(74 days)
The NS3000 laser system is intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, and General Surgery.
Urology: Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: urethral strictures, bladder neck incisions (BNI), ablation and resection of bladder tumors, uretheral tumors and ureteral tumors, condylomas, and lesions of external genitalia.
Lithotripsy and Percutaneous Urinary Lithotripsy: Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi, endoscopic fragmentation of kidney calculi, and treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed.
General Surgery: Open, laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: skin incision, excision of external and internal lesions, complete or partial resection of internal organs, tumors and lesions, and biopsy.
The New Star Model NS3000 is a compact, portable, self-contained system that produces a beam of infrared radiation at 2,100 nm wavelength for treatment, and a visible laser diode beam at 532 nm for aiming. The system emits a pulsed laser beam which is delivered to the treatment site using a fiber-optic delivery system. The system consists of a laser console, a fiber-optic delivery system, and a footswitch.
The system provides safety features that are designed to protect the user and patient from high voltages and laser emissions.
The console consists of a control panel, a laser head assembly, a power supply, and a cooling system. It also contains an ON/OFF key switch, Emergency Off switch, External Power Meter connector, Fiber-Optic receptacle, Interlock Jumper plug/receptacle, and a footswitch receptacle. The fiber-optic delivery system includes a linear flash lamp pumped holmium laser cavity and resonator, a 3 milliwatt laser diode, two optical detector assemblies, lenses and cables. The footswitch is used to initiate delivery of laser energy according to preset parameters.
The provided FDA document (K142286) is a 510(k) summary for the NS3000™ StoneLight Laser System. This document describes a submission seeking substantial equivalence to existing predicate devices, rather than presenting a de novo study with strict acceptance criteria for a new AI/ML device.
Therefore, the requested information regarding acceptance criteria, study samples, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable in the context of this 510(k) submission.
The document demonstrates equivalence through a comparison of technical characteristics and compliance with existing standards for similar devices. There is no mention of an AI/ML component in the NS3000™ StoneLight Laser System.
However, I can extract information related to the technical characteristics of the device and its predicate, which can be seen as a form of "performance" in this context.
Here's a summary based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a 510(k) submission for substantial equivalence rather than a new device demanding specific "acceptance criteria" and a direct "device performance" in the AI/ML sense, the document relies on demonstrating that the NS3000™ meets or exceeds the specifications and performance of its predicate devices. The "acceptance criteria" are implicitly that the new device is as safe and effective as the predicate. The "reported device performance" is essentially its technical specifications and compliance with safety standards.
| Characteristic | Predicate (K132607) | NS3000™ StoneLight Laser System (K142286) |
|---|---|---|
| RoHS-Compliant | No | Yes |
| Keypad | Yes | Replaced by Touch Screen |
| Type Of Laser | Pulsed, solid-state Holmium: YAG | Pulsed, solid-state Holmium: YAG |
| Pulse Width | 150-800 µsec | 150-800 µsec |
| Power Output | 30W | 30W |
| Aiming Beam | 1 mW Green 532 nm | 1 mW Green 532 nm |
| Beam Delivery | 200-1000 µm single use; reusable fiber assemblies | 150-1000 µm single use; reusable fiber assemblies |
| Exposure Time | Single Pulse; Repeat Pulse; Continuous | Single Pulse; Repeat Pulse; Continuous |
| Repetition Rate | 5-20 Hz | 5-20 Hz |
| Energy per Pulse | 0.4 to 2.5 J | 0.25 to 3.0 J |
| Wavelength | 2100 nm | 2100 nm |
| Utilities | 200/208/220/230/240 vAC, 50/60 Hz, 10A single phase | 200/208/220/230/240 vAC, 50/60 Hz, 10A single phase |
2. Sample size used for the test set and the data provenance: Not applicable. This is a comparison of technical specifications and safety standards compliance, not a clinical trial with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a test set is not relevant for this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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. The device is a laser system, not an AI-assisted diagnostic or treatment planning tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is compliance with established electrical and laser safety standards (e.g., IEC 60601-1-2: EN 61000-3-3) and the demonstrated performance of the predicate device.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
Study that proves the device meets the acceptance criteria (based on the provided text):
The "study" cited in the document is a summary of non-clinical tests and a comparison to the predicate device.
- Non-Clinical Tests: New Star utilized IEC 60601-1-2: EN 61000-3-3 test standards. These are international standards related to electromagnetic compatibility (EMC) for medical electrical equipment.
- Methodology: "The NS3000 Holmium Laser System performance characteristics were established by referencing the known performance characteristics of the predicate device." Specifications for the NS2500 Laser System (predicate) were used to assure an equivalent manner of performance.
- Conclusion of Tests: "All testing was conducted and established that the NS3000 Holmium Laser System met or exceeded its design specifications and performed equally or better than the stated performance of the predicate."
- Rationale for Substantial Equivalence: The NS3000 Holmium Laser System shares the same indications for use, device operation, overall technical and functional capabilities, and is therefore substantially equivalent to the predicate device (K132607, and its predicate K033437). Minor modifications (e.g., touchscreen, RoHS compliance, expanded beam delivery options, slightly wider energy range) do not represent substantive changes to the technical, functional, or operational capabilities and introduce no new safety or effectiveness questions.
§ 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.