(134 days)
Not Found
No
The device description focuses on electrosurgical functions, suction, and irrigation, with no mention of AI or ML terms or capabilities.
No
The device is an electrosurgical tool designed for cutting and coagulation, along with suction and irrigation, during laparoscopic surgical procedures. It is a surgical instrument and not a device that provides therapeutic treatment itself.
No
Explanation: The device description states it is an "electrosurgical device" used for "electrocautery cutting and coagulation along with suction and irrigation." These are interventional and surgical functions, not diagnostic ones.
No
The device description clearly states it is an "electrosurgical device" and includes physical components like a "probe" and "tips," indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: This section is "Not Found," but the "Device Description" clearly states its function.
- Device Description: The description explicitly states the device is an "electrosurgical device" used for "electrocautery cutting and coagulation along with suction and irrigation" during "laparoscopic surgical procedures." This describes a device used during a surgical procedure on a patient, not a device used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the Stryker StrykeFlow Electrocautery Probe is a surgical tool, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
Product codes
85KNF, 79GEI, 85HET
Device Description
The Stryker StrykeFlow Electrocautery Probe is an electrosurgical device which enables the user to have the functions of electrocautery cutting and coagulation along with suction and irrigation in the same tool when used in combination with the Stryker Strykeflow Suction / Irrigator (K934094 and K954726). The Electrocautery Probe includes a variety of tip configurations for those laparoscopic surgical procedures where the delivery of electrosurgical current, irrigation, and suction via a single probe is desirable. The tips are packaged non-sterile for reusable purposes, and validated to packaging standard ASTM 4169.
The Electrocautery Probe is tested to a voluntary standard for electrosurgical devices, AAMI HF18.
The Electrocautery Probe is constructed of materials which are tested for biocompatibility per ISO-10993 and are safe, effective, and durable for their intended purposes. Sterilization is per AAMI SSSA and is validated for a minimum SAL of 106
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
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.
Not Found
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
JAN 3 1 1997
2590 Walsh Ave. Santa Clara, CA 95051
SUMMARY SAFETY AND EFFICACY
Device Name
K 963765
Current Classification Name(s): Unipolar Endoscopic Coagulator-Cutter and Accessories, CFR 21 884.4160, Class (II), Product code 85KNF Electrosurgical Cutting and Coagulation Device and Accessories, CFR 21 878.4400, Class (II), Product code 79GEI Gynecologic Laparoscope and Accessories, CFR 21 884.1720, Class (II), Product code 85HET
Common and Usual Name: Electrocautery Probe Stryker StrykeFlow Electrocautery Probe Proprietary Name:
This summary of 510(k) safety and effectiveness is being submitted in accordance with requirements of SMDA 1990.
The Stryker StrykeFlow Electrocautery Probe is an electrosurgical device which enables the user to have the functions of electrocautery cutting and coagulation along with suction and irrigation in the same tool when used in combination with the Stryker Strykeflow Suction / Irrigator (K934094 and K954726). The Electrocautery Probe includes a variety of tip configurations for those laparoscopic surgical procedures where the delivery of electrosurgical current, irrigation, and suction via a single probe is desirable. The tips are packaged non-sterile for reusable purposes, and validated to packaging standard ASTM 4169.
The Electrocautery Probe is tested to a voluntary standard for electrosurgical devices, AAMI HF18.
The Electrocautery Probe is constructed of materials which are tested for biocompatibility per ISO-10993 and are safe, effective, and durable for their intended purposes. Sterilization is per AAMI SSSA and is validated for a minimum SAL of 106
The Electrocautery Probe is equivalent in safety and effectiveness to a variety of devices currently marketed including the Valleylab Laparoscopic Handswitch/ Electrodes and the Stryker Strykeflow Suction / Irrigator Accessories. These devices are used in the applications noted above for general suction, irrigation, and electrocautery.
This device does not raise new issues when compared to its predicate devices or uses. Therefore, it is considered substantially equivalent to those devices.
Signature
Tom Keast Design Engineer