NS 2500 HOLMIUM LASER SYSTEM

K132607 · New Star Lasers, Inc. · GEX · Mar 21, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K132607
• Device Name: NS 2500 HOLMIUM LASER SYSTEM
• Applicant: New Star Lasers, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 21, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Compact, portable Holmium:YAG laser system; emits 2,100 nm infrared pulsed laser beam for soft tissue treatment and 532 nm visible diode beam for aiming. System comprises laser console, fiber-optic delivery system, and footswitch. Operated by physicians in clinical/surgical settings. Laser energy delivered via fiber-optic cable to treatment site; footswitch initiates delivery based on preset parameters. Provides incision, excision, resection, ablation, vaporization, coagulation, and hemostasis. Benefits include precise soft tissue management and endoscopic stone fragmentation. Safety features include interlocks and emergency off switch.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1-2 and EN 61000-3-3 standards for safety and electromagnetic interference. Performance characteristics compared to predicate device to establish equivalence in output, safety, and functionality.

Technological Characteristics

Pulsed, solid-state Holmium:YAG laser; 2100 nm wavelength; 30W power output; 150-800 µsec pulse width; 5-20 Hz repetition rate; 0.4-2.5 J energy per pulse. 532 nm aiming beam. Fiber-optic delivery (200-1000 µm). Console includes laser head, power supply, cooling system, and footswitch. Electrical requirements: 200-240 VAC, 50/60 Hz. Standards: IEC 60601-1-2, EN 61000-3-3.

Indications for Use

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

• Sphinx30 (K033437)

Submission Summary (Full Text)

{0}------------------------------------------------

# MAR 2 1 2014

# 510(K) SUMMARY (REVISED 2.14)

# K132607

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

Contact Person:

Pamela M. Buckman Regulatory Consultant T 925 980 7007 F 925 705 7381 [e-mail]

| Summary | |
|-------------------|-------------------|
| Preparation Date: | February 19, 2014 |

#### II. Names

| Proprietary Name: | NS2500™ 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 |

#### Predicate Device III.

Allmed Systems, Inc. Sphinx30 (K033437)

#### IV. Device Description

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.

{1}------------------------------------------------

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.

#### Summary of Non Clinical Tests V.

New Star utilized IEC 60601-1-2; EN 61000-3-3 test standards to establish a basis for the determination of equivalence. The NS2500 Holmium Laser System performance characteristics were established by referencing the known performance characteristics of the predicate device. Specifications for the NS500 Laser System were established to assure that the predicate system and the NS2500 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 NS2500 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 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

2/4

{2}------------------------------------------------

- 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

| Technical<br>Characteristics | K033437 | K132607 |
|------------------------------|----------------------------------------|--------------------------------------------------------|
| Type Of Laser | Pulsed, solid-state<br>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<br>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<br>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<br>single phase | 200/208/220/230/240 vAC, 50/60 Hz,<br>10A single phase |

#### Summary of Technological Characteristics VII.

# VIII. Rationale for Substantial Equivalence

The NS2500 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.

#### Safety and Effectiveness Information IX.

The review of the indications for use and technical characteristics demonstrates that the NS2500 Laser System is substantially equivalent to the predicate device. No new safety or effectiveness questions are applicable.

{3}------------------------------------------------

#### X. Conclusion

The NS2500 Laser System was found to be substantially equivalent to the predicate device. The NS2500 Laser System shares the same indications for use, similar design features, and functional features with, and thus is substantially equivalent to the predicate device.

{4}------------------------------------------------

Public Health Service

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

March 21, 2014

New Star Lasers Incorporated % Ms. Pamela M. Buckman, MSN Regulatory Consultant 2800 Pleasant Hill Road, Suite #175 Pleasant Hill, California 94523

Re: K132607

Trade/Device Name: New Star NS2500 Holmium 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: February 17, 2014 Received: February 21, 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

{5}------------------------------------------------

Page 2 - Ms. Pamela M. Buckman, MSN

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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Felipe Aquel

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

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo of the Department of Health and Human Services, along with the Food and Drug Administration. The text is in a simple, sans-serif font and is aligned to the left. The logo is simple and professional, and it conveys the message that the organization is responsible for protecting the health of the public.

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K132607

## Device Name

New Star NS2500 Holmium Laser System

## Indications for Use (Describe)

The NS2500 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 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, resection, ablation, vaporization, coagulation and hemostasis) including; skin incision, excision of external and internal lesions, complete or partial resection of internal organs, tumors and Iesions, 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)

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

Image /page/6/Picture/18 description: The image shows a document with the heading "FOR FDA USE ONLY". It indicates the concurrence of the Center for Devices and Radiological Health (CDRH). The document includes the name "Neil R Ogden -S" and the date and time "2014.03.21 15:23:26 -04'00'".

FORM FDA 3881 (1/14)

SC Publuking Services [phone]

{7}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."