(104 days)
Not Found
No
The summary describes a passive intervertebral body fusion device made of PEEK with markers, with no mention of AI or ML in its function, design, or testing.
Yes.
The device is an intervertebral body fusion implant intended to treat degenerative disc disease and stabilize spinal segments, indicating a therapeutic purpose.
No
The device is an intervertebral body fusion implant, designed to stabilize spinal segments and aid in fusion, not to diagnose medical conditions.
No
The device description explicitly states that the devices are made of PEEK-OPTIMA LT1 with titanium or tantalum markers and are provided in various configurations and heights, indicating they are physical implants, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Rampart™ implants are described as intervertebral body fusion devices made of PEEK with titanium or tantalum markers. They are surgically implanted into the lumbar spine to stabilize spinal segments and promote fusion.
- Intended Use: The intended use is for intervertebral body fusion in the lumbar spine for patients with degenerative disc disease. This is a surgical procedure, not a diagnostic test performed on a specimen outside the body.
The information provided clearly indicates that this is a surgically implanted medical device used for treatment, not a diagnostic tool used on in vitro samples.
N/A
Intended Use / Indications for Use
Rampart™ O, Rampart™ T, and Rampart™ A 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™ O, Rampart™ T, and Rampart™ A implants are designed for use with autograft and/or allograft 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 O, Rampart T, and Rampart A 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 made of PEEK-OPTIMA LT1 with titanium or tantalum markers and are provided in various configurations and heights, containing a hollow core to receive bone autograft and/or allograft. 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
Prescription Use
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: Bacterial Endotoxin testing (BET), also known as the Limulus amebocyte lysate (LAL) test, was performed per ANSI/AAMI/ST72 to a limit of
§ 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.
0
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol representing the human form, depicted as three stylized profiles facing to the right. The profiles are connected and flow together, creating a sense of unity and collaboration.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 14, 2016
Spineology, Incorporated Ms. Jacqueline A. Hauge Regulatory Affairs Manager 7800 3rd Street, Suite 600 Saint Paul, Minnesota 55128
Re: K160906
Trade/Device Name: Rampart™ O Lumbar Interbody Fusion Device, Rampart™ T Lumbar Interbody Fusion Device, 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: April 15, 2016 Received: April 18, 2016
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 Parts 801); medical device reporting (reporting of medical devicerelated 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/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 yours, Lori A. Wiggins -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K160906
Device Name
Rampart™ O Lumbar Interbody Fusion Device Rampart™ T Lumbar Interbody Fusion Device Rampart™ A Lumbar Interbody Fusion Device
Indications for Use (Describe)
Rampart™ O, Rampart™ T, and Rampart™ A 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™ O, Rampart™ T, and Rampart™ A implants are designed for use with autograft and/or allograft 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.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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| Date Prepared: | June 30, 2016 |
|---|---|
| Submitter: | Spineology Inc. |
| 7800 3rd Street North | |
| Suite 600 | |
| Saint Paul, MN 55128 | |
| Establishment Registration Number: 2135156 | |
| Contact Person: | Jacqueline A. Hauge |
| Regulatory Affairs Manger | |
| Phone: 651.256.8534 | |
| Fax: 651.256.8505 | |
| Email: jhauge@spineology.com |
Device Name and Classification
| Trade Name: | Rampart™ O Lumbar Interbody Fusion Device |
|---|---|
| Rampart™ T Lumbar Interbody Fusion Device | |
| Rampart™ A 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 |
| Predicate Devices | |
|---|---|
| ------------------- | -- |
| Primary: | K150788 | Talos Intervertebral Body Fusion Devices (Meditech Spine, LLC) |
|---|---|---|
| Additional: | K132053 | Rampart O, Rampart T Lumbar Interbody Fusion Device |
| K153082 | Rampart A Lumbar Interbody Fusion Device |
Purpose
The purpose of this 510(k) is to obtain clearance to expand the current indications for use to include use of either autograft and/or allograft as a substitute/addition to autologous bone.
Device Description
Rampart O, Rampart T, and Rampart A 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 made of PEEK-OPTIMA LT1 with titanium or tantalum markers and are provided in various configurations and heights, containing a hollow core to receive bone autograft and/or allograft. Placement is achieved with an insertion instrument that allows for manipulation of the implant in the intervertebral disc space.
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Indications for Use
Rampart O, Rampart T, and Rampart A implants are intervertebral body fusion devices indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar soine 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 0, Rampart T, and Rampart A implants are designed for use with autograft and/or allograft 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.
Technological Characteristics
The technological characteristics of Rampart O, Rampart T, and Rampart A are identical to the additional predicate devices in terms of intended use and design. The indications for use are similar. The addition of allograft comprised of cancellous and/or corticocancellous bone graft to Rampart O. Rampart T, and Rampart A does not increase the risks associated with use of the device.
Non-Clinical Testing
There have been no design changes made to the Rampart 0, Rampart T, and Rampart A devices to support use of allograft material. No design changes were made to the existing devices, nor were any new components added to these systems; therefore, mechanical testing was not required or performed to support substantial equivalence.
Bacterial Endotoxin testing (BET), also known as the Limulus amebocyte lysate (LAL) test, was performed per ANSI/AAMI/ST72 to a limit of