The Heartport Handswitch Electrocautery Probe is used in conjunction with standard electrosurgical generators for the hemostatic dissection of tissue and coagulation of blood. The long, narrow shaft allows the device to be used during the endoscopic takedown of the Internal Mammary Artery. The probe's central lumen allows for the evacuation of smoke generated by electrocautery as well as the removal of fluid from the thoracic cavity. The central lumen may also be used to provide irrigation fluid to the surgical site.

Device Description

The Heartport Handswitch Electrocautery Probe is a device used in conjunction with standard electrosurgical generators for the hemostatic dissection of tissue and coagulation of blood. It has a long, narrow shaft and a central lumen for smoke evacuation, fluid removal, and irrigation.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and study information:

The provided text describes a 510(k) summary for a "Handswitch Electrocautery Probe." However, this document does not contain the information requested for a detailed description of acceptance criteria and a study proving a device meets these criteria in the context of an AI/medical imaging device.

The document focuses on:

Device Identification: Trade name, common name, classification, and applicant information.
Intended Use: Description of what the electrocautery probe is designed to do (dissect tissue, coagulate blood, evacuate smoke/fluid).
Predicate Devices: Identifying similar devices already on the market.
Non-Clinical Test Results: Brief statements on performance (dissecting/cauterizing tissue, evacuating smoke/fluids) and biocompatibility.
Summary of Substantial Equivalence: Concluding that the device is substantially equivalent to predicates.

It lacks any mention of AI, diagnostic imaging, or the specific types of performance metrics that would be associated with AI-driven medical devices (e.g., sensitivity, specificity, AUC). Therefore, it's impossible to fill out the requested table and answer the questions based on this input.

Given the nature of the input, it seems to be a regulatory submission for a physical medical device (an electrocautery probe) rather than a software as a medical device (SaMD) or an AI-powered diagnostic tool. The questions you've asked are highly relevant for AI/ML medical devices, but the provided text doesn't cater to those.

If you can provide a different document that pertains to an AI-driven medical device, I would be able to answer your questions thoroughly.

Summary

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Appendix A. 510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K961334

Applicant Information:

Date Prepared:

April 5, 1996

Name: Address: Heartport, Inc. 200 Chesapeake Drive Redwood City, CA 94063

Contact Person: Phone Number: Fax Number:

Isabella Abati (415) 306-7900 (415) 306-7905

Device Information:

Classification	Class II
Trade Name:	Handswitch Electrocautery Probe
Common Name:	Electrocautery Probe
Classification Name:	21 CFR 878.4400 Electrosurgical Cutting andCoagulation Device and Accessories21 CFR 884.4120 Gynecologic Electrocauteryand Accessories

Equivalent Devices:

The Heartport Handswitch Electrocautery Probe is substantially equivalent in intended use and/or method of operation to a combination of the following predicate devices:

1.DLP (a division of Medtronic) -	I.M.A. Electrocautery Knife Blades
2.Valleylab (a Pfizer company) -	Disposable Handswitching Laparoscopic Handsetand Laparoscopic Electrode
3.Ximed Medical Systems -	Electroprobe Single-Use Surgical Probe

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510(k) Summary of Safety and Effectiveness (continued)

Intended Use

Comparison To Predicate Devices

The Handswitch Electrocautery Probe is equivalent in intended use and operational characteristics to the following devices: (1) DLP (a division of Medtronic) I.M.A. Electrocautery Knife Blades. (2) Valleylab (a Pfizer company) Disposable Handswitching Laparoscopic Handset and Laparoscopic Electrode and (3) Ximed Medical Systems Electroprobe Single-Use Surgical Probe.

The Heartport Handswitch Electrocautery Probe combines the same functions as the individual predicate devices into a single electrocautery device.

Non-Clinical Test Results

Performance:

The Handswitch Electrocautery Probe was evaluated for its ability to dissect and cauterize tissue as well as evacuate smoke and fluid during operation . All Electrocautery Probes tested, effectively dissected and cauterized tissue, and evacuated smoke and fluids from the thoracic cavity.

Biocompatibility:

The patient contacting materials used to fabricate the Heartport Handswitch Electrocautery Probe are similar, and in most cases identical, to the materials used in the predicate devices.

Summary

Based on the product information, intended use, performance and biocompatibility data provided in this Notification, the Heartport Handswitch Electrocautery Probe has been shown to be substantially equivalent to currently marketed predicate devices.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.