(385 days)
No
The device description and performance studies focus solely on the mechanical properties and design of a tibial nail system, with no mention of AI or ML.
Yes
The device is intended to stabilize fractures and treat malunion/non-unions of the tibial shaft, which falls under the definition of treating or alleviating a disease or injury.
No
This device is described as an implantable system for stabilizing tibial shaft fractures and malunions/non-unions, functioning as a fixation device rather than for diagnostic purposes.
No
The device description explicitly lists physical components like a tibial nail, locking screws, and end caps, which are hardware.
Based on the provided information, the Ins Hilden Tibial Arzzt is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for stabilizing fractures of the tibial shaft, open and closed tibial shaft fractures, and tibial malunion and non-unions. This is a surgical implant used directly on the patient's body to treat a physical condition.
- Device Description: The description details a tibial nail, locking screws, and end caps. These are all components of a surgical implant used for bone fixation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. The Ins Hilden Tibial Arzzt is a device implanted within the body for structural support and fixation.
N/A
Intended Use / Indications for Use
Ins Hilden Tibial Arzzt is intended to stabilize fractures of the tibial shaft; open and closed tibial shaft fractures; and tibial malunion and non-unions.
Product codes
HSB
Device Description
The Ins Hilden Tibial Arzzt is a single use system that consist the following components:
- The Tibial Nail: a solid nail, with four orifices, two for distal locking and two for the proximal . locking. One of the orifices on the proximal locking is for static locking and one for dynamic locking. Also the nail is milled on the distal end and flat at the proximal end with a threaded insertion/extraction hole.
- Locking Screws with conical head and self-tapping on the head and blunt. ●
- End caps.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tibial shaft
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
According the ASTM F-1264: Standard Guide for Mechanical Performance Considerations for Intramedullary Fixation Devices, our system was tested and met the requirements in the following categories:
- Static Testing
- Torsion Testing
- Fatigue Testing ●
Also, we performed an engineering analysis comparing the static bending and static torsional yield strengths of the Ins Hilden Tibial 8 mm Tibial Nail to the Synthes UTN 8 mm proving to be as strong as the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image is a circular seal for the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around the perimeter, with "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" clearly visible. At the center of the seal is a stylized emblem consisting of three overlapping profiles, which are meant to represent the health and well-being of individuals and communities.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 6, 2014
Trumed Group, LLC % Ms. Rhonda Alexander Senior Regulatory Specialist Registrar Corporation 144 Research Drive Hampton, Virginia 23669
Re: K133166
Trade/Device Name: Ins Hilden Tibial Arzzt Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: October 10, 2014 Received: October 14, 2014
Dear Ms. Alexander:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Ms. Rhonda Alexander
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 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/Resourcesfor You/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 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 vours.
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K133166
Device Name
Ins Hilden Tibial Arzzt
Indications for Use (Describe)
Ins Hilden Tibial Arzzt is intended to stabilize fractures of the tibial shaft; open and closed tibial shaft fractures; and tibial malunion and non-unions.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
| FOR FDA USE ONLY | |
|---|---|
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) |
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:
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| FORM FDA 3881 (1/14) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
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Premarket Notification 510(k) Summary
| 1. | Submitter's Name: | Trumed Group LLC |
|---|---|---|
| 2. | Contact Person: | Jorge Trujillo Zavala |
| 600 Kenrick C-32 | ||
| Houston, Texas 77060 | ||
| 281 847 4098 (phone) | ||
| 3. | Date Prepared: | August 13, 2013 |
| 4. | Device Name: | Ins Hilden Tibial Arzzt |
| 5. | Common Name: | Intramedullary Nail and Locking Screws |
| 6. | Classification Name: | Intramedullary Fixation Rod |
| 7. | Product Code: | HSB |
| 8. | Device Classification: | Class 2 |
| 9. | Regulation Number: | 21 CFR 888.3020 |
| 10. | Predicate Devices: | Synthes (USA) |
| Universal Tibial Nail and Unreamed Tibial | ||
| Nail | ||
| K914453 |
Synthes (USA)
Ti-6al-7nb Urtn
K932330 |
11. Device Description:
The Ins Hilden Tibial Arzzt is a single use system that consist the following components:
- The Tibial Nail: a solid nail, with four orifices, two for distal locking and two for the proximal . locking. One of the orifices on the proximal locking is for static locking and one for dynamic locking. Also the nail is milled on the distal end and flat at the proximal end with a threaded insertion/extraction hole.
4
Image /page/4/Picture/0 description: The image shows the logo for ARZZT. The logo features the letters "ARZZT" in a dark gray, sans-serif font. Above the letters, there is a stylized graphic of a person with their arms raised, also in dark gray. A blue swoosh arcs over the person and the letters, adding a dynamic element to the design.
- Locking Screws with conical head and self-tapping on the head and blunt. ●
- End caps.
-
- Intended Use: Ins Hilden Tibial Arzzt is intended to stabilize fractures of the tibial shaft; open and closed tibial shaft fractures; and tibial malunion and non-unions.
-
- Standards
ASTM F 983-86 (Reapproved 2009). Standard Practice for Permanent Marking of Orthopedic Implant Components
ASTM F1264-03 (Reapproved 2007). Standard Specification and Test Methods for Intramedullary Fixation Devices
ISO 5832-03:1996. Implants for surgery - Metallic materials - Part 3: Wrought titanium 6aluminum 4-vanadium allov
The Ins Hilden Tibial Arzzt has met the requirements of the above standards.
-
- Comparison of Technological Characteristics and Substantial Equivalence The Ins Hilden Tibial Arzzt has similar intended use, target population, anatomical sites, materials, biocompatibility as the Ti-6al-7nb Urtn and the UTN.
The engineering analysis comparing the static bending and static torsional yield strengths of the Ins Hilden Tibial Arzzt 8 mm Tibial Nail to the Synthes UTN 8 mm demonstrates that the performance and properties of Ins Hilden Tibial Arzzt are substantially equivalent to the predicate device.
- Comparison of Technological Characteristics and Substantial Equivalence The Ins Hilden Tibial Arzzt has similar intended use, target population, anatomical sites, materials, biocompatibility as the Ti-6al-7nb Urtn and the UTN.
Test Performed
According the ASTM F-1264: Standard Guide for Mechanical Performance Considerations for Intramedullary Fixation Devices, our system was tested and met the requirements in the following categories:
- Static Testing
- Torsion Testing
- Fatigue Testing ●
Also, we performed an engineering analysis comparing the static bending and static torsional yield strengths of the Ins Hilden Tibial 8 mm Tibial Nail to the Synthes UTN 8 mm proving to be as strong as the predicate device.