(107 days)
Dermatology, Plastic & General Surgery
The CO2 laser, model MedArt 620, is intended to be used by physicians in the performance of the following specialties:
The ablation and coagulation of soft tissue in dermatology, plastic and general surgery in the performance of:
- Skin resurfacing I
- Treatment of wrinkles and rhytids .
- Treatment of furrows I
- Soft tissue ablation .
Not Found
I am sorry, but the provided text from the FDA 510(k) summary for the MedArt 620 Laser System does not contain the specific information required to address your comprehensive request regarding acceptance criteria and a study proving the device meets those criteria.
The 510(k) summary primarily focuses on:
- Substantial Equivalence Determination: This document confirms that the FDA has reviewed the device and determined it to be "substantially equivalent" to legally marketed predicate devices, based on its indications for use.
- Regulatory Information: It details the device's regulation number, name, class, product code, and relevant FDA regulations.
- General Controls: It reminds the applicant of obligations under general controls provisions (registration, labeling, GMP, etc.).
- Indications for Use: It clearly outlines the intended medical applications for the CO2 laser system in dermatology, plastic, and general surgery (skin resurfacing, treatment of wrinkles, furrows, soft tissue ablation).
- Contraindications: It specifies conditions for which the device should not be used (hard tissue dental applications, not evaluated as a fractionated scanner).
Missing Information:
The document does not include details about:
- Specific performance acceptance criteria for the device (e.g., specific thresholds for ablation depth, coagulation effectiveness, wrinkle reduction percentages).
- Any performance study, clinical trial, or validation report that would describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance (e.g., country of origin, retrospective/prospective).
- Number and qualifications of experts for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance (not applicable for this type of laser device).
- Type of ground truth used (e.g., pathology, outcomes data).
- Training set sample size (not applicable for a physical laser device).
- How ground truth for the training set was established.
This is typical for a 510(k) clearance for a device like a surgical laser, where substantial equivalence is often demonstrated through adherence to recognized performance standards, engineering testing, and a comparison of features, materials, and intended use against a legally marketed predicate device, rather than a clinical study proving specific objective performance metrics with human readers or AI.
To obtain the kind of detailed study information you're asking for, you would typically need to review:
- PMA (Premarket Approval) applications: For novel, high-risk devices, which require extensive clinical data.
- Clinical Study Reports: Published literature, or data submitted as part of a 510(k) if the device presents new technological characteristics or different indications that warrant clinical data.
- Specific performance data submitted to the FDA: This is usually summarized in the 510(k) Decision Summary if available publicly, but not embedded in the initial clearance letter itself.
Therefore,Based on the provided text, I cannot answer your specific questions about the device's acceptance criteria and the study proving it meets those criteria.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 1 3 2012
Medart A/S % Energist Limited Mr. Darren Thomas Group Clinical Development Director 2, Park Pavilions, Clos Llyn CWM, Enterprise Park Swansea United Kingdom SA6 8QY
Re: K120573
Trade/Device Name: MedArt 620 Laser Systam 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: May 15, 2012 Received: May 18, 2012
Dear Mr. Thomas:
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.
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Page 2 – Mr. Darren Thomas
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 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/CDRH0ffices/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/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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerso Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K120573
pgiofl
Device Name: MedArt 620 Laser System
Indications for Use:
Dermatology, Plastic & General Surgery
The CO2 laser, model MedArt 620, is intended to be used by physicians in the performance of the following specialties:
The ablation and coagulation of soft tissue in dermatology, plastic and general surgery in the performance of:
- Skin resurfacing I
- Treatment of wrinkles and rhytids .
- Treatment of furrows I
- Soft tissue ablation .
Contraindications for MedArt® 620
The MedArt® 620 may not be used for hard tissue dental applications such as tooth enamel, dentin or fillings and other indications not cleared by the FDA.
The system has not been evaluated for safety and effectiveness as a fractionated scanner
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120573
Section 4
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.