(103 days)
Not Found
No
The summary describes a physical implant and associated instruments for spinal fusion, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for intervertebral body fusion of the spine and treatment of degenerative disc disease, which are therapeutic interventions.
No
The device description clearly states it is a "spacer" used between vertebral bodies to facilitate fusion, not to diagnose a condition. Its purpose is therapeutic, not diagnostic.
No
The device description explicitly states that the system is comprised of "implant and instrument components," including a PEEK spacer with Tantalum markers. This indicates the presence of physical hardware, not just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Reliance LUMBAR IBF System is described as a "spacer, which inserts between vertebral bodies in the anterior column of the lumbar spine." This is an implantable surgical device, not a device used for testing samples outside the body.
- Intended Use: The intended use is for "intervertebral body fusion of the spine," which is a surgical procedure.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of biomarkers, or diagnostic purposes.
This device falls under the category of implantable surgical devices used for structural support and fusion in the spine.
N/A
Intended Use / Indications for Use
The Reliance LUMBAR IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.
The Reliance LUMBAR IBF System, when used as an Intervertebral Body Fusion device is also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment.
Product codes
MAX
Device Description
The Reliance Lumbar IBF System is comprised of implant and instrument components. The implant component, the Reliance Lumbar IBF device, is a spacer, which inserts between vertebral bodies in the anterior column of the lumbar spine. The spacer is made of PEEK Optima LT1 with Tantalum markers.
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 patients
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)
Mechanical testing was performed on the worst case Reliance Lumbar IBF device following ASTM Standards. Static and Dynamic Compression testing was performing following ASTM Standard F2077-03, Subsidence Testing was performed following ASTM F2267-04, and Static Push-out Testing was performed following ASTM Draft F-04.25.02.02. The Reliance Lumbar IBF was found to be substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K090782, K090816, K093242, P950019, P960025
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
MAR 1 2 2012
510(k) Summary
Date: 8 March 2012
Reliance Medical Systems, LLC 545 West 500 South, Suite 100 Bountiful, UT 84010 801-295-3280 Telephone: 801-294-0074 Fax:
Contact: Bret M. Berry Member-Manager
510(k) Number: Common or Usual Name: Proposed Proprietary or Trade Name: Classification Name: Regulation Number: Product Code:
Intervertebral Body Fusion Device Reliance Lumbar IBF System Intervertebral Body Fusion Device 21 CFR 888.3080 MAX
Substantial Equivalence
The Reliance Lumbar IBF is substantially equivalent to the legally marketed Alphatec NOVEL System (K090782), the Stryker AVS System (K090816), the Globus Patriot System (K093242), the US Surgical Ray Threaded Fusion Cage (P950019), and the Depuy I/F Cage (P960025), The Reliance Lumbar IBF is equivalent to these commercially available devices in terms of material, intended use, levels of attachment, size range, and use with supplemental fixation.
Device Description
The Reliance Lumbar IBF System is comprised of implant and instrument components. The implant component, the Reliance Lumbar IBF device, is a spacer, which inserts between vertebral bodies in the anterior column of the lumbar spine. The spacer is made of PEEK Optima LT1 with Tantalum markers.
Intended Use/Indications for Use
The Reliance Lumbar IBF System, when used as an Intervertebral Body Fusion device, is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.
The Reliance Lumbar IBF System, when used as an Intervertebral Body Fusion device is also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment.
pegn. 1 of 2
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Performance Data and Substantial Equivalence
Mechanical testing was performed on the worst case Reliance Lumbar IBF device following ASTM Standards. Static and Dynamic Compression testing was performing following ASTM Standard F2077-03, Subsidence Testing was performed following ASTM F2267-04, and Static Push-out Testing was performed following ASTM Draft F-04.25.02.02. The Reliance Lumbar IBF was found to be substantially equivalent to the predicate devices.
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the shape of a bird in flight.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Reliance Medical Systems, LLC % Mr. Bret M. Berry 545 West 500 South, Suite 100 Bountiful, Utah 84010
MAR 1 2 2012
Re: K113540
Trade/Device Name: LUMBAR IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: February 20, 2012 Received: February 21, 2012
Dear Mr. Berry:
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
3
Page 2 - Mr. Bret M. Berry
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 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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Mark N. Millers
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K113540
Device Name: Reliance LUMBAR IBF System
Indications for Use:
The Reliance LUMBAR IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device systems are designed for use with autogenous bone graft to facilitate fusion. One device may be used per intervertebral space. The implants are intended to be used with legally cleared supplemental spinal fixation cleared for the implanted level.
The Reliance LUMBAR IBF System, when used as an Intervertebral Body Fusion device is also intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
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KIJ3540 510(k) Number_