(84 days)
The Intense Pulsed Light Treatment System (Model: HM-IPL-B8) is indicated for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign 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 HM-IPL-B8 device is an intense pulsed light system which delivers intense pulsed light at wavelengths ranging from 430mm-1200mm. 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.
The provided text is a 510(k) summary for the "Intense Pulsed Light Treatment System" (Model: HM-IPL-B8) and details its substantial equivalence to a predicate device (Intense Pulsed Light (IPL) Systems, K122995).
Based on the document, here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present acceptance criteria in a quantitative table format with specified thresholds. Instead, it demonstrates "Substantial Equivalence (SE)" to a predicate device by comparing various specifications and performance parameters. The "acceptance criteria" can be inferred as being "substantially equivalent" to the predicate device for each listed characteristic.
| Parameter | Acceptance Criteria (inferred: Substantially Equivalent to Predicate) | Reported Device Performance (Proposed Device) | Comparison Remark |
|---|---|---|---|
| Product Code | ONF | ONF | SE |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | SE |
| Class | II | II | SE |
| Intended Use | Matching predicate's core intended use | Matches predicate's core uses (hair removal, pigmented lesions, vascular lesions) | SE (with slight wording differences) |
| Light Source | Intense pulsed light | Intense pulsed light | SE |
| Wavelength | 430-1200nm, 530-1200nm, 640-1200nm, Optional: 480-1200nm, 560-1200nm, 590-1200nm, 690-1200nm, 750 -1200nm | 430-1200nm, 530-1200nm, 640-1200nm, Optional: 480-1200nm, 560-1200nm, 590-1200nm, 690-1200nm, 750 -1200nm | SE |
| Delivery System | Sapphire | Sapphire | SE |
| Energy Density | 10-60 J/cm² | 10-50 J/cm² | Analysis 1 (slight difference, not negative effect) |
| Pulse Delay | 5-50ms | 5-50ms | SE |
| Pulse Width | 1-20ms | 1-20ms | SE |
| Max. Power | 2000W | 2000W | SE |
| Spot Size (General) | Various sizes (e.g., 15mmX50mm, 12mmX33mm, 15mmX35mm) | 15mm×50mm; 80mm×40mm; | Analysis 2 (difference for treatment area, not negative effect) |
| Permanent Hair Reduction | |||
| Wavelength Range (nm) | 640-1200/690-1200/ 750-1200 | 640-1200/690-1200/ 750-1200 | SE |
| Energy Range (J/cm²) | 10-44 | 10-44 | - |
| Pulse Width (ms) | 3-14 | 3-14 | - |
| Pulse Delay (ms) | 16-32 | 16-32 | - |
| Spot Size (mm) | 12mm X33mm; 15mmX50mm; 15mmX35mm | 15mm×50mm; 80mm×40mm; | - |
| Pigmented Lesions | |||
| Wavelength Range (nm) | 480-1200/530-1200/560-1200 | 480-1200/530-1200/560-1200 | SE |
| Energy Range (J/cm²) | 12-44 | 12-44 | - |
| Pulse Width (ms) | 3-9 | 3-9 | - |
| Pulse Delay (ms) | 16-32 | 16-32 | - |
| Spot Size (mm) | 12mm X33mm; 15mmX50mm; 15mmX35mm | 15mm×50mm; 80mm×40mm; | - |
| Vascular Lesions | |||
| Wavelength Range (nm) | 530-1200/560-1200/ 590-1200 | 530-1200/560-1200/ 590-1200 | SE |
| Energy Range (J/cm²) | 10-42 | 10-42 | SE |
| Pulse Width (ms) | 3-8 | 3-8 | - |
| Pulse Delay (ms) | 16-32 | 16-32 | - |
| Spot Size (mm) | 12mm X33mm; 15mmX50mm; 15mmX35mm | 15mm×50mm; 80mm×40mm; | - |
| Power Supply | $220V \pm 20V \ 50Hz$ or $110V \pm 20V \ 60Hz$ | $110V \pm 10% \ 60Hz$ | SE |
| Electrical Safety | Compliance with IEC 60601-1 | Compliance with IEC 60601-1 | SE |
| EMC | Compliance with IEC 60601-1-2 | Compliance with IEC 60601-1-2 | SE |
| Patient Contact Material | Handpiece (Sapphire Crystal) | Handpiece (Sapphire Crystal) | SE |
| Biocompatibility (Cytotoxicity) | No toxicity (ISO 10993-5) | No toxicity (ISO 10993-5) | SE |
| Biocompatibility (Irritation) | No irritation (ISO 10993-10) | No irritation (ISO 10993-10) | SE |
| Biocompatibility (Sensitization) | No sensitization (ISO 10993-10) | No sensitization (ISO 10993-10) | SE |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "7. Clinical Test Conclusion: No clinical study is included in this submission."
Therefore, there is no test set, sample size, or data provenance related to clinical performance. The evaluation for substantial equivalence is based on non-clinical engineering tests and comparison of specifications to a previously cleared predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Since no clinical study was conducted, there are no experts involved in establishing ground truth for a clinical test set. The approval is based on non-clinical engineering and biological safety evaluations.
4. Adjudication Method for the Test Set
As there was no clinical study or test set involving expert assessments, no adjudication method was used.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done, as no clinical study was performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is an Intense Pulsed Light Treatment System, which is a physical device used for treatment, not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance study is not applicable. The performance is related to its physical parameters and biological effects.
7. The Type of Ground Truth Used
For the non-clinical tests conducted (e.g., electrical safety, EMC, biocompatibility), the "ground truth" would be the established standards and regulations (e.g., IEC 60601-1, ISO 10993-5, ISO 10993-10). The device's performance was compared against these standards to demonstrate compliance. For the comparison to the predicate, the "ground truth" is the specifications and intended use of the legally marketed predicate device.
8. The Sample Size for the Training Set
There is no training set as this is a physical medical device, not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set.
§ 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.