FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05

K061865 · Guidant Corp. · NEY · Jul 27, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K061865
• Device Name: FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05
• Applicant: Guidant Corp.
• Product Code: NEY · General, Plastic Surgery
• Decision Date: Jul 27, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Guidant FLEX 10® MIS Ablation Probe is indicated for the surgical ablation of soft tissue and striated, cardiac, and smooth muscles. The system is a device indicated for use, under direct visualization, in surgical procedures, including minimally invasive cardiac surgery procedures. The probes ablate the target tissue by creating an inflammatory response, or thermal necrosis.

Device Story

Intraoperative, single-use, hand-held microwave ablation probe; used with Guidant 1000 Series Microwave Generator. Device features rigid handle with position indicators, metallic shaft, flexible sheath with numbered segments, and coaxial cable. Generator delivers 2450 MHz microwave energy to distal antenna. Physician selects ablation segments via sliding ring on handle; energy creates continuous 26 mm lesion via thermal necrosis or inflammatory response. Used in surgical settings under direct visualization to ablate target tissue. Benefits include precise, controlled tissue ablation during minimally invasive cardiac procedures.

Clinical Evidence

Bench testing only. Verification testing demonstrated the device meets established acceptance criteria and performs substantially equivalent to the predicate device.

Technological Characteristics

Microwave ablation probe; 24-cm rigid handle; metallic shaft; flexible sheath with numbered segments; 2-m insulated coaxial cable. Energy source: 2450 MHz microwave generator. Single-use; sterile. No software algorithm described.

Indications for Use

Indicated for surgical ablation of soft tissue, striated, cardiac, and smooth muscles in patients undergoing surgical procedures, including minimally invasive cardiac surgery, under direct visualization.

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

• FLEX 10® Ablation Probe (K013946, K041340)

Submission Summary (Full Text)

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Guidant Corporation

Guidant FLEX 100 MIS Ablat Special 510(k)

JUL 2 7 2006

## KO61865 APPENDIX A: 510(K) SUMMARY

Submitter Guidant Corporation, Cardiac Surgery Submitter's 3200 Lakeside Drive Address Santa Clara, CA 95054 Telephone [phone] Fax [phone] Contact Person Christina L. Rowe Date Prepared June 29, 2005 Device Trade Guidant FLEX 108 MIS Ablation Probe Name Device System, ablation, microwave and accessories Common Name Device System, ablation, microwave and accessories Classification Name Class II Device Classification Summary of The design, materials, method of delivery, features, and intended use of the substantial Guidant FLEX 100 MIS Ablation Probe are substantially equivalent to the equivalence predicate device: FLEX 10® Ablation Probe for the Guidant Microwave Ablation System (K013946, February 27, 2002 and K041340, July 28, 2004) The FLEX 10® MIS Ablation Probe is designed for use in conjunction with the Device Guidant 1000 Series Microwave Generator. The Ablation Probe is an description intraoperative, sterile, single-use, hand-held device that applies microwave energy to tissue. The Ablation Probe is comprised of a 24-cm-long, rigid handle with position indicators, a metallic shaft, a proximal control tube, a flexible sheath featuring black numbered markings together with right and left hand side markings, a detachable distal control tube, and a guide lead with sutures. The Ablation Probe further includes a 2-m-long insulated coaxial cable, which attaches to the generator output cable connector. The Microwave Generator's output (2450 MHz) is conducted through the output cable connector, into the cabling of the Ablation Probe, and out the antenna at the distal section of the Ablation Probe. The emitted microwave energy is directed toward the target tissue from the active surface opposite the corresponding numbered marking (segment), and creates a continuous lesion approximately 26 mm long. The black side-markings indicate the sides of the sheath. The numbered markings designate each numbered segment of the sheath and correspond to the position indicators on the handle. The ablations are created by independently activating the microwave ablation element at one or more of the corresponding numbered segments, which are selected by moving the sliding ring on the handle.

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Guidant Corporation

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:

| Indications for<br>Use | The Guidant FLEX 10® MIS Ablation Probe is indicated for the surgical<br>ablation of soft tissue and striated, cardiac, and smooth muscles. The system is a<br>device indicated for use, under direct visualization, in surgical procedures,<br>including minimally invasive cardiac surgery procedures. The probes ablate the<br>target tissue by creating an inflammatory response, or thermal necrosis. | |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Technological<br>characteristics | The Guidant FLEX 10® MIS Ablation Probe incorporates the same fundamental<br>scientific technology as the predicate device. | |
| Performance<br>data | The results of the verification testing demonstrate that the Guidant FLEX 10®<br>MIS Ablation Probe meets the established acceptance criteria and performs in a<br>manner substantially equivalent to the predicate device. | |

K 061 865

:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

DEPARTMENT OF HEALTH & HUMAN SERVICES · USA

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Guidant Corporation c/o Ms. Christina L. Rowe Principal Regulatory Affairs Associate 3200 Lakeside Drive

Re: K061865

Santa Clara, CA 95054-2807

Trade/Device Name: Guidant FLEX 108 MIS Ablation Probe Regulatory Number: 21 CFR 878.4400 Regulatory Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II (two) Product Code: OCL, NEY Dated: June 30, 2006 Received: July 11 2006

FEB 2 1 2008

Dear Ms. Rowe:

This letter corrects our substantially equivalent letter of July 27, 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.

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Page 2 - Ms. Christina L. Rowe

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.

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 vours.

e2gmaell

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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## APPENDIX B: INDICATIONS FOR USE STATEMENT

| 510(k) number (if known) | K061865 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | Guidant FLEX 10® MIS Ablation Probe |
| Indications for Use | The Guidant FLEX 10® MIS Ablation Probe is indicated for the surgical ablation of soft tissue and striated, cardiac, and smooth muscles. The system is a device indicated for use, under direct visualization, in surgical procedures, including minimally invasive cardiac surgery procedures. The probes ablate the target tissue by creating an inflammatory response, or thermal necrosis. |

Prescription Use X (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

| Qoncurrence of CDRH, Office of Device Evaluation (ODE) |
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(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number Kob1865