STRYKER STRYKEFLOW SUCTION IRRIGATOR GRAVITY FLOW

K963646 · Stryker Endoscopy · GEI · Apr 16, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K963646
• Device Name: STRYKER STRYKEFLOW SUCTION IRRIGATOR GRAVITY FLOW
• Applicant: Stryker Endoscopy
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2

Intended Use

The Stryker Strykeflow Suction Irrigator Gravity Flow (SIGF) is an irrigation suction device which is provided sterile for single use disposable application. The SIGF accepts a variety of tips for laparoscopic and open general surgery, laparoscopic and open obstetric surgery, laparoscopic and open urologic surgery, endoscopic and open nasal surgery, open otolaryncolologic surgery, and open plastic surgery.

Device Story

SIGF is a sterile, single-use suction/irrigation device; accepts various tips for laparoscopic and open surgical procedures; functions via gravity flow or external suction source; provides irrigation fluid delivery and fluid evacuation from surgical sites; tips may also serve as cannula/portal to operation site; used by surgeons in OR; provides visualization/access maintenance; benefits patient by clearing surgical field of debris/fluids.

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993; sterilization validation per AAMI ST 32 (gamma irradiation, SAL 10^-6); electrocautery compatibility validation per AAMI HF18.

Technological Characteristics

Materials tested for biocompatibility per ISO 10993. Sterilization via gamma irradiation (AAMI ST 32, 1.66 Mrads). Validated for electrocautery per AAMI HF18. Single-use disposable construction. Gravity flow or suction-assisted operation.

Indications for Use

Indicated for suction and irrigation during laparoscopic and open general, obstetric, urologic, nasal, otolaryngologic, and plastic surgeries. Intended for use by surgeons in clinical settings.

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

• Nezhat-Dorsey device
• Stryker Strykeflow Suction Irrigator

Submission Summary (Full Text)

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stryker

ENDOSCOPY

K963646

APR 16 1997

2590 Walsh Ave. Santa Clara, CA 95051

# SUMMARY SAFETY AND EFFICACY

## Device Name

Current Classification Name(s):

- Vacuum-powered Body Fluid Suction Apparatus CFR 21 Class II 880.6740
- Irrigation Device CFR 21 Class I 880.6960
- Gynecologic Laparoscope and Accessories CFR 21 Class II 884.1720
- Gastroenterology-urology Evacuator CFR 21 Class II 876.4370
- Laparoscope General and Plastic Surgery CFR 21 Class II 878.4400
- Cardiopulmonary Bypass Cardiotomy Return Sucker CFR 21 Class II 870.4430
- Ear, Nose, and Throat Manual Surgical Instrument CFR 21 Class II 874.4420

Common and Usual Name: Suction Irrigator GF or SIGF

Proprietary Name: Stryker Strykeflow Suction Irrigator Gravity Flow

## Device Sponsor

Stryker Endoscopy

2590 Walsh Ave.

Santa Clara, CA 95051

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

The Stryker Strykeflow Suction Irrigator Gravity Flow (SIGF) is an irrigation suction device which is provided sterile for single use disposable application. The SIGF accepts a variety of tips for laparoscopic and open general surgery, laparoscopic and open obstetric surgery, laparoscopic and open urologic surgery, endoscopic and open nasal surgery, open otolaryncolologic surgery, and open plastic surgery. The SIGF is validated per AAMI HF18 for electrocautery application. The tips may be sterile packaged and disposable (single-use only) or non-sterile packaged for reusable purposes.

The SIGF is constructed of materials which are tested for biocompatibility per ISO 10993 and are safe, effective, and durable for their intended purposes. Gamma irradiation validation is per AAMI standard ST 32, method 1, section 5.2.3.1. The minimum dose for an SAL of $10^{-6}$ is 1.66 Mrads.

The SIGF is equivalent in safety and effectiveness to a variety of devices currently marketed (the Nezhat-Dorsey device, the Stryker Strykeflow Suction Irrigator, and equivalent gravity flow and bulb/syringe devices) which are used in the applications noted above for general suction or irrigation purposes. Additionally, the suction/irrigator tips may serve as a cannula to the laparoscopic surgeon to provide a portal to the operation site similar to the function of the trocar cannula.

This device does not raise new issues when compared to its predicate devices or uses. Therefore, it is considered substantially equivalent to those devices.

Tony Lee

Senior Design Engineer