(54 days)
Not Found
Not Found
No
The 510(k) summary describes a purely mechanical and electrical device for polyp removal and makes no mention of AI or ML capabilities, image processing, or data sets for training/testing.
No.
The device is used to remove polyps, which is a surgical procedure, not a therapeutic treatment in the sense of treating a disease or condition with medication or non-invasive means. It is an instrument for surgical removal.
No
Explanation: The device description states its purpose is to "grasp and electrosurgically dissect and transect" polyps, which are therapeutic actions, not diagnostic.
No
The device description clearly states it is a physical instrument (polypectomy snare) used to grasp and transect polyps, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of this device is to directly interact with and remove polyps within the body during an endoscopic procedure. It's a surgical tool, not a diagnostic test performed on a sample.
- The description focuses on a surgical procedure. The device is used to "grasp and electrosurgically dissect and transect" polyps, which are actions performed directly on tissue inside the patient.
- There is no mention of analyzing a sample. The device doesn't collect a sample (like blood, urine, or tissue) for analysis outside the body.
Therefore, this device falls under the category of a surgical instrument used in a medical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Angled Tip Polypectomy Snare will be used in Flexible Endoscopy in order to grasp and electrosurgically dissect and transect flat (sessile) or stalked polyps during endoscopic procedures.
Product codes
Not Found
Device Description
A polypectory snare is an instrument which enables the physician to grasp the polyp, transmit electrical current and transect the polyp. The Angled Tip Polypectomy Snare is for use in Flexible Endoscopy to grasp, electrosurgically dissect, and transect flat (sessile) or stalked polyps.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
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.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Pin2
SECTION TO 510k Summary of Safety and Effectiveness
SAFETY AND EFFECTIVENESS U.S.E. ANGLED TIP SNARE SUMMARY
The Summary of Safety and Effectiveness on the endoscopic procedure for removal of polyps and the Angled Tip 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 polypectory snare is an instrument which enables the physician to grasp the polyp, transmit electrical current and transect the polyp.
The Angled Tip Polypectomy Snare will be used in Flexible Endoscopy in order to grasp and electrosurgically dissect and transect flat (sessile) or stalked polyps during endoscopic procedures.
Contraindications for Polypectomy
Polypectomy via flexible endoscopy is contraindicated in the following cases: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
-
- If the polyp is too large to safely remove via flexible endoscopy .
-
- If the depth of the polyp and the thickness of the wall and the level of penetration of thermal energy can not be determined.
-
- Coagulopathy.
-
- Poor bowel preparation.
-
- Uncooperative patient.
-
- Any contraindication to performing a colonoscopy.
The physician will determine patient's appropriateness for the procedure.
Manufacturing Overview
U.S.E. designs, manufactures and tests the product to performance specifications based on predicate and/or substantially equivalent devices .
1
$$
\begin{array}{c}
\bullet \urcorner \bullet \urcorner \bullet \urcorner \bullet \urcorner \bullet \urcorner \
\bullet \urcorner \bullet \urcorner \bullet \urcorner \bullet \urcorner
\end{array}
$$
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
This product is sterilized using ETO sterilization method.
Bibliography
Manual of Gastroenterologic Procedures Drossman, D.A. (Editor). (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." Waye, Jerome D. Gastroenterology & Endoscopy, May 1993, pp 23.
- J., Geenan, J., Fleischer, D. and Venue, R. Techniques in Waye, Therapeutic Endoscopy, New York: Gowen Medical Publishing, Ltd., 1987.
- Lynne M., McCulloch, Catherine S., Saclarides, Theodore J.
"Laparoscopic Colotomy, Polypectomy." AQRN Journal, December Zuro, 1992, pp. 1068-1073.