(277 days)
The device FlexSys is a multi-modality skin surface treatment system. Depending on the chosen modules the intended use and the mode of operation varies.
Modules UVB EPL 308 and UVB EPL 308 lite:
The GME FlexSys System with module UVB EPL 308 or UVB EPL 308 lite is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only.
Module Infrared 1550:
The GME FlexSys System with Infrared 1550 module 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 treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars.
The device FlexSys consists of a base unit with up to two installed internal laser modules, handpieces and/or scanners for these modules and attachable applicators. All applicators, handpieces, and scanners are connected by an electrical cable.
The base unit contains most of the controls, such as the touch-screen, the on / off switch or the emergency stop button. In addition, the power cord, foot switch, and the door plug are connected there. The touch-screen serves as the main control panel.
The applicators, handpieces, and scanners direct the light onto the skin. Some applicators contain a hand switch on the front of the handle by which light emission can be triggered.
The scanners and handpieces of the internal modules are connected to the base unit by an electric signal cable and by an optical fiber which guides the aiming beam and working beam laser light to the handpiece/scanner in its core. The light is then guided onto the skin via several mirrors and lenses. Due to the round shape of the fiber core the resulting laser spot on the skin is circular. The size of the working beam spot corresponds to the nominal value when the distance tip touches the skin. For larger distances the spot size will increase, i.e. the laser beam is divergent.
The provided text is a 510(k) Summary for a medical device (FlexSys). This type of document is for demonstrating substantial equivalence to a predicate device, not typically a full clinical study with acceptance criteria and performance metrics in the way a diagnostic AI device would be evaluated. Lasers are hardware devices, and their performance is primarily assessed through compliance with safety and performance standards, not diagnostic accuracy metrics like sensitivity or specificity.
Therefore, many of the requested points are not applicable or cannot be extracted from this document, as it describes a laser system for dermatological procedures, not a diagnostic AI device.
Here's a breakdown based on the provided text, indicating where information is not applicable (N/A) or not provided:
1. Table of acceptance criteria and reported device performance:
This document focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering and safety standards, rather than specific performance metrics against clinical acceptance criteria for a diagnostic purpose. The "performance" for a laser device often refers to its safety and specified output parameters (e.g., wavelength, power, pulse duration), which are generally demonstrated through engineering and electrical/laser safety testing reports rather than clinical outcome measures with predefined acceptance thresholds.
| Acceptance Criteria (typically from predicate device or standards) | Reported Device Performance (as demonstrated by compliance) |
|---|---|
| UVB Modules (FlexSys EPL 308, EPL 308 lite) | (Demonstrated through equivalence to predicate devices and adherence to standards) |
| - Wavelength: 308nm | Consistent with ExSys 308 (K150752) and Clarteis Exciplex (K171702, K191086) |
| - Indication: Treatment of psoriasis and vitiligo (on intact skin only) | Same as predicate devices |
| - Mechanism of Action: UVB light penetrates skin, modulates immune system, stimulates melanocytes | Same as predicate devices |
| - Compliance with IEC 60825-1, IEC 60601-2-22, IEC 60601-1, IEC 60601-1-2 | Testing reports submitted, indicating compliance |
| Infrared 1550 Module (FlexSys Infrared 1550) | (Demonstrated through equivalence to predicate devices and adherence to standards) |
| - Wavelength: 1550nm | Consistent with Solta Fraxel DUAL (K130193) |
| - Indication: Coagulation of soft tissue, skin resurfacing, treatment of dyschromia, cutaneous lesions, periorbital wrinkles, acne scars, surgical scars | Same as predicate devices |
| - Mechanism of Action: Heats water in skin, denatures skin, stimulates healing reaction | Same as predicate devices |
| - Compliance with IEC 60825-1, IEC 60601-2-22, IEC 60601-1, IEC 60601-1-2 | Testing reports submitted, indicating compliance |
2. Sample size used for the test set and the data provenance:
N/A. This is a laser device, not a diagnostic AI device that would typically have a "test set" of clinical data to evaluate algorithms. Its performance is evaluated through engineering and safety testing. The document states "Testing reports were submitted for the following standards," implying laboratory/bench testing rather than clinical data from a "test set."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
N/A. As this is not a diagnostic AI device, there is no "ground truth" in the context of expert diagnosis or interpretation of images/data for a test set. The validation revolves around engineering specifications and safety compliance.
4. Adjudication method for the test set:
N/A. Not applicable for a laser device's regulatory submission focused on engineering and safety standards.
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:
N/A. This device is a laser system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
N/A. Not applicable to a laser device.
7. The type of ground truth used:
N/A. The "ground truth" for a laser device would be its physical properties and measured output (e.g., wavelength accuracy, power output, beam profile) confirmed against engineering specifications, and its safety compliance proven through adherence to international standards (IEC 60825-1, IEC 60601-2-22, IEC 60601-1, IEC 60601-1-2).
8. The sample size for the training set:
N/A. This is a hardware device; there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
N/A. Not applicable to a hardware device.
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March 10, 2023
GME German Medical Engineering GmbH Dietmar Fischer Technical Director Dreikoenigstr. 6-8 Erlangen, Bavaria 91054 Germany
Re: K221623
Trade/Device Name: FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm 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: GEX, FTC Dated: December 6, 2022 Received: December 12, 2022
Dear Dietmar Fischer:
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 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.
Jianting Wang -S
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) K221623
Device Name FlexSys
Indications for Use (Describe)
The device FlexSys is a multi-modality skin surface treatment system. Depending on the chosen modules the intended use and the mode of operation varies.
Modules UVB EPL 308 and UVB EPL 308 lite:
The GME FlexSys System with module UVB EPL 308 or UVB EPL 308 lite is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only.
Module Infrared 1550:
The GME FlexSys System with Infrared 1550 module 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 treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars.
| 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 K221623
This 510(k) Summary is submitted in accordance with the requirements of 21 CFR 807.92. Summary preparation date 2023-03-08 [21 CFR 807.92(a)(1)].
A. Applicant Name and Address [21 CFR 807.92(a)(1)]
GME German Medical Engineering GmbH. Dreikoenigstrasse 6-8 91054 Erlangen Bavaria, Germany Tel: +49 9131 934159 10 Fax: +49 9131 934159 99
B. Contact Information
GME German Medical Engineering GmbH. Dreikoenigstrasse 6-8 91054 Erlangen Bavaria, Germany Contact person: Dr. Dietmar Fischer Dietmar.fischer@gmeonline.de
C. Device Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
Trade Name: FlexSys Device Common Name: Laser Instrument for Dermatology Classification Name: Laser Instrument, Surgical Powered 21 CFR 878.4810 Product Code: GEX, FTC Device Classification: Class II
D. Predicate Devices [21 CFR 807.92(a)(3)]
The FleySys uses similar technology and physical output characteristics as the following predicate devices: K130193 Solta Medical Inc., Fraxel DUAL 1550/1927 Laser System K150752 GME ExSys 308 K171702, K191086 Clarteis Exciplex308nm
E. Device Description [21 CFR 807.92(a)(4)]
The device FlexSys consists of a base unit with up to two installed internal laser modules, handpieces and/or scanners for these modules and attachable applicators. All applicators, handpieces, and scanners are connected by an electrical cable.
The base unit contains most of the controls, such as the touch-screen, the on / off switch or the emergency stop button. In addition, the power cord, foot switch, and the door plug are connected there. The touch-screen serves as the main control panel.
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The applicators, handpieces, and scanners direct the light onto the skin. Some applicators contain a hand switch on the front of the handle by which light emission can be triggered.
The scanners and handpieces of the internal modules are connected to the base unit by an electric signal cable and by an optical fiber which guides the aiming beam and working beam laser light to the handpiece/scanner in its core. The light is then guided onto the skin via several mirrors and lenses. Due to the round shape of the fiber core the resulting laser spot on the skin is circular. The size of the working beam spot corresponds to the nominal value when the distance tip touches the skin. For larger distances the spot size will increase, i.e. the laser beam is divergent.
During development and manufacturing applicable directives, legal requirements and standards for medical devices were considered. Our product complies to them.
F. Indications for Use [21 CFR 807.92(a)(5)]
The device FlexSys is a multi-modality skin surface treatment system. Depending on the chosen modules the intended use and the mode of operation varies.
Modules EPL 308 and EPL 308 lite:
The GME Flex.Sys System with module EPL 308 lite is intended to be used for the treatment of psoriasis and vitiligo. It is to be used on intact skin only.
Module Infrared 1550:
The GME Flex.Sys System with Infrared 1550 module 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 treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars.
G. Device Specifications and Comparison to Predicates [21 CFR 807.92(a)(6)]
The FlexSys Platform is a multi-modality skin treatment device that can be equipped with up to six different modules. Thus, the predicate devices will vary from module to module. Three of these modules have already been approved, see K203054. Thus this comparison to predicates only deals with the remaining three modules, the Infrared 1550mm module and the two UVB 308nm modules.
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The predicate devices used to argue substantial equivalence are the GME ExSys 308 (K150752) and Clarteis Exciplex (K171702, K191086) for the UVB 308nm modules, and the Solta Fraxel DUAL (K130193) for the Infrared 1550nm module.
The equivalence comparisons for the UVB 308 nm wavelengths use the predicates GME ExSys 308 and Clarteis Exciplex.
The equivalence comparisons for the infrared 1550 nm laser wavelength use the predicate Solta Fraxel DUAL.
| Characteristic | GME FlexSysSystemModule EPL 308"FlexSys EPL 308" | GME FlexSysSystemModule EPL 308 lite"FlexSys EPL 308 lite" | GME ExSys 308"ExSys 308" | ClarteisExciplex308nm"Exciplex" |
|---|---|---|---|---|
| Applicable 510(k)s | NA | NA | K150752 | K171702, K191086 |
| Panel/ | General and PlasticSurgery | General and PlasticSurgery | General and PlasticSurgery | General and PlasticSurgery |
| Product Code/ | FTC | FTC | FTC | FTC |
| RegulationNumber | 21 CFR 878.4630 | 21 CFR 878.4630 | 21 CFR 878.4630 | 21 CFR 878.4630 |
| Indications for UseStatement | The GME FlexSysSystem with moduleEPL 308 is intendedto be used for thetreatment ofpsoriasis andvitiligo. It is to beused on intact skinonly | The GME FlexSysSystem with moduleEPL 308 lite isintended to be usedfor the treatment ofpsoriasis andvitiligo. It is to beused on intact skinonly | The GME ExSys308 System isintended to be usedfor the treatment ofpsoriasis andvitiligo. It is to beused on intact skinonly. | The Exciplex308nmis intended to beused for thetreatment ofpsoriasis, vitiligo,atopic dermatitis,and leukoderma. |
| Classification | Class II | Class II | Class II | Class II |
| Common Name | Ultraviolet lamp fordermatologicdisorders | Ultraviolet lamp fordermatologicdisorders | Ultraviolet lamp fordermatologicdisorders | Ultraviolet lamp fordermatologicdisorders |
| Mechanism ofAction | UVB lightpenetrates the skinand modulates theimmune system andstimulatesmelanocytes toproduce melanin | UVB lightpenetrates the skinand modulates theimmune system andstimulatesmelanocytes toproduce melanin | UVB lightpenetrates the skinand modulates theimmune system andstimulatesmelanocytes toproduce melanin | UVB lightpenetrates the skinand modulates theimmune system andstimulatesmelanocytes toproduce melanin |
1. UVB modules
2. Infrared 1550 module
| Characteristic | GME FlexSys System | Solta Fraxel DUAL1550/1927 Laser System |
|---|---|---|
| - | Module Infrared 1550 | |
| - | "FlexSys Infrared1550" | "Fraxel" |
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| Applicable510(k)s | NA | K130193 |
|---|---|---|
| Panel/ | General and PlasticSurgery | General and Plastic Surgery |
| Product Code/ | GEX | GEX |
| RegulationNumber | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Indications forUse Statement | The GME FlexSysSystem with Infrared1550 module is indicatedfor use in dermatologicalprocedures requiring thecoagulation of soft tissue,as well as for skinresurfacing procedures. Itis also indicated fortreatment of dyschromiaand cutaneous lesions,such as, but not limited tolentigos (age spots), solarlentigos (sun spots),actinic keratosis, andmelasma, and fortreatment of periorbitalwrinkles, acne scars andsurgical scars. | The Fraxel 1550 nm laser isindicated for use indermatological proceduresrequiring the coagulation ofsoft tissue, as well as for skinresurfacing procedures. It isalso indicated for treatment ofdyschromia and cutaneouslesions, such as, but notlimited to lentigos (age spots),solar lentigos (sun spots),actinic keratosis, andmelasma, and for treatment ofperiorbital wrinkles, acnescars and surgical scars. |
| Classification | Class II | Class II |
| Common Name | Laser surgical instrumentfor use in general andplastic surgery and indermatology | Laser surgical instrument foruse in general and plasticsurgery and in dermatology |
| Mechanism ofAction | Heats water in skinthrough the absorption oflight. The heatingdenatures the skin andstimulates a healingreaction by the skin. | Heats water in skin throughthe absorption of light. Theheating denatures the skin andstimulates a healing reactionby the skin. |
H. Performance Data [21 CFR 807.92(b)(2)]
The Guidance Document, Laser Products – Conformance with IEC 60825-1 and IEC 60601-2-22 (Laser Notice 56) January 19, 2018 was used.
Testing reports were submitted for the following standards:
- IEC 60825-1 Edition 2.0 2007-03: Safety of Laser Products Part 1: Equipment -Classification, and Requirements
- IEC 60601-2-22 Edition 3.1 2012-10: Medical Electrical Equipment Part 2-22: -Particular Requirements for Basic Safety and Essential Performance of Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment
- -IEC 60601-1:2005, AMD1:2012: Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance
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- -IEC 60601-1-2:2014: Medical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests
- I. Conclusion [21 CFR 807.92(b)(3)]
The GME FlexSys System is substantially equivalent to the predicate devices; in terms of technology, function and indications for use. There are no new questions of safety or efficacy raised by the introduction of the FlexSys System.
§ 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.