(48 days)
Not Found
No
The summary describes a physical implant and associated screws for spinal fusion, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on mechanical testing of the device itself.
Yes
The device is described as an "intervertebral fusion device" intended for "spinal fusion procedures" to "restore biomechanical height and act as an aid in fusion of the cervical spine," which directly addresses a medical condition (degenerative disc disease) with a therapeutic action.
No
The device description indicates it is an intervertebral fusion device used to restore biomechanical height and aid in spinal fusion, not to diagnose a condition.
No
The device description clearly states the device is a physical implant manufactured from titanium alloy and PEEK, and secured with bone screws. It is a hardware device, not software.
Based on the provided information, 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 and Intended Use: The Irix-C Cervical Integrated Fusion System is a physical implant designed to be surgically placed in the cervical spine to aid in fusion. It is a medical device used within the body, not for testing samples outside the body.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples, chemical reactions, or diagnostic testing.
Therefore, the Irix-C Cervical Integrated Fusion System is a surgical implant/device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Irix-C Cervical Integrated Fusion System is a stand-alone cervical intervertebral fusion device intended for spinal fusion procedures at one level (C3 - T1 inclusive) in skeletally mature patients for treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Implants are to be implanted via an open, anterior approach and packed with autogenous bone graft. Patients should receive at least six (6) weeks of nonoperative treatment prior to treatment with a cervical intervertebral fusion device.
Product codes
OVE
Device Description
The Irix-C Cervical Integrated Fusion System is a stand-alone intervertebral fusion device to restore biomechanical height and act as an aid in fusion of the cervical spine in anterior discectomy procedures. The device is generally boxed shaped with teeth on the superior and inferior faces of the Irix-C implant is manufactured from both titanium alloy (Ti6Al4V) in accordance with ASTM F136 and Invibio PEEK Optima LT1 in accordance with ASTM F2026, or from Ti6Al4V titanium alloy alone. The device will be supplied with the option of having the superior and inferior surfaces of the device plasma coated with medical-grade commercially pure titanium (CP Ti) per ASTM F1580. The device is then secured in location through the use of bone screws, also manufactured from titanium alloy (Ti6Al4V) per ASTM F136. The devices are provided in various sizes and screws are offered in multiple lengths to adjust for variations in patient anatomy. The implant components are provided clean and non-sterile. These devices are sterilized by a healthcare professional using a steam autoclave in accordance with the instructions for use provided by X-spine Systems Inc., as well as the instructions provided by the manufacturer of the autoclave.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine, one level (C3 - T1 inclusive)
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 implant components were tested using the following standards:
ASTM F2077 - Test Methods for Intervertebral Body Fusion Devices
- Static and Dynamic Compression
- Static and Dynamic Torsion
ASTM F2267 - Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device under Static Axial Compression
In addition to the above standard testing, expulsion, screw back out and dissociation tests were performed as part of this submission. There are no cited standard for these tests.
The mechanical testing results indicate that the Irix-C Cervical Integrated Fusion System is substantially equivalent to predicate device performance and is capable of safely and effectively performing in accordance with its intended use.
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
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
510(k) Summary
ADMINISTRATIVE INFORMATION
Manufacturer Name:
X-spine Systems, Inc. 452 Alexandersville Rd. Miamisburg, OH 45342
Telephone (937) 847-8400 FAX (937) 847-8410
Official Contact:
David Kirschman, M.D. Chief Medical Officer
June 26, 2013
AUG 1 4 2013
Date Prepared:
DEVICE NAME
Trade/Proprietary Name: Common Name: Device Class: Regulation Number: Product Code: Classification Name:
Irix-C™ Cervical Integrated Fusion System Intervertebral body fusion device Class II $888.3080 OVE Intervertebral Fusion Device with Integrated Fixation, Cervical
ESTABLISHMENT REGISTRATION NUMBER
The X-spine Systems, Inc. establishment registration number is 3005031160. The owner/operator number for X-spine Systems, Inc. is 9063903.
INDICATIONS FOR USE
The Irix-C Cervical Integrated Fusion System is a stand-alone cervical intervertebral fusion device intended for spinal fusion procedures at one level (C3 - T1 inclusive) in skeletally mature patients for treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Implants are to be implanted via an open, anterior approach and packed with autogenous bone graft. Patients should receive at least six (6) weeks of nonoperative treatment prior to treatment with a cervical intervertebral fusion device.
DEVICE DESCRIPTION
The Irix-C Cervical Integrated Fusion System is a stand-alone intervertebral fusion device to restore biomechanical height and act as an aid in fusion of the cervical spine in anterior discectomy procedures. The device is generally boxed shaped with teeth on the superior and inferior faces of the Irix-C implant is manufactured from both titanium alloy (Ti6Al4V) in accordance with ASTM F136 and Invibio PEEK Optima LT1 in accordance with ASTM F2026, or from Ti6Al4V titanium alloy alone. The device will be supplied with the option of having the superior and inferior surfaces of the device plasma coated with medical-grade commercially pure titanium (CP Ti) per ASTM F1580. The device is then secured in location through the use of bone screws, also manufactured from titanium alloy (Ti6Al4V) per ASTM F136. The devices are provided in various sizes and screws are offered in multiple lengths to adjust for variations in patient anatomy.
1
The implant components are provided clean and non-sterile. These devices are sterilized by a healthcare professional using a steam autoclave in accordance with the instructions for use provided by X-spine Systems Inc., as well as the instructions provided by the manufacturer of the autoclave.
EQUIVALENCE TO MARKETED PRODUCT
X-spine Systems, Inc. has submitted information to demonstrate that, for the purposes of FDA's regulation of medical devices, the Irix-C Cervical Integrated Fusion System is substantially equivalent to predicate devices based on a comparison including the following characteristics:
- . FDA Product Code
- Indications for Use .
- . Surgical Approach
- . Anatomical Region
- . Implant Materials
- . Product Dimensions
- . Mechanical Performance
PREDICATE DEVICES
- . Globus Medical, Inc. - COALITION Spacer (K083389)
- . Centinel Spine. Inc. - STALIF-C (K120819)
- . X-spine Systems, Inc. - Calix PC Spinal Implant System (K112036)
PERFORMANCE DATA
The implant components were tested using the following standards:
ASTM F2077 - Test Methods for Intervertebral Body Fusion Devices
- Static and Dynamic Compression .
- Static and Dynamic Torsion .
ASTM F2267 - Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device under Static Axial Compression
In addition to the above standard testing, expulsion, screw back out and dissociation tests were performed as part of this submission. There are no cited standard for these tests.
The mechanical testing results indicate that the Irix-C Cervical Integrated Fusion System is substantially equivalent to predicate device performance and is capable of safely and effectively performing in accordance with its intended use.
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
August 14, 2013
X-Spine Systems, Incorporated David Kirschman, M.D. Chief Medical Officer 452 Alexandersville Road Miamisburg, Ohio 45342
Re: K131951
Trade/Device Name: Irix-C Cervical Integrated Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: June 26, 2013 Received: June 27, 2013
Dear Dr. Kirschman:
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
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wing-like shapes, representing health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.
3
Page 2 - David Kirschman, M.D.
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/dcfault.htm.
Sincerely yours,
Erinil. Keith
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Premarket Notification
Irix-C Cervical Integrated Fusion System
Indications for Use
510(k) Number (if known): K131951
Device Name: Irix-C™ Cervical Integrated Fusion System
Indications for Use:
The Irix-C Cervical Integrated Fusion System is a stand-alone cervical intervertebral fusion device intended for spinal fusion procedures at one level (C3 - T1 inclusive) in skeletally mature patients for treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Implants are to be implanted via an open, anterior approach and packed with autogenous bone graft. Patients should receive at least six (6) weeks of nonoperative treatment prior to treatment with a cervical intervertebral fusion device.
Prescription Use × (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD Division of Orthopedic Devices