(77 days)
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No
The device description and performance studies focus on the mechanical and electrical properties of a surgical instrument, with no mention of AI or ML.
Yes
The device is used for transendoscopic papillotomy, a medical procedure to cut the papilla of Vater and/or the Sphincter of Oddi, which directly treats a medical condition.
No
Explanation: The device is indicated for transendoscopic papillotomy, which is a surgical procedure, not a diagnostic one. It is used to perform an intervention (cutting), not to diagnose a condition.
No
The device description clearly outlines physical components made of materials like nylon, silicone, PVC, ABS, and stainless steel, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "transendoscopic papillotomy of the Papilla of Vater and/or the Sphincter of Oddi under endoscopic and/or fluoroscopic visualization." This describes a surgical procedure performed directly on the patient's anatomy, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details the physical components and materials of a surgical instrument designed for cutting tissue.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is a surgical tool used for intervention.
N/A
Intended Use / Indications for Use
The Bard® High Flow papillotome is indicated for use in transendoscopic papillotomy of the Papilla of Vater and/or the Sphincter of Oddi under endoscopic and/or fluoroscopic visualization.
Product codes
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Device Description
The High Flow papillotome dual lumen shaft is constructed out of nylon with a MDX silicone coating. The luer fitting is PVC and the handle assembly material is ABS. The electrode assembly is similar in construction to the Bard Proforma except that the set screw is stainless steel. The High Flow papillotome shaft is an 8 french O. D. that tapers to a 5.5 french tip O. D.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
endoscopic and/or fluoroscopic visualization
Anatomical Site
Papilla of Vater and/or the Sphincter of Oddi
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)
Comparative movement testing through a side viewing endoscope and guidewire movement testing has demonstrated substantial equivalence.
Electrical testing has confirmed the High Flow papillotome meets the requirements of the ANSI/AMMI HF18-1993 standard.
Biocompatibility testing has confirmed the materials used for the proposed High Flow papillotome are safe for contacting mucosa and tissue.
In Vitro flow testing has confirmed the device is substantially equivalent to the Microvasive® Ultratome XL sphincterotome.
In addition, bow force, bow orientation, radiopacity and joint integrity tests were completed to confirm device safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
0
NOV 1 9 1996
963484
PI 14
Bard Interventional Products Division C.R. Bard, Inc. 129 Concord Road P.O. Box 7031 Billerica, MA 01821-7031 508-663-8989
BARRID
510(k) SUMMARY FOR THE BARDOHIGH FLOW PAPILLOTOME 6.0
As required under Section 12, part (a)(i)(3A) of the Safe Medical Device Act of 1990, an adequate summary of any information respecting safety and effectiveness follows.
- 6.1 General Information
- -Name and address of submitter:
Bard Interventional Products Division, C.R. Bard, Inc. 129 Concord Road Billerica, MA 01821-7031
-
Contact: a
Beth A. Rochette Regulatory Affairs Manager Phone: (508) 663-8989 Fax: (508) 670-9827 -
Date of Summary: -
August 12, 1996 -
Name of Device: -
Trade Name: Common/Usual Name: Classification Name:
Bard® High Flow Papillotome Papillotome Endoscopic Electrosurgical Accessory
Predicate Device(s):
Bard ProForma Papillotome and the Microvasive® (Boston Scientific Corp.) Fluorotome™/Ultratome™/Ultratome XL Sphincterotomes
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