(78 days)
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No
The summary describes a mechanical stone dislodger basket and does not mention any AI/ML terms, image processing, or data sets typically associated with AI/ML development.
Yes
The device is described as a "Stone Dislodger" intended to "grasp, manipulate and remove calculi and other foreign objects" during urological and gastroenterological procedures. This direct action of removing harmful objects from the body constitutes a therapeutic intervention.
No
The device is described as a "Stone Dislodger" intended to "grasp, manipulate and remove calculi and other foreign objects." This describes a therapeutic or interventional function, not a diagnostic one.
No
The device description explicitly states it is a "2Fr, 8.3 mm Stone Dislodger Basket, Helical Design," which is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used during procedures to physically grasp, manipulate, and remove objects (calculi and foreign objects) from the body. This is a therapeutic and interventional use, not a diagnostic one.
- Device Description: The description of a "Stone Dislodger Basket" with a "Helical Design" is consistent with a physical tool used within the body, not a reagent or instrument used to test samples outside the body.
- Lack of IVD Characteristics: The information provided does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances
- Providing information for diagnosis, monitoring, or screening
IVDs are used to perform tests on samples taken from the body to provide information about a person's health status. This device is used to directly interact with and remove objects from within the body.
N/A
Intended Use / Indications for Use
The proposed Stone Dislodger is intended to be used during urological and/or gastroenterological procedures including use during intracorporeal lithotripsy, to endoscopically grasp, manipulate and remove calculi and other foreign objects.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
2Fr, 8.3 mm Stone Dislodger Basket, Helical Design
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)
The proposed devices have been tested and compared to the predicate devices (K871777, K871779, K925495, K951309). The results indicate that the proposed devices are "Substantially Equivalent" to the predicate devices in terms of performance characteristics tested.
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.
K871777, K871779, K925495, K951309
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
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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
APR - 2 1997
户门户 |
1
510 (k) Summary Of Safety And Effectiveness K970121
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| Sponsor: | Boston Scientific Corporation
One Scientific Place
Natick, MA 01760-1537 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Carol J. Holloway
Regulatory Affairs Specialist |
| Submission Date: | January 13, 1997 |
| Description of
Device: | 2Fr, 8.3 mm Stone Dislodger Basket, Helical Design |
| Intended Uses: | The proposed Stone Dislodger is intended to be used during
urological and/or gastroenterological procedures including use
during intracorporeal lithotripsy, to endoscopically grasp,
manipulate and remove calculi and other foreign objects. |
| Substantial
Equivalence: | The proposed devices are "Substantially Equivalent" to the
predicate devices (K871777, K871779, K925495, K951309)
indicated for use during urological and/or gastroenterological
procedures to endoscopically grasp, manipulate
and remove calculi and other foreign objects. |
| Product Testing: | The proposed devices have been tested and compared to the predicate
devices (K871777, K871779, K925495, K951309). The results
indicate that the proposed devices are "Substantially Equivalent" to
the predicate devices in terms of performance characteristics tested. |