(213 days)
The NS2500 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 turnors, 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
Open, laparoscopic and endoscopic surgery (incision, excision, General Surgery: 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 2500 is a compact, portable, self-contained system that produces a bearn 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.
This submission, K132607, is for the New Star NS2500 Holmium Laser System. The device is a compact, portable, self-contained system that produces an infrared radiation beam and a visible laser diode beam for aiming. It is intended for surgical procedures using incision, excision, resection, ablation, vaporization, coagulation, and hemostasis of soft tissue in medical specialties including Urology, Urinary Lithotripsy, and General Surgery.
The acceptance criteria and device performance are established based on substantial equivalence to a predicate device, the Allmed Systems, Inc. Sphinx30 (K033437).
1. Table of Acceptance Criteria and Reported Device Performance
| Technical Characteristics | Predicate Device (K033437) Acceptance Criteria | NS2500 (K132607) Reported Device Performance |
|---|---|---|
| Type Of Laser | Pulsed, solid-state Holmium: YAG | Pulsed, solid-state Holmium: YAG |
| Pulse Width | 150-800 µsec | 150-800 µsec |
| Power Output | 30 W | 30W |
| Aiming Beam | 1mW Red 635 nm or 1 mW Green 532 nm | 1 mW Green 532 nm |
| Beam Delivery | 200 µm and 273 µm fibers | 200-1000 µm single use; reusable fiber assemblies |
| Exposure Time | Single Pulse; Continuous | Single Pulse; Repeat Pulse; Continuous |
| Repetition Rate | 4-20 Hz | 5-20 Hz |
| Energy per Pulse | 0.5-4.0 J | 0.4 to 2.5 J |
| Wavelength | 2100 nm | 2100 nm |
| Utilities | 230 vAC; 50/60 Hz; 16A single phase | 200/208/220/230/240 vAC, 50/60 Hz, 10A single phase |
Study That Proves the Device Meets Acceptance Criteria:
The device's compliance is established through non-clinical testing and comparison to a predicate device to demonstrate substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No human test set or data provenance (country of origin, retrospective/prospective) is mentioned in the provided text. The evaluation is based on non-clinical engineering and performance tests against established standards and comparison to a predicate 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):
Not applicable. The submission does not detail the use of human experts to establish ground truth for a test set, as the evaluation is based on technical specifications and substantial equivalence to a predicate device, not on diagnostic or interpretive performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There is no mention of a human test set requiring adjudication in this 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:
Not applicable. This submission is for a laser surgical instrument, not an AI-assisted diagnostic or interpretive device. Therefore, no MRMC study or AI assistance evaluation is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI algorithm; it's a physical medical device. The "standalone" performance refers to the device's operational characteristics as detailed in the non-clinical tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the device's performance is based on established engineering specifications, national and international standards for such devices (e.g., IEC 60601-1-2; EN 61000-3-3), and the known performance characteristics of the legally marketed predicate device (Allmed Systems, Inc. Sphinx30). This is primarily a technical and comparative ground truth rather than a clinical one derived from patient outcomes or expert consensus on clinical data.
8. The sample size for the training set:
Not applicable. This is a medical device, not a machine learning algorithm, so there is no "training set."
9. How the ground truth for the training set was established:
Not applicable. As there is no training set for a machine learning algorithm, there is no ground truth established for one.
§ 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.