(91 days)
Not Found
No
The document describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for the temporary stabilization of the anterior spine and is used in procedures for spinal fusions, addressing various medical conditions.
No
Explanation: The device is an Anterior Cervical Plating System used for spinal fusions, which is a therapeutic device, not a diagnostic one.
No
The device description explicitly states that the system consists of bone plates, screws, and associated instruments, which are physical hardware components intended for surgical implantation.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for "anterior interbody screw fixation of the cervical spine" and "temporary stabilization of the anterior spine... during the development of cervical spinal fusions." This describes a surgical implant used in vivo (within the body) for structural support and stabilization.
- Device Description: The description details "bone plates, screws, and associated instruments" made from titanium alloy and Nitonol, which are materials used for surgical implants.
- 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
Properly used, this system is intended for anterior interbody screw fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: (1) Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies): (2) Spondylolisthesis: (3) Trauma (including fractures or dislocations); (4) Spinal cord stenosis: (5) Deformity or curvatures (i.e. kyphosis, lordosis or scoliosis); (6) Tumors; (7) Pseudarthrosis; (8) Failed previous fusions.
Nota Bene: This device system is intended for anterior cervical interverterbral body fusions only.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The IRIS™ Anterior Cervical Plating System consists of a variety of shapes and sizes of bone plates, screws, and associated instruments. Fixation is provided by bone screws inserted through the plates and into the vertebral body of the cervical spine using an anterior approach.
The IRIS™ Anterior Cervical Plate System implant components are made from titanium alloy described by ASTM F136 and Nitonol per ASTM F2063. Stainless steel and titanium implant components must not be used together in a construct. LIFE SPINE expressly warrants that these devices are fabricated from the foregoing material specification. No other warranties express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. Do not use any of the IRIS™ Anterior Cervical Plate System components with the components from any other system or manufacturer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine from C2 to T1
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, 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)
Static compression, static torsion and dynamic compression testing per ASTM F1717 as well as Screw Push-out testing were presented to demonstrate the substantial equivalency of the IRIS™ Anterior Cervical Plate System.
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.
Life Spine Anterior Cervical Plate System (K070285), K2M Cervical Plate System (K113329)
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
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
K130202 Page 1 of 2
510(k) Summary IRIS™ Anterior Cervical Plate System
APR 2 9 2013
| Submitted By: | Life Spine, Inc.
2401 W. Hassell Road, Suite 1535
Hoffman Estates, IL 60169
Telephone: 847-884-6117
Fax: 847-884-6118 |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Randy Lewis
Life Spine
2401 W. Hassell Road, Suite 1535
Hoffman Estates, IL 60169
Telephone: 847-884-6117
Fax: 847-884-6118 |
| Date Prepared: | January 25th, 2013 |
| Trade Name: | IRISTM Anterior Cervical Plate |
| Common Name: | Spinal Fixation System |
| Classification: | KWQ, CFR 888.3060, Class II |
| Predicate Device: | Life Spine Anterior Cervical Plate System (K070285)
K2M Cervical Plate System (K113329) |
Device Description:
The IRIS™ Anterior Cervical Plating System consists of a variety of shapes and sizes of bone plates, screws, and associated instruments. Fixation is provided by bone screws inserted through the plates and into the vertebral body of the cervical spine using an anterior approach.
The IRIS™ Anterior Cervical Plate System implant components are made from titanium alloy described by ASTM F136 and Nitonol per ASTM F2063. Stainless steel and titanium implant components must not be used together in a construct. LIFE SPINE expressly warrants that these devices are fabricated from the foregoing material specification. No other warranties express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. Do not use any of the IRIS™ Anterior Cervical Plate System components with the components from any other system or manufacturer.
1
Intended Use of the Device:
Properly used, this system is intended for anterior interbody screw fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: (1) Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies): (2) Spondylolisthesis: (3) Trauma (including fractures or dislocations); (4) Spinal cord stenosis: (5) Deformity or curvatures (i.e. kyphosis, lordosis or scoliosis); (6) Tumors; (7) Pseudarthrosis; (8) Failed previous fusions.
Nota Bene: This device system is intended for anterior cervical interverterbral body fusions only.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Technological Characteristics:
The IRIS™ Anterior Cervical Plate System is substantially equivalent to the predicate system in terms of design, materials, indications for use and sizing.
Material:
The IRIS™ Anterior Cervical Plate System material is 6AL-4V-ELI titanium manufactured according to ASTM F136 and Nitonol manufactured according to ASTM F2063. The device is comprised of a variety of non-sterile, single use components.
Performance Data:
Static compression, static torsion and dynamic compression testing per ASTM F1717 as well as Screw Push-out testing were presented to demonstrate the substantial equivalency of the IRIS™ Anterior Cervical Plate System.
Conclusion:
The information presented demonstrates the substantial equivalency of the IRIS™ Anterior Cervical Plate System.
2
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling a bird or a person with outstretched arms, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 29, 2013
Life Spine, Incorporated % Mr. Randy Lewis Director, RA/QA 2401-West-Hassell-Road, Suite-1-535 Hoffman Estates, Illinois 60169
Re: K130202
Trade/Device Name: IRISTM Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: February 27, 2013 Received: February 28, 2013
Dear Mr. Lewis:
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 vour 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. Randy Lewis
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 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" (21CFR 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 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,
Image /page/3/Picture/6 description: The image shows the name "Erin I.D. Keith" in a stylized font. The letters "Erin" and "ith" are in a standard bold font. The letters "I.D.Ke" are stylized with a pattern of lines and shapes.
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K130202 Page 1 of 1
510(k) number (if known):
Device Name: IRISTM Anterior Cervical Plate System_
Properly used, this system is intended for anterior interbody screw fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: 1.) Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); 2). Spondylolisthesis; 3.) Trauma (including fractures or dislocations); 4.) Spinal cord stenosis; 5.) Deformity or curvatures (i.e. kyphosis, lordosis or scoliosis); 6.) Tumors; 7.) Pseudarthrosis; and/or 8.) Failed previous fusions.
Nota Bene: This device system is intended for anterior cervical interverterbral body fusions only.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Prescription Use _ x (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)
Anton E. Dmitriev, PhD Division of Orthopedic Devices