(218 days)
No
The summary describes a physical implant device and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
This device is an intervertebral body fusion device intended to aid in the fusion of the lumbar spine, which directly treats degenerative disc disease.
No
Explanation: The device is an intervertebral body fusion device designed to restore biomechanical height and aid in spinal fusion, not to diagnose medical conditions.
No
The device description clearly states it is a physical implant made from titanium alloy and PEEK, 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 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 and Intended Use: The Irix-A Lumbar Integrated Fusion System is a physical implant designed to be surgically placed in the spine to aid in fusion. It is a structural device, not a device that analyzes biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to sample collection, analysis, reagents, or diagnostic testing.
Therefore, the Irix-A Lumbar Integrated Fusion System falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Irix-A Lumbar Integrated Fusion System is a stand-alone intervertebral body fusion device intended for use in patients with degenerative disc disease (DDD) at one (1) contiguous levels of the lumbosacral spine (L2-S1 inclusive). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have had a previous non-fusion spinal surgery at the involved level(s) and may have had up to a Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Irix-A System is intended to be used with autogenous bone graft material, and is to be used with three titanium alloy screws included as part of the system.
Product codes
OVD
Device Description
The Irix-A Lumbar Integrated Fusion System is a stand-alone intervertebral fusion device to restore biomechanical height and act as an aid in fusion of the lumbar spine in anterior discectomy procedures. The device is generally box-shaped with teeth on the superior and inferior faces of the drix-A 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 Ti6AMV 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 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 CP-Ti coated devices will be sterile packed with the balance of system components being provided clean and non-sterile. The non-sterile components are to be 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
lumbosacral spine (L2-S1 inclusive), lumbar spine
Indicated Patient Age Range
skeletally mature
Intended User / Care Setting
healthcare professional
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 compression-shear
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 testing was performed as part of this submission. There is no cited standard for this test.
For validation of the plasma coating, a full material performance qualification and characterization was performed per published FDA guidance, as well as wear debris particulate analysis from dynamic compression-shear testing.
In summary, the mechanical testing results indicate that the Irix-A Lumbar Integrated Fusion System is substantially equivalent to predicate device performance and is capable of 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
K133947 Page 1 of 2
510(k) Summary
JUL 2 9 2014
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 |
| Date Prepared: | July 29, 2014 |
| DEVICE NAME | |
| Trade/Proprietary Name: | Irix-A™ Lumbar Integrated Fusion System |
| Classification Name: | Intervertebral Fusion Device with Integrated Fixation, Lumbar |
| Regulation Description: | Intervertebral body fusion device |
| Device Class: | Class II |
| Product Code: | OVD |
| Regulation Number: | §888.3080 |
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-A Lumbar Integrated Fusion System is a stand-alone intervertebral body fusion device intended for use in patients with degenerative disc disease (DDD) at one (1) contiguous levels of the lumbosacral spine (L2-S1 inclusive). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have had a previous non-fusion spinal surgery at the involved level(s) and may have had up to a Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Irix-A System is intended to be used with autogenous bone graft material, and is to be used with three titanium alloy screws included as part of the system.
DEVICE DESCRIPTION
The Irix-A Lumbar Integrated Fusion System is a stand-alone intervertebral fusion device to restore biomechanical height and act as an aid in fusion of the lumbar spine in anterior discectomy procedures. The device is generally box-shaped with teeth on the superior and inferior faces of the drix-A 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 Ti6AMV titanium alloy alone. The device will be supplied with the option of having the superior and inferior surfaces of the device plasma coated with
1
medical-grade commercially pure titanium (CP Ti) per ASTM F1580. The device is 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 CP-Ti coated devices will be sterile packed with the balance of system components being provided clean and non-sterile. The non-sterile components are to be 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.
PREDICATE DEVICES
- Surgicraft Limited STALIF-TT Intervertebral Body Fusion System (K073109) .
- Globus Medical, Inc. INDEPENDENCE Spacer (K082252) .
- Spinal Elements, Inc. LUCENT OR LUCENT MAGNUM (K110632) .
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-A Lumbar 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 .
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 compression-shear .
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 testing was performed as part of this submission. There is no cited standard for this test.
For validation of the plasma coating, a full material performance qualification and characterization was performed per published FDA guidance, as well as wear debris particulate analysis from dynamic compression-shear testing.
In summary, the mechanical testing results indicate that the Irix-A Lumbar Integrated Fusion System is substantially equivalent to predicate device performance and is capable of 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
July 29, 2014
X-spine Systems. Incorporated David Kirschman, M.D. Chief Medical Officer 452 Alexandersville Road Miamisburg, Ohio 45342
Re: K133947
Trade/Device Name: Irix-ATM Lumbar Integrated Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: July 3. 2014 Received: July 3. 2014
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 complics 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 - 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 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. 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/Safetv/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.
Ronald P. Jean -S for
- 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) K133947
Device Name
Irix-ATM Lumbar Integrated Fusion System
Indications for Use (Describe)
The Irix-A Lumbar Integrated Fusion System is a stand-alone intervertebral body fusion device intended for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous levels of the lumbosacral spine (L2-S1 inclusive). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and at least six (6) months of non-operative treatment. In addition, these patients may have had a previous non-fusion spinal surgery at the involved level(s) and may have had up to a Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Irix-A System is intended to be used with autogenous bone graft material, and is to be used with three titanium alloy bone screws included as part of the system.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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)
Katherine D. Kavlock, PhD
Division of Orthopedic Devices
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