(213 days)
Not Found
No
The device description and performance studies focus on the laser technology and its physical characteristics, with no mention of AI or ML algorithms for image processing, data analysis, or decision support.
Yes
The device is used in various surgical procedures, including soft tissue incision, excision, and tumor ablation, which are therapeutic interventions aimed at treating medical conditions.
No
The device is a laser system intended for surgical procedures, including incision, excision, resection, ablation, vaporization, coagulation, and hemostasis of soft tissue, as well as fragmentation of calculi. These are all therapeutic and interventional functions, not diagnostic ones.
No
The device description clearly outlines hardware components such as a laser console, fiber-optic delivery system, footswitch, laser head assembly, power supply, cooling system, and various connectors and optical components. This indicates it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The NS2500 laser system is a surgical device that uses laser energy to directly interact with and modify soft tissue and break up calculi within the body. It is used for procedures like incision, excision, ablation, and fragmentation.
- Intended Use: The intended use clearly describes surgical procedures performed on the patient's body, not the analysis of specimens from the patient's body.
The device description and intended use are consistent with a surgical laser system, not an in vitro diagnostic device.
N/A
Intended Use / 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
- 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
Product codes (comma separated list FDA assigned to the subject device)
GEX
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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 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: | February 19, 2014 |
II. Names
| Proprietary Name: | NS2500™ Laser System |
|---|---|
| Common Name: | Holmium YAG Laser |
| Classification Name: | Laser surgical instrument for use in |
| 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
| Characteristics | K033437 | K132607 |
|---|---|---|
| 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 |
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
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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.
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FORM FDA 3881 (1/14)
SC Publuking Services (301) 443-6740
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