ACCU-PULSE 1000 CO2 SURGICAL LASER SYSTEM

K983543 · Argus Photonics Group · GEX · Dec 16, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K983543
• Device Name: ACCU-PULSE 1000 CO2 SURGICAL LASER SYSTEM
• Applicant: Argus Photonics Group
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For use in cutting, vaporizing and coagulating soft tissue for clinical applications in dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology, arthroscopy, open & endoscopic general surgery.

Device Story

Accu-Pulse 1000 is a DC-excited gas-slab pulsed CO2 surgical laser; produces 1-15 watts average power; operates at 9.6 or 10.6 microns wavelength. Device utilizes microprocessor-based control system with self-diagnosis capabilities. Used by clinicians in clinical settings (dermatology, plastic surgery, podiatry, neurosurgery, gynecology, ENT, arthroscopy, general surgery) to perform soft tissue cutting, vaporization, and coagulation. System includes 633 nm aiming beam. Clinician operates device to deliver laser energy to target tissue; output affects tissue via thermal ablation/coagulation. Benefits include precise soft tissue management during surgical procedures.

Clinical Evidence

No clinical data. Performance data were not required as the device is substantially equivalent to the predicate.

Technological Characteristics

DC-excited gas-slab CO2 laser; 1-15W average power; 9.6 or 10.6 micron wavelength; TEM 00 mode; 250 micron-3mm spot size; 1-20 Hz repetition rate; 633 nm aiming beam; microprocessor control with self-diagnosis.

Indications for Use

Indicated for cutting, vaporizing, and coagulating soft tissue in dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology, arthroscopy, and open/endoscopic general surgery.

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

• Accu-Pulse pulsed CO2 laser (K971830)

Reference Devices

• Tissue Technologies Tru-Pulse

Submission Summary (Full Text)

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983543

### 510 (k) SUMMARY ACCU-PULSE 1000 CO2 SURGICAL LASER SYSTEM

This 510 (k) summary of safety and effectiveness for the Accu-Pulse 1000 CO2 Surgical Laser System is submitted in accordance with the requirements set forth in SMDA 1990 and following guidance concerning the organization and content of a 510 (k) summary.

| Applicant: | Argus Photonics Group, Inc. |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 759 Parkway Street, Suite 102<br>Jupiter, Florida 33477 |
| Contact Person: | Kevin Dickenson, Vice President |
| Telephone: | [phone]<br>[phone] (fax) |
| Preparation Date: | 9/30/98 |
| Device Trade Name: | Accu-Pulse 1000 Surgical Laser System |
| Common Name: | CO2 laser, Pulsed CO2 Surgical Laser |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery and in<br>dermatology (see 21 CFR 878.4810) |
| Legally Marketed<br>Predicate Device: | Accu-Pulse pulsed CO2 laser manufactured by Argus<br>Photonics Group, Inc. |
| Description of the<br>Accu-Pulse 1000 CO2<br>Laser: | Accu-Pulse 1000 is a DC excited gas-slab pulsed CO2 laser which<br>produces 1-15 watts average power (see below for additional Surgical<br>specifications). |
| Intended Use of the<br>Accu-Pulse 1000 CO2 laser: | The intended use is the same or similar to that of the Accu-Pulse<br>pulsed CO2 laser marketed by Argus Photonics, Inc., i.e:<br>"For use in cutting, vaporizing and coagulating soft tissue for clinical<br>applications in dermatology, plastic surgery, podiatry, neurosurgery,<br>gynecology, otorhinolaryngology, arthroscopy, open & endoscopic<br>general surgery". |

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# Argus Photonics Group 510 (k) Summary
9/30/98

# Table of Substantial Equivalence

| FEATURE | Tissue Technologies<br>Tru-Pulse | Argus Photonics<br>Accu-Pulse | Argus Photonics<br>Accu-Pulse 1000 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Power | 1- 10 Watts | 1-15 Watts | 1-15 Watts |
| Wavelength | 10.6 microns | 10.6 microns | 9.6 or 10.6 microns |
| Indications for Use | Coagulation,<br>vaporization,<br>ablation of or cutting<br>of soft tissue in<br>dermatology, plastic<br>surgery, podiatry and<br>otorhinolaryngology | Coagulation,<br>vaporization,<br>ablation of or cutting<br>of soft tissue in<br>dermatology, plastic<br>surgery, podiatry and<br>otorhinolaryngology | Coagulation,<br>vaporization, ablation<br>of or cutting of soft<br>tissue in dermatology,<br>plastic surgery,<br>podiatry and<br>otorhinolaryngology |
| Laser Type | DC slab excited | DC slab excited | DC slab excited |
| Spot Size | 1,3,5mm | 3mm, 5mm & 7mm | 250 microns-3mm |
| Average Power | 1-10 Watts | 1-15 Watts | 1-15 Watts |
| Mode | Multi-mode | Multi-mode | TEM 00 |
| Exposure Duration | < 250 us | 4 us | 4-10 ps |
| Control System | Microprocessor, self<br>diagnosis | Microprocessor, self<br>diagnosis | Microprocessor, self<br>diagnosis |
| Repetition Rate | 1-20 Hz | 0.5-5Hz | 1-20 Hz |
| Aiming Beam | 633 nanometer | 633 nanometer | 633 nanometer |
| Excitation | DC excited | DC excited | DC excited |
| | | | |

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Argus Photonics Group 510 (k) Summary 9/30/98

None. The specifications and intended use of the Accu-Pulse 1000 Performance Data: Surgical Laser System are the same or very similar to those of the Accu-Pulse pulsed CO2 laser. Because of this, performance data were not required. Argus Photonics Group, Inc., has implemented a Software Software Validation: Development Procedure outlined in the following pages. This software will be verified and validated by programmers as each element is added to the program. In addition, the software will be challenged by intentional breaches or breaks in interlocks and / or input parameters. Argus Photonics Group certifies that software validation will occur prior to the sale of the Accu-Pulse 1000 laser system described herein. Based on the foregoing, Argus Photonics Group, Inc., believes that Conclusion: the Accu-Pulse 1000 CO2 Surgical Laser System is substantially equivalent to a legally marketed predicate device, i.e. the Accu-Pulse Pulsed Surgical Laser as marketed by Argus Photonics Group, Inc., (K971830).

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three horizontal lines representing its wings. The eagle appears to be in flight or soaring upwards.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 16 1998

Mr. Kevin Dickenson Vice President Argus Photonics Group, Incorporated 759 Parkway Street, Suite 102 Jupiter, Florida 33477

Re: K983543 Trade Name: Accu-Pulse 1000 Surgical Laser System Regulatory Class: II Product Code: GEX Dated: September 30, 1998 Received: October 9, 1998

Dear Mr. Dickenson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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#### Page 2 - Mr. Kevin Dickenson

This letter will allow you to begin marketing your device as described in your 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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K983143

## INDICATIONS FOR USE

For use in cutting, vaporizing and coagulating soft tissue for clinical in dermatology, plastic surgery, podiatry, neurosurgery, applications gynecology, otorhinolaryngology, arthroscopy, open & endoscopic general surgery.

Prescription Use
(Per 21 CFR 801.109)

Pcoole

(Division Sign-Off) (Division of General Restorative Devices | | 9 8 3 SYS 510(k) Number