(80 days)
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Not Found
No
The summary describes a mechanical device (sphincterotome) and its physical features and intended uses, with no mention of AI, ML, image processing, or any computational analysis.
Yes
The device is indicated for procedures like sphincterotomy, which is a therapeutic intervention to treat a medical condition.
No
The device is indicated for therapeutic procedures (sphincterotomy, cannulation, injection of contrast medium), not for diagnosing conditions.
No
The device description clearly describes a physical, triple-lumen sphincterotome, which is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical procedure (transendoscopic sphincterotomy, cannulation, and contrast injection) performed on the patient's body. IVDs are used to examine specimens from the body (like blood, urine, tissue) to diagnose conditions.
- Device Description: The description details a surgical instrument (a sphincterotome) used for cutting and injecting within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or diagnostic tests.
Therefore, the UltratomeRX is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The UltratomeRX is indicated for use in transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. The Microvasive UltratomeRX can also be used to cannulate and inject contrast medium.
Product codes
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Device Description
The Microvasive UltratomeRX is a triple lumen sphincterotome. The UltratomeRX is capable of accepting a .035" guidewire in one open channel while simultaneously injecting or cutting in another lumen. The open channel allows for the quick exchange of a guidewire completely isolated from injection agents and cutting. No stylet is necessary for scope passage.
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
Papilla of Vater and/or the Sphincter of Oddi
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
Laboratory testing regarding characteristics was performed on the UltratomeRX to verify its safety and performance. A biocompatibility assessment was performed on the patient- and fluidcontact materials of the UltratomeRX with satisfactory results.
Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
K970053 8172 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 | |
|---|---|---|
| COMMON/USUAL NAMES: | Sphincterotome | |
| TRADE/PROPRIETARY NAME: | Unknown this time | |
| CLASSIFICATION NAME & | ||
| DEVICE CLASSIFICATION: Class II | ||
| Name | Number | 21 CFR Ref |
| Endoscopic Electrosurgical | ||
| Unit and Accessories. | 78 KNS | 876.4300 |
| DEVICE PANEL/BRANCH: | Gastroenterology-Urology (GU) | |
| Gastro-Renal (GRDB) | ||
| OWNER/OPERATOR: | Boston Scientific Corporation | |
| One Boston Scientific Place | ||
| Natick, MA 01760 |
DESCRIPTION OF DEVICE
The Microvasive UltratomeRX is a triple lumen sphincterotome. The UltratomeRX is capable of accepting a .035" guidewire in one open channel while simultaneously injecting or cutting in another lumen. The open channel allows for the quick exchange of a guidewire completely isolated from injection agents and cutting. No stylet is necessary for scope passage.
INDICATIONS FOR USE
1
The UltratomeRX is indicated for use in transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi. The Microvasive UltratomeRX can also be used to cannulate and inject contrast medium.
DESCRIPTIVE AND TECHNOLOGICAL CHARACTERISTICS OF PROPOSED AND PREDICATE DEVICES
Boston Scientific Corporation believes that the UltratomeRX is substantially equivalent to the currently-marketed Boston Scientific Ultratome XL. The major components of the UltratomeRX are the catheter shaft, cutting wire, handle, guidewire introducer, and outer sheath. A thorough comparison of the descriptive characteristics between the UltratomeRX and the predicate device shows equivalence.
PERFORMANCE CHARACTERISTICS
Laboratory testing regarding characteristics was performed on the UltratomeRX to verify its safety and performance. A biocompatibility assessment was performed on the patient- and fluidcontact materials of the UltratomeRX with satisfactory results.
CONCLUSION
Boston Scientific Corporation believes that UltratomeRX is substantially equivalent to the currently-marketed UltratomeRX. A comparison of the descriptive characteristics of these products demonstrate the UltratomeRX 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 UltratomeRX will meet the minimum requirements that are considered acceptable for its intended use.