(595 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 an intervertebral body fusion system indicated for the treatment of cervical degenerative disc disease, which involves mitigating symptoms and facilitating fusion, thereby providing a therapeutic effect.
No
The device is an intervertebral body fusion system designed to fuse the spine, not to diagnose a condition.
No
The device description explicitly states that the Reliance Cervical IBF System is comprised of implant and instrument components, and the implant component is a physical spacer made of Titanium. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a system for intervertebral body fusion of the spine. This is a surgical implant used within the body.
- Device Description: The device is described as a spacer that is inserted between vertebral bodies. This is a physical implant.
- No mention of in vitro testing: There is no indication that this device is used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
IVD devices are typically used to test blood, urine, tissue, or other bodily fluids outside of the body. This device is a surgical implant used directly in the spine.
N/A
Intended Use / Indications for Use
The Reliance Cervical IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system devices 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 Cervical IBF System is intended for use at one level in the cervical spine, from C3 to T1, for treatment of cervical degenerative disc disease (DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The Reliance Cervical IBF System is to be used in patients who have six weeks of non-operative treatment.
Product codes
ODP
Device Description
The Reliance Cervical IBF System is comprised of implant and instrument components. The implant component, the Reliance Cervical IBF device, is a spacer which inserts between vertebral bodies in the anterior column of the cervical spine. The subject Reliance Cervical IBF spacer is additively manufactured from Titanium 6A1-4V ELI as specified in ASTM F3001, with predicate spacers manufactured from PEEK Optima LT1 or PEEK Optima LT1-HA.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, from C3 to T1
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)
The Reliance Cervical IBF device was subjected to performance testing that followed ASTM F2077-18 and F2267-04 (2018) standards. Additionally, the porous lattice structures within the implants presented a new worst-case scenario for sterilization, cleaning and packaging. Therefore, packaging testing was performed according to the following ASTM standards: D4169, D4332, F88, F1886 and F2096, and cleaning validation in accordance to the following ASTM standards: F2459 and F2847. Sterilization was performed to the following standards: ANSI/AAMI/ISO 11137-1:2006/A1:2013/A2:2019, ANSI/AAMI/ISO 11137-2:2013, ANSI/AAMI/ISO 11737-1:2006, ANSI/AAMI/ISO 11737-2:2009, and ANSI/AAMI/ISO TIR13004:2013. The Reliance Cervical IBF System is substantially equivalent to the predicate devices in terms of biocompatibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K173102, K120396, K131429, K172489, K171140
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
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March 29, 20222
Reliance Medical Systems, LLC Bret Berry Owner P.O. Box 1693 Bountiful, Utah 84010
Re: K202266
Trade/Device Name: Reliance Cervical IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: February 24, 2022 Received: February 28, 2022
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. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202266
Device Name Reliance Cervical IBF System
Indications for Use (Describe)
The Reliance Cervical IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system devices 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 Cervical IBF System is intended for use at one level in the cervical spine, from C3 to T1, for treatment of cervical degenerative disc disease (DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The Reliance Cervical IBF System is to be used in patients who have six weeks of non-operative treatment.
Type of Use (Select one or both, as applicable) | |
---|---|
------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Reliance Medical Systems, LLC 545 West 500 South Suite 100 Bountiful, UT 84010 Telephone: (801) 295-3280 Fax: (801) 294-0079
Contact: Bret M. Berry, Member-Manager 510(k) Number: K202266 Common or Usual Name: Intervertebral Body Fusion Device Proposed Proprietary or Trade Name: Reliance Cervical IBF System Classification Name: Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Product Code: ODP
Substantial Equivalence:
The subject Reliance Cervical IBF System is substantially equivalent to the legally marketed predicate devices, the Reliance Cervical IBF System (K120396/K131429/K172489/ K173102, with K173102 as the primary predicate) and the Nexxt Spine Matrixx System (K171140). The subject Reliance Cervical IBF System is equivalent to its commercially available predicates in terms of intended use, indications for use, design, function, principle of operation, materials, levels of attachment, size range, strength and use with supplemental fixation.
Device Description:
The Reliance Cervical IBF System is comprised of implant and instrument components. The implant component, the Reliance Cervical IBF device, is a spacer which inserts between vertebral bodies in the anterior column of the cervical spine. The subject Reliance Cervical IBF spacer is additively manufactured from Titanium 6A1-4V ELI as specified in ASTM F3001, with predicate spacers manufactured from PEEK Optima LT1 or PEEK Optima LT1-HA.
Intended Use / Indications for Use:
The Reliance Cervical IBF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system devices 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.
29 March 2022
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The Reliance Cervical IBF System is intended for use at one level in the cervical spine, from C3 to T1, for treatment of cervical degenerative disc disease (DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The Reliance Cervical IBF System is to be used in patients who have six weeks of non-operative treatment.
Technological Modifications:
The subject Reliance Cervical IBF system offers intervertebral body spacers in an additional material, Titanium 6A1-4V ELI. There have been no changes to intended use, indications for use, function, principle of operation, sizes or size range, levels of attachment, or method of insertion.
Performance Data and Substantial Equivalence:
The Reliance Cervical IBF device was subjected to performance testing that followed ASTM F2077-18 and F2267-04 (2018) standards. Additionally, the porous lattice structures within the implants presented a new worst-case scenario for sterilization, cleaning and packaging. Therefore, packaging testing was performed according to the following ASTM standards: D4169, D4332, F88, F1886 and F2096, and cleaning validation in accordance to the following ASTM standards: F2459 and F2847. Sterilization was performed to the following standards: ANSI/AAMI/ISO 11137-1:2006/A1:2013/A2:2019, ANSI/AAMI/ISO 11137-2:2013, ANSI/AAMI/ISO 11737-1:2006, ANSI/AAMI/ISO 11737-2:2009, and ANSI/AAMI/ISO TIR13004:2013. The Reliance Cervical IBF System is substantially equivalent to the predicate devices in terms of biocompatibility.