SMITH & NEPHEW DYONICS ELECTROBLADE RESECTOR

K031675 · Smith & Nephew, Inc. · GEI · Jun 20, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K031675
• Device Name: SMITH & NEPHEW DYONICS ELECTROBLADE RESECTOR
• Applicant: Smith & Nephew, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jun 20, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Smith & Nephew Dyonics® ElectroBlade™ Resector is indicated in arthroscopic surgical procedures of large and small articular cavities for resection and excision of soft and osseous tissues. The Smith & Nephew Dyonics® ElectroBlade™ Resector is effective in tissue resection and hemostasis of bleeding vessels. It is intended for arthroscopic procedures using saline solution, Ringer's lactate or other conductive solutions as an irrigant under direct or video-assisted fiber-optic visualization.

Device Story

The Smith & Nephew Dyonics® ElectroBlade™ Resector is a surgical instrument combining mechanical shaver technology with electrosurgical capabilities. It is used by surgeons during arthroscopic procedures to simultaneously resect soft or osseous tissue and provide hemostasis for bleeding vessels. The device operates in conductive irrigation fluids (e.g., saline, Ringer's lactate) under direct or video-assisted fiber-optic visualization. By integrating cutting and coagulation into a single instrument, it streamlines the surgical workflow, potentially reducing procedure time and improving patient outcomes through efficient tissue management.

Clinical Evidence

Bench testing only. Compliance with ANSI/AAMI HF18-1993, IEC 601-1, IEC 601-1-2, and IEC 60601-2-2 standards for electrosurgical safety and electromagnetic compatibility. Biocompatibility and sterilization validation performed per ISO 10993-1 and ISO 11135.

Technological Characteristics

Electrosurgical cutting and coagulation device; mechanical shaver integration. Operates in conductive irrigation media. Complies with ANSI/AAMI HF18-1993, IEC 601-1, IEC 601-1-2, and IEC 60601-2-2. Biocompatible per ISO 10993-1. Ethylene oxide sterilization validated per ISO 11135.

Indications for Use

Indicated for patients undergoing arthroscopic surgery of large and small articular cavities requiring resection and excision of soft and osseous tissues and hemostasis of bleeding vessels.

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

• 7205961 4.5mm Full Radius Bipolar ElectroBlade™
• 7209700 4.5mm Full Radius Elite Bipolar ElectroBlade™

Submission Summary (Full Text)

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.IUN 2 0 2003

Exhibit C

K031675

Endoscor

Smith & Nephew Inc 50 Minuteman Road, Andover, MA 01810-1031 U.S.A lephone: 978-749-1000

Smith & Nephew

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as required by the safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.

# Smith & Nephew Dyonics® ElectroBlade™ Resector

Date Prepared: May 19,2003

# A. Submitter's Name:

Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810

# B. Company Contact

Karen Provencher Regulatory Affairs Specialist 978-749-1365 (phone) 978-749-1443 (fax)

# C. Device Name

| Trade Name: | Smith & Nephew Dyonics® ElectroBlade™ Resector |
|----------------------|------------------------------------------------------|
| Common Name: | Arthroscopic Surgery Blade and Electrosurgical Probe |
| Classification Name: | Electrosurgical cutting and coagulation device |

# D. Predicate Devices

The Smith & Nephew Dyonics® ElectroBlade™ Resector is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device(s) in commercial distribution:

7205961 4.5mm Full Radius Bipolar ElectroBlade™ 7209700 4.5mm Full Radius Elite Bipolar ElectroBlade™

#### Description of Device E.

The Smith & Nephew Dyonics® ElectroBlade™ Resector combines electrosurgical and shaver technology to provide hemostasis and mechanical cutting in a single instrument.

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# F. Intended Use

The Smith & Nephew Dyonics® ElectroBlade™ Resector is indicated in arthroscopic surgical procedures of large and small articular cavities for resection and excision of soft and osseous tissues. The Smith & Nephew Dyonics® ElectroBlade™ Resector is effective in tissue resection and hemostasis of bleeding vessels. It is intended for arthroscopic procedures using saline solution, Ringer's lactate or other conductive solutions as an irrigant under direct or video-assisted fiber-optic visualization.

# G. Comparison of Technological Characteristics

The Vulcan™ Compatible ElectroBlade™ has the same technological characteristics and intended use as the predicate device, Smith & Nephew Dyonics® ElectroBlade™ Resector.

# H. Summary Performance Data

The modified device, performs as well as the unmodified device as demonstrated in the testing performed to the following standards:

- ANSVAAMI HF18-1993 for Electrosurgical Devices ●
- IEC 601-1(A1 + A2) Medical Electrical Equipment: Part 1 General . Requirements for Safety
- IEC 601-1-2 Medical electrical equipment Part1: General Requirements for . Safety and Part 2: Collateral standard: Electromagnetic compatibility -Requirements and tests
- IEC60601-2-2:1998 for Medical Electrical Equipment (Part2-2): Particular ● Requirements for the Safety of High Frequency Surgical Equipment.

As with the cleared Dyonics® ElectroBlade™ Resectors, these proposed devices have been demonstrated to be in compliance with the following standards:

- ANSI/AAMI ISO 10993-1 for Biological evaluation of medical devices -. Part1: Guidance on selection of tests
- ANSI/AAMI ISO 11135 Validation and Routine control of Ethylene Oxide Sterilization

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings or feathers.

Public Health Service

JUN 2 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Karen Provencher Regulatory Affairs Specialist Smith & Nephew. Inc. Endoscopy Division 150 Minuteman Road Andover, Massachusetts 01810

Re: K031675

Trade/Device Name: Smith & Nephew Dyonics® ElectroBlade™ Resector Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: May 29, 2003 Received: May 30, 2003

Dear Ms Provencher:

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. Iisting 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 mav 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 - Ms. Karen Provencher

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 Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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 yours,

Muriam C. Provost

( Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

| 510(k) Number (if known): | K031675 |
|---------------------------|---------|
|---------------------------|---------|

Device Name: Smith & Nephew Dyonics® ElectroBlade™ Resector

Indications For Use:

The Smith & Nephew Dyonics® ElectroBlade™ Resector is indicated in arthroscopic surgical procedures of large and small articular cavities for resection and excision of soft and osseous tissues. The Smith & Nephew Dyonics® ElectroBlade™ Resector is effective in tissue resection and hemostasis of bleeding vessels. It is intended for arthroscopic procedures using solution, Ringer's lactate or other conductive solutions as an irrigant under direct or video-assisted fiber-optic visualization.

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K031675

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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