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The Tissue Retractor System is intended for use in dissecting and retracting in all types of surgical procedures requiring dissection and retraction of tissue.

The RadLite™ Tissue Retractor System has application for the creation and maintenance of an operative cavity in the extraperitoneal spaces such as the retroperitoneal, preperitoneal and subcutaneous areas. The device may be used in all types of surgical procedures requiring retraction of tissue.

The Genzyme Tissue Retractor System s is a surgical instrument that provides a means to create and maintain a cavity by retracting the subcutaneous layer to expose the conduit. The retraction is sufficient to allow enough exposure to dissect and retract subcutaneous tissue for performing all types of surgical procedures. This system consists of the following components:

• Handle: The handle securely holds the retractor blade, light panel, and provides a host adaptor for ACMI connection to a variety of commercially available light sources.
• Retractor/blade: The stainless steel retractor blade attaches to the handle for lifting the subcutaneous layer.
• Fiber Optic Light Panel: The light panel fits securely into the handle on the underside of the retractor blade to provide illumination for the procedure.

The provided document, K022989, is a 510(k) Summary of Safety and Effectiveness for the "Tissue Retractor System" from Genzyme Biosurgery. It focuses on demonstrating substantial equivalence to predicate devices and does NOT contain information regarding acceptance criteria or a study proving device performance against such criteria.

The document primarily covers:

• Manufacturer Information: Genzyme Biosurgery
• Device Identification: Tradename (Tissue Retractor System), Classification (Endoscopic Instruments and Accessories per 21 CFR §876.1500), Common Name (Tissue Retractor).
• Predicate Devices: SaphLITE® System (K960400) by Genzyme Biosurgery and ENDOPATH® Ultra-Retractor (K973139) by Ethicon Endo-Surgery, Inc.
• Device Description: Components (Handle, Retractor/blade, Fiber Optic Light Panel) and function (creating and maintaining a cavity by retracting the subcutaneous layer).
• Intended Use: Dissecting and retracting in all types of surgical procedures requiring dissection and retraction of tissue.
• Comparison of Characteristics: States "The technological characteristics of the New Device are the same as the predicate devices."
• Conclusion of Substantial Equivalence: Based on detailed device description, conformance to consensus standards, and voluntary standards.
• FDA Response Letter: Confirms substantial equivalence and outlines regulatory responsibilities.
• Indications for Use: Reiterates the intended use in extraperitoneal spaces and for tissue retraction in all types of surgical procedures.

Therefore, I cannot populate the table or answer the questions regarding acceptance criteria and performance studies because this information is not present in the provided text. The 510(k) pathway often relies on demonstrating equivalence to existing legally marketed devices rather than conducting extensive performance studies against specific acceptance criteria for a novel technology that would require such detailed reporting.

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