EDWARDS E360 SURGICAL ABLATION DEVICE

K041739 · Edwards Lifesciences, LLC · GEX · Sep 29, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K041739
• Device Name: EDWARDS E360 SURGICAL ABLATION DEVICE
• Applicant: Edwards Lifesciences, LLC
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 29, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Edwards E360 surgical ablation device is intended to be used as a surgical instrument for coagulation of soft tissue (including cardiac tissue) in conjunction with or without equipment (including laparoscopes, hysteroscopes, bronchoscopes, endoscopic cystoscopes, gastroscopes, and colonoscopes), and coagulation of soft tissue in the contact mode in both open or closed surgical procedures (with or without handpiece). The Edwards E360 surgical ablation device is indicated for use in medicine and surgery with 980 to 1064 nm wavelength laser energy in the following surgical specialties: General Surgery, Cardiac/Thoracic Surgery, Plastic Surgery, and Dermatology.

Device Story

The Edwards E360 is a sterile, single-use, disposable surgical ablation device. It delivers 980 nm laser energy in contact mode to coagulate soft tissue. Used in open or closed surgical procedures, with or without endoscopic equipment (e.g., laparoscopes, bronchoscopes). Operated by surgeons in clinical settings (OR). The device enables precise tissue coagulation, potentially reducing bleeding and improving surgical outcomes in cardiac, thoracic, general, plastic, and dermatological procedures.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Sterile, single-use, disposable surgical ablation device. Delivers 980 nm laser energy in contact mode. Designed for use with or without endoscopic equipment.

Indications for Use

Indicated for coagulation of soft tissue, including cardiac tissue, in patients undergoing open or closed surgical procedures in General, Cardiac/Thoracic, Plastic, and Dermatology surgery specialties. Used with or without endoscopic equipment.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• Malleable Surgical Lightstic 180 (K013901)
• AFx FLEX 10 Accessory for the AFx Microwave Ablation System (K013946)
• Edwards Retrograde Cardioplegia Cannula (K880103)
• Edwards Swan-Ganz™ Synthetic ControlCath Thermodilution Catheter (K001063)

Submission Summary (Full Text)

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September 13, 2004

## Attachment 3 - 510(k) Summary K041739

| Submitter: | Edwards Lifesciences LLC |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Elizabeth Moran, Regulatory Affairs Specialist |
| Date Prepared: | September 13, 2004 |
| Trade Name: | Edwards E360 surgical ablation device |
| Classification Name: | Class II, Laser Surgical Instrument |
| Predicate Device(s): | Malleable Surgical Lightstic 180 (Marketed under the trade<br>name of Edwards surgical ablation handpiece) (K013901) |
| | AFx FLEX 10 Accessory for the AFx Microwave Ablation<br>System (K013946) |
| | Edwards Retrograde Cardioplegia Cannula (K880103) |
| | Edwards Swan-Ganz™ Synthetic ControlCath<br>Thermodilution Catheter (K001063) |
| Device Description: | The Edwards E360 surgical ablation device is a sterile,<br>single-use, disposable device for delivery of 980 nm laser<br>energy in the contact mode. |
| Indications for Use: | The Edwards E360 surgical ablation device is intended to<br>be used as a surgical instrument for coagulation of soft<br>tissue (including cardiac tissue) in conjunction with or<br>without endoscopic equipment (including laparoscopes,<br>hysteroscopes, bronchoscopes, cystoscopes, gastroscopes,<br>and colonoscopes), and coagulation of soft tissue in the<br>contact mode in both open or closed surgical procedures<br>(with or without handpiece). |
| | The Edwards E360 surgical ablation device is indicated for<br>use in medicine and surgery with 980 to 1064 nm<br>wavelength laser energy in the following surgical<br>specialties: General Surgery, Cardiac/Thoracic Surgery,<br>Plastic Surgery, and Dermatology. |

PROPRIETARY INFORMATION: This document and information contained herein may not be reproduced, used, or disclosed without written permission from Edwards Lifesciences LLC.

K041739 Amendment 2

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| Comparative Analysis: | It is demonstrated that the Edwards E360 surgical ablation device is comparable to the predicate device in design, intended use, materials, and principal of operation. |
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| Functional/Safety Testing: | The Edwards E360 surgical ablation device has successfully completed design verification testing. |
| Conclusion: | The Edwards E360 surgical ablation device is substantially equivalent to the predicate device. |

PROPRIETARY INFORMATION. This document and information contained herein may not be reproduced, used, or disclosed without written permission from Edwards Lifesciences LLC.

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K041739 Amendment 2

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FFB 2 1 2008

Edwards Lifesciences, LLC c/o Ms. Elizabeth Moran Regulatory Affairs Specialist One Edwards Way Irvine, CA 92614

Re: K041739

Trade Name: Edwards E360 Surgical Ablation Device Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology Regulatory Class: II (two) Product Code: OCL, GEX Dated: September 13, 2004 Received: September 14, 2004

Dear Ms. Moran:

This letter corrects our substantially equivalent letter of September 29, 2004.

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 (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 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 - Ms. Elizabeth Moran

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 (OS) 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 continue 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 [phone]. Also, please note the regulation entitled, "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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

eemall

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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## Attachment 2 - Indications for Use Statement

510(k) Number (if known): K041739

Device Name:

Edwards E360 surgical ablation device

## Indications for Use:

The Edwards E360 surgical ablation device is intended to be used as a surgical instrument for coagulation of soft tissue (including cardiac tissue) in conjunction with or without equipment (including laparoscopes, hysteroscopes, bronchoscopes, endoscopic cystoscopes, gastroscopes, and colonoscopes), and coagulation of soft tissue in the contact mode in both open or closed surgical procedures (with or without handpiece).

The Edwards E360 surgical ablation device is indicated for use in medicine and surgery with 980 to 1064 nm wavelength laser energy in the following surgical specialties: General Surgery, Cardiac/Thoracic Surgery, Plastic Surgery, and Dermatology.

041239 Blümmerstern

ivision Sign-Off)
vision of Cardiovascular Devices
: 0(k) Number

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (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)

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PROPRIETARY INFORMATION: This document and information contained herein may not be reproduced, used, or disclosed without written permission from Edwards Lifesciences LLC.

K041739 Amendment 2

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