DYONICS ELECTROBLADE RESECTOR

K012314 · Smith & Nephew, Inc. · GEI · Feb 1, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K012314
• Device Name: DYONICS ELECTROBLADE RESECTOR
• Applicant: Smith & Nephew, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 1, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DYONICS Electroblade Resector is indicated for use in arthroscopic surgical procedures of large and small articular cavities. The DYONICS Electroblade Resector is effective in soft and osseous tissue resection and in 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 fiberoptic visualization.

Device Story

The DYONICS ElectroBlade Resector is a surgical instrument combining rotary mechanical cutting with bipolar electrosurgical coagulation. It consists of an inner rotational blade electrified by connection to a standard electrosurgical generator and an outer blade with insulation to isolate electrical energy to the cutting window. Used in arthroscopic procedures of large and small articular cavities; operated by surgeons in an OR setting. The device functions with standard Dyonics shaver systems and electrosurgical generators. By enabling simultaneous tissue resection and hemostasis, it facilitates efficient surgical workflows and reduces the need for instrument exchanges, potentially improving patient outcomes during arthroscopic procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Combination bipolar RF and mechanical resector. Features an inner rotational blade and an outer blade with electrical insulation. Operates via connection to standard electrosurgical generators and Dyonics shaver systems. Designed for use with conductive irrigation fluids (saline, Ringer's lactate).

Indications for Use

Indicated for arthroscopic surgical procedures of large and small articular cavities for resection and excision of soft and osseous tissues and hemostasis of bleeding vessels. Used with conductive irrigation solutions under direct or video-assisted fiber-optic 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

• DYONICS ElectroBlade (K994365)

Submission Summary (Full Text)

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K012314

## 510(k) Summary DYONICS ElectroBlade Resector™ Date Prepared: July 20, 2001

This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

FEB 0 1 2002

#### Submitter A.

Smith & Nephew, Inc. Endoscopy Division 160 Dascomb Road Andover, MA 01810

#### B. Company Contact

Tim Crabtree Regulatory Affairs Specialist

#### C. Device Name

Trade Name: DYONICS EletroBlade Resector Common Name: Arthroscopic Surgery Blade / Electrosurgical Probe Classification Name: Electrosurgical Probe

#### D. Predicate Devices

DYONICS ElectroBlade (K994365)

#### E. Description of Device

The DYONICS ElectroBlade Resector combines the rotary cutting technology of Dyonics Arthroscopic Surgery Blades with the electrosurgical capabilities of a bipolar electrosurgery probe. The inner rotational blade is electrified by connection to a standard generator. Insulation on the outer blade isolates the electrical energy to the inner tube where it is exposed to tissue at the cutting window of the blade. The DYONICS ElectroBlade Resector operates in conjunction with the standard Dyonics shaver system and standard electrosurgical generator systems.

## D. Intended Use

్ట్రాల్యాల్లో ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ప్రాథమిక ఆరోగ్య కేంద్రం, ప్రాథమిక ఆరోగ్య కేంద్రం, ప్రాథమిక ఆరోగ్య కేంద్రం, ప్రాథమిక ఆరోగ్య కేంద్

The DYONICS Electroblade Resector is indicated for use in arthroscopic surgical procedures of large and small articular cavities. The DYONICS Electroblade Resector is effective in soft and osseous tissue resection and in 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 fiberoptic visualization.

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### Comparison of Technological Characteristics E.

The DYONICS Electroblade Resector is a combination of both bipolar RF and mechanical resector technologies. The design reflects this combination of these technologies. The resection and coagulation capabilities are features that are also found in the DYONICS Electroblade. The modified DYONICS Electroblade Resector is substantially equivalent to the DYONICS Electroblade in intended use, materials and method of operation.

Tim Licht

ాజ్యాల్లో

Tim Crabtree Regulatory Affairs Specialist

:

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 01 2002

Mr. Tim Crabtree Regulatory Affairs Specialist Smith & Nephew, Inc. Endoscopy Division 160 Dascomb Road Andover. Massachusetts 01810

Re: K012314

Trade/Device Name: DYONICS Electroblade Resector™ Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulating device and accessories Regulatory Class: II Product Code: GEI Dated: November 2, 2001 Received: November 5, 2001

Dear Mr. Crabtree:

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 - Mr. Tim Crabtree

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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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# 510(k) Number : KO123/4

Device Name: DYONICS Electroblade Resector™

## Indications for Use:

The 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 DYONICS EletroBlade 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.

(PLEASE DO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use سك (Per 21 CFR 801.109)

OR

Over-the-Counter ------

(Optional Format 1-2-96)

Miriam C. Provost

on of General, Restorative and Neurological Devices

510(k) Number K012314

Smith & Nephew Electroblade Resector Page 18 of 57