(51 days)
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No
The summary provides no information suggesting the use of AI or ML. The device description is purely functional and does not mention any computational or analytical capabilities beyond the basic intended use.
Yes
The device description states its intended use is in endoscopic papillotomy and sphincterotomy, which are therapeutic procedures.
No
Explanation: The device is intended for interventional procedures (papillotomy and sphincterotomy), not for diagnosing conditions.
No
The device description explicitly states "The Papillotome is intended for use in endoscopic papillotomy and sphincterotomy," which are surgical procedures typically performed with physical instruments. The lack of any mention of software, algorithms, or data processing strongly suggests this 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 "endoscopic papillotomy and sphincterotomy." This describes a surgical procedure performed on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The description reiterates the intended use, confirming it's a tool for a surgical procedure.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on sample analysis
- Using reagents or assays
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Papillotome, as described, is a surgical instrument used for a therapeutic procedure.
N/A
Intended Use / Indications for Use
The Papillotome is intended for use in endoscopic papillotomy and sphincterotomy.
Product codes
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Device Description
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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
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Indicated Patient Age Range
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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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
1962346
AUG - 8 1996
SECTION II 510(K) Summary of Safety & Effectiveness
Summary of Safety and Effectiveness for the Papillotome The reflects data available and presented at the time the submission was prepared, but, caution should be exercised in interpreting the data. The results of future studies may require alterations of the conclusions or recommendations set forth.
Procedure/Product Overview
The Papillotome is intended for use in endoscopic papillotomy and sphincterotomy.
Contraindications for Papillotomy and Sphincterotomy Procedure
- Coagulopathy .
- Acute pancreatitis (relative) -
- Allergy to contrast medium (relative) .
- Long stricture of the distal common bile duct .
- Presence of an extremely large stone .
- Inability to properly position sphinctertome .
- Other contraindications as determined by physician .
Complications that May Occur
- Bleeding •
- Perforation and impaction of stone or basket may occur as . immediate complications
- Torrential and late bleeding are rare .
- The occurrence of pancreatitis .
Manufacturing Overview
U.S.E. manufactures and tests the product to performance specifications based on predicate and/or substantially equivalent devices.
U.S.E. manufacturing processes and procedures are based on good manufacturing practices. Quality assurance methods and procedures based on MIL-STD-9858 are utilized to assure conformance to design specifications.
Materials used in the manufacturing process are certified to standards appropriate for their use.
Sterility Testing
The Papillotome is sterilized using Eto.
1
(962346
Bibliography
- Manual of (Editors), Hardick, Marcia and Beck , Marjorie Gastrointestinal Procedures, (2nd Edition). New York: Society of Gastroenterology Nurses and Associates, Inc., 1989.
Ravenscroft, M.M. and Swan, C.H.J. Gastrointestinal Endoscopy and Related Procedures. Baltimore: Williams & Wilkins, 1984.
Berci, George Endoscopy. New York: Appleton-Century-Crofts, 1976.
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