(197 days)
The SR-1 Skin Treatment System is indicated for use in dermatologic procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.
The SR-1 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 SR-1 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.
The SR-1 Skin Treatment System is a 1550nm-based laser system intended to generate thermal zones of damage in skin. The system 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 optics, scanner, laser aperture, and contact cooling interface.
The SR-1 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 device is intended to be used by a suitably trained professional in a clinical setting. There are no sterile components.
The provided text describes the 510(k) summary for the SR-1 Skin Treatment System, comparing it to predicate devices. However, it does not contain detailed acceptance criteria or a specific study proving the device meets acceptance criteria in the manner requested (e.g., performance metrics in a table, sample size for test set with data provenance, number of experts, adjudication method, MRMC study, or standalone algorithm performance).
Instead, the document focuses on demonstrating substantial equivalence based on technological characteristics and safety and efficacy studies rather than outlining specific performance metrics for acceptance.
Here's an attempt to structure the information based on the request, extracting what is available and noting what is missing:
Acceptance Criteria and Study for SR-1 Skin Treatment System
The provided 510(k) summary does not detail specific quantitative acceptance criteria or a dedicated study designed to prove the device meets such criteria in the format requested. Instead, the submission relies on demonstrating substantial equivalence to predicate devices, which involves:
- Technological Characteristics Comparison: Showing the SR-1 has similar operating principles, laser source, output power, etc., to predicate devices.
- Safety and Performance Testing: Compliance with international standards for electrical safety, EMC, usability, biocompatibility, and laser safety.
- In-vivo Human Study: A histological assessment comparing the thermal damage zones and healing rates to a predicate.
Therefore, a table of "acceptance criteria" as performance metrics isn't explicitly provided, as the criteria for clearance are primarily based on substantial equivalence and safety/functionality compliance with established standards.
1. Table of Acceptance Criteria and Reported Device Performance
As specific quantitative "acceptance criteria" for clinical performance (e.g., a specific percentage of improvement in skin resurfacing) are not detailed in this document, such a table cannot be constructed from the provided text. The document states that the histological data "show that the SR-1 Skin Treatment System performs in accordance with its specifications and requirements," implying that its performance (specifically in terms of thermal damage zones and healing rate) was found comparable to the predicate.
2. Sample Size for Test Set and Data Provenance
- Sample Size for In Vivo Study: 14 healthy subjects.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It is implied to be a prospective in vivo human study based on the description "A 14 day in vivo human study assessing safety, healing and MTZ morphology was performed..."
3. Number of Experts and Qualifications for Ground Truth for Test Set
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified, other than "histological analysis" was performed.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done?: No. The device is a laser treatment system, not an imaging interpretation device where human reader performance would be compared with and without AI assistance. The study described is an in vivo histological assessment.
- Effect size of human readers with/without AI: Not applicable.
6. Standalone (Algorithm Only) Performance
- Was a standalone study done?: Not directly applicable in the terms of an "algorithm only" performance for diagnosis. The device is a physical laser treatment system with software control. Software verification and validation were performed according to IEC 62304 and FDA guidance, indicating that the software's functionality was tested.
7. Type of Ground Truth Used
- Ground Truth Type: "Histological analysis" was used to determine the zones of thermal damage and healing rate in the in vivo human study.
8. Sample Size for the Training Set
- Sample Size: Not applicable. This device is a laser treatment system, not an AI model that requires a training set in the conventional sense (e.g., for image classification or diagnosis). Its software underwent "verification and validation testing."
9. How the Ground Truth for the Training Set was Established
- Ground Truth Establishment: Not applicable, as there is no "training set" in the context of an AI model being trained for diagnostic or predictive tasks. The software "ground truth" (i.e., its correct functionality) would be established through software requirements, design specifications, and subsequent verification and validation testing.
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April 13, 2021
AVAVA, Inc. Lewis Levine Executive Director, Engineering 275 Second Avenue, Floor 3 Waltham, Massachusetts 02451
Re: K202884
Trade/Device Name: SR-1 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: September 25, 2020 Received: September 28, 2020
Dear Lewis Levine:
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.
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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) 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 mediation-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,
Purva U. Pandya -S
Purva Pandya 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) K202884
Device Name SR-1 Skin Treatment System
Indications for Use (Describe)
The SR-1 Skin Treatment System is indicated for use in dermatologic procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.
The SR-1 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 SR-1 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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K202884
510(k) Summary
| General Provisions | |
|---|---|
| 510(k) Owner's Name: | AVAVA, Inc. |
| Address: | 245 Second Avenue, Floor 3 |
| Waltham, MA 02451 USA | |
| Contact Person: | Lewis Levine |
| Executive Director-Engineering | |
| Phone Number: | Office: (857) 305-9604, Cell: (617) 510-2103 |
| 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: | SR-1 Skin Treatment System |
| Common Name: | Powered Laser Surgical Instrument withMicrobeam/Fractional Output |
| Date Summary Prepared: | September 25, 2020 |
Name of Predicate Device(s)
Intended Use
The SR-1 Skin Treatment System is indicated for use in dermatologic procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.
The SR-1 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.
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Device Description
The SR-1 Skin Treatment System is a 1550nm-based laser system intended to generate thermal zones of damage in skin. The system 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 optics, scanner, laser aperture, and contact cooling interface.
The SR-1 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 device is intended to be used by a suitably trained professional in a clinical setting. There are no sterile components.
Technological Characteristics
The SR-1 Skin Treatment System has the same intended use and similar indications for use, technological characteristics and operating principles as the 1550 module of the Fraxel DUAL and the ResurFX module of the Lumenis Stellar M22. The design and components are very similar to the predicate devices as shown in the following table. The differences are minor and do not raise any new issues of safety or efficacy of the SR-1 Skin Treatment System device as shown in the performance testing results.
| Proposed SR-1 SkinTreatment System | Predicate device FraxelDUAL 1550 module(K130193) | Predicate deviceLumenis Stellar M22ResurFX module(K193500) | |
|---|---|---|---|
| Intended Use | The SR-1 Skin TreatmentSystem is indicated foruse in dermatologicprocedures requiring thecoagulation of soft tissue,as well as for skinresurfacing procedures. | The Fraxel 1550 nm laseris indicated for use indermatologicalprocedures requiring thecoagulation of soft tissue,as well as for skinresurfacing procedures. Itis also indicated for thetreatment of dyschromiaand cutaneous lesions,such as, but not limited tolentigos (age spots), solarlentigos (sun spots),actnic keratosis, andmelasma, and for thetreatment or periorbital | Use in dermatologicalprocedures requiringfractional skinresurfacing andcoagulation of softtissue. |
Table 8-1. Device Comparison
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| Operating Principals | wrinkles, acne scars andsurgical scars. | ||
|---|---|---|---|
| Scanned pulsed 1550nmlaser energy directed intothe skin via an operatorcontrolled deliverysystem. | Scanned pulsed 1550nmlaser energy directed intothe skin via an operatorcontrolled deliverysystem. | Scanned pulsed1550nm laser energydirected into the skinvia an operatorcontrolled deliverysystem. | |
| Laser Source | 1550nm erbium glassdiode pumped fiber laser | 1550nm erbium glassdiode pumped fiber laser | 1565nm erbium glassdiode pumped fiberlaser |
| Output power | 20W | 30W | 15W |
| Maximum pulseenergy | 70 mJ | 70 mJ | 70 mJ |
| Maximum pulsewidth | 10 ms | 10 ms | 10 ms |
| Tissue contact | Reusable sapphire cooledtip | Disposable contact tips | Reusable sapphirecooled tip |
| Cooling mechanism | Continuous contactcooling | Air cooling | Continuous contactcooling |
| Software control | Yes | Yes | Yes |
| User interface | Touchscreen | Touchscreen | Touchscreen |
Risk Analysis
Risk analysis was performed according to IEC 14971:2007 Medical Devices- Application of Risk Management to Medical Devices, reviewed by a nationally recognized testing laboratory (NRTL), and found to be in compliance.
Summary of Performance Testing
Electrical Safety, Electromagnetic Compatibility, Usability, Biocompatibility and Laser Safety
Evaluation of the device was conducted by a nationally recognized testing laboratory (NRTL) and was found in compliance with the following standards:
- . IEC 60601-1-2:2014 Ed 4.0 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012 Medical electrical equipment Part ● 1: General requirements for basic safety and essential performance
- IEC 62304:2006 + A1:2015, Ed. 1.0 Medical device software Software life cycle processes ●
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- IEC 60601-1-6:2010, AMD1:2013 Medical electrical equipment Part 1-6: General . requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 62366-1: 2015 Medical devices - Part 1: Application of usability engineering to medical devices
- . IEC 60601-2-22: 2007 (Third Edition) + A1:2012 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- . IEC 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements
- . ISO 10993-1:2018 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
Non-Clinical Performance Data
The SR-1 Skin Treatment System performance characteristics have been evaluated through usability testing compliant to FDA Guidance Applying Human Factors and Usability Engineering to Medical Devices (2016) and IEC 62366-1 and verification of the SR-1 Skin Treatment System's laser energy, performance and control mechanisms. The performance of the SR-1 Skin Treatment System and related parameters of the predicate device are substantially equivalent.
A 14 day in vivo human study assessing safety, healing and MTZ morphology was performed in 14 healthy subjects using a power range of 20 - 70ml. The resulting zones of thermal damage and the healing rate were determined, through histological analysis, to be comparable to the predicate Fraxel DUAL 1550 module.
Software verification and validation testing was conducted, and documentation provided as recommended by FDA Guidance Content of Premarket Submissions for Software Contained in Medical Devices (2005) and IEC 62304. Device software verification and validation results were found acceptable for software release.
Biocompatibility of the patient contacting materials was established per FDA Guidance Use of International Standard ISO 10993-1 Biological evaluation of medical devices –Part 1: Evaluation and Testing Within a Risk Management Process (2018) and the referenced standard.
Clinical Performance Data
Clinical trials were not deemed necessary as the device is using the same key technology, operating principles, and intended use as the predicate devices.
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Summary of Substantial Equivalence
The SR-1 Skin Treatment System and the predicate devices have the same intended use. The SR-1 Skin Treatment System presents similar technological characteristics as its predicate devices, including the laser type, wavelength, and device design. Although there are minor differences in the details of the device design, they are not sufficient to raise new questions of safety or efficacy.
Conclusion
The SR-1 Skin Treatment System is substantially equivalent to the Fraxel DUAL 1550/1927 and the ResurFX module of the Lumenis Stellar M22. The new device has similar intended use and indications for use, technological characteristics and the same principle of operation as the predicate device. The minor design differences raise no new issues of safety or efficacy as demonstrated by histological assessments. The histological data show that the SR-1 Skin Treatment System performs in accordance with its specifications and requirements.
§ 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.