REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULA

K052081 · Estech, Inc. · DWF · Dec 16, 2005 · Cardiovascular

Device Facts

• Record ID: K052081
• Device Name: REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULA
• Applicant: Estech, Inc.
• Product Code: DWF · Cardiovascular
• Decision Date: Dec 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ESTECH Remote Access Perfusion Femoral Venous Cannula is intended for use as a venous drainage cannula during cardiopulmonary bypass up to 6 hours.

Device Story

The RAP Femoral Venous Cannula is a sterile, single-use, hollow polymer tube with distal perforations and a barbed proximal end. It is inserted into the vena cava via the femoral vein to provide extracorporeal circulation during cardiopulmonary bypass, typically for stopped-heart surgeries. The device includes a flexible obturator for placement assistance, compatibility with 0.035" guidewires, and depth markers for physician guidance. It is operated by clinicians in a surgical setting. The cannula facilitates venous drainage, supporting the patient's circulatory needs during bypass procedures lasting up to 6 hours.

Clinical Evidence

No clinical data. Evidence consists of biocompatibility testing per ISO 11193 and preclinical performance testing to demonstrate substantial equivalence to predicate devices.

Technological Characteristics

Sterile, single-use, hollow polymer tube; 18-26 Fr outside diameter; 60-76 cm length; distal perforations; barbed proximal connector; includes flexible obturator; compatible with 0.035" guidewire; depth markers for positioning.

Indications for Use

Indicated for use as a venous drainage cannula during cardiopulmonary bypass procedures for up to 6 hours. Intended for prescription use.

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

• ULTRAFLEX™ Venous Cannula (K031827)
• RMI Fem-Flex Femoral Access Cannulation Set (K891576)

Submission Summary (Full Text)

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## DEC 16 2005

## Endoscopic Technologies, Inc.

ESTECH Remote Access Perfusion FV Catheter Premarket Notification Exemption

# SECTION 2 - 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

| Category | Comments |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Estech<br>4135 Blackhawk Plaza Circle.<br>Suite 150<br>Danville, CA 94506<br>Tel: [phone] |
| Correspondent: | Craig Coombs<br>Coombs Medical Device Consulting<br>1193 Sherman Street<br>Alameda, CA 94501<br>Tel: [phone] |
| Contact Information: | Fax: [phone] |
| Device Common Name: | Cardiopulmonary bypass catheter, cannula<br>or tubing |
| Device Proprietary Name: | Remote Access Perfusion (RAPTM)<br>Femoral Venous Cannula |
| Device Classification Name: | Cardiopulmonary bypass catheter, cannula<br>or tubing, 21 CFR 870.4210 |
| Device Classification & Code: | Class II. DWF |

#### Predicate Device Information:

| Predicate Devices: | ULTRAFLEX™ Venous Cannula<br>(K031827)<br>RMI Fem-Flex Femoral Access Cannulation<br>Set (K891576) |
|-----------------------------------------|----------------------------------------------------------------------------------------------------|
| Predicate Device Manufacturers: | Medtronic<br>Research Medical Incorporation |
| Predicate Device Common Name: | Cardiopulmonary bypass catheter, cannula or<br>tubing |
| Predicate Device Classification: | 21 CFR 870.4210 |
| Predicate Device Classification & Code: | Class II, DWF |

#### b. Date Summary Prepared

July 25, 2005

### c. Description of Device

The Estech Remote Access Perfusion (RAP™) Femoral Venous Cannula is a sterile, single-use, open-ended, hollow polymer tube with multiple perforations at the distal end. The barbed proximal end is intended to connect into cardiopulmonary bypass tubing to provide extracorporeal circulation of the blood, most typically during stopped-heart surgical procedures.

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The RAP FV cannula is provided with a flexible obturator to assist with the placement The RAI TV cannula is provided can be guided over a 0.035" guidewire. The RAP FV allu positioning of the bailing to and depth markers to assist the physician with placement.

The RAP FV cannula ranges in outside diameter from J8 - 26 Fr, and in length from 60 -76 cm.

#### d. Intended Use

ilued Use
The ESTECH Remote Access Perfusion Femoral Venous Cannula is intended for use as a venous drainage cannula during cardiopulmonary bypass.up To 6 houls ,

### e. Comparison to Predicate Device

e. Comparison to Predicate Device
The Estech Remote Access Perfusion (RAP™) Femoral Venous Cannula is substantially The Estoon Remote Prose, technology, design and materials to the predicate devices.

The Estech RAP Femoral Venous Cannula is substantially equivalent to the Medtronic I IIC Ecorp Venous Cannula (K031827) and the RMI Fem-Flex Femoral Access Cannulation Set (K891576).

The current and predicate devices are sterile, single use, open-ended, hollow polymer tubes inserted into the vena cava via the femoral vein. They are all intended to be used with cardiopulmonary bypass equipment as venous drainage cannula.

#### f. Summary of Supporting Data

If Summal y of Supporting Data
Biocompatibility testing consistent with ISO 11193 is presented in Section 6. All components of the Estech RAP Femoral Venous Cannula passed the testing.

Preclinical performance data was supplied to demonstrate that the RAP FV cannula can meet its labeled performance claims, and to demonstrate substantial equivalence with the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

DEC 16 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Coombs Medical Device Consulting c/o Mr. Craig Coombs President 1193 Sherman Street Alameda, CA 940501

Re: K052081

K052081
Remote Access Perfusion (RAPTM) Femoral Venous Cannula Regulation Number: 21 CFR 870.4210 Regulation Name: 21 CH 070.1210
Regulation Name: Cardiopulmonary Bypass Catheter, Cannula or Tubing Regulatory Class: Class II (Two) Product Code: DWF Dated: October 24, 2005 Received: October 26, 2005

Dear Mr. Coombs:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(x) premaint is substantially equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced above and have determined the devices marketed in interstate
for use stated in the enclosure) to legally marketed predical Device Amendments for use stated in the enclosure) to regally manced peopless (Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug. commerce prior to May 28, 1970, the chaculture with the provisions of the Federal Food. Drug, devices that have been reciassified in accordance while approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . The and Cosmetic Act (Act) that to not require approved controls provisions of the Act. The Act. The
You may, therefore, market the device, subject to the general provision You may, merelore, market the device, subject to annual registration, listing of
general controls provisions of the Act include requirements michranding and general controls provisions of the rict morations against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations FITA may be subject to such additional controls. Existing major be found in the Code of Poderal Regaring your device in the Federal Register.

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Page 2 - Mr. Craig Coombs

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 losames or our device complies with other requirements of the Act that IDA has made a dolorimiation administered by other Federal agencies. You must of any I cuchares and regarations and regarations and limited to: registration and listing (21 Comply with an the Fee 610 care and 301); good manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050. product launation conta of pro note (stime (eting your device as described in your Section 510(k) I his icher wif anow you to organization of substantial equivalence of your device to a legally prematics notification: "The Pressification 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 arriouse at [phone]. Also, please note the regulation entitled, Connect the Office of Comment notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Duma R. Ladner

Image /page/3/Picture/5 description: The image shows a black and white drawing of a signature. The signature appears to be stylized and illegible. The signature is composed of curved lines and sharp angles, and it is difficult to discern any specific letters or characters.

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): とらこ 08 |

Remote Access Perfusion (RAP™) Femoral Venous Cannula Device Name:

Indications For Use:

The ESTECH Remote Access Perfusion Femoral Venous Cannula - during The ESTECH Remote Association rainage cannula during cardiopulmonary bypass up to 6 hours.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 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 ____________________________________________________________________________________________________________________________________________________________________

Dune P. Vachner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number k052081