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.

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.

AI/ML Overview

This FDA 510(k) summary does not contain the detailed information necessary to answer all aspects of your question regarding acceptance criteria, study details, and specific performance metrics. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a comprehensive clinical trial report.

Here's what can be extracted and what information is missing:

1. A table of acceptance criteria and the reported device performance

The document mentions "performance testing results" and that "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." However, specific numerical acceptance criteria or performance metrics are not provided.

The performance testing listed is:

Software verification and validation
Electrical Safety testing (per ANSI AAMI ES 60601-1:2005(R)2012 and A1:2012)
EMC Testing (per IEC 60601-1-2: 2014-02)
Histology study and computational simulations to evaluate lesion geometry
Sample clinical data to confirm the shape of the CTZs (conical thermal zones) and demonstrate safety.

Without the specific criteria for "lesion geometry" or "safety" from these studies, a table cannot be fully constructed.

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 states: "Sample clinical data were provided to confirm the shape of the CTZs (conical thermal zones) and demonstrate safety."

Sample size: Not specified. It only says "Sample clinical data."
Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

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)

This information is not provided. The document mentions a "Histology study" and "computational simulations" to evaluate lesion geometry, and "sample clinical data" for safety and CTZ shape. It does not elaborate on how ground truth was established for these or who was involved.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

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

This is not applicable as the device is a laser skin treatment system, not an AI-assisted diagnostic tool that would involve human readers interpreting cases.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable in the context of typical AI algorithm evaluation. The device is a physical laser system. While it is "software-controlled," the performance testing described relates to the physical and electrical safety and the biological effect of the laser, not a diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Based on the performance testing mentioned:

Histology study and computational simulations: This suggests histology (pathology) would be a key ground truth for "lesion geometry." Computational simulations provide a model, not empirical ground truth.
Sample clinical data: This would typically rely on clinical observations/assessments for safety and the confirmation of CTZ shape.

8. The sample size for the training set

This is not provided. If there was any machine learning involved in the device's control software to optimize treatment parameters, the document does not elaborate on it or any specifics about training data. Given the device type, "training set" in the context of typical AI/ML is likely not directly applicable here.

9. How the ground truth for the training set was established

This is not provided, and again, may not be applicable in the traditional AI/ML sense for this type of device.

In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence through technical specifications, safety standards compliance, and general performance statements rather than detailed clinical study data with specific acceptance criteria, sample sizes, and ground truth methodologies, especially those relevant to AI device evaluations.

Summary

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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

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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 3Waltham, MA 02451
Contact Person:	Jay Bhawalkar, PhDChief Technology Officer
Phone Number:	Office: (617) 377-7945
Fax Number:	Not Applicable
Classification Name:	Laser Surgical Instrument for Use in General and PlasticSurgery and Dermatology
Regulation:	21 CFR § 878.4810
Regulatory Class:	II
Product Code:	ONG
Proprietary Name:	MIRIA Skin Treatment System
Common Name:	Powered Laser Surgical Instrumentwith 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.

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Device Description

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.

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 SkinTreatment System K223871	Existing MIRIA Skin TreatmentSystem K221268
Operating principal	Scanned pulsed 1550nm laserenergy directed into the skin via anoperator controlled delivery system.	Scanned pulsed 1550nm laserenergy directed into the skin via anoperator controlled delivery system.
Laser source	1550nm erbium glass diode pumpedfiber laser	1550nm erbium glass diode pumpedfiber laser
Output power	20W	20W
Maximum pulseenergy	150 mJ	150 mJ
Maximum pulsewidth	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.

Regulation Number and Section

§ 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.