(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.
§ 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.