ATRICURE DISSECTOR

K111020 · AtriCure, Inc. · FTD · Jun 9, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K111020
• Device Name: ATRICURE DISSECTOR
• Applicant: AtriCure, Inc.
• Product Code: FTD · General, Plastic Surgery
• Decision Date: Jun 9, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4580
• Device Class: Class 2

Intended Use

The AtriCure Dissector™ is intended to dissect soft tissue during general, ENT, thoracic, urological and gynecological surgical procedures. The Dissector's battery-powered light source is used to navigate soft tissue for identification of anatomic structures.

Device Story

AtriCure Dissector is a hand-held, single-use, surgical articulated dissector featuring an integral battery-powered light source. Operated by qualified surgeons, the device allows manual articulation of the distal tip via a rotation knob to facilitate tissue dissection. The integrated light source illuminates the surgical field to assist in the identification of anatomic structures. Available in multiple shaft lengths to accommodate varying patient habitus and surgeon preference. The light source remains illuminated for a minimum of four hours. The device is used in general, ENT, thoracic, urological, and gynecological surgical procedures to aid in navigation and tissue separation.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included biocompatibility (ISO 10993-1) for limited patient contact (<24 hours), risk analysis, and process verification to confirm conformance to product specifications.

Technological Characteristics

Hand-held, single-use, articulated surgical dissector. Materials include medical grade silicone, stainless steel, medical grade adhesive, and acrylic epoxy resin. Features an integral battery-powered light source. Biocompatibility tested per ISO 10993-1. No electronic software or complex algorithms; mechanical articulation controlled by manual rotation knob.

Indications for Use

Indicated for soft tissue dissection during general, ENT, thoracic, urological, and gynecological surgical procedures. Intended for use by qualified surgeons to navigate and identify anatomic structures.

Regulatory Classification

Identification

A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.

Special Controls

*Classification.* Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

Predicate Devices

• AtriCure Dissector (K041681)

Submission Summary (Full Text)

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K///.020

# ATRICURE DISSECTOR™ 510(k) SUMMARY

### General Information

| Date Compiled | April 11, 2011 |
|----------------|------------------------------------------------------------------------------------|
| Classification | Class II (Surgical Lamp)<br>21 CFR 878.4580 |
| Product Code | FTD, GDI |
| Trade Name | AtriCure DissectorTM |
| Manufacturer | AtriCure, Inc<br>6217 Centre Park Drive<br>West Chester, OH 45069 |
| Contact | James L. Lucky<br>VP of Quality Assurance and Regulatory Affairs<br>[phone] |

### Indications for Use

The AtriCure Dissector™ is intended to dissect soft tissue during general, ENT, thoracic, urological and gynecological surgical procedures. The Dissector's battery-powered light source is used to navigate soft tissue for identification of anatomic structures.

#### Cleared Device

The device proposed for modification in this submission is the AtriCure Dissector™ (K041681).

#### Device Description

The AtriCure Dissector™ is a hand held, single use, surgical articulated dissector with intearal light source intended to for use by qualified surgeons only. The surgeon is able to articulate the distal member of the device by means of hand actuated rotation knob. The surgeon directly controls the amount of articulation and tissue dissection. A small light source is attached to the distal tip of the articulation member, which remains illuminated for a minimum of four (4) hours. Multiple models of the Dissector™ are available with varving shaft lengths to accommodate surgeon preference and differing patient habitus.

#### Materials

All materials used in the manufacture of the AtriCure Dissector™ are suitable for their intended use and have been used in numerous previously cleared products. Materials used include, but are not limited to, medical grade silicone, stainless steel, medical grade adhesive, and acrylic epoxy resin. Testing was conducted in Accordance with ISO 10993-1 to ensure appropriate biocompatibility of all materials.

#### Testing

Appropriate product testing was conducted according to the Design Control requirements as defined in 21 CFR 820.30 to evaluate conformance to product specification and substantial equivalence to the legally marketed device. These activities included Risk

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Analysis, Process Verification, and Biocompatibility Testing. Biocompatibility testing was conducted according to ISO 10993-1 to confirm that the modified Dissector™ is safe for limited use (<24 hrs) as a patient contacting device. .

Summary of Substantial Eguivalence
substantially equivalent to the Dissector™ (MID1) device cleared via K041681. The modification does not affect the technological characteristics, scientific principles, or performance specifications. The indications for use, basic overall function, and materials used are substantially equivalent.

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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 depiction of an eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN - 9 2011

AtriCure, Inc. % Mr. James L. Lucky VP, Quality Assurance and Regulatory Affairs 6217 Centre Park Drive West Chester, Ohio 45069

Re: K111020

Trade/Device Name: AtriCure Dissector"™ Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: FTD, GDI Dated: May 19, 2011 Received: May 23, 2011

Dear Mr. Lucky:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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.

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

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Page 2 - Mr. James L. Lucky

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fdai.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

> Sincerely yours. Mark N. Melkerson

> Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

KII/020 510(k) Number (if known):

Device Name: AtriCure Dissector™

Indications For Use:

The AtriCure Dissector™ is intended to dissect soft tissue during general, ENT, thoracic, urological and gynecological surgical procedures. The Dissector's battery-powered light source is used to navigate soft tissue for identification of anatomic structures.

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)

Neil R.P. Ogden for mxm

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number.