ECLIPSE 2000

K961560 · Cardiogenes · GEX · Jan 27, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K961560
• Device Name: ECLIPSE 2000
• Applicant: Cardiogenes
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Eclipse 2000™ is intended for use in general surgery, including thoracic and abdominal surgeries. This includes the incision, excision, vaporization or coagulation of soft tissue and firm cartilage: - cholecystectomy - lysis of adhesions - herniorrhaphy - sessile polyps of the intestine and colon - hemorrhoidectomy - condyloma - appendectomy

Device Story

Eclipse Model 2000™ is a holmium laser system for general surgery. Input: electrical power; Output: laser energy delivered via disposable fiber optic delivery systems. Operation: physician-controlled via keyswitch, power thumbwheel, and foot pedal. Used in OR by trained physicians/staff. Laser energy performs incision, excision, vaporization, or coagulation of soft tissue/cartilage. Clinical decision-making relies on physician visual/tactile feedback during contact delivery. Benefits: precise tissue management in thoracic/abdominal procedures.

Clinical Evidence

No clinical data provided; device relies on established holmium laser technology for surgical applications.

Technological Characteristics

Holmium laser system; energy delivered via disposable fiber optic delivery systems; features security keyswitch, power thumbwheel adjustment, and foot pedal activation; requires protective eyewear for holmium wavelength.

Indications for Use

Indicated for patients requiring incision, excision, vaporization, or coagulation of soft tissue and firm cartilage during general, thoracic, or abdominal surgical procedures. No specific age or gender restrictions; contraindications include obscured operating fields and non-observability of target tissue.

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.

Submission Summary (Full Text)

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JAN 27 1997
Eclipse Surgical Technologies, Inc.
510(k) Notification of Modification
K961560
Page D1

# APPENDIX D - SUMMARY OF SAFETY AND EFFECTIVENESS

## Summary of Safety and Effectiveness for the Eclipse Model 2000™

## Intended Use

The Eclipse 2000™ is intended for use in general surgery, including thoracic and abdominal surgeries. This includes the incision, excision, vaporization or coagulation of soft tissue and firm cartilage:

- cholecystectomy
- lysis of adhesions
- herniorrhaphy
- sessile polyps of the intestine and colon
- hemorrhoidectomy
- condyloma
- appendectomy

## Description of Device and Method of Operation

The Eclipse Model 2000™ laser system is designed to be easy to operate and user-friendly. It features a security keyswitch and simple one-button start-up. Energy output is controlled by the Power thumbwheel adjustment. Energy is delivered through the Eclipse delivery system only when:

1) the laser is in Ready mode,
2) the Foot Pedal is depressed, and
3) the delivery system is properly installed in the laser aperture.

A variety of disposable fiber optic delivery systems in a range of sizes, designs and configurations is available from Eclipse. A fiber optic delivery system must be used to delivery laser energy to the treatment site.

## Safety Information

Prior to turning the laser system on, all persons in the operating room, including the patient, should be wearing protective eyewear suitable for holmium laser energy

IT IS ESSENTIAL THAT THE PHYSICIAN AND ATTENDING STAFF BE TRAINED IN ALL ASPECTS OF THE LASER PROCEDURE. NO PHYSICIAN SHOULD USE THESE LASER PRODUCTS FOR THE ABOVE STATED INDICATIONS WITHOUT FIRST OBTAINING DETAILED INSTRUCTIONS IN LASER USE

CONFIDENTIAL information of Eclipse Surgical Technologies, Inc.

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Eclipse Surgical Technologies, Inc.
510(k) Notification of Modification
Page D2

Precautions such as careful assessment of the target and surrounding tissue during treatment and use of appropriate power and pulse duration should be taken.

Tissue perforation can occur if excessive laser energy is applied, whether through the use of excessive laser power or the application of power for excessive periods of time.

Use the laser only on tissues that are fully observable. Do not use the laser if the desired operating field is obscured.

Aim the laser beam only at tissues intended for treatment otherwise damage to surrounding tissues may result.

Flash fires can occur. Nonflammable anesthetics should be used. It is recommended that oxygen levels in the direct operative area be below 30%.

No clinical information or experience concerning the use of holmium laser systems on pregnant women or nursing mothers is available.

Patients who experience discomfort during laser treatment may require analgesics.

There is no guarantee that treatment with the holmium laser will entirely eliminate the disease entity. Repeat treatment or alternative therapies may be subsequently required.

Alterations in surgical approach or technique may be required to accommodate laser use.

Physicians should be thoroughly trained and proficient in all aspects of arthroscopic, endoscopic, or fluoroscopic surgery prior to using the laser through an arthroscope, endoscope, or fluoroscope, keeping in mind that depth of perception through these devices is distorted. The physician must learn to rely on both the visual and tactile feedback of the contact delivery system.

Any clinical use of a holmium laser system not in accordance with indications for use included in the system labeling, unless specifically exempt, is subject to the provisions of 21 CFR Part 812, the Food and Drug Administration's investigational device exemption (IDE) regulations.

CONFIDENTIAL information of Eclipse Surgical Technologies, Inc.