(42 days)
Not Found
No
The summary describes a physical intervertebral body fusion device made of PEEK with Tantalum markers. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The performance studies focus on substantial equivalence to a predicate device based on physical characteristics and intended use, not on algorithmic performance.
Yes
The device is an intervertebral body fusion device used to stabilize spinal segments and treat degenerative disc disease, which are therapeutic interventions.
No
This device is an intervertebral body fusion device, designed to stabilize spinal segments and aid in fusion, not to diagnose medical conditions. Its use of "radiographic studies" is for confirming a pre-existing diagnosis of degenerative disc disease, not for its own diagnostic capability.
No
The device description clearly states it is a physical intervertebral body fusion device made of PEEK-OPTIMA LT1 with Tantalum markers, designed for surgical implantation. It is not software.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Rampart™ L is an implantable medical device made of PEEK-OPTIMA LT1 with Tantalum markers. It is designed to be surgically placed in the lumbar spine to facilitate bone fusion.
- Intended Use: The intended use is for intervertebral body fusion in patients with degenerative disc disease. This is a surgical procedure involving the implantation of a device, not a diagnostic test performed on a sample outside the body.
- Input Imaging Modality: While radiographic studies are used to assess the patient's condition and potentially the outcome of the fusion, the device itself does not process or analyze these images for diagnostic purposes.
The Rampart™ L is a therapeutic device used in a surgical procedure, not a diagnostic test.
N/A
Intended Use / Indications for Use
Rampart™ L 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 have had six months of non-operative studies. Rampart™-L 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
MAX
Device Description
Rampart™-L is an intervertebral body fusion device for use with autogenous bone graft in the intervertebral disc space to stabilize spinal segments as an adjunct to fusion. The device is made of PEEK-OPTIMA LT1 with Tantalum markers and is 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)
New performance testing was not performed for the subject 18mm and 22mm Rampart™-L devices. In order to confirm the safety and effectiveness of the subject 18mm and 22mm Rampart™-L devices as well as their substantial equivalence to the predicate 12mm Rampart™-L device, Spineology conducted a thorough assessment which included the following activities:
- Comparison of intended use
- Comparison of the technological characteristics; including primary design features and materials of construction
- Comparison of the areas and volume; including through growth area, surface contact area, and bone graft volume
- Review of predicate performance data
- Review of predicate risks and risk mitigation measures
Based on this assessment, Spineology confirmed that the subject 18mm and 22mm Rampart™-L devices are substantially equivalent to the predicate device, do not represent a new worst-case device configuration when compared to the predicate device, and the predicate performance data and risk mitigation measures support the safe and effective use of these devices.
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.
Not Found
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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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Spineology, Inc. Jacqueline Hauge Regulatory Affairs Manager 7800 3rd Street N.. Suite 600 St. Paul. Minnesota 55128-5455 July 24, 2017
Re: K171724
Trade/Device Name: Rampart™ L Lumbar Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: June 26, 2017 Received: June 27, 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 of medical device
1
related 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.
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)
K171724 Page 1 of 1
Device Name Rampart™ L Lumber Interbody Fusion Device
Indications for Use (Describe)
Rampart™ L 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 sketally mature and six months of non-operative studies. Rampart™-L 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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| Date Prepared: | June 09, 2017 | K171724
Page 1 of 2 |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| 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 Names: | Rampart™ L Lumbar Interbody Fusion System | |
| Common Name: | Intervertebral body fusion device | |
| Product Code: | MAX | |
| Regulatory Class: | Class II | |
| Regulation Number: | 21 CFR 888.3080 | |
| Panel: | Orthopedic | |
| Predicate Device
Primary: | K133371 | Rampart™ L Lumbar Interbody Fusion Device (Spineology Inc.) |
Purpose of Submission A.
Currently, the FDA-cleared Rampart™-L system includes 12mm wide implantable devices. The purpose of this submission is for the expansion of the Rampart™-L product line to include 18mm and 22mm wide implantable devices. All other primary technological characteristics of the subject 18mm and 22mm devices remain unchanged from the 12mm predicate device.
B. Device Description
Rampart™-L is an intervertebral body fusion device for use with autogenous bone graft in the intervertebral disc space to stabilize spinal segments as an adjunct to fusion. The device is made of PEEK-OPTIMA LT1 with Tantalum markers and is 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.
C. Indications for Use
Rampart™-L 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 have had six months of non-operative studies. Rampart™-L 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.
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D. Comparison to Predicate
When compared to the predicate device, the subject Rampart™-L device has the same or equivalent:
- Intended Use
- Indications for Use
- Fundamental Scientific Technology
- Principle of Operation
- Device Design
- Materials of Construction ●
- Lengths
- Heights
ட். Non-Clinical Testing
New performance testing was not performed for the subject 18mm and 22mm Rampart™-L devices. In order to confirm the safety and effectiveness of the subject 18mm and 22mm Rampart™-L devices as well as their substantial equivalence to the predicate 12mm Rampart™-L device, Spineology conducted a thorough assessment which included the following activities:
- Comparison of intended use
- Comparison of the technological characteristics; including primary design features and materials of construction
- Comparison of the areas and volume; including through growth area, surface contact area, and bone graft volume
- o Review of predicate performance data
- Review of predicate risks and risk mitigation measures
Based on this assessment, Spineology confirmed that the subject 18mm and 22mm Rampart™-L devices are substantially equivalent to the predicate device, do not represent a new worst-case device configuration when compared to the predicate device, and the predicate performance data and risk mitigation measures support the safe and effective use of these devices.
F. Conclusion
Based on the same indications for use, similar technological characteristics, and comparison to the predicate device, the 18mm and 22mm Rampart™-L devices have been shown to be substantially equivalent to the legally marketed predicate device.