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K Number
K093048
Device Name
D-STORM 810NM, D-STORM 980NM
Manufacturer
LIGHT INSTRUMENTS
Date Cleared
2010-03-23

(174 days)

Product Code
GEX
Regulation Number
878.4810
Type
Traditional
Panel
General & Plastic Surgery
Reference & Predicate Devices
K073411,K063384,K083034
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The D-Storm system is intended to aid during dental procedures performed in oral and maxillofacial surgery and dentistry.
The D-Storm diode laser system is indicated for:

  • Incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery and dentistry
  • Light activation of bleaching materials for teeth whitening
    The D-Storm specific indications include the following:
    Marginal and interdental gingiva and epithelial lining of free gingiva, frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gigngivioplasty, gingival troughing crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incision and draining of abscesses, tissue retraction, for impressions, papillectomy, vestibuloplasty, excision of lesions, exposure of unerupted/partially erupted teeth, removal of hyperplastic tissues, treatment of aphtous ulcers, leukoplakia, sulcular debridement (removal of diseased or inflamed soft tissue, in the periodontal pocket), pulpotomy as adjunct to root canal therapy and light activation of bleaching materials for teeth whitening.
Device Description

The D-STORM Diode Laser is an advanced microprocessor-controlled laser system, composed of the following units:

  • Control panel; .
  • . Diode laser
  • Safe System Control .
  • . Cooling System
  • A hand-piece and foot panel; .
AI/ML Overview

Here's an analysis of the provided text regarding the D-STORM Diode Laser System and its acceptance criteria and supporting study information:

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense (e.g., sensitivity, specificity, accuracy against a threshold). Instead, the acceptance criteria for this device appear to be based on:

  1. Substantial Equivalence: The primary acceptance criterion for a 510(k) submission is demonstrating substantial equivalence to legally marketed predicate devices. This means the device must have the same intended use and technological characteristics as the predicate, or if there are different technological characteristics, they must not raise new questions of safety or effectiveness.
  2. Compliance with Standards: Meeting recognized performance standards for laser products and medical electrical equipment.
Acceptance CriterionReported Device Performance/Compliance
Intended Use (Substantial Equivalence)Intended to aid during dental procedures in oral and maxillofacial surgery and dentistry for soft tissue procedures and light activation of bleaching materials. This aligns with the indications for the predicate devices.
Technological CharacteristicsDiode Laser System with wavelength of 0.81, 0.98 micron and power up to 7 Watts. Stated to be "well within the previous cleared values" of predicate devices, implying similar technical specifications.
Predicate Device EquivalenceClaims substantial equivalence to LITEDUO (K073411), DioDent Micro (K063384), and FOTONA XD (K083034), all of which are diode laser systems for similar dental applications.
U.S. Federal Performance StandardsComplies with 21 CFR 1040.10 and 21 CFR 1040.11 for Class IV Laser Products.
European Medical DirectiveComplies with 93/42/EEC (Annex II).
Voluntary Standards (Safety & EMC)Complies with: - EN 60601-1 (Medical Electrical Equipment-Part 1: General Requirements for Safety) - EN 60825-1 (Safety of laser products) - EN 60601-2-22 (Particular Requirements for safety and diagnostics and therapeutic laser equipment) - IEC 60601-1-2 (Electromagnetic compatibility (EMC))
Clinical Performance (Safety & Efficacy)Safety and efficacy of diode laser devices with similar wavelengths and power are well established in scientific research and literature. It is asserted that "clinical studies are not required to determine the safety and efficacy of the device" due to comprehensive existing literature and the device's technical parameters being within previously cleared values. This implies that the device is expected to perform comparably to established devices.

Study Details

Based on the provided text, a new clinical study to demonstrate the device's performance against specific acceptance criteria was not conducted for this 510(k) submission. Therefore, most of the requested fields are not applicable in the traditional sense of a performance study on the D-STORM Diode Laser System itself.

  1. Sample size used for the test set and the data provenance:

    • N/A. No new clinical test set was used for the D-STORM Diode Laser System. The submission relies on existing published scientific research and literature. The "data provenance" would therefore refer to a broad body of pre-existing scientific literature.

  2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • N/A. As no new clinical study data were generated for this submission, there was no expert panel needed to establish ground truth for a test set. The validation relies on the expertise embedded in the existing scientific literature.

  3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

    • N/A. No test set requiring expert adjudication was used.

  4. 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:

    • N/A. This device is a laser system, not an AI-assisted diagnostic tool or an imaging modality requiring interpretation by "readers." Therefore, an MRMC study is not relevant to its regulatory pathway.

  5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

    • N/A. This is a medical device (laser system), not a software algorithm.

  6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

    • The "ground truth," in an indirect sense, is derived from the established safety and efficacy of diode laser devices through "scientific research and literature," which would include published clinical outcomes, expert consensus on best practices, and histological/pathological evidence for the effects of laser on tissues in those prior studies.

  7. The sample size for the training set:

    • N/A. This device is not an AI/ML algorithm that requires a training set. Its design and validation are based on engineering principles and comparison to existing, cleared devices.

  8. How the ground truth for the training set was established:

    • N/A. Not applicable, as there is no training set for this type of device.

In summary: The D-STORM Diode Laser System obtained 510(k) clearance primarily through demonstrating substantial equivalence to predicate devices and adherence to relevant safety and performance standards. The manufacturer explicitly states that "clinical studies are not required to determine the safety and efficacy of the device" because the technology (diode lasers with similar parameters) is well-established in scientific literature.

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Image /page/0/Picture/0 description: The image shows a logo with a stylized graphic above the text "LIGHT INSTRUMENTS". The graphic appears to be a geometric shape, possibly representing a molecule or a stylized flower. The text "LIGHT" is in a bold, sans-serif font, and "INSTRUMENTS" is in a smaller font size directly below it.

510(K) SUMMARY

D-STORM Diode Laser System 510(k) Number K_09304

Applicant's Name:Light instruments Ltd
Tavor Building 1
Yokneam Ind. Zone
P.O.Box 223
Yokneam Elite 20692MAR 2 3 2010
Tel: (972)4-959-7531
Fax: (972)73-244-2610
Contact Person:Yoram Levy, Qsite31 Haavoda St.Binyamina, Israel 30500Tel (972)4-638-8837; Fax (972)4-638-0510Yoram@qsitemed.com
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D-STORM Diode Laser System Classification: Name: Laser Instrument, Surgical, Powered Product Code: GEX Regulation No: 21 CFR 878.4810 Class: II

Panel: General & Plastic Surgery

Device Description:

Trade Name:

The D-STORM Diode Laser is an advanced microprocessor-controlled laser system, composed of the following units:

  • Control panel; .
  • . Diode laser
  • Safe System Control .
  • . Cooling System
  • A hand-piece and foot panel; .

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D-STORM Dental Laser System – 510k Notification

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Image /page/1/Picture/0 description: The image shows a logo for "LIGHT INSTRUMENTS". The logo features a stylized graphic above the text, resembling a three-dimensional shape with rounded edges. The word "LIGHT" is in a bold, sans-serif font, and the word "INSTRUMENTS" is in a smaller, sans-serif font below it.

Intended Use Statement:

The D-Storm system is intended to aid during dental procedures performed in oral and maxillofacial surgery and dentistry.

The D-Storm diode laser system is indicated for

  • . Incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery and dentistry.
  • Light activation of bleaching materials for teeth whitening. .

The D-Storm specific indications include the following:

Marginal and interdental gingiva and epithelial lining of free gingiva, frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gigngivioplasty, gingival troughing crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incision and draining of abscesses, tissue retraction, for impressions, papillectomy, vestibuloplasty, excision of lesions, exposure of unerupted/partially erupted teeth, removal of hyperplastic tissues, treatment of aphtous ulcers, leukoplakia, sulcular debridement (removal of diseased or inflamed soft tissue, in the periodontal pocket), pulpotomy as adjunct to root canal therapy and light activation of bleaching materials for teeth whitening.

Substantial equivalence to the following predicate devices is claimed: Predicate Devices:

Device NameManufacture510k NoClearance Date
LITEDUOLight Instruments LtdK073411May 13, 2008
DioDent MicroHoya Conbio, IncK063384March 16, 2007
FOTONA XDFOTONAK083034Feb 04, 2009

Performance Standards

D-STORM Diode Laser System complies with U.S. Federal Performance Standards 21 CFR 1040.10 and 21 CFR 1040.11 for class IV Laser Products. In addition, the device complies with the European Medical Directive 93/42/EEC concerning medical devices (Annex II) and with the following voluntary standards:

  • . EN 60601-1 (Medical Electrical Equipment-Part 1: General Requirements for Safety-1. Collateral Standard: Safety Requirements for Medical Electrical Systems).
  • . EN 60825-1 (Safety of laser products);

D-STORM Dental Laser System - 510k Notification

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Image /page/2/Picture/0 description: The image shows a logo for "LIGHT INSTRUMENTS". The logo consists of a stylized graphic above the text. The graphic appears to be a circular shape with four curved lines intersecting within it, creating a symmetrical design. The text "LIGHT" is in a larger, blocky font, while "INSTRUMENTS" is in a smaller font below it.

  • EN 60601-2-22 (Medical device equipment, Particular Requirements . for the safety and diagnostics and therapeutic laser equipment).
  • IEC 60601-1-2 (Electromagnetic compatibility (EMC) .

A detailed description appears in Section 14.

Summary of Clinical performance data

The safety and efficacy of Diode Laser devices with wavelength of 0.81, 0.98 micron and power up to 7 Watts are well established in scientific research and literature including procedures performed in soft oral tissue, Cosmetic Endodontology and Periodontology.

Due to the comprehensive clinical study performed in scientific research and published in literature, and since the power, wavelength, pulse duration and frequency of the D-STORM Diode Laser System are well within the previous cleared values, Light Instruments believes that clinical studies are not required to determine the safety and efficacy of the device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

MAR 2 3 2010

Light Instruments, Ltd. % Osite Mr. Yoram Levy 31 Haavoda Street Binyamina, Israel 30500

Re: K093048

Trade/Device Name: D-STORM Diode 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: January 25, 2010 Received: January 29, 2010

Dear Mr. Levy:

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

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Page 2 - Mr. Yoram Levy

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):K093048
Device Name:D-Storm Diode Laser System
Indications for Use:The D-Storm system is intended to aid during dental proceduresperformed in oral and maxillofacial surgery and dentistry.The D-Storm diode laser system is indicated for:Incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery and dentistryLight activation of bleaching materials for teeth whitening
The D-Storm specific indications include the following:Marginal and interdental gingiva and epithelial lining of free gingiva.

frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gigngivioplasty, gingival troughing crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incision and abscesses. tissue retraction, for impressions, draining of papillectomy, vestibuloplasty, excision of lesions, exposure of unerupted/partially erupted teeth, removal of hyperplastic tissues, treatment of aphtous ulcers, leukoplakia, sulcular debridement (removal of diseased or inflamed soft tissue, in the periodontal pocket), pulpotomy as adjunct to root canal therapy and light activation of bleaching materials for teeth whitening.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-off)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

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D-STORM Dental Laser System 2 Stok T

§ 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.