(57 days)
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or specific performance metrics typically associated with AI/ML algorithms. The software section focuses on standard software verification and validation for a "major" level of concern device.
Yes.
The device is used for "hair removal and permanent hair reduction," which are dermatological procedures that alter a biological function of the body, falling under the definition of a therapeutic device.
No
Explanation: The device is a laser system designed for dermatological and general surgical procedures, specifically hair removal and reduction. Its function is to deliver pulsed laser energy to damage hair follicles, which is a therapeutic action, not a diagnostic one.
No
The device description clearly outlines multiple hardware components including a main console unit, handpiece, umbilical, and footswitch, in addition to the software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "dermatological and general surgical procedures including hair removal and permanent hair reduction." This involves direct interaction with the patient's body for therapeutic purposes.
- Device Description: The description details a laser system that delivers energy to the skin to damage hair follicles. This is a physical intervention on the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This device does not perform any such tests on samples.
The device described is a therapeutic laser system used for cosmetic and surgical procedures, not for diagnostic testing of biological samples.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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.
Animal Study: An animal study was not conducted.
Clinical Studies: Clinical testing was not conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K073300 Milesman Premium Diode Laser System by Milesman S.L.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K140009 Alma Soprano™ Laser by Alma Lasers Ltd.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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.
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 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
2
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.
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."
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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.
5
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/Proprietary | ||||
| Name | The Modified Alma Lasers XL™ | |||
| Family of Multi-Application and | ||||
| Multi- Technology Platforms | ||||
| [SopranoXL SopranoXLi and | ||||
| SopranoICE] | Milesman Premium Pulsed Diode | |||
| Array Laser System | Milesman Compact Diode | |||
| Laser System | Similar (predicate and subject device are | |||
| made by the same company; Compact is a | ||||
| smaller lighter version of the Premium, | ||||
| made possible by using the latest available | ||||
| laser diode technology) | ||||
| Generic/Common | ||||
| Name | Hair removal laser | Hair removal laser | Hair removal laser | Identical |
| Classification | ||||
| Name | Laser Instrument, Surgical, | |||
| Powered | Laser Instrument, Surgical, | |||
| Powered | Laser Instrument, Surgical, | |||
| Powered | Identical | |||
| Regulation Name | Laser surgical instrument for use | |||
| in general, and plastic surgery | ||||
| and in dermatology | Laser surgical instrument for use | |||
| in general, and plastic surgery | ||||
| and in dermatology | Laser surgical instrument for | |||
| use in general, and plastic | ||||
| surgery 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) and | |||
| Super Hair Removal (SHR) | ||||
| Mode is intended for permanent | ||||
| reduction in hair regrowth, | ||||
| defined as a 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. | ||||
| The treatment of benign vascular | ||||
| lesions (The laser blanch (LB) | ||||
| mode). | ||||
| Use on all skin types (Fitzpatrick | ||||
| I-VI) including tanned skin (HR, | ||||
| SHR and LB modes) | The Milesman Premium Pulsed | |||
| Diode Array Laser System is | ||||
| intended for use in general and | ||||
| plastic surgery and dermatology | ||||
| procedures for the treatment of | ||||
| vascular lesions, such as | ||||
| angiomas, hemangiomas, | ||||
| telangiectasia and other benign | ||||
| vascular lesions and treatment | ||||
| for pseudofolliculitis barbae. The | ||||
| Milesman Premium is also used | ||||
| for removal of unwanted hair, | ||||
| permanent hair reduction and the | ||||
| treatment of benign pigmented | ||||
| lesions and leg veins in all skin | ||||
| types (Fitzpatrick I-VI), including | ||||
| tanned skin. | 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. | Similar but narrower in scope (subject | |||
| device indication does not mention vascular | ||||
| lesions, benign pigmented lesions or leg | ||||
| veins as the predicate does; subject device | ||||
| indication includes the same "permanent" | ||||
| definition that the reference device does | ||||
| whereas predicate does not; predicate | ||||
| mentions specific medical conditions | ||||
| whereas subject and reference devices do | ||||
| not) | ||||
| 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 hair | ||||
| removal" mode) | 1-3 Hz | 1-10 Hz | Similar (subject device is more comparable | |
| to the reference device than the predicate | ||||
| when 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 range | |
| of values than either the predicate or | ||||
| reference (in "HR" mode) device) | ||||
| Maximum fluence | ||||
| utilized per | ||||
| treatment protocols | 40 J/cm² | 40 J/cm² | 30 J/cm² | Similar (subject device has a lower |
| maximum value than either the predicate or | ||||
| reference device) | ||||
| Pulse Duration | 3.3-200 ms | 5 - 400 ms | 5 to 150 ms | Similar (Reference device provides the |
| greatest range of values; subject device | ||||
| provides the narrowest range) | ||||
| Spot Size | 12 x 10 mm | 10 x 10 mm | 10 x 10 mm | Identical (subject device compared to |
| predicate; reference device has larger spot | ||||
| size) | ||||
| Maximum average | ||||
| power | 100 W | 120 W | 120 W | Similar (subject device and predicate are |
| identical but both are 20% greater than the | ||||
| reference device) | ||||
| Peak Power | Unknown | 2000 W | 2000 W | Identical (subject device compared to |
| predicate) | ||||
| 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 somewhat |
| smaller than the predicate; both are smaller | ||||
| than the reference device) | ||||
| Weight | 50 kg. / 110 lbs. | 45 kg. / 120.64 lbs. | 9 kg. / 19 lbs. | Different (the subject device is considerably |
| lighter than both the predicate and reference | ||||
| devices) |
6
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
7
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.
8
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.