GENESIS

K081559 · Medisiss · GEI · Aug 28, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K081559
• Device Name: GENESIS
• Applicant: Medisiss
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Aug 28, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Genesis is indicated for use in surgical procedures (general neurosurgical, laparoscopic, orthopedic, gynecologic, etc.) where monopolar electrosurgical cutting and coagulation are normally used. The Genesis instruments are an alternative to conventional monopolar electrodes used for these indications.

Device Story

Genesis is a monopolar electrosurgical accessory instrument; compatible with standard electrosurgical pencils from various manufacturers. Device features a specialized outer layer designed to reduce tissue accumulation and eschar buildup during use. Operates by delivering electrical energy to tissue for cutting and coagulation; requires lower power settings than conventional electrodes. Used by surgeons in clinical settings (OR); reduces smoke emission and tissue damage. Benefits include improved surgical visibility due to reduced smoke and easier cleaning of the electrode tip during procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Monopolar electrosurgical electrode; features a specialized outer coating to minimize tissue adhesion and eschar buildup. Compatible with standard electrosurgical pencils. Energy source: external electrosurgical generator. Form factor: blade-style electrode. No software or electronic components.

Indications for Use

Indicated for patients undergoing surgical procedures (general, neurosurgical, laparoscopic, orthopedic, gynecologic) requiring monopolar electrosurgical cutting and coagulation.

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

• Valleylab Uncoated Electrosurgical Blade (E1551X)
• Valleylab EDGE Coated Electrosurgical Blade (K991855)
• Conmed Coated Electrosurgical Blade (K913473)
• Megadyne Coated Electrosurgical Blade (K062350)
• Surginetics AdvantageBlade Electrosurgical Blade

Reference Devices

• Myco Medical Surgical Blades

Submission Summary (Full Text)

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## 510(K) Summary of Safety & Effectiveness

AUG 2 8 2008

| Submitted By | MEDISISS<br>2747 SW 6th St.<br>Redmond, OR 97756 | |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| Contact Names | Brandi James<br>Director, Technical Services<br>P: 541-923-3310<br>F: 541-923-3375<br>E: [e-mail] | |
| Submission Date | June 2, 2008 | |
| Proprietary Device Name | GenesisTM | |
| Classification | Electrosurgical Electrodes, Class II, Electrosurgical cutting and<br>coagulation device and accessories, General and plastic surgery (21 CFR<br>878.4400), GEI | |
| Predicate Devices | Valleylab Uncoated Electrosurgical Blade (E1551X)<br>(Preamendment)<br>Valleylab EDGETM Coated Electrosurgical Blade ( E1450X):<br>Conmed Coated Electrosurgical Blade (139100)<br>Megadyne Coated Eelectrosurgical Blade (0012)<br>Surginetics AdvantageBlade Electrosurgical Blade<br>Myco Medical Surgical Blades (non-electrosurgical) | K962044<br>K991855<br>K913473<br>K062350<br>Exempt |
| Indications for Use | The Genesis is indicated for use in surgical procedures (general<br>neurosurgical, laparoscopic, orthopedic, gynecologic, etc.) where<br>monopolar electrosurgical cutting and coagulation are normally<br>used. The Genesis instruments are an alternative to conventional<br>monopolar electrosurgical electrodes used for these indications. | |
| Product Description | The Genesis is an instrument intended for use as a monopolar<br>electrosurgical accessory. The device reduces the smoke emitted into<br>the surgical area, uses lower power with less tissue damage and the<br>outer layer provides a surface that reduces tissue accumulations and<br>facilitates removing tissue residues, such as eschar, that may<br>accumulate during use.<br>Genesis devices are intended for use with monopolar electrosurgical<br>accessories and will be packaged separately. Genesis instruments<br>will also fit in currently marketed electrosurgical pencils offered by<br>other manufacturers. | |

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DEPARTMENT OF HEALTH & HUMAN SERVICES · USA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 2 8 2008

MEDISISS % Ms. Brandi James Director, Technical Services 2747 SW 6th Street Redmond, Oregon 97756

Re: K081559

·

Trade/Device Name: Genesis Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 5, 2008 Received: August 5, 2008

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.

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 - Mc. Brandi James

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 Postmarket 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 M. Millerson

- 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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## 4. Indications for Use

K081559

510(k) Number (if known): Not assigned at this time.

Device Name: Genesis

Indications For Use:

The Genesis is indicated for use in surgical procedures (general neurosurgical, laparoscopic, orthopedic, gynecologic, etc.) where monopolar electrosurgical cutting and coagulation are normally used. The Genesis instruments are an alternative to conventional monopolar electrodes used for these indications.

Prescription Use X (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)

| (Division Sign-Off) | |
|------------------------------------------------------------|---------|
| Division of General, Restorative, and Neurological Devices | |
| 510(k) Number | K081559 |

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