(276 days)
The PlatinumGMT™ IPL System Cloud device (inclusive of the hand piece used to deliver pulsed-light energy) is indicated for use in surgical, aesthetic and cosmetic applications in permanent hair reduction, moderate inflammatory acne vulgaris, benign cutaneous pigmented and vascular lesions.
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.
The PlatinumGMT™ IPL System Cloud device is an intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 560 nm-1200 nm. Intense Pulsed Light (IPL) systems work on the principles of selective thermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin.
IPL Systems are different from lasers in that they deliver many wavelengths in each pulse of light instead of just one wavelength. Generally, IPL enhances penetration without using excessive energy levels and enables targeting of specific chromophores. Based on this, the PlatinumGMT™ IPL System Cloud device (inclusive of the hand piece used to deliver pulsed light energy) is indicated for use in surgical, aesthetic and cosmetic applications in permanent hair reduction, moderate inflammatory acne vulgaris, benign cutaneous pigmented, and vascular lesions.
This document is a 510(k) summary for the PlatinumGMT™ IPL System Cloud, an Intense Pulsed Light (IPL) system. It outlines the device's indications for use and demonstrates its substantial equivalence to previously cleared predicate devices through non-clinical bench testing.
Here's an analysis of the provided information, focusing on acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for clinical performance. Instead, it demonstrates the device's performance by showing its adherence to various safety and electrical standards and by drawing a comparison of its technical specifications to predicate devices. The implicit "acceptance criterion" for this 510(k) submission is that the proposed device is substantially equivalent to legally marketed predicate devices, meaning it is as safe and effective as the predicates.
The "reported device performance" in this context refers to its technical specifications and its compliance with relevant international standards.
| Acceptance Criteria (Implicit) | Reported Device Performance (PlatinumGMT™ IPL System Cloud) |
|---|---|
| Electrical Safety Standards Compliance | Complies with: - IEC 60601-1-2 Ed 3:2007-03 (EMC) - IEC 60601-1: 1988, Amend 1, II, Amend 2, 1995 (General Safety) - IEC 60335-2-27 Ed 4.0 (Skin exposure to UV/IR radiation) - IEC/EN 60335-1 (Safety of household and similar electrical appliances - General) |
| Electromagnetic Compatibility (EMC) Standards Compliance | Complies with: - EN 55014-1:2008 (Emission) - IEC 61000-3-2 (Harmonics) - IEC 61000-3-3 (Flicker) - EN 55014-2 (HHA Immunity Standard) - IEC 61000-4-2 (Electrostatic Discharge) - IEC 61000-4-3 (Radiated RF) - IEC 61000-4-4 (Electrical Fast Transients) - IEC 61000-4-5 (Surge) - IEC 61000-4-6 (Conducted RF) - IEC 61000-4-11 (Voltage Dips and Interrupts) |
| Performance Test (Output Energy, Spot Size) | Test results demonstrated compliance (details not specified, but the comparative tables provide the ranges). |
| Technological Characteristics Substantial Equivalence to Predicates | Same light medium, wavelength range (430-1200nm), control method, and intended use as predicate devices. Specifics compared to predicates (K131859 & K122995): - Indications for Use: Permanent hair reduction, moderate inflammatory acne vulgaris, benign cutaneous pigmented, and vascular lesions. - Wavelength: 430-1200nm (Proposed), 530-1200nm (K131859), 430-1200nm (K122995) - Energy Range: 10-60 J/cm² (Proposed), 20-50 J/cm² (K131859), 10-60 J/cm² (K122995) - Pulse Delay: 1-99 ms (Proposed), 0.1-40 ms (K131859), 5-50 ms (K122995) - Pulse Duration: 1-9.9 ms (Proposed), 1-25 ms (K131859), 1-14 ms (K122995) - Spot Size: 10x45mm & 8x34mm (Proposed), 8x40mm & 15x60mm (K131859), 12x33mm; 15x50mm & 15x35mm (K122995) Differences in wavelength range, energy density, pulse delays, and duration are considered not to affect safety and efficacy. |
2. Sample Size Used for the Test Set and the Data Provenance
The document explicitly states: "Bench tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate devices."
This indicates that there was no human clinical test set in the traditional sense for this 510(k) submission. The "test set" comprised physical measurements and evaluations of the device against engineering and safety standards.
- Sample Size: Not applicable in terms of human subjects or medical images. The "sample" would be the device itself and its components undergoing bench testing.
- Data Provenance: The data provenance is from non-clinical bench testing conducted to evaluate the device's technical specifications and compliance with international standards (e.g., IEC, EN). The country of origin for the testing itself is not specified but would typically be conducted by the manufacturer or a certified testing laboratory. The submission is from Global Medical Technology S.L. in Spain.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: Not applicable, as no human clinical "test set" was used requiring expert review for ground truth establishment.
- Qualifications of Experts: N/A. The "truth" for the bench tests is defined by the technical specifications and the requirements of the international safety and performance standards.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable, as no human clinical test set requiring expert adjudication was performed. The bench tests would have objective pass/fail criteria based on the standard requirements.
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
- MRMC Study: No. This 510(k) submission describes a traditional medical device (IPL system) that delivers energy for treatment. It is a physical device, not an AI or imaging diagnostic tool that would involve human readers interpreting output, and therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is not an algorithm or AI device; it's a physical light-based therapy system. The "performance" is its ability to meet declared technical specifications and safety standards, which was evaluated via bench testing.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this submission is based on:
- Engineering Specifications: The device must meet its own design specifications for output energy, spot size, wavelength, etc.
- International Standards Compliance: The device must comply with specific electrical safety and EMC standards (e.g., IEC 60601 series, EN 55014 series). These standards represent an established "ground truth" for device safety and basic performance.
- Substantial Equivalence to Predicate Devices: The key "ground truth" for a 510(k) is demonstrating that the new device is as safe and effective as existing legally marketed devices, which is assessed by comparing technological characteristics and intended uses.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device is not an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no "training set" for this type of device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three heads facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 19, 2014
Global Medical Technology S.L. % Mr. George J. Hattub Medicsense, USA 291 Hillside Avenue Somerset, Massachusetts 02726
Re: K140668
Trade/Device Name: PlatinumGMT™ IPL System Cloud 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: ONF Dated: November 16, 2014 Received: November 24, 2014
Dear Mr. Hattub:
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. 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.
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
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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Binita S. Ashar -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number K140668:
Device Name: PlatinumGMT™ IPL System Cloud
Indications For Use: The PlatinumGMT™ IPL System Cloud device (inclusive of the hand piece used to deliver pulsed-light energy) is indicated for use in surgical, aesthetic and cosmetic applications in permanent hair reduction, moderate inflammatory acne vulgaris, benign cutaneous pigmented and vascular lesions.
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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
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510(k) Summary
This 510(k) summary of safety and effectiveness is submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990 and follows the office of Device Evaluation (ODE) guidance concerting the organization and content of a 510(k) summary.
The assigned 510(k) Number: K140668
- Date of Submission: December 5, 2014
2. Sponsor
GLOBAL MEDICAL TECHNOLOGY S.L. C/ Isla de Alegranza, 2 (Nave 51) - CP 28703 - San Sebastián de los Reyes - Madrid -ESPANA Teléfono: (+34) 902 024 191 www.gmt-europa.com Contact Person: Name: Derliz David Díaz Title: Operations Manager Phone number: +52-155-4858-7812 E-mail: derliz.diaz@gmt-europa.com
3. Submission Correspondent
George J. Hattub Medicsense, USA 291 Hillside Avenue Somerset, MA 02726 Tel: 508-479-6116 Email: ghattub@comcast.net
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4. Proposed Device Identification
Proposed Device Name: PlatinumGMT™ IPL System Cloud Classification: Class II Product Code: ONF Regulation Number: 21 CFR 878.48 I 0 Review Panel: General and Plastic Surgery
Indications for Use
The PlatinumGMT™ IPL System Cloud device (inclusive of the hand piece used to deliver pulsed-light energy) is indicated for use in surgical, aesthetic and cosmetic applications in permanent hair reduction, moderate inflammatory acne vulgaris, benign cutaneous pigmented and vascular lesions.
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 reqimen.
| Filter Setting and | Skin Types | |||||
|---|---|---|---|---|---|---|
| Condition | Wavelength Range | I | II | III | IV | V |
| Hair Reduction | 695-1200 | 695-1200 | 695-1200 | 695-1200 | 755-1200 | |
| Acne | 430-1200 | 430-1200 | 430-1200 | 430-1200 | ---------- | |
| Vascular Lesions | 560-1200 | 560-1200 | 560-1200 | 560-1200 | ---------- | |
| Pigmented Lesions | 560-1200 | 560-1200 | 560-1200 | 560-1200 | ---------- |
5. Predicate Device Identification
510(k) Number: K131859
Product Name: Multifunctional Series
Manufacturer: Beijing Honkon Technologies Co., Ltd.
510(k) Number: K122995
Product Name: Intense Pulse Light (IPL) Systems/ MED-210/230
Manufacturer: Beijing Kes Biology Technology Co., Ltd.
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6. Device Description
The PlatinumGMT™ IPL System Cloud device is an intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 560 nm-1200 nm. Intense Pulsed Light (IPL) systems work on the principles of selective thermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin.
IPL Systems are different from lasers in that they deliver many wavelengths in each pulse of light instead of just one wavelength. Generally, IPL enhances penetration without using excessive energy levels and enables targeting of specific chromophores. Based on this, the PlatinumGMT™ IPL System Cloud device (inclusive of the hand piece used to deliver pulsed light energy) is indicated for use in surgical, aesthetic and cosmetic applications in permanent hair reduction, moderate inflammatory acne vulgaris, benign cutaneous pigmented, and vascular lesions.
7. Non-Clinical Test Conclusion
Bench tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate devices. The test results demonstrated that the proposed device complies with the following: (a) IEC 60601-1-2 Edition 3:2007-03, medical electrical equipment - Part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests
(b) IEC 60601-1. Medical Electrical Equipment- Part 1: General Requirements for Safety. 1988: Amendment I, 1991-II, Amendment 2, 1995.
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(c) IEC 60335-2-27 ed 4.0 Household and similar electrical appliances - Safety - Part 2-27: Particular requirements for appliances for skin exposure to ultraviolet and infrared radiation
(d) IEC/EN 60335-1 Safety of household and similar electrical appliances - General
(e) EN 55014-1:2008 Electromagnetic compatibility - Reguirements for household appliances, electric tools and similar apparatus -- Part 1: Emission; Harmonics IEC 61000-3-2; Flicker IEC 61000-3-3
(f) EN 55014-2 (HHA Immunity Standard ); Electrostatic Discharge IEC 61000-4-2 (±6kV Contact ±8kV Air); Radiated RF IEC 61000-4-3 (80 – 2500 MHz 3V/m); Electrical Fast Transients IEC 61000-4-4 (±2kV AC mains ±1kV other); Surge IEC 61000-4-5 (±1kV Differential ±2kV Common; Conducted RF IEC 61000-4-6 (3Vrms, 0.15 – 80 MHz); IEC 61000-4-11 Voltage Dips and Interrupts (>95%V for 0.5 Cycle 60%V for 5 Cycles).
(q) Performance Test (output energy, spot size)
8. Technological Characteristics Comparison
The proposed device has the same technological characteristics with the predicate devices, such as light medium, wavelength, control method and intended use.
9. Substantially Equivalent Conclusion
The wavelength range, energy density, pulse delays and duration of the proposed device are similar to the predicate devices, the slight differences are not considered to affect safety and efficacy.
Based on the comparison and analysis below, the proposed device is determined to be Substantially Equivalent (SE) to the predicate devices.
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Substantial Equivalence Comparison
| ITEM | Proposed DevicePlatinumGMT™ IPLSystem (CLOUD) | Predicate DeviceMultifunctional Series(K131859) | Predicate DeviceIntense Pulsed Light(IPL) Systems(K122995) | Pulse Delay | 1-99ms | 0.1-40ms | 5-50ms |
|---|---|---|---|---|---|---|---|
| ProductCode | ONF | ONF | ONF | PulseDuration | 1-9.9 ms | 1-25ms | 1-14ms |
| Regulation Number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Maximum Power | 1200W | 2000W | 1400W (MED-210)2000W (MED-230) |
| Class | II | II | II | PowerSupply | AC 230V +/- 20V50Hz/60Hz12A | unknown | 220V+/-20V 50Hz110V+/-20V 60Hz |
| IntendedUse | The PlatinumGMT™IPL System Clouddevice (inclusive of thehand piece used todeliver pulsed lightenergy) is indicated foruse in surgical,aesthetic and cosmeticapplications inpermanent hairreduction; moderateinflammatory acne ,benign cutaneouspigmented, andvascular lesions.Permanent hair | The MultifunctionalSeries device (inclusiveof the handpiece usedto deliver pulsed-lightenergy) are indicatedfor use insurgical, aesthetic andcosmetic applications inhair removal, moderateinflammatory acnevulgaris, and benigncutaneousvascular lesions. | The Intense PulsedLight (IPL) Systems(inclusive of thehandpiece used todeliver pulsed-lightenergy) are indicatedfor use in surgical,aesthetic and cosmeticapplications inpermanent hairreduction, treatment ofpigmented lesions,moderate inflammatoryacne vulgaris,ephelides (freckles),and vascular lesions | Spot Size | 10 x 45mm &8 x 34 mm | 8 x 40mm &15 x 60mm | 12 x 33mm;15 x 50mm &15 x 35mm |
| LightSource | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | ||||
| Wavelength | 430-1200nm | 530-1200nm | 430-1200nm | ||||
| DeliverySystem | Sapphire | Sapphire | Sapphire | ||||
| EnergyRange | 10-60J/cm2 | 20-50J/cm2 | 10-60J/cm2 |
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| Settings for Specific Indications for Use- Hair Reduction | |||
|---|---|---|---|
| Proposed DevicePlatinumGMT™ IPLSystem (CLOUD) | Predicate DeviceMultifunctional Series(K131859) | Predicate DeviceIntense Pulsed Light(IPL) Systems(K122995) | |
| Wavelength(mm) | 695 -1200 | 610-1200 | 640-1200 |
| Energy Range (J/cm2) | 10-60 | 20-50 | 10-44 |
| Pulse Duration (ms) | 9.9 | 13-15 | 3-14 |
| Pulse Delay (ms) | 1-99 | 15-35 | 16-32 |
| Spot Size(mm) | 10 x 44 | 8 x 4015 x 60 | 12 x 3315 × 5015 x 35 |
| Settings for Specific Indications for Use- Treating Acne | |||
|---|---|---|---|
| Proposed DevicePlatinumGMT™ IPLSystem (CLOUD) | Predicate DeviceMultifunctional Series(K131859) | Predicate DeviceIntense Pulsed Light(IPL) Systems(K122995) | |
| Wavelength(mm) | 430-1200 | 530-1200 | 430-1200 |
| Energy RangeJ/cm2 | 10-40 | 20-50 | 10-40 |
| Pulse Duration(ms) | 3-8 | 3-10 | 3-8 |
| Pulse Delay(ms) | 16-32 | 15-35 | 16-32 |
| Spot Size(mm) | 8 × 34 | 8 × 4015 × 60 | 12 × 3315 × 5015 × 35 |
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| Settings for Specific Indications for Use Vascular Lesions | |||
|---|---|---|---|
| Proposed DevicePlatinumGMT™ IPLSystem (CLOUD) | Predicate DeviceMultifunctional Series(K131859) | Predicate DeviceIntense Pulsed Light(IPL) Systems(K122995) | |
| Wavelength(mm) | 560-1200 | 585-1200 | 530-1200 |
| Energy RangeJ/cm2 | 10-50 | 20-50 | 10-42 |
| Pulse Duration(ms) | 9.9 | 3-10 | 3-8 |
| Pulse Delay(ms) | 16-32 | 15-35 | 16-32 |
| Spot Size(mm) | 8 x 34 | 8 x 4015 x 60 | 12 x 3315 x 5015 x 35 |
| Settings for Specific Indications for Use Pigmented Lesions | |||
|---|---|---|---|
| Proposed DevicePlatinumGMT™ IPLSystem (CLOUD) | Predicate DeviceMultifunctional Series(K131859) | Predicate DeviceIntense Pulsed Light(IPL) Systems(K122995) | |
| Wavelength (mm) | 560-1200 | Not cleared | 480-1200 |
| Energy Range J/cm2 | 12-44 | Not cleared | 12-44 |
| Pulse Duration (ms) | 3-9 | Not cleared | 3-9 |
| Pulse Delay (ms) | 16-32 | Not cleared | 16-32 |
| Spot Size (mm) | 8 × 34 | Not cleared | 12 × 3315 × 5015 × 35 |
§ 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.