(90 days)
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
Accu-Pulse is a DC excited gas-slab pulsed CO2 laser which produces 1-15 watts average power (see below for additional Surgical specifications).
The document provided is a 510(k) summary for the Accu-Pulse CO2 Surgical Laser System. It focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study to prove the device meets specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study to prove device performance is not available in the provided text.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not present a formal table of acceptance criteria with corresponding device performance metrics from a study. Instead, it provides a "Table of Substantial Equivalence" which compares the Accu-Pulse to two predicate devices on various features. This table implicitly defines the acceptable range of performance as being comparable to the predicate devices.
| Feature | Predicate Device (Tissue Technologies Tru-Pulse) | Accu-Pulse (Reported Performance) |
|---|---|---|
| Power | 1-10 Watts | 1-15 Watts |
| Wavelength | 10.6 microns | 10.6 microns |
| Energy Density at Tissue | 5 J/cm² | 5 J/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 |
| Laser Type | DC slab excited | DC slab excited |
| Spot Size | 1, 3, 5mm | 3mm, 5mm & 7mm |
| Average Power | 1-10 Watts | 1-15 Watts |
| Mode | Multi-mode | Multi-mode |
| Exposure Duration | < 250 μs | < 250 μs |
| Control System | Microprocessor, self diagnosis | Microprocessor, self diagnosis |
| Repetition Rate | 1-20 Hz | 1-5 Hz |
| Aiming Beam | 633 nanometer | 633 nanometer |
| Excitation | DC excited | DC excited |
2. Sample size used for the test set and the data provenance
The document explicitly states: "Performance Data: 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."
Therefore, there was no separate test set used, and no data provenance information is available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
As no performance data or test set was required, there were no experts used to establish ground truth for a test set.
4. Adjudication method for the test set
Not applicable, as no test set was used.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device for surgical applications, not a diagnostic AI system involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a laser system, not an algorithm. The document mentions "Software Validation" for its internal control system, but this is a technical validation of the software's functionality, not a standalone performance study in the context of user interaction or diagnostic outputs.
7. The type of ground truth used
Not applicable, as no performance study was conducted requiring ground truth. The basis for acceptance was substantial equivalence to a predicate device.
8. The sample size for the training set
Not applicable, as this is a hardware device submission, not an AI/machine learning model that would require a training set of data.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
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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: | (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". |
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Argus Photonics Group 510 (k) Summary 5/14/97
Table of Substantial Equivalence
| FEATURE | CoherentUltraPulse | Tissue TechnologiesTru-Pulse | Argus PhotonicsAccu-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 cuttingof soft tissue indermatology, plasticsurgery, podiatry andotorhinolaryngology | Coagulation,vaporization, ablationof or cutting of softtissue in dermatology,plastic surgery,podiatry andotorhinolaryngology | Coagulation,vaporization, ablationof or cutting of softtissue in dermatology,plastic surgery,podiatry andotorhinolaryngology |
| 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, selfdiagnosis | Microprocessor, selfdiagnosis | Microprocessor, selfdiagnosis |
| 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-PulseSurgical Laser System are the same or very similar to those of theTru-Pulse™ pulsed CO2 laser. Because of this, performance datawere not required. |
|---|---|
| Software Validation: | Argus Photonics Group, Inc., has implemented a SoftwareDevelopment Procedure outlined in the following pages. Thissoftware will be verified and validated by programmers as eachelement is added to the program. In addition, the software will bechallenged by intentional breaches or breaks in interlocks and / orinput parameters. Argus Photonics Group certifies that softwarevalidation will occur prior to the sale of the Accu-Pulse laser systemdescribed herein. |
| Conclusion: | Based on the foregoing, Argus Photonics Group, Inc., believes thatthe Accu-Pulse CO2 Surgical Laser System is substantially equivalentto a legally marketed predicate device, I.e. the Tru-Pulse™ PulsedSurgical 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 (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
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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
§ 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.