(114 days)
Not Found
No
The description focuses on the mechanical design and function of a physical implant for spinal fixation and fusion. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML.
Yes
The device is intended for the purpose of achieving supplemental fusion in various conditions related to the spine, indicating its use in treating and managing a medical condition.
No
The device is described as a "posterior, non-pedicle supplemental fixation device" intended for "achieving supplemental fusion" in the spine. It is a surgical implant designed to provide structural support, not to diagnose medical conditions.
No
The device description clearly outlines physical components (ISP female plate and ISP male plate) made of materials designed for surgical implantation and mechanical fixation to bone. There is no mention of software as a component of the device itself.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided description clearly states that the Interspinous Plate System is a surgical implant used for posterior fixation of the spine to achieve fusion. It is a physical device implanted into the body.
- Intended Use: The intended use is for supplemental fixation in the spine for conditions like degenerative disc disease, trauma, spondylolisthesis, and tumor. This is a therapeutic and structural purpose, not a diagnostic one based on analyzing bodily specimens.
The information provided describes a surgical implant, not a device used for testing samples outside the body.
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.
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)
The Precision Spine Interspinous Plate System has been tested in the following test modes:
- Static axial compression per ASTM F1717-13
- Static torsion per ASTM F1717-13
- Dynamic axial compression per ASTM F1717-13
- Static axial pull-out
- Static plate dissociation
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.
K133363, K073278, K131238, K123093, K100354, K122509
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.
Not Found
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.
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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol representing the human form, depicted as three stylized profiles facing to the right. The profiles are connected and flow together, creating a sense of unity and collaboration.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18, 2014
Precision Spine % Mr. Kenneth C. Maxwell II Empirical Testing Corporation 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K142378
Trade/Device Name: Interspinous Plate System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: November 14, 2014 Received: November 20, 2014
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
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 | ||||
| Indications for Use | Expiration Date: January 31, 2017 | |||
| See PRA Statement on last page. | ||||
| 510(k) Number (if known) | ||||
| K142378 | ||||
| Device Name | ||||
| 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. | ||||
| I ype of Use (Select one or both, as applicable) |
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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This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration
Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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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: | 11 December 2014 |
| 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: | 87 Orthopedics |
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.
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.
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 35-55mm.
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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: Primary Predicate Device
| 510k Number | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| K133363 | InterBRIDGE Interspinous Posterior | |
| Fixation System | LDR Spine USA, Inc. |
Table 5-2: Additional Predicate Devices
| 510k Number | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| K073278, K131238 | Affix Spinous Process Plate System | NuVasive® |
| K123093 | StabiLink™ MIS Spinal Fixation System | Southern Spine |
| K100354 | PrimaLOK™ Interspinous Fusion System | OsteoMed |
| K122509 | Spinous Process Fixation Plate | VertiFlex® |
PERFORMANCE DATA
The Precision Spine Interspinous Plate System has been tested in the following test modes:
- Static axial compression per ASTM F1717-13 ●
- Static torsion per ASTM F1717-13 ●
- Dynamic axial compression per ASTM F1717-13 ●
- Static axial pull-out ●
- Static plate dissociation
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.