(177 days)
Not Found
No
The summary describes a simple mechanical catheter with no mention of AI, ML, or any computational processing.
Yes
The device is used to vent the left heart during cardiopulmonary bypass. This function directly contributes to treating a patient's medical condition, qualifying it as therapeutic.
No
This device is a left heart vent catheter used during cardiopulmonary bypass to vent the left heart, which is a therapeutic rather than a diagnostic function.
No
The device description clearly describes a physical catheter made of plastic with a tube, tip, connector, and marking rings. This 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 the device is used for "venting the left heart during cardiopulmonary bypass." This is a procedure performed on the patient's body, not on a sample of the patient's body (like blood, urine, or tissue) outside of the body.
- Device Description: The description details a physical catheter designed for insertion into the heart. This is a surgical/interventional device, not a device used for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used directly in a surgical procedure on the patient.
N/A
Intended Use / Indications for Use
The CHASE Curved Left Heart Vent Catheter is indicated for use in venting the left heart during cardiopulmonary bypass with entrance made at the juncture of the right superior pulmonary vein with the left atrium and passing through the mitral valve.
Product codes
Not Found
Device Description
The vent catheter consists of a preformed, flexible plastic tube, (20 French), with a perforated section. A small tapered tip of rigid plastic is attached to the perforated section to aid in the insertion of the catheter. A rigid plastic tube connector for 6.4mm (1/4") I.D. tubing is permanently attached to the other end of the catheter tube. Marking rings on the tube serve as an indication of insertion depth.
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
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
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Summary of Performance Studies
Functional Testing: All functional characteristics of the Chase Medical Curved Left Heart Vent Catheter are non-differentiable as compared with the predicate because both devices have the exact same fit, form, and material composition.
Leak Test Requirements: No leaks at 10 psi air on Chase device at 4ºC and 40°C
Tubing Bond Strength: Exceeds 10 lb. tensile strength @ 4°C and 40°C
Package Integrity: Tyvek/Polymylar passed burst test per ASTM F1140-88
Shipping & Distribution Testing: Per National Safe Transit Ass. vibration and drop tests
Accelerated Aging: Two year shelf life
Key Metrics
Not Found
Predicate Device(s)
Sarns Curved Left Heart Vent Catheter K770430
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
K964194
APR 16 1994
SUMMARY OF SAFETY AND EFFECTIVENESS
CHASE CURVED LEFT HEART VENT CATHETER
| General Information | |
|---|---|
| A. Generic Name: | Curved Left Heart Vent Catheter |
| B. Trade Name of Device: | CHASE CURVED LEFT HEART VENT CATHETER |
| C. Applicant's Name and Address: | CHASE MEDICAL INC. , Richardson, TX |
| D. Pre-market Notification Number: | Not assigned |
- II. Indication for Use:
I.
The CHASE Curved Left Heart Vent Catheter is indicated for use in venting the left heart during cardiopulmonary bypass with entrance made at the juncture of the right superior pulmonary vein with the left atrium and passing through the mitral valve.
-
III. Device Description
The vent catheter consists of a preformed, flexible plastic tube, (20 French), with a perforated section. A small tapered tip of rigid plastic is attached to the perforated section to aid in the insertion of the catheter. A rigid plastic tube connector for 6.4mm (1/4") I.D. tubing is permanently attached to the other end of the catheter tube. Marking rings on the tube serve as an indication of insertion depth. -
IV. Device Classification: Class II device
-
V. Safety and Effectiveness:
Substantial Equivalence: This device is substantially equivalent to the Sarns Curved Left Heart Vent Catheter K770430.
- 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 Medical Curved Left Heart Vent Catheter 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:
Tubing Bond Strength:
Package Integrity:
Shipping & Distribution Testing:
Accelerated Aging:
No leaks at 10 psi air on Chase device at 4ºC 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
월
Two year shelf life