(154 days)
The IRIDERM Apex 800 is indicated for hair removal.
The IRIDERM Apex 800 is a semiconductor diode laser system that delivers pulsed infrared 800 nm laser light intended to be used for the indication of hair removal. Energy is delivered into treatment spots of 7 mm, 8.5 mm or 10 mm diameter. The Pulse Duration can be selected from 5 to 30 msec. The maximum Energy Density that can be delivered is dependent on the diameter of the treatment spot and is 40, 32 and 23 J/cm2 for spot sizes of 7, 8.5 and 10 mm respectively. Visible red (630-650 nm) semiconductor diode lasers are used for aiming.
The provided text is a 510(k) summary for the IRIDERM Apex 800, a laser system for hair removal. It details the device's characteristics and compares it to predicate devices to establish substantial equivalence.
Based on the information provided in the text, here's a breakdown regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not present in the provided document. The 510(k) summary focuses on establishing substantial equivalence to predicate devices, rather than defining and testing against specific acceptance criteria for performance metrics.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Test Set: Not applicable. The document explicitly states: "Non-Clinical performance Data: None" and "Clinical performance Data: None". Therefore, there was no test set in the context of performance data collection for this submission. The substantial equivalence was based on technological similarity to predicate devices.
- Data Provenance: Not applicable, as no performance data was presented.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. No test set was used, and thus no ground truth was established by experts for performance evaluation.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No test set was used for performance evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size
- MRMC Study: No. The document explicitly states: "Clinical performance Data: None".
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a laser system, not an AI algorithm. The concept of "standalone performance" in the context of an algorithm does not apply here.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable. As acknowledged in points 2, 3, and 4, there was no performance data or test set presented to establish a ground truth. The submission relies on establishing substantial equivalence based on technological characteristics and intended use compared to legally marketed predicate devices.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The device is a physical medical device (laser system), not an AI/ML 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 mentioned, this is not an AI/ML algorithm requiring a training set.
Summary of Acceptance Criteria and Study:
The provided 510(k) summary for the IRIDERM Apex 800 does not describe any specific acceptance criteria or an inferential study to prove that the device meets those criteria.
Instead, the submission relies entirely on demonstrating substantial equivalence to existing predicate devices (Cynosure, Inc., PhotoGenica LPIR (K971737) and Coherent, Inc., LightSheer (K973324)) already on the market for the indication of hair removal. The argument for substantial equivalence is based on:
- Similar Intended Use: All devices are indicated for hair removal.
- Similar Technological Characteristics: The IRIDERM Apex 800 is a semiconductor diode laser system delivering infrared 800 nm light, with comparable spot sizes, pulse durations, and energy densities to the predicate devices. The document directly compares these specifications across all three devices.
The text explicitly states: "Non-Clinical performance Data: None" and "Clinical performance Data: None." This means the submission did not include new performance studies (either non-clinical or clinical) to establish safety and effectiveness against specific acceptance criteria. The FDA's clearance (DEC - 9 1999 letter) indicates that they reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed devices, allowing it to proceed to market without new performance data.
§ 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.