(150 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.
No
Explanation: A therapeutic device is used to treat a disease or condition. This device is an intervertebral fusion device intended for spinal fusion procedures to stabilize the spine, rather than actively treating a condition. It facilitates the fusion process but is not a therapy in itself.
No
Explanation: The device is an interbody fusion device intended for spinal fusion procedures, not for diagnosing medical conditions. It is used to facilitate fusion of the cervical spine.
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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The InTice™-C Porous Ti Cervical Interbody System is a physical implant designed to be surgically placed in the cervical spine for fusion procedures. It is a medical device used in vivo (within the body), not in vitro (outside the body).
- Intended Use: The intended use clearly describes a surgical procedure for spinal fusion, not a diagnostic test performed on a sample.
Therefore, the InTice™-C Porous Ti Cervical Interbody System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The InTice™-C Porous Ti Cervical Interbody System is intended for spinal fusion procedures at one level (C2 - T1 inclusive) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autograft comprised of cancellous and/or corticocancellous bone graft. Patients should receive at least six (6) weeks non-operative treatment with the InTice™-C Porous Ti Cervical Interbody System.
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine (i.e. posterior cervical screw and rod systems and anterior cervical plate systems).
Product codes
ODP
Device Description
The InTice™-C Porous Ti Cervical Interbody System is an intervertebral fusion device, generally box or oval-shaped, and available in a variety of shapes and sizes to accommodate the individual patient anatomy. The implants are made from highly porous commercially pure titanium (CP-TI Grade 2) that complies with ASTM F67. The material is formed into an integrated titanium scaffold, OsteoSync™ Ti (manufactured by Sites Medical), which assists in securing the implant in the intervertebral space. The formed titanium material has a porosity created by a designed hole pattern, and the superior and inferior surfaces of the implant have a tooth pattern to help resist implant dislodgement or expulsion once placed in its desired location. The hollow center of the implant allows the device to be packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The single use implants are provided sterile, and should not be reused under any circumstances.
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
Cervical spine (C2 - 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
Nonclinical testing was performed to demonstrate that the subject InTice™-C Porous Ti Cervical Interbody System is substantially equivalent to its predicate devices. The following testing was performed:
- ASTM F2077: Static and Dynamic Compression Testing
- ASTM-F2077: Static and Dynamic Torsion Testing
- ASTM F 2267: Subsidence
- Expulsion Testing
The results of these studies show that the subject device meets or exceeds the performance of the predicate devices and does not introduce any new risks; therefore, the system is substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION".
May 17, 2018
X-Spine Systems, Inc. Charlene Brumbaugh Regulatory Affairs Manager 452 Alexandersville Rd. Miamisburg, Ohio 45342
Re: K173832
Trade/Device Name: InTice™ -C Porous Ti Cervical Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: April 13, 2018 Received: April 16, 2018
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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
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Indications for Use
510(k) Number (if known)
Device Name
InTice™-C Porous Ti Cervical Interbody System
Indications for Use (Describe)
The InTice™-C Porous Ti Cervical Interbody System is intended for spinal fusion procedures at one level (C2 - T1 inclusive) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autograft comprised of cancellous and/or corticocancellous bone graft. Patients should receive at least six (6) weeks non-operative treatment with the InTice™-C Porous Ti Cervical Interbody System.
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine (i.e. posterior cervical screw and rod systems and anterior cervical plate systems).
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) |
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510(K) SUMMARY
InTice™-C Porous Ti Cervical Interbody System
| I. SUBMITTER/MANUFACTURER: | X-spine Systems, Inc.
664 Cruiser Lane
Belgrade, MT 59714
Telephone (406) 388-0480
FAX (406) 388-1354 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| | Establishment Registration Number: 3005031160 |
| | |
| Official Contact: | Charlene Brumbaugh
Regulatory Affairs Manager
Email: cbrumbaugh@xtantmedical.com
Telephone (937) 847-8400, ext. 2192 |
| | |
| II. DATE PREPARED: | May 17, 2018 |
| | |
| III. OWNER/OPERATOR: | Xtant Medical Inc.
664 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: | InTice™-C Porous Ti Cervical Interbody System |
| Device Common Name: | Intervertebral Fusion Device With Bone Graft |
| Regulation Number: | 21 CFR §888.3080 |
| Product Code: | ODP -- Intervertebral Fusion Device, Cervical |
| | |
| Regulatory Class: | Class II |
| Review Panel: | Orthopedic |
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V. PURPOSE OF THE SUBMISSION
The purpose for this submission is to submit a new medical device for review.
VI. PRIMARY PREDICATE DEVICE
- . Primary Predicate Device: X-spine, Inc.: Calix-C™ Cervical Interbody Spacer – K171075
VII. ADDITIONAL PREDICATE DEVICES
- X-spine, Inc.: Irix-C™ Cervical Integrated Fusion System - K162944
- · FortiCore™ -- K161485 [Cervical Intervertebral Body Fusion Device]
REFERENCE DEVICE VIII.
Arthrex BioSync Bone Wedge K151256
IX. INDICATIONS FOR USE
The InTice™-C Porous Ti Cervical Interbody System is intended for spinal fusion procedures at one level (C2 - T1 inclusive) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Patients should receive at least six (6) weeks non-operative treatment prior to treatment with the InTice™-C Porous Ti Cervical Interbody System.
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine (i.e. posterior cervical screw and rod systems and anterior cervical plate systems).
X. DEVICE DESCRIPTION
The InTice™-C Porous Ti Cervical Interbody System is an intervertebral fusion device, generally box or oval-shaped, and available in a variety of shapes and sizes to accommodate the individual patient anatomy. The implants are made from highly porous commercially pure titanium (CP-TI Grade 2) that complies with ASTM F67. The material is formed into an integrated titanium scaffold, OsteoSync™ Ti (manufactured by Sites Medical), which assists in securing the implant in the intervertebral space. The formed titanium material has a porosity created by a designed hole pattern, and the superior and inferior surfaces of the implant have a tooth pattern to help resist implant dislodgement or expulsion once placed in its desired location. The hollow center of the implant allows the device to be packed with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. The single use implants are provided sterile, and should not be reused under any circumstances.
5
The system does not contain software/firmware or electrical equipment.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES XI.
The technological principle for both the subject and predicate devices is fixation in the cervical spine for skeletally mature patients with degenerative disc disease.
As was established in this submission, the subject device, InTice™-C Porous Ti Cervical Interbody 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 and reference device through comparison in areas including design, intended use, material composition, and function.
XII. PERFORMANCE DATA
Nonclinical testing was performed to demonstrate that the subject InTice™-C Porous Ti Cervical Interbody System is substantially equivalent to its predicate devices. The following testing was performed:
- ASTM F2077: Static and Dynamic Compression Testing ●
- ASTM-F2077: Static and Dynamic Torsion Testing
- ASTM F 2267: Subsidence
- Expulsion Testing
The results of these studies show that the subject device meets or exceeds the performance of the predicate devices and does not introduce any new risks; therefore, the system is substantially equivalent to the predicate devices.
XIII. CONCLUSION
Based on assessment of the indications for use, technological characteristics, performance data, and comparison to the predicate and reference devices, the subject device, InTice™-C Porous Ti Cervical Interbody System has been shown to be substantially equivalent to legally marketed predicate devices.