Search Results
Found 1 results
510(k) Data Aggregation
(209 days)
The Heager Medical Laser Family device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures. The device's 980nm laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology. The device is further indicated for laser assisted lipolysis. The device's 1470nm laser is intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures, indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
The Heager Medical Laser Family generates a 980nm wavelength laser to act on a target tissue to achieve hemostasis, ablation, and coagulation of the target tissue. The Heager Medical Laser Family generates a 1470 nm wavelength laser that acts on the water molecules of the target tissue to achieve the function of treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
The Heager Medical Laser Family has following characteristics:
- Dual wavelengths
- Temperature monitoring system
This document is a 510(k) clearance letter for a medical laser device, not a study report. Therefore, it does not contain the specific details about acceptance criteria and study results you requested in the format typically found in a clinical or performance study.
Based on the provided FDA 510(k) clearance letter for the Heager Medical Laser Family, here's what can be extracted and what information is not available within this document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative, measurable way for device performance in terms of clinical outcomes or diagnostic accuracy. Instead, it demonstrates substantial equivalence to predicate devices based on technical specifications and adherence to recognized electrical and safety standards.
The "reported device performance" is primarily presented as technical specifications and compliance with safety standards rather than clinical performance metrics.
| Feature/Standard | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Wavelength | Within specified range | 980nm±20nm, 1470nm±20nm |
| Laser Output Power | Within specified range | 980nm±20nm cw 20W, 1470nm±20nm cw 15W |
| Aiming Beam | Within specified range | Diode laser of 650nm, power Max. 10mW, adjustable brightness |
| Pulse Width Range | Appropriately wide for intended use, similar to reference devices | 0.1s - 10s (stepping 0.1s) |
| Electrical Safety | Compliance with IEC 60601-1 ed. 3.2, IEC 60825-1 ed. 2.0, IEC 60601-2-22 ed. 4.0 | Complies with IEC 60601-1:2005+A1:2012+A2:2020, IEC 60825-1:2014, IEC 60601-2-22:2019 (Note: IEC 60825-1 is listed as ed 2.0 in section 7.0 and 2014 in section 12, need clarification if 2014 is equivalent to or supersedes 2.0) |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 ed. 4.1 | Complies with IEC 60601-1-2:2014+A1:2021 |
| User Interface (IEC 60601-1-6) | Compliance with IEC 60601-1-6 ed. 3.2 | Complies with IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION |
| Biocompatibility of contact materials (implied for fiber) | Compliance with ISO 10993 series | Fibers must meet ISO 10993 series standards |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided document. As this is a 510(k) for a laser surgical instrument, the primary "test set" would be the device itself tested against engineering and safety standards, not a clinical data set in the way an AI/diagnostic device would have. The document explicitly states: "No clinical study implemented for the Diode laser therapy device."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not available. Given that "No clinical study implemented," there would be no ground truth established by experts in a clinical context for the purpose of a study demonstrating effectiveness. The "ground truth" here is the adherence to engineering standards and technical specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available. Adjudication methods are typically associated with clinical studies involving human observers or raters, which were not conducted for this 510(k) submission.
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
This information is not applicable and not available. This is a laser surgical instrument, not an AI software/diagnostic device that would involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and not available. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this 510(k) context is primarily compliance with recognized electrical, safety, and performance standards (e.g., IEC standards) and technical specifications of the device, demonstrated through non-clinical testing.
8. The sample size for the training set
This information is not applicable and not available. There is no "training set" in the context of an AI/machine learning model for this type of laser device 510(k) submission.
9. How the ground truth for the training set was established
This information is not applicable and not available for the same reason as point 8.
Ask a specific question about this device
Page 1 of 1