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The Diomed Delta 15 and Diomed Delta 30 Lasers are intended for use in delivering up to 15 or up to 30 Watts, respectively, of continuous wave or pulsed radiation to a flexible optical fiber or spot handpiece for use in ablation, incision, excision, coagulation and vaporisation of soft tissues in open and endoscopic surgical procedures, including EndoVenous Laser Treatment (EVLT).

Indications For Use:

• General Surgery .
• Ophthalmology/Oculoplastic .
• Urology .
• Gastroenterology .
• Gynecology .
• Otorhinolaryngology .
• Pulmonary/Thoracic .
• Dermatology/Plastic Surgery .
• Neurosurgery (coagulation only) .
• Orthopedic .
• Treatment of varicose veins and varicosities with superficial reflux of the Greater ● Saphenous Vein.
• Treatment of incompetent refluxing veins in the superficial venous system in the lower limb

The purpose of this Special 510(k) is to notify FDA of the proposed new Diòmed Delta 15 and Diomed Delta 30 Lasers, which are equivalent replacements for the Diomed 15plus and 30plus. Like their predecessors, the Diomed Delta 15 and Diomed Delta 30 Lasers consist of a Class IV GaAlAs (Gallium Aluminium Arsenide) diode laser with a wavelength of 810 ± 20 nm and a visible light (aiming beam) 5 milliwatt Class IIIa diode laser with a wavelength of 635 - 655 nm.

The Diomed Delta 15 and Diomed Delta 30 Lasers are made up of a treatment laser and aiming beam. The Diomed Delta 15 is a diode laser capable of delivering up to 119 J/cm² of pulsed radiation via a fiber optic hand piece or 15 W of continuous wave radiation via an optical fiber coupled to the laser aperture. The Diomed Delta 30 is a diode laser capable of delivering up to 400 J/cm2 of pulsed radiation via a fiber optic hand piece or 30 W of continuous wave radiation via an optical fiber coupled to the laser aperture.

The provided text is a 510(k) summary for the Diomed Delta 15 and Delta 30 Lasers. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results in the same way an AI/ML device submission would.

Therefore, many of the requested elements for an AI/ML device (like sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this document as it describes a laser device, not an AI/ML diagnostic tool.

However, I can extract the acceptance criteria (implicitly, the claim of equivalence) and the "study" that proves it as described in the document.

Detailed Breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Not Applicable. This document describes a laser device, not an AI/ML diagnostic system that uses test sets of data. The "test protocols" refer to engineering and functional testing of the physical laser device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. See point 2.

4. Adjudication method for the test set:

• Not Applicable. See point 2.

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:

• Not Applicable. This device is a surgical laser, not an AI assistance tool for human readers.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:

• Not Applicable. See point 5.

7. The type of ground truth used:

• Not Applicable. For a medical device like a laser, "ground truth" would relate to its physical specifications and safety standards, confirmed through engineering tests and compliance, rather than clinical outcomes or expert labels on data as in AI/ML. The "performance data" refers to technical validation that the device operates as specified and safely.

8. The sample size for the training set:

• Not Applicable. This document does not describe an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

• Not Applicable. See point 8.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document states:
"The Diomed Delta 15 and Diomed Delta 30 lasers have undergone a comprehensive series of test protocols in order to qualify and validate the performance of the devices. The results of the qualification/validation demonstrates equivalent performance to the predicate devices which themselves have substantial clinical and market evidence of acceptable performance. The Diomed Delta 15 and Diomed Delta 30 are therefore validated for use on this basis."

This indicates that the "study" was a technical qualification and validation process comparing the new Delta 15 and Delta 30 lasers against their predecessors (Diomed D15Plus and D30Plus Diode Lasers). The core of the acceptance criteria is substantial equivalence to these predicate devices. The "proof" is the outcome of these internal "test protocols" which demonstrated that the new devices perform equivalently to the previously cleared devices. This equivalence includes matching specifications like wavelength, power output, and intended uses. The clinical efficacy and safety are implicitly covered by the "substantial clinical and market evidence" of the predicate devices.

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The VARI-LASE procedure kit is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein

The VARI-LASE procedure kit contains a 600um fiber and the following accessories used to gain endovascular access: 0.035" / 150cm stainless steel guide wire 5Fr/45cm introducer sheath 19 Gauge/7cm Percutaneous Entry Needle

The provided text is a 510(k) Summary for a medical device (Vari-Lase Endovenous Laser Procedure Kit) and the FDA's clearance letter. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through extensive clinical studies.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The reasons are as follows:

• No specific acceptance criteria are listed for device performance. The submission relies on comparing the device's characteristics and intended use to an already cleared (predicate) device.
• No detailed study is described to demonstrate performance against acceptance criteria. The "Summary of Non-Clinical Testing" mentions tests for integrity and biocompatibility of marker bands, but these are general safety and materials tests, not performance studies as typically envisioned for clinical efficacy.
• There is no mention of a test set, ground truth, experts, or adjudication methods. These are elements of a clinical trial designed to prove effectiveness, which is not the primary purpose of a 510(k) submission focused on substantial equivalence.
• No information on MRMC studies or standalone algorithm performance is present, as this device is a physical instrument, not an AI or imaging diagnostic tool.
• No sample size for training or establishment of ground truth for a training set is applicable here, again because it's not an AI or algorithm-driven device.

In summary, the provided document is a regulatory submission for substantial equivalence, not a performance study report. It shows that the device is considered safe and effective because it is very similar to other devices already on the market, not through a head-to-head performance study against derived acceptance criteria.

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