(43 days)
Not Found
No
The summary describes a physical implant and surgical instruments, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
Explanation: The device is indicated for intervertebral body fusion of the spine for the treatment of cervical disc disease, degenerative disc disease, tumors, and fractures of the thoracic and lumbar spine, aiming to restore height and biomechanical integrity, which are therapeutic actions.
No
This device is an implantable medical device used for spinal fusion and vertebral body replacement, not for diagnosing medical conditions.
No
The device description explicitly states it includes "implantable devices manufactured from PEEK with tantalum or titanium alloy radiographic markers" and "Implant-specific and 510(k) exempt orthopedic manual surgical instruments," indicating it is a hardware device, not software only.
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 (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that this device is an implantable system (Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System) made of PEEK with radiographic markers. Its intended use is for surgical implantation in the spine to facilitate fusion or replace vertebral bodies.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is mechanical support and facilitating bone fusion within the body.
Therefore, this device falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
CERVICAL INTERBODY FUSION DEVICE
When used as a cervical intervertebral body fusion implant the Interbody Fusion (IBF)/ Vertebral Body Replacement (VBR) System ("IBF/VBR System") is indicated for intervertebral body fusion of the spine in skeletally mature patients. Cervical IBFs are intended for use at one level in the cervical spine, from the C2 to C3 intervertebral body space to the C7 to T1 intervertebral body space, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Cervical IBFs are to be used in patients who have had six weeks of non-operative treatment. IBFs are designed for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level.
LUMBAR INTERBODY FUSION DEVICE
When used as a lumbar intervertebral body fusion implant the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is indicated for intervertebral body fusion of the spine in skeletally mature patients. Lumbar IBFs are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1 intervertebral body space, for the treatment of degenerative disc disease (DDD) with up to Grade One spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Lumbar IBFs are to be used in patients who have had six months of non-operative treatment. IBFs are designed for use with autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level.
VERTEBRAL BODY REPLACEMENT
When used as a vertebral body replacement (VBR) implant the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is intended for use in the thoracolumbar spine, from T1 to L5 intervertebral body space for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. VBRs are also indicated for treating fractures of the thoracic and lumbar spine. VBRs are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The system is intended to be used with supplemental fixation cleared for the conditions listed above (i.e., tumor or trauma of T1 to L5 intervertebral body space). Additionally, the VBR implant is intended to be used with bone graft.
Product codes (comma separated list FDA assigned to the subject device)
MAX, ODP, MQP
Device Description
The system includes implantable devices manufactured from PEEK with tantalum or titanium alloy radiographic markers that are available in a variety of different shapes and sizes to accommodate varying patient anatomy and surgical approach. The IBF/VBR implants may be implanted via a variety or open or minimally invasive approaches, including anterior, lateral, posterior and oblique. Implant-specific and 510(k) exempt orthopedic manual surgical instruments, including the Clarity Retractor System, are also available for use with the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic studies
Anatomical Site
Cervical spine, from the C2 to C3 intervertebral body space to the C7 to T1 intervertebral body space.
Lumbar spine, from L2 to S1 intervertebral body space.
Thoracolumbar spine, from T1 to L5 intervertebral body space.
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)
No new performance data was provided to support substantial equivalence. Instead, a literature analysis of published clinical data for the lumbar interbody fusion devices similar to the predicate device Rotate, Bullet-Tip, T-Plus, Contact, Cross-Fuse, and Cross-Fuse II (K150521) was provided in support of the expanded Indications for Use. The published clinical outcomes demonstrated that the use of allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, in lumbar interbody fusion procedures to treat patients diagnosed with lumbar disc disease, as defined, poses no new risks to patients. Performance data was also not required in the removal of the spinal fixation system trade names, as this is only an administrative change.
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.
Pioneer IBF/VBR System K150521, K043206, K061151, K073177, K112496, K133623, K133455, Rampart™ O, Rampart™ T and Rampart™ A Lumbar Interbody Fusion Device (K160906)
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.
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them, resembling a symbol or emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
RTI Surgical, Inc. dba RTI Biologics Jennifer Bonacci Regulatory Affairs Specialist 11621 Research Circle Alachua, Florida 32615
April 14, 2017
Re: K170643
Trade/Device Name: Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, ODP, MQP Dated: February 28, 2017 Received: March 2, 2017
Dear Ms. Bonacci:
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K170643
Device Name
Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System
Indications for Use (Describe)
CERVICAL INTERBODY FUSION DEVICE
When used as a cervical intervertebral body fusion implant, the Interbody Fusion (IBF)/ Vertebral Body Replacement (VBR) System ("IBF/VBR System") is indicated for intervertebral body fusion of the spine in skeletally mature patients. Cervical IBFs are intended for use at one level in the cervical spine, from the C2 to C3 intervertebral body space to the C7 to T1 intervertebral body space, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Cervical IBFs are to be used in patients who have had six weeks of non-operative treatment. IBFs are designed for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level.
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."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K170643
Device Name
Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System
Indications for Use (Describe)
LUMBAR INTERBODY FUSION DEVICE
When used as a lumbar intervertebral body fusion implant, the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is indicated for intervertebral body fusion of the spine in skeletally mature patients. Lumbar IBFs are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1 intervertebral body space, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Lumbar IBFs are to be used in patients who have had six months of non-operative treatment. IBFs are designed for use with autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level.
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."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
4
Indications for Use
Page 3 of 3 Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K170643
Device Name
Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System
Indications for Use (Describe)
VERTEBRAL BODY REPLACEMENT
When used as a vertebral body replacement (VBR) implant, the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is intended for use in the thoracolumbar spine, from T1 to L5, for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. VBRs are also indicated for treating fractures of the thoracic and lumbar spine. VBRs are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The system is intended to be used with supplemental fixation cleared for the conditions listed above (i.e., tumor or trauma of T1 to L5). Additionally, the VBR implant is intended to be used with bone graft.
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."
5
510(k) Summary Pursuant to 21 CFR 807.92
| Sponsor: | Pioneer Surgical Technology, Inc. dba RTI Surgical, Inc.
375 River Park Circle
Marquette, MI 49855 USA
Contact: Jennifer Bonacci, Regulatory Affairs Specialist
Kristina Hall, Sr. Manager, Regulatory Affairs
Ph: (386) 418-8888
Fax: (386) 418-418-1627
Prepared: April 13, 2017 |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name: | Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System |
| Trade names: | C-Plus, Rotate, Bullet-Tip, T-Plus, Contact, Cross-Fuse, Cross-Fuse
II, Cross-Fuse II Coronal Taper, Cross-Fuse II Hyperlordotic |
| Common name: | Intervertebral Body Fusion Device/ Vertebral Body Replacement
Device |
| Classifications: | 21 CFR 888.3080 – Class II
21 CFR 888.3060 – Class II |
| Product Codes: | MAX, ODP, MQP |
| Panel/ Branch: | Orthopedic and Rehabilitation Devices Panel; Panel Code 87
Restorative Devices Branch |
| Primary
Predicate Device | Pioneer IBF/VBR System K150521 |
| Additional
Predicate
Devices: | Pioneer IBF/VBR System (K043206, K061151, K073177, K112496,
K133623, K133455, and K150521)
Rampart™ O, Rampart™ T and Rampart™ A Lumbar Interbody Fusion
Device (K160906) |
| Description: | The system includes implantable devices manufactured from PEEK with
tantalum or titanium alloy radiographic markers that are available in a
variety of different shapes and sizes to accommodate varying patient
anatomy and surgical approach. The IBF/VBR implants may be
implanted via a variety or open or minimally invasive approaches,
including anterior, lateral, posterior and oblique.
Implant-specific and 510(k) exempt orthopedic manual surgical |
6
instruments, including the Clarity Retractor System, are also available for use with the system.
The purpose of this submission is to expand the lumbar interbody fusion Purpose of Submission: device indications to include the use of allogenic bone graft comprised of cancellous and/or corticocancellous bone graft as an alternative to autogenous bone graft for use with K150521 predicate devices. Also, removal of referenced supplemental spinal fixation trade names from the indications statement. Additional administrative changes to the package insert were also included. No changes to the devices were subject to this submission.
CERVICAL INTERBODY FUSION DEVICE Intended Use /
Indications for
Use:
When used as a cervical intervertebral body fusion implant the Interbody Fusion (IBF)/ Vertebral Body Replacement (VBR) System ("IBF/VBR System") is indicated for intervertebral body fusion of the spine in skeletally mature patients. Cervical IBFs are intended for use at one level in the cervical spine, from the C2 to C3 intervertebral body space to the C7 to T1 intervertebral body space, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Cervical IBFs are to be used in patients who have had six weeks of non-operative treatment. IBFs are designed for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level.
LUMBAR INTERBODY FUSION DEVICE
When used as a lumbar intervertebral body fusion implant the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is indicated for intervertebral body fusion of the spine in skeletally mature patients. Lumbar IBFs are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1 intervertebral body space, for the treatment of degenerative disc disease (DDD) with up to Grade One spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Lumbar IBFs are to be used in patients who have had six months of non-operative treatment. IBFs are designed for use with autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. IBFs are intended to be used with supplemental spinal fixation cleared for the implanted level.
7
VERTEBRAL BODY REPLACEMENT
When used as a vertebral body replacement (VBR) implant the Interbody Fusion (IBF) / Vertebral Body Replacement (VBR) System ("IBF/VBR System") is intended for use in the thoracolumbar spine, from T1 to L5 intervertebral body space for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. VBRs are also indicated for treating fractures of the thoracic and lumbar spine. VBRs are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column, even in the absence of fusion for a prolonged period of time. The system is intended to be used with supplemental fixation cleared for the conditions listed above (i.e., tumor or trauma of T1 to L5 intervertebral body space). Additionally, the VBR implant is intended to be used with bone graft.
Summary of The technological characteristics remain unchanged since K150521. As stated above, the purpose of this 510(k) submission is to modify the Technological K150521 indications for use statement only; the subject system is Characteristics: equivalent in terms of design, materials, surgical approaches, sterilization and packaging as compared to K150521.
Performance No new performance data was provided to support substantial Data Supporting equivalence. Instead, a literature analysis of published clinical data for the Substantial lumbar interbody fusion devices similar to the predicate device Rotate, Equivalence Bullet-Tip, T-Plus, Contact, Cross-Fuse, and Cross-Fuse II (K150521) Determination: was provided in support of the expanded Indications for Use. The published clinical outcomes demonstrated that the use of allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, in lumbar interbody fusion procedures to treat patients diagnosed with lumbar disc disease, as defined, poses no new risks to patients. Performance data was also not required in the removal of the spinal fixation system trade names, as this is only an administrative change.
No changes were made to the existing devices, nor were any new components added to the system. There were no changes to the sterilization, shelf life and packaging as presented in K150521. However, pvorgenicity evaluation of the sterile implants has been added based on recent Agency guidance. Pyrogenicity of the device was evaluated using the Limulus Amoebocyte Lysate (LAL) assay on the final sterilized device. The device did not elicit a response. All device lots will be tested to ensure the endotoxin level is 20 EU/device.
8
- Conclusion: The subject indications for use changes to the predicate K150521 system does not raise new issues of safety or effectiveness. The device itself remains unchanged and will perform as safe and as effective as previously cleared. A literature analysis was performed and no new performance data was required to support substantial equivalence.