ACCU-PULSE CARBON DIOXIDE LASER SYSTEM

K971830 · Argus Photonics Group · GEX · Aug 14, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K971830
• Device Name: ACCU-PULSE CARBON DIOXIDE LASER SYSTEM
• Applicant: Argus Photonics Group
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use is the same or similar to that of the Tru-Pulse pulsed CO2 laser marketed by Tissue Technologies, Inc., i.e: "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 is a DC-excited gas-slab pulsed CO2 laser system; produces 1-15 watts average power at 10.6 microns wavelength. Used by clinicians in dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology, and general surgery for soft tissue cutting, vaporization, and coagulation. System includes a microprocessor for control and self-diagnosis; features a 633 nm aiming beam. Clinician operates the laser to deliver energy to target tissue; output affects tissue via thermal ablation/coagulation. Benefits include precise tissue management during surgical procedures.

Clinical Evidence

No clinical data. Substantial equivalence is based on technical specifications and intended use similarity to the predicate device.

Technological Characteristics

DC-excited gas-slab CO2 laser; 10.6 micron wavelength; 1-15W average power; 1-5Hz repetition rate; <250 μs exposure duration; 3mm, 5mm, 7mm spot sizes; 633nm aiming beam; microprocessor-based control system 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

• Tru-Pulse pulsed CO2 laser (K952049)

Reference Devices

• Coherent UltraPulse

Submission Summary (Full Text)

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AUG | 4 |997

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

This 510 (k) summary of safety and effectiveness for the Accu-Pulse 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 Jupiter, Florida 33477 |
| Contact Person: | Kevin Dickenson, Vice President |
| Telephone: | [phone] [phone] (fax) |
| Preparation Date: | 5/14/97 |
| Device Trade Name: | Accu-Pulse 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 dermatology (see 21 CFR 878.4810) |
| Legally Marketed Predicate Device: | <i>Tru-Pulse</i> ^TM pulsed CO2 laser manufactured by Tissue Technologies, Inc. |
| Description of the Accu-Pulse CO2 Laser: | <i>Accu-Pulse</i> is a DC excited gas-slab pulsed CO2 laser which produces 1-15 watts average power (see below for additional Surgical specifications). |
| Intended Use of the Accu-Pulse CO2 laser: | The intended use is the same or similar to that of the <i>Tru-Pulse</i> pulsed CO2 laser marketed by Tissue Technologies, Inc., i.e: "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". |

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Argus Photonics Group 510 (k) Summary 5/14/97

## Table of Substantial Equivalence

| FEATURE | Coherent<br>UltraPulse | Tissue Technologies<br>Tru-Pulse | Argus Photonics<br>Accu-Pulse |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Power | 2-120 Watts | 1-10 Watts | 1-15 Watts |
| Wavelength | 10.6 microns | 10.6 microns | 10.6 microns |
| Energy Density at Tissue | 5J/cm² | 5J/cm² | 5J/cm² |
| 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, ablation<br>of or cutting of soft<br>tissue in dermatology,<br>plastic surgery,<br>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 | RF slab excited | DC slab excited | DC slab excited |
| Spot Size | 3mm-2 cm | 1,3, 5mm | 3mm, 5mm & 7mm |
| Average Power | 1-100 Watts | 1-10 Watts | 1-15 Watts |
| Mode | TEM 00 | Multi-mode | Multi-mode |
| Exposure Duration | < 950 μs | < 250 μs | <250 μs |
| Control System | Microprocessor, self<br>diagnosis | Microprocessor, self<br>diagnosis | Microprocessor, self<br>diagnosis |
| Repetition Rate | 1Hz- continuous | 1-20 Hz | 1-5 Hz |
| Aiming Beam | 633 nanometer | 633 nanometer | 633 nanometer |
| Excitation | RF excited | DC excited | DC excited |

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Argus Photonics Group 510 (k) Summary 5/14/97

| Performance Data: | None. The specifications and intended use of the Accu-Pulse<br>Surgical Laser System are the same or very similar to those of the<br>Tru-Pulse™ pulsed CO2 laser. Because of this, performance data<br>were not required. |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Software Validation: | Argus Photonics Group, Inc., has implemented a Software<br>Development Procedure outlined in the following pages. This<br>software will be verified and validated by programmers as each<br>element is added to the program. In addition, the software will be<br>challenged by intentional breaches or breaks in interlocks and / or<br>input parameters. Argus Photonics Group certifies that software<br>validation will occur prior to the sale of the Accu-Pulse laser system<br>described herein. |
| Conclusion: | Based on the foregoing, Argus Photonics Group, Inc., believes that<br>the Accu-Pulse CO2 Surgical Laser System is substantially equivalent<br>to a legally marketed predicate device, I.e. the Tru-Pulse™ Pulsed<br>Surgical Laser as marketed by Tissue Technologies, Inc., (K952049). |

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a series of human profiles, rendered in black. The overall design is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

AUG 1 4 1997

Re: K971830

> Trade Name: Accu-Pulse Carbon Dioxide Laser System Regulatory Class: II Product Code: GEX Dated: May 14, 1997 Received: May 16, 1997

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 requirements , 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 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 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,

Sincerely yours,

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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971830

## INDICATIONS FOR 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 surger y

Prescription Use
(Per 21 CFR 801.109)

Acòèè

10971830