(100 days)
No
The document describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes.
The device is an anterior cervical fixation system used in fusion procedures to treat degenerative disc disease and provide structural stability, indicating its use in treating a condition.
No
Explanation: The device is an anterior cervical fixation system intended for surgical implantation to facilitate spinal fusion, not for diagnosing medical conditions.
No
The device description clearly outlines physical components made of PEEK polymer, tantalum, and titanium alloy, including implants, screws, and surgical instruments. This indicates a hardware-based medical device, not a software-only one.
No, 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 about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The Unison-C Anterior Cervical Fixation System is an implantable medical device. It is surgically placed inside the body to provide structural support and facilitate bone fusion.
- Intended Use: The intended use is for anterior cervical interbody fusion procedures, which is a surgical treatment for degenerative disc disease. This is a therapeutic intervention, not a diagnostic test.
While the device description mentions "radiographic imaging inside the implant to evaluate fusion status," this is a feature of the implant to allow for post-operative assessment using imaging techniques. The device itself is not performing a diagnostic test on a specimen.
Therefore, based on the provided information, the Unison-C Anterior Cervical Fixation System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Unison-C Anterior Cervical Fixation System is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2 to T1. Degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The system is intended to be used with autograft bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion, and is implanted via an anterior approach. Implants must be used with two of the provided bone screws. This system is to be used in patients who have had six weeks of non-operative treatment.
Product codes
OVE
Device Description
The Unison-C Anterior Cervical Fixation system is intended for stand-alone cervical interbody fusion procedures to provide structural stability in skeletally mature individuals following discectomy. The system includes intervertebral body implants (with an integrated locking mechanism and radiographic pins) and screws, and does not require the use of supplemental fixation.
These implants are manufactured from a radiolucent polymer (PEEK-OPTIMA® LT1 polymer from INVIBIO® Biomaterial Solutions (polyether ether ketone) (ASTM F2026)), to allow radiographic imaging inside the implant to evaluate fusion status. The implants are assembled with radiographic markers composed of tantalum (ASTM F560) to facilitate proper implant positioning. The screws and locking mechanism are manufactured from of titanium alloy (ASTM F136). Sterile implants are provided sterile by gamma irradiation.
Implants are supplied with instrumentation necessary to facilitate the insertion and removal of the implants, as well as general manual surgical instruments. Cases and caddies are supplied for sterilization and transport of the non-sterile implants and instruments.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic imaging
Anatomical Site
Cervical spine, one level from C2 to T1
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
Non-clinical performance studies were conducted. These included:
- Static axial compression per ASTM F2077-14
- Static compressive shear per ASTM F2077-14
- Static torsion per ASTM F2077-14
- Static Subsidence per ASTM F2267-04
- Dynamic axial compression fatique per ASTM F2077-14
- Dynamic compressive shear per ASTM F2077-14
- Dynamic torsion per ASTM F2077-14
- Locking mechanism disassociation testing
- Screw push-out
- Screw-interbody torque-to-failure testing
- Locking mechanism torque-to-failure testing
The results of this non-clinical testing demonstrate that the subject Unison-C Anterior Cervical Fixation System is substantially equivalent to the predicate system. Pyrogenicity of the sterile devices was evaluated using the Limulus amebocyte lysate (LAL) assay, ensuring the endotoxin level meets the requirements of maximum endotoxin limit for implantable medical devices [20 EU per device]. No clinical performance data was required for a determination of substantial equivalence.
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc. Sarah Pleaugh Regulatory Affairs Specialist 375 River Park Circle Marquette, Michigan 49855
June 28, 2017
Re: K170830
Trade/Device Name: Unison®-C Anterior Cervical Fixation System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: June 1, 2017 Received: June 2, 2017
Dear Ms. Pleaugh:
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
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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170830
Device Name
Unison®-C Anterior Cervical Fixation System
Indications for Use (Describe)
The Unison-C Anterior Cervical Fixation System is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2 to T1. Degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The system is intended to be used with autograft bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion, and is implanted via an anterior approach. Implants must be used with two of the provided bone screws. This system is to be used in patients who have had six weeks of non-operative treatment.
Type of Use (Select one or both, as applicable)|X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for RTI Surgical. The logo consists of the letters "rti" in a blue square, followed by the word "surgical" in gray. The "i" in "rti" has a small green dot above it. The logo is simple and modern, and the colors are clean and professional.
| 510(k) Owner / Submitter: | Pioneer Surgical Technology, Inc.
dba RTI Surgical, Inc.
375 River Park Circle
Marquette, MI 49855
Telephone: 906.226.9909
Fax: 906.225.5868 |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact Person: | Sarah Pleaugh, RAC
Regulatory Affairs Specialist |
| Date Prepared: | June 1, 2017 |
| Trade or Proprietary Name: | Unison®-C Anterior Cervical Fixation System |
| Common or Usual Name: | Intervertebral Fusion Device With Bone Graft, Cervical |
| Classification: | Class II per 21 CFR §888.3080 Device Classification |
| Product Code: | OVE |
| Classification Panel: | Division of Orthopedic Devices |
| Predicate Devices: | Primary: K152793 Unison-C Anterior Cervical Fixation System
(Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc.)
Reference: K141314 SCARLET®AC-T Secured Anterior
Cervical Cage (SPINEART) |
DESCRIPTION OF THE DEVICE
510(k) SUMMARY
The Unison-C Anterior Cervical Fixation system is intended for stand-alone cervical interbody fusion procedures to provide structural stability in skeletally mature individuals following discectomy. The system includes intervertebral body implants (with an integrated locking mechanism and radiographic pins) and screws, and does not require the use of supplemental fixation.
These implants are manufactured from a radiolucent polymer (PEEK-OPTIMA® LT1 polymer from INVIBIO® Biomaterial Solutions (polyether ether ketone) (ASTM F2026)), to allow radiographic imaging inside the implant to evaluate fusion status. The implants are assembled with radiographic markers composed of tantalum (ASTM F560) to facilitate proper implant positioning. The screws and locking mechanism are manufactured from of titanium alloy (ASTM F136). Sterile implants are provided sterile by gamma irradiation.
Implants are supplied with instrumentation necessary to facilitate the insertion and removal of the implants, as well as general manual surgical instruments. Cases and caddies are supplied for sterilization and transport of the non-sterile implants and instruments.
The purpose of this submission is to obtain clearance of modifications to the predicate system (K152793).
4
INDICATIONS FOR USE
The Unison-C Anterior Cervical Fixation System is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2 to T1. Degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The system is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion, and is implanted via an anterior approach. Implants must be used with two of the provided bone screws. This system is to be used in patients who have had six weeks of non-operative treatment.
TECHNOLOGICAL CHARACTERISTICS
The subject and predicate devices have the same or similar technological characteristics, indications for use, materials of manufacture and principles of operation. The minor design modifications do not raise any new issues of safety and effectiveness.
NON-CLINICAL PERFORMANCE
The subject Unison-C Anterior Cervical Fixation System has been tested in the following test modes:
- Static axial compression per ASTM F2077-14 .
- .. Static compressive shear per ASTM F2077-14
- Static torsion per ASTM F2077-14 "
- Static Subsidence per ASTM F2267-04 =
- Dynamic axial compression fatique per ASTM F2077-14 =
- Dynamic compressive shear per ASTM F2077-14 "
- Dynamic torsion per ASTM F2077-14 י
- Locking mechanism disassociation testing =
- Screw push-out 트
- Screw-interbody torque-to-failure testing "
- Locking mechanism torque-to-failure testing ..
The results of this non-clinical testing demonstrate that the subject Unison-C Anterior Cervical Fixation System is substantially equivalent to the predicate system.
Pyrogenicity of the sterile devices was evaluated using the Limulus amebocyte lysate (LAL) assay. The device will be tested to ensure the endotoxin level meets the requirements of maximum endotoxin limit for implantable medical devices [20 EU per device].
CLINICAL PERFORMANCE
No clinical performance data was required for a determination of substantial equivalence.
CONCLUSION OF SUBSTANTIAL EQUIVALENCE
The subject Unison-C Anterior Cervical Fixation System is substantially equivalent to the predicates based on a comparison of overall technological characteristics, principles of operation, indications for use, materials, sterilization, packaging, and mechanical performance.