(90 days)
No
The device description explicitly states that the system does not contain software/firmware or electrical equipment, and there are no mentions of AI, DNN, or ML.
Yes
The device is described as an "intervertebral body fusion device" used to aid in the fusion of the lumbar spine for patients with degenerative disc disease, which indicates it is designed to treat a medical condition.
No
The device is an intervertebral body fusion device, used to restore biomechanical height and aid in fusion of the lumbar spine, which is a therapeutic function, not diagnostic.
No
The device description explicitly states "The system does not contain software/firmware or electrical equipment."
Based on the provided text, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: 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 made of materials like titanium and PEEK.
- Intended Use: The intended use is to treat degenerative disc disease by providing structural support and promoting bone fusion in the lumbosacral spine. This is a surgical intervention, not a diagnostic test performed on a sample.
The description clearly indicates a surgically implanted device, not a diagnostic tool used with biological samples.
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) 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 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 autograft and/or allograft comprised of cancellous bone graft material, and is to be used with three titanium alloy screws included as part of the system.
Hyperlordotic implants >20° are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).
Product codes (comma separated list FDA assigned to the subject device)
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 boxed shaped with teeth on the superior and inferior faces of the device. The IRIX-A™ implant is manufactured from both titanium alloy (Ti6AI4V) 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 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 spacers of the IRIX-A™ System are supplied clean and STERILE. The screws and accompanying instruments of the IRIX™-A System are provided clean and non-sterile.
The system does not contain software/firmware or electrical equipment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbosacral spine (L2-S1 inclusive)
Indicated Patient Age Range
skeletally mature
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)
Nonclinical testing was performed to demonstrate that the subject IRIX-A™ Lumbar Integrated Fusion System is substantially equivalent to its primary predicate device. The following testing was performed:
- ASTM F2077: Static and dynamic compression testing
- ASTM F 2267: Subsidence ●
- . Expulsion as recommended by FDA
The results of these studies show that the subject device meets or exceeds the performance of the predicate device and does not introduce any new risks; therefore, the system is substantially equivalent to the predicate device.
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.
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.
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
§ 888.3080 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
Public Health Service
Image /page/0/Picture/12 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus-like symbol with three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 28, 2017
X-Spine Systems, Inc. Charlene Brumbaugh Regulatory Affairs Manager 452 Alexanderville Rd. Miamisburg, Ohio 45342
Re: K171567
Trade/Device Name: IRIX-A™ Lumbar Integrated Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: May 26, 2017 Received: May 30, 2017
Dear Ms. Brumbaugh:
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 of medical device
1
related adverse events) (21 CFR 803); 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 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/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 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,
Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K171567
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 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 autograft and/or allograft comprised of cancellous bone graft material, and is to be used with three titanium alloy screws included as part of the system.
Hyperlordotic implants >20° are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).
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) |
|---|---|
| ----------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
510(K) SUMMARY
IRIX-A™ Lumbar Integrated Fusion System
| I. | SUBMITTER/MANUFACTURER: | X-spine Systems, Inc.
452 Alexandersville Rd.
Miamisburg, OH 45342 |
|------|---------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Telephone (937) 847-8400
FAX (937) 847-8410 |
| | | Establishment Registration Number: 3005031160 |
| | Official Contact: | Charlene Brumbaugh
Regulatory Affairs Manager
Email: cbrumbaugh@X-spine.com
Telephone (937) 847-8400, ext. 2192 |
| II. | DATE PREPARED: | August 28, 2017 |
| III. | OWNER/OPERATOR: | Xtant Medical Inc.
604 Cruiser Lane
Belgrade, MT 59714 |
| | Owner/Operator Number: | 10028385 |
| | Official Correspondent: | Stephen Smith, Vice President
Regulatory Assurance/ Quality Assurance
Xtant Medical, Inc.
Telephone (406) 388-0480 |
| IV. | DEVICE | |
| | Trade/Proprietary Name:
Device Common Name:
Regulation Number:
Product Code: | IRIX-A™ Lumbar Integrated Fusion System
Intervertebral Body Fusion Device
21 CFR §888.3080
OVD -- Intervertebral Fusion Device with
Integrated Fixation, Lumbar
[disc spacer, holds bone graft] |
| | Regulatory Class:
Review Panel: | Class II
Orthopedic |
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K171567 Page 2 of 3
V. PURPOSE OF THE SUBMISSION
The purpose for this submission is to add hyperlordotic angle options and to expand the Indications for Use to include the use of allograft comprised of cancellous and/or corticancellous bone graft material.
VI. PREDICATE DEVICES
- Primary: X-spine, Inc.: IRIX-A™ Lumbar Integrated Fusion System - K133947
- Additional: Globus Medical, Inc.: INDEPENDENCE® Spacers -- K152022
VII. REFERENCE DEVICES
- · NuVasive, BASE Interfixated Titanium System (K170592)
- · Synthes, T-PAL Spacer System (K162358)
- SeaSpine, Vu A Pod™ Prime NanoMetalene® Intervertebral Body Fusion Device (K162351)
VIII. 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) 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 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 autograft and/or allograft comprised of cancellous and/or corticancellous bone graft material, and is to be used with three titanium alloy screws included as part of the system.
Hyperlordotic implants >20° are intended for use with supplemental fixation (e.g. facet screws or posterior fixation).
DEVICE DESCRIPTION IX.
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 boxed shaped with teeth on the superior and inferior faces of the device. The IRIX-A™ implant is manufactured from both titanium alloy (Ti6AI4V) 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.
5
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 spacers of the IRIX-A™ System are supplied clean and STERILE. The screws and accompanying instruments of the IRIX™-A System are provided clean and non-sterile.
The system does not contain software/firmware or electrical equipment.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES X.
The technological principle for both the subject and primary predicate device is fixation in the lumbar spine for skeletally mature patients with degenerative disc disease.
As was established in this submission, the subject device, IRIX-A™ Lumbar Integrated Fusion System, is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, and function.
XI. PERFORMANCE DATA
Nonclinical testing was performed to demonstrate that the subject IRIX-A™ Lumbar Integrated Fusion System is substantially equivalent to its primary predicate device. The following testing was performed:
- ASTM F2077: Static and dynamic compression testing
- ASTM F 2267: Subsidence ●
- . Expulsion as recommended by FDA
The results of these studies show that the subject device meets or exceeds the performance of the predicate device and does not introduce any new risks; therefore, the system is substantially equivalent to the predicate device.
XII. CONCLUSION
The subject device, IRIX-A™ Lumbar Integrated Fusion System, has been modified to expand the Indications for Use and to expand the implant offerings to include three additional lordotic angles. Based on the indications for use, technological characteristics, performance testing, and comparison to predicate and reference devices, the subject IRIX-A™ Lumbar Integrated Fusion System has been shown to be substantially equivalent to legally marketed predicate devices.