(57 days)
The Global Med Systems Milesman Compact Laser is intended for use in dermatological and general surgical procedures including hair removal and permanent hair reduction. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen. It is intended for use on all skin types (Fitzpatrick skin types 1-VI), including tanned skin.
The Global Med Systems Milesman Compact Laser delivers pulsed laser energy at 810 nm to the surface of the skin using a handpiece which contains the laser diodes. The Milesman Compact consists of the following components:
- The main console unit
- Handpiece
- Umbilical (between main console and handpiece)
- Footswitch
The system is operated using the touch screen on top of the main console unit. Firing of the laser is controlled with either the footswitch or the trigger on the handpiece.
During hair removal, the laser emits a wavelength of light that is absorbed by the pigment (melanin) in the hair. The light energy is converted to heat, which damages the tube-shaped sacs within the skin (hair follicles) that produce the hair. This damage inhibits or delays future hair growth.
The face of the hand piece which comes into contact with skin is actively cooled with a circulating coolant fluid.
The Global Med Systems Milesman Compact Laser (K203804) did not provide acceptance criteria and device performance that would traditionally be found in the context of an Artificial Intelligence/Machine Learning (AI/ML) powered medical device. The provided document is a 510(k) summary for a laser surgical instrument and focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data, rather than clinical efficacy or AI model performance.
Therefore, many of the requested fields regarding acceptance criteria, study methodologies for AI, expert involvement, and ground truth are not applicable or cannot be extracted from this document because it describes a hardware device, not an AI/ML-powered one.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
The document does not present a table of specific acceptance criteria for AI model performance and corresponding reported device performance, as it is not an AI/ML device. Instead, the device's performance is demonstrated through compliance with various safety and electrical standards, and through a comparison of technological characteristics with predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This device is a laser surgical instrument, and no clinical test set data for an AI/ML model is involved or reported. The performance data provided is focused on engineering and safety standards compliance.
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)
Not applicable. As this is not an AI/ML device, there is no "ground truth" to establish through expert consensus for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set for an AI/ML model to require an adjudication method.
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
Not applicable. This is not an AI/ML device, so no MRMC study or AI-assisted human reader performance was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML device, so no standalone algorithm performance was assessed.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. There is no "ground truth" in the context of an AI/ML model for this device. The assessment of the device's capabilities is based on its functional specifications and compliance with safety standards.
8. The sample size for the training set
Not applicable. This device is a laser surgical instrument and does not involve AI model training.
9. How the ground truth for the training set was established
Not applicable. There is no training set or associated ground truth for an AI model.
Summary of Relevant Performance Data from the Document (Non-AI/ML):
The performance data provided for the Global Med Systems Milesman Compact Laser focuses on the following non-clinical assessments to support its safety and design verification:
- Standards Compliance:
- IEC 60825-1 Edition 3.0 2014-05: Safety of laser products – Part 1: Equipment classification and requirements
- IEC 60601-2-22: Medical electrical equipment - Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- Biocompatibility Testing:
- Compact Biocompatibility report for in vitro cytotoxicity
- Compact Biocompatibility report for Dermal Irritation
- Compact Biocompatibility report for Skin Sensitization
- Electrical Safety and Electromagnetic Compatibility (EMC):
- IEC 60601-1:2005: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- Note: A gap analysis was performed to demonstrate compliance with FDA-recognized standard AAMI/ANSI ES60601-1:2005(R) 2012 and A1:2012.
- Software Verification and Validation Testing:
- Considered a "major" level of concern.
- Testing performed at unit and integrated levels using written protocols.
- Acceptance criteria defined by the Software Requirements Specification (SRS).
- Verification tested actual outputs against expected outputs for pre-established inputs.
- Validation performed at the system level using simulated use scenarios.
- Traceability matrix used for thoroughness.
- All software successfully passed verification and validation testing.
Conclusion stated in the document (Non-AI/ML):
The non-clinical data support the safety of the device and design verification and validation demonstrate that the Global Med Systems Milesman Compact device performs as intended in the specified use conditions. It performs comparably to the predicate device (and reference device) for the same intended use and shares similar indications, design features, and functional features, making it as safe, effective, and performant as the legally marketed predicate devices.
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Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 23, 2021
Global Med Systems SL % Kevin Morningstar Senior Consultant Morningstar Consulting Group 20319 E Costilla Ave Centennial, Colorado 80016
Re: K203804
Trade/Device Name: Global Med Systems Milesman Compact Laser 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 Dated: December 21, 2020 Received: December 28, 2020
Dear Kevin Morningstar:
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 and Part 809); 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 (OS) 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.
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name
Global Med Systems Milesman Compact Laser
Indications for Use (Describe)
The Global Med Systems Milesman Compact Laser is intended for use in dermatological and general surgical procedures including hair removal and permanent hair reduction. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen. It is intended for use on all skin types (Fitzpatrick skin types 1-VI), including tanned skin.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/3/Picture/1 description: The image shows the Milesman Compact logo. The logo consists of a blue square with a white "M" inside, followed by the word "milesman" in blue. Below the word "milesman" is a green rectangle with the word "compact" in white.
Compact 510(k) Summary
I. SUBMITTER: Fernando Diéz, CEO Global Med Systems S.L. AV / Padre Isla 127. Bajo, 24008 Leon Spain Phone: +34 619 118 489 Fax: N/A fdiez@milesman.com
Contact Person: Kevin Morningstar, Regulatory Consultant (510k Preparer and FDA correspondent) Morningstar Consulting Group LLC 20319 E Costilla Ave Centennial, CO 80016 (720) 940-8271 Fax: N/A kevin.morningstar@gmail.com
Date Prepared: February 14, 2021
II. DEVICE
Name of Device: Global Med Systems Milesman Compact Laser Common or Usual Name: Powered Laser Surgical Instrument Classification Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Requlation Number: 21 CFR 878.4810 Regulatory Class: Class II Product Code: GEX
III. PREDICATE DEVICE
K073300 Milesman Premium Diode Laser System by Milesman S.L.
This predicate has not been subject to a design-related recall.
Reference Device: K140009 Alma Soprano™ Laser by Alma Lasers Ltd.
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Image /page/4/Picture/1 description: The image shows the logo for Milesman Compact. The logo consists of a blue square with a white "M" inside, followed by the word "milesman" in blue. Below the word "milesman" is a green rectangle with the word "compact" in white.
IV. DEVICE DESCRIPTION
The Global Med Systems Milesman Compact Laser delivers pulsed laser energy at 810 nm to the surface of the skin using a handpiece which contains the laser diodes. The Milesman Compact consists of the following components:
-
- The main console unit
-
- Handpiece
-
- Umbilical (between main console and handpiece)
-
- Footswitch
The system is operated using the touch screen on top of the main console unit. Firing of the laser is controlled with either the footswitch or the trigger on the handpiece.
During hair removal, the laser emits a wavelength of light that is absorbed by the pigment (melanin) in the hair. The light energy is converted to heat, which damages the tube-shaped sacs within the skin (hair follicles) that produce the hair. This damage inhibits or delays future hair growth.
The face of the hand piece which comes into contact with skin is actively cooled with a circulating coolant fluid.
V. INDICATIONS FOR USE
The Global Med Systems Milesman Compact Laser is intended for use in dermatological and general surgical procedures including hair removal and permanent hair reduction. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen. It is intended for use on all skin types (Fitzpatrick skin types 1-VI), including tanned skin.
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Image /page/5/Picture/1 description: The image shows the logo for Milesman Compact. The logo consists of a blue square with a white "M" inside, followed by the word "milesman" in blue. Below the word "milesman" is the word "compact" in white on a green background.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE AND REFERENCE DEVICES
| Alma Soprano* | Milesman Premium | Milesman Compact | Comparison Remarks | |
|---|---|---|---|---|
| (Reference) - K140009 | (Predicate) - K073300 | (Subject) - K203804 | (subject to predicate/reference) | |
| Trade/ProprietaryName | The Modified Alma Lasers XL™Family of Multi-Application andMulti- Technology Platforms[SopranoXL SopranoXLi andSopranoICE] | Milesman Premium Pulsed DiodeArray Laser System | Milesman Compact DiodeLaser System | Similar (predicate and subject device aremade by the same company; Compact is asmaller lighter version of the Premium,made possible by using the latest availablelaser diode technology) |
| Generic/CommonName | Hair removal laser | Hair removal laser | Hair removal laser | Identical |
| ClassificationName | Laser Instrument, Surgical,Powered | Laser Instrument, Surgical,Powered | Laser Instrument, Surgical,Powered | Identical |
| Regulation Name | Laser surgical instrument for usein general, and plastic surgeryand in dermatology | Laser surgical instrument for usein general, and plastic surgeryand in dermatology | Laser surgical instrument foruse in general, and plasticsurgery and in dermatology | Identical |
| Regulatory Class | Class II | Class II | Class II | Identical |
| Product Code | GEX | GEX | GEX | Identical |
| Regulation Number | 21CFR 878.4810 | 21CFR 878.4810 | 21CFR 878.4810 | Identical |
| Review Panel | General and Plastic Surgery | General and Plastic Surgery | General and Plastic Surgery | Identical |
| Indications for use | The Hair Removal (HR) andSuper Hair Removal (SHR)Mode is intended for permanentreduction in hair regrowth,defined as a long term, stablereduction in the number of hairsregrowing when measured at 6,9 and 12 months after thecompletion of a treatmentregimen.The treatment of benign vascularlesions (The laser blanch (LB)mode).Use on all skin types (FitzpatrickI-VI) including tanned skin (HR,SHR and LB modes) | The Milesman Premium PulsedDiode Array Laser System isintended for use in general andplastic surgery and dermatologyprocedures for the treatment ofvascular lesions, such asangiomas, hemangiomas,telangiectasia and other benignvascular lesions and treatmentfor pseudofolliculitis barbae. TheMilesman Premium is also usedfor removal of unwanted hair,permanent hair reduction and thetreatment of benign pigmentedlesions and leg veins in all skintypes (Fitzpatrick I-VI), includingtanned skin. | The Global Med SystemsMilesman Compact Laser isintended for use indermatological and generalsurgical procedures includinghair removal and permanenthair reduction. Permanent hairreduction is defined as thelong-term, stable reduction inthe number of hairs regrowingwhen measured at 6, 9, and 12months after the completion ofa treatment regimen. It isintended for use on all skintypes (Fitzpatrick skin types 1-VI), including tanned skin. | Similar but narrower in scope (subjectdevice indication does not mention vascularlesions, benign pigmented lesions or legveins as the predicate does; subject deviceindication includes the same "permanent"definition that the reference device doeswhereas predicate does not; predicatementions specific medical conditionswhereas subject and reference devices donot) |
| Light/Laser Source | Diode | Diode | Diode | Identical |
| Alma Soprano* | Milesman Premium | Milesman Compact | Comparison Remarks | |
| (Reference) - K140009 | (Predicate) - K073300 | (Subject) - K203804 | (subject to predicate/reference) | |
| Wavelength | 810 nm | 810 nm (nominal) | 810 nm | Identical |
| Repetition rate | .5-3 Hz ("HR" or "hair removal"mode)5-10 Hz ("SHR" or "super hairremoval" mode) | 1-3 Hz | 1-10 Hz | Similar (subject device is more comparableto the reference device than the predicatewhen combining predicate's "HR" mode and"SHR" mode) |
| Fluence -Energy Density | 2-120 J/cm² ("HR" mode)2-20 J/cm² ("SHR" mode) | 10 - 100 J/cm² | 12-30 J/cm² | Similar (subject device has a narrower rangeof values than either the predicate orreference (in "HR" mode) device) |
| Maximum fluenceutilized pertreatment protocols | 40 J/cm² | 40 J/cm² | 30 J/cm² | Similar (subject device has a lowermaximum value than either the predicate orreference device) |
| Pulse Duration | 3.3-200 ms | 5 - 400 ms | 5 to 150 ms | Similar (Reference device provides thegreatest range of values; subject deviceprovides the narrowest range) |
| Spot Size | 12 x 10 mm | 10 x 10 mm | 10 x 10 mm | Identical (subject device compared topredicate; reference device has larger spotsize) |
| Maximum averagepower | 100 W | 120 W | 120 W | Similar (subject device and predicate areidentical but both are 20% greater than thereference device) |
| Peak Power | Unknown | 2000 W | 2000 W | Identical (subject device compared topredicate) |
| Tissue Cooling | Contact | Contact | Contact | Identical |
| How Supplied | Non-sterile - cleanable | Non-sterile - cleanable | Non-sterile - cleanable | Identical |
| Exposure Indicator | Audible & visual indicator | Audible & visual indicator | Audible & visual indicator | Identical |
| User Interface | Touch screen | Touch Screen | Touch Screen | Identical |
| Laser Dimension | 53 cm x 57 cm x 120 cm | 40 cm x 50 cm x 36 cm | 35 cm x 42 cm x 23 cm | Different (the subject device is somewhatsmaller than the predicate; both are smallerthan the reference device) |
| Weight | 50 kg. / 110 lbs. | 45 kg. / 120.64 lbs. | 9 kg. / 19 lbs. | Different (the subject device is considerablylighter than both the predicate and referencedevices) |
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Global Med Systems Milesman Compact Laser 510(k) K203804
Image /page/6/Picture/1 description: The image shows the logo for Milesman Compact. The logo consists of a blue square with a white "M" inside, followed by the word "milesman" in blue. Below the word "milesman" is the word "compact" in white, set against a green background.
- 810 nm diode laser version of the Soprano™ with 1.2 cm² laser spot size, in either HR (hair removal) mode
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Image /page/7/Picture/1 description: The image shows the logo for Milesman Compact. The logo consists of a blue square with a white "M" inside, followed by the word "milesman" in blue. Below the word "milesman" is a green rectangle with the word "compact" in white.
VII. PERFORMANCE DATA
The following performance data on the current design were provided in support of the substantial equivalence determination.
IEC 60825-1 Edition 3.0 2014-05 Safety of laser products – Part 1: Equipment classification and requirements
IEC 60601-2-22 Medical electrical equipment - Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
Biocompatibility testing
Compact Biocompatibility report for in vitro cytoxicity Compact Biocompatibility report for Dermal Irritation Compact Biocompatibility report for Skin Sensizitation
Electrical safety and electromagnetic compatibility (EMC)
IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
Note: A gap analysis was conducted to demonstrate compliance with the FDArecognized standard for electrical safety (AAMI/ANSI ES60601-1:2005(R) 2012 and A1:2012) because testing to the non-FDA-recognized standard IEC 60601-1:2005 was conducted.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
Software verification and validation testing was performed at both the unit level and integrated level using written protocols. The written protocols include a description of the acceptance criteria, which in most cases is taken as defined by the SRS (Software Requirements Specification). Test results are documented in test reports. Verification testing exercised software functionality by comparing actual outputs to those expected in response to pre-established inputs. Validation testing was done at the system level by operating the device in simulated use scenarios. A traceability matrix was used to account for each software requirement in the SRS to ensure testing thoroughness. For test failures, the software under test was analyzed and rewritten and the software test repeated. All software successfully passed verification and validation testing.
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Image /page/8/Picture/1 description: The image shows the logo for Milesman Compact. The logo consists of a blue square with a white "M" inside, followed by the word "milesman" in blue. Below the word "milesman" is a green rectangle with the word "compact" in white.
Animal Study An animal study was not conducted.
Clinical Studies Clinical testing was not conducted.
VIII. CONCLUSIONS
The non-clinical data support the safety of the device and design verification and validation demonstrate that the Global Med Systems Milesman Compact device performs as intended in the specified use conditions. The Global Med Systems Milesman Compact device performs comparably to the predicate device (and reference device) that was marketed for the same intended use and shares the same or similar indications for use, similar design features, and functional features with, and thus is as safe, as effective, and performs as well as the legally marketed predicate devices.
§ 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.