AORTIC CANNULA, METAL J-TIP (24FR) MODEL #CF00100; AORTIC CANNULA, PLASTIC J-TIP (24FR) MODEL #CF00101

K020693 · Embol-X, Inc. · DWF · Sep 5, 2002 · Cardiovascular

Device Facts

• Record ID: K020693
• Device Name: AORTIC CANNULA, METAL J-TIP (24FR) MODEL #CF00100; AORTIC CANNULA, PLASTIC J-TIP (24FR) MODEL #CF00101
• Applicant: Embol-X, Inc.
• Product Code: DWF · Cardiovascular
• Decision Date: Sep 5, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EMBOL-X Aortic Cannula is indicated for the perfusion of the ascending aorta during cardiopulmonary bypass (CPB) surgery where procedures may require the hemostatic introduction and removal of compatible intravascular devices into the vascular system.

Device Story

Aortic cannula for cardiopulmonary bypass (CPB) surgery; 3/8" ID wire-reinforced tube body with J-tip and suture flange. Features integrated introducer port with hemostatic valve and removable self-venting keyed snap-lock obturator. Obturator provides smooth fit along J-tip groove; removal allows passage of 12 FR to 14 FR intravascular devices. Used in OR by surgeons; provides perfusion while maintaining hemostasis during device introduction. Benefits patient by enabling concurrent intravascular procedures during CPB without compromising aortic perfusion.

Clinical Evidence

Bench testing only. In-vitro performance testing evaluated joint strength, gasket seal integrity, and flow rates. Biocompatibility of all materials was confirmed.

Technological Characteristics

3/8" ID wire-reinforced tube; J-tip configuration (metal or plastic); 24 FR insertion diameter. Includes hemostatic valve and removable obturator. Sterile, non-pyrogenic, single-use. Optional porous vent plug included.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass (CPB) surgery requiring perfusion of the ascending aorta and the hemostatic introduction/removal of compatible intravascular devices.

Regulatory Classification

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.

Predicate Devices

• EMBOL-X® Introducer
• DLP® Curved Metal Tip Arterial Cannula

Submission Summary (Full Text)

{0}------------------------------------------------

## SEP 5 2002

Image /page/0/Picture/1 description: The image shows a sequence of alphanumeric characters, specifically "K020693". The characters are written in a bold, sans-serif font, and they appear to be handwritten or stylized. The numbers are clearly distinguishable, and the overall image is simple and straightforward.

## 510(k) SUMMARY

| SUBMITTER'S NAME: | EMBOL-X®, INC. |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ADDRESS: | 645 Clyde Ave, Mountain View, CA |
| PHONE NUMBER: | [phone] |
| FAX NUMBER: | [phone] |
| CONTACT PERSON: | Edwin Lee |
| DATE PREPARED: | July 3, 2002 |
| TRADE NAME: | Aortic Cannula |
| COMMON NAME: | Aortic Cannula |
| CLASSIFICATION<br>NAME: | Cardiopulmonary Bypass Vascular Cannula |
| PREDICATE<br>DEVICE(S): | a) EMBOL-X® Introducer<br>b) DLP® Curved Metal Tip Arterial Cannula |
| DEVICE<br>DESCRIPTION: | The EMBOL-X® Aortic Cannula consist of a standard 3/8" ID wire reinforced tube<br>body having a curved J-tip end and a flange for suture attachment. Attached to the<br>side of the J-tip end is an Introducer port having a single lumen housing and a<br>removable self-venting keyed snap-lock Obturator. The outer portion of the J-tip<br>includes a radiused groove that accepts the complimentary radiused distal end of<br>the provided Obturator. With the Obturator inserted, the Obturator provides a<br>smooth, minimally disruptive fit along the J-tip's radiused groove. Removal of<br>the Obturator from the Introducer port reveals a channel through which a<br>physically compatible device may be introduced through the Introducer's<br>hemostatic valve and along the groove of the J-tip. The Introducer port acts as an<br>intravascular hemostasis conduit that can accommodate the introduction of<br>intravascular devices with an exit diameter ranging from 12 FR to 14 FR in size.<br>The Obturator is removed only when intravascular access with a device is<br>necessary. The EMBOL-X Aortic Cannulas have an insertion diameter size of 24<br>FR. All models are a J-tip configuration whose tips are made from metal or<br>plastic. The device is packaged sterile and non-pyrogenic, is single use only, and<br>come with a separate optional use porous vent plug for cannula venting. |
| INTENDED USE: | The EMBOL-X Aortic Cannula is indicated for the perfusion of the ascending<br>aorta during cardiopulmonary bypass (CPB) surgery where procedures may<br>require the hemostatic introduction and removal of compatible intravascular<br>devices into the vascular system.<br>The intended use is substantially equivalent to that of the predicates. |
| TECHNOLOGICAL<br>CHARACTERISTICS<br>COMPARISON: | The EMBOL-X Aortic Cannula is technologically and substantially equivalent to<br>the predicate devices. The EMBOL-X Aortic Cannula combines the predicate<br>arterial cannula design with the predicate EMBOL-X Introducer design into one<br>device. The device's principle operating functions and technological<br>characteristics have remained unchanged. |
| BIOCOMPATIBILITY: | All materials used in the EMBOL-X Aortic Cannula are shown to be<br>biocompatible. |

{1}------------------------------------------------

biocompatible.

In-vitro bench test results for joint strength, gasket seal integrity, and flow rate PERFORMANCE characteristics was substantially equivalent or better than in performance to the TESTS: predicate device(s).

{2}------------------------------------------------

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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare, featuring a staff with a serpent entwined around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## 5 2002 SEP

Embol-X c/o Mr. Edwin Lee 645 Clyde Avenue Mountain View, CA 94043-2208

Re: K020693

> Aortic Cannula Regulation Number: 870.4210 Regulation Name: CPB Catheter, cannula, tubing Regulatory Class: Class II (two) Product Code: DWF Dated: June 28, 2002 Received: July 1, 2002

Dear Mr. Lee:

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.

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.

{3}------------------------------------------------

Page 2 - Mr. Edwin Lee

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Dalk Telle

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

Enclosure

{4}------------------------------------------------

Ver/ 3 - 4/24/96

EMBOL-X®, Inc. Applicant:

K020693 510(K) NUMBER (IF KNOWN):

Device Name: Aortic Cannula

Indications For Use:

The EMBOL-X Aortic Cannula is indicated for the perfusion of the ascending aorta during cardiopulmonary bypass (CPB) surgery where procedures may require the hemostatic introduction and removal of compatible intravascular devices into the vascular system.

| ਾ ਦੇ<br>1 1 | קחר | ాగా<br>/ YO |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|--------------------|
| ្រី | 8 | C |
| 177<br>4218518 - 144 | ਹੈ | H U G<br>y |
| aller | 50 | 0<br>ું મું<br>દિવ |
| 1":"7 | 11 | / |
| ﻠﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍ | ్ర | મ (1<br>0 |
| | | |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K020693

Prescription Use X
(Per 21 CFR 801.109)

OR

.

Over-The-Counter Use ____________

(Optional Format 1-2-96)