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K Number
K991960
Device Name
SERFAS, SERFAS GENERATOR, SERFAS CONSOLE, SERFAS PROBE, SERFAS HANDPIECE CABLE, SERFAS FOOTSWITCH
Manufacturer
Stryker Endoscopy
Date Cleared
1999-08-13

(64 days)

Product Code
GEI
Regulation Number
878.4400
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The SERFAS RF system is an electrosurgical system designed for general surgical use, including orthopedic and arthroscopic applications of ablation and coagulation of soft tissues, and hemostasis of blood vessels. The system is intended for use in arthroscopic surgery of the joints such as knee, shoulder, elbow, ankle, hip and wrist. The system is intended for use in saline solution, Ringer's lactate or other conductive solution as an irrigant.

Device Description

The Stryker SERFAS is a bipolar electrosurgery system for ablation and coagulation of tissue in presence of a conductive irrigant. The SERFAS system includes a generator, a cable, probes with a variety of tip configurations and a footswitch. The probes are packaged sterile and the generator, cable and footswitch are packaged non-sterile.

AI/ML Overview

This document does not contain information about the acceptance criteria or a study proving that the Stryker SERFAS system meets specific performance criteria.

The document is a "Summary of Safety and Effectiveness" (a 510(k) submission) and an FDA clearance letter for the Stryker SERFAS Radio Frequency Ablation System.

It states that the device is tested to certain voluntary consensus standards (IEC 60601-2-2, EN-60601-1, IEC 601-1-4) and biocompatibility standards (ISO-10993, G95-1), and that the sterilization methods are validated. It also declares the device substantially equivalent to predicate devices (Arthrocare System 2000 and Mitek VAPR System).

However, it does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Information about sample sizes for a test set, data provenance, or ground truth establishment.
  3. Details on expert involvement, adjudication methods, or MRMC studies.
  4. Data from standalone algorithm performance studies.
  5. Training set sample size or how ground truth was established for a training set.

The document focuses on regulatory compliance (following standards, substantial equivalence to predicate devices) rather than detailing specific performance studies with acceptance criteria.

§ 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.