(257 days)
No
The summary describes a physical implant and surgical instruments, 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, specifically for the treatment of degenerative disc disease, which implies it directly treats a medical condition.
No
This device is an implantable intervertebral body fusion system, designed to facilitate spinal fusion, not to diagnose a condition.
No
The device description explicitly states the system is comprised of physical implants (spacers, screws, faceplates, locking plates) and associated surgical instruments, which are hardware components.
Based on the provided text, 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 the Reliance Lumbar IBF System is a physical implant (spacers, screws, plates) intended for surgical implantation in the lumbar spine to facilitate bone fusion. It is a therapeutic device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's condition based on laboratory analysis.
The device is a surgical implant used to treat a specific condition (degenerative disc disease with spondylolisthesis) by providing structural support and promoting bone fusion. This falls under the category of a medical device, but not an in vitro diagnostic device.
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. Additional supplemental fixation is not necessary for the Lumbar IBF-S if the integrated screws are implanted.
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
OVD, MAX
Device Description
The Reliance Lumbar IBF System is comprised of lumbar intervertebral body fusion devices and associated surgical instruments. This submission adds a line extension, the Reliance Lumbar IBF-S devices, which consist of spacers made of PEEK Optima LT1 with Tantalum markers, and integrated screws, faceplates, and locking plates manufactured from titanium alloy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine, lumbar spine, 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 (footprint) Reliance Lumbar IBF device following ASTM Standards. Static and Dynamic Axial Compression and Compression Shear testing was performing following ASTM Standard F2077-03, Subsidence Testing was performed following ASTM F2267-04, and Static Push-out Testing was performed. 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)
Reliance Lumbar IBF (K113540, K160463)
Reference Device(s)
Globus Intercontinental Plate-Spacer (K103382), Globus Independence Spacer (K120101), K2M Chesapeake System (120031), Lanx Fusion System (K131547), Synthes SynFix (K131276)
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
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January 9, 2019
Reliance Medical Systems, LLC Mr. Bret M. Berry Member-Manager 545 West 500 South, Suite 100 Bountiful, Utah 84010
Re: K181118
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: OVD, MAX Dated: December 17, 2018 Received: December 20, 2018
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Melissa Hall -S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181118
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. Additional supplemental fixation is not necessary for the Lumbar IBF-S if the integrated screws are implanted.
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.
| 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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3. 510(k) Summary
510(k) Summary
Date: 17th December 2018 Reliance Medical Systems, LLC 545 West 500 South, Suite 100 Bountiful, UT 84010 801-295-3280 Telephone: Fax: 801-294-0074 Bret M. Berry Contact:
Member-Manager
Common or Usual Name: Intervertebral Body Fusion Device Proposed Proprietary or Trade Name: Reliance Lumbar IBF System Classification Name: Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Product Code: OVD, MAX
Substantial Equivalence
The Reliance Lumbar IBF is substantially equivalent to the legally marketed primary predicate Reliance Lumbar IBF (K113540, K160463) and to the secondary predicate devices Globus Intercontinental Plate-Spacer (K103382). Globus Independence Spacer (K120101). K2M Chesapeake System (120031), Lanx Fusion System (K131547) and Synthes SynFix (K131276). 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 lumbar intervertebral body fusion devices and associated surgical instruments. This submission adds a line extension, the Reliance Lumbar IBF-S devices, which consist of spacers made of PEEK Optima LT1 with Tantalum markers, and integrated screws, faceplates, and locking plates manufactured from titanium alloy.
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. Additional supplemental fixation is not necessary for the Lumbar IBF-S if the integrated screws are implanted.
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
4
and radiographic studies. The lumbar device is to be used in patients who have had six months of non-operative treatment.
Performance Data and Substantial Equivalence
Mechanical testing was performed on the worst case (footprint) Reliance Lumbar IBF device following ASTM Standards. Static and Dynamic Axial Compression and Compression Shear testing was performing following ASTM Standard F2077-03, Subsidence Testing was performed following ASTM F2267-04, and Static Push-out Testing was performed. The Reliance Lumbar IBF was found to be substantially equivalent to the predicate devices.