(181 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description of the device and its operation does not mention any AI/ML capabilities. The software control is described as parameter entry and initiation of laser energy, which is typical for non-AI/ML controlled devices.
Yes.
The device is used in dermatologic procedures for coagulation of soft tissue and skin resurfacing, which are therapeutic interventions.
No
Explanation: The device is indicated for "coagulation of soft tissue" and "skin resurfacing procedures," which are therapeutic treatments, not diagnostic functions.
No
The device description explicitly states it includes hardware components such as a Console, Tablet, and Patient Interface, which house the laser, control electronics, power distribution, and optics. While it is software-controlled, it is not a software-only device.
Based on the provided information, the MIRIA Skin Treatment System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "dermatologic procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures." This involves direct treatment of the patient's skin using a laser.
- Device Description: The description details a laser system that projects energy into the skin to create lesions. This is a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, tissue, or urine) or to provide information about a patient's health status based on such analysis. IVD devices are designed for this purpose.
- Anatomical Site: The device is used on the "Skin," which is a direct application to the patient's body for treatment.
In summary, the MIRIA Skin Treatment System is a therapeutic medical device used for treating skin conditions with a laser, not a device used for diagnosing diseases or conditions through the analysis of in vitro samples.
N/A
Intended Use / Indications for Use
The MIRIA Skin Treatment System is indicated for use in dermatologic procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.
The MIRIA Skin Treatment System is intended to be used by medical professionals and staff who are trained in the use of lasers and who are familiar with the technology, operation of the system, and safety precautions. The MIRIA Skin Treatment System is a prescription device. Federal law restricts this device to sale by or on the order of a physician or any practitioner licensed by state law to use or order the use of this device.
Product codes (comma separated list FDA assigned to the subject device)
ONG
Device Description
The MIRIA Skin Treatment System falls under a class of intradermally focused lasers creating a targeted spatially selective conical lesion in the skin. This intradermal conical lesion profile distinguishes this class of lasers from those that generate a cylindrical column of injury. The ability of the beam to be focused to different depths is important for treatment of all skin tones and safety in the extended energy range in the MIRIA.
The MIRIA is a 1550nm-based laser system that includes three (3) main components: Console, Tablet, and Patient Interface. The Console houses the system control electronics, power distribution, contact cooling, and laser. The Tablet is the primary user interface for controlling the system through a touch screen graphical user interface. The Patient Interface contains the focusing optics, scanner, laser aperture, and contact cooling interface.
The MIRIA Skin Treatment System is a software-controlled device. The operator enters treatment parameters on the Tablet and places the Patient Interface on the treatment site. A treatment is initiated by the operator to cause laser energy to be projected into the skin of a patient. The system also has a USB port.
The device is intended to be used by suitably trained personnel in a professional setting. There are no sterile components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals and staff who are trained in the use of lasers and who are familiar with the technology, operation of the system, and safety precautions.
professional setting.
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)
- Software verification and validation for those elements impacted by the changes were conducted according to the FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005) and IEC 62304:2006 +A1:2015, Ed. 1.0 Medical device software -Software life cycle processes.
- Electrical Safety testing was conduct per ANSI AAMI ES 60601-1:2005(R)2012 and A1:2012 Medical Electrical Equipment Part 1: General requirements for basic safety
- EMC Testing was conducted per IEC 60601-1-2: 2014-02 Medical electrical equipment Part 1-2 . General requirements for basic safety and essential performance
- Histology study and computational simulations were conducted to evaluate lesion geometry
- Sample clinical data were provided to confirm the shape of the CTZs (conical thermal zones) and demonstrate safety.
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.
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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 22, 2023
Avava, Inc. Jay Bhawalkar, Phd Chief Technology Officer 275 Second Avenue. Floor 3 Waltham, Massachusetts 02451
Re: K223871
Trade/Device Name: Miria Skin Treatment System 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: ONG Dated: May 23, 2023 Received: May 23, 2023
Dear Jay Bhawalkar, Phd:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/5 description: The image shows the name "Jianting Wang -S" in a large, clear font. The text is horizontally aligned and appears to be the primary focus of the image. The background is plain, ensuring the text is easily readable.
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223871
Device Name MIRIA Skin Treatment System
Indications for Use (Describe)
The MIRIA Skin Treatment System is indicated for use in dermatologic procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.
The MIRIA Skin Treatment System is intended to be used by medical professionals and staff who are of lasers and who are familiar with the technology, operation of the system, and safety precautions. The MIRIA Skin Treatment System is a prescription device. Federal law restricts this device to sale by or on the order of a physician or any practitioner licensed by state law to use or order the use of this device.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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| 510(k) Summary | K223871 | |
|---|---|---|
| General Provisions | ||
| 510(k) Owner's Name: | AVAVA, Inc. | |
| Address: | 275 Second Avenue, Floor 3 | |
| Waltham, MA 02451 | ||
| Contact Person: | Jay Bhawalkar, PhD | |
| Chief Technology Officer | ||
| Phone Number: | Office: (617) 377-7945 | |
| Fax Number: | Not Applicable | |
| Classification Name: | Laser Surgical Instrument for Use in General and Plastic | |
| Surgery and Dermatology | ||
| Regulation: | 21 CFR § 878.4810 | |
| Regulatory Class: | II | |
| Product Code: | ONG | |
| Proprietary Name: | MIRIA Skin Treatment System | |
| Common Name: | Powered Laser Surgical Instrument | |
| with Microbeam/Fractional Output | ||
| Date Summary Prepared: | May 23, 2023 |
Name of Predicate Device(s)
- MIRIA Skin Treatment System: K221268
Intended Use
The MIRIA Skin Treatment System is indicated for use in dermatologic procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.
The MIRIA Skin Treatment System is intended to be used by medical professionals and staff who are trained in the use of lasers and who are familiar with the technology, operation of the system, and safety precautions.
4
Device Description
The MIRIA Skin Treatment System falls under a class of intradermally focused lasers creating a targeted spatially selective conical lesion in the skin. This intradermal conical lesion profile distinguishes this class of lasers from those that generate a cylindrical column of injury. The ability of the beam to be focused to different depths is important for treatment of all skin tones and safety in the extended energy range in the MIRIA.
The MIRIA is a 1550nm-based laser system that includes three (3) main components: Console, Tablet, and Patient Interface. The Console houses the system control electronics, power distribution, contact cooling, and laser. The Tablet is the primary user interface for controlling the system through a touch screen graphical user interface. The Patient Interface contains the focusing optics, scanner, laser aperture, and contact cooling interface.
The MIRIA Skin Treatment System is a software-controlled device. The operator enters treatment parameters on the Tablet and places the Patient Interface on the treatment site. A treatment is initiated by the operator to cause laser energy to be projected into the skin of a patient. The system also has a USB port.
The device is intended to be used by suitably trained personnel in a professional setting. There are no sterile components.
Indications for Use
The MIRIA Skin Treatment System is indicated for use in dermatologic procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.
The MIRIA Skin Treatment System is intended to be used by medical professionals and staff who are trained in the use of lasers and who are familiar with the technology, operation of the system, and safety precautions. The MIRIA Skin Treatment System is a prescription device. Federal law restricts this device to sale by or on the order of a physician or any practitioner licensed by state law to use or order the use of this device.
Summary of Technological Similarities/Differences
The intended use, technological characteristics, and operating principles of the MIRIA Skin Treatment System for the subject device and the predicate device are the same with the exception of the microbeam shape. The subject device carries forward the previously cleared focused beam architecture but also adds microbeam shaping. Specifically, the incident beam is a donut beam where the energy is predominantly contained in a ring, with minimal energy in the central region. This difference does not raise different issues of safety or efficacy for the MIRIA Skin Treatment System as shown in the performance testing results.
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Table 8-1. Device Comparison
| | Proposed MIRIA Skin
Treatment System K223871 | Existing MIRIA Skin Treatment
System K221268 |
|-------------------------|-------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Operating principal | Scanned pulsed 1550nm laser
energy directed into the skin via an
operator controlled delivery system. | Scanned pulsed 1550nm laser
energy directed into the skin via an
operator controlled delivery system. |
| Laser source | 1550nm erbium glass diode pumped
fiber laser | 1550nm erbium glass diode pumped
fiber laser |
| Output power | 20W | 20W |
| Maximum pulse
energy | 150 mJ | 150 mJ |
| Maximum pulse
width | 12 ms | 12 ms |
| Tissue contact | Reusable sapphire cooled tip | Reusable sapphire cooled tip |
| Cooling mechanism | Continuous contact cooling | Continuous contact cooling |
| Software control | Yes | Yes |
| User interface | Touchscreen | Touchscreen |
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Risk Analysis
Risk analysis was performed according to IEC 14971:2007 Medical Devices- Application of Risk Management to Medical Devices.
Summary of Performance Testing
- . Software verification and validation for those elements impacted by the changes were conducted according to the FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005) and IEC 62304:2006 +A1:2015, Ed. 1.0 Medical device software -Software life cycle processes.
- . Electrical Safety testing was conduct per ANSI AAMI ES 60601-1:2005(R)2012 and A1:2012 Medical Electrical Equipment Part 1: General requirements for basic safety
- EMC Testing was conducted per IEC 60601-1-2: 2014-02 Medical electrical equipment Part 1-2 . General requirements for basic safety and essential performance
- . Histology study and computational simulations were conducted to evaluate lesion geometry
- Sample clinical data were provided to confirm the shape of the CTZs (conical thermal zones) and demonstrate safety.
Conclusion
The modified MIRIA Skin Treatment System has the same intended use, technological characteristics, and principle of operation as the predicate device. The modification to the microbeam shaping and the addition of connectivity raise no new issues of safety or efficacy as demonstrated by the risk analysis and performance data. The data show that the MIRIA Skin Treatment System performs in accordance with its specifications and requirements for both safety and effectiveness in similarity to the predicate device. Thus, the modified MIRIA Skin Treatment System and the existing MIRIA Skin Treatment System are substantially equivalent.