Who is the manufacturer of SUCTION SAFETY DEVICE?

R D Intl. filed the 510(k) submission for SUCTION SAFETY DEVICE (K960937).

What is the FDA product code for SUCTION SAFETY DEVICE?

MJJ. It is classified under 21 CFR 870.4400 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for SUCTION SAFETY DEVICE?

510(k) clearance (submission type: Traditional).

What are the predicate devices for SUCTION SAFETY DEVICE?

Delta Vacuum Relief Valve (K760894).

Who can help prepare an FDA 510(k) submission like SUCTION SAFETY DEVICE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SUCTION SAFETY DEVICE

K960937 · R D Intl. · MJJ · Jun 5, 1996 · Cardiovascular

Device Facts

Record ID	K960937
Device Name	SUCTION SAFETY DEVICE
Applicant	R D Intl.
Product Code	MJJ · Cardiovascular
Decision Date	Jun 5, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.4400
Device Class	Class 2

Intended 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.

Indications for Use

Indicated for use during open heart surgery to manage suction line flow, pressure, and vacuum in patients undergoing cardiac procedures.

Regulatory Classification

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)

Related Devices

K964391 — CHASE LEFT VENT SAFETY VALVE · Chase Medical, Inc. · May 13, 1997
K982406 — COBE VACUUM RELIEF CHECK VALVE · Cobe Cardiovascular, Inc. · Oct 7, 1998
K992657 — IBC VRV, MODEL 1350 · International Biophysics Corp. · Feb 18, 2000
K961287 — ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM · Rocket Medical Plc · Jul 26, 1996
K964198 — CAHSE AORTIC ROOT CANNULA · Chase Medical, Inc. · Mar 19, 1997

Submission Summary (Full Text)

{0} 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 |