(104 days)
No
The summary describes a physical implant device and its intended use, materials, and performance testing (FEA). There is no mention of AI, ML, image processing, or any software-based functionality that would suggest the use of these technologies.
Yes
The device is an intervertebral body fusion device used to stabilize spinal segments and promote fusion, which is a direct therapeutic intervention for degenerative disc disease.
No
Explanation: The device is an intervertebral body fusion device designed to stabilize spinal segments and facilitate fusion, not to diagnose medical conditions. It is used in conjunction with radiographic studies for confirmation, but it does not perform the diagnostic function itself.
No
The device description clearly states that the device is an implant made of PEEK-OPTIMA LT1 with Tantalum markers, which are physical components, not software.
Based on the provided information, the Rampart A device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that the Rampart A is an implantable device designed to be placed within the human body (in the lumbar spine) to facilitate fusion. It does not analyze or test samples taken from the body.
- The purpose of an IVD is to provide information about a patient's health status. The Rampart A's purpose is structural support and to promote bone fusion, not to diagnose or provide diagnostic information.
- The input is radiographic studies, not biological specimens. While radiographic studies are used to assess the patient's condition and guide the use of the device, the device itself does not process or analyze these images in a diagnostic manner.
The Rampart A is a medical device, specifically an implantable surgical device used in spinal fusion procedures.
N/A
Intended Use / Indications for Use
Rampart A is an intervertebral body fusion device 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 1 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 A is designed for use with autograft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
Rampart A implants are intervertebral body fusion devices for use with autogenous bone graft in the intervertebral disc space to stabilize spinal segments as an adjunct to fusion. These devices are made of PEEK-OPTIMA LT1 with Tantalum markers and are provided in various configurations and heights, containing a hollow core to receive bone autograft. 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)
No performance testing was required for this change. An engineering rationale, including a finite element analysis (FEA) to compare the Rampart A to the existing predicate testing (conducted in accordance with ASTM F2077) supported the substantial equivalence of the Rampart A device.
Because the materials of construction remain unchanged from the predicate devices, the existing biological data remain valid and no new biocompatibility testing was required for this change.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
February 4, 2016
Spineology, Incorporated Ms. Jacqueline Hauge Regulatory Affairs Manager 7800 3rd Street North, Suite 600 St. Paul, Minnesota 55128
Re: K153082
Trade/Device Name: Rampart A Lumbar Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: October 22, 2015 Received: October 23, 2015
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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/ResourcesforYou/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 yours,
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
510(k) Number (if known) K153082
Device Name
Rampart A Lumbar Interbody Fusion Device
Indications for Use (Describe)
Rampart A is an intervertebral body fusion device 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 1 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 A is designed for use with autograft as an adjunct to fusion and is 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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Image /page/3/Picture/1 description: The image shows the logo for Spineology. The word "Spineology" is written in a bold, sans-serif font. Below the word "Spineology" is the phrase "anatomy conserving surgery" in a smaller font. To the right of the word "Spineology" is a pink graphic of a cluster of circles.
Date Prepared:
| Applicant: | Spineology, Inc.
7800 3rd Street N.
Suite 600
Saint Paul, MN 55128 |
|---------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| | Phone: 651.256.8500
Fax: 651.256.8505 |
| | 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:
Regulation Name:
Regulation Number:
Product Code:
Regulatory Class:
510(k) Review Panel: | Rampart A Lumbar Interbody Fusion Device
Intervertebral body fusion device
21 CFR 888.3080
MAX
Class II
Orthopedic |
| Predicate Devices | |
| Primary Predicate
K123652 | Spineology PEEK Lumbar Interbody Fusion Device |
| Additional Predicates | |
October 22, 2015
Rampart O, Rampart T Lumbar Interbody Fusion Device K132053 Spineology PEEK Lumbar Interbody Fusion Device K121129
Reference Device
K072253 SynFix-LR (Synthes Spine)
Purpose of Submission
The purpose of this submission is to introduce the Rampart A Lumbar Interbody Fusion Device, a modified version of Spineology's previously cleared interbody fusion devices designed to accommodate anatomical features conducive to anterior or anterolateral placement within the intervertebral disc space.
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Device Description
Rampart A implants are intervertebral body fusion devices for use with autogenous bone graft in the intervertebral disc space to stabilize spinal segments as an adjunct to fusion. These devices are made of PEEK-OPTIMA LT1 with Tantalum markers and are provided in various configurations and heights, containing a hollow core to receive bone autograft. Placement is achieved with an insertion instrument that allows for manipulation of the implant in the intervertebral disc space.
Indications for Use
Rampart A is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative 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 nonoperative treatment.
Rampart A is designed for use with autograft as an adjunct to fusion and is intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.
Comparison to Predicate
When compared to the predicate devices, Rampart A has the same:
- · Intended Use
- · Technological Characteristics · · · Method of Sterilization
-
- · Materials of Construction
Summary of Performance and Biological Testing
No performance testing was required for this change. An engineering rationale, including a finite element analysis (FEA) to compare the Rampart A to the existing predicate testing (conducted in accordance with ASTM F2077) supported the substantial equivalence of the Rampart A device.
Because the materials of construction remain unchanged from the predicate devices, the existing biological data remain valid and no new biocompatibility testing was required for this change.
Conclusion
Spineology has demonstrated that Rampart A devices are substantially equivalent to the predicate devices. The fundamental scientific principle, technological characteristics, and intended use are unchanged from the predicate devices.
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· · · · · · · · · Packaging Materials
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Operating Principle