MEDISSISS REPROCESSEDENT ABLATION WANDS (COBLATORS), MODEL#EIC8872-01

K100543 · Medisiss · GEI · Jul 23, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K100543
• Device Name: MEDISSISS REPROCESSEDENT ABLATION WANDS (COBLATORS), MODEL#EIC8872-01
• Applicant: Medisiss
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jul 23, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MEDISISS Reprocessed ENT Ablation Wands (Coblators) are indicated for coagulation, ablation, resection, of soft tissue and hemostasis of blood vessels in otoloaryngology (ENT) procedures including: tonsillectomy/adenoidectomy and soft tissue reduction.

Device Story

Reprocessed high-frequency, bipolar ablation wand; features integrated suction, electrical cable, and saline delivery system. Used by surgeons in ENT procedures to perform soft tissue ablation, resection, and hemostasis. Device functions via electrosurgical energy to achieve tissue effects. Reprocessed to restore functionality of original predicate devices.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and performance specifications.

Technological Characteristics

High-frequency, bipolar electrosurgical ablation wand; includes integrated suction, electrical cable, and saline delivery system. Class II device (21 CFR 878.4400).

Indications for Use

Indicated for patients undergoing otolaryngology (ENT) procedures, including tonsillectomy, adenoidectomy, and soft tissue reduction, requiring soft tissue coagulation, ablation, resection, and hemostasis.

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

• ArthroCare ENT® Plasma Wands™ (K070374)
• ArthroCare ENTec® Plasma Wands™ (K014290)
• ArthroCare ENT® Plasma Wands™ (K063538)
• ArthroCare ArthroWands®, ENTec® EVac™ Plasma Wand™ (K013463)
• MEDISISS Reprocessed Soft Tissue Ablators (K012669)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the word "MEDISISS" in bold, black letters. To the left of the word is a graphic of lines radiating outward, resembling a sun or starburst. A small "tm" symbol is located to the upper right of the word.

### 510(k) Notification: MEDISISS Reprocessed ENT Ablation Wands (Coblators)

# Section 5: 510(K) Summary of Safety & Effectiveness

100595

| Submitted By | MEDISISS<br>2747 SW 6th St.<br>Redmond, OR 97756 | JUL 23 2010 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Names | Brandi James<br>Sr. Director Quality Assurance/Regulatory Affairs<br>P: 541-923-3310<br>F: 541-923-3375<br>E: [e-mail] | |
| Date Prepared | February 22, 2010 | |
| Proprietary Device Name | MEDISISS Reprocessed ENT Ablation Wands (Coblators) | |
| Classification | Electrosurgical Electrodes, Class II, Electrosurgical cutting and coagulation<br>device and accessories, General and plastic surgery (21 CFR 878.4400), GEI | |
| Predicate Devices | K070374 ArthroCare ENT® Plasma Wands™<br>K014290 ArthroCare ENTec® Plasma Wands™<br>K063538 ArthroCare ENT® Plasma Wands™<br>K013463 ArthroCare ArthroWands®, ENTec® EVac™ Plasma Wand™<br>K012669 MEDISISS Reprocessed Soft Tissue Ablators | |
| Intended Use | MEDISISS Reprocessed ENT Ablation Wands (Coblators) are indicated for<br>coagulation, ablation, resection, of soft tissue and hemostasis of blood vessels in<br>otoloaryngology (ENT) procedures including: tonsillectomy/adenoidectomy and<br>soft tissue reduction. | |
| Device Description | The device is a high frequency, bipolar ablation wand with suction capability<br>that contains an integrated electrical cable and integrated saline delivery system. | |
| Substantial Equivalence | The indications for use, technological characteristics, and performance<br>specifications are substantially equivalent to the predicate devices. | |

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling a human figure with outstretched arms, accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The symbol is composed of three curved lines that form the shape of a person, and the text is written in a simple, sans-serif font.

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

#### MEDISISS % Ms. Brandi J. James Sr. Director, Quality Assurance/

#### JUL 2 3 2010

Regulatory Affairs 2747 SW 6th Street Redmond, Oregon 97756

Re: K100543

Trade/Device Name: Medisiss Reprocessed ENT Ablation Wands Regulation Number: 21 CFR 878.4400

Regulation Name: Electrosurgical cutting and coagulation device

and accessories

Regulatory Class: Class II Product Code: GEI Dated: February 22, 2010 Received: February 25, 2010

Dear Ms. James:

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.

{2}------------------------------------------------

Page 2 - Ms. Brandi J. James

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); 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.fda.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 A. Millan

Mark N. Melkerson Director Division of Surgical. Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the word "MEDISISS" in bold, black letters. To the left of the word, there is a graphic of lines radiating outward, resembling a sun or starburst. A small "tm" symbol is located to the upper right of the word.

## Section 4: Indications for Use

510(k) Number: TBD

Device Name: MEDISISS Reprocessed ENT Ablation Wands (Coblators)

Indications For Use:

MEDISISS Reprocessed ENT Ablation Wands (Coblators) are indicated for coagulation, resection, of soft tissue and hemostasis of blood vessels in otoloaryngology (ENT) procedures including: tonsillectomy/adenoidectomy and soft tissue reduction.

Prescription Use X (Part 21 CFR 801.109)

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)

Mark A. Mchum

(Division Sign-Off) (Division Sign-On)
Division of Surgical, Orthopedic, Division of Suices

ાડિત્ત્વે ત્વે સ

510(k) Number .

Page 1 of