(123 days)
Not Found
No
The summary describes a simple mechanical device (cannula) with no mention of software, image processing, AI, or ML.
Yes
The device is used "to perfuse fluid into vein grafts" during open-heart surgery, which directly contributes to the treatment of a medical condition.
No
The device is described as a tool for perfusing fluid during open-heart surgery, and its intended use does not involve diagnosing conditions or diseases.
No
The device description clearly states it is a physical cannula with stepped barbs and a luer fitting, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to perfuse fluid into vein grafts during open-heart surgery." This describes a device used in vivo (within the living body) for a surgical procedure.
- Device Description: The description of the device (cannula with barbs and luer fitting) is consistent with a surgical instrument used for fluid delivery during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the living body) to analyze biological samples. This device is clearly intended for direct use within the patient during surgery.
N/A
Intended Use / Indications for Use
The Vessel Cannula is indicated for use during open-heart surgery to perfuse fluid into vein grafts.
Product codes
74 DWF
Device Description
The Vessel Cannula has stepped barbs at its tip and female luer fitting.
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
open-heart surgery
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 Vessel Cannula 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 FI 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 VESSEL CANNULA
JUL 21 1997
l. General Information
| A. Generic Name: | Vessel Cannula |
|---|---|
| B. Trade Name of Device: | Chase Vessel Cannula |
| C. Applicant's Name and Address: | CHASE MEDICAL, INC., Richardson, TX |
| D. Pre-market Notification Number: | Not assigned |
Indication for Use: II.
The Vessel Cannula is indicated for use during open-heart surgery to perfuse fluid into vein grafts.
-
III. Device Description:
The Vessel Cannula has stepped barbs at its tip and female luer fitting. -
Class I device IV. Device Classification:
-
V. Safety and Effectiveness:
Substantial Equivalence: This device is substantially equivalent to the Cobe Labs Vessel Cannula (K760624).
- VI. Other Safety and Effectiveness Data:
All material are identical to the predicate device. Materials: Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL 10° Sterilization:
Functional Testing
All functional characteristics of the Chase Vessel Cannula 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:
Tyvek/Polymylar passed burst test per ASTM FI 140-88
Per National Safe Transit Ass. vibration and
Shipping & Distribution Testing:
. .
Accelerated Aging:
Two year shelf life
drop tests
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Mr. Bert Davis President Chase Medical, Inc. 1876 Firman Drive Richardson, Texas 75081 - -
JUL 2 | 1997
K971019 Re : Chase Vessel Cannula 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 Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Requiation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq 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.
3
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) 594-4648. 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. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| 870. 4210 - DWF II - CPB Vascular Catheter, Cannula, | or Tubing | |
|---|---|---|
| ------------------------------------------------------ | -- | ----------- |
| 510 (k) Number (if known) : | K971019 |
|---|---|
| Page | of |
| Device Name: | |
| Indications For Use: |
CHASE MEDICAL, INC.
VESSEL CANNULA
Intended Use:
The Vessel Cannula is indicated for use during open-heart surgery to perfuse fluid into vein grafts.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bess R. Lamperle
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number_ 8971019
Prescription Use______________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)