(197 days)
Not Found
No
The summary describes a laser system with software control for setting parameters, but there is no mention of AI or ML being used for image processing, decision-making, or adapting treatment based on patient data or feedback. The performance study focuses on histological analysis and comparison to a predicate device, not on the performance of any AI/ML algorithm.
Yes
The device is used in dermatologic procedures for the coagulation of soft tissue and skin resurfacing, which are therapeutic interventions.
No
The device is described as a "Skin Treatment System" used for "dermatologic procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures." Its function involves generating thermal zones of damage in skin, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states that the system includes three main hardware components: Console, Tablet, and Patient Interface, which house the control electronics, power distribution, laser, optics, scanner, etc. While it is software-controlled, it is not a software-only device.
Based on the provided information, the SR-1 Skin Treatment System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside the body (in vitro).
- SR-1 Function: The SR-1 Skin Treatment System is a laser system that directly applies energy to the skin of a patient for therapeutic purposes (coagulation of soft tissue, skin resurfacing). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes a dermatologic procedure performed directly on the patient's skin.
- Device Description: The description details a laser system with components for delivering energy to the skin, not for analyzing biological samples.
Therefore, the SR-1 Skin Treatment System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes
ONG
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.
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.
clinical 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)
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.
Key results: The histological data showed that the SR-1 Skin Treatment System performs in accordance with its specifications and requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K130193, K060310, K193500, K130028
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized design. To the right is the FDA logo, with the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
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.
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 Plastic |
| Surgery 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 with |
| Microbeam/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.
4
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 Skin
Treatment System | Predicate device Fraxel
DUAL 1550 module
(K130193) | Predicate device
Lumenis Stellar M22
ResurFX module
(K193500) |
|--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| 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 Fraxel 1550 nm laser
is indicated for use in
dermatological
procedures requiring the
coagulation of soft tissue,
as well as for skin
resurfacing procedures. It
is also indicated for the
treatment of dyschromia
and cutaneous lesions,
such as, but not limited to
lentigos (age spots), solar
lentigos (sun spots),
actnic keratosis, and
melasma, and for the
treatment or periorbital | Use in dermatological
procedures requiring
fractional skin
resurfacing and
coagulation of soft
tissue. |
Table 8-1. Device Comparison
5
| Operating Principals | | wrinkles, acne scars and
surgical scars. | |
|-------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| | 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. | 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 | 1565nm erbium glass
diode pumped fiber
laser |
| Output power | 20W | 30W | 15W |
| Maximum pulse
energy | 70 mJ | 70 mJ | 70 mJ |
| Maximum pulse
width | 10 ms | 10 ms | 10 ms |
| Tissue contact | Reusable sapphire cooled
tip | Disposable contact tips | Reusable sapphire
cooled tip |
| Cooling mechanism | Continuous contact
cooling | Air cooling | Continuous contact
cooling |
| 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 ●
6
- 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.
7
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.