(75 days)
Not Found
No
The summary describes a physical intervertebral body fusion device and its intended use, with no mention of software, algorithms, or any terms related to AI or ML.
Yes
The device is an intervertebral body fusion device indicated for treating degenerative disc disease with spondylolisthesis, which is a medical condition. Its purpose is to facilitate fusion and alleviate symptoms associated with these conditions, classifying it as a therapeutic device.
No
This device is described as an "intervertebral body fusion device" used for surgical fusion in the lumbar spine, not for diagnosing medical conditions.
No
The device description clearly states that Rampart™-O and Rampart™-T are physical intervertebral body fusion devices, available in different sizes and provided sterile or non-sterile. This indicates a hardware component, not a software-only 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that Rampart™-O and Rampart™-T are "intervertebral body fusion devices" intended for surgical implantation in the lumbar spine to aid in bone fusion. This is a physical implant used in vivo (within the body), not a test performed in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic testing, or any of the typical characteristics of an IVD.
Therefore, the Rampart™-O and Rampart™-T devices are surgical implants, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Rampart™-O: Rampart™-O 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 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. Rampart™-O is designed for use with autograft as an adjunct to fusion and is intended for use with supplemental fixation systems (e.g. pedicle screws) cleared by the FDA for use in the lumbar spine.
Rampart™-T: Rampart™-T 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 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. Rampart™-T is designed for use with autograft as an adjunct to fusion and is intended for use with supplemental fixation systems (e.g. pedicle screws) 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 and Rampart™-T devices are designed for use with autograft as an adjunct to fusion and are intended for use with supplemental fixation systems cleared for use in the lumbar spine. The devices are available in a range of lengths and heights. The devices are provided sterile and non-sterile. The associated instruments are provided non-sterile.
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 testing was performed.
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.
Rampart™ O (K131216), Rampart™ T (K121129)
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.
0
: ·
510(k) Summary
| Applicant: | Spineology Inc.
7800 3rd Street N., Suite 600
Saint Paul, MN 55128
Phone: 651-256-8500
Fax: 651-256-8505 |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Bryan Becker |
| Date Prepared: | July 1, 2013 |
| Trade Name: | Rampart™-O and Rampart™-T |
| Product Classification
and Code: | Class II Medical Device, Product Code MAX, 21 CRF 888.3080 |
| Predicate Device(s): | Rampart™ O (K131216) and Rampart™ T (K121129) |
| Device Description: | Rampart™-O and Rampart™-T devices are designed for use with
autograft as an adjunct to fusion and are intended for use with supplemental
fixation systems cleared for use in the lumbar spine. The devices are
available in a range of lengths and heights. The devices are provided sterile
and non-sterile. The associated instruments are provided non-sterile. |
| Intended Use: | Rampart™-O: Rampart™-O 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 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. Rampart™-O is designed for use with
autograft as an adjunct to fusion and is intended for use with supplemental
fixation systems (e.g. pedicle screws) cleared by the FDA for use in the
lumbar spine.
Rampart™-T:
Rampart™-T 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 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. Rampart™-T is designed for use with
autograft as an adjunct to fusion and is intended for use with supplemental
fixation systems (e.g. pedicle screws) cleared by the FDA for use in the
lumbar spine. |
| Purpose of this 510(k): | The purpose of this 510(k) is to update the indications statements and the
ability to provide the products as sterile. |
| Summary of
Technological
Characteristics: | The device is shown to be substantially equivalent to the intended use, materials, configuration, and performance characteristics of the predicate products. |
| Testing | No testing was performed. |
| Conclusion: | The information submitted in this premarket notification supports a determination that the devices subject to this submission are substantially equivalent in technological characteristics and intended use to the predicate devices. |
SEP 1 6 2013
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K132053; Page 2 of 2
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Contro! Center - WO66-G609 Silver Spring, MD 20993-0002
September 16, 2013
Spineology, Incorporated Mr. Bryan Becker Regulatory Affairs Manager 7800 3rd Street North, Suite 600 Saint Paul, Minnesota 55128
Re: K132053
Trade/Device Name: Rampart™-O, Rampart™-T Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: July 18, 2013 Received: July 19, 2013
Dear Mr. Becker:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Bryan Becker
forth in the quality systems (OS) 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 Small Manufacturers. International and Consumer Assistance at its tollfree 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/Reportal?roblem/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 Small Manufacturers, International and Consumer Assistance 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.
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K132053
Device Name: Rampart™ O and Rampart™ T
Indications for Use:
Rampart™ O: Rampart™ O 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 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. Rampart™ O is designed for use with autograft as an adjunct to fusion and is intended for use with supplemental fixation systems (e.g. pedicle screws) cleared by the FDA for use in the lumbar spine.
Rampart™ T: Rampart™ T 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 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. Rampan™ T is designed for use with autograft as an adjunct to fusion and is intended for use with supplemental fixation systems (e.g. pedicle screws) cleared by the FDA for use in the lumbar spine.
Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD Division of Orthopedic Devices