NS3000 Holmium Laser System

K142286 · New Star Lasers, Inc. · GEX · Oct 31, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K142286
• Device Name: NS3000 Holmium Laser System
• Applicant: New Star Lasers, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 31, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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. 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 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.

Device Story

Compact, portable Holmium:YAG laser system; produces 2,100 nm infrared radiation for tissue treatment and 532 nm visible diode for aiming. System comprises laser console, fiber-optic delivery system, and footswitch. Physician operates system in clinical/surgical settings to deliver pulsed laser energy to target site via fiber-optic cable. Footswitch initiates energy delivery based on preset parameters. Used for soft tissue surgery and lithotripsy; laser energy facilitates incision, resection, ablation, and stone fragmentation. Provides clinical benefit by enabling minimally invasive endoscopic procedures and precise tissue management.

Clinical Evidence

Bench testing only. Performance characteristics established via comparison to predicate device (NS2500) and adherence to IEC 60601-1-2 and EN 61000-3-3 standards. Testing confirmed output, safety features, and electromagnetic interference performance met or exceeded design specifications and predicate performance.

Technological Characteristics

Pulsed, solid-state Holmium:YAG laser; 2,100 nm wavelength; 30W power output; 150-800 µsec pulse width; 5-20 Hz repetition rate; 0.25-3.0 J energy per pulse. 532 nm green aiming beam. Fiber-optic delivery (150-1000 µm). Touch screen interface. RoHS compliant. Powered by 200-240 vAC. Safety features include emergency off switch and interlock.

Indications for Use

Indicated for patients requiring soft tissue surgery (incision, excision, resection, ablation, vaporization, coagulation, hemostasis) in urology, general surgery, and lithotripsy. Includes treatment of urethral strictures, bladder/ureteral tumors, condylomas, external genital lesions, and fragmentation of urethral, ureteral, bladder, and renal calculi.

Regulatory Classification

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.

Predicate Devices

• NS2500™ Laser System (K132607)

Reference Devices

• K033437

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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.

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 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)

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|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <svg class="bi bi-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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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 |
| | [e-mail] |

| 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 in<br>General/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 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.

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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.

- 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.

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.

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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.

| Technical<br>Characteristics | K033437 | K132607 | K142286 |
|------------------------------|------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------|
| RoHS-<br>Compliant | No | No | Yes |
| Keypad | Yes | Yes | Replaced by Touch<br>Screen |
| Type Of Laser | Pulsed, solid-state<br>Holmium: YAG | Pulsed, solid-state<br>Holmium: YAG | Pulsed, solid-state<br>Holmium: YAG |
| Pulse Width | 150-800 µsec | 150-800 µsec | 150-800 µsec |
| Power Output | 30W | 30W | 30W |
| Aiming Beam | 1 mW Green 532<br>nm or<br>1 mW Red 635 | 1 mW Green 532 nm | 1 mW Green 532 nm |
| Beam Delivery | 200 µm and 273<br>µm fibers | 200-1000 µm single use;<br>reusable fiber assemblies | 150-1000 µm single use;<br>reusable fiber assemblies |
| Exposure Time | Single Pulse;<br>Continuous | Single Pulse; Repeat<br>Pulse; Continuous | Single Pulse; Repeat<br>Pulse; Continuous |
| Repetition Rate | 4-20 Hz | 5-20 Hz | 5-20 Hz |
| Energy per<br>Pulse | 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 50/60<br>Hz; 16A single<br>phase | 200/208/220/230/240<br>vAC, 50/60 Hz, 10A<br>single phase | 200/208/220/230/240<br>vAC, 50/60 Hz, 10A<br>single 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.