(160 days)
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Not Found
No
The summary describes a mechanical device (trauma screw) with a surface treatment. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
The device is a trauma screw indicated for use in bone reconstruction, fracture repair, and fixation, which are therapeutic interventions.
No
The document describes a trauma screw used for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation. These are therapeutic and structural support functions, not diagnostic ones. There is no mention of the device being used to identify or detect a disease or condition.
No
The device is a physical trauma screw with a surface treatment, not a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Description and Intended Use: The description and intended use of the Tyber Medical BioTy® Nanotopography Trauma Screw clearly state it is a surgical implant used for bone reconstruction, fracture repair, etc. It is a physical device implanted into the body, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The document does not mention any testing of biological samples, analysis of biomarkers, or diagnostic purposes.
Therefore, based on the provided information, this device is a surgical implant, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Tyber Medical BioTy® Nanotopography Trauma Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the device. The screw is intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones
Indicated Patient Age Range
Not Found
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 in regards to the strength of the implant was performed for this submission because the devices are identical to previously cleared devices.
The purpose of this submission is to add detail to the description of the modified surface treatment. Additional invitro testing and engineering analysis of the surface treatment was performed.
Pyrogenicity testing was performed per ST72:2011.
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.
Not Found
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Image /page/0/Picture/1 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 to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 16, 2016
Tyber Medical LLC Mark Schenk Vice President Of Regulatory And Quality 89 Headquarters Plaza North, #1464 Morristown. New Jersey 07960
Re: K161597
Trade/Device Name: Tyber Medical BioTy® Nanotopography Trauma Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: October 26, 2016 Received: October 31, 2016
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 (reporting of medical devicerelated 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.
1
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 yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K161597
Device Name
Tyber Medical BioTy® Nanotopography Trauma Screw
Indications for Use (Describe)
The Tyber Medical BioTy® Nanotopography Trauma Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the device. The screw is intended for single use only.
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)
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3
Traditional 510(k) Summary
as required by section 807.92(c).
Tyber Medical
BioTy® Nanotopography Trauma Screw
K161597
4
| Intended Use | A trauma screw with BioTy® Nanotopography Surface Treatment is
designed to apply compression and fixation between two adjacent
segments of cortical and/or cancellous bone. |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Tyber Medical BioTy® Nanotopography Trauma Screw is
indicated for use in bone reconstruction, osteotomy, arthrodesis,
joint fusion, fracture repair, and fracture fixation of bones
appropriate for the size of the device. The screw is intended for
single use only. |
| Statement of | Tyber Medical BioTy® Nanotopography Trauma Screw and its |
|---|---|
| Technological | predicate device have the same as or similar indications for use, |
| Comparison and | design, materials, technology and principles of operation and test |
| Fundamental Scientific | results. |
| Technology |
| Nonclinical Testing
Summary | No new mechanical testing in regards to the strength of the implant
was performed for this submission because the devices are identical
to previously cleared devices.
The purpose of this submission is to add detail to the description of
the modified surface treatment. Additional invitro testing and
engineering analysis of the surface treatment was performed.
Pyrogenicity testing was performed per ST72:2011. |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Test Summary | n/a |
| Conclusion | The Tyber Medical BioTy® Nanotopography Trauma Screw and its predicate device have the same indications for use, and the same design, and test results. Both devices are manufactured using materials with a long history of use in orthopedic implants. |
|---|---|
| ------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |