suitable fit in the disc space.
This document is a 510(k) premarket notification decision letter from the FDA regarding the Spineology Rampart™-T Interbody Fusion System. It primarily discusses the device's substantial equivalence to predicate devices and does not contain information about the acceptance criteria or a specific study proving the device meets those criteria in the context of AI/ML performance.
The "Performance Data" section mentions that the device "previously underwent performance testing" in accordance with FDA guidance and ASTM standards (F2077 and F2267). This testing included:
- Static compression shear
- Shear
- Dynamic axial and shear compression
- Subsidence
- Expulsion
However, this refers to mechanical and biocompatibility testing of the interbody fusion device itself, an orthopedic implant, and not performance criteria for an AI/ML device. The document also states this testing was "previously submitted and reviewed by the FDA," implying the detailed results and acceptance criteria for these mechanical tests are not included within this particular submission.
Therefore, none of the requested information regarding acceptance criteria and studies for an AI/ML device's performance can be extracted from this document, as it is related to a traditional medical device (an intervertebral body fusion device).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 22, 2015
Spineology, Incorporated Ms. Karen Roche Vice President, Operations & Technology 7800 Third Street North, Suite 600 Saint Paul, Minnesota 55128
Re: K151020
Trade/Device Name: Rampart™T Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 24, 2015 Received: June 24, 2015
Dear Ms. Roche:
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
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Page 2 - Ms. Karen Roche
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 vours.
Mark N. Melkerson -S
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)
K151020
Device Name Rampart™-T Interbody Fusion System
Indications for Use (Describe)
Rampart-T implants are 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 six months of non-operative treatment.
Rampart-T implants are designed for use with autograft to facilitate fusion and are intended for use with supplemental fixation systems cleared by the 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
I. SUBMITTER
Spineology Inc. 7800 3rd Street N., Suite 600 Saint Paul, MN 55128
Phone: 651.256.8500 Fax: 651.256.8505
Contact Person: Karen Roche Date Prepared: July 15, 2015
II. DEVICE
Name of Device: Rampart™-T Interbody Fusion System Common Name or usual name: Intervertebral fusion device with bone graft, lumbar Classification Name: Intervertebral body fusion device (21 CFR §888.3080) Regulatory Class: Class II Product Code: MAX
III. PREDICATE DEVICE
Spineology PEEK LIFD K110933 (Primary Predicate), K111880, K132053, K113030 (Additional Predicates)
DEVICE DESCRIPTION IV.
The Spineology Rampart™-T Interbody Fusion implant is a tapered version of the predicate Spineology PEEK Crescent implant. The subject and predicate devices are composed of PEEK -OPTIMA® LT1 (polyetheretherketone). The subject device and the primary predicate are both manufactured as a curved (crescent) shape and contain two areas for the placement of autograft. Additionally, the subject and predicate devices contain tantalum alloy markers to assist in device placement through intraoperative imaging. The devices all have a toothed fish-scale style antibackout design on the surfaces that interface with the vertebral body endplates. The subject device is tapered at its leading end for ease of initial implantation and will maintain the same 6 degree lordotic angle to accommodate a suitable fit in the disc space.
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V. INDICATIONS FOR USE
Rampart-T implants are 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 of non-operative treatment.
Rampart-T implants are designed for use with autograft as an adjunct to fusion and are intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.
COMPARISON OF TECHNOLOGICAL FEATURES WITH THE PREDICATE VI. DEVICE
The Spineology Rampart-T Interbody Fusion Implant shares the same indications, materials, function, and performance as the predicate implants.
VII. PERFORMANCE DATA
The Rampart-T Interbody Fusion System has previously undergone performance testing. The testing was performed in accordance with the FDA's guidance titled: Class II Special Controls Guidance Document: Intervertebral Body Fusion Device. Additionally preclinical testing was performed in accordance with ASTM F2077 and ASTM F2267. This testing included static compression shear, shear, and dynamic axial and shear compression, subsidence and expulsion. This testing has been previously submitted and reviewed by the FDA.
VII. CONCLUSIONS
The Rampart-T Interbody implant is substantially equivalent to the cited predicate implants. This conclusion is based on a comparison of intended use, materials, technological features, and comparative performance testing.
§ 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.