K Number
K971830
Device Name
ACCU-PULSE CARBON DIOXIDE LASER SYSTEM
Date Cleared
1997-08-14

(90 days)

Product Code
Regulation Number
878.4810
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 surger y
Device Description
Accu-Pulse is a DC excited gas-slab pulsed CO2 laser which produces 1-15 watts average power (see below for additional Surgical specifications).
More Information

Not Found

No
The summary describes a CO2 laser device and does not mention any AI or ML capabilities, image processing, or data sets typically associated with AI/ML development.

No
The device, Accu-Pulse, is described as a surgical laser system for cutting, vaporizing, and coagulating tissue, which performs surgical procedures rather than providing therapy.

No
Explanation: The device is described as a surgical laser used for cutting, vaporizing, and coagulating soft tissue, which are therapeutic actions, not diagnostic ones.

No

The device description explicitly states it is a "DC excited gas-slab pulsed CO2 laser," which is a hardware device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states it's for "cutting, vaporizing and coagulating soft tissue for clinical applications" in various surgical specialties. This describes a device used on the patient's body for treatment, not a device used to test samples from the patient's body in a lab setting.
  • Device Description: The description of a "pulsed CO2 laser" further reinforces its function as a surgical tool for tissue manipulation.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely different.

N/A

Intended Use / 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 surgery"

Product codes (comma separated list FDA assigned to the subject device)

GEX

Device Description

Accu-Pulse is a DC excited gas-slab pulsed CO2 laser which produces 1-15 watts average power.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Soft tissue

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

None. The specifications and intended use of the Accu-Pulse Surgical Laser System are the same or very similar to those of the Tru-Pulse™ pulsed CO2 laser. Because of this, performance data were not required.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Tru-Pulse™ Pulsed Surgical Laser as marketed by Tissue Technologies, Inc., (K952049)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

0

Image /page/0/Picture/0 description: The image shows the logo for Argus photonics group. The logo consists of a black diamond shape with two white curved lines intersecting it. Below the diamond shape, the word "ARGUS" is written in a bold, sans-serif font. Below "ARGUS" is the text "photonics group" in a smaller, sans-serif font.

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:(561) 748-8151 (561) 748-8157 (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:Tru-Pulse TM pulsed CO2 laser manufactured by Tissue Technologies, Inc.
Description of the Accu-Pulse CO2 Laser:Accu-Pulse 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 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".

1

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

Table of Substantial Equivalence

| FEATURE | Coherent
UltraPulse | Tissue Technologies
Tru-Pulse | Argus Photonics
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,
vaporization,
ablation of or cutting
of soft tissue in
dermatology, plastic
surgery, podiatry and
otorhinolaryngology | Coagulation,
vaporization, ablation
of or cutting of soft
tissue in dermatology,
plastic surgery,
podiatry and
otorhinolaryngology | Coagulation,
vaporization, ablation
of or cutting of soft
tissue in dermatology,
plastic surgery,
podiatry and
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 | 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.

4

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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

5

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