(49 days)
Nd:YAG (1064nm): The DUOLITE Q-Switched laser is intended for treatment of vascular lesions, pigmented lesions, and for hair removal and the incision, excision, ablation, vaporization of soft tissue for general dermatology. The DUOLITE Q-Switched laser is intended for tattoo removal (blue, black and green tattoo)
Nd: YAG (532nm): The DUOLITE Q-Switched laser is intended for treatment of vascular lesions, pigmented lesions, and for hair removal and the incision, excision, ablation, vaporization of soft tissue for general dermatology. The DUOLITE Q-Switched laser is intended for tattoo removal (red, violet, orange, yellow and brown tattoo)
The device includes a Q-Switched Nd: YAG laser source with 900mJ max energy at 1064 nm and 450mJ max energy at 532 nm wavelengths. The optical delivery system for the two wavelengths is the articulated arm. In addition, the DUOLITE includes a power supply; a cooling system; an optical delivery system; a microprocessor based controller; and safety features to ensure use of the appropriate laser, wavelength and hand piece.
The provided text is a 510(k) summary for the Quanta System DUOLITE laser, which is a predicate device application. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with detailed acceptance criteria and performance metrics. Therefore, many of the requested details about acceptance criteria, clinical study specifics, and ground truth establishment are not typically found or required in a 510(k) summary for a predicate device of this nature.
However, I can extract the relevant information that is present in the document.
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) for a predicate device, explicit "acceptance criteria" in the sense of predefined thresholds for a clinical study endpoint are not presented. Instead, the device's performance is demonstrated through its "Technological Characteristics" being substantially equivalent to the predicate device. The performance comparison is based on technical specifications rather than clinical outcomes.
| Characteristic | Quanta System DUOLITE Reported Performance | Predicate Device (Cynosure Affinity QS K050382) Performance | Acceptance Criteria (Implied by Substantial Equivalence) |
|---|---|---|---|
| Nd:YAG Wavelength | 1064 nm | 1064 nm | Match/be equivalent to predicate |
| 532 nm Wavelength | 532 nm | 532 nm | Match/be equivalent to predicate |
| Pulse Width | 6 ns (for both 1064 nm and 532 nm) | 6 ns (for both 1064 nm and 532 nm) | Match/be equivalent to predicate |
| Fluence (1064 nm) | |||
| @ 2mm spot size | 28 J/cm² | 28 J/cm² | Match/be equivalent to predicate |
| @ 3mm spot size | 12 J/cm² | 12 J/cm² | Match/be equivalent to predicate |
| @ 6mm spot size | 3 J/cm² | 3 J/cm² | Match/be equivalent to predicate |
| Fluence (532 nm) | |||
| @ 2mm spot size | 14 J/cm² | 14 J/cm² | Match/be equivalent to predicate |
| @ 3mm spot size | 6 J/cm² | 6 J/cm² | Match/be equivalent to predicate |
| @ 6mm spot size | 1.5 J/cm² | 1.5 J/cm² | Match/be equivalent to predicate |
| Spot Sizes | 2, 3, and 6mm | 2, 3, 4, and 6mm | Similar spot sizes (DUOLITE offers a subset of the predicate's) |
| Repetition Rate | 1, 2, 5, and 10Hz | 1, 2, 5, and 10Hz | Match/be equivalent to predicate |
| Biocompatible Handpiece Tip | Yes | Yes | Match/be equivalent to predicate |
| Sterilization Method | Same as predicate | Same as predicate | Match/be equivalent to predicate |
| Intended Use / Indications | Same as predicate, with specific tattoo colors listed. | Same as predicate, with specific tattoo colors listed. | Similar intended uses and indications |
| Principles of Operation | Same as predicate | Same as predicate | Match/be equivalent to predicate |
The "acceptance criteria" for a 510(k) in this context is that the device is "as safe and effective as the predicate devices" and that "Minor technological differences...raise no new issue of safety or effectiveness," leading to a determination of "Substantial Equivalence."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a clinical "test set" with a sample size or data provenance in the way one would for a new clinical study. The equivalence is demonstrated through comparison of technical specifications, not patient data.
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. There was no clinical test set requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no clinical test set requiring adjudication.
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 device is a laser surgical instrument, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a laser surgical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No clinical ground truth was established for this 510(k) submission. The "ground truth" for demonstrating substantial equivalence lies in the technical specifications, intended uses, and principles of operation being comparable to the predicate device.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not a machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no "training set."
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510(k) SUMMARY Quanta System DUOLITE
Laser surgical instrument for use in general surgery and
Cynosure, Inc Affinity QS Q-Switched Nd: YAG Laser
tattoo removal ( blue, black and green tattoo)
wavelengths is the articulated arm.
The DUOLITE Q-Switched laser is intended for treatment of vascular lesions, pigmented lesions, and for hair removal and the incision, excision, ablation, vaporization of soft tissue for general dermatology. The DUOLITE O-Switched laser is intended for
The DUOLITE Q-Switched laser is intended for treatment of vascular lesions, pigmented lesions, and for hair removal and the incision, excision, ablation, vaporization of soft tissue for general dermatology. The DUOLITE Q-Switched laser is intended for tattoo removal (red, violet, orange, yellow and brown tattoo)
The device includes a Q-Switched Nd: YAG laser source with
532 nm wavelengths. The optical delivery system for the two
In addition, the DUOLITE includes a power supply; a cooling system; an optical delivery system; a microprocessor based
900mJ max energy at 1064 nm and 450mJ max energy at
controller; and safety features to ensure use of the appropriate laser, wavelength and hand piece.
Submitter:
Contact:
Title:
Quanta System SpA via IV Novembre, 1 16 21058 Solbiate Olona VA / Italy
Dr. Maurizio Bianchi QA and Regulatory Affairs Manager
Instrument, surgical, powered, laser
February 28, 2013
System (K050382);
Nd:YAG (1064nm):
Nd:YAG (532nm):
None
Dermatology
Date Prepared:
Quanta System DUOLITE Device Trade Name:
Common Name:
Classification Name:
Predicate Devices:
Intended Use / Indications for use:
Technological Characteristics:
Performance data:
Substantial Equivalence: The Quanta System DUOLITE is as safe and effective as the predicate devices. The DUOLITE has the same intended uses and similar indications, technological characteristics,
Page 4 of 55
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| Wavelength[nm] | pulsewidth[ns] | Fluence[J/cm²] | spotsize[mm] | Rep.rate[Hz] | |
|---|---|---|---|---|---|
| QUANTASYSTEMDUOLITE | 1064 nm | 6 ns | 28J/cm² at 2mm12J/cm² at 3mm3J/cm² at 6mm | 2,3 and6mm | 1,2,5and10Hz |
| 532 nm | 6 ns | 14J/cm² at 2mm6J/cm² at 3mm1,5J/cm² at 6mm | 2,3 and6mm | 1,2,5and10Hz | |
| CYNOSUREAFFINITYQS (K050382) | 1064 nm | 6 ns | 28J/cm² at 2mm12J/cm² at 3mm7J/cm² at 4mm3J/cm² at 6mm | 2,3,4and6mm | 1,2,5and10Hz |
| 532 nm | 6 ns | 14J/cm² at 2mm6J/cm² at 3mm3J/cm² at 4mm1,5J/cm² at 6mm | 2,3,4and6mm | 1,2,5and10Hz |
and principles of operation as its predicate device as demonstrated in the table below.
The tip of the handpiece of the DUOLITE is made of Biocompatible material as the predicate device. This Sterilization method is the same as its predicate device. The Minor technological differences between the DUOLITE and its predicate devices raise no new issue of safety or effectiveness. Thus, the DUOLITE is substantially equivalent.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Quanta System, S.P.A. % Regulatory Technology Services, LLC Mr. Mark Job 1394 25th Street, Northwest Buffalo, Minnesota 55313
March 15, 2013
Re: K103539 Trade/Device Name: DUOLITE Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: January 06, 2011 Received: January 07, 2011
Dear Mr. Job:
This Letter corrects our substantially equivalent letter of January 20, 2011.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
{3}------------------------------------------------
Page 2 - Mr. Mark Job
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours, FOR
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
DUOLITE Device Name:
Indications for use:
Nd:YAG (1064nm):
The DUOLITE Q-Switched laser is intended for treatment of vascular lesions, pigmented lesions, and for hair removal and the incision, excision, ablation, vaporization of soft tissue for general dermatology. The DUOLITE Q-Switched laser is intended for tattoo removal (blue, black and green tattoo)
Nd: YAG (532nm):
The DUOLITE Q-Switched laser is intended for treatment of vascular lesions, pigmented lesions, and for hair removal and the incision, excision, ablation, vaporization of soft tissue for general dermatology. The DUOLITE Q-Switched laser is intended for tattoo removal (red, violet, orange, yellow and brown tattoo)
Neil R Ogdens 2013.03.15 12:54:24 -04'00'
(Division Sign Off) for MXM Division of Surgical, Orthopedic, And Restorative Devices
510(k) Number K103539 .
Prescription Use AND/OR ਮ (Part 21 C.F.R. 801 Subpart D)
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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.