(37 days)
Not Found
No
The summary describes a device for endoscopic injection and electrohemostasis, focusing on its physical characteristics and intended use for treating bleeding sites. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
Yes
The device is indicated for use in endoscopic injection therapy and endoscopic electrohemostasis for treating bleeding sites in the gastrointestinal tract, which are therapeutic interventions.
No
The device is described as being used for endoscopic injection therapy and endoscopic electrohemostasis, which are therapeutic interventions rather than diagnostic procedures.
No
The device description and intended use clearly describe a physical probe used for endoscopic procedures, including injection and electrohemostasis, which are hardware-based functions. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body (endoscopic injection therapy and electrohemostasis in the gastrointestinal tract) for therapeutic purposes (delivering pharmacological agents, cauterization, coagulation).
- Device Description: The description aligns with an endoscopic probe used for direct intervention within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. IVDs typically involve analyzing biological samples like blood, urine, tissue, etc.
Therefore, this device falls under the category of a therapeutic endoscopic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Modified Injection Gold Probe and Injection Gold Probe Direct are indicated for use in endoscopic injection therapy (to deliver pharmacological injection arents, such as vasoconstrictors) and endoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract. These sites include the following: peptic ulcers; Mallory-Weiss tears; arteriovenous malformations (AVMs); Dieulafoy lesions; bleeding polyp stocks; and angiomata. The Modified Injection Gold Probe and Injection Gold Probe Direct also have irrigation capability.
Product codes (comma separated list FDA assigned to the subject device)
78 KNS, 78 KOG
Device Description
Boston Scientific Corporation believes that the Modified Injection Gold Probe is substantially equivalent to the currently-marketed Injection Gold Probe. Figure 9-1 compares the descriptive characteristics of these products.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Gastrointestinal tract
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 Modified Injection Gold Probe to verify its safety and performance. A biocompatibility assessment was performed on the patient- and fluid-contact materials of the Modified Injection Gold Probe with satisfactory results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
MAY 1 5 1996
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.
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Common/Usual Names: Electrohemostasis and Injection Therapy Catheter
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TRADE/PROPRIETARY NAME: Injection Gold Probes™
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Classification Name &
| DEVICE CLASSIFICATION: | Class I/II/III | ||
|---|---|---|---|
| Name | Number | 21 CFR Ref | |
| Unit, Electrosurgical, Endoscopic | |||
| (with Accessories) | 78 KNS | 876.4300 | |
| Endoscope and/or Accessories | 78 KOG | 876.1500 | |
| > DEVICE PANEL/BRANCH: | Gastroenterology-Urology (GU) | ||
| Gastro-Renal (GRDB) | |||
| > OWNER/OPERATOR: | Boston Scientific Corporation | ||
| One Boston Scientific Place | |||
| Natick, MA 01760 | |||
| Owner/Operator No. 9912058 | |||
| > CONTACT PERSON: | Daniel J. Dillon, Senior Regulatory Affairs Specialist |
INDICATIONS FOR USE
The Modified Injection Gold Probe and Injection Gold Probe Direct are indicated for use in endoscopic injection therapy (to deliver pharmacological injection arents, such as vasoconstrictors) and endoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract. These sites include the following: peptic ulcers; Mallory-Weiss tears; arteriovenous malformations (AVMs); Dieulafoy lesions; bleeding polyp stocks; and angiomata. The Modified Injection Gold Probe and Injection Gold Probe Direct also have irrigation capability.
CONTRAINDICATIONS
Contraindications for this device are those specific to injection therapy and bipolar electrohemostasis treatments. These contraindications include, but are not limited to: non-focal bleeding sites; esophageal/gastric varices; diffuse lesions; allergies to injection agents.
1
POTENTIAL COMPLICATIONS
Possible complications include, but may not be limited to: perforation; bleeding, post-injection ulceration with delayed bleeding; aspiration pneumonia; pleural effusion; other respiratory difficulties; hepatic failure; septicemia/infection; chest pain; esophageal strictures; dysphagia, fulguration, burns, stimulation and cardiac arrhythmias
Descriptive And Technological Characteristics OF Proposed And Predicate Devices
Boston Scientific Corporation believes that the Modified linjection Gold Probe is substantially equivalent to the currently-marketed Injection Gold Probe. Figure 9-1 compares the descriptive characteristics of these products.
PERFORMANCE CHARACTERISTICS
Laboratory testing regarding characteristics was performed on Modified Injection Gold Probe to verify its safety and performance. A biocompatibility assessment was performed on the patient- and fluid-contact materials of the Modified Injection Gold Probe with satisfactory results.
Packaging, Sterilization, And Pyrogenicity
The Modified Injection Gold Probe will be packaged in a styrene tray with a spun-bonded polyolefin lid. Modified Injection Gold Probe will be sterilized using ethylene oxide gas using the AAMI protocol for ethylene oxide sterilization. Pyrogenicity testing will be performed on a periodic basis to monitor bacterial endotoxin levels.
CONCLUSION
Boston Scientific Corporation believes that Modified Injection Gold Probe is substantially equivalent to the currently-marketed Modified Injection Gold Probe. Figure 9-1 compares the descriptive characteristics of these products. As demonstrated in Figure 9-1. the Modified Injection Gold Probe 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 Modified Injection Gold Probe will meet the minimum requirements that are considered acceptable for its intended use.
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Figure 9-1: Comparison of Modified Injection Gold Probe and Injection Gold Probe
| | Modified Injection Gold Probe
(This 510(k)) | Injection Gold Probe
(510(k) No. K942301) |
| -- | ------------------------------------------------ | ---------------------------------------------- |
|---|
USE
| Indication | Endoscopic injection therapy and
electrohemostasis of actual or potential
bleeding sites in the gastrointestinal tract. | «- Same |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------|---------|
| Route of Administration | Endoscopic | «- Same |
CATHETER SHAFT
| Usable Length | 210 - 350 cm | ← Same |
|---|---|---|
| Shaft OD | 7 - 10 F | ← Same |
BIPOLAR HEMOSTASIS
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Status Collection
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INJECTION THERAPY
| Needle Material | Stainless Steel |