STRYKER SUCTION REGULATOR

K963648 · Stryker Endoscopy · GCX · Nov 26, 1996 · General Hospital

Device Facts

• Record ID: K963648
• Device Name: STRYKER SUCTION REGULATOR
• Applicant: Stryker Endoscopy
• Product Code: GCX · General Hospital
• Decision Date: Nov 26, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6740
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Stryker Suction Regulator (SSR) controls the rate of suction from any product that requires suction control. It is intended for uses in any procedure in which the control of suction force is desired.

Device Story

Stryker Suction Regulator (SSR) controls suction rate for medical procedures; consists of inlet tube, outlet tube, and handpiece. Operation: handpiece regulates suction by varying ambient air intake; increased air intake reduces suction force at inlet; decreased air intake increases suction force. Used in clinical settings to manage suction levels during various procedures. Device provides manual control of suction force to assist healthcare providers in maintaining appropriate vacuum levels for patient safety and procedural efficacy.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993. Sterilization validation performed per AAMI ST 27 (ETO) and AAMI ST 32 (Gamma) to SAL 10^-6.

Technological Characteristics

Mechanical suction regulator; handpiece with ambient air intake control. Materials tested for biocompatibility per ISO 10993. Sterilization: ETO (AAMI ST 27) or Gamma irradiation (AAMI ST 32, 1.66 Mrads minimum dose for SAL 10^-6).

Indications for Use

Indicated for use in any medical procedure requiring the control of suction force.

Regulatory Classification

Identification

A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.

Predicate Devices

• Arthrex Suction Regulator

Submission Summary (Full Text)

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K963649
NOV 26 1996
Stryker® ENDOSCOPY 2590 Walsh Ave. Santa Clara, CA 95051

# SUMMARY SAFETY AND EFFICACY

## Device Name

Current Classification Name:

- Vacuum-powered Body Fluid Suction Apparatus CFR 21 Class II 880.6740
- 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
- Arthroscopic Accessories CFR 21 Class II 888.1100
- Cardiopulmonary Bypass Intracardiac Suction Control CFR 21 Class II 870.4430

Common and Usual Name: Suction Regulator or SSR
Proprietary Name: Stryker Suction Regulator

## 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 Suction Regulator (SSR) controls the rate of suction from any product that requires suction control. It consists of an inlet tube with a suction adapter at the end, an outlet tube with a suction adapter at the end, and a handpiece. The handpiece controls suction by varying the amount of ambient air entering the tube set. As more air is let into the tube set, suction force at the inlet tube is reduced. As less air is let into the tube set, suction force is increased.

The SSR is constructed of materials which are tested for biocompatibility per ISO 10993 and are safe, effective, and durable for their intended purposes. The SIGF ETO sterilization processes are validated per AAMI standard ST 27, to a SAL of $10^{-6}$. 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 SSR is equivalent in safety and effectiveness to the Arthrex Suction Regulator. It is intended for uses in any procedure in which the control of suction force is desired.

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