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K Number
K963648
Device Name
STRYKER SUCTION REGULATOR
Manufacturer
Stryker Endoscopy
Date Cleared
1996-11-26

(75 days)

Product Code
GCX
Regulation Number
880.6740
Type
Traditional
Panel
HO
Reference & Predicate Devices
K983216
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

It is intended for uses in any procedure in which the control of suction force is desired.

Device Description

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.

AI/ML Overview

The provided text is a summary of safety and efficacy for a medical device (Stryker Suction Regulator) and does not contain information about acceptance criteria or a study proving that the device meets those criteria. Therefore, I cannot extract the requested information.

The document focuses on:

  • Device Classification and Name: Listing various classifications and the proprietary name of the device.
  • Device Description: Explaining how the suction regulator works.
  • Material and Sterilization Standards: Mentioning biocompatibility testing (ISO 10993) and sterilization validation (AAMI ST 27, AAMI ST 32).
  • Substantial Equivalence Claim: Stating that the device is equivalent to the "Arthrex Suction Regulator" and does not raise new issues.

There's no mention of specific performance metrics, acceptance thresholds, or a study that evaluates the device against such criteria.

§ 880.6740 Vacuum-powered body fluid suction apparatus.

(a)
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).(b)
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.