(80 days)
Not Found
No
The 510(k) summary describes a mechanical spinal fixation device and associated manual instruments. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The "Not Found" entries for AI/ML mentions, training/test sets, and performance metrics further support this conclusion.
Yes
The device is indicated for conditions like spondylolisthesis, spondylolysis, and degenerative disc disease to stabilize the spine and aid fusion, directly addressing a health condition.
No
The device is described as aiding in spinal fusion and stabilizing the spine, not diagnosing medical conditions. It uses "radiographic studies" as confirmation for diagnosis, but it does not perform the diagnosis itself.
No
The device description explicitly states it consists of physical components like screws, collars, rings, washers, and manual surgical instruments, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The PERPOS™ FCD-2 System is a surgical implant designed to stabilize the spine and aid in fusion. It is a physical device implanted into the body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or diagnostic testing.
Therefore, the PERPOS™ FCD-2 System falls under the category of a surgical device or implant, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The PERPOS™ FCD-2 System isindicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by back pain of discogenic origin as confirmed by rediographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis, or failed previous fusion.
The intended use of the PERPOS™ FCD-2 Anchor and Stabilizer is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The PERPOS™ FCD-2 may be used to supplement legally marketed anterior fusion products in order to create an anterior/posterior fixation construction as an aid to fusion. The PERPOS FCD-2 is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from L1-S1. The intended use of the associated manual surgical instruments is to aid in the implantation of the PERPOS™ FCD-2 Anchor and Stabilizer.
Product codes
MRW
Device Description
The PERPOS™ FCD-2 Single Use System consists of two each of a double-helix facet screw with a compression-locking collar, retaining ring and a self-retaining polymer washer packaged in a single use tray with the associated manual instruments. Modifications from the predicate device include changes to the washer configuration, instrumentation and packaging.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
from L1-S1
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)
Risk analysis was conducted on the impact of the changes and appropriate design verification and validation was conducted under the company's design controls.
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
N/A
0
1690767
SECTION 5
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Special 510(k)
SUBMITTER INFORMATION
Company Name: Company Address:
Company Phone:
Company Facsimile:
Interventional Spine, Inc 13700 Alton Parkway Suite 160 Irvine, CA 92618 (949) 472-0006 (949) 472-0016 Carol Emerson
JUN 1 1 2009
DEVICE IDENTIFICATION
Contact Person:
Trade Name:
Common Name:
Classification Name:
Product Code: Device Panel: Device Class:
PERPOS™ FCD-2 System, Single Patient Use PERPOS™ FCD-2 Implant, ANCHOR AND STABILIZER Facet Screw and associated manual surgical instruments Unclassified, various manual surgical instruments MRW Orthopedic, General, and Plastic Surgery
PREDICATE DEVICES
PERPOS™ PLS System previously cleared under 510(k) K082795
DEVICE DESCRIPTION
The PERPOS™ FCD-2 Single Use System consists of two each of a double-helix facet screw with a compression-locking collar, retaining ring and a self-retaining polymer washer packaged in a single use tray with the associated manual instruments. Modifications from the predicate device include changes to the washer configuration, instrumentation and packaging.
Unclassified
Interventional Spine, Inc.
Proprietary and Confidential
1
INTENDED USE/INDICATIONS for USE
The PERPOS™ FCD-2 System isindicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by back pain of discogenic origin as confirmed by rediographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis, or failed previous fusion.
The intended use of the PERPOS™ FCD-2 Anchor and Stabilizer is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The PERPOS™ FCD-2 may be used to supplement legally marketed anterior fusion products in order to create an anterior/posterior fixation construction as an aid to fusion. The PERPOS FCD-2 is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from L1-S1. The intended use of the associated manual surgical instruments is to aid in the implantation of the PERPOS™ FCD-2 Anchor and Stabilizer.
TECHNOLOGICAL CHARACTERISTICS and SUBSTANTIAL EQUIVALENCE
Documentation was provided to demonstrate that the PERPOS™ FCD-2 System is identical or similar to the predicate device in technological characteristics. The PERPOS™ FCD-2 System is identical to the predicate device in intended use and identical or substantially equivalent to the predicate device in materials, design and technological characteristics.
PERFORMANCE TESTING
Risk analysis was conducted on the impact of the changes and appropriate design verification and validation was conducted under the company's design controls.
CONCLUSION
The results from design controls and the information provided in this submission support the conclusion that the PERPOS™ FCD-2 System is substantially equivalent-to-the-predicate-PERPOS™ PLS-System-
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 emblem featuring three stylized, overlapping shapes that resemble birds in flight. The emblem is positioned in the upper right portion of the circle.
Public Health Service
JUN 11 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Interventional Spine, Incorporated % Ms. Carol Emerson VP, Quality and Logistics 13700 Alton Parkway, Suite 160 Irvine, California 92618
Re:
11:21:3
Trade/Device Name: PerPos FCD-2 System Regulatory Name/Number: Unclassified Regulatory Class: Unclassified Product Code: MRW Dated: May 4, 2009 Received: May 12, 2009
Dear Ms. Emerson:
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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:
The safety and effectiveness of this device for the indication of spinal stabilization without fusion have not been established.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
3
Page 2-Ms. Carol Emerson
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to vour labeling.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
4
Page 3-Ms. Carol Emerson
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Christy Foreman for
Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K090767
Device Name:
Single Use PERPOS™ FCD-2 System
Indications For Use:
The PERPOS™ FCD-2 is indicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by back pain of discogenic origin as confirmed by radiographic studies, degeneration of the facets with instability and fracture. pseudoarthrosis, or failed previous fusion.
The intended use of the PERPOS™ FCD-2 is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The PERPOS FCD-2 may be used to supplement legally marketed anterior fusion products in order to create an anterior fixation fixation construction as an aid to fusion. The screws are inserted posteriorly through the superior side of the facet, across the facet joint and into the pedicle. The PERPOS™ FCD-2 is intended for lumbar bilateral facet fixation, with bone graft, at single or multiple levels from L1 to S1. The intended use of the associated manual surgical instruments is to aid in the implantation of the PERPOS™ FCD-2 Anchor and Stabilizer.
Prescription Use ਮ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
E
c.(Division, or Office)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K090767 510(k) Number_
Page 1 of 1