SAPHYRE BIPOLAR ABLATION PROBES

K031371 · Smith & Nephew, Inc. · GEI · May 23, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K031371
• Device Name: SAPHYRE BIPOLAR ABLATION PROBES
• Applicant: Smith & Nephew, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: May 23, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Smith & Nephew Saphyre Bipolar Ablation Probes, in combination with the Smith & Nephew Vulcan EAS Generator, are intended for general surgical use, including orthopedic and arthroscopic applications for resection, ablation, excision of soft tissue, hemostasis of blood vessels, and in coagulating soft tissue in joints including but not limited to the knee, shoulder, wrist, hip, etc. Arthroscopic surgery could include a variety of procedures, as listed in the table below. Examples of Arthroscopic Surgery: All Joints: Debridement (tendon, cartilage, fracture), Plica Removal, Resection, Synovectomy, Bursectomy, Ablation, Excision of Soft Tissue (scar tissue), Hemostasis of Blood Vessels, Coagulating Soft Tissues (ligament, articular cartilage), and Chondroplasty. Knee: Meniscectomy, Meniscal Cystectomy, PCL/ACL Debridement, Notchplasty, Lateral Release, Labral Tear. Shoulder: Acromioplasty, Rotator Cup Debridement, Subacromial Decompression, CA Ligament Resection, and Capsular Release. Wrist: Triangular Fibrocartilage (TFC).

Device Story

Single-use bipolar electrosurgical probe; consists of insulated shaft, power electrode, return electrode, and handle. Used with Vulcan EAS Generator for soft tissue coagulation, resection, and hemostasis. Some models include suction for tissue removal. Operated by surgeons in OR/arthroscopic settings. Device delivers electrical energy to target tissue; surgeon controls application via handle. Output facilitates tissue ablation/hemostasis, aiding surgical visualization and procedure completion.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Bipolar electrosurgical probe; single-use; insulated shaft; power and return electrodes; handle; optional suction. Energy source: Vulcan EAS Generator. Class II device.

Indications for Use

Indicated for patients undergoing general, orthopedic, or arthroscopic surgery requiring soft tissue resection, ablation, excision, or hemostasis in joints including knee, shoulder, wrist, and hip.

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

• Vulcan Electrosurgical Probes (K000691)
• ArthroCare ArthroWands (K011083)
• Bipolar Ablation Probes (K991218)

Submission Summary (Full Text)

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This summary of the 510(k) pre-market notification for the Smith & Nephew Saphyre Bipolar Ablation Probes is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

MAY 2 3 2003

1872

| Manufacturer | Contact Person(s) |
|----------------------|--------------------------------------------|
| Smith & Nephew, Inc | Deborah Connors |
| Endoscopy Division | Smith & Nephew, Regulatory Affairs Manager |
| 3700 Haven Court | 150 Minuteman Road |
| Menlo Park, CA 94025 | Andover, MA 01810 |

#### Device Name

Saphyre Bipolar Ablation Probes, Class II device (21 CFR 878.4400)

#### Generic/Common Name

Electrosurgical cutting and coagulation device and accessories

### Device Description

The Smith & Nephew Saphyre Bipolar Ablation Probes are single-use, bipolar, electrosurgical devices intended for coagulation of soft tissues. The Saphyre Bipolar Ablation Probes consist of an insulated shaft, an insulated power electrode, a return electrode, and a handle. Saphyre Bipolar Ablation Probes with Suction incorporate suction capability for the removal of tissue from the surgical site.

## Technological Characteristics

Smith & Nephew is requesting clearance to modify the device's existing general indications for use to more specific indications for use. There was no actual physical change to the device as a result of the proposed modified indications for use statement and, therefore, no changes to the technological characteristics.

#### Indications for Use

The Smith & Nephew Saphyre Bipolar Ablation Probes, in combination with the Smith & Nephew Vulcan EAS Generator, are intended for general surgical use, including orthopedic and arthroscopic applications for resection, ablation, excision of soft tissue, hemostasis of blood vessels, and in coagulating soft tissue in joints including but not limited to the knee, shoulder, wrist, hip, etc. Arthroscopic surgery could include a variety of procedures.

## Predicate Device(s)

| • Indication for Use: | Vulcan Electrosurgical Probes K000691, cleared May 15, 2000<br>ArthroCare ArthroWands K011083, cleared June 28, 2001 |
|-----------------------|----------------------------------------------------------------------------------------------------------------------|
| • Design: | Bipolar Ablation Probes K991218, cleared September 13, 1999 |

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## Substantial Equivalence Determination

The modified indications for use for the Smith & Nephew Saphyre Bipolar Ablation Probes are substantially equivalent to the predicate devices. This determination is based on the following:

- I. The indications for use, as modified for the Saphyre Bipolar Ablation Probes, and design are equivalent to that of the predicate devices and;
-

- 2. No new risks have been introduced as a result of the modification.

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MAY 2 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Linda Guthrie Manager Regulatory Affairs and Compliance Smith & Nephew, Inc. Endoscopy Division 3700 Haven Court Menlo Park, California 94025

Re: K031371

Trade/Device Name: Smith & Nephew Saphyre Bipolar Ablation Probes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: April 25, 2003 Received: April 30, 2003

Dear Ms. Guthrie:

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 - Ms. Linda Guthrie

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,

Miriam 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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Section 1 - General Information

# INDICATIONS FOR USE STATEMENT

| 510(k) Number: | K031371 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Smith & Nephew Saphyre Bipolar Ablation Probes |
| Indications for Use: | The Smith & Nephew Saphyre Bipolar Ablation Probes, in combination<br>with the Smith & Nephew Vulcan EAS Generator, are intended for general<br>surgical use, including orthopedic and arthroscopic applications for<br>resection, ablation, excision of soft tissue, hemostasis of blood vessels, and<br>and in coagulating soft tissue in joints including but not limited to the<br>knee, shoulder, wrist, hip, etc. Arthroscopic surgery could include a |
| | variety of procedures, as listed in the table below. |

#### Examples of Arthroscopic Surgery

| All Joints | Debridement (tendon, cartilage, fracture), Plica Removal, Resection, Synovectomy,<br>Bursectomy, Ablation, Excision of Soft Tissue (scar tissue), Hemostasis of Blood<br>Vessels, Coagulating Soft Tissues (ligament, articular cartilage), and Chondroplasty. |
|------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Knee | Meniscectomy, Meniscal Cystectomy, PCL/ACL Debridement, Notchplasty, Lateral<br>Release, Labral Tear. |
| Shoulder | Acromioplasty, Rotator Cup Debridement, Subacromial Decompression, CA Ligament<br>Resection, and Capsular Release. |
| Wrist | Triangular Fibrocartilage (TFC). |

Image /page/4/Picture/8 description: The image shows a document with the title "Division Sign-Off" and the text "Division of General, Restorative and Neurological Devices". The document includes the number K031371 and states "PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED". There is a section for "Concurrence of CDRH, Office of Device Evaluation (ODE)" and options for "Prescription Use" and "Over-The-Counter Use", with the former selected.