(68 days)
Not Found
No
The summary describes a CO2 laser for surgical applications and does not mention any AI or ML components or functionalities.
Yes
The device is intended for clinical applications such as cutting, vaporizing, and coagulating soft tissue in various medical specialties, which are therapeutic procedures.
No
The device is described as a surgical laser for cutting, vaporizing, and coagulating soft tissue, which are therapeutic actions, not diagnostic ones.
No
The device description clearly 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 the device is for "cutting, vaporizing and coagulating soft tissue for clinical applications" in various surgical specialties. This describes a surgical tool used directly on the patient's body.
- Device Description: The description details a "pulsed CO2 laser" which is a type of surgical instrument.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to diagnose diseases or conditions. This device is a surgical laser used for treatment and manipulation of tissue in vivo.
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
GEX
Device Description
Accu-Pulse 1000 is a DC excited gas-slab pulsed CO2 laser which produces 1-15 watts average power (see below for additional Surgical specifications).
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 date "DEC 16 1998" in the upper left corner. Below the date is a logo with two overlapping ellipses surrounding a diamond shape. Underneath the logo, the text "ARGUS photonics group" is displayed. To the right of the logo is the handwritten text "K983".
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 |
| Jupiter, Florida 33477 | |
| Contact Person: | Kevin Dickenson, Vice President |
| Telephone: | (561) 748-8151 |
| (561) 748-8157 (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 |
| dermatology (see 21 CFR 878.4810) | |
| Legally Marketed | |
| Predicate Device: | Accu-Pulse pulsed CO2 laser manufactured by Argus |
| Photonics Group, Inc. | |
| Description of the | |
| Accu-Pulse 1000 CO2 | |
| Laser: | Accu-Pulse 1000 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 1000 CO2 laser: | The intended use is the same or similar to that of the Accu-Pulse |
| pulsed CO2 laser marketed by Argus Photonics, 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
9/30/98
Table of Substantial Equivalence
| FEATURE | Tissue Technologies
Tru-Pulse | Argus Photonics
Accu-Pulse | Argus Photonics
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,
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 | 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 |