OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)

K964445 · Dlp, Inc. · DWS · Jan 30, 1997 · Cardiovascular

Device Facts

• Record ID: K964445
• Device Name: OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)
• Applicant: Dlp, Inc.
• Product Code: DWS · Cardiovascular
• Decision Date: Jan 30, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4500
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The indications or intended use for the DLP Octopus™ Tissue Stabilizer and the predicate product, Cardiothoracic Systems, Inc. (CTS) Thoracic Access Platform and Stabilizer are the same. Both are intended for use during coronary artery bypass grafting to isolate diseased artery and minimize motion of the beating heart to facilitate the grafting procedure.

Device Story

DLP Octopus™ Tissue Stabilizer; surgical instrument for coronary artery bypass grafting (CABG). Device stabilizes beating heart tissue to facilitate grafting. Input: controlled vacuum suction applied to myocardium via suction tip/tentacles. Design: plastic handle, vacuum tubing connection, malleable stainless steel arm, plastic contact feet. Operation: positions anastomosis site between two feet; applies suction to isolate and stabilize tissue. Used in OR by surgeons. Benefit: facilitates grafting procedure on beating heart by minimizing motion. Comparison: differs from CTS Stabilizer by using controlled suction rather than random pressure.

Clinical Evidence

Bench testing only; no clinical data provided. Biocompatibility testing performed on plastic contact surfaces.

Technological Characteristics

Materials: plastic contact surface (biocompatibility tested), stainless steel arm. Mechanism: vacuum-assisted tissue stabilization. Form factor: malleable arm with suction tip and dual-foot design. Energy source: external vacuum source. Connectivity: none. Software: none.

Indications for Use

Indicated for use during coronary artery bypass grafting to isolate diseased artery and minimize motion of the beating heart to facilitate the grafting procedure.

Regulatory Classification

Identification

Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.

Predicate Devices

• Cardiothoracic Systems, Inc. (CTS) Thoracic Access Platform and Stabilizer
• DLP Cardiac Suction Tube

Submission Summary (Full Text)

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JAN 30 1997
K964445

# SUMMARY OF SAFETY AND EFFECTIVENESS
CFR 807.92(c)

1. INDICATIONS: The indications or intended use for the DLP Octopus™ Tissue Stabilizer and the predicate product, Cardiothoracic Systems, Inc. (CTS) Thoracic Access Platform and Stabilizer are the same. Both are intended for use during coronary artery bypass grafting to isolate diseased artery and minimize motion of the beating heart to facilitate the grafting procedure.

2. DESIGN: The design of the Octopus™ is similar to both predicate products referenced in the Comparison Information Section. It features plastic handle with vacuum tubing connection, malleable stainless steel arm and suction tip similar to the DLP Cardiac Suction Tube product. The “feet” design of the Octopus™ is intended to position the anastomosis site between two “feet” for isolation and stabilization control which is the same as the CTS Thoracic Access Platform and Stabilizer.

3. MATERIALS: The contact surface of the Octopus™ feet or tentacles on the heart is a plastic material that has been biocompatibility tested.

4. SAFETY AND EFFICACY: No differences in safety and efficacy. Materials have undergone acceptable biocompatibility testing. Intended use is same as CTS Stabilizer predicate product. Design characteristics are similar to both DLP Cardiac Suction and CTS Stabilizer predicate products.

5. DIFFERENCES: Primary differences between Octopus™ and CTS Stabilizer is the Octopus™ functions by applying controlled suction to the myocardium whereas the CTS Stabilizer applies random amount of pressure.

Roger W. Brink
Director of Regulatory Affairs
DLP, Div. of Medtronic, Inc.

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