(149 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and functional performance of a catheter, with no mention of AI or ML.
Yes
The device is used for venous drainage during extracorporeal circulation for open heart surgery, which is a therapeutic intervention.
No
Explanation: The device, a venous return catheter, is used for drainage during extracorporeal circulation in open heart surgery. Its function is to facilitate blood flow, not to obtain information for diagnosis.
No
The device description clearly outlines physical components made of plastic tubing and a reducer, indicating it is a hardware device, not software-only.
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, or tissue) to detect diseases, conditions, or infections. These tests are performed outside of the body.
- Device Function: The CHASE Two Stage Venous Return Catheter is a surgical instrument designed to be inserted into the body (specifically the right atrium and vena cava) to facilitate venous drainage during open heart surgery. It is a device used in vivo (within the living body), not in vitro (in glass or outside the body).
- Intended Use: The intended use clearly states its purpose is for "single tube venous drainage from the right atrium and vena cava during extracorporeal circulation for open heart surgery." This is a procedural function, not a diagnostic test.
The description and intended use clearly indicate this is a surgical catheter used for a therapeutic/procedural purpose, not for performing diagnostic tests on bodily samples.
N/A
Intended Use / Indications 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.
Product codes
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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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
right atrium and vena cava
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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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
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 【.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
| A. Generic Name: | Two Stage Venous Return Catheter |
|---|---|
| B. Trade Name of Device: | CHASE TWO STAGE VENOUS RETURN |
| CATHETER | |
| 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.
1
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