← Product Code [MJJ](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJJ) · K960937

# SUCTION SAFETY DEVICE (K960937)

_R D Intl. · MJJ · Jun 5, 1996 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJJ/K960937

## Device Facts

- **Applicant:** R D Intl.
- **Product Code:** [MJJ](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJJ.md)
- **Decision Date:** Jun 5, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.4400
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Indications for Use

The RDI Suction Safety Device is intended to be used during open heart surgery and placed in a suction line to permit flow only away from the heart, prevent buildup of line pressure, and limit line vacuum.

## Device Story

Three-function assembly positioned in suction line during open heart surgery; contains check valve for unidirectional flow and combination valve for pressure/vacuum relief. Operated by surgical staff; prevents line pressure buildup and limits vacuum. Benefits patient by ensuring controlled suction flow away from heart.

## Clinical Evidence

Bench testing only. Functional testing demonstrated similarity to predicate for pressure relief, one-way flow, and vacuum relief. Package integrity passed ASTM F1140-88; distribution testing passed NSTA Project 1A; accelerated aging confirmed two-year shelf life. Materials comply with Tripartite Biocompatibility Guidance for short-term, direct blood path contact. Device is non-pyrogenic.

## Technological Characteristics

Three-function assembly; check valve and combination pressure/vacuum relief valve. Fluid contact materials comply with Tripartite Biocompatibility Guidance. Sterilization via Gamma radiation (AAMI/ISO Method 1). Package integrity per ASTM F1140-88.

## Regulatory Identification

A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.

## Special Controls

*Classification.* Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

## Predicate Devices

- Delta Vacuum Relief Valve ([K760894](/device/K760894.md))

## Submission Summary (Full Text)

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JUN - 5 1996
K960937

# SUMMARY OF SAFETY OF EFFECTIVENESS

## RDI SUCTION SAFETY DEVICE

### I. General Information

A. Generic Name: Suction Safety Device
B. Trade Name of Device: RDI Suction Safety Device
C. Applicants Name and Address: RDI, Richardson, TX
D. Pre-market Notification Number: Not assigned

### II. Indication for Use

The RDI Suction Safety Device is intended to be used during open heart surgery and placed in a suction line to permit flow only away from the heart, prevent buildup of line pressure, and limit line vacuum.

### III. Device Description

The RDI Suction Safety Device is a three function assembly that is positioned in a suction line. The Suction Safety Device contains to valves. The first valve is a check valve that insures unidirectional flow. The second valve is a combination valve that relieves excess pressure and relieves excess vacuum.

### IV. Device Classification: Class II

### V. Safety and Effectiveness:

Substantial Equivalence: This device has been shown to be substantially equivalent to the Delta Vacuum Relief Valve 510(k) 760894.

### VI. Other Safety and Effectiveness Data:

**Material:** Fluid contact materials of construction comply with Tripartite Biocompatibility Guidance for external devices, blood path direct, short term use.

**Sterilization:** Validated AAMI/ISO Method 1 validation for Gamma radiation sterilization.

**Pyrogenicity:** Non-Pyrogenic

**Functional Testing:**

|  Pressure Relief: | Found to be similar to predicate  |
| --- | --- |
|  One-Way Flow: | Found to be similar to predicate  |
|  Vacuum Relief: | Found to be similar to predicate  |
|  Package Integrity: | Passed in accordance with ASTM F1140-88  |
|  Ship/Distribution: | Passed in accordance with NSTA Project 1A vibration/drop tests  |
|  Accelerated Aging | Successful two year shelf life  |

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJJ/K960937](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/MJJ/K960937)

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