(68 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 surgery.
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).
Here's an analysis of the provided 510(k) summary regarding the Accu-Pulse 1000 CO2 Surgical Laser System:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present "acceptance criteria" in the format of pass/fail metrics with associated studies for the Accu-Pulse 1000 CO2 Surgical Laser System. Instead, it relies on demonstrating substantial equivalence to a previously marketed predicate device (Accu-Pulse pulsed CO2 laser). The "reported device performance" is essentially a comparison of specifications to the predicate device and another similar device.
Here's a table based on the provided "Table of Substantial Equivalence":
| Feature | Acceptance Criteria (Predicate Device K971830) | Reported Device Performance (Accu-Pulse 1000) | Meets Criteria? |
|---|---|---|---|
| Power | 1-15 Watts | 1-15 Watts | Yes |
| Wavelength | 10.6 microns | 9.6 or 10.6 microns | (See Note 1) |
| 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 | Yes |
| Laser Type | DC slab excited | DC slab excited | Yes |
| Spot Size | 3mm, 5mm & 7mm | 250 microns-3mm | (See Note 2) |
| Average Power | 1-15 Watts | 1-15 Watts | Yes |
| Mode | Multi-mode | TEM 00 | (See Note 3) |
| Exposure Duration | 4 us | 4-10 ps | (See Note 4) |
| Control System | Microprocessor, self diagnosis | Microprocessor, self diagnosis | Yes |
| Repetition Rate | 0.5-5Hz | 1-20 Hz | (See Note 5) |
| Aiming Beam | 633 nanometer | 633 nanometer | Yes |
| Excitation | DC excited | DC excited | Yes |
Notes on "Meets Criteria?":
- Wavelength: The Accu-Pulse 1000 offers an additional wavelength (9.6 microns) which is a difference from the predicate. The FDA's approval indicates this difference was considered acceptable for substantial equivalence, likely due to similar tissue interaction properties or it being an enhancement.
- Spot Size: The Accu-Pulse 1000 has a significantly different spot size range (250 microns-3mm) compared to the predicate (3mm, 5mm & 7mm). This represents a change in performance/capability. Again, the FDA's approval implies this was deemed acceptable for substantial equivalence, perhaps offering more precise control.
- Mode: The Accu-Pulse 1000 operates in "TEM 00" mode, while the predicate is "Multi-mode". TEM 00 (Transverse Electromagnetic Mode 00) is often referred to as a Gaussian mode and typically provides a more focused and precise beam profile compared to multi-mode. This is a significant difference in laser beam quality and performance. The FDA's acceptance suggests this change was considered an improvement or not a significant safety/effectiveness difference that would preclude substantial equivalence.
- Exposure Duration: The Accu-Pulse 1000's exposure duration is in picoseconds (ps) versus microseconds (us) for the predicate. This is a massive difference (picoseconds are orders of magnitude shorter than microseconds). Ultrafast lasers (picosecond/femtosecond) have very different tissue interaction characteristics (e.g., photoablation with minimal thermal damage). This is a major technological change and would typically require a strong justification for substantial equivalence if the indications for use remain the same. The FDA's approval implies this difference was considered acceptable.
- Repetition Rate: The Accu-Pulse 1000 has a higher repetition rate (1-20 Hz) compared to the predicate (0.5-5Hz). This allows for faster treatment.
Study That Proves the Device Meets Acceptance Criteria:
The document explicitly states: "Performance Data: None. The specifications and intended use of the Accu-Pulse 1000 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."
Therefore, there was no specific study conducted to prove the Accu-Pulse 1000 meets acceptance criteria in the traditional sense of comparative clinical or non-clinical performance data. The device's acceptance was based on a demonstration of substantial equivalence to a predicate device, arguing that its design and performance specifications are comparable or improved such that new safety and effectiveness concerns are not raised.
Detailed Information based on the provided text:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not applicable. No performance data or test set was used for substantial equivalence.
- Data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No ground truth was established by experts for a test set. Substantial equivalence was determined by comparing technical specifications and intended use with a predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set requiring adjudication 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 surgical laser system, not an AI-assisted diagnostic device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a surgical laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The basis for approval was substantial equivalence to a predicate device, rather than performance against a defined ground truth derived from clinical data. The "ground truth" in this context is the established safety and effectiveness of the predicate device.
8. The sample size for the training set
- Not applicable. This is a physical device, not an AI model requiring a training set. The mention of "Software Development Procedure" and "software will be verified and validated" refers to internal software quality assurance processes for the device's control system, not machine learning model training.
9. How the ground truth for the training set was established
- Not applicable for the same reasons as above. The software validation mentioned refers to standard software engineering practices (verification against specifications, validation through testing against intended use and intentional breaches/breaks to confirm safety interlocks and input parameters), not ground truth for a machine learning model.
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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 102Jupiter, 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 indermatology (see 21 CFR 878.4810) |
| Legally MarketedPredicate Device: | Accu-Pulse pulsed CO2 laser manufactured by ArgusPhotonics Group, Inc. |
| Description of theAccu-Pulse 1000 CO2Laser: | Accu-Pulse 1000 is a DC excited gas-slab pulsed CO2 laser whichproduces 1-15 watts average power (see below for additional Surgicalspecifications). |
| Intended Use of theAccu-Pulse 1000 CO2 laser: | The intended use is the same or similar to that of the Accu-Pulsepulsed CO2 laser marketed by Argus Photonics, Inc., i.e:"For use in cutting, vaporizing and coagulating soft tissue for clinicalapplications in dermatology, plastic surgery, podiatry, neurosurgery,gynecology, otorhinolaryngology, arthroscopy, open & endoscopicgeneral surgery". |
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Argus Photonics Group 510 (k) Summary
9/30/98
Table of Substantial Equivalence
| FEATURE | Tissue TechnologiesTru-Pulse | Argus PhotonicsAccu-Pulse | Argus PhotonicsAccu-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 cuttingof soft tissue indermatology, plasticsurgery, podiatry andotorhinolaryngology | 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 |
| 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 | < 250 us | 4 us | 4-10 ps |
| Control System | Microprocessor, selfdiagnosis | Microprocessor, selfdiagnosis | Microprocessor, selfdiagnosis |
| Repetition Rate | 1-20 Hz | 0.5-5Hz | 1-20 Hz |
| Aiming Beam | 633 nanometer | 633 nanometer | 633 nanometer |
| Excitation | DC excited | DC excited | DC excited |
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Argus Photonics Group 510 (k) Summary 9/30/98
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. Based on the foregoing, Argus Photonics Group, Inc., believes that Conclusion: the Accu-Pulse 1000 CO2 Surgical Laser System is substantially equivalent to a legally marketed predicate device, i.e. the Accu-Pulse Pulsed Surgical Laser as marketed by Argus Photonics Group, Inc., (K971830).
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three horizontal lines representing its wings. The eagle appears to be in flight or soaring upwards.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 16 1998
Mr. Kevin Dickenson Vice President Argus Photonics Group, Incorporated 759 Parkway Street, Suite 102 Jupiter, Florida 33477
Re: K983543 Trade Name: Accu-Pulse 1000 Surgical Laser System Regulatory Class: II Product Code: GEX Dated: September 30, 1998 Received: October 9, 1998
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 requirement, 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 vour 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,
Celia M. Witten, Ph.D., M.D.
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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INDICATIONS FOR USE
For use in cutting, vaporizing and coagulating soft tissue for clinical in dermatology, plastic surgery, podiatry, neurosurgery, applications gynecology, otorhinolaryngology, arthroscopy, open & endoscopic general surgery.
Prescription Use
(Per 21 CFR 801.109)
Pcoole
(Division Sign-Off) (Division of General Restorative Devices | | 9 8 3 SYS 510(k) Number
§ 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.