(231 days)
Not Found
No
The summary describes a physical medical device (cannulation set) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for rapid femoral venous and arterial access for short-term cardiopulmonary bypass, which is a therapeutic intervention.
No
Explanation: The device is intended for rapid femoral venous and arterial access for short-term cardiopulmonary bypass, which is a therapeutic intervention, not a diagnostic one.
No
The device is described as a "Femoral Access Cannulation Set" and is compared to a predicate device which is also a "Femoral Access Cannulation Set". This strongly suggests a physical device (cannulas, etc.) rather than software. The lack of any mention of software, algorithms, or digital processing further supports this conclusion.
Based on the provided information, the Chase Medical Femoral Access Cannulation Set is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for providing rapid femoral venous and arterial access for short-term cardiopulmonary bypass. This is a procedure performed directly on a patient's body, not on samples taken from the body for diagnostic purposes.
- Device Description (or lack thereof): While the description is "Not Found," the intended use and anatomical site point towards a device used for direct patient intervention.
- No mention of diagnostic testing: There is no indication that this device is used to analyze samples (blood, tissue, etc.) to diagnose a condition or provide information about a patient's health status.
- Anatomical Site: The device is used for access at the femoral venous and arterial sites, which are locations on the patient's body.
- Predicate Device: The predicate device is also a "Femoral Access Cannulation Set," further reinforcing its use for direct patient access rather than in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to provide physical access to blood vessels within the body.
N/A
Intended Use / Indications for Use
The Chase Medical Femoral Access Cannulation Set is intended for use in situations which require rapid femoral venous and arterial access for short term cardiopulmonary bypass. Venous and arterial access is left to the discretion of the physician.
Product codes
74DWF
Device Description
The CHASE Femoral Access Cannulation Set is an exact duplicate of the RMI Femoral Access Cannulation Set, model number FEM-020. The CHASE device and the RMI device have identical physical form, material composition and functional characteristics. Each component is supplied by the EXACT SAME VENDOR (Angeion Corporation, Plymouth, MN) WITH IDENTICAL SPECIFICATIONS. Both devices are packaged in Tyvek / Polymylar pouches.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral venous and arterial access
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance characteristics of the CHASE catheters compared with the RMI device are non-differentiable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
MAR 3 1 1998
August 11, 1997
Food and Drug Administration Center for Device and Radiological Health Office of Device Evaluation Document Mail Center (HFZ-401) 9200 Corporate Blvd. Rockville, Maryland 20850
Re: 510(k) Summary
Document Control Clerk Attention:
This document is to notify you of the intention of Chase Medical Inc. to manufacture and market the following device.
Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass Classification Name:
Common / Usual Name: Femoral Access Cannulation Set
CHASE FEMORAL ACCESS CANNULATION SET Proprietary Name:
Establishment Registration Number: 9028011
Classification: Femoral Access Cannulation Sets are reviewed by the FDA Cardiovascular (CV) Classification Panel. The Product Classification Code and number for the predicate device and this device is 74DWF. According to the classification code, this is a class two device.
Performance Standards: None
Manufacturing Site: 1876 Firman Dr. Richardson, TX 75081
Sterilization Site: Steritec Inc. , Athens TX
Intended Use:
The Chase Medical Femoral Access Cannulation Set is intended for use in situations which require rapid femoral venous and arterial access for short term cardiopulmonary bypass. Venous and arterial access is left to the discretion of the physician.
1
Substantial Equivalence:
RMI has marketed a Femoral Access Cannulation Set (K891576) worldwide for 6 years. The CHASE Femoral Access Cannulation Set is an exact duplicate of the RMI Femoral Access Cannulation Set, model number FEM-020.
BASIS
The CHASE device and the RMI device have identical physical form, material composition and functional characteristics. Each component is supplied by the EXACT SAME VENDOR (Angeion Corporation, Plymouth, MN) WITH IDENTICAL SPECIFICATIONS. Section 2 contains a Substantial Equivalence Chart.
STERILIZATION
Sterilization of both catheters is conducted using 100% EtO. Section 7 contains Chase Medical's sterilization information.
PERFORMANCE
The performance characteristics of the CHASE catheters compared with the RMI device are non-differentiable. This can be expected considering that the two devices are the exact same product. Please see Section 6.
BIOCOMPATIBILITY
All materials used in the CHASE device are identical to those used in the predicate device. Please see section 5.
PACKAGING
Both devices are packaged in Tyvek / Polymylar pouches. Packaging integrity for the CHASE device is validated after packaged samples are subjected to sterilization, simulated transportation, and two year accelerated heat aging. The CHASE device will be labeled with a two year expiration date. Please see Section 6.
LABELING AND ASSEMBLY DRAWING
All proposed labeling and assembly drawings can be found in Section 3.
In accordance with requirements of the final rule for summaries addressed by the SMDA 1990, Section 8 contains a summary of the safety and effectiveness information upon which the substantial equivalence is based.
If you have any questions pertaining to this submission, please contact me at 972-783-0644.
Sincerely,
Bert Davis President
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Bert Davis President Chase Medical, Inc. 1876 Firman Drive Richardson, TX 75081
MAR 3 1 1998
Re : K972993 Chase Femoral Access Cannulation Set Regulatory Class: II (Two) Product Code: DWF Dated: December 23, 1997 December 31, 1997 Received:
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, Druq, 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 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 requlation 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 requlations.
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. Callahan
Thomas J. CallaMan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K972993
Device Name: Chase femoral Access Cannulatimfet
Indications For Use:
CHASE MEDICAL INC.
FEMORAL ACCESS CANNULATION SET
Intended Use:
The Chase Medical Femoral Access Cannulation Set is intended for use in situations which require rapid femoral venous and arterial access for short term cardiopulmonary bypass. Venous and arterial access is left to the discretion of the physician.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bate R. Cooper a
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 1697299 510(k) Number .
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)