(88 days)
Not Found
Not Found
No
The device description and intended use are purely mechanical and material-based, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
Yes
The device is described as insulating the myocardium to reduce undesired rewarming of the heart during open heart surgery, which directly indicates a therapeutic purpose.
No
The device is a pad used for insulation during surgery, not for diagnosing medical conditions. It is a therapeutic/surgical device.
No
The device description clearly states it is a physical pad made of foam and plastic, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The RDI Cardiac Insulation Pad is a physical device used during surgery to insulate the heart. It does not analyze any biological samples or provide diagnostic information.
- Intended Use: The intended use clearly states its purpose is to "insulate the myocardium... and thus reduce undesired rewarming of the heart." This is a therapeutic/surgical function, not a diagnostic one.
Therefore, based on the provided information, the RDI Cardiac Insulation Pad is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
Not Found
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".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
myocardium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
open heart surgery
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 1 A vibration/drop tests
Successful two year shelf life Accelerated Aging
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Sorin/Shiley Inc. Cardiac Insulation Pad #
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4475 Surgical vessel dilator.
(a)
Identification. A surgical vessel dilator is a device used to enlarge or calibrate a vessel.(b)
Classification. Class II (performance standards).
0
K960312 APR 191
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.
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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". -
Device Classification: Class II IV.
-
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 I validation for Gamma radiation sterilization. Pvrogenicity: Non-Pyrogenic Functional Testing:
Thermal Conductivity Found to be similar to Sorin/Shiley Tail Pull Test Found to be similar to Sorin/Shiley Found to be similar to Sorin/Shiley Water Absorption Package Integrity Passed in accordance with ASTM F1140-88 Shipping & Distribution Passed in accordance with NSTA Project 1 A vibration/drop tests Successful two year shelf life Accelerated Aging