(77 days)
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Not Found
No
The device description and summary of performance studies focus on the mechanical and material properties of a retrieval balloon catheter, with no mention of AI or ML capabilities.
Yes
The device is used to remove stones from the biliary system, which is a therapeutic action.
No
The device description indicates its use for removing stones and injecting contrast medium, not for diagnosing medical conditions. While it facilitates the injection of contrast, which can be part of a diagnostic procedure, the device itself is a tool for intervention/treatment, not for generating a diagnosis.
No
The device description clearly states it is a "triple lumen retrieval balloon catheter," which is a physical hardware device used endoscopically.
No, 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, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- ExtractorRX Function: The ExtractorRX is a device used inside the body (in vivo) during an endoscopic procedure. Its purpose is to physically remove stones or facilitate contrast injection within the biliary system. It does not analyze or test specimens taken from the body.
The description clearly indicates a device used for a therapeutic and diagnostic procedure performed directly on the patient's anatomy, not for laboratory testing of samples.
N/A
Intended Use / Indications for Use
The ExtractorRX is indicated for use endoscopically to remove stones from the biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon.
Product codes
78 FGE
Device Description
The Microvasive ExtractorRX is a triple lumen retrieval balloon catheter. The ExtractorRX is capable of accepting an .035" guidewire in one open channel while simultaneously injecting and/or inflating the balloon in the other two lumens. An open channel allows for the quick exchange of a guidewire completely isolated from injection agents and balloon inflation. No stylet is necessary for scope passage. The ExtractorRX may be placed with or without the aid of a guidewire.
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
biliary system
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)
Laboratory testing regarding characteristics was performed on ExtractorRX to verify its safety and performance. A biocompatibility assessment was performed on the patient- and fluidcontact materials of the ExtractorRX with satisfactory results.
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.
Microvasive Extractor XL
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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§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
9700052
Pinz
MAR 2 5 1997
SECTION 9 510(K) SUMMARY
FOI RELEASABLE
Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification "...adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Boston Scientific Corporation chooses to submit a summary of information respecting safety and effectiveness.
Date: January 6, 1997
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COMMON/USUAL NAMES: Endoscopic Biliary Stone Retrieval Balloon Catheter
Trade/Proprietary Name: Unknown at this Time
-
CLASSIFICATION NAME & DEVICE CLASSIFICATION: Class II
| Name | Number | 21 CFR Ref |
|---|---|---|
| Catheter, Biliary | 78 FGE | 876.5010 |
| > DEVICE PANEL/BRANCH: Gastroenterology-Urology (GU) | ||
| Gastro-Renal (GRDB) | ||
| > OWNER/OPERATOR: | Boston Scientific Corporation | |
| One Boston Scientific Place | ||
| Natick, MA 01760 |
Contact Person: Lisa M. Quaglia, Senior Regulatory Affairs Specialist
DESCRIPTION OF DEVICE
The Microvasive ExtractorRX is a triple lumen retrieval balloon catheter. The ExtractorRX is capable of accepting an .035" guidewire in one open channel while simultaneously injecting and/or inflating the balloon in the other two lumens. An open channel allows for the quick exchange of a guidewire completely isolated from injection agents and balloon inflation. No stylet is necessary for scope passage. The ExtractorRX may be placed with or without the aid of a guidewire.
1
INDICATIONS FOR USE
The ExtractorRX is indicated for use endoscopically to remove stones from the biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon.
PESCRIPTIVE AND TECHNOLOGICAL CHARACTERISTICS OF PROPOSED AND PREDICATE DEVICES
Boston Scientific Corporation believes that the ExtractorRX is substantially equivalent to the currently-marketed Microvasive Extractor XL. The major components of the ExtractorRX are the shaft, balloon, bifurcation, guidewire introducer, and the outer sheath. A thorough comparison of the descriptive characteristics between the ExtractorRX and the predicate device shows equivalence.
PERFORMANCE CHARACTERISTICS
Laboratory testing regarding characteristics was performed on ExtractorRX to verify its safety and performance. A biocompatibility assessment was performed on the patient- and fluidcontact materials of the ExtractorRX with satisfactory results.
CONCLUSION
Boston Scientific Corporation believes that ExtractorRX is substantially equivalent to the currently-marketed Microvasive Extractor XL. A comparison of the descriptive characteristics of these products demonstrate the ExtractorRX is equivalent in its indications for use, while being very similar in design and materials. In addition, Boston Scientific Corporation has presented laboratory testing and biocompatibility information. The information presented provides assurance that the ExtractorRX will meet the minimum requirements that are considered acceptable for its intended use.