Who is the manufacturer of RDI CARDIAC INSULATION PAD?

R D Intl. filed the 510(k) submission for RDI CARDIAC INSULATION PAD (K960312).

What is the FDA product code for RDI CARDIAC INSULATION PAD?

DWP. It is classified under 21 CFR 870.4475 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for RDI CARDIAC INSULATION PAD?

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

Who can help prepare an FDA 510(k) submission like RDI CARDIAC INSULATION PAD?

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.

RDI CARDIAC INSULATION PAD

Q: What are the predicate devices for RDI CARDIAC INSULATION PAD?

Sorin/Shiley Inc. Cardiac Insulation Pad.

K960312 · R D Intl. · DWP · Apr 19, 1996 · Cardiovascular

Device Facts

Record ID	K960312
Device Name	RDI CARDIAC INSULATION PAD
Applicant	R D Intl.
Product Code	DWP · Cardiovascular
Decision Date	Apr 19, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.4475
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The RDI Cardiac Insulation Pad is intended to be used during open heart surgery to insulate the myocardium from the warmer organs and tissues in the body and thus reduce undesired rewarming of the heart.

Device Story

Pear-shaped, 1/8” thick, closed-cell polyethylene foam pad with 4 mil thick, 1/2” wide, 20” long polyvinyl chloride 'tail'. Used during open heart surgery by surgeons to insulate myocardium from warmer adjacent tissues/organs. Prevents undesired rewarming of heart during procedure. Device provides thermal barrier; performance verified via thermal conductivity, water absorption, and mechanical pull testing compared to predicate.

Clinical Evidence

Bench testing only. Functional testing demonstrated similarity to predicate in thermal conductivity, tail pull strength, and water absorption. Package integrity validated per ASTM F1140-88; shipping/distribution validated per NSTA Project 1A. Biocompatibility compliant with Tripartite Guidance for short-term, direct blood path contact. Non-pyrogenic. Two-year shelf life established via accelerated aging.

Technological Characteristics

Materials: Closed-cell polyethylene foam, polyvinyl chloride. Biocompatibility: Tripartite Guidance (external, blood path direct, short-term). Sterilization: Gamma radiation (AAMI/ISO Method 1). Mechanical: 1/8” thick pad, 20” tail. Standards: ASTM F1140-88 (package integrity), NSTA Project 1A (shipping).

Indications for Use

Indicated for patients undergoing open heart surgery to provide myocardial insulation against surrounding body heat.

Regulatory Classification

Identification

A surgical vessel dilator is a device used to enlarge or calibrate a vessel.

Predicate Devices

Sorin/Shiley Inc. Cardiac Insulation Pad

Related Devices

K992932 — CIPA (ADULTS) CIPI (INFANTS) · Dmc Medical, Ltd. · Jun 7, 2000
K971021 — CHASE PHRENIC NERVE PAD · Chase Medical, Inc. · Aug 12, 1997
K020365 — 3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE · 3t Medical Systems, LLC · May 3, 2002
K971013 — CHASE TEMPERATURE PROBE · Chase Medical, Inc. · Oct 28, 1997
K100071 — EMCOOLSPAD · Emcools Emergency Medical Cooling Systems AG · Oct 12, 2010

Submission Summary (Full Text)

{0} K960312 APR 19 1996 # SUMMARY OF SAFETY AND EFFECTIVENESS ## RDI CARDIAC INSULATION PAD ### I. General Information A. Generic Name: Cardiac Insulation Pad B. Trade Name of Device: RDI Cardiac Insulation Pad C. Applicants Name and Address: RDI Richardson, Texas D. Pre-market Notification Number: Not assigned ### II. Indications for Use The RDI Cardiac Insulation Pad is intended to be used during open heart surgery to insulate the myocardium from the warmer organs and tissues in the body and thus reduce undesired rewarming of the heart. ### III. Device Description The RDI Cardiac Insulation Pad consists of a pear shaped, 1/8” thick, closed cell polyethylene foam material. Attached to the foam is a 1/2” wide, 20” long, 4 mil thick, polyvinyl chloride strip referred to as a “tail”. ### IV. Device Classification: Class II ### V. Safety and Effectiveness: Substantial Equivalence: This device has been shown to be substantially equivalent to the Sorin/Shiley Inc. Cardiac Insulation Pad # ### VI. Other Safety and Effectiveness Data: **Materials:** 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:** | Thermal Conductivity | Found to be similar to Sorin/Shiley | | --- | --- | | Tail Pull Test | Found to be similar to Sorin/Shiley | | Water Absorption | Found to be similar to Sorin/Shiley | | Package Integrity | Passed in accordance with ASTM F1140-88 | | Shipping & Distribution | Passed in accordance with NSTA Project 1A vibration/drop tests | | Accelerated Aging | Successful two year shelf life |