(74 days)
Not Found
No
The document describes a laser system for surgical procedures and lithotripsy. There is no mention of AI or ML in the intended use, device description, or performance studies. The performance studies focus on equivalence to a predicate device based on established standards and specifications, not on AI/ML model performance.
Yes
The device is intended for use in surgical procedures to perform actions like incision, excision, resection, ablation, vaporization, coagulation, and hemostasis of soft tissue, which indicates it is used for treatment and thus is a therapeutic device.
No
The NS3000 laser system is described as being for "surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue," which are all therapeutic actions, not diagnostic ones.
No
The device description explicitly details 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.
Based on the provided information, the NS3000 laser system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes surgical procedures performed directly on the patient's body (incision, excision, resection, ablation, vaporization, coagulation, hemostasis, fragmentation of calculi). This involves direct interaction with living tissue.
- Device Description: The device description details a laser system that emits a beam of infrared radiation delivered via a fiber-optic system for treatment. This is a therapeutic device used for surgical intervention.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or compatibility testing.
Therefore, the NS3000 laser system is a surgical laser system, not an IVD.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, urethral, ureteral, bladder, renal, kidney, external genitalia, skin, internal organs.
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 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.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles incorporated into its design. The profiles are facing to the right and are stacked on top of each other.
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
1
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.
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)
| 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 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 |
- 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
| Characteristics | K033437 | K132607 | K142286 |
|---|---|---|---|
| RoHS- | |||
| Compliant | No | No | Yes |
| Keypad | Yes | Yes | Replaced by Touch |
| Screen | |||
| Type Of Laser | Pulsed, solid-state | ||
| Holmium: YAG | Pulsed, solid-state | ||
| Holmium: YAG | Pulsed, solid-state | ||
| Holmium: YAG | |||
| Pulse Width | 150-800 µsec | 150-800 µsec | 150-800 µsec |
| Power Output | 30W | 30W | 30W |
| Aiming Beam | 1 mW Green 532 | ||
| nm or | |||
| 1 mW Red 635 | 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 | 150-1000 µm single use; | ||
| reusable fiber assemblies | |||
| Exposure Time | Single Pulse; | ||
| Continuous | Single Pulse; Repeat | ||
| Pulse; Continuous | Single Pulse; Repeat | ||
| Pulse; Continuous | |||
| Repetition Rate | 4-20 Hz | 5-20 Hz | 5-20 Hz |
| Energy per | |||
| 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 | ||
| Hz; 16A single | |||
| phase | 200/208/220/230/240 | ||
| vAC, 50/60 Hz, 10A | |||
| single phase | 200/208/220/230/240 | ||
| vAC, 50/60 Hz, 10A | |||
| 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.