STRYKER STRYKEFLOW ELECTROCAUTERY PROBES

K963765 · Stryker Endoscopy · GEI · Jan 31, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K963765
• Device Name: STRYKER STRYKEFLOW ELECTROCAUTERY PROBES
• Applicant: Stryker Endoscopy
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jan 31, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Electrosurgical probe; enables cutting, coagulation, suction, and irrigation via single tool. Used in laparoscopic surgery; requires connection to Stryker Strykeflow Suction/Irrigator. Tip configurations vary; reusable; non-sterile packaging. Operated by surgeons in clinical/OR settings. Provides integrated delivery of electrosurgical current and fluid management; enhances procedural efficiency by reducing instrument exchanges.

Clinical Evidence

Bench testing only. Tested to AAMI HF18 electrosurgical standards. Biocompatibility testing per ISO-10993. Packaging validated to ASTM 4169. Sterilization validated to AAMI SSSA for SAL 10⁻⁶.

Technological Characteristics

Electrosurgical probe with integrated suction/irrigation channels. Materials biocompatibility tested per ISO-10993. Sterilization via AAMI SSSA (SAL 10⁻⁶). Packaging per ASTM 4169. Complies with AAMI HF18 electrosurgical standard. Reusable design.

Indications for Use

Indicated for laparoscopic surgical procedures requiring electrosurgical cutting, coagulation, irrigation, and suction.

Regulatory Classification

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.

Predicate Devices

• Valleylab Laparoscopic Handswitch/ Electrodes
• Stryker Strykeflow Suction / Irrigator Accessories

Reference Devices

• Stryker Strykeflow Suction / Irrigator (K934094)
• Stryker Strykeflow Suction / Irrigator (K954726)

Submission Summary (Full Text)

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Stryker®

ENDOSCOPY 2590 Walsh Ave. Santa Clara, CA 95051

JAN 31 1997

# 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

Proprietary Name: Stryker StrykeFlow Electrocautery Probe

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 10⁻⁶

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