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.

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.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a medical device called the Avalon Elite™ Multi-Port Venous Femoral Catheter. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. As such, it does not contain acceptance criteria for specific performance metrics in the same way a clinical trial for a novel device would. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence through comparative testing with the predicate device.

Here's an analysis based on the provided text, addressing your questions as much as possible given the nature of a 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission based on substantial equivalence, explicit "acceptance criteria" (e.g., "device must achieve X% accuracy") are not stated. The performance is reported in comparison to a predicate device, aiming to show similar or equivalent performance.

Test Category	Implied Acceptance Criteria (Substantial Equivalence)	Reported Device Performance (Avalon Elite™)
Pressure/Burst	Similar to predicate device	Testing conducted, results suggest substantial equivalence
Simulated Use	Similar to predicate device; maintain performance	Testing conducted, maintains performance after 7 days
Kink Resistance	Similar to predicate device	Testing conducted, results suggest substantial equivalence
Tensile Strength	Similar to predicate device	Testing conducted, results suggest substantial equivalence
Flow Characteristics	Similar to predicate device	Testing conducted, results suggest substantial equivalence
Hemolysis	Biocompatible and similar to predicate device	Testing conducted, results suggest substantial equivalence
Biocompatibility	Biocompatible and similar to predicate device	Testing conducted, results suggest substantial equivalence
Overall	Substantially equivalent to Bio-Medicus Multi-Stage Venous Femoral Cannula with Introducer (K052524) in design, size, materials, features, and performance.	"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."

2. Sample Size Used for the Test Set and Data Provenance

This document does not specify the exact sample sizes used for each performance test (e.g., number of catheters tested for pressure/burst). The tests are typically laboratory-based engineering and material performance assessments, not clinical studies with human participants. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" don't apply here.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The performance testing described (Pressure/Burst, Simulated Use, etc.) are engineering and material tests, not tests that require expert assessment of a "ground truth" derived from human interpretation.

4. Adjudication Method for the Test Set

Not applicable. This type of testing involves objective performance measurements rather than subjective expert interpretations requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical medical catheter, not an AI/software device that assists human readers. Therefore, an MRMC study related to AI assistance is not relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical catheter, not an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by objective engineering measurements and material science standards for parameters like pressure resistance, tensile strength, flow rates, and biocompatibility. The comparison is then made against the established performance characteristics of the predicate device.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable. As there's no training set, there's no ground truth to be established for it.

Summary of the Study Proving Acceptance Criteria:

The "study" proving the device meets the (implicit) acceptance criteria is a series of "numerous tests and comparisons to the predicate device" conducted by Avalon Laboratories, LLC. These tests are listed as:

Pressure/Burst
Simulated Use
Kink Resistance
Tensile Strength
Flow Characteristics
Hemolysis
Biocompatibility

The conclusion from these tests was that the Avalon Elite™ Multi-Port Venous Femoral Catheter is "substantially equivalent to the predicate device currently in commercial distribution," specifically the Bio-Medicus Multi-Stage Venous Femoral Cannula with Introducer (K052524). The equivalence was demonstrated across "similar design, size, and generic materials of construction," and the Avalon products were found "equivalent to the predicate products in all key areas of features and performance." The document also explicitly states that "Testing under simulated use conditions shows that the Avalon catheter maintains performance after 7 days."

The FDA's review and approval (K081933) indicate their agreement that the device demonstrates substantial equivalence based on the submitted data, allowing it to be marketed.

Summary

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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:

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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

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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.

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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,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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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

Regulation Number and Section

§ 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).