K Number

Device Name

EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC VENOUS RETURN CANNULAE

Manufacturer

EDWARDS LIFESCIENCES LLC.

Date Cleared

2004-06-22

(235 days)

Product Code

DWF

Regulation Number

870.4210

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The provided text describes various types of venous cannulae used in cardiopulmonary bypass. The description focuses on the physical characteristics, intended use, and performance testing (functional and biocompatibility). There is no mention of any software, algorithms, data processing, or AI/ML terms.

Therapeutic

No.
The device is used for venous cannulation to facilitate extracorporeal circulation during cardiopulmonary bypass, which is a supportive rather than therapeutic function.

Diagnostic

No.
The device descriptions indicate the cannulae are used for venous cannulation and drainage during extracorporeal circulation, which are therapeutic procedures, not diagnostic ones.

SaMD (Software as a Medical Device)

The device description and intended use clearly describe physical cannulae used for venous access during cardiopulmonary bypass, which are hardware components. There is no mention of software as the primary or sole component.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use/Indications for Use: The text clearly states the devices are intended for "venous cannulation so that extracorporeal circulation of venous blood to a heart-lung machine may be achieved" and for "cannula drainage superior and inferior vena cavae during extracorporeal circulation." These are procedures performed on the patient's body to facilitate blood flow during surgery.
Device Description: The description states the cannulae are used to "access the vena cavae or femoral vein during cardiopulmonary bypass." This further reinforces their use as surgical tools for accessing blood vessels.
Lack of IVD Characteristics: An IVD is a medical device intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The provided text does not mention any analysis of blood or other bodily fluids for diagnostic purposes.

The devices described are surgical cannulae used to facilitate extracorporeal circulation, which is a therapeutic procedure, not a diagnostic one.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Research Medical Dual Drainage Venous Return Cannulae are 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 are 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 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.

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.

Product codes

DWF

Device Description

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

vena cavae, femoral vein, right atrium

Indicated Patient Age Range

Pediatric

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Functional/Safety Testing: The ERMI Pediatric Venous Return Cannulae have successfully undergone functional and biocompatibility testing.
Conclusion: The ERMI Pediatric Venous Return Cannulae are substantially equivalent to the predicate devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Research Industries' Various Cardiovascular Devices, Research Medical, Inc. Fem-Flex Femoral Access Cannulation Kit, Terumo L-Series 1968 Type Pediatric Venous Catheters

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

JUN 2 2 2004

510(k) Summary

| Submitter: | Edwards Lifesciences LLC
One Edwards Way
Irvine, California 92614 USA |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jason Smith, Senior Regulatory Affairs Specialist
Phone: 949-250-2662
Fax: 949-250-3579
E-mail: jason_smith@edwards.com |
| Date Prepared: | October 29, 2003 |
| Trade Name: | Edwards Lifesciences Research Medical Inc. Pediatric
Venous Return Cannulae (abbreviated to ERMI Pediatric
Venous Return Cannulae) |
| Common Name: | Cardiopulmonary Bypass Vascular Catheter, Cannula, or
Tubing (21 CFR 870.4210) |
| Predicate
Devices: | Research Industries' Various Cardiovascular Devices |
| | Research Medical, Inc. Fem-Flex Femoral Access
Cannulation Kit |
| | Terumo L-Series 1968 Type Pediatric Venous Catheters |
| Device
Description: | The ERMI Pediatric Venous Return Cannulae are used to
access the vena cavae or femoral vein during
cardiopulmonary bypass. |
| Indications for
Use: | The Research Medical Dual Drainage Venous Return
Cannulae are 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 are 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.

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.

KO33464 PG 3043

| Comparative
Analysis: | 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. |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Functional/Safety
Testing: | The ERMI Pediatric Venous Return Cannulae have
successfully undergone functional and biocompatibility
testing. |
| Conclusion: | The ERMI Pediatric Venous Return Cannulae are
substantially equivalent to the predicate devices. |

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.

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

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