SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-6921

K023624 · Surgical Laser Technologies, Inc. · GEX · Jan 27, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K023624
• Device Name: SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-6921
• Applicant: Surgical Laser Technologies, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 27, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SLT Venous Fiber is intended for use in endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

Device Story

SLT Venous Fiber Delivery Systems consist of flexible optical fibers (Flat, Conical, or Diffuser models) designed to deliver laser energy for endovascular coagulation. The device is inserted into the vein via a catheter or cannula. The Diffuser fiber provides a uniform cylindrical coagulation zone; the Conical fiber provides a focused radial coagulation zone; the Flat fiber provides forward-directed high-energy density. The fibers connect to compatible laser systems (810nm-1064nm depending on model) via proprietary or SMA-905 connectors. Used by physicians in clinical settings to treat superficial vein reflux by thermally coagulating the greater saphenous vein. The output is laser energy that induces thermal tissue interaction, resulting in vein closure. The device is sterile and for single use only.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by animal study results demonstrating safe and effective performance comparable to the predicate devices.

Technological Characteristics

Flexible optical fibers with three tip geometries: Diffuser (cylindrical), Conical (radial), and Flat (forward). Compatible with laser wavelengths 810nm-1064nm. Connectors: SLT proprietary or SMA-905. Materials are biocompatible per USP Class VI and ISO 10993-1/4. Sterilized for single use.

Indications for Use

Indicated for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• Diomed 810nm Surgical Lasers and EVLT Procedure Kit (K012398)
• VNUS® Closure™ System (K003092)
• VNUS® Closure™ System (K982816)
• VNUS® Closure™ System (K974521)
• Ceralas D10-60 810nm Diode Laser System and ELVS Procedure Kit (K020835)
• Ceralas D Diode 980nm Laser System (K013691)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains a logo for Surgical Laser Technologies. The logo has the letters SLT in bold black font on the left side of the image. To the right of the letters are the words Surgical, Laser, and Technologies stacked on top of each other in a smaller font.

147 Keystone Drive Montgomeryville, Pennsylvania 18936-9638

Tel: [phone] [phone] Fax: [phone]

AND AND ALL BA

JAN 2 7 2003

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## 510(k) SUMMARY SLT Venous Fiber Delivery Systems

K023624

This 510(k) summary of safety and effectiveness information for the SLT Venous Fiber Delivery Systems is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is:

Surgical Laser Technologies, Inc. Applicant:

Surgical Laser Technologies, Inc. Address: 147 Keystone Drive Montgomeryville, PA, 18936

Davis Woodward Contact Person: Vice President, CFO

[phone] Telephone: [phone] (fax)

Preparation Date: October 9, 2002

"SLT Venous Fiber Delivery Systems", comprised of the following models: Proprietary Device Name:

| Model Name | Model Number |
|--------------------------------|--------------|
| Venous Flat Fiber, SLT | 0041-6772 |
| Venous Flat Fiber, SMA-905 | 0041-6781 |
| Venous Conical Fiber, SLT | 0041-6752 |
| Venous Conical Fiber, SMA-905 | 0041-6761 |
| Venous Diffuser Fiber, SLT | 0041-6912 |
| Venous Diffuser Fiber, SMA-905 | 0041-6921 |

Surgical Laser Fiber Delivery System Common Name:

Laser surgical instrument for use in general and plastic surgery and in Classification dermatology (see 21 CFR 878.4810). Name:

Product Code: GEX

79, General and Plastic Surgery Panel:

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| Legally Marketed<br>Predicate Devices: | Diomed 810nm Surgical Lasers and EVLT Procedure Kit (K012398)<br>VNUS® Closure™ System (K003092)<br>VNUS® Closure™ System (K982816)<br>VNUS® Closure™™ System (K974521)<br>Ceralas D10-60 810nm Diode Laser System and ELVS Procedure Kit<br>(K020835)<br>Ceralas D Diode 980nm Laser System (K013691) |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description of the<br>Device: | SLT Venous FDS products include the Venous Diffusing Fiber, the Venous<br>Conical Fiber, and the Venous Flat Fiber.<br><br>SLT Venous Diffuser Fibers are flexible fibers with an active diffusing<br>portion that diffuses the laser energy in a uniform pattern about its active<br>diffusing length, resulting in a cylindrical or elongated spheroidal zone of<br>coagulation.<br><br>SLT Venous Conical Fibers splay the laser energy radially at their distally<br>conical portion, providing a much smaller and more focused coagulation<br>zone than the Venous Diffuser Fiber.<br><br>SLT Venous Flat Fibers direct the laser energy forward from their distally<br>flat end, providing the highest energy density of the three SLT Venous<br>Fibers.<br><br>SLT Venous Fibers are available with SLT proprietary connectors (to fit<br>SLT Contact Laser™ Systems) and SMA-905 connectors (to fit lasers with<br>standard SMA-905 launch interfaces).<br><br>SLT Venous Diffuser Fibers are compatible for use only with lasers having<br>wavelengths between 980nm and 1064nm.<br><br>SLT Venous Conical and Flat Fibers are compatible for use with lasers<br>having wavelengths between 810nm and 1064nm.<br><br>SLT Venous Fibers are flexible and therefore, when used for endovascular<br>applications, a catheter, cannula, or similar device should be used to insert<br>the fiber into the vein.<br><br>SLT Venous Fiber products are sold sterile, and are intended for single use<br>only. |
| Indications for Use: | The SLT Venous Fiber is intended for use in endovascular coagulation of<br>the greater saphenous vein of the thigh in patients with superficial vein<br>reflux. |
| Substantial<br>Equivalence: | The intended use, method of tissue interaction, specifications, clinical<br>technique and animal study results of the SLT Venous Conical and Flat<br>Fiber Delivery Systems are the same or very similar to those of the legally<br>marketed fiber delivery system in the Diomed 810 Surgical Lasers and<br>EVLT™ Procedure Kit (K012398), to the legally marketed Ceralas D10-60<br>810nm Diode Laser System and ELVS Procedure Kit (K020835), and to the<br>legally marketed Ceralas D Diode 980nm Laser System (K013691). |
| | The intended use, method of tissue interaction (thermal), clinical technique<br>and animal study results of the SLT Venous Diffuser Fiber Delivery System<br>is the same or very similar to those of the legally marketed VNUS®<br>Closure™ System (K003092, K982816, K974521). |
| | The intended use, method of tissue interaction (thermal), clinical technique<br>and animal study results of the SLT Venous Flat Fiber Delivery System is<br>the same or very similar to those of the legally marketed Ceralas D Diode<br>980nm Laser System (K013691). |
| Safety and<br>Effectiveness: | Animal studies have demonstrated the substantially equivalent safe and<br>effective performance of the SLT Venous Conical and Flat Fiber Delivery<br>Systems with the legally marketed fiber delivery system in the Diomed 810<br>Surgical Lasers and EVLT™ Procedure Kit (K012398) to the legally<br>marketed Ceralas D10-60 810nm Diode Laser System and ELVS Procedure<br>Kit (K020835), and to the legally marketed Ceralas D Diode 980nm Laser<br>System (K013691). |
| | Animal studies have demonstrated the substantially equivalent safe and<br>effective performance of the SLT Venous Flat Fiber Delivery System with<br>the legally marketed VNUS® Closure™ System (K003092, K982816,<br>K974521). |
| | The intended use, method of tissue interaction (thermal), clinical technique<br>and animal study results of the SLT Venous Flat Fiber Delivery System is<br>the same or very similar to those of the legally marketed legally marketed<br>Ceralas D Diode 980nm Laser System (K013691). |
| | The materials used in the SLT Venous Fiber Delivery Systems are<br>biocompatible. |
| | Toxological testing and evaluation per both USP Class VI and ISO 10993-1,<br>including hemocompatibility testing per ISO 10993-4, were successfully<br>performed. |
| Conclusion: | Based on the foregoing, Surgical Laser Technologies, Inc., believes that the<br>SLT Venous Fiber Delivery Systems are substantially equivalent to and as<br>safe and effective as the legally marketed fiber delivery system in the<br>Diomed 810 Surgical Lasers and EVLT™ Procedure Kit (K012398), the<br>legally marketed VNUS® Closure™ System (K003092, K982816,<br>K974521), the legally marketed Ceralas D10-60 810nm Diode Laser System<br>and ELVS Procedure Kit (K020835), and the Ceralas D Diode 980nm Laser<br>System (K013691). |

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 7 2003

Surgical Laser Technologies, Inc. Davis Woodward Vice President, CFO 147 Keystone Drive Montgomervville, Pennsylvania 18936

Re: K023624

Trade/Device Name: SLT Venous Fiber Delivery Systems Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic Surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: October 25, 2002 Received: October 29, 2002

Dear Mr. Woodward:

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

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Page 2 - Mr. Davis Woodward

(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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]. 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours.

Miriam C. Provost

for 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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## 5. STATEMENT OF INDICATIONS FOR USE

| Applicant: | Surgical Laser Technologies, Inc.<br>147 Keystone Drive<br>Montgomeryville, PA, 18936<br>Establishment registration number: 2523356 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number (if known): | K023624 |
| Device Name: | SLT Venous Fiber Delivery Systems |
| Indications for Use: | The SLT Venous Fiber is intended for use in endovascular coagulation of the greater saphenou vein of the thigh in patients with superficial vein reflux. |

(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 _________________________________________________________________________________________________________________________________________________________

saphenous

Miriam C. Provost

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

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