(91 days)
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 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.
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.
The provided documents are a 510(k) Pre-market Notification from the FDA regarding the "Reliance Lumbar IBF System." This document primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study of its own performance against specific acceptance criteria.
Therefore, the requested information about acceptance criteria and a study proving the device meets them, particularly regarding AI or algorithm performance, cannot be extracted from this document because:
- The device is a physical medical implant (intervertebral body fusion device), not an AI/software device. This type of device does not have "acceptance criteria" in the sense of performance metrics for an algorithm (e.g., sensitivity, specificity, AUC). Its acceptance is based on meeting mechanical and material specifications, biocompatibility, and substantial equivalence to existing devices.
- The document describes "Non-Clinical Testing" which is Finite Element Analysis (FEA). This is a computational method to analyze the mechanical behavior of the additional components, ensuring they do not create a "new worst-case scenario" compared to the predicate device. It's not a study with a test set, ground truth, experts, or statistical performance metrics.
- There is no mention of an algorithm, AI, human readers, or any form of software performance evaluation.
The document does state:
- Device Name: Reliance Lumbar IBF System
- Regulation Number: 21 CFR 888.3080
- Regulation Name: Intervertebral body fusion device
- Product Code: MAX
- Predicate Devices: Reliance Lumbar IBF System (K113540) and Globus Patriot TransContinental System (K093242, K102313).
- Intended Use/Indications for Use: Intervertebral body fusion of the spine in skeletally mature patients, with autogenous bone graft, intended for the lumbar spine (L2 to S1) for treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis.
- Device Description: Made of PEEK OPTIMA LT1 with Tantalum markers.
- Non-Clinical Testing: Finite Element Analysis (FEA) was performed on additional components using Solidworks software and compared to test results of already approved components per K113540. No new components create a new worst-case scenario.
In summary, none of the requested information regarding algorithm-specific acceptance criteria, study design parameters (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance), or training set details can be provided from this document as it pertains to a physical implant and not an AI/software medical device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 20, 2016
Reliance Medical Systems, LLC Mr. Bret M. Berry Owner 545 West 500 South, Suite 100 Bountiful, Utah 84010
Re: K160463
Trade/Device Name: Reliance Lumbar IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: April 27, 2016 Received: April 28, 2016
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 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/Resourcesfor You/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 yours,
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name RELIANCE LUMBAR IBF SYSTEM
Indications for Use (Describe)
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 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.
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)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
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FORM FDA 3881 (8/14)
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510(k) Summary
Reliance Medical Systems 545 South 500 West Suite 100 Bountiful, UT 84010 Telephone: 801-388-0700 801-294-0079 Fax:
Bret M. Berry Contact: Member-Manager
Common or Usual Name: Proposed Proprietary or Trade Name: Classification Name:
Intervertebral Body Fusion Device Reliance Lumbar IBF System Intervertebral Body Fusion Device
21 CFR 888.3080 MAX
Date: 04/26/2016
Product Code:
Substantial Equivalence
The Reliance Lumbar IBF is substantially equivalent to the legally marketed, primary predicate device, Reliance Lumbar IBF System (K113540). The subject devices have similar geometry and larger sizes to the predicate devices.
Reliance Lumbar IBF system also substantially equivalent to the legally marketed, secondary predicate device, Globus Patriot TransContinental System (K093242, K102313).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 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
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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.
Non-Clinical Testing
Finite Element Analysis (FEA) was done on the additional components of the Reliance Lumbar IBF implant using Solidworks software and was compared to the test results of the already approved components per K113540. None of the new components create a new worst case scenario.
Technological Modifications
The subject Reliance Lumbar IBF system offers additional components. The subject devices have similar geometry and larger sizes to the predicate devices. The subject Reliance Lumbar IBF system is substantially equivalent to the predicate devices in terms of sterilization and bicompatibility.
§ 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.