(61 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 int he lumbar spine, from L2 to S1, for the treatment of degenerative dise 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 radios. 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 either made of PEEK OPTIMA LT1 with Tantalum markers or with PEEK OPTIMA LT1-HA with Tantalum markers.
The provided text appears to be a 510(k) summary for a medical device called the "Reliance Lumbar IBF System." This type of document is submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific clinical performance acceptance criteria in the way a diagnostic AI model might.
Therefore, much of the requested information regarding acceptance criteria, device performance tables, sample sizes for test/training sets, expert ground truth, adjudication methods, and MRMC studies is not applicable to this document as it describes a structural intervertebral body fusion device, not a diagnostic algorithm.
The document primarily focuses on demonstrating substantial equivalence through non-clinical testing (mechanical and material properties) and comparison to predicate devices, rather than clinical efficacy involving human readers or AI.
Here's an attempt to answer the applicable questions based on the provided text:
1. A table of acceptance criteria and the reported device performance
This information is not presented in a table format in the document, nor are there explicit "acceptance criteria" for clinical performance in the sense of accuracy, sensitivity, or specificity for a diagnostic device. The document states that the "design verification testing results were equivalent to the identified predicate device" and "results show that the subject implants do not create a new worst case condition for mechanical testing, performance testing, sterilization, biocompatibility, cleaning or packaging."
The non-clinical testing involved various ASTM Standard tests and Finite Element Analysis (FEA).
The acceptance criterion for the FEA was that the new components "are not the new worst case when compared to the approved Reliance Lumbar IBF component."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This device is an implantable medical device, and the testing described is non-clinical (mechanical, material, and sterilization). There are no "test sets" of patient data in the context of an AI or diagnostic study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not a diagnostic device requiring expert interpretation of results. The "ground truth" for non-clinical testing would be the physical properties and performance metrics measured according to established engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no "test set" or adjudication method in the context of clinical interpretation for this device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical testing, the "ground truth" would be established by:
- ASTM Standard Tests: Results measured according to specific, recognized engineering standards for material strength, fatigue, etc.
- Predicate Device Performance: The established mechanical and performance characteristics of the legally marketed predicate devices (K113540, K160463 & K173283).
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this type of device and testing.
9. How the ground truth for the training set was established
Not applicable.
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Reliance Medical Systems Bret Berry Member-Manager 545 West 500 South Suite 100 Bountiful, Utah 84010
May 15, 2018
Re: K180687
Trade/Device Name: Reliance Lumber IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: April 13, 2018 Received: April 16, 2018
Dear Bret 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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-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,
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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Indications for Use
510(k) Number (if known) K180687
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 int he lumbar spine, from L2 to S1, for the treatment of degenerative dise 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 radios. 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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510(k) Summary
Bret M. Berry 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:
Product Code: Date:
Intervertebral Body Fusion Device Reliance Lumbar IBF System Class II, Intervertebral Body Fusion Device 21 CFR 888.3080 MAX 05/09/2018
Substantial Equivalence
The Reliance Lumbar IBF is substantially equivalent to the legally marketed, primary predicate device, Reliance Lumbar IBF System (K113540, K160463 & K173283). The subject devices have same size & configurations as the predicate devices. Subject devices differ in terms of material used and method of sterilization.
It's 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 either made of PEEK OPTIMA LT1 with Tantalum markers or with PEEK OPTIMA LT1-HA 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
The RELIANCE Lumbar IBF System (K113540) has undergone Non-Clinical Testing using various ASTM Standard tests at a third party facility. The subject Reliance Lumbar IBF System has the same design, sizes, indication of use & biocompatibility as the predicate devices.
Finite Element Analysis has been carried out to access the effect of new material on the structural properties of the implant. Test results show the new components are not the new worst case when compared to the approved Reliance Lumbar IBF component, 1-04-XXX, per K113540.
Technological Modifications
The subject Reliance Lumbar IBF system offers additional components. These new components differ in terms of material & sterilization method. LAL testing to test the pyrogen levels have been performed & the specifications have been met.
The Reliance Lumbar IBF System components will be sold either non-sterile or sterile.
All implants under Reliance Lumbar IBF System made out of PEEK Optima LT1 or PEEK Optima LT1-HA which are intended to be sold non-sterile, will be shipped nonsterile and can be steam sterilized. For the non-sterile components, directions for steam sterilization are provided in the package insert, which accompanies the product.
All implants under Reliance Lumbar IBF System made out of PEEK Optima LT1 or PEEK Optima LT1-HA which are intended to be sold sterile, will be sterilized using Gamma Irradiation before shipping.
The subject Reliance Lumabr IBF System will have same indication of use as the currently approved Reliance Lumbar IBF System (K113540 & 160463).
Finite Element Analysis (FEA) was performed on the subject components (Reliance Lumbar IBF-HA System) using Solidworks software and was compared to the test results of the worst case component (1-04-XXX) approved per K113540.
The design verification testing results were equivalent to the identified predicate device and results show that the subject implants do not create a new worst case condition for mechanical testing, performance testing, sterilization, biocompatibility, cleaning or packaging. Sterilization method for subject components intended to be sold sterile, was validated.
§ 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.