K Number
K932330
Device Name
TI-6AL-7NB URTN
Manufacturer
Date Cleared
1996-03-08

(1030 days)

Product Code
Regulation Number
888.3020
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Synthes Titanium-6Aluminum-7Niobium Unreamed Tibial Nail is intended for use in stabilizing fractures of the tibia.
Device Description
Synthes Titanium-6Aluminum-7Niobium Unreamed Tibial Nail is available in diameters of 8mm - 9mm, and lengths from 255mm to 420mm. The nail has a proximal angulation of 9° in the sagittal plane; it allows for interlocking with locking bolts.
More Information

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Not Found

No
The device description and intended use are for a physical implant (tibial nail) and do not mention any software, algorithms, or data processing capabilities that would suggest AI/ML.

Yes
The device is intended for "stabilizing fractures," which is a therapeutic function.

No
Explanation: The device is an implant (tibial nail) used to stabilize fractures, not to diagnose them.

No

The device description clearly states it is a "Synthes Titanium-6Aluminum-7Niobium Unreamed Tibial Nail," which is a physical implantable device made of metal, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is "stabilizing fractures of the tibia." This is a surgical procedure performed in vivo (within the body) to treat a physical condition.
  • Device Description: The description details a physical implant (a nail) used for internal fixation.
  • Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide diagnostic information.

IVD devices are used to perform tests on samples taken from the body to diagnose diseases or conditions. This device is a surgical implant used for treatment.

N/A

Intended Use / Indications for Use

Synthes Titanium-6Aluminum-7Niobium Unreamed Tibial Nail is intended for use in stabilizing fractures of the tibia.

Product codes

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Device Description

Synthes Titanium-6Aluminum-7Niobium Unreamed Tibial Nail is available in diameters of 8mm - 9mm, and lengths from 255mm to 420mm. The nail has a proximal angulation of 9 degrees in the sagittal plane; it allows for interlocking with locking bolts. The Unreamed Tibial Nail was modified (e.g., locking hole number/placement, material) to make the Titanium-6Aluminum-7Niobium Unreamed Tibial Nail. The method used to sterilize the Synthes Titanium-6Aluminum-7Niobium Unreamed Tibial Nail is gamma radiation. The packaging system used to maintain device sterility consists of two sealed trays, one within the other, providing a double sterility barrier. The packaging trays and lids are manufactured from medical grade, blue tint, 6763 PETG plastic for the trays and Tyvek 1073 B for the lids. The sealed trays are placed in a paperboard shipping carton and shrink wrapped.

Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

Tibia

Indicated Patient Age Range

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Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies

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Key Metrics

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Predicate Device(s)

Synthes Unreamed Tibial Nail (stainless steel)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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§ 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/0 description: The image shows the logo for SYNTHES. The logo consists of a circular symbol on the left and the word "SYNTHES" in bold, sans-serif font on the right. There is a small circle with an R in it to the right of the S in SYNTHES, indicating that it is a registered trademark.

KC93330

4/. - 8

Attachment VI: Summary of Safety and Effectiveness Information [510(k) Summary]

Synthes (USA) 1690 Russell Road Paoli, PA 19301

(215) 647-9700 Contact: Diane Cochet-Wynant May 12, 1993

Device: Synthes Titanium-6Aluminum-7Niobium Unreamed Tibial Nail, as compared to Synthes Unreamed Tibial Nail (stainless steel)

Synthes Titanium-6Aluminum-7Niobium Unreamed Tibial Nail is intended for use in stabilizing fractures of the tibia. It is available in diameters of 8mm - 9mm, and lengths from 255mm to 420mm. The nail has a proximal angulation of 9° in the sagittal plane; it allows for interlocking with locking bolts.

Synthes Unreamed Tibial Nail is also indicated for fractures of the tibia.

To facilitate insertion and anatomic fit, the Unreamed Tibial Nail was modified (e.g., locking hole number/placement, material) to make the Titanium-6Aluminum-7Niobium Unreamed Tibial Nail.

The method used to sterilize the Synthes Titanium-6Aluminum-7Niobium Unreamed Tibial Nail is gamma radiation, as recognized by the United States Pharmacopeia.

The method used to validate the sterilization cycle was the Biological Indicator - Overkill Method for Low Bioburden Medical Devices per guidelines established by the Association for Advancement of Medical Instrumentation (AAMI). Synthes applied the guidelines appearing in "Process Control Guidelines for Gamma Radiation Sterilization of Medical Devices," AAMI, October 18, 1991.

The AAMI Biological - Overkill Method dictates a sterility assurance level in excess of 10-6 which assures a 12 logarithmic reduction in a possible micro-organism population.

The packaging system used to maintain device sterility consists of two sealed trays, one within the other, providing a double sterility barrier. The packaging trays and lids are manufactured from industry accepted components for EO and gamma radiation, namely, medical grade, blue tint, 6763 PETG plastic for the trays and Tyvek 1073 B for the lids. The sealed trays are placed in a paperboard shipping carton and shrink wrapped.

The radiation dose used to insure sterility basis, is 2.5 - 3.2 MegaRads. The validation minimum dose range, per AAMI, is 1.8 - 2.6 MegaRads.