(93 days)
Not Found
No
The 510(k) summary describes a passive intervertebral body fusion device made of PEEK with Tantalum markers. There is no mention of any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The performance studies rely on a review of published clinical data for similar devices, not on the performance of an AI/ML algorithm.
Yes
The device is used for intervertebral body fusion to treat degenerative disc disease, which involves addressing a medical condition (back pain) and restoring function (spinal stability), thus having a therapeutic effect.
No
The device is an intervertebral body fusion device designed to stabilize spinal segments and aid in fusion, not to diagnose a medical condition.
No
The device description explicitly states the device is made of PEEK-OPTIMA LT1 with Tantalum markers and is provided in various configurations and heights, indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Rampart T implant is a physical device designed to be surgically implanted into the lumbar spine to aid in spinal fusion. It is a structural implant, not a diagnostic test.
- Intended Use: The intended use is to provide structural support and promote fusion in the spine, not to diagnose a condition or provide information based on biological samples.
The information provided clearly describes a surgical implant used for treatment, not a diagnostic test performed outside the body.
N/A
Intended Use / 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 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 treatment.
Rampart T implants are designed for use with autograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion and are 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 T 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. 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 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)
Non-Clinical Testing: There have been no design changes made to the Rampart T device to support the use of allograft material; therefore, non-clinical testing was not required to demonstrate substantial equivalence. Bacterial endotoxin testing (BET), also known as limulus amebocyte lysate (LAL) testing, was conducted in accordance with ANSI/AAMI/ST72:2011.
Clinical Testing: A review of published clinical data for lumbar intervertebral body fusion devices similar to the Rampart T device was provided in support of this application. The published clinical outcomes demonstrate that the use of allograft in interbody fusion procedures to treat patients with degenerative disc disease, as defined above, pose no new risks to patients. No design changes were made to the existing device, nor were any new components added to this system to support the use of allograft material; therefore, clinical testing was not required or performed to demonstrate substantial equivalence.
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/1 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
March 8, 2017
Spineology Inc. Jacqueline Hauge Regulatory Affairs Manager 7800 3rd Street North, Suite 600 St. Paul. Minnesota 55128
Re: K163409
Trade/Device Name: Rampart™ T Lumbar Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: February 2, 2017 Received: February 3, 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.
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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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K163409
Device Name Rampart TTM Lumbar Interbody Fusion Device
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 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 treatment.
Rampart T implants are designed for use with autograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to 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)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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| Date Prepared: | February 2, 2017 |
|---|---|
| Submitter: | Spineology Inc. |
| 7800 3rd Street North | |
| Suite 600 | |
| Saint Paul, MN 55128 | |
| Establishment Registration Number: 213515 | |
| 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™ T Lumbar Interbody Fusion Device |
|---|---|
| Common Name: | Spinal Implant |
| Classification Name: | Intervertebral body fusion device |
| Product Codes: | MAX |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 888.3080 |
| Panel: | Orthopedic |
Predicate Devices
| Primary: | K151020 Rampart™ T Lumbar Interbody Fusion Device |
|---|---|
| Additional: | K160906 Rampart™ T, Rampart™ O, Rampart™ A Lumbar Interbody Fusion Device |
l. Purpose
The purpose of this submission is to obtain FDA clearance for the expanded indications for use statement to allow optional use of allograft comprised of cancellous and/or cortical cancellous bone graft as an adjunct to fusion.
II. Device Description
Rampart T 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. 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 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.
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III. 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 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 treatment.
Rampart T implants are designed for use with autograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion and are intended for use with supplemental fixation systems cleared by the FDA for use in the lumbar spine.
IV. Non-Clinical Testing
There have been no design changes made to the Rampart T device to support the use of allograft material; therefore, non-clinical testing was not required to demonstrate substantial equivalence. Bacterial endotoxin testing (BET), also known as limulus amebocyte lysate (LAL) testing, was conducted in accordance with ANSI/AAMI/ST72:2011.
V. Clinical Testing
A review of published clinical data for lumbar intervertebral body fusion devices similar to the Rampart T device was provided in support of this application. The published clinical outcomes demonstrate that the use of allograft in interbody fusion procedures to treat patients with degenerative disc disease, as defined above, pose no new risks to patients. No design changes were made to the existing device, nor were any new components added to this system to support the use of allograft material; therefore, clinical testing was not required or performed to demonstrate substantial equivalence.
VI. Technological Characteristics
The Rampart T device has the same primary technological characteristics, including design and materials, as the predicate device. The fundamental scientific technology remains unchanged.
VII. Conclusion
The Rampart T device has the same intended use, technological characteristics, and principle of operation as the predicate devices. The clinical literature review presented in this application supports the expansion of the indications for use statement to include the optional use of allograft bone graft as an adjunct to fusion and a substantial equivalence determination of the Rampart T Lumbar Interbody Fusion Device as compared to the predicate devices.