RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLET

• K Number: K953945
• Device Name: RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLET
• Manufacturer: DLP, INC.
• Date Cleared: 1996-03-26 ( 218 days)
• Product Code: DWF
• Regulation Number: 870.4210

Intended Use

The indications or intended use for the DLP Elongated and Treaded Cuff Retrograde Coronary Sinus Perfusion (RCSP) cannula are the same as the DLP, Research Medical and Sarns 3M marketed RCSP cannula. The cannula are intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus.

Device Description

The design of the DLP Elongated and Treaded Cuff RCSP cannula is similar to predicate products. Size and shape contain minor differences. Technological characteristics are equivalent. Cuff length and texture differences do not affect flow characteristics.

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical device (cannula) with minor design differences from predicate devices. There is no mention of software, algorithms, or any terms related to AI/ML.

Therapeutic

Yes
The device is used to perfuse cardioplegia solutions, which are drugs, retrograde through the coronary sinus for therapeutic purposes (e.g., protecting the heart during surgery).

Diagnostic

No
The device is described as a cannula used for perfusing cardioplegia solutions, which is a therapeutic rather than diagnostic function. It is a tool for delivering treatment, not for identifying a medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly indicates a physical cannula, which is a hardware component, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is to perfuse cardioplegia solutions retrograde through the coronary sinus. This is a therapeutic procedure performed directly on a patient's circulatory system.
• Device Description: The description details a cannula, which is a surgical instrument used for accessing blood vessels.
• Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.

IVDs are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) for a therapeutic purpose.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The indications or intended use for the DLP Elongated and Treaded Cuff Retrograde Coronary Sinus Perfusion (RCSP) cannula are the same as the DLP, Research Medical and Sarns 3M marketed RCSP cannula. The cannula are intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus.

Product codes

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Device Description

The design of the DLP Elongated and Treaded Cuff RCSP cannula is similar to predicate products. Size and shape contain minor differences. Technological characteristics are equivalent. Cuff length and texture differences do not affect flow characteristics.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

coronary sinus

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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Key Metrics

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Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.

(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).

Summary

0

Image /page/0/Picture/0 description: The image shows a handwritten sequence of characters that appear to be alphanumeric. The sequence reads as 'KC953945'. The characters are written in a cursive style, with some connections between the letters and numbers. The writing is dark against a light background, suggesting it could be ink on paper.

MAR 26 1996

SUMMARY OF SAFETY AND EFFECTIVENESS

• 1. INDICATIONS: The indications or intended use for the DLP Elongated and Treaded Cuff Retrograde Coronary Sinus Perfusion (RCSP) cannula are the same as the DLP, Research Medical and Sarns 3M marketed RCSP cannula. The cannula are intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus.
• 2. DESIGN: The design of the DLP Elongated and Treaded Cuff RCSP cannula is similar to predicate products. Size and shape contain minor differences. Technological characteristics are equivalent. Cuff length and texture differences do not affect flow characteristics.
• 3. MATERIALS: The materials used for the cuffs and cannula body are silicone which is same as that for DLP and SARNS 3M marketed RCSP devices. Materials have been tested to be biocompatiability acceptable.
• 4 . SAFETY & EFFICACY: No difference in Safety and Efficacy. Since materials, indications and technology are the same, no new issues of Safety and Efficacy of the device are introduced.
• 5. DIFFERENCES: The differences are minor and nonsignificant differences.

Roger W. Brink

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