(190 days)
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No
The device description and performance studies focus on mechanical functions (check valve, vent valve, umbrella valve) and physical properties (leak testing, package integrity, aging). There is no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is used during open heart surgery to manage flow, pressure, and vacuum in a vent line, directly interacting with the patient's circulatory system to maintain physiological conditions during a medical procedure. While it doesn't directly treat a disease, it performs a critical therapeutic function by supporting the heart and preventing complications during surgery.
No
The device description indicates it is a valve designed to manage fluid flow, pressure, and vacuum during open heart surgery, not to diagnose a medical condition.
No
The device description clearly outlines a physical, three-function assembly with valves, indicating it is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's used during open heart surgery and placed in a vent line to manage flow and pressure. This is a device used in vivo (within the body) during a surgical procedure.
- Device Description: The description details mechanical components (check valve, vent valve, umbrella valve) that control fluid flow and pressure. This is consistent with a surgical or medical device used directly on or within a patient.
- Lack of IVD Characteristics: An IVD is a device used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This device does not interact with or analyze such specimens.
The device described is a surgical accessory used to manage fluid dynamics during open heart surgery, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
The Chase Left Vent Safety Valve is intended to be used during open heart surgery and placed in a vent line to permit flow only away from the heart, prevent buildup of line pressure, and limit line vacuum.
Product codes
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Device Description
The Left Vent Safety Valve is a three function assembly that is positioned in the vent line and includes a check valve which permits flow only away from the heart. A second vent valve is located downstream of the check valve to prevent buildup of drain line pressure. A third inwardly directed umbrella valve limits line vacuum intensity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).
0
K96439|
MAY 13 1997
SUMMARY OF SAFETY AND EFFECTIVENESS
CHASE LEFT VENT SAFETY VALVE
I. General Information
| A. Generic Name: | Left Vent Safety Valve |
|---|---|
| B. Trade Name of Device: | CHASE LEFT VENT SAFETY VALVE |
| C. Applicant's Name and Address: | CHASE MEDICAL INC., Richardson, TX |
| D. Pre-market Notification Number: | Not assigned |
II. Indication for Use:
The Chase Left Vent Safety Valve is intended to be used during open heart surgery and placed in a vent line to permit flow only away from the heart, prevent buildup of line pressure, and limit line vacuum.
III. Device Description
The Left Vent Safety Valve is a three function assembly that is positioned in the vent line and includes a check valve which permits flow only away from the heart. A second vent valve is located downstream of the check valve to prevent buildup of drain line pressure. A third inwardly directed umbrella valve limits line vacuum intensity.
- IV. Class II device Device Classification:
- Safety and Effectiveness: V.
Substantial Equivalence: This device is substantially equivalent to the C.R. Bard overpressure safety valve, (K820297).
- VI. Other Safety and Effectiveness Data:
| Materials: | All material are identical to the predicate device. |
|---|---|
| Sterilization: | Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL 10 -6 |
Functional Testing
All functional characteristics of the Chase Left Vent Safety Valve are non-differentiable as compared with the predicate because both devices have the exact same fit, form, and material composition.
1
SUMMARY OF SAFETY AND EFFECTIVENESS
Leak Test Requirements:
Package Integrity:
Shipping & Distribution Testing:
Accelerated Aging:
No leaks at 10 psi air on Chase device at 4℃ and 40°C
Tyvek/Polymylar passed burst test per ASTM F1140-88
Per National Safe Transit Ass. vibration and drop tests
Two year shelf life