(210 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and materials of the interbody fusion device. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes. This device is an intervertebral body fusion device used to treat degenerative disc disease and facilitate fusion in the spine.
No
The device is described as an intervertebral body fusion device used to facilitate fusion in the spine. Its purpose is to physically support and stabilize the spine, not to diagnose a condition.
No
The device description clearly states the device is manufactured from PEEK-Optima® and has physical features like "teeth" and a titanium coating, indicating it is a physical implant, not software.
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 and Intended Use: The Tyber Medical Interbody Systems are described as implants made of PEEK-Optima® with the intended use of facilitating fusion in the lumbar and cervical spine. They are surgically placed within the body.
- Lack of Mention of Samples or Testing: The document does not mention any analysis of biological samples or any diagnostic testing being performed by the device.
Therefore, the Tyber Medical Interbody Systems are medical devices intended for surgical implantation, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Tyber Medical Interbody Systems are 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 Cervical Interbody Systems 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
The Tyber Medical Interbody System, manufactured from PEEK-Optima®. consist of implants available in various foot prints, heights and lordlotic configurations with an open architecture to accept packing of autograft 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 a PEEK or PEEK with a plasma-sprayed commercially pure titanium coating on the superior and inferior surfaces.
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)
Non-clinical mechanical testing was performed consisting of Static and Dynamic Compression, Torsion, Compression-Shear per ASTM F2077. Additionally, Subsidence Testing per ASTM F2267 and Expulsion testing was performed. The coating characterization tests include Static Shear per ASTM F 1044, Static Tension per ASTM F 1147, and Abrasion per ASTM F 1978. All data indicates the device is substantial equivalence to the predicate systems Clinical data and conclusions were not needed for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K112036, K110632, K081917, K071983, K072791, K100089, K120570
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
TYBER MEDICAL Interbody System
510(k) Premarket Notification
K130573 Page 1 of 2
510(k) Summary
TYBER MEDICAL Interbody System
| Submitter by: | Tyber Medical LLC
89 Headquarters Plaza North, #1464
Morristown, New Jersey 07960 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Jeff Tyber
CEO and President
Phone: (303) 717-5060 Fax: (866) 889-9914
Email: jtyber@tybermed.com |
| Date Prepared | July 22, 2013 |
| Common Names | Intervertebral Body Fusion Device |
| Trade Name | Tyber Medical Interbody System - ACIF, ALIF, PLIF, TLIF, and DLIF |
| Classification Name
and Number | Intervertebral body fusion device (21 CFR 888.3080) |
| Product Code | ODP and MAX |
| Predicate Devices | 1. X-SPINE; Calix - K112036
2. SPINAL ELEMENTS; Lucent and Lucent Magnum - K110632
3. DEPUY SPINE; Bengal, Concorde, Cougar, Devex, and Leopard - K081917
4. AESCULAP; ASpace, CESpace, Prospace, T-Space - K071983
5. SYNTHES; Opal and Oracle Spacer - K072791
6. SYNTHES; T-Pal - K100089
7. CHOICE SPINE; STEATH PEEK Cervical Fusion Device- K120570 |
| Device Description | The Tyber Medical Interbody System, manufactured from PEEK-Optima®.
consist of implants available in various foot prints, heights and lordlotic
configurations with an open architecture to accept packing of autograft
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 a
PEEK or PEEK with a plasma-sprayed commercially pure titanium coating on
the superior and inferior surfaces. |
| Intended Use/
Indications for use | The Tyber Medical Interbody Systems are 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. |
SEP 3 0 2013
1
TYBER MEDICAL Interbody System
510(k) Premarket Notification
K130573 Page 2 of 2
Cervical System Indications
The Tyber Medical Cervical Interbody Systems 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 mechanical testing was performed consisting of Static and (Non-Clinical and/or Dynamic Compression, Torsion, Compression-Shear per ASTM F2077. Clinical) Additionally, Subsidence Testing per ASTM F2267 and Expulsion testing was performed. The coating characterization tests include Static Shear per ASTM F 1044, Static Tension per ASTM F 1147, and Abrasion per ASTM F 1978. All data indicates the device is substantial equivalence to the predicate systems Clinical data and conclusions were not needed for this device. Statement of The Tyber Medical Interbody System and its predicate devices have the same Technological indications for use; same design; are made of similar materials, same Comparison application, and have the same anatomic mechanical properties. Conclusion The Tyber Medical Interbody System is substantially equivalent to its predicate devices. This conclusion is based upon indications for use, materials, design, test data and principles of operation.
2
Image /page/2/Picture/0 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 an abstract symbol that resembles an eagle or bird-like figure with three curved lines representing its body and wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug. Administration 10903 New Hampshire Asemne Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 30, 2013
Tyber Medical LLC Mr. Jeff Tyber CEO and President 89 Headquarters Plaza North, #1464 Morristown, New Jersey 07960
Rc: K130573
Trade/Device Name: Tyber Medical Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, ODP Dated: August 10, 2013 Received: August 12. 2013
Dear Mr. Tyber:
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 warrenties. We remind you, however, that device labeling must be truthful and not misfeading.
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Jeff Tyber
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark NijMelkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K130573 510(k) Number (if known):
Device Name:
Tyber Medical Interbody System
Indications for Use:
The Tyber Medical Interbody Systems are indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative dise 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 cither 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 Cervical Interbody Systems System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative 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 symploms. Patients should have six weeks of non-operative treatment prior to surgery. Cervical implans 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.
Prescription Use X AND/OR Over-the-counter
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODI)
Anton E. Dmitriev, PhD Division of Orthopedic Devices