(88 days)
Not Found
No
The device description focuses on standard laser technology components and a microcontroller-based control system, with no mention of AI or ML terms or functionalities.
Yes
The device is intended for the "treatment" of benign vascular and pigmented lesions, which is a therapeutic purpose.
No
The device is described as being "intended for treatment of benign vascular and benign pigmented lesions," indicating a therapeutic rather than diagnostic purpose.
No
The device description explicitly details numerous hardware components including a main panel, touch screen display, optical fiber connector, status LEDs, footswitch connector, remote interlock connector, power supply cable connector, key switch, emergency knob, opto-mechanical block, laser source, heat dissipation system, aiming beam, control system, power electronics, and power supply. While software is mentioned as part of the control electronics, the device is clearly a physical laser system with integrated software, not a standalone software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for treatment of benign vascular and benign pigmented lesions." This describes a therapeutic device that directly treats a condition on the patient's body.
- Device Description: The description details a laser device used for dermatology, with components like a laser source, optical fiber, and controls. This aligns with a therapeutic laser device, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to treat, not to diagnose or analyze specimens.
N/A
Intended Use / Indications for Use
The device is intended for treatment of benign vascular and benign pigmented lesions.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
585 is a diode laser device used mainly for dermatology.
It includes a main panel with the touch screen display, the optical fiber connector (SMA 905) and the status LEDs. On the rear panel the connectors for footswitch, remote interlock and power supply cable are located. The key switch and the emergency knob are located on the upper part of the device.
The laser system is composed of an opto-mechanical block containing the laser source and heat dissipation system, aiming beam, control system and power electronics.
The power electrical system is composed of a power supply. The control electronics, based on a microcontroller, manages power electronics, thermalization of the laser source and controls the user interface.
Emission is triggered by means of a footswitch.
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
Not Found
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)
Safety and electromagnetic compatibility (EMC) testing for proposed device was conducted by an independent test laboratory in accordance with IEC 60601-1, Medical electrical equipment, Part 1: General requirements for basic safety and essential performance and with IEC 60601-1-2, Collateral Standard: Electromagnetic Compatibility - Requirements and Tests, 3rd ed.
585 was determined to be in conformance with applicable IEC standards (IEC 62366, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1).
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
The biocompatibility of the proposed device is established based on the predicate devices.
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.
QuadroStarPRO (K133297), YellowStar (K013940)
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 17, 2017
Quanta System S.p.A. Francesco Dell'antonio V.P. Regulatory Affairs and Quality Assurance Via Acquedotto, 109 Samarate, 21017 It
Re: K172198 Trade/Device Name: 585 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX Dated: July 10, 2017 Received: July 21, 2017
Dear Francesco Dell'antonio:
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 application (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820):
1
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 contact the Division of Industry and Consumer Education (DICE) 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education (DICE) 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, Jennifer R. Stevenson -S3
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K172198
Device Name ર્ ૪૪૨
Indications for Use (Describe)
The device is intended for treatment of benign vascular and benign pigmented lesions.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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5. 510(K) SUMMARY
Introduction:
This document contains the 510(k) Summary for the 585. The content of this summary is based on the requirements of 21 CFR 807.92(c).
| Applicant /
Manufacturer
Name and Address: | Quanta System SPA
Via Acquedotto, 109
Samarate (VA)
Italy, 21017 |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------|
| 510(k) Contact Person: | Francesco Dell'Antonio
Vice President Regulatory Affairs and QA
Quanta System SPA |
| | Email: francesco.dellantonio@quantasystem.com
Phone: +39-0331-376797
Fax: +39-0331-367815 |
| Date Prepared: | July 10th 2017 |
| Device Name: | 585 |
| Classification: | Class II |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery and
in dermatology. |
| Regulation Number: | 21 CFR 878.4810 |
| Product Code: | GEX |
Predicate Devices:
585 is substantially equivalent to the following legally marketed predicate devices:
- Main predicate device: QuadroStarPRO (K133297), Asclepion Laser Technologies GmbH ●
- . Additional Predicate device: YellowStar (K013940), Asclepion Laser Technologies GmbH
Description of the device:
585 is a diode laser device used mainly for dermatology.
It includes a main panel with the touch screen display, the optical fiber connector (SMA 905) and the status LEDs. On the rear panel the connectors for footswitch, remote interlock and power supply cable are located. The key switch and the emergency knob are located on the upper part of the device.
The laser system is composed of an opto-mechanical block containing the laser source and heat dissipation system, aiming beam, control system and power electronics.
The power electrical system is composed of a power supply. The control electronics, based on a microcontroller, manages power electronics, thermalization of the laser source and controls the user interface.
4
Emission is triggered by means of a footswitch.
Intended use
The device is intended for treatment of benign vascular and benign pigmented lesions.
Performance data:
The following performance data are provided in support of the substantial equivalence determination:
Safety and electromagnetic compatibility (EMC)
Electrical safety and electromagnetic compatibility (EMC) testing for proposed device was conducted by an independent test laboratory in accordance with IEC 60601-1, Medical electrical equipment, Part 1: General requirements for basic safety and essential performance and with IEC 60601-1-2, Collateral Standard: Electromagnetic Compatibility - Requirements and Tests, 3rd ed.
585 was determined to be in conformance with applicable IEC standards (IEC 62366, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1).
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Biocompatibility:
The biocompatibility of the proposed device is established based on the predicate devices.
Substantial Equivalence:
585 has the same intended use and the same indications for use as its predicate devices, as it has the same or similar technological characteristics, including the laser type, wavelength, pulse width, frequency and spot size. Any minor differences do not raise any new types of safety or effectiveness questions since the parameters are the same as the predicate devices.
Therefore, 585 is substantially equivalent to its predicate devices.