(84 days)
The Laserscope Aura Dye Laser System and Accessories are intended for the surgical Incision/excision, ablation and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
Dermatology/Plastic Surgery: Indications include epidermal nevi, telangiectasia, spider veins, verrucae, skin tags, anal tags, keratoses, debulking benign tumors and cysts, superficial skin lesions, and benign pigmented lesions.
General Surgery: Indications include surgical incision, vaporization, ablation and coagulation of soft tissue where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablations and/or vessel coagulation may be indicated.
Genitourinary: Indications include lesions of the external genitalia, urethra and anus, penis, scrotum and urethra (Includes condyloma acuminata, giant perineal condyloma and verruccous carcinoma), vulvar lesions, polyps and familial polyps of the colon.
Gynecology: Indications include cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts, and condyloma.
Oral/Maxillofacial: Indications include benign oral tumors, oral and glossal lesions.
Otorhinolaryngology/Head and Neck (ENT): Indications include ear, nose and throat lesions, polyps, cysts, excision of carcinogenic tissue and oral leukoplakia.
Ophthalmology: Indications include soft tissue surrounding the eye and orbit.
Podiatry: Indications include wart, plantar verrucae, and large mosiac verrucae.
The Laserscope Aura Dye Laser System and Accessories consists of a moveable consoles containing power supples, aiming and treatment lasers on a solid optical deck, and a cooling mechanism to dissipate the heat generated by the system.
The entire laser unit and controls are contained in two consoles, an Aura KTP/532 laser as a pump source, and a Dye Module to produce treatment light. Consoles 1 and 2 are electrically connected to the facility's power source. Emission of the pumping laser beam from Console 1 is through a flexible fiber optic to Console 2, the Dye Laser Module. Treatment light is delivered from Dye Module through fiber optic handpieces and/or scanner. The user interface consists of an LCD on Console 1 which displays laser parameters, data on connected devices and information on messages and prompts. Located on the front panel of Console 1 are four knobs enabling the user to select laser settings, and a READY/STANDBY button for selecting READY or STANDBY mode. An on/off keyswitch turns the laser system on and off. An emergency shut off button disables the laser and places the laser system in a holding status.
The provided 510(k) summary for the Laserscope Aura Dye Laser System (ADLS) does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for a diagnostic or AI-driven medical device.
The document is a traditional 510(k) submission for a surgical laser system, focusing on substantial equivalence to predicate devices based on safety and fundamental functional characteristics (wavelength, pulse duration, frequency), rather than performance metrics like sensitivity, specificity, or image quality, which would be relevant for devices involving image analysis or diagnostic outcomes.
Therefore, many of the requested details, such as sample sizes, ground truth establishment, expert qualifications, and MRMC studies, are not applicable or present in this type of submission.
Here's a breakdown of what can be extracted based on the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with Federal Regulations | The Laserscope Aura Dye Laser System and accessories complies with federal regulations and the performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems. |
| Substantial Equivalence to Predicate Devices | The Laserscope Aura Dye Laser System is substantially equivalent to Laserscope Aura and Orion Lasers systems, as well as the Coherent Versa Pulse C, Candela ScleroPulse, and Cynosure PhotoGenica LV laser systems based on wavelength, pulse duration and/or pulse frequency. The risks and benefits are comparable to predicate devices when used for similar clinical applications. The device meets requirements for substantial equivalence according to Section 510(k) guidelines regarding indications for use, materials, method of operation, and physical construction. |
| Safety and Effectiveness | Safety and effectiveness are reasonably assured, therefore justifying 510(k) clearance for commercial sale. |
Limitations: The document does not specify quantitative performance metrics (e.g., specific power output ranges, energy delivery accuracy, beam spot size consistency) that would typically be associated with "acceptance criteria" for a detailed engineering or performance study. The "acceptance criteria" here are high-level regulatory compliance and substantial equivalence demonstrations.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not Applicable/Not Provided. This submission is for a physical laser device, not a diagnostic algorithm that would typically use a "test set" of data. The "testing" referred to is likely engineering verification and validation of the device's physical parameters and safety functions against internal specifications and regulatory standards, not clinical data analysis.
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/Not Provided. Ground truth establishment by experts is relevant for diagnostic performance evaluation, which is not the focus of this submission. The "ground truth" for a laser device would be its physical specifications and functionality.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable/Not Provided. Adjudication methods are used in studies involving subjective expert review of cases, which is not relevant for this device.
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/Not Provided. MRMC studies are specific to evaluating diagnostic systems, especially those with AI components that assist human readers. This document is for a surgical laser, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable/Not Provided. This is a hardware device (laser), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not Applicable/Not Provided in this context. For a physical device like a laser, "ground truth" would relate to its manufacturing specifications, output parameters (e.g., wavelength stability, power output accuracy, beam profile), and safety features, which are verified through engineering tests and quality control, not clinical data labels like pathology or expert consensus.
8. The sample size for the training set
Not Applicable/Not Provided. Surgical lasers do not have "training sets" in the context of statistical or machine learning models.
9. How the ground truth for the training set was established
Not Applicable/Not Provided. As there is no "training set," this question is not applicable.
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3/5/99
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
REGULATORY AUTHORITY:
Safe Medical Devices Act of 1990, 21 CFR 807.92
COMPANY NAME/CONTACT:
Paul H. Hardiman Manager, Regulatory Affairs/Clinical Affairs Laserscope 3052 Orchard Drive San Jose, CA 95134-2011 408 943-0636 Phone: FAX: 408 943-1454
DEVICE TRADE NAME:
Aura Dye Laser System (ADLS)
DEVICE COMMON NAME:
Tunable Dye Laser System
DEVICE DESCRIPTION:
The Laserscope Aura Dye Laser System and Accessories consists of a moveable consoles containing power supples, aiming and treatment lasers on a solid optical deck, and a cooling mechanism to dissipate the heat generated by the system.
The entire laser unit and controls are contained in two consoles, an Aura KTP/532 laser as a pump source, and a Dye Module to produce treatment light. Consoles 1 and 2 are electrically connected to the facility's power
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source. Emission of the pumping laser beam from Console 1 is through a flexible fiber optic to Console 2, the Dye Laser Module. Treatment light is delivered from Dye Module through fiber optic handpieces and/or scanner. The user interface consists of an LCD on Console 1 which displays laser parameters, data on connected devices and information on messages and prompts. Located on the front panel of Console 1 are four knobs enabling the user to select laser settings, and a READY/STANDBY button for selecting READY or STANDBY mode. An on/off keyswitch turns the laser system on and off. An emergency shut off button disables the laser and places the laser system in a holding status.
DEVICE CLASSIFICATION:
KTP/532 Pumped Dye Laser Systems and Accessories have not been specifically classified; however Nd.YAG, C02, and Argon Surgical Lasers have been classified as Class II medical devices by the OB/GYN, General Plastic Surgery and ENT Device Advisory Panels (884.4550, 878.4810, and 874.4490 & 874.4500. respectively)..
PERFORMANCE STANDARDS:
The Laserscope Aura Dye Laser System and accessories complies with federal regulations and the performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems.
INDICATION FOR USE STATEMENT:
The Laserscope Aura Dye Laser System and Accessories is indicated for use in the procedures involving cutting (incision/excision), vaporizing.
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ablation and coagulation of soft tissue.
All soft tissue in included such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
CLINICAL APPLICATIONS:
Dermatology / Plastic Surgery General Surgery Genitourinary Gynecology Oral / Maxillofacial Otorhinolaryngology / Head and Neck (ENT) Ophthalmology Podiatry
COMPARISON WITH PREDICATE DEVICE:
The Laserscope Aura Dye Laser System is substantially equivalent to Laserscope Aura and Orion Lasers systems, as well as the Coherent Versa Pulse C, Candela ScleroPulse, and Cynosure PhotoGenica LV laser systems based on wavelength, pulse duration and/or pulse frequency.
The risks end benefits for the Laserscope Aura Dye Laser System and Accessories are comparable to the predicate devices when used for similar clinical applications.
Since the Laserscope Aura Dye Laser System and Accessories are
Image /page/2/Picture/8 description: The image shows a series of black shapes against a white background. The shapes appear to be stylized and somewhat abstract, resembling a series of connected or overlapping forms. The contrast between the black shapes and the white background is stark, making the shapes stand out prominently. The shapes are arranged horizontally, creating a visual pattern across the image.
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substantially equivalent with respect to indications for use, materials, method of operation and physical construction to the predicate device, we believe it clearly meets the requirements for substantial equivalence according to Section 510(k) guidelines. Safety and effectiveness are reasonably assured, therefore justifying 510(k) clearance for commercial sale.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 5 1999
Mr. Paul H. Hardiman Manager, Regulatory Affairs, Clinical Affairs Laserscope 3052 Orchard Drive San Jose, California 95134
K984424 Re: Trade Name: Tunable Aura Dye Laser System Regulatory Class: II Product Code: GEX Dated: December 10, 1998 Received: December 11, 1998
Dear Mr. Hardiman:
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. Paul H. Hardiman
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.
Stipt Rurdu
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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14081 943-8c33
... ...
INDICATIONS FOR USE STATEMENT
Page 1
510(k) Number.
Device Name:
Tunable Aura Dye Laser System
Indications for Use:
The Laserscope Aura Dye Laser System and Accessories are intended for the surgical Incision/excision, I the Lastlation and coagulation of soft tissue. All soft fissue is included, such as skin, cutaneous tissue, subcitaneous tissue, strated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
Dermatology/Plastic Surgery.Indications include epidermal nevi, telangiectasia, spider veins, verrucae, skin tags, anal tags, keratoses, debulking benign tumors and cysts, superficial skin lesions, and benign pigmented lesions.
General Surgery: Indications include surgical incision, vaporization, ablation and coagulation of soft tissue where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, turnors and lesions, tissue ablations and/or vessel coagulation may be in indicated.
Genitourinary: Indications include lesions of the external genitalia, urethra and anus, periis, scrotum and urethra (Includes condyloma acuminata, giant perineal condyloma and verruccous carcinoma), vulvar lesions, polyps and familial polyps of the colon.
Gynecology: Indications include cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts, and condyloma.
Oral/Maxillofacial:Indications include benign oral tumors, oral and glossal lesions.
Otorhinolaryngology/Head and Neck (ENT): Indications include ear, nose and throat lesions, polyps, cysts, excision of carcinogenic tissue and oral leukoplakia.
Ophthalmology: Indications include soft tissue surrounding the eye and orbit.
Podiatry: Indications include wart, plantar verrucae, and large mosiac verrucae.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use: | X | or | Over -The-Counter-Use |
|---|---|---|---|
| (per 21 CFR 801.109) |
(Division Sign-Off)
Division of General Restorative Devices K984424
Response to FDA Questions 02/24/99 Confidential
§ 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.