The Research Medical Dual Drainage Venous Return Cannulae is indicated for venous cannulation so that extracorporeal circulation of venous blood to a heart-lung machine may be achieved for a duration ≤ 6 hours. Venous Cannulae in sizes 6 Fr. to 18 Fr. can be used in pediatric patient populations.

The Research Medical Duraflo Heparin Treated Dual Drainage Venous Return Cannulae is indicated for venous cannulation so that extracorporeal circulation of venous blood to a heart-lung machine may be achieved for a duration ≤ 6 hours. Venous Cannulae in sizes 6 Fr. to 18 Fr. can be used in pediatric patient populations. Extracorporeal circuit components with a Duraflo Treatment are indicated for use in cardiopulmonary surgery when a heparin-treated blood path is desired.

The Research Medical Venous Return Cannulae are intended for cannula drainage superior and inferior vena cavae during extracorporeal circulation for a duration ≤ 6 hours. Venous Cannulae in sizes 6 Fr. to 18 Fr. can be used in pediatric patient populations. NOTE: The Research Medical 40 Fr. and 46 Fr. Venous Return Cannulae are also intended for use in single cannula return of the right atrium.

The Research Medical Duraflo Heparin Treated Venous Return Cannulae are intended for cannula drainage superior and inferior vena cavae during extracorporeal circulation for a duration ≤ 6 hours. Venous Cannulae in sizes 6 Fr. to 18 Fr. can be used in pediatric patient populations. NOTE: The Research Medical 40 Fr. and 46 Fr. Venous Return Cannulae are also intended for use in single cannula return of the right atrium. Extracorporeal circuit components with a Duraflo Treatment are indicated for use in cardiopulmonary surgery when a heparin-treated blood path is desired.

The Research Medical FEM-FLEX Femoral Access Cannulae are 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 for a duration ≤ 6 hours. Femoral Cannulae in sizes 6 Fr. to 14 Fr. can be used in pediatric patient populations.

The Research Medical Duraflo Heparin Treated FEM-FLEX Femoral Access Cannulae are 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 for a duration ≤ 6 hours. Femoral Cannulae in sizes 6 Fr. to 14 Fr. can be used in pediatric patient populations. Extracorporeal circuit components with a Duraflo Treatment are indicated for use in cardiopulmonary surgery when a heparin-treated blood path is desired.

Device Description

The ERMI Pediatric Venous Return Cannulae are used to access the vena cavae or femoral vein during cardiopulmonary bypass.

AI/ML Overview

This 510(k) submission describes the Edwards Lifesciences Research Medical Inc. Pediatric Venous Return Cannulae. It refers to a comparative analysis and functional/safety testing, but does not provide specific acceptance criteria or detailed study results in the provided text.

Here's a breakdown of the information that can be extracted and a clear indication of what is not present in the provided document:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the provided text. The document mentions "Functional/Safety Testing" was successfully undergone, but no specific performance metrics or their acceptance thresholds are listed.	The device "successfully undergone functional and biocompatibility testing." No specific numerical performance results are provided.

Missing Information: The document does not explicitly state the acceptance criteria (e.g., minimum flow rates, pressure resistance, biocompatibility standards, etc.) or detailed numerical performance data for functional and safety testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not mentioned.
Data Provenance: Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as the device is a medical cannulae, not an AI/diagnostic imaging device that requires expert-established ground truth for its performance evaluation (e.g., in terms of accuracy, sensitivity, specificity). The testing would involve engineering and biocompatibility evaluations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for a medical device of this type. Adjudication methods are typically relevant for complex diagnostic interpretations or clinical endpoints where inter-rater variability might be a factor.

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 instrument, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a physical medical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for a device like this would be established through engineering specifications, material standards, and validated testing methodologies to ensure it meets its intended functional and safety requirements.

8. The sample size for the training set

Not applicable. There is no training set involved for this type of medical device as it is not an AI/machine learning product.

9. How the ground truth for the training set was established

Not applicable. There is no training set involved.

Summary of what the document does provide regarding the study:

Study Title/Description: "Functional/Safety Testing" and "Biocompatibility Testing."
Conclusion of Testing: The ERMI Pediatric Venous Return Cannulae "have successfully undergone functional and biocompatibility testing."
Comparative Analysis: The primary "study" in this context is a comparative analysis against predicate devices. The document states: "The only difference between the subject catheters and the predicate Research Medical catheters is the subject catheters are smaller in diameter and length. Aside from the smaller sizes, there is no difference between the ERMI Pediatric Venous Return Cannulae and the predicate devices." This implies that the performance of the new device is expected to be similar to the predicate devices due to their fundamental similarity, with the primary change being size.
Substantial Equivalence: Based on the comparative analysis and the successful functional/biocompatibility testing, the conclusion is that the ERMI Pediatric Venous Return Cannulae are "substantially equivalent to the predicate devices."

In essence, the provided document focuses on demonstrating substantial equivalence to predicate devices through a comparative analysis and successful completion of standard functional and biocompatibility testing, rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics typically found for novel diagnostic or therapeutic devices.

Summary

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JUN 2 2 2004

510(k) Summary

Submitter:	Edwards Lifesciences LLCOne Edwards WayIrvine, California 92614 USA
Contact:	Jason Smith, Senior Regulatory Affairs SpecialistPhone: 949-250-2662Fax: 949-250-3579E-mail: jason_smith@edwards.com
Date Prepared:	October 29, 2003
Trade Name:	Edwards Lifesciences Research Medical Inc. PediatricVenous Return Cannulae (abbreviated to ERMI PediatricVenous Return Cannulae)
Common Name:	Cardiopulmonary Bypass Vascular Catheter, Cannula, orTubing (21 CFR 870.4210)
PredicateDevices:	Research Industries' Various Cardiovascular Devices
	Research Medical, Inc. Fem-Flex Femoral AccessCannulation Kit
	Terumo L-Series 1968 Type Pediatric Venous Catheters
DeviceDescription:	The ERMI Pediatric Venous Return Cannulae are used toaccess the vena cavae or femoral vein duringcardiopulmonary bypass.
Indications forUse:	The Research Medical Dual Drainage Venous ReturnCannulae are indicated for venous cannulation so thatextracorporeal circulation of venous blood to a heart-lungmachine may be achieved for a duration ≤ 6 hours.Venous Cannulae in sizes 6 Fr. to 18 Fr. can be used inpediatric patient populations.
	The Research Medical Duraflo Heparin Treated DualDrainage Venous Return Cannulae are indicated forvenous cannulation so that extracorporeal circulation ofvenous blood to a heart-lung machine may be achieved fora duration ≤ 6 hours. Venous Cannulae in sizes 6 Fr. to18 Fr. can be used in pediatric patient populations.Extracorporeal circuit components with a DurafloTreatment are indicated for use in cardiopulmonary

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surgery when a heparin-treated blood path is desired.

The Research Medical Venous Return Cannulae are intended for cannula drainage superior and inferior vena nnendod ing extracorporeal circulation for a duration for a duration for a duration for a hours. Venous Cannulae in sizes 6 Fr. to 18 Fr. can be used in pediatric patient populations.

NOTE: The Research Medical 40 Fr. and 46 Fr. Venous Return Cannulae are also intended for use in single cannula return of the right atrium.

The Research Medical Duraflo Heparin Treated Venous Return Cannulae are intended for cannula drainage superior and inferior vena cave during extracorporeal circulation for a duration ≤ 6 hours. Venous Cannulae in sizes 6 Fr. to 18 Fr. can be used in pediatric patient populations.

NOTE: The Research Medical 40 Fr. and 46 Fr. Venous Return Cannulae are also intended for use in single cannula return of the right atrium. Extracorporeal circuit components with a Duraflo Treatment are indicated for use in cardiopulmonary surgery when a heparin-treated blood path is desired.

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KO33464 PG 3043

ComparativeAnalysis:	The only difference between the subject catheters and thepredicate Research Medical catheters is the subjectcatheters are smaller in diameter and length. Aside fromthe smaller sizes, there is no difference between the ERMIPediatric Venous Return Cannulae and the predicatedevices.
Functional/SafetyTesting:	The ERMI Pediatric Venous Return Cannulae havesuccessfully undergone functional and biocompatibilitytesting.
Conclusion:	The ERMI Pediatric Venous Return Cannulae aresubstantially equivalent to the predicate devices.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized eagle with three lines representing its wings.

JUN 2 2 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Edwards Lifesciences LLC c/o Mr. Jason Smith Senior Regulatory Affairs Specialist One Edwards Way Irvine, CA 92614

Re: K033464

R055404
Duraflo® coated and uncoated Venous Return, Dual Drainage Venous Return, and FEM-FLEX Femoral Access Cannulae Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, and Tubing Regulatory Class: Class II (two) Product Code: DWF Dated: May 25, 2004 Received: May 26, 2004

Dear Mr. Smith:

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 for the barrant 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 r ou may, arontrols 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. Jason Smith

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Frease oc advised that I Dri 3 issuants or our device complies with other requirements of the Act that IDA has made a dolorimiansis as as as as a ministered by other Federal agencies. You must or any it cach statutes and registments, including, but not limited to: registration and listing (21 Comply with an the 110 110 - 5 requirements (01); good manufacturing practice requirements as set CFR I at 607); and img (21 CFR Part 820); and if applicable, the electronic form in the quarty by overns (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provider as arketing your device as described in your Section 510(k) I his icher will anow you to ough finding of substantial equivalence of your device to a legally premarket notification: "The PDF intelling of easification 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 If you desire specific acrioliance at (301) 594-4646. Also, please note the regulation entitled, eonalor the Office of Centre to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Dina R. Vichner

( 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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Indications for Use

510(k) Number (if known): _K033464

Device Name: Research Medical Venous Return, Dual Drainage Venous Return, Duraflo Heparin Treated Venous Return and FEM-FLEX Femoral Access Cannulae

Indications For Use:

: For Use:
The Research Medical Dual Drainage Venous Return Cannulae is indicated for venous of for a duretion l . I he Research Medical Dual Dramage Venous Retarn Balline may be achieved or a duration ≤
that extracorporeal circulation of venous blood to a heart-lung machine may that extraction of vehicles of vehous blood to a near thegative patient populations.
The Research Medical Duraflo Heparin Treated Dual Drainage Venous Return Cannulae is indicated for 2. I he Research Medical Durano Heparti Treated Bud of venous blood to a heart-lung may be and in adjatrio venous cannulation ≤6 hours. Venous Cannulac in sizes 6 Fr. to 18 Fr. can be used in pediatric achieved for a duration ≤ 0 nous. Venous Califation in views Treatment are indicated for use in parent populations. Bitharbirn a heparin-treated blood path is desired.
The Research Medical Venous Return Cannulac are intended for cannula drainage superior and inferior 3. I he Research Medical Venous Recurn Camination ≤ 6 hours. Venous Cannulae in sizes 6 Fr. to 18 Fr. can be used in pediatric patient populations.

NOTE: The Research Medical 40 Fr. and 46 Fr. Venous Return Cannulae are also intended for use in single cannula return of the right atrium.

The Research Medical Duraflo Heparin Treated Venous Return Cannulae are intended for Cannula 4. I he Research Medical Duratio repair. Trucios extracorporeal circulation for a duration ≤ 6 hours. dramage superior and interior rena 8 Fr. can be used in pediatric patient populations.
NOTE: The Research Medical 40 Fr. and 46 Fr. Venous Return Cannulae are also intended for use in NOTE: The Research Medical 4011: and 40 11: Volvou receit components with a Duraflo Treatment are single cannulu rount of the or monary surgery when a heparin-treated blood path is desired.
The Research Medical FEM-FLEX Femoral Access Cannulae are intended for use in situations which รา I he Research Medical I EM-I LEA I entrolate resease bart term cardiopulmonary bypass. Venous and require rapid remoral vonoda and antentation ≤ 6 hours. Femoral Cannulae in aires 6 Fr. to 14 Fr. can be used in pediatric patient populations.
The Research Medical Duraflo Heparin Treated FEM-FLEX Femoral Access Cannulae are intended for 6. The Research Medical i2arano reparts 1761 venous and arterial access for short term cardiopulmonary use in studions which require rapie seef to the discretion of the physician for a duration ≤ 6 hours. bygass. Venous and arterial access is lett to 14 Fr. can be used in pediatric patient populations. Extracorporeal Femoral Califialat in Sizes of F. I Freatment are indicated for use in cardiopulmonary surgery when a heparin-treated blood path is desired.

Prescription Use X_____________________________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1 -

Dana D. Vachner

(Division Sian-C Division of Cardiovascular Devices

510(k) Number K033464

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).