(122 days)
Not Found
No
The document describes a physical interbody spacer system made of PEEK and titanium, with no mention of software, algorithms, or any AI/ML related terms or functionalities. The submission focuses on updating language and MR testing, not on technological changes.
Yes
The device is a Tyber Medical PT Interbody Spacer System, which is indicated for use in intervertebral body fusion to treat degenerative disc disease and facilitate fusion in the spine. Such devices are used to restore function and alleviate symptoms, qualifying them as therapeutic.
No
The Tyber Medical PT Interbody Spacer System is an implantable device designed to facilitate spinal fusion, not to diagnose medical conditions. Its function is to provide structural support and promote bone growth between vertebrae.
No
The device description clearly states the device is manufactured from PEEK-Optima® LT1 with a plasma-sprayed integrated commercially pure titanium, and has physical features like "teeth". This indicates it is a physical implant, not a software-only device.
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 description clearly states that this is an "intervertebral body fusion device" made of PEEK and titanium, designed to be surgically implanted in the spine.
- Intended Use: The intended use is to facilitate fusion in the cervical and lumbar spine in patients with degenerative disc disease. This is a surgical procedure, not a diagnostic test performed on a sample outside the body.
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples, diagnostic markers, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, the Tyber Medical PT Interbody Spacer System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Cervical System Indications:
The Tyber Medical PT Interbody Spacer 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 and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as an interbody fusion device, supplemental fixation must be used.
Lumbar System Indications:
The Tyber Medical PT Interbody Spacer 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). DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may also have had a previous non-fusion spinal surgery at the involved spinal level(s). Additionally, the Tyber Medical PT Interbody System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. Patients should have six weeks 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 autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as interbody fusion devices these implants are intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine.
Product codes (comma separated list FDA assigned to the subject device)
ODP, MAX
Device Description
This submission is to update language in the Indications for Use, and update language in the package insert in reference to MR testing.
There is no change with this submission from the primary predicate.
This submission does not change or add any new instruments.
The Tyber Medical PT Interbody System, manufactured from PEEK-Optima® LT1, with a plasma-sprayed integrated commercially pure titanium. The system consists 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (C2-T1), Lumbar spine (L2-S1)
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 mechanical testing was performed, because there is no change to the device.
MR testing was performed per ASTM F2052-15, ASTM F2119-07, ASTM F2213-06, ASTM F2503-13 & ASTM F2182-11a.
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.
Tyber Medical PT Interbody Spacer System (172185), K151773, K132421, K162358, K133653
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.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food & Drug Administration. The Department of Health and Human Services logo is on the left and consists of a stylized caduceus. The U.S. Food & Drug Administration logo is on the right and consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Tyber Medical, LLC Mark Schenk Vice President of Regulatory and Quality 83 South Commerce Way Suite 310 Bethlehem, Pennsylvania 18017
Re: K180590
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: June 4, 2018 Received: June 8, 2018
Dear Mark 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 (OS) regulation (21 CFR Part 820);
July 6, 2018
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 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,
Brent Showalter -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) K180590
Device Name
Tyber Medical PT Interbody Spacer System
Indications for Use (Describe)
Cervical System Indications:
The Tyber Medical PT Interbody Spacer System is indicated for use as an intervertebral body fusion device in sketally 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 faciliate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as an interbody fusion device, supplemental fixation must be used.
Lumbar System Indications:
The Tyber Medical PT Interbody Spacer 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). DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may also have had a previous non-fusion spinal surgery at the involved spinal level(s). Additionally, the Tyber Medical PT Interbody System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. Patients should have six weeks of nonoperative 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 autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as interbody fusion devices these implants are intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine.
| 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) |
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510(k) Summary
Tyber Medical PT Interbody Spacer System
K180590
| 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 | July 6, 2018 |
| 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, Class II) |
| Product Code | ODP and MAX |
| Primary Predicate
Device | Tyber Medical PT Interbody Spacer System (172185) |
| Additional Predicates | DPS Concorde Bullet Lumbar Interbody (K151773), Aesculap Plasmapore XP
Spinal System (K132421), DPS T-PAL Spacer System (K162358) and
Medtronic Anatomic PEEK PTC Cervical Fusion System (K133653). |
| Device Description | This submission is to update language in the Indications for Use, and
update language in the package insert in reference to MR testing.
There is no change with this submission from the primary predicate.
This submission does not change or add any new instruments.
The Tyber Medical PT Interbody System, manufactured from PEEK-
Optima® LT1, with a plasma-sprayed integrated commercially pure
titanium. The system consists 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. |
| Intended Use/
Indications for use | Cervical System Indications:
The Tyber Medical PT Interbody Spacer 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 ofto facilitate fusion in the cervical spine (C2-T1) and are placed via an
anterior approach using autogenous bone and/or allogenic bone graft
comprised of cancellous and/or corticocancellous bone graft. When
used as an interbody fusion device, supplemental fixation must be
used.
Lumbar System Indications:
The Tyber Medical PT Interbody Spacer 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). DDD patients may have up to Grade 1 spondylolisthesis
or retrolisthesis at the involved levels. These patients may also have
had a previous non-fusion spinal surgery at the involved spinal
level(s). Additionally, the Tyber Medical PT Interbody System can be
used in patients diagnosed with spinal deformities as an adjunct to
fusion. Patients should have six weeks 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 autograft and/or allogenic bone
graft comprised of cancellous and/or corticocancellous bone graft.
When used as interbody fusion devices these implants are intended
for use with supplemental fixation systems cleared for use in the
thoracolumbar spine. |
| Performance Data
(Non-Clinical) | No new mechanical testing was performed, because there is no change to
the device.
MR testing was performed per ASTM F2052-15, ASTM F2119-07, ASTM
F2213-06, ASTM F2503-13 & ASTM F2182-11a. |
| 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. There is no change in design, materials, or
mechanical properties from the primary predicate.
The Tyber Medical PT Interbody System has similar design, materials, and
mechanical properties to the additional predicate devices. |
| Conclusion | The Tyber Medical PT Interbody System is substantially equivalent to the
predicate device because it has similar indications for use, and the design,
materials, application, manufacturing process, and anatomic mechanical
properties are all unchanged.
The Tyber Medical PT Interbody System is substantially equivalent to the
additional predicate devices because the materials, indications, product
code, application, range of sizes, and designs are similar. |
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K180590
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