(429 days)
No
The device description and performance studies focus on mechanical properties and surgical implantation, with no mention of AI or ML.
Yes
The device is described as an implantable system intended for "supplemental fusion" in conditions like degenerative disc disease, spondylolisthesis, trauma, and spinal tumor, which clearly points to a therapeutic purpose by treating or alleviating a medical condition.
No
The document states that the device is a "posterior non-pedicle supplemental fixation system" for "achieving supplemental fusion" in the spine. It is an implantable spacer. Its purpose is to fix spine issues, not to diagnose them.
No
The device description clearly states it is an implantable spacer made of Ti-6Al-4V ELI, a physical hardware component.
Based on the provided information, 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 Integra Spinous Process System is an implantable device made of metal (Ti-6Al-4V ELI) designed to be surgically attached to the spinous processes of the spine.
- Intended Use: Its intended use is for posterior non-pedicle supplemental fixation in the spine to achieve supplemental fusion in specific conditions. This is a surgical intervention, not a diagnostic test performed on a sample.
The description clearly indicates a physical implant used in surgery, not a device for analyzing biological samples.
N/A
Intended Use / Indications for Use
Integra Spinous Process System is a posterior non-pedicle supplemental fixation system intended for use at a single level in the non-cervical spine (T1- S1). It is intended for plate fixation/ attachment to the spinous processes 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)
- spondylolisthesis
- trauma (i.e., fracture or dislocation)
- spinal tumor
The device is not intended for stand-alone use.
Product codes
PEK
Device Description
The Integra Spinous Process System consists of an implantable spacer featuring plates of varying lengths with fixed hub diameters and set screws in order to clamp bilaterally to the spinous processes. It is a multicomponent device consisting of two plates coupled by a central hub and locked by a set screw. Each plate contains spikes for fixation to the spinous process to aid in resisting rotation after implantation. The device is available in a range of sizes to accommodate variations in patient pathology and anatomy. It is manufactured from Ti-6Al-4V ELI per ASTM F136. The device is provided non-sterile and is single use only. The complete system, including insertion and accessory instrumentation for implantation, is packaged in a tray for transportation, cleaning and sterilization.
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 processes
Indicated Patient Age Range
Not Found
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)
Performance testing and a detailed engineering analysis were provided to demonstrate substantial equivalence with respect to compression bending and torsion. Test standards referenced were ASTM F1717 and ASTM F1798. Analysis and interpretation of the test results and device comparisons demonstrate that the Integra device is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K100407, K073278, K090252, K083581, K043484, K032037
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.
0
Integra Spinous Process System Premarket Notification
K121924
Page 1 of 2
.
510(k) Summary
| Company Name: | SeaSpine, Inc.
An Integra Life Sciences Company
2302 La Mirada Drive
Vista, CA 92081 |
|------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information: | Nicholas M. Cordaro, Director of Engineering
E-mail: Nick.Cordaro@integralife.com
Phone: (760) 727-8399, Fax: (760) 477-8260 |
| | Michelle Willis, Director of Regulatory Affairs
Email: Michelle.Willis@integralife.com
Phone: (760) 216-5104, Fax: (760) 727-8891 |
| Date Prepared: | August 23, 2013 |
| Trade Name:
Common Name:
Classification Name:
Classification:
Product Codes: | Integra Spinous Process System
Spinous Process System
Spinal Interlaminal Fixation Orthosis
21 CFR 888.3050, Class II
PEK |
| Device Description: | The Integra Spinous Process System consists of an implantable spacer featuring
plates of varying lengths with fixed hub diameters and set screws in order to
clamp bilaterally to the spinous processes. It is a multicomponent device
consisting of two plates coupled by a central hub and locked by a set screw.
Each plate contains spikes for fixation to the spinous process to aid in resisting
rotation after implantation. The device is available in a range of sizes to
accommodate variations in patient pathology and anatomy. It is manufactured
from Ti-6Al-4V ELI per ASTM F136. The device is provided non-sterile and is
single use only. The complete system, including insertion and accessory
instrumentation for implantation, is packaged in a tray for transportation,
cleaning and sterilization. |
| Intended Use: | Integra Spinous Process System is a posterior non-pedicle supplemental
fixation system intended for use at a single level in the non-cervical spine (T1-
S1). It is intended for plate fixation/ attachment to the spinous processes 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) - spondylolisthesis
- trauma (i.e., fracture or dislocation)
- spinal tumor |
| | The device is not intended for stand-alone use. |
| • Predicate Devices: | Integra Spinous Process System is substantially equivalent, in whole or in part,
to the following commercially available predicate devices in design, materials,
indications and performance: |
| | Life Spine Interspinous Fixation System K100407
NuVasive® Spinous Process Plate System K073278 |
1
510(k) Summary
Page 2 of 2
4
Lanx Spinous Process Fusion Plate (SPFP) K090252; K083581; K043484 Medtronic CD Horizon Spinous Process Plate K032037
The technological characteristics of the Integra Spinous Process device are the Technological same as the referenced devices in that it is composed of two clamping plates, a Characteristics: locking set screw, various hub diameters and Ti-6AL-4V per ASTM F136.
Performance testing and a detailed engineering analysis were provided to Testing Summary: demonstrate substantial equivalence with respect to compression bending and torsion. Test standards referenced were ASTM F1717 and ASTM F1798. Analysis and interpretation of the test results and device comparisons demonstrate that the Integra device is substantially equivalent to the predicate devices.
The information submitted in this premarket notification supports a Conclusions: determination that the Integra Spinous Process System is substantially equivalent in technological characteristics and intended use to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 04, 2013
SeaSpine, Incorporated Mr. Nicholas M. Cordaro Director of Engineering 2302 La Mirada Drive Vista, California 92081
Re: K121924
Trade/Device Name: Integra Spinous Process System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: August 27, 2013 Received: August 28, 2013
Dear Mr. Cordaro:
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
3
Page 2 - Mr. Nicholas M. Cordaro
forth in the quality systems (OS) regulation (2) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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/McdicalDevices/Safety/ReportaProblem/default.htm for the CDRH is Office of Surveillance and Biometries/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance 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
4
Indications for Use
510(k) Number (if known): K121924
Device Name: Integra Spinous Process System
Indications for Use:
Integra Spinous Process System is a posterior non-pedicle supplemental fixation system intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous processes for the purpose of achieving supplemental fusion in the following conditions:
- degenerative disc disease (defined as back pain of discogenic origin with . confirmed by history and radiographic studies) degeneration of the disc
- . spondylolisthesis
- trauma (i.e., fracture or dislocation) .
- . spinal tumor
The device is not intended for stand-alone use.
Prescription Use __ ਮ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ronald P. Jean -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K121924.