(89 days)
760894
Not Found
No
The device description and performance studies focus on mechanical functions (valves, pressure/vacuum relief, flow control) and do not mention any computational or learning-based components. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as a "Suction Safety Device" that manages flow, pressure, and vacuum in a suction line during surgery. It does not directly provide therapy or treatment to the patient. Its function is to ensure the safe and proper operation of a surgical suction system, which is a supportive role rather than a therapeutic one.
No
The device's function is to regulate pressure and vacuum in a suction line during surgery, ensuring one-way flow for safety and preventing buildup; it does not diagnose medical conditions.
No
The device description clearly states it is a "three function assembly" containing "two valves" positioned in a "suction line," indicating a physical hardware device. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be placed in a suction line during open heart surgery to manage flow, pressure, and vacuum. This is a device used during a surgical procedure on a patient, not a device used to examine specimens in vitro (outside the body) to provide diagnostic information.
- Device Description: The description details mechanical valves that control flow, pressure, and vacuum. This aligns with a surgical accessory, not a diagnostic test.
- Lack of Diagnostic Information: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide any kind of diagnostic result about a patient's condition.
- Performance Studies: The performance studies focus on the mechanical function of the device (pressure relief, one-way flow, vacuum relief, packaging integrity, aging), not on the accuracy or reliability of a diagnostic test.
IVD devices are specifically designed to examine specimens from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Delta Vacuum Relief Valve 510(k) 760894
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.4400 Cardiopulmonary bypass blood reservoir.
(a)
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.(b)
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.
0
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 |
11. 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:
Máterial: 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 |