(149 days)
The CHASE Two Stage Venous Return Catheter is indicated for single tube venous drainage from the right atrium and vena cava during extracorporeal circulation for open heart surgery.
The CHASE Two Stage Venous Return Catheter consists of a 27.9 cm (11") length of 51 French flexible plastic tubing attached to a molded, rigid plastic reducer. The reducer has six openings which permit drainage from the right atrium. The reducer is attached to a 7.6 cm (3") length of 36 French flexible plastic tubing, which has a rigid plastic tip. The tip has six openings which allow drainage from the vena cava. The tubing is marked approximately 3 cm and 4.5 cm from the base of the reducer as a reference for determining tip and side hole location during catheter insertion. An obturator is installed in the catheter to minimize blood loss from the reducer during the insertion of the catheter into the right atrium and vena cava.
This document is a summary of safety and effectiveness for the CHASE TWO STAGE VENOUS RETURN CATHETER, a medical device. It describes the device and its intended use, but it does not contain information about acceptance criteria or a study that proves the device meets acceptance criteria in the format requested.
The "Functional Testing" section explicitly states: "All functional characteristics of the Chase Medical Two Stage Venous Return/Catheter are nondifferentiable as compared with the predicate because both devices have the expect same fit, form, and material composition." This indicates that direct comparison to a predicate device (Sarns two stage venous return catheter K770431) is the basis for demonstrating safety and effectiveness, rather than a separate study with defined acceptance criteria for the CHASE device itself.
The "VI. Other Safety and Effectiveness Data" section lists several tests (Leak Test, Tubing Bond Strength, Package Integrity, Shipping & Distribution Testing, Accelerated Aging) along with their results. While these could be considered performance characteristics, the document does not present them as "acceptance criteria" met by a "study" in the typical sense of a clinical or analytical performance study of an AI/algorithm-based device as implied by the user's request. There is no mention of a device performance metric, sample sizes, ground truth establishment, or expert involvement as would be relevant for an AI/algorithm-based device.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, or details about the study, sample size, experts, or ground truth, as this information is not present in the provided text for an AI/algorithm-based device.
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Image /page/0/Picture/0 description: The image shows a handwritten sequence of characters. The sequence starts with the letter 'K', followed by the number '9', then the number '6', then the number '4', then the number '1', then the number '9', and ends with the number '5'. The characters are written in a bold, somewhat stylized manner.
19 1997
SUMMARY OF SAFETY AND EFFECTIVENESS
CHASE TWO STAGE VENOUS RETURN CATHETER
General Information 【.
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| A. Generic Name: | Two Stage Venous Return Catheter |
|---|---|
| B. Trade Name of Device: | CHASE TWO STAGE VENOUS RETURNCATHETER |
| C. Applicant's Name and Address: | CHASE MEDICAL INC. , Richardson, TX |
| D. Pre-market Notification Number: | Not assigned |
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II. Indication for Use:
The CHASE Two Stage Venous Return Catheter is indicated for single tube venous drainage from the right atrium and vena cava during extracorporeal circulation for open heart surgery. -
III. Device Description
The CHASE Two Stage Venous Return Catheter consists of a 27.9 cm (11") length of 51 French flexible plastic tubing attached to a molded, rigid plastic reducer. The reducer has six openings which permit drainage from the right atrium. The reducer is attached to a 7.6 cm (3") length of 36 French flexible plastic tubing, which has a rigid plastic tip. The tip has six openings which allow drainage from the vena cava. The tubing is marked approximately 3 cm and 4.5 cm from the base of the reducer as a reference for determining tip and side hole location during catheter insertion. An obturator is installed in the catheter to minimize blood loss from the reducer during the insertion of the catheter into the right atrium and vena cava. -
IV. Device Classification: Class II device
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Safety and Effectiveness: V.
Substantial Equivalence: This device is substantially equivalent to the Sarns two stage venous return catheter K770431.
- Other Safety and Effectiveness Data: VI.
| 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 Medical Two Stage Venous Return/Catheter are nondifferentiable as compared with the predicate because both devices have the expect same fit, form, and material composition.
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SUMMARY OF SAFETY AND EFFECTIVENESS
Leak Test Requirements:
Tubing Bond Strength:
Package Integrity:
Shipping & Distribution Testing:
Accelerated Aging:
No leaks at 10 psi air on Chase device at 4°C and 40°C
Exceeds 10 lb. tensile strength @ 4°C 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
§ 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).