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.

Device Description

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.

AI/ML Overview

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.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 31, 2014

New Star Lasers Incorporated % Ms. Pamela M. Buckman Buckman Company Incorporated 2800 Pleasant Hill Road, Suite 175 Pleasant Hill, California 94523

Re: K142286

Trade/Device Name: NS3000" StoneLight Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: October 4, 2014 Received: October 7, 2014

Dear Ms. Buckman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K142286

Device Name NS3000™ StoneLight Laser System

Indications for Use (Describe)

The NS3000 laser system is intended for use in surgical procedures using open, laparoscopic 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, resection, ablation, vaporization, coagulation and hemostasis) including: urethral strictures, bladder neck incisions (BNI), ablation and resection of bladder tumors and ureteral tumors, condylomas, and lesions of external genitalia.

General Surgery: Open, laparoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: skin incision of external and internal lesions, complete or partial resection of internal organs, tumors and lesions, and biopsy.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

K142286

Submitter:	New Star Lasers, Inc.
	9085 Foothills Blvd.
	Roseville, CA 95747
	916 677 1900 tel
	916 677 1901 fax

Contact Person:	Pamela M. Buckman
	Regulatory Consultant
	T 925 980 7007
	F 925 705 7381
	pmbuckman@gmail.com

Summary
Preparation Date:	October 27, 2014

II. Names

Proprietary Name:	NS3000™ StoneLight Laser System
Common Name:	Holmium YAG Laser
Classification Name:	Laser surgical instrument for use inGeneral/Plastic Surgery and Dermatology
Reference:	21 CFR Part 878.4810
Regulatory Class:	Class II
FDA Panel:	General and Plastic Surgery
Product Code:	GEX

III. Predicate
NS2500™ Laser System (K132607)

IV. Device Description

The system provides safety features that are designed to protect the user and patient from high voltages and laser emissions.

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V. Summary of Non Clinical Tests
New Star utilized IEC 60601-1-2: EN 61000-3-3 test standards to establish a basis for the determination of equivalence. 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 were established to assure that the predicate system and the NS3000 Laser System performed in an equivalent manner. Performance specifications were set utilizing national and international standards for such devices with respect to output, indications for use, safety features and electromagnetic interference where it was established as suitable for the environment of use. 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.

Conclusions drawn from these non-clinical tests demonstrate that the device is as safe, as effective and performs at least as safely and as effectively as the legally marketed device identified in this Summary.

VI. Indications for Use
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.

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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.

TechnicalCharacteristics	K033437	K132607	K142286
RoHS-Compliant	No	No	Yes
Keypad	Yes	Yes	Replaced by TouchScreen
Type Of Laser	Pulsed, solid-stateHolmium: YAG	Pulsed, solid-stateHolmium: YAG	Pulsed, solid-stateHolmium: YAG
Pulse Width	150-800 µsec	150-800 µsec	150-800 µsec
Power Output	30W	30W	30W
Aiming Beam	1 mW Green 532nm or1 mW Red 635	1 mW Green 532 nm	1 mW Green 532 nm
Beam Delivery	200 µm and 273µm fibers	200-1000 µm single use;reusable fiber assemblies	150-1000 µm single use;reusable fiber assemblies
Exposure Time	Single Pulse;Continuous	Single Pulse; RepeatPulse; Continuous	Single Pulse; RepeatPulse; Continuous
Repetition Rate	4-20 Hz	5-20 Hz	5-20 Hz
Energy perPulse	0.5-4.0 J	0.4 to 2.5 J	0.25 to 3.0 J
Wavelength	2100 nm	2100 nm	2100 nm
Utilities	230 vAC 50/60Hz; 16A singlephase	200/208/220/230/240vAC, 50/60 Hz, 10Asingle phase	200/208/220/230/240vAC, 50/60 Hz, 10Asingle phase
		(Predicate)	(Modified NS2500)

VII. Summary of Technological Characteristics

VIII. Rationale for Substantial Equivalence

The NS3000 Holmium Laser System shares the same indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate device (K132607, and its predicate K033437). The minor modifications to the predicate device do not represent substantive changes to the technical, functional or operational capabilities.

IX. Safety and Effectiveness Information

The review of the indications for use and technical characteristics demonstrates that the NS3000 Laser System is substantially equivalent to the

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predicate device. The modifications to the NS2500 are minor and no new safety or effectiveness questions are applicable.

X. Conclusion
The NS3000 Laser System was found to be substantially equivalent to the predicate device. The NS3000 Laser System shares the same indications for use, similar design features, and functional features with, and thus is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.