ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1, MAX2 AND ASB1

K061593 · AtriCure, Inc. · OCL · Jul 12, 2006 · General, Plastic Surgery

Device Facts

Record IDK061593
Device NameATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1, MAX2 AND ASB1
ApplicantAtriCure, Inc.
Product CodeOCL · General, Plastic Surgery
Decision DateJul 12, 2006
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 878.4400
Device ClassClass 2
AttributesTherapeutic

Intended Use

The Isolator™ Transpolar™ Pen is a sterile, single use electrosurgery device intended to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the Atricure Ablation and Sensing Unit or for temporary cardiac pacing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.

Device Story

The Isolator Transpolar Pen System is a hand-held, sterile, single-use electrosurgical instrument used during cardiac surgery. It consists of the Pen, the AtriCure Ablation and Sensing Unit (ASU), a footswitch, and an ASB1 Source Switch. The device operates in two mutually exclusive modes: 1) Ablation: delivers radiofrequency (RF) energy to cardiac tissue when connected to the ASU and activated by the footswitch; 2) Pacing/Sensing: enables temporary cardiac pacing, recording, or stimulation when connected to an external pacemaker or recording device via the ASB1 auxiliary port. The system is operated by surgeons in a clinical setting. The output allows for the treatment of cardiac arrhythmias through tissue ablation or the diagnostic evaluation of electrical activity. The device benefits patients by providing a dual-function tool for both therapeutic ablation and intraoperative electrophysiological assessment.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing evaluating conformance to product specifications and biocompatibility per ISO 10993-1.

Technological Characteristics

Hand-held electrosurgical pen; RF energy source (via ASU); materials biocompatible per ISO 10993-1; single-patient use; sterile; connectivity via ASB1 Source Switch to either AtriCure ASU or external pacing/recording equipment; mechanical footswitch activation.

Indications for Use

Indicated for cardiac surgery patients requiring cardiac tissue ablation via radiofrequency energy or temporary cardiac pacing, sensing, recording, and stimulation for arrhythmia evaluation during surgery.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ ### 510(k) Summary ## JUL 1 2 2005 000223 General Information Classification Class II, Electrosurgical cutting and coagulation device and accessories (21 CFR 878.4400) Product Cod Trade Name Isolator™ Transpolar™ Pen System Elsa Abruzzo GEI Manufacturer AtriCure, Inc. 6033 Schumacher Park Drive West Chester, OH 45069 Contact Vice President, Clinical and Regulatory Affairs ### Intended Use The Isolator™ Transpolar™ Pen is a sterile, single use electrosurgery device intended to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the Atricure Ablation and Sensing Unit or for temporary cardiac pacing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device. ### Predicate Devices - AtriCure Isolator Transpolar Pen (K050459) ಂ - Medtronic Detect Mapping and Sensing Tool (K040812) 0 - 0 Viking Diagnostic Electrode Catheter (K971265) - 0 Estech Cobra System (K051749) ### Device Description The Isolator™ Transpolar™ pen System (Pen) is comprised of the AtriCure® Ablation and Sensing Unit (ASU), Isolator " Transpolar™ pen, a footswitch, and the ASB1 Source Switch accessor. The Pen is a hand-held, sterile, single patient use electrosurgical instrument intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy. When the Pen is connected to the ASU, either directly or via the ASB1 Source Switch set to the ASU port, the device delivers RF energy for cardiac tissue ablation when the operator presses the Footswitch. When the ASB1 is set to the auxiliary port the pen may be used with a commercially available temporary pacemaker or recorder for temporary cardiac pacing, sensing, recording, or stimulation for the evaluation of cardiac arrhythmias during surgery, based on the function of the device to which it is connected. The two modes of operation, ablation and pacing/sensing cannot be active at the same time. #### Materials All materials used in the manufacture of the Isolator Transpolar Pen System are suitable for this use and have been used in numerous previously cleared products. Testing was conducted in Accordance with ISO 10993-1 to ensure appropriate biocompatibility of all materials. ### Testing Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices. ### Summary of Substantial Equivalence The Isolator Transpolar Pen System is equivalent to the predicate products. The indications for use, basic overall function, and materials used are substantially equivalent. page 1 of 1 {1}------------------------------------------------ Public Health Service Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, symbolizing care and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The overall design is simple and professional, reflecting the department's role in public health and welfare. FEB 2 1 2008 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Atricure, Inc. c/o Ms. Elsa C. Abruzzo, RAC Vice President, Regulatory and Clinical Affairs 6033 Schumacher Park Dr. West Chester, OH 45069 Re: K061593 Trade Name: Atricure Isolator Transpolar Pen System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II (two) Product Code: OCL Dated: June 7, 2006 Received: June 8, 2006 Dear Ms. Abruzzo: This letter corrects our substantially equivalent letter of July 12, 2006. 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. {2}------------------------------------------------ Page 2 - Ms. Elsa C. Abruzzo. RAC 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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely vours Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known): K061593 Device Name: Atricure Isolator Transpolar Pen™ Indications For Use: The Isolator™ Transpolar™ Pen is intended to ablate cardiac tissues during cardiac surgery using radiofrequency energy when connected to the Atricure Ablation and Sensing Unit or for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device. 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) B. Aymuma ular Devices 510(k) Number Page 1 of 1 000225
Innolitics
510(k) Summary
Decision Summary
Classification Order
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