(69 days)
Not Found
No
The summary describes a passive intervertebral body fusion device made of PEEK with tantalum markers. There is no mention of any software, algorithms, image processing, or AI/ML terms. The performance studies are based on mechanical testing, not algorithmic performance.
Yes
The device is indicated for intervertebral body fusion to treat degenerative disc disease, which is a therapeutic intervention.
No
The device is an intervertebral body fusion device, which is an implant used for treatment in the spine, not for diagnosis.
No
The device description clearly states the device is made of PEEK-OPTIMA LT-1 with tantalum markers and is provided sterile, indicating it is a physical implantable device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "intervertebral body fusion device indicated for intervertebral body fusion... in the lumbar spine". This describes a surgical implant used to facilitate bone fusion, not a test performed on biological samples to diagnose a condition.
- Device Description: The description details the material (PEEK-OPTIMA LT-1 with tantalum markers), form factor (range of lengths and heights), and sterilization status (provided sterile). This aligns with a surgical implant.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory testing.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is an implant used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
RampartTM 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 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. RampartTM 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 (comma separated list FDA assigned to the subject device)
MAX
Device Description
RampartTM L 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 device is available in a range of lengths and heights and is made of PEEK-OPTIMA LT-1 with tantalum markers. The device is provided sterile and 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)
Preclinical testing according to ASTM F2077 (static compression and static sheer compression) and ASTM F2267 (subsidence), was used to justify substantial equivalence. This testing demonstrated similar performance characteristics to the identified predicate 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.
K111880, K113030, K120293, K123652, K130396, K131216, K132053
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
JAN - 9 2014 ・
.
| 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: | October 30, 2013 |
| Trade Name: | RampartTM-L |
| Product Classification
and Code: | Class II Medical Device, Product Code MAX, 21 CFR 888.3080 |
| Predicate Device(s): | Spineology PEEK Lumbar Interbody Fusion Devices/Rampart™-O
(K111880, K113030, K120293, K123652, K130396, K131216,
and K132053) |
| Device Description: | RampartTM L 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 device is available in a range of lengths
and heights and is made of PEEK-OPTIMA LT-1 with tantalum markers.
The device is provided sterile and associated instruments are provided non-
sterile. |
| Intended Use: | RampartTM 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 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. RampartTM 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. |
| Purpose of this 510(k): | The purpose of this 510(k) is to extend the range of sizes of Rampart O to
create the Rampart-L devices. |
| 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 | Preclinical testing according to ASTM F2077 (static compression and
static sheer compression) and ASTM F2267 (subsidence), was used to
justify substantial equivalence. This testing demonstrated similar
performance characteristics to the identified predicate devices. |
| Conclusion: | The information submitted in this premarket notification supports a
determination that RampartTM L is substantially equivalent in
technological characteristics and intended use to the predicate device. |
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K133371 Page 2 of 2
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's emblem, which features a stylized caduceus-like symbol with three wavy lines extending from a central point. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem within the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 9, 2014
Spineology, Incorporated Mr. Bryan Becker Regulatory Affairs Manager and Compliance Officer 7800 Third Street North, Suite 600 Saint Paul, Minnesota 55128
Re: K133371
Trade/Device Name: Rampart™-L Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: December 13, 2013 · Received: December 16, 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 (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 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" (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 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,
Lori A. Wigqins
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Rampart-L
Indications for Use (Describe)
Rampar™ 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 I spondyolisthesis 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™ 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)
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PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
... . FOR FDA USE ONLY : 14 : 14
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
STATE PARTY
Division of Orthopedic Devices
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
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