(221 days)
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No
The provided text describes a standard electrosurgical probe with features for dissection, coagulation, smoke evacuation, and fluid management. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML functionality. The performance studies focus on the device's physical capabilities, not algorithmic performance.
No
The device is used for electrosurgical purposes (dissection and coagulation) and fluid/smoke management during surgery, which are active interventional procedures rather than therapeutic in nature. While it aids in a surgical procedure meant to treat a condition, the device itself is a surgical tool, not a therapeutic device that directly treats, cures, or rehabilitates a disease or injury.
No
Explanation: The device is described as an electrocautery probe used for dissection, hemostasis, and fluid/smoke management during surgery. Its function is to perform a therapeutic procedure (tissue modification) rather than to diagnose a condition.
No
The device description clearly indicates it is a physical probe with a shaft and lumen, used in conjunction with hardware (electrosurgical generators). It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "hemostatic dissection of tissue and coagulation of blood" during surgical procedures, specifically the endoscopic takedown of the Internal Mammary Artery. This is a direct surgical intervention on living tissue within the body.
- Device Description: The description reinforces its use in conjunction with electrosurgical generators for surgical purposes.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue samples) outside the body to provide information about a patient's health status. This device does not perform any such analysis on specimens.
The device is a surgical tool used in vivo (within the living body) for therapeutic and hemostatic purposes, not for diagnostic testing of samples in vitro.
N/A
Intended Use / Indications for Use
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.
Product codes
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Device Description
The Heartport Handswitch Electrocautery Probe combines the same functions as the individual predicate devices into a single electrocautery device.
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
thoracic cavity, Internal Mammary Artery
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
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.
Key Metrics
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Predicate Device(s)
1.DLP (a division of Medtronic) - I.M.A. Electrocautery Knife Blades, 2.Valleylab (a Pfizer company) - Disposable Handswitching Laparoscopic Handset and Laparoscopic Electrode, 3.Ximed Medical Systems - Electroprobe Single-Use Surgical Probe
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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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 and |
| Coagulation Device and Accessories | |
| 21 CFR 884.4120 Gynecologic Electrocautery | |
| and 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 Handset |
| and Laparoscopic Electrode | |
| 3.Ximed Medical Systems - | Electroprobe Single-Use Surgical Probe |
1
510(k) Summary of Safety and Effectiveness (continued)
Intended Use
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.
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.