ATRILAZE LASER ABLATION SYSTEM

K081457 · Medical Cv, Inc. · GEX · Aug 8, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K081457
• Device Name: ATRILAZE LASER ABLATION SYSTEM
• Applicant: Medical Cv, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 8, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The ATRILAZE™ Surgical Ablation System is indicated for delivery of 810nm, 1064nm or 1083nm laser light to soft tissue to include cardiac tissue during surgical procedures. Indications include the incision, excision, dissection, vaporization, ablation, or coagulation of soft tissue. The ATRILAZE™ Surgical Ablation System Accessories are intended for use in the support of the delivery of laser light to soft tissue to include cardiac tissue during surgical procedures.

Device Story

System delivers 810nm, 1064nm, or 1083nm laser energy to soft/cardiac tissue. Components include laser energy generator, system cart, fluid delivery pump, tubing set, and sterile, single-use surgical ablation wand (rigid or flexible). Saline solution delivered to wand tip via fluid path. Wand connects to generator via 905 SMA connector; optical fiber directs laser energy to target tissue. Used intraoperatively by surgeons. Output provides thermal energy for tissue ablation/coagulation. Benefits include precise tissue management during surgery. Warning: not for cardiac arrhythmia treatment; risk of adjacent organ damage, perforation, or burns.

Clinical Evidence

Bench testing only. Testing confirmed that lesions produced using the 1083nm laser wavelength are substantially equivalent to those produced by the predicate device's cleared wavelengths.

Technological Characteristics

Laser surgical instrument; 810nm, 1064nm, or 1083nm wavelengths. Components: laser generator, fluid pump, tubing, and rigid/flexible ablation wands. Connectivity: SMA 905 fiber optic connector. Sterile, single-use wands. Energy source: laser generator. No software-based control or algorithm described.

Indications for Use

Indicated for incision, excision, dissection, vaporization, ablation, or coagulation of soft tissue, including cardiac tissue, during surgical procedures. Not indicated for the treatment of cardiac arrhythmias.

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

• ATRILAZE™ Surgical Ablation System (K060680)

Submission Summary (Full Text)

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Summary of Safety and Effectiveness (as required by 21 CFR 807.92)

AUG - 8 2008

ATRILAZE™ Surgical Ablation System [(K08XXXX)]

K081457

| Submitter: | MedicalCV, Inc.<br>9725 South Robert Trail<br>Inver Grove Heights, MN 55077<br>USA |
|----------------------|---------------------------------------------------------------------------------------------------------|
| Contact: | Kirk S, Honour<br>Regulatory, Clinical & Quality Management<br>Phone: [phone]<br>Fax: [phone] |
| Date of Summary: | [DATE] |
| Product Code: | GEX, OCL |
| Classification Name: | Laser Instrument, Surgical Powered |
| Common Name: | Surgical Laser Instrument |
| Proprietary Name | ATRILAZET™ Surgical Ablation System |

### Description of Device:

The ATRILAZE™ Surgical Ablation System consists of a Laser Energy Generator, system cart, fluid delivery pump, fluid delivery tubing set and a fixed or flexible surgical ablation wand of various lengths. The wand is an intraoperative, sterile, single-use device designed to apply laser energy to cardiac tissue. The fluid delivery tubing set is a single-use device having a sterile fluid path designed for the delivery of sterile saline solution to the wand tip. The fluid delivery tubing may be provided together with the wand or as an accessory device. The fluid delivery pump and laser energy generator are sold separately. The wand includes a ridged metallic shaft or a flexible shaft of various lengths, and is equipped with a 905 SMA connector cable which attaches to the laser energy generator output connector. The emitted laser energy is directed toward the target tissue from the end of the optical fiber which rides within the flexible track.

### Statement of Intended Use:

The ATRILAZE™ Surgical Ablation System is indicated for delivery of 810nm, 1064nm or 1083nm laser light to soft tissue to include cardiac tissue during surgical procedures. Indications include the incision, excision, dissection, vaporization, ablation, or coagulation of soft tissue.

Confidential MedicalCVTM, Inc. Revision: 21-May-2008

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The ATRILAZE™ Surgical Ablation System Accessories are intended for use in the support of the delivery of laser light to soft tissue to include cardiac tissue during surgical procedures.

## Warning:

The ATRILAZE™ Surgical Ablation System is not indicated for the treatment of cardiac arrhythmias.

The risk of actual damage to adjacent organs from the instrument exists and perforation, rupture or tearing of tissue, may occur as a complication of laser use. Burns can occur if the laser energy is not correctly applied. These complications may be serious.

### Technological Comparison:

The ATRILAZE™ Surgical Ablation System was compared to the current ATRILAZE™ Surgical Ablation System (K060680).

Both the currently available device and the ATRILAZE™ wand as reviewed in this 510(k) are provided sterile with a sterile fluid path for saline delivery at the laser tip. Both fiber optic delivery systems utilize the same laser energy generator and are connected via an SMA 905 connector to deliver laser energy to the target tissue.

For purposes of this submission, the ATRILAZE™ Surgical Ablation System was compared to the following predicate devices: ATRILAZE™ Surgical Ablation System (K060680).

### Testing:

Testing demonstrated that adherence to specifications was demonstrated and the lesions obtained using the ATRILAZE™ wand with 1083nm laser light are substantially equivalent to those obtained with the currently cleared ATRILAZE™ Surgical Ablation System wavelengths.

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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 consists of a stylized eagle symbol on the right side. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MedicalCV, Inc. % Mr. Kirk S. Honour Regulatory, Clinical & Quality Management 9725 South Robert Trail Inver Grove Heights, Minnesota 55077-4424

AUG - 8 2008

Re: K081457

Trade/Device Name: ATRILAZETM Surgical Ablation System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical insgrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: May 21, 2008 Received: May 28, 2008

Dear Mr. Honour:

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.

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Page 2 - Mr. Kirk S. Honour

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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Protmarket, Surveillance at [phone]. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/industry/support/index.html.

Sincerely yours.

Mark N Wilkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

510(K) Number: K081457

ATRILAZE™ Surgical Ablation System Device Name:

#### Indications for Use:

The ATRILAZE™ Surgical Ablation System is indicated for delivery of 810nm, 1064nm or 1083nm laser light to soft tissue to include cardiac tissue during surgical procedures. Indications include the incision, excision, dissection, vaporization, ablation, or coagulation of soft tissue.

The ATRILAZE™ Surgical Ablation System Accessories are intended for use in the support of the delivery of laser light to soft tissue to include cardiac tissue during surgical procedures.

### Warning:

The ATRILAZE™ Surgical Ablation System is not indicated for the treatment of cardiac arrhythmias.

The risk of actual damage to adjacent organs from the instrument exists and perforation, rupture or tearing of tissue, may occur as a complication of laser use. Burns can occur if the laser energy is not correctly applied. These complications may be serious.

Prescription Use X (Per 21 CFR 801.109)

OR

Over--the-Counter Use

(Please do not write below this line - Continue on another page if necessary)

Concurrence of CDRH, Office of Deyice Evaluation (ODE)

**Division**

Division Jign-Ui Division of General, Restorative, and Neurological Devices

**510(k) Number** /ic(r)457

Confidential MedicalCVTM, Inc. Revision: 21-May-2008