Ophthalmic Applications; Ear, Nose and Throat Applications; Dentistry; and Dermatologic Applications. A complete list is contained in the Indications for Use Statement.
Ophthalmology: Retinal Photocoagulation, Trabeculoplasty, Iridotomy, Diabetic retinopathy, Peripheral Iridectomy, Posterior and Anterior procedures, Senile macular degeneration.
Ear, Nose and Throat (ENT): Stapedectomy, Stapedotomy, Myringotomies, Lysis of Adhesions, Control of Bleeding, Removal of Acoustic Neuromas, Soft Tissue Adhesion in Micro/Macro Otologic Procedures.
Dermatology: Pigmented lesions, including soar lentgine, Vascular lesions, including cherry hemangiomas and angiokeratomas, Extremeties telangiectasias, including facial and leg telangiectasias, Cutaneous lesions, Flat warts, Dermatosis Papulosa Nigra.
Dentistry: Frenectomy, Treatment of Oral Mucous Cyst, Treatment of Benign Vascular Lesions: Capillary hemangioma, Hemorrhagic hereditary telangiectasia, Capillary/cavernous hemangiomas, Lymphangioma, AV malformation of the tongue, Hemangiolymphangiomas, Photocoagulation of superficial vessels, Vaporization of superficial blood or lymph containing vessels, Treatment of superficial tongue lesions, Tissue management and hemostasis for crown and bridge impressions, Incision and drainage for abscess, Gingivoplasty/ gingivectomy, Operative procedures, Crown and bridge, gingival reduction, Crown lengthening, Hyperplasia (Drug, Irritation, Epulus, ... ), Hemostasis during dental procedures, Operculectomy (Operculotomy), Excisional biopsy, Free Ginvical Graft (Adjunct): Hemostasis of donor site, Hemostasis of graft site, Vestibuloplasty, Soften Gutta Percha, Treatment of canker sores, herpetic lesions, and aphthous ulcers, Laser-assisted bleaching/whitening.

Device Description

The Novus Spectra solid state, frequency-doubled, green Nd:YAG surgical laser system is an instrument used in the photothermolysis (photocoagulation) of soft tissue at en emission wavelength of 532nm. Compatible delivery devices include: slit lamps, slit lamp adapters/attachments, laser indirect ophthalmoscopes (LIO), microfilters, collimated handpieces with spot sizes ranging from 200-1200microns, fibers and endocular and endooto probes.

AI/ML Overview

This document is a 510(k) summary statement for the Lumenis Novus Spectra Laser System, seeking substantial equivalence to predicate devices (Elite and Corium laser systems). It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

Therefore, many of the requested sections regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth cannot be extracted from the provided text.

Here is a summary of what can be extracted or inferred based on the nature of a 510(k) submission:

1. A table of Acceptance Criteria and the Reported Device Performance:

This information is not provided in the document. 510(k) submissions for substantial equivalence generally focus on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than meeting specific quantifiable performance targets in the same way a de novo or PMA submission might. The document states the Novus Spectra Laser System "has the same indications for use as the Elite family of lasers and the Corium series of lasers. They have similar functional elements such as treatment wavelengths, pulse rates, treatment power, spot size and cooling system."

Further requested information which is not available in the provided text:

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The sample size for the training set
How the ground truth for the training set was established

Key takeaway: This document represents a regulatory submission for substantial equivalence based on similarity to existing devices, not a study demonstrating a novel device's performance against predefined acceptance criteria for a specific clinical task. The focus is on showing the new device has "similar functional elements" and "same indications for use" as its predicates.

Summary

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OCT 1 6 2002

022322

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Attachment 5 510(k) Summary Statement for the Lumenis Novus Spectra Laser System

General Information:

Submitter:	Lumenis2400 Condensa StreetSanta Clara, California, U. S. A.95051-0901
Contact Person:	Karen Baker
Summary Preparation Date:	October 10, 2002
Names:
Device Names:	Novus Spectra Laser System
Primary Classification Name:	79 GEX, Laser Instrument, Surgical Powered

Predicate Devices:

Elite Solid State Green Dlode Pumped 532nm Elite Ultra Solid State Green Diode Pumped 532nm Corium 200 Solid State Green Diode Pumped 532nm Corium 400 Solid State Green Diode Pumped 532nm

Ratlonale for Substantial Equivalence:

The Novus Spectra Laser System has the same indications for use as the Elite family of lasers and the Corium series of lasers. They have similar functional elements such as treatment wavelengths, pulse rates, treatment power, spot size and cooling system. Control systems such as the door interlock, and the safety systems and displays are constantly monitored in these systems for user intervention during a procedure or maintenance.

Description of Submitted Device:

Compatible delivery devices include: slit lamps, slit lamp adapters/attachments, laser indirect ophthalmoscopes (LIO), microfilters, collimated handpieces with spot sizes ranging from 200-1200microns, fibers and endocular and endooto probes.

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022327 2/2

Indications for Use:

Ophthalmic Applications; Ear, Nose and Throat Applications; Dentistry; and Dermatologic Applications. A complete list is contained in the Indications for Use Statement.

Technological Characteristics and Substantial Equivalence

The Novus Spectra Laser System, the Elite family of lasers, and the Corium series deliver the same frequency-doubled Nd:YAG wavelength. Both deliver a 532nm wavelength of similar power and pulses having similar duration in single and repeat modes.

The Novus Spectra Laser System is identical to the Elite family of lasers, and the Corium series in terms of its intended uses and functionality. The Novus Spectra improves on the industry-standard digital operating environment present in the Elite to manage energy output, pulse duration and other functional aspects. A digital "closed loop" control system in the Novus Spectra replaces the analog "closed loop" control system in the Elite and Corium. In addition the digital environment improves the overall safety of the system through improved and more rigorously controlled hazard mitigation hardware

Conclusion

The Novus Spectra Laser System is substantially equivalent to the Elite and Corium laser systems that are now in commercial distribution and have been successful in meeting the intended uses. The Novus Spectra has an improved hazard mitigation and risk management operating environment that reduces the level of concern regarding its uses per the Intended Uses document.

The Lumenis Novys Spectra shares the same intended use, indications for use, and similar technological characteristics as the predicate laser systems.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or connection.

Public Health Service

OCT 1 6 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Karen Baker Regulatory Consultant to Lumenis, Inc. Lumenis, Inc. 2400 Condensa Street Santa Clara, California 95051-0901

Re: K022327

Trade/Device Name: Novus Spectra Laser System Regulation Number: 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: July 10, 2002 Received: July 18, 2002

Dear Ms. Baker:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as setforth 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.

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Page 2 - Ms. Karen Baker

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Muriam C. Provost

for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment 2 Indications for Use Statement as Requested by FDA

510(K) Number (if Known):

Device Name: Novus Spectra Laser System

Indications for Use:

Ophthalmology

Retinal Photocoagulation Trabeculoplasty Iridotomy Diabetic retinopathy Peripheral Iridectomy Posterior and Anterior procedures Senile macular degeneration

Ear, Nose and Throat (ENT) Stapedectomy Stapedotomy Myringotomies Lysis of Adhesions Control of Bleeding Removal of Acoustic Neuromas Soft Tissue Adhesion in Micro/Macro Otologic Procedures

Dermatology

Pigmented lesions, including soar lentgine Vascular lesions, including cherry hemangiomas and angiokeratomas Extremeties telangiectasias, including facial and leg telangiectasias Cutaneous lesions Flat warts Dermatosis Papulosa Nigra

Dentistry

Frenectomy .
Treatment of Oral Mucous Cyst
Treatment of Benign Vascular Lesions: Capillary hemangioma Hemorrhagic hereditary telangiectasia Capillary/cavernous hemangiomas Lymphangioma AV malformation of the tongue Hemangiolymphangiomas
Photocoagulation of superficial vessels .
Vaporization of superficial blood or lymph containing vessels
Treatment of superficial tongue lesions .
Tissue management and hemostasis for crown and bridge impressions
Incision and drainage for abscess .
- Gingivoplasty/ gingivectomy Operative procedures Crown and bridge, gingival reduction Crown lengthening
- Hyperplasia (Drug, Irritation, Epulus, ... )
Hemostasis during dental procedures ●
Operculectomy (Operculotomy) ●
Excisional biopsy .
Free Ginvical Graft (Adjunct): . Hemostasis of donor site Hemostasis of graft site
Vestibuloplasty .
Soften Gutta Percha .
Treatment of canker sores, herpetic lesions, and aphthous ulcers
Laser-assisted bleaching/whitening

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

◆

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: ✓
(Per 21 CFR 801.109) ,

sion of General, Restorative Neurological Devices

510(k) Number K022327

Regulation Number and Section

§ 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.