(172 days)
Not Found
No
The summary describes a simple drainage catheter with no mention of AI/ML, image processing, or performance metrics typically associated with AI/ML devices.
No.
A therapeutic device is used to treat a disease, injury, or condition. This device is used to drain fluid, which is a supportive function, but not a direct treatment or therapy.
No
The device is a catheter designed for fluid drainage, which is a therapeutic function, not a diagnostic one. It does not provide information for identifying the nature or cause of a disease.
No
The device description clearly states it is a "polyvinyl chloride tube," indicating it is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The Chase Thoracic Catheter is a device used during and after surgery to drain fluid from the pericardium (the sac around the heart). It is a physical tool used within the body, not a test performed on a sample outside the body.
The description clearly indicates a surgical drainage device, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Chase Thoracic Catheter is indicated for use during and after open-heart surgery to drain fluid from the pericardium.
The Thoracic Catheter is indicated for use during and after open-heart surgery to drain fluid from the pericardium.
Product codes
74 DWF
Device Description
The Chase Thoracic Catheter is a polyvinyl chloride tube with precut holes at the distal tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pericardium
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
Functional Testing All functional characteristics of the Chase Thoracic Catheter are non-differentiable as compared with the predicate because both devices have the exact same fit, form, and material composition.
Package Integrity: Tyvek/Polymylar passed burst test per ASTM F I 140-88
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)
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
SUMMARY OF SAFETY AND EFFECTIVENESS
CHASE THORACIC CATHETER
I. General Information Thoracic Catheter A. Generic Name: SEP - 8 1997 B. Trade Name of Device: Chase Thoracic Catheter C. Applicant's Name and Address: CHASE MEDICAL INC. , Richardson, TX Not assigned D. Pre-market Notification Number: II. Indication for Use: The Chase Thoracic Catheter is indicated for use during and after open-heart surgery to drain fluid from the pericardium. Device Description 【】. The Chase Thoracic Catheter is a polyvinyl chloride tube with precut holes at the distal tip. Class I device IV. Device Classification: Safety and Effectiveness: V. This device is substantially equivalent to the Sherwood Substantial Equivalence: Medical Thoracic Catheter (K760351). VI. Other Safety and Effectiveness Data: Materials: All material are identical to the predicate device. Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL 10° Sterilization:
Functional Testing
All functional characteristics of the Chase Thoracic 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
Package Integrity:
Shipping & Distribution Testing:
Accelerated Aging:
Tyvek/Polymylar passed burst test per ASTM F I 140-88
Per National Safe Transit Ass. vibration and drop tests
Two year shelf life
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
SEP = 8 1997
Mr. Bert Davis Chase Medical 1876 Firman Drive Richardson, Texas 75081
Re: K971023 Chase Thoracic Catheter Requlatory Class: II (two) Product Code: 74 DWF Dated: June 30, 1997 Received: June 30, 1997
Dear Mr. Davis:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Bert Davis
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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CHASE MEDICAL, INC.
THORACIC CATHETER
Intended Use:
The Thoracic Catheter is indicated for use during and after open-heart surgery to drain fluid from the pericardium.
(Division Sign-Off) I con of Cardiovascular Respiratory, and Neurological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________