(154 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of the interbody fusion device, with no mention of AI or ML technology.
Yes.
The device is an intervertebral body fusion device indicated for use in skeletally mature patients with degenerative disc disease to facilitate fusion in the lumbar and cervical spine, which directly treats a medical condition.
No
The device is described as an intervertebral body fusion device used to facilitate fusion in the spine, not to offer diagnostic information. It is a surgical implant.
No
The device description clearly states it is an implantable interbody system made of PEEK-Optima® with an optional titanium coating, which are physical hardware components. The submission is for adding shapes and coatings to this hardware.
Based on the provided information, 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 description clearly states that the Tyber Medical PT Interbody System is an implantable device made of PEEK-Optima® with an optional titanium coating. It is designed to be surgically placed in the spine to facilitate fusion.
- Intended Use: The intended use is to treat degenerative disc disease by providing structural support and promoting bone fusion in the lumbar and cervical spine. This is a surgical intervention, not a diagnostic test performed on a sample.
The information provided describes a surgical implant, which falls under the category of medical devices, but not specifically in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Tyber Medical PT Interbody System is indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a posterior, transforaminal, lateral or anterior approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine.
The Tyber Medical PT Interbody System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. Cervical implants are used to facilitate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone. When used as an interbody fusion device, supplemental fixation must be used.
Product codes
ODP, MAX
Device Description
This submission is to add additional shape configurations, with an optional optimized coating process, to the previously cleared interbody system.
This submission does not include any new instruments. However, part of the changes to implants, were made to interface with instruments that were cleared with previous submissions.
The Tyber Medical PT Interbody System, manufactured from PEEK-Optima®, consist of implants available in various foot prints, heights, and lordotic configurations with an open architecture to accept packing of bone graft materials. The exterior of the device has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the device from migrating once it is surgically positioned. The device comes in PEEK with a plasma-sprayed commercially pure titanium coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbar spine (L2-S1), cervical spine (C2-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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following tests were performed on the Tyber Medical PT Interbody Spacer and the results were compared to with the previously cleared 510k K130573.
Static and Dynamic Compression Test per ASTM F2077
Static and Dynamic Compression Shear per ASTM F2077
Wear Debris per ASTM F2077 and ASTM F1877
Static Torsion per ASTM F2077
Pyrogenicity testing was performed per ST72:2011.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Tyber Medical Interbody Spacer System (K130573)
Reference Device(s)
Synthes ACIS (K120275), DePuy Spine Concorde Curve (K101923), DePuy Spine Lateral System (K090899); Aesculap ASpace, CESpace, Prospace, T-Space (K071983)
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 contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 21, 2017
Tyber Medical, LLC Mark F. Schenk Vice President of Regulatory and Quality 83 South Commerce Way, Suite 310 Bethlehem, Pennsylvania 18017
Re: K172185
Trade/Device Name: Tyber Medical PT Interbody Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, MAX Dated: November 7, 2017 Received: November 15, 2017
Dear Mr. Schenk:
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 (QS) regulation (21 CFR Part 820);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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,
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) K172185
Device Name
Tyber Medical PT Interbody Spacer System
Indications for Use (Describe)
Lumbar System Indications
The Tyber Medical PT Interbody System is indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a posterior, transforaminal, lateral or anterior approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine.
Cervical System Indications
The Tyber Medical PT Interbody System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. Cervical implants are used to facilitate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone. When used as an interbody fusion device, supplemental fixation must be used.
| 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.
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
510(k) Summary:
TYBER MEDICAL PT Interbody Spacer System K172185
| Submitted by | Tyber Medical, LLC
83 South Commerce Way
Suite 310
Bethlehem, PA 18017 |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Mark F. Schenk
Vice President of Regulatory and Quality
Phone: (610) 849-0645 Fax: (866) 889-9914
Email: mschenk@tybermed.com |
| Date Prepared | December 19, 2017 |
| Common Names | Interbody Spacer System |
| Trade Name | Tyber Medical PT Interbody Spacer System |
| Classification Name
and Number | Intervertebral body fusion device
(21 CFR 888.3080) |
| Product Code | ODP and MAX |
| Predicate Device | Tyber Medical Interbody Spacer System (K130573) |
| Additional Predicates | Synthes ACIS (K120275), DePuy Spine Concorde Curve (K101923), DePuy
Spine Lateral System (K090899); Aesculap ASpace, CESpace, Prospace,
T-Space (K071983) |
| Device Description | This submission is to add additional shape configurations, with an optional
optimized coating process, to the previously cleared interbody system.
This submission does not include any new instruments. However, part of
the changes to implants, were made to interface with instruments that were
cleared with previous submissions.
The Tyber Medical PT Interbody System, manufactured from PEEK-Optima®,
consist of implants available in various foot prints, heights, and lordotic
configurations with an open architecture to accept packing of bone graft
materials. The exterior of the device has "teeth" or other generally sharp
engagement members on the superior and inferior surfaces to help prevent
the device from migrating once it is surgically positioned. The device comes
in PEEK with a plasma-sprayed commercially pure titanium coating. |
| Intended Use/
Indications for use | Lumbar System Indications
The Tyber Medical PT Interbody System is indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a posterior, transforaminal, lateral or anterior approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine.
Cervical System Indications
The Tyber Medical PT Interbody System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. Cervical implants are used to facilitate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone. When used as an interbody fusion device, supplemental fixation must be used. |
| Performance Data
(Non-Clinical) | The following tests were performed on the Tyber Medical PT Interbody Spacer and the results were compared to with the previously cleared 510k K130573.
Static and Dynamic Compression Test per ASTM F2077 Static and Dynamic Compression Shear per ASTM F2077 Wear Debris per ASTM F2077 and ASTM F1877 Static Torsion per ASTM F2077 Pyrogenicity testing was performed per ST72:2011. |
| Performance Data
(Clinical) | Clinical data and conclusions were not needed for this device. |
| Statement of
Technological
Comparison | The Tyber Medical PT Interbody System and its predicate devices have the same indications for use, same design, are made of identical materials, identical application, and have the same anatomic mechanical properties. |
| Conclusion | The new Tyber Medical PT Interbody System is substantially equivalent to the predicate device because the material, tooth profile, worst case construct, smallest cross sectional and manufacturing process are all unchanged.
The addition of the new interbody device does not add a new worst-case device for mechanical testing purposes, as demonstrated by mechanical test results. Given the above, Tyber Medical PT Interbody System is determined to be substantially equivalent to the predicate device. |
4