(78 days)
Not Found
No
The document describes a bipolar electrocautery probe with a central irrigation channel and does not mention any AI or ML capabilities.
Yes
The device is indicated for electrocautery of bleeding sites and other therapeutic interventions in the gastrointestinal tract.
No
The device is described as an electrocautery probe for treating bleeding and non-bleeding sites in the gastrointestinal tract, indicating a therapeutic function rather than a diagnostic one.
No
The device description clearly describes a physical probe (catheter) with specific dimensions and features for delivering electrocautery, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Gold Probe Function: The description clearly states the Gold Probe is used for "transendoscopic electrocautery of visible bleeding and non-bleeding sites in the gastrointestinal tract." This is a therapeutic procedure performed inside the body (in vivo) to stop bleeding or treat lesions. It does not involve testing samples taken from the body.
The device description and intended use clearly indicate it's a therapeutic device used during an endoscopic procedure, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Gold Probe is indicated for use in transendoscopic electrocautery of visible bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus, stomach, duodenum, and colon. The indications include peptic ulcers, Mallory-Weiss tears, arteriovenous malfunctions (AVMs), Dieulafoy lesions, bleeding polyp stocks, angiomata, Watermelon Stomach, Barrett's Esophagus, angiodysplasia, and esophageal tumors.
Product codes
78 KNS
Device Description
The Microvasive Gold Probe and is a bipolar probe available in 7 Fr and 10 Fr. The catheter length is 217 - 350 cm long and is designed as circumactive probes which deliver effective electrocautery en fosse and tangentially. A central irrigation channel allows for site washing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal tract including but not limited to, the esophagus, stomach, duodenum, and colon.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Laboratory testing regarding characteristics was performed on the Gold Probe to verify its safety and performance. A biocompatibility assessment was performed on the patient- and fluidcontact materials of the Gold Probe with satisfactory results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Microvasive Gold Probe, ACMI Bicap Tumor Probe
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
APR 11 1997
142 SECTION 9 510(K) SUMMARY 970278
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.
January 22, 1997 > Date:
COMMON/USUAL NAMES: Endoscopic Electrosurgical Unit
Trade/Proprietary Name: Microvasive Gold Probe
-
Classification Name & DEVICE CLASSIFICATION: Class II
| Name | Number | 21 CFR Ref | |
|---|---|---|---|
| Unit, Electrosurgical | 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 |
Lisa M. Quaglia, Senior Regulatory Affairs Specialist > Contact Person:
DESCRIPTION OF DEVICE
The Microvasive Gold Probe and is a bipolar probe available in 7 Fr and 10 Fr. The catheter length is 217 - 350 cm long and is designed as circumactive probes which deliver effective electrocautery en fosse and tangentially. A central irrigation channel allows for site washing.
INDICATIONS FOR USE
The Gold Probe is indicated for use in transendoscopic electrocautery of visible bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus, stomach, duodenum, and colon. The indications include peptic ulcers, Mallory-Weiss tears,
1
2+2
arteriovenous malfunctions (AVMs), Dieulafoy lesions, bleeding polyp stocks, angiomata, Watermelon Stomach, Barrett's Esophagus, angiodysplasia, and esophageal tumors.
DESCRIPTIVE AND TECHNOLOGICAL CHARACTERISTICS OF PROPOSED AND PREDICATE DEVICES
Boston Scientific Corporation believes that the Gold Probe is substantially equivalent to the currently-marketed Microvasive Gold Probe and the ACMI Bicap Tumor Probe. The major components of the Gold Probe are the catheter shaft, the tip, and the irrigation port. A thorough comparison of the descriptive characteristics between the Gold Probe and the predicate devices show equivalence.
PERFORMANCE CHARACTERISTICS
Laboratory testing regarding characteristics was performed on the Gold Probe to verify its safety and performance. A biocompatibility assessment was performed on the patient- and fluidcontact materials of the Gold Probe with satisfactory results.
CONCLUSION
Boston Scientific Corporation believes that Gold Probe is substantially equivalent to the currently-marketed Gold Probe and ACMI Bicap Tumor Probe. A comparison of the descriptive characteristics of these products demonstrate the Gold Probe is equivalent in its indications for use, while being very similar in design and materials. In addition, Boston Scientific Corporation has presented biocompatibility information. The information presented provides assurance that the Gold Probe will meet the minimum requirements that are considered acceptable for its intended use.