(54 days)
Not Found
Not Found
No
The description focuses on the mechanical and electrical functions of a traditional polypectomy snare and explicitly states "Not Found" for mentions of AI, DNN, or ML.
Yes
The device is used to remove polyps from the gastrointestinal tract, which is a therapeutic procedure.
No
The device description clearly states its purpose is to remove polyps (transect and excise), which is a treatment or surgical intervention, not a diagnostic act. It grasps and transmits electrical current for removal.
No
The device description clearly describes a physical instrument (polypectomy snare) with a snare wire and electrocautery capabilities, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to remove polyps from the gastrointestinal tract through a physical procedure (polypectomy) involving grasping, electrical current, and transection. This is a surgical/interventional procedure performed directly on the patient's body.
- Device Description: The device is a physical instrument (polypectomy snare) used to perform this procedure. It is introduced through an endoscope and physically interacts with the polyp.
- Lack of Diagnostic Purpose: The description does not mention any diagnostic purpose. The device is used for treatment (removal of the polyp), not for analyzing samples from the body to diagnose a condition.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Polypectomy is a procedure whereby a polyp is removed from the gastrointestinal tract. A polypectomy snare is an instrument which enables the physician to grasp the polyp, transmit electrical current and transect the polyp. The polypectomy snare is introduced through an endoscope and the snare wire is place around the polyp. The snare wire is closed while simultaneously transmitting electrocautery to excise the polyp. Polypectomy snares have been clinically used for more than years. Some Endoscope models have irrigation and suction 20 capabilities that are commonly used during polypectomy procedures. irrigation/aspiration polypectomy snare incorporates these The capabilities into one device.
Product codes
Not Found
Device Description
Polypectomy is a procedure whereby a polyp is removed from the gastrointestinal tract. A polypectomy snare is an instrument which enables the physician to grasp the polyp, transmit electrical current and transect the polyp. The polypectomy snare is introduced through an endoscope and the snare wire is place around the polyp. The snare wire is closed while simultaneously transmitting electrocautery to excise the polyp. Polypectomy snares have been clinically used for more than years. Some Endoscope models have irrigation and suction 20 capabilities that are commonly used during polypectomy procedures. irrigation/aspiration polypectomy snare incorporates these The capabilities into one device.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
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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.
Not Found
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
§ 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
MAR 2 5 1997
P102
SECTION II 510k Summary of Safety and Effectiveness
SAFETY AND EFFECTIVENESS U.S.E. IRRIGATION/ASPIRATION POLYPECTOMY SNARES
The Summary of Safety and Effectiveness on the endoscopic procedure for removal of polyps and the polypectomy snare used reflects data available and present at the time the summary was prepared, but, caution should be exercised in interpreting the data. The results of future studies may require alteration for the conclusions or recommendations set forth.
Procedure/Product Overview
Polypectomy is a procedure whereby a polyp is removed from the gastrointestinal tract. A polypectomy snare is an instrument which enables the physician to grasp the polyp, transmit electrical current and transect the polyp.
The polypectomy snare is introduced through an endoscope and the snare wire is place around the polyp. The snare wire is closed while simultaneously transmitting electrocautery to excise the polyp. Polypectomy snares have been clinically used for more than years. Some Endoscope models have irrigation and suction 20 capabilities that are commonly used during polypectomy procedures. irrigation/aspiration polypectomy snare incorporates these The capabilities into one device.
Contraindications for Polypectomy
Polypectomy via flexible endoscopy is contraindicated in the following cases:
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- If the polyp is too large to safely remove via flexible endoscopy .
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- If the depth of the polyp and the thickness of the wall and the level of penetration of thermal energy can not be determined.
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- Coagulopathy. ·
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- Poor bowel preparation.
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- Uncooperative patient.
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- Any contraindication to performing a colonoscopy.
The physician will determine patient's appropriateness for the procedure.
1
K9703J6
P202
Manufacturing Overview
U.S.E. designs, 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.
are certified to Materials used in the manufacturing process standards appropriate for their use.
Sterility Testing
This product is sterilized using ETO sterilization method.
Bibliography
Drossman, D.A. (Editor). Manual of Gastroenterologic Procedures (2nd Edition), New York: Raven Press, 1987.
- Society of Gastroenterology Nurses & Associates, Inc. Manual of Gastrointestinal Procedures. (2nd Edition). Rochester: SGNA, 1989.
- "The Management of Colonoscopy Complications." Jerome D. Waye, Gastroenterology & Endoscopy, May 1993, pp 23.
- Waye, J., Geenan, J., Fleischer, D. and Venue, R. Techniques in Therapeutic Endoscopy, New York: Gowen Medical Publishing, Ltd., 1987.
- Zuro, Lynne M., McCulloch, Catherine S., Saclarides, Theodore J. "Laparoscopic Colotomy, Polypectomy." AORN Journal, December 1992, pp. 1068-1073.
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