(30 days)
Not Found
No
The device description and intended use focus on mechanical fixation and do not mention any AI/ML capabilities or data processing.
Yes
The device is described as a "posterior, non-pedicle supplemental fixation device" intended "for the purpose of achieving supplemental fusion" for various medical conditions, indicating its use in treating a health issue.
No
The device is a posterior, non-pedicle supplemental fixation device for spinal fusion, not for diagnosing conditions.
No
The device description clearly states it consists of physical plates (ISP female plate and ISP male plate) made of materials that interface with bone, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fixation to achieve fusion. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is described as plates designed to be surgically implanted and attached to the spinous processes. This is a physical device used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
The Reli SP Spinous Plating System of Precision Spine, Inc. is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1) of skeletally mature patients. It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), trauma (i.e. fracture or dislocation), spondylolisthesis, and/or tumor. It is not intended for stand-alone use.
Product codes
PEK
Device Description
The Precision Spine Reli SP Spinous Plating System consists of an ISP female plate and an ISP male plate for posterior fixation of the spine in order to achieve fusion. The ISP female plate and an ISP male plate are available in multiple sizes to accommodate various patient anatomies. The ISP female plate and an ISP male plate feature teeth to interface with the bone of the spinous processes. The ISP male plate is passed through the insert such that, in their final position, the ISP female plate and an ISP male plate surround the spinous processes on both sides, and fixation is achieved via compression of the two components onto the spinous processes. The purpose of this submission is to offer an expanded size range for the Reli SP Spinous Plating System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spine (T1-S1), spinous process
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)
Precision Spine has not conducted mechanical testing as part of this Special 510(k) Device Modification Premarket Notification. An analysis was performed to determine the subject implants were substantially equivalent to the predicate devices, therefore no mechanical testing was conducted as part of this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring three stylized human profiles facing to the right, representing health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 7, 2015
Precision Spine, Incorporated % Mr. Kenneth C. Maxwell II Regulatory and Quality Specialist Empirical Testing, Corporation 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K151863
Trade/Device Name: Reli SP Spinous Plating System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: July 7, 2015 Received: July 8, 2015
Dear Mr. Maxwell:
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 - Mr. Kenneth C. Maxwell II
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/ResourcesforYou/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 yours, Lori A. Wiggins -S
for
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
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known)
Device Name
Reli SP Spinous Plating System
Indications for Use (Describe)
The Reli SP Spinous Plating System of Precision Spine, Inc. is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1) of skeletally mature patients. It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), trauma (i.e. fracture or dislocation), spondylolisthesis, and/or tumor. It is not intended for stand-alone use.
Type of Use (Select one or both, as applicable)
□ Over-The-Counter Use (21 CFR 801 Subpart C) 区 Prescription Use (Part 21 CFR 801 Subpart D) PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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5.510(K) SUMMARY
| Submitter's Name: | Precision Spine |
|---|---|
| Submitter's Address: | 2050 Executive Drive |
| Pearl, MS 39208 | |
| Submitter's Telephone: | 973-455-7150 |
| Contact Person: | Kenneth C Maxwell II |
| Empirical Testing Corp. | |
| 904.392.7576 | |
| Date Summary was Prepared: | 06 Aug 2015 |
| Trade or Proprietary Name: | Reli SP Spinous Plating System |
| Common or Usual Name: | Spinous Process Plate |
| Classification: | Class II per 21 CFR §888.3050 |
| Spinal interlaminal fixation orthosis | |
| Product Code: | PEK |
| Classification Panel: | 87 Orthopedics |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Precision Spine Reli SP Spinous Plating System consists of an ISP female plate and an ISP male plate for posterior fixation of the spine in order to achieve fusion. The ISP female plate and an ISP male plate are available in multiple sizes to accommodate various patient anatomies. The ISP female plate and an ISP male plate feature teeth to interface with the bone of the spinous processes. The ISP male plate is passed through the insert such that, in their final position, the ISP female plate and an ISP male plate surround the spinous processes on both sides, and fixation is achieved via compression of the two components onto the spinous processes. The purpose of this submission is to offer an expanded size range for the Reli SP Spinous Plating System.
INDICATIONS FOR USE
The Reli SP Spinous Plating System of Precision Spine, Inc. is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1) of skeletally mature patients. It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), trauma (i.e. fracture or dislocation), spondylolisthesis, and/or tumor. It is not intended for stand-alone use.
TECHNICAL CHARACTERISTICS
The Precision Spine Reli SP Spinous Plating System is 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 total heights of 28-55mm.
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Reli SP Spinous Plating System is made from material that conforms to ASTM F136. 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 ●
Table 5-1 Predicate Devices
| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Type |
|---|---|---|---|
| K142378 | Interspinous Plate System | Precision Spine | Primary |
| K130438 | Axle Interspinous Fusion System | Spine-X | Additional |
PERFORMANCE TESTING SUMMARY
Precision Spine has not conducted mechanical testing as part of this Special 510(k) Device Modification Premarket Notification. An analysis was performed to determine the subject implants were substantially equivalent to the predicate devices, therefore no mechanical testing was conducted as part of this submission.
CONCLUSION
The subject modified is the Reli SP Spinous Plating System and is very similar to previously cleared Reli SP Spinous Plating System. The subject Reli SP Spinous Plating System has the same intended uses, indications, technological characteristics, and principles of operation as the predicate devices. The modifications raise no new types of safety or effectiveness questions. The overall technology characteristics lead to the conclusion that the Reli SP Spinous Plating System is substantially equivalent to the predicate devices.