(15 days)
Superficial incision, excision, resection, ablation, coagulation, hemostasis, and vaporization, with or without an endoscope, in the following indications:
- Dermatology and Plastic Surgery of soft, mucosal, fatty, and cartilaginous tissues, in therapeutic plastic, therapeutic dermatological and aesthetic surgical procedures
- Gastroenterological/Gastrointestinal Surgery
- General Surgery of soft tissue
- Genitourinary Surgery/Urology
- Gynecological Surgery during open and endoscopic procedures
- Lithotripsy and Percutaneous Urinary Lithotripsy
- Orthopedic Surgery in pathological soft and cartilaginous tissue in small and large joints
- Otorhinolaryngology (ENT) Surgery in soft, mucosal, cartilaginous and bony tissue
- Percutaneous Cervical, Lumbar, and Thoracic Disc Decompression / Discectomy
Interstitial incision, excision, resection, ablation, coagulation, hemostasis, and vaporization in multispecialty applications; interstitial applications should only be performed using the Trimedyne Side Firing Needle with Vent Sheath family of optical fiber delivery devices.
The OmniPulse" Mini Laser System Model 2120 is a pulsed solid-state Holmium:YAG laser system is designed to deliver infrared laser energy with a wavelength of 2.1 um and a nominal pulse width of 350 microseconds. Menu driven control options allow the operator to select the pulse energy, the pulse repetition rate or frequency, and one of three exposure modes (continuous, single burst or repetitive burst).
The provided document is a 510(k) summary for the Trimedyne OmniPulse™ Mini, Model 2120, a Holmium:Yttrium Aluminum Garnet (Ho:YAG) Laser System. It outlines the device's technical characteristics, intended use, and its substantial equivalence to predicate devices. However, this document clearly states that "No nonclinical data was submitted in this Premarket Notification" and "No clinical data was submitted in this Premarket Notification."
Therefore, based on the provided information, there is no study detailed that proves the device meets specific acceptance criteria. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices (Trimedyne OmniPulse™-MAX and OmniPulse Jr.™ laser systems) based on similar technological characteristics and intended use.
Consequently, most of the requested information (acceptance criteria, reported device performance, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) cannot be extracted from this document as no such studies were submitted or referenced.
Here's a breakdown of what can and cannot be stated based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated as this was a substantial equivalence submission relying on predicate devices, not a de novo clearance requiring novel performance thresholds.
- Reported Device Performance: No performance data from new studies are reported in this document. The device's technological characteristics such as wavelength, pulse width, pulse energy range, and pulse repetition rates are described, but these are specifications, not performance metrics against acceptance criteria from a study.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable, as no test set or clinical study was submitted.
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Experts and Qualifications: Not applicable, as no test set requiring ground truth establishment was submitted.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable, as no test set was submitted.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No MRMC comparative effectiveness study was mentioned or submitted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Standalone Performance Study: Not applicable, as this is a laser device, not an AI algorithm. No standalone performance study was mentioned or submitted.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable, as no studies requiring ground truth were submitted.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable, as this is a laser device, not a machine learning model requiring a training set. No study involving a training set was mentioned or submitted.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable.
Summary of what can be extracted:
The submission for the OmniPulse™ Mini, Model 2120, based its clearance on demonstrated substantial equivalence to existing predicate devices (Trimedyne OmniPulse™-MAX and OmniPulse Jr.™ laser systems). This means the FDA concluded that the new device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness.
The document describes the technological characteristics of the OmniPulse™ Mini, including:
- Wavelength: 2.1 µm
- Nominal Pulse Width: 350 microseconds
- Pulse Frequencies: 7, 10, 15, and 20 Hz
- Pulse Energies: 0.2 to 2.0 Joules (range depends on frequency)
- Exposure Modes: Continuous, single burst, or repetitive burst
Its intended use covers a broad range of applications in various surgical specialties, identical to the predicate devices. The key argument for acceptance was that "All of the characteristics of the OmniPulse Mini fall with the previously cleared ranges for the predicate devices." This implies that the 'acceptance criteria' were met by demonstrating that the new device's specifications and capabilities were within the established safe and effective parameters of the predicate devices, rather than through new performance studies specific to this device model.
§ 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.