(87 days)
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No
The summary describes a mechanical retrieval basket and does not mention any computational or algorithmic components, let alone AI/ML.
No.
The device is used to retrieve objects from the gastrointestinal or biliary tract, which is a diagnostic or interventional procedure, not a therapeutic treatment for a disease.
No
Explanation: The device is described as a retrieval basket used to remove foreign bodies, polyps, or tissues. Its function is to grasp and retrieve, which is a therapeutic or interventional action, not diagnostic.
No
The device description explicitly states it is a "retrieval basket," which is a physical instrument used in endoscopic procedures, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states the device is used for "Endoscopic Retrieval," which involves physically removing objects from the gastrointestinal or biliary tract within the body.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze specimens or perform any diagnostic tests on samples taken from the patient.
Therefore, this device is an in vivo (within the body) medical device used for a therapeutic or interventional procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Endoscopic Retrieval is a procedure whereby a foreign body, polyp or tissue, stone or calculi is removed from the gastrointestinal tract or biliary tract. A retrieval device is an instrument which enables the physician to grasp and retrieve the object via endoscopic methods.
The retrieval basket is introduced through an endoscope and the basket is placed around the object. Retrieval baskets have been clinically used for more than 20 years.
Product codes
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Device Description
The retrieval basket is introduced through an endoscope and the basket is placed around the object. Retrieval baskets have been clinically used for more than 20 years.
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
gastrointestinal tract or biliary tract
Indicated Patient Age Range
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Intended User / Care Setting
physician
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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§ 876.4680 Ureteral stone dislodger.
(a)
Identification. A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
0
OCT = 4 1996
K962676
SECTION II 510(k) Summary of SAFETY AND BFFECTIVENESS U.S.E. BNDOSCOPIC RETRIEVAL DEVICES (all versions) SUMMARY
The Summary of Safety and Effectiveness on the endoscopic procedure for retrieval of foreign bodies, tissue or polyps, stones or calculi used 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
Endoscopic Retrieval is a procedure whereby a foreign body, polyp or tissue, stone or calculi is removed from the gastrointestinal tract or biliary tract. A retrieval device is an instrument which enables the physician to grasp and retrieve the object via endoscopic methods.
The retrieval basket is introduced through an endoscope and the basket is placed around the object. Retrieval baskets have been clinically used for more than 20 years.
Contraindications for retrieval of foreign body, tissue or polyp, stones or calculi
Retrieval via flexible endoscopy is contraindicated in the following cases:
- If the risk or removal of the object is greater than the endoscopic 1) procedure.
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- Uncooperative patient
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- Any contraindication to performing endoscopy
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- Known or suspected perforated viscus
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- Presence of large stones in biliary tract and other associated contraindications for therapeutic biliary procedures.
The physician will determine patient's appropriateness for procedure.
Manufacturing Overview
U.S.E. manufactures and tests the product to performance designs, 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 Endoscopic Retrieval Devices will be sterilized using ETO gas and the methods will conform to AMI standards for sterilization of medical devices.
1
Bibliography
Hardick, Marcia and Beck, Marjorie (Editors), Manual of 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.