K Number
K142217
Device Name
Reliance Interspinous Plate System
Date Cleared
2015-04-02

(233 days)

Product Code
Regulation Number
888.3050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Reliance Interspinous Plate System is a supplemental fixation device intended as an adjunct to fusion of the thoracolumbar (T1- S1) spine by fixation to the spinous processes in skeletally mature patients, and is indicated for the following: - degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) - spondylolisthesis - trauma (i.e., fracture or dislocation) - tumors This device is not intended for stand-alone use.
Device Description
The Reliance Interspinous Plate System consists of an interspinous process spacer-plate and process lock plate assembly for posterior fixation of the spine in order to achieve fusion. The interspinous process spacer-plate and process lock plate are available in multiple sizes to accommodate various patient anatomies. The insert features a lateral plate with teeth to interface with the bone of the spinous processes. The process lock plate also features teeth which contact the bone of the spinous processes. The process lock plate is passed through the insert such that, in their final position, interspinous process spacer-plate and process lock plate surround the spinous processes on both sides, and fixation is achieved via compression of the two components onto the spinous processes.
More Information

Not Found

No
The device description and performance studies focus on the mechanical properties and structural integrity of a physical implant for spinal fusion. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.

Yes
The device is described as a "supplemental fixation device intended as an adjunct to fusion of the thoracolumbar (T1- S1) spine by fixation to the spinous processes," which directly indicates a therapeutic purpose.

No

Explanation: The device is described as a "supplemental fixation device intended as an adjunct to fusion" and is used for treating conditions like "degenerative disc disease," "spondylolisthesis," "trauma," and "tumors." Its purpose is to achieve posterior fixation of the spine, not to identify or diagnose medical conditions.

No

The device description clearly outlines physical components (interspinous process spacer-plate and process lock plate assembly) made of materials intended for surgical implantation and fixation to the spine. This is a hardware device, not software.

Based on the provided information, the Reliance Interspinous Plate System is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The description of the Reliance Interspinous Plate System clearly states it is a supplemental fixation device intended for surgical implantation in the spine to aid in fusion.
  • The intended use and device description focus on mechanical support and fixation within the body. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
  • The performance studies described are mechanical tests (static and dynamic compression, torsion, pull-out, dissociation) which are relevant to the structural integrity and function of an implantable device, not an IVD.

Therefore, the Reliance Interspinous Plate System is a surgical implant/device, not an IVD.

N/A

Intended Use / Indications for Use

The Reliance Interspinous Plate System is a supplemental fixation device intended as an adjunct to fusion of the thoracolumbar (T1- S1) spine by fixation to the spinous processes in skeletally mature patients, and is indicated for the following:

  • degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)

  • spondylolisthesis

  • trauma (i.e., fracture or dislocation)

  • tumors

This device is not intended for stand-alone use.

Product codes

PEK

Device Description

The Reliance Interspinous Plate System consists of an interspinous process spacer-plate and process lock plate assembly for posterior fixation of the spine in order to achieve fusion. The interspinous process spacer-plate and process lock plate are available in multiple sizes to accommodate various patient anatomies. The insert features a lateral plate with teeth to interface with the bone of the spinous processes. The process lock plate also features teeth which contact the bone of the spinous processes. The process lock plate is passed through the insert such that, in their final position, interspinous process spacer-plate and process lock plate surround the spinous processes on both sides, and fixation is achieved via compression of the two components onto the spinous processes.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

thoracolumbar (T1- S1) spine

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 Interspinous Plate System has been tested in the following test modes:

  • Static axial compression per ASTM F1717-13
  • Static torsion per ASTM F1717-13
  • Static axial pull-out per ASTM F1717-13 ●
  • Dynamic axial compression per ASTM F1717-13 .
  • . Static plate dissociation

The results of this non-clinical testing show that the strength of the Reliance Medical Interspinous Plate is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K100354, K133363, K073278, K131238, K123093, K122509

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most complete and the bottom profile being the least complete.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 2, 2015

Reliance Medical Systems, LLC % Meredith L. May, MS, RAC Empirical Consulting, LLC 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K142217

Trade/Device Name: Reliance Interspinous Plate System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: February 19, 2015 Received: February 20, 2015

Dear Ms. May:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

1

Page 2 - Meredith L. May, MS, RAC

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" (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.

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 vours.

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) K142217

Device Name Reliance Interspinous Plate System

Indications for Use (Describe)

The Reliance Interspinous Plate System is a supplemental fixation device intended as an adjunct to fusion of the thoracolumbar (T1- S1) spine by fixation to the spinous processes in skeletally mature patients, and is indicated for the following:

  • degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)

  • spondylolisthesis

  • trauma (i.e., fracture or dislocation)

  • tumors

This device is not intended for stand-alone use.

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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Submitter's Name:Reliance Medical Systems, LLC
Submitter's Address:545 West 500 South Suite 100
Bountiful, UT 84010
Submitter's Telephone:(801) 295-3280
Contact Person:Meredith L. May, MS, RAC
Empirical Consulting, LLC
719.337.7579
Date Summary was Prepared:31 March 2015
Trade or Proprietary Name:Reliance Interspinous Plate System
Common or Usual Name:Spinous Process Plate
Classification:Class II per 21 CFR §888.3050
Product Code:PEK
Classification Panel:Orthopedic (87)

5.510(K) SUMMARY

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The Reliance Interspinous Plate System consists of an interspinous process spacer-plate and process lock plate assembly for posterior fixation of the spine in order to achieve fusion. The interspinous process spacer-plate and process lock plate are available in multiple sizes to accommodate various patient anatomies. The insert features a lateral plate with teeth to interface with the bone of the spinous processes. The process lock plate also features teeth which contact the bone of the spinous processes. The process lock plate is passed through the insert such that, in their final position, interspinous process spacer-plate and process lock plate surround the spinous processes on both sides, and fixation is achieved via compression of the two components onto the spinous processes.

INDICATIONS FOR USE

The Reliance Interspinous Plate System is a supplemental fixation device intended as an adjunct to fusion of the thoracolumbar (T1- S1) spine by fixation to the spinous processes in skeletally mature patients, and is indicated for the following:

  • Degenerative disc disease (defined as back pain of discogenic origin with ● degeneration of the disc confirmed by patient history and radiographic studies)
  • spondylolisthesis ●
  • trauma (i.e., fracture or dislocation) .
  • tumors ●

This device is not intended for stand-alone use.

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The indications for use for the Reliance Medical Interspinous Plate is similar to that of the predicates listed in Table 5-1 below.

TECHNOLOGICAL CHARACTERISTICS

The interspinous process spacer-plate and process lock plate are manufactured from medical grade Titanium (Ti 6Al-4V) per ASTM F136. The implants are provided non-sterile with instructions for sterilization. The interspinous plates are designed in interspinous heights of 18mm, total heights of 35-50mm, and widths of 25-30.

The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:

  • Indications for Use
  • Materials of manufacture ●
  • Structural support mechanism ●
  • Sterilization

Table 5-1 Predicate Devices

510k NumberTrade or Proprietary or Model NameManufacturerPredicate Type
K133363Interspinous Posterior Fixation SystemInterBRIDGEAdditional
K073278,
K131238Affix Spinous Process Plate SystemNuVasive®Additional
K123093StabiLink™ MIS Spinal Fixation SystemSouthern SpineAdditional
K100354PrimaLOK™ Interspinous Fusion SystemOsteoMedPrimary
K122509Spinous Process Fixation PlateVertiFlex®Additional

Performance Data

The Reliance Interspinous Plate System has been tested in the following test modes:

  • Static axial compression per ASTM F1717-13
  • Static torsion per ASTM F1717-13
  • Static axial pull-out per ASTM F1717-13 ●
  • Dynamic axial compression per ASTM F1717-13 .
  • . Static plate dissociation

The results of this non-clinical testing show that the strength of the Reliance Medical Interspinous Plate is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

5

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Reliance Interspinous Plate System is substantially equivalent to the predicate device.