(65 days)
Cook™ Trocar Tunnelator™, Davol® Tunneler
No
The device description and intended use are purely mechanical, and there is no mention of AI, ML, image processing, or data analysis.
No
The device description indicates it is used for positioning and tunneling catheters/ports, not for treating a disease or condition itself. It is an accessory device rather than a therapeutic one.
No
Explanation: The device description indicates that it is used for the positioning of catheters and ports, which is a procedural/surgical function rather than obtaining diagnostic information.
No
The device description explicitly states it is comprised of biosafe materials and an angled stainless steel shaft, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used for the physical placement of implantable drug delivery ports and catheters within the body (subcutaneously). This is a surgical or procedural use, not a diagnostic test performed on samples outside the body.
- Device Description: The device is described as a physical tool (angled stainless steel shaft) used for tunneling. This aligns with a surgical instrument, not a diagnostic reagent or instrument used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely mechanical and procedural.
N/A
Intended Use / Indications for Use
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Product codes (comma separated list FDA assigned to the subject device)
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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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
Cook™ Trocar Tunnelator™, Davol® Tunneler
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.
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
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”
0
Image /page/0/Picture/0 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers 9, 6, 1, 8, 5, and 6. The numbers are written in a connected manner, with a slight slant to the right. The handwriting style is casual and the ink appears to be black.
United States Surqical Corporation 510(k) Premarket Notification Auto Suture* Chemosite* Tunneler**
SUMMARY OF INFORMATION SUPPORTING SAFETY AND EFFECTIVENESS:
As is evident in the submitted information on design, indications, materials and method of use, the Auto Suture* Chemosite* Tunneler** is substantially equivalent to the Cook™ Trocar Tunnelator™, the Davol® Tunneler and other currently marketed devices by United States Surgical Corporation.
- Both the Auto Suture* Chemosite* and the Davol® Tunneler have . similar indications, namely, for use with implantable drug delivery ports and catheters and for use in the subcutaneous positioning of long-term vascular access catheters and subcutaneous ports.
- . Both the Auto Suture* Chemosite* Tunneler** and the Cook™ Trocar Tunnelator™ are comprised of biosafe materials, such as stainless steel.
- . Both the Auto Suture* Chemosite* Tunneler** and the Cook™ Trocar Tunnelator™ are composed of an angled stainless steel shaft.
- Both the Auto Suture* Chemosite* Tunneler** and Auto Suture* Chemosite* . Implantable Drug Delivery System (K952748) currently marketed by United States Surgical Corporation are manufactured in similar facilities, using similar materials and process methods and controls.
- . Both the Auto Suture* Chemosite* Tunneler** and the Auto Suture* Chemosite* Implantable Drug Delivery System (K952748) currently marketed by United States Surgical Corporation are packaged in similar facilities, with the same materials and with the same process methods and controls.
- . Both the Auto Suture* Chemosite* Tunneler** and the Auto Suture* Chemosite* Implantable Drug Delivery System (K952748) currently marketed by United States Surgical Corporation are sterilized in similar facilities, with the same materials and with the same process methods and controls.