(65 days)
No
The device description and intended use focus solely on the mechanical components and surgical application of a spinal fixation system. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is intended for supplemental spinal fixation to achieve fusion in patients with conditions such as degenerative disc disease, trauma, spondylolisthesis, and/or tumor, indicating a therapeutic purpose.
No
The device is described as a "posterior, non-pedicle supplemental fixation device" intended for "achieving supplemental fusion" in the spine. Its purpose is to physically stabilize the spine, not to detect, diagnose, or monitor a medical condition.
No
The device description clearly details physical components (plates, screws) intended for surgical implantation, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The provided text describes a surgical implant (an Interspinous Plate System) used for spinal fixation. It is a physical device implanted into the body to provide structural support and aid in fusion.
- Intended Use: The intended use is for "posterior, non-pedicle supplemental fixation device" in the spine to achieve "supplemental fusion." This is a surgical procedure, not a diagnostic test performed on a sample.
The description clearly indicates a device used in vivo (within the body) for structural support and fusion, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Interspinous Plate System 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 (comma separated list FDA assigned to the subject device)
PEK
Device Description
The Precision Spine Interspinous Plate 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 screws are available in multiple variations of fixed or variable angle. All lengths are provided in Ø4.0mm for primary use, or Ø4.5 mm rescue use. They have self-drilling and selftapping threads. The screws are type II anodized in varying colors depending on the length and diameter. The plate has a tear drop shaped anti-back out mechanism to prevent the screws from backing out. The variable screw has a 4.5 degree cone angulation (9.0 degree total sweep) within the plate. The use of the screws is optional and the intent is to add further fixation to stop implant dislocation/ migration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spine (T1-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)
The Precision Spine Interspinous Plate System has been tested in the following test modes:
- Biomechanical static testing
- Biomechanical dynamic testing
The results of this non-clinical testing show that the strength of the Interspinous Plate System 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name encircling a symbol. The symbol is a stylized representation of human profiles facing right, stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
May 4, 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Precision Spine, Incorporated Mr. Michael C. Dawson Senior Director of Regulatory Affairs/Deputy General Counsel 2050 Executive Drive Pearl, Mississippi 39208
Re: K160568
Trade/Device Name: Precision Spine Interspinous Plate System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: February 29, 2016 Received: February 29, 2016
Dear Mr. Dawson:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 yours,
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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: January 31, 2017 |
| See PRA Statement on last page. |
Indications for Use
| 510(k) Number ( if known ) | K160568 |
|---|---|
| Device Name | Precision Spine Interspinous Plate System |
| Indications for Use (Describe) |
The Interspinous Plate System 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)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (8/14)
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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: | 601-420-4244 ext. 128 |
| Contact Person: | Michael C. Dawson |
| Date Summary was Prepared: | February 25, 2016 |
| Trade or Proprietary Name: | Precision Spine Interspinous Plate 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: | Orthopedic |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Precision Spine Interspinous Plate 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 screws are available in multiple variations of fixed or variable angle. All lengths are provided in Ø4.0mm for primary use, or Ø4.5 mm rescue use. They have self-drilling and selftapping threads. The screws are type II anodized in varying colors depending on the length and diameter. The plate has a tear drop shaped anti-back out mechanism to prevent the screws from backing out. The variable screw has a 4.5 degree cone angulation (9.0 degree total sweep) within the plate. The use of the screws is optional and the intent is to add further fixation to stop implant dislocation/ migration.
INDICATIONS FOR USE
The Interspinous Plate System 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.
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TECHNOLOGICAL CHARACTERISTICS
The Precision Spine Interspinous Plate 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.
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 Number | Trade or Proprietary or Model Name | Manufacturer | Predicate |
|---|---|---|---|
| K151863, K142378 | Interspinous Plate System | Precision Spine | Primary |
| K093438, K112595 | Coflex-F Implant System | Paradigm Spine, LLC |
The subject device differs from the previously cleared version of the device in that optional screw fixation can be employed in addition to the spikes (which are unchanged) to attach the plate to the spinous process. The screws are available in fixed or variable angles in lengths of 10, 12, 14, and 16mm. All lengths are provided in Ø4.0mm diameter for primary use, or Ø4.5 mm rescue use. They have self-drilling and self-tapping threads. The screws are type II anodized in varving colors depending on the length and diameter. The plate has a tear drop shaped antiback out mechanism to prevent the screws from backing out. The variable screw has a 4.5 degree cone angulation (9.0 degree total sweep) within the plate. The use of the screws is optional and the intent is to add further fixation
PERFORMANCE DATA
The Precision Spine Interspinous Plate System has been tested in the following test modes:
- Biomechanical static testing
- . Biomechanical dynamic testing
The results of this non-clinical testing show that the strength of the Interspinous Plate System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Interspinous Plate System is substantially equivalent to the predicate device.