(115 days)
No
The document describes a physical intervertebral body fusion device and its intended use, without any mention of software, algorithms, or AI/ML capabilities.
Yes
The device is an intervertebral body fusion device used to treat degenerative disc disease and promote fusion in the lumbar spine, which directly impacts the patient's health by alleviating pain and stabilizing the spine.
No
The device is an intervertebral body fusion device, which is an implant used for treatment (fusion) of the spine, not for diagnosing a condition.
No
The device description clearly indicates it is a physical intervertebral body fusion device made of material (likely PEEK, based on the predicate) and associated instruments, not software.
No, 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 about a person's health.
- Device Description and Intended Use: The provided text clearly describes the Rampart O and Rampart P as intervertebral body fusion devices intended for surgical implantation in the lumbar spine to promote fusion. They are physical implants used within the body, not devices that analyze samples outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or diagnostic testing.
Therefore, based on the provided information, the Rampart O and Rampart P devices are surgical implants, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The Rampart O and P Devices are 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.
These devices may be implanted singly or in pairs via an open or a minimally invasive posterior or transforaminal approach.
The Rampart O and P Devices are 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
MAX
Device Description
The Spineology Rampart O and P Devices are designed for use with autograft as an adjunct to fusion and is 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. The device and associated instruments are provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
No imaging modality serves as an input to the device described.
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)
The Rampart O and P Devices were tested in compliance with FDA's guidance document titled "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device". Preclinical testing according to ASTM F2077, including static compression and static compression shear. This testing demonstrated similar performance characteristics to the identified predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Spineology PEEK Lumbar Interbody Fusion Devices (K111880, K113030, and K120293)
Reference Device(s)
Not Found
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.
0
510(k) Summary
MAR 22 2013
| 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: | November 21, 2012 |
| Trade Name: | Rampart O and Rampart P |
| Product Classification
and Code: | Class II Medical Device, Product Code MAX, 21 CFR 888.3080 |
| Predicate Device(s): | Spineology PEEK Lumbar Interbody Fusion Devices (K111880,
K113030, and K120293) |
| Device Description: | The Spineology Rampart O and P Devices are designed for use with
autograft as an adjunct to fusion and is 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. The device and associated
instruments are provided non-sterile. |
| Intended Use: | The Rampart O and P Devices are 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.
These devices may be implanted singly or in pairs via an open or a
minimally invasive posterior or transforaminal approach.
The Rampart O and P Devices are 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 add devices as small as 20 mm in length
and add products that include features that allow for rotation of the
devices after insertion on implants with tantalum markers. |
| 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 | The Rampart O and P Devices were tested in compliance with FDA's
guidance document titled "Class II Special Controls Guidance
Document: Intervertebral Body Fusion Device". Preclinical testing
according to ASTM F2077, including static compression and static
compression shear. This testing demonstrated similar performance
characteristics to the identified predicate devices. |
| Conclusion: | The information submitted in this premarket notification supports a
determination that the Spineology Rampart O and P Devices are
substantially equivalent in technological characteristics and intended use
to the predicate devices. |
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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 consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 22, 2013
Spineology, Incorporated % Mr. Brvan Becker Regulatory Affairs Manager 7800 3rd Street North, Suite 600 Saint Paul, Minnesota 55128
Re: K123652
Trade/Device Name: Rampart O and Rampart P Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: February 20, 2012 Received: March 8, 2012
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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.
ErinL.Keith
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K123652
Device Name: Rampart O and Rampart P
Indications for Use:
Rampart O and Rampart P are 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 nonoperative treatment.
These devices may be implanted singly or in pairs via an open or a minimally invasive posterior or transforaminal approach.
Rampart O and Rampart P are 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.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (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