(148 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of the interbody spacers, with no mention of AI or ML technology.
Yes
The device is a cervical interbody spacer, which is used to treat various cervical spine conditions by facilitating fusion and providing stability, thereby correcting or alleviating a medical condition.
No
The device description indicates it is an interbody fusion device (spacers) intended for surgical implantation in the cervical spine to treat various spinal conditions. It does not perform any diagnostic function.
No
The device description clearly states the device is manufactured from PEEK and titanium, and includes trials made of stainless steel, indicating it is a physical medical device, not software-only.
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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this device is a "Cervical Interbody Spacer" and is an implantable device made of PEEK and titanium.
- Intended Use: The intended use is for surgical implantation in the cervical spine to facilitate fusion. This is a therapeutic device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
Therefore, this device falls under the category of a surgical implant or medical device used for treatment, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Cervical System Indications:
The Tyber Medical PT Cervical Interbody Spacers are interbody fusion devices indicated at one or more levels of the cervical spine C2-T1 in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment.
Tyber Medical PT Cervical Interbody spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone. These devices are intended to be used with supplemental fixation.
Product codes
ODP
Device Description
This submission is to add additional ACIF configurations to the Tyber Medical PT Interbody System and corresponding trials. Additionally, the Indications for Use are being revised.
The new configurations will be manufactured from PEEK – Optima® and plasma sprayed with commercially pure titanium coating, identical to the existing devices in the system. The new ACIF configurations have superior and inferior surfaces that are inclined at larger angles than the existing configurations. In addition, a new extra-large configuration for these sizes will be included. Other geometries, such as the open lumen area and teeth geometry on the superior and inferior surfaces remain identical to the devices within the Tyber Medical PT Interbody System.
The trials will be manufactured from stainless steel and will incorporate trial geometries that match the corresponding implant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine C2-T1
Indicated Patient Age Range
skeletally mature
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 the previously cleared 510k K130573.
Static and Dynamic Compression Test per ASTM F2077 Static and Dynamic Compression Shear per ASTM F2077 Static and Dynamic Torsion per ASTM F2077 Expulsion Testing Pyrogenicity testing was performed per ST72:2011.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K180590, K163491, K173722, K130573, K172185
Reference Device(s)
Not Found
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
February 25, 2019
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes 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: K182284
Trade/Device Name: Tyber Medical PT Interbody Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: December 13, 2018 Received: December 18, 2018
Dear Mark Schenk:
This letter corrects our substantially equivalent letter of January 18, 2019.
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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.
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) K182284
Device Name
Tyber Medical PT Interbody Spacer System
Indications for Use (Describe)
Cervical System Indications:
The Tyber Medical PT Cervical Interbody Spacers are interbody fusion devices indicated at one or more levels of the cervical spine C2-T1 in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment.
Tyber Medical PT Cervical Interbody spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone. These devices are intended to be used with supplemental fixation.
| 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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Traditional 510(k) Summary
TYBER MEDICAL PT Interbody Spacer System K182284
| 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 | January 16, 2019 |
| 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 |
| Primary Predicate | Tyber Medical PT Interbody System (K180590), |
| Additional Predicate
Devices | Nuvasive (K163491), Globus (K173722), Tyber Medical Interbody
System (K130573) and Tyber Medical PT Interbody Line Extension
(K172185) |
| Device Description | This submission is to add additional ACIF configurations to the Tyber
Medical PT Interbody System and corresponding trials. Additionally,
the Indications for Use are being revised.
The new configurations will be manufactured from PEEK – Optima®
and plasma sprayed with commercially pure titanium coating,
identical to the existing devices in the system. The new ACIF
configurations have superior and inferior surfaces that are inclined at
larger angles than the existing configurations. In addition, a new extra-
large configuration for these sizes will be included. Other geometries,
such as the open lumen area and teeth geometry on the superior and
inferior surfaces remain identical to the devices within the Tyber
Medical PT Interbody System.
The trials will be manufactured from stainless steel and will
incorporate trial geometries that match the corresponding implant. |
| Intended Use/
Indications for use | Cervical System Indications: |
| | The Tyber Medical PT Cervical Interbody Spacers are interbody fusion
devices indicated at one or more levels of the cervical spine C2-T1 in
patients with cervical disc disease, instability, trauma including
fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical
spondylotic myelopathy, spinal stenosis, and failed previous fusion.
Cervical disc disease is defined as intractable radiculopathy and/or
myelopathy with herniated disc and/or osteophyte formation on
posterior vertebral endplates producing symptomatic nerve root
and/or spinal cord compression confirmed by radiographic studies.
These patients should be skeletally mature and have had at least six
(6) weeks of non-operative treatment. |
| | Tyber Medical PT Cervical Interbody spacers are to be filled with
autograft bone and/or allogenic bone graft composed of cancellous,
cortical, and/or corticocancellous bone. These devices are intended to
be used with supplemental fixation. |
| Performance Data
(Non-Clinical) | The following tests were performed on the Tyber Medical PT Interbody
Spacer and the results were compared to the previously cleared 510k
K130573. |
| | Static and Dynamic Compression Test per ASTM F2077 Static and Dynamic Compression Shear per ASTM F2077 Static and Dynamic Torsion per ASTM F2077 Expulsion Testing Pyrogenicity testing was performed per ST72:2011. |
| Performance Data
(Clinical) | Clinical data and conclusions were not needed for this device. |
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| Statement of
Technological
Comparison | The Tyber Medical PT Interbody System and its predicate devices have
the same design; are made of identical materials, have similar
applications, and indications, and have equivalent anatomic
mechanical properties. |
| --------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
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| Conclusion | The new configurations are substantially equivalent to the devices in the
Tyber Medical PT Interbody System, based on design, material, indications
and test results. Additionally, the Tyber Medical PT Interbody devices are
similar in design and material to the additional predicate devices. |
|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Tyber Medical PT Interbody devices included in this submission, do not
raise any additional risk to safety and effectiveness. |