INDIGO OPTIMA LASER SYSTEM, OPTIMA DIFFUSER-TIP FIBEROPTIC-BPH, OPTIMA BARE-TIP FIBEROPTIC,OPTIMA LASER CART WITH PRINTS

K023182 · Ethicon Endo-Surgery, Inc. · GEX · Oct 24, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K023182
• Device Name: INDIGO OPTIMA LASER SYSTEM, OPTIMA DIFFUSER-TIP FIBEROPTIC-BPH, OPTIMA BARE-TIP FIBEROPTIC,OPTIMA LASER CART WITH PRINTS
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 24, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Indigo OPTIMA Laser System when used with the Diffuser-Tip Fiberoptic is intended for the safe and effective treatment of symptoms of benign prostatic hyperplasia (BPH).

Device Story

The Indigo OPTIMA Laser System is a diode laser surgical instrument delivering 800-850 nm wavelengths. It utilizes fiberoptic delivery devices (Diffuser-Tip or Bare-Tip) to perform interstitial thermotherapy (ITT), interstitial laser coagulation (ILC), or tissue incision/ablation. The system includes a treatment laser, footswitch, and optional cart with printer. Used in clinical settings by physicians for urological, gynecological, and gastroenterological procedures. The device provides controlled laser energy doses to target tissues, facilitating coagulative necrosis or hemostatic tissue removal. Modifications to the Diffuser-Tip Fiberoptic include removal of an inner sleeve, updated non-patient-contacting adhesive, and software adjustments to accommodate design changes. The system is intended to alleviate symptoms of BPH and manage various soft tissue conditions.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by design verification and validation testing confirming the modified fiberoptic performs as intended.

Technological Characteristics

Diode laser system (800-850 nm); fiberoptic energy delivery (Diffuser-Tip or Bare-Tip); sterile, single-use disposable fibers; footswitch-operated; optional cart/printer. Modifications include removal of fiber inner sleeve and use of new non-patient-contacting adhesive. Software modified to accommodate hardware changes. Class II device (21 CFR 878.4810).

Indications for Use

Indicated for treatment of urinary outflow obstruction secondary to BPH in men >50 years with prostate volumes 20-85 cc (median/lateral lobes); general surgery, urological, gynecological, and gastroenterological procedures; coagulative necrosis and interstitial laser coagulation of soft tissues (tumors, fibroids). With Bare-Tip Fiberoptic: incision, excision, ablation, or coagulation of tissues with hemostasis in general surgery, gastroenterological, and urological procedures (urethral strictures, bladder neck contractures, condylomata).

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

• Indigo® OPTIMA Laser System (K013493)

Submission Summary (Full Text)

{0}------------------------------------------------

OCT 2 4 2002

K 023182

Ethicon Endo-Surgery, Inc. Special 510(k) Premarket Notification for Índigo® OPTIMA Laser System

# Índigo® OPTIMA Laser System 510(k) Summary of Safety & Effectiveness

#### Company

Contact Carol Sprinkle Regulatory Affairs Specialist

Ethicon Endo-Surgery, Inc. 4545 Creek Rd. Cincinnati, OH 45242

## Date Prepared

September 23, 2002

#### Name of Device

Trade Name: Índigo® OPTIMA Laser System Classification Name: Laser powered surgical instrument

#### Predicate Device

İndigo® OPTIMA Laser System (K013493)

#### Device Description

The Indigo® OPTIMA Laser System consists of a treatment diode laser, fiberoptic energy delivery devices, a footswitch, and an optional cart with printer. The treatment laser allows delivery of controlled doses of laser energy in wavelengths between 800 and 850 nanometers (nm). When used with the OPTIMA Diffuser-Tip Fiberoptic, this laser energy is diffused radially at 360° to the affected tissue to provide interstitial thermotherapy (ITT), or interstitial laser coagulation (ILC). The fiberoptics (fibers) are designed to be sterile, single patient use, disposable devices.

Modifications to design of the Diffuser-Tip Fiberoptic have been made to improve manufacturability. Changes include removal of the inner sleeve, use of a new non patient-contacting adhesive, and a software modification.

#### Intended Use

The Indigo OPTIMA Laser System when used with the Diffuser-Tip Fiberoptic is intended for the safe and effective treatment of symptoms of benign prostatic hyperplasia (BPH).

### Comparison of Technological Characteristics

The technological features of the modified Diffuser-Tip Fiberoptic are the same as the predicate with exception of the above design changes. The operating parameters of the laser have been adjusted slightly to accommodate the design changes with no loss in performance. No new issues of safety and effectiveness have been raised by these modifications.

#### Performance Data

Design verification and validation testing confirms the modified Diffuser-Tip Fiberoptic performs as intended and is equivalent to the predicate.

{1}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle, with three curved lines forming its body and wings. The eagle faces to the left. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Carol Sprinkle Regulatory Affairs Specialist Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242

Re: K023182

Trade/Device Name: Indigo® OPTIMA Laser System Regulation Number: 21 CFR 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: September 23, 2002 Received: September 24, 2002

Dear Ms. Sprinkle:

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.

{2}------------------------------------------------

Page 2 - Ms. Carol Sprinkle

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,

Miriam C. Provost

fel 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

{3}------------------------------------------------

Page __ of

510(k) Number (if known): K023182

Device Name: Índigo® OPTIMA Laser System

Indications for Use:

The Índigo OPTIMA Laser System with Diffuser-Tip Fiberoptic is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostates with median and/or Jateral lobes ranging in total volume from 20-85 cc; and for general surgery, general urological, general gynecological and general gastroenterological procedures; and coagulative necrosis and interstitial laser coagulation of soft tissues such as tumors and fibroids.

The Indigo OPTIMA Laser System, when used in conjunction with the Bare-Tip Fiberoptic, is indicated for the incision, excision, and ablation or coagulation of tissues with hemostasis during general surgery, and general gastroenterological and urological procedures, including those involving urethral strictures, bladder neck contractures, and condylomata.

Miriam C. Provost

eral. Restorative

510(k) Number Ko23182

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Prescription use