(88 days)
No
The summary describes a physical medical device (catheter) and its performance characteristics, with no mention of software, algorithms, or AI/ML capabilities.
No.
The device is indicated for draining central venous blood during extracorporeal procedures, which is a supportive function during medical procedures rather than a direct therapeutic intervention to treat a disease or condition.
No
The device is described as a catheter used to drain central venous blood during extracorporeal procedures, which is a therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical catheter and introducer, which are hardware components.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the Avalon Elite™ Multi-Port Venous Femoral Catheter is used to "drain central venous blood via the femoral vein during extracorporeal procedures." This is a surgical or interventional device used to access and manipulate blood flow within the body, not to analyze samples taken from the body.
- Lack of Diagnostic Testing: The description does not mention any form of testing or analysis of blood or other bodily fluids for diagnostic purposes. The performance studies focus on the physical properties and function of the catheter itself (pressure, flow, biocompatibility, etc.).
Therefore, based on the provided information, the Avalon Elite™ Multi-Port Venous Femoral Catheter is a medical device used for extracorporeal procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Avalon Elite™ Multi-Port Venous Femoral Catheter with Introducer is indicated to drain central venous blood via the femoral vein during extracorporeal procedures for up to six hours.
Product codes
DWF
Device Description
The Avalon Elite Multi-Port Venous Femoral Catheter is a one piece, wire reinforced cannula with multiple side hole drainage openings proximal to an open tip. The catheter is supplied with a dilator/introducer to facilitate placement into the vasculature by normal access techniques. The introducer/dilator is intended to follow a pre-positioned standard guidewire (not supplied.) The cannulae are available in 20 Fr, 22 Fr, 24 Fr, 26 Fr, and 28 Fr sizes. The insertable length is 24 inches [61cm]. The device is supplied sterile, non-pyrogenic and is intended for single use via prescription.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral vein
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
The Avalon Elite™ Multi-Port Venous Femoral Catheter was subjected to numerous tests and comparisons to the predicate device. Testing included Pressure/Burst, Simulated Use, Kink Resistance, Tensile Strength, Flow Characteristics, Hemolysis, and Biocompatibility. Testing under simulated use conditions shows that the Avalon catheter maintains performance after 7 days.
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
510(k) Premarket Notification Avalon Elite™ Multi-Port Venous Femoral Catheter
OCT 3 - 2008
K08/933
510(k) Summary Pursuant to 21 CFR 807.92
- Avalon Laboratories, LLC 1. Submitted By: 2610 E. Homestead Place Rancho Dominguez, CA 90220
-
Contact: Lee Wirth Avalon Laboratories, LLC 2610 E. Homestead Place Rancho Dominguez, CA 90220 310-603-2147
-
Product: Avalon Elite™ Multi-Port Venous Femoral Catheter CFR Section 870.4210 Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass Class II Product Code: DWF
-
Common/Trade Name:
Avalon Elite™ Multi-Port Venous Femoral Catheter
Description:
The Avalon Elite Multi-Port Venous Femoral Catheter is a one piece, wire reinforced cannula with multiple side hole drainage openings proximal to an open tip. The catheter is supplied with a dilator/introducer to facilitate placement into the vasculature by normal access techniques. The introducer/dilator is intended to follow a pre-positioned standard guidewire (not supplied.)
1
The cannulae are available in 20 Fr, 22 Fr, 24 Fr, 26 Fr, and 28 Fr sizes. The insertable length is 24 inches [61cm].
The device is supplied sterile, non-pyrogenic and is intended for single use via prescription.
Intended Use:
The Avalon Elite™ Multi-Port Venous Femoral Catheter with Introducer is indicated to drain central venous blood via the femoral vein during extracorporeal procedures for up to six hours.
Tcchnological Characteristics and Substantial Equivalence:
The Avalon Elite™ Multi-Port Venous Femoral Catheter is substantially equivalent to the Bio-Medicus Multi-Stage Venous Femoral Cannula with Introducer (K052524). Device comparisons show both products have . similar size ranges, materials, lengths, drainage openings, introducers, and packaging. Both devices are supplied as single use sterile products.
Performance Testing:
The Avalon Elite™ Multi-Port Venous Femoral Catheter was subjected to numerous tests and comparisons to the predicate device. Testing included Pressure/Burst, Simulated Use, Kink Resistance, Tensile Strength, Flow Characteristics, Hemolysis, and Biocompatibility.
Conclusions:
The studies conducted on Avalon Elite™ Multi-Port Venous Femoral Catheters demonstrate that the device is substantially equivalent to the predicate device currently in commercial distribution.
The predicate catheters and the Avalon catheters share similar design, size, and generic materials of construction. Comparisons show that the Avalon products are equivalent to the predicate products in all key areas of features and performance. The indications for use are similar to the indications for
2
510(k) Premarket Notification Avalon Elite™ Multi-Port Venous Femoral Catheter
:
:
use of the predicate. Testing under simulated use conditions shows that the Avalon catheter maintains performance after 7 days.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle.
Public Health Service
OCT 3 - 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Avalon Laboratories, LLC c/o Mr. Lee Wirth Director of Quality Assurance and Regulatory Affairs 2610 E. Homestead Placc Rancho Dominguez, CA 90220
K081933 Re:
Avalon Elite™ Multi-Port Venous Fomoral Catheter 20Fr, 22Fr, 24FR, 26Fr, 28FR Models 11020, 11022, 11024, 11026, 11028 Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula and tubing, Regulatory Class: Class II (two) Product Code: DWF Dated: July 7, 2008 Received: July 8, 2008
Dear Mr. Wirth:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 - Mr. Lee Wirth
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation cntitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
W
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Premarket Notification Avalon Elite™ Multi-Port Venous Femoral Catheter
Indications for Use Statement
510(k) Number:
1081933
Device Name:
Avalon Elite™ Multi-Port Venous Femoral Catheter
Indications for Use:
The Avalon Elite™ Multi-Port Venous Femoral Catheter with Introducer is indicated to drain central venous blood via the femoral vein during extracorporcal procedures for up to six hours.
Prescription Use __X (per CFR 801.109)
Over-the-counter use
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division No.
(Division Sign-Off) Division of Cardlovasculo ir Dovices 510(k) Number
or