(278 days)
No
The summary describes a passive interbody fusion device made of standard materials, with no mention of AI/ML capabilities or data processing.
Yes
The device is an intervertebral body fusion device used to treat degenerative disc disease and is designed to provide mechanical support and promote fusion, which falls under the definition of a therapeutic device.
No
This medical device is an intervertebral body fusion device used to provide mechanical support and promote fusion in the lumbar spine. It is a therapy device, not a diagnostic one.
No
The device description explicitly states it is made of physical materials (PEEK-OPTIMA® LT-1, titanium alloy, polyethylene terephthalate (PET), and tantalum markers) and is an intervertebral implant, indicating it is a hardware device.
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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The Rampart™ D Lumbar Interbody Fusion Device is a physical implant designed to provide mechanical support and facilitate fusion in the lumbar spine. It is surgically implanted into the body.
- Intended Use: The intended use clearly describes a surgical procedure for treating degenerative disc disease and spondylolisthesis by fusing vertebrae.
- Device Description: The description details the materials and design of a physical implant, not a diagnostic test kit or instrument.
The information provided describes a medical device used in a surgical procedure, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
The Rampart™ D Lumbar Interbody Fusion Device is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to L5 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. The Rampart™ D device is designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft 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
The Rampart™D Lumbar Interbody Fusion Device is an intervertebral implant designed to provide mechanical support within the intradiscal space as an adjunct to fusion. The device is made of PEEK-OPTIMA® LT-1, titanium alloy, polyethylene terephthalate (PET), and tantalum markers. It is available in varying lengths and heights with two lordotic configurations, and is provided sterile. It is designed with a porous central cavity for graft containment. The device features a rounded nose to aid implant insertion and includes ridged teeth to resist migration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine from L2 to L5
Indicated Patient Age Range
skeletally mature
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 was performed according to ASTM F2077 (static and dynamic axial compression and compression shear), ASTM F2267 (subsidence) and expulsion testing. Particulate analysis, bench-top and cadaveric implantation evaluations and load sharing tests were completed. All testing was conducted on worst case configurations for both sizing and recommended graft fill. Existing biological data on device materials was used to support the performance and biological safety of the device. Patient-level clinical data that was supplemented with a literature review was also provided to support the substantial equivalence of the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem depicts a stylized image of a human figure in profile, with three overlapping faces suggesting community and support. The overall design is simple and professional, reflecting the department's role in public health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 18, 2016
Spineology Inc. Ms. Karen Roche VP. Operations & Technology 7800 Third Street North, Suite 600 Saint Paul, Minnesota 55128
Re: K160074
Trade/Device Name: Rampart™ D Lumbar Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: September 7, 2016 Received: September 8, 2016
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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,
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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K160074
Page 1 of 1
Device Name
Rampart™ D Lumbar Interbody Fusion Device
Indications for Use (Describe)
The Rampart™ D Lumbar Interbody Fusion Device is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to L5 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. The Rampart™ D device is designed for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion and is 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(k) Summary
| Applicant: | Spineology Inc.
7800 3rd Street N., Suite 600
Saint Paul, MN 55128-5455
Phone: 651-256-8500
Fax: 651-256-8505 | |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Contact Person: | Karen Roche | |
| Date Prepared: | October 17, 2016 | |
| Trade Name: | Rampart™ D Lumbar Interbody Fusion Device | |
| Common Name: | Interbody Spacer | |
| Product Classification
and Name: | 21 CFR § 888.3080 - Intervertebral body fusion device
(Class II, Special Controls) | |
| Product Code: | MAX - Intervertebral Fusion Device With Bone Graft, Lumbar | |
| Predicate Device(s): | Primary Predicate: | Rampart™L (K133371); Spineology Inc. |
| | Additional Predicates: | 1. Interfuse L (K131540);
Vertebral Technologies, Inc. |
| | | 2. Elite L Expandable Lumbar Fusion System
(K150954); Innova Spinal Technologies, LLC |
| Reference Device: | OptiMesh (K014200); Spineology Inc. | |
| Device Description: | The Rampart™D Lumbar Interbody Fusion Device is an intervertebral
implant designed to provide mechanical support within the
intradiscal space as an adjunct to fusion. The device is made of
PEEK-OPTIMA® LT-1, titanium alloy, polyethylene terephthalate
(PET), and tantalum markers. It is available in varying lengths and
heights with two lordotic configurations, and is provided sterile. It is
designed with a porous central cavity for graft containment. The
device features a rounded nose to aid implant insertion and includes
ridged teeth to resist migration. | |
| Indications for Use: | The Rampart™D Lumbar Interbody Fusion Device is indicated for
intervertebral body fusion at one level or two contiguous levels in
the lumbar spine from L2 to L5 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. The Rampart D
device is designed for use with autograft and/or allograft comprised
of cancellous and/or corticocancellous bone graft as an adjunct to
fusion and is intended for use with supplemental fixation systems
cleared by the FDA for use in the lumbar spine. | |
| Purpose of this 510(k): | To receive FDA clearance to market the Rampart D Lumbar
Interbody Fusion Device in the US. | |
| Summary of
Technological
Characteristics: | The Rampart D Lumbar Interbody Fusion Device and the predicates
share some technological characteristics, including materials of
construction, comparable profile, dimensions and lordotic angles,
serrated surfaces for endplate contact, similar graft containment
areas and graft volume capacities. The reference device shares the
same material and design features for use in graft containment. | |
| Testing | Non-clinical testing was performed according to ASTM F2077 (static
and dynamic axial compression and compression shear), ASTM F2267
(subsidence) and expulsion testing. Particulate analysis, bench-top
and cadaveric implantation evaluations and load sharing tests were
completed. All testing was conducted on worst case configurations for
both sizing and recommended graft fill. Existing biological data on
device materials was used to support the performance and biological
safety of the device. Patient-level clinical data that was supplemented
with a literature review was also provided to support the substantial
equivalence of the subject device. | |
| Conclusion: | The Rampart D device has the same intended use and Indications for
Use statement as the predicate devices identified. The differences
in technological characteristics between Rampart D and the
predicate devices do not raise different safety or effectiveness
questions. Non-clinical and clinical testing demonstrates substantial
equivalence to legally marketed predicate devices when used under
the labeled conditions. | |
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