(76 days)
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No
The summary describes a mechanical handle for endoscopic accessories and makes no mention of AI, ML, image processing, or any data-driven algorithms.
No
The device is described as an "Accessory Handle" for endoscopic tools like biopsy forceps and polypectomy snares. These tools are used for diagnostic or treatment procedures, but the handle itself does not directly perform a therapeutic action; it enables the use of other tools.
No
Explanation: The device is described as a handle for endoscopic accessories like biopsy forceps and polypectomy snares. These accessories are used for sampling or removal, not for diagnosing conditions. The handle itself facilitates the use of these tools, but does not perform a diagnostic function.
No
The device description explicitly states it is a "Reusable Endoscopic Accessory Handle," which is a physical hardware component used with other endoscopic accessories. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be a handle for endoscopic accessories like biopsy forceps and polypectomy snares. These are used during a medical procedure to collect tissue or remove polyps from within the body.
- Device Description: The description reinforces its function as a handle for these accessories.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to obtain information about a physiological state, health, or disease. IVDs typically involve analyzing samples like blood, urine, tissue, etc.
This device is a surgical accessory used in conjunction with other endoscopic instruments for procedures performed in vivo (within the body).
N/A
Intended Use / Indications for Use
The Reusable Endoscopic Accessory Handle can be used with various types of endoscopic accessories including biopsy forceps and polypectomy snares.
Product codes (comma separated list FDA assigned to the subject device)
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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): 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.
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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).
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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
JUL 222 1996
SECTION II SAFETY AND EFFECTIVENESS U.S.E. REUSABLE HANDLE SUMMARY
The Summary of Safety and Effectiveness on the Reusable Endoscopic Accessory Handle 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
The Reusable Endoscopic Accessory Handle can be used with various types of endoscopic accessories including biopsy forceps and polypectomy snares.
Contraindications
Reusable handle is contraindicated for use in The any contraindication to performing any type of endoscopic procedure.
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.
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.
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.
- Waye, Jerome D. "The Management of Colonoscopy Complications." 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.