(183 days)
Not Found
Not Found
No
The device description details a laser system with standard controls and a microprocessor for basic functions like power adjustment and pulsing. There is no mention of AI/ML capabilities for image processing, data analysis, or adaptive control.
Yes
Explanation: The device is described as a surgical diode laser system intended for incision, excision, coagulation, and vaporization in various surgical specialties, which are all therapeutic applications.
No
The device is described as a surgical diode laser system for incision, excision, coagulation, and vaporization, which are therapeutic applications, not diagnostic ones.
No
The device is a surgical diode laser system, which is a hardware device that delivers optical power for surgical procedures. While it includes microprocessor control and software for operation, it is fundamentally a physical medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states surgical applications like incision, excision, coagulation, and vaporization in various surgical specialties. This involves direct interaction with the patient's body for therapeutic purposes.
- Device Description: The description details a surgical laser system that delivers optical power for tissue modification.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) outside of the body to provide diagnostic information. IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
The device is a surgical laser system used for therapeutic procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The AOC Phase II 25 surgical diode laser system has the same general intended use as the predicate diode lasers. This intended use includes incision, excision, coagulation and vaporization applications in the following surgical specialties:
Urology Gynecology Gastroenterology Pulmonology General and Thoracic Surgery Neurosurgery (hemostasis) Ear, Nose, and Throat; Head/Neck Surgery Dermatology/Plastic Surgery
No new intended use was sought in this Premarket Notification.
The wavelength (980 nm) and tissue effects of the AOC Phase II 25 diode laser are closely matched to the predicate lasers at 805-830 and 980 nm. The 980 nm wavelength absorption in tissue is less dependent on variations in tissue pigment or vascularity than at 805 nm and has a slightly higher water absorption than the 1064 nm wavelength. Other predicate 980 nm diode laser systems have been found substantially equivalent to Nd:YAG and 805 nm diode lasers.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The AOC Medical Systems Model Phase II 25 Fiber-Coupled Diode Laser System delivers up to 25 watts of CW optical power from a compact, air cooled unit. It is a complete, self-contained instrument, including a high efficiency power supply, an adjustable light output with constant current operation and a visible aiming laser. The system couples the laser light into high numerical aperture delivery fibers fitted with standard SMA-905 fiber connectors.
The diode lasers in this unit were fabricated by Applied Optronics Corp. from single quantum well, strained-layer, indium gallium aluminum on gallium arsenide semiconductor material. The diode lasers are sealed in a rugged, factory-aligned, environmentally protective module. High electrical efficiency of the diode lasers eliminate the need for water cooling and assure low maintenance, reliable laser operation for this allsolid-state system. Each individual diode laser emits at a narrow wavelength; however coupling several diodes through a fiber optic bundle results in each diode wavelength contributing to a broader spectrum emitted form the final delivery fiber. The laser energy is centered at 980nm with a total range from approximately 970-1000nm.
The AOC Phase II 25 has a modular design comprised of:
Laser Diode and Cooling Module containing the laser diodes, the heat sink and fans.
Optics Module containing a beamsplitter pick-off for display of the total optical power.
Front panel for simple control of the unit.
Transformer isolated power supplies and control electronics.
Unique attributes of this system include the following:
Multiple, individually fiber-coupled, high power diode lasers mounted on a large thermal footprint to allow sustained high power CW operation without water cooling.
Optical power level continuously adjustable from the front panel, with display of optical output power.
Low power, visible aiming laser for beam targeting prior to activation of the high power lasers. The aiming laser is controlled independently of the high power lasers.
Immediate turn-on capability. No warm-up period. No system alignments or maintenance to be made by the user.
Forced air cooling (no water). Maximum inlet air temperature 30° C.
Individually replaceable, fiber pigtailed diode lasers. Repairs performed at factory.
The microprocessor controlled AOC Phase II 25 diode laser system is designed to allow easy and safe operation of the laser using controls common to other surgical laser systems. The laser system utilizes a menu driven set-up operation for user prompts and program entry. The laser can be set for continuous output or programmed for single or repeat pulses at output powers up to 25 watts. A footswitch or handswitch, activated by the user, always controls laser output. An optional remote control for use in a sterile plastic dressing (e.g., standard OR microscope drape) allows the user to change the power and activate Ready and Standby Modes.
The following pre-packaged, presterilzed disposable optical fibers are available for use with the AOC Phase II 25 laser system:
| Fiber Model | Type |
|---|---|
| AOC DCLF-600 | 600um Conical tip |
| AOC DCLF-1000 | 1000um Conical tip |
| AOC DCLF-600B | 600um Hemispherical Ball tip |
| AOC DCLF-1000B | 1000um Hemispherical Ball tip |
| AOC DBLF-60S | 600um Side firing |
| AOC DBLF-100S | 1000um Side firing |
| AOC DBLF-60SF | 600um Scatter Free Side firing |
| AOC DBLF-60 | 600um Free Beam |
| AOC Neos | Conical (conical shaped) |
| AOC Neos | Delta (wedge shaped) Handpiece, Laparoscopic and Bare Fiber |
| AOC HSD | Conical shaped with electrode |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified physicians
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)
No clinical test data was submitted in support of this submission. Peer reviewed clinical articles on the tissue interaction at 980 nm were included in the 510 (k). Bench test data was submitted demonstrating that the design is able to produce the rated power and wavelength.
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.
Not Found
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
APPLIED OPTRONICS CORP.
K 961710
1 1 1 Corporate Blvd. • Building J • South Plainfield, NJ 07080 TEL (908) 753-6300 · FAX (908) 753-4041
NOV - I 1996
SECTION K
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitter Information 1.
AOC Medical Systems A Division of Applied Optronics Corporation 111 Corporate Blvd. Building J South Plainfield, NJ 07080 Telephone: (908) 753-6300 Fax: (908) 753-4041 Contact Person: Douglass Mead Regulatory Affairs Date Prepared: April 30, 1996
Model AOC Phase II 25 Surgical Diode Laser 2.
Predicate or Legally Marketed Devices: 3.
| Manufacturer | Model | Laser Type |
|---|---|---|
| AOC Medical Sys. | AOC 25 | 980 nm Diode Laser |
| Cynosure | Phototome | 980 nm Diode Laser |
| Cytocare | DioLase HP-1 | 980 nm Diode Laser |
| DioMed | DioMed 25 | 810 nm Diode Laser |
| Indigo Medical | IDE 830E | 830 nm Diode Laser |
| Sharplan Lasers | 6020 | 810 nm Diode Laser |
General System Description 4.
The AOC Medical Systems Model Phase II 25 Fiber-Coupled Diode Laser System delivers up to 25 watts of CW optical power from a compact, air cooled unit. It is a complete, self-contained instrument, including a high efficiency power supply, an adjustable light output with constant current operation and a visible aiming laser. The system couples the laser light into high numerical aperture delivery fibers fitted with standard SMA-905 fiber connectors.
The diode lasers in this unit were fabricated by Applied Optronics Corp. from single quantum well, strained-layer, indium gallium aluminum on gallium arsenide semiconductor material. The diode lasers are sealed in
1
a rugged, factory-aligned, environmentally protective module. High electrical efficiency of the diode lasers eliminate the need for water cooling and assure low maintenance, reliable laser operation for this allsolid-state system. Each individual diode laser emits at a narrow wavelength; however coupling several diodes through a fiber optic bundle results in each diode wavelength contributing to a broader spectrum emitted form the final delivery fiber. The laser energy is centered at 980nm with a total range from approximately 970-1000nm.
The AOC Phase II 25 has a modular design comprised of:
Laser Diode and Cooling Module containing the laser diodes, the heat sink and fans.
Optics Module containing a beamsplitter pick-off for display of the total optical power.
Front panel for simple control of the unit.
Transformer isolated power supplies and control electronics.
Unique attributes of this system include the following:
Multiple, individually fiber-coupled, high power diode lasers mounted on a large thermal footprint to allow sustained high power CW operation without water cooling.
Optical power level continuously adjustable from the front panel, with display of optical output power.
Low power, visible aiming laser for beam targeting prior to activation of the high power lasers. The aiming laser is controlled independently of the high power lasers.
Immediate turn-on capability. No warm-up period. No system alignments or maintenance to be made by the user.
Forced air cooling (no water). Maximum inlet air temperature 30° C.
Individually replaceable, fiber pigtailed diode lasers. Repairs performed at factory.
The microprocessor controlled AOC Phase II 25 diode laser system is designed to allow easy and safe operation of the laser using controls common to other surgical laser systems. The laser system utilizes a menu driven set-up operation for user prompts and program entry. The laser can be set for continuous output or programmed for single or repeat pulses at output powers up to 25 watts. A footswitch or handswitch, activated by the user, always controls laser output. An optional remote control for use in a sterile plastic dressing (e.g., standard OR microscope drape) allows the user to change the power and activate Ready and Standby Modes.
The following pre-packaged, presterilzed disposable optical fibers are available for use with the AOC Phase II 25 laser system:
2
| Fiber Model | Type |
|---|---|
| AOC DCLF-600 | 600um Conical tip |
| AOC DCLF-1000 | 1000um Conical tip |
| AOC DCLF-600B | 600um Hemispherical Ball tip |
| AOC DCLF-1000B | 1000um Hemispherical Ball tip |
| AOC DBLF-60S | 600um Side firing |
| AOC DBLF-100S | 1000um Side firing |
| AOC DBLF-60SF | 600um Scatter Free Side firing |
| AOC DBLF-60 | 600um Free Beam |
| AOC Neos | Conical (conical shaped) |
| AOC Neos | Delta (wedge shaped) Handpiece, Laparoscopic |
| and Bare Fiber | |
| AOC HSD | Conical shaped with electrode |
Intended Use: 5.
The AOC Phase II 25 surgical diode laser system has the same general intended use as the predicate diode lasers. This intended use includes incision, excision, coagulation and vaporization applications in the following surgical specialties:
Urology Gynecology Gastroenterology Pulmonology General and Thoracic Surgery Neurosurgery (hemostasis) Ear, Nose, and Throat; Head/Neck Surgery Dermatology/Plastic Surgery
No new intended use was sought in this Premarket Notification.
The wavelength (980 nm) and tissue effects of the AOC Phase II 25 diode laser are closely matched to the predicate lasers at 805-830 and 980 nm. The 980 nm wavelength absorption in tissue is less dependent on variations in tissue pigment or vascularity than at 805 nm and has a slightly higher water absorption than the 1064 nm wavelength. Other predicate 980 nm diode laser systems have been found substantially equivalent to Nd:YAG and 805 nm diode lasers.
3
Comparison of Technological Characteristics 6.
The AOC Phase II 25 laser output is at the same nominal wavelength, 980 nanometers as the AOC 25, Cynosure Phototome, and Cytocare DioLase HP-1 lasers. Its laser tissue interactions would be expected to be identical. The same individual diode laser components are supplied Optronics for all four laser systems. The AOC Phase II 25 differs in wavelength from the DioMed 25, Indigo 830 and Sharplan 6020 (at 805 -830 nanometers) which has a slightly greater energy absorption in pigment and blood rich tissue. The 980 nm wavelength, like the Nd:YAG wavelength at 1064 nm, is less dependent on variations in tissue pigment and blood content.
The temporal output of all these systems is the same. These lasers are operated most often in the Continuous Wave (steady state) Mode but can be electronically gated to produce time pulses, single or repeated. The AOC Phase II 25 laser has a Continuous, Single Pulse, Countdown Pulse, Repeat Pulse, and Exponetial Pulse output which are found on one or more of the predicate lasers. Its range of timed outputs are within the ranges of the above cleared products.
The output power of the AOC Phase II 25 is about the same as the power of the Diomed 25, Indigo 830, and Sharplan 6020. For applications using contact fibers with sculpted tips which typically operate below 25 watts, the difference in output is not clinically significant. The lower output power of the AOC Phase II 25 in comparison to the CytoCare and Cynosure 980 nm lasers can be compensated for by using smaller diameter fibers for equal power density or exposing target tissue for longer duration (equivalent energy).
The AOC Phase II 25 laser system has the same overall characteristics and features as the predicate diode laser systems. Like these lasers, the AOC Phase II 25 provides for adjustable power output, internal monitoring of power output accuracy, prominent power output display, operation in the Continuous Mode and Single Pulse, and other Modes (with adjustable pulse duration), foot switch activation, safety interlocks, a red aiming beam, Ready and Standby Modes, an electrically safe design, visual and audible indicators of operation, as well as a rugged cabinet designed for the clinical environment.
Like The Sharplan 6020, the AOC Phase II 25 is equipped for handswitch activation of the laser output for convenient surgical control. Also, like the Indigo unit, the AOC Phase II 25 has a Decay (e.g., exponential) Pulse mode.
7. Performance Data
No clinical test data was submitted in support of this submission. Peer reviewed clinical articles on the tissue interaction at 980 nm were included in the 510 (k). Bench test data was submitted demonstrating that the design is able to produce the rated power and wavelength.
Notice: This Summary was prepared in order to comply with CFR 21 807.87. AOC Medical Systems makes no claim that any disease or other condition can be cured and promotes its laser as a surgical tool only for use by qualified physicians. Laser surgery, like any surgery, entails necessary risks, some of which may result in complications, injury or, in the extreme, death.