The Novus TTx Laser and Delivery Devices is intended for use in the treatment of ocular pathology. The Novus TTx is indicated for use in photocoagulation of both anterior and posterior segments including:

Retinal photocoagulation, panretinal photocoagulation, and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including:
- Diabetic retinopathy (proliferative retinopathy, nonproliferative retinopathy, macular edema):
- Retinal tears, detachments and holes
- Lattice degeneration
- Age-related macular degeneration
- Intraocular tumors (choroidal hemangioma, choroidal melanoma, retinoblastoma)
- Retinopathy of prematurity
- Choroidal neovascularization;
- Central and branch retinal vein occlusion;
Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma

Laser Indirect Ophthalmoscope: The Laser Indirect Ophthalmoscope is indicated for use in the following ophthalmic treatments: diabetic retinopathy (panretinal photocoagulation); retinopexy; segmental peripheral photocoagulation; segmental photocoagulation; cloudy vitreous cavities; and, pediatric retinal repairs (under general anesthesia).

Endophotocoagulation: The Acculite Endoprobe is indicated for use in the following ophthalmic applications: photocoagulation of the anterior and posterior segment, including: anterior segment treatment in the surgical management of glaucoma; endophotocoagulation in vitreoretinal surgery, including panretinal photocoagulation, retinopexy, and treatment of neovascularization.

Device Description

The Novus TTx Laser is an air cooled, solid-state, diode laser system intended for use in the treatment of ocular pathology as stated in Section V. The Novus TTx is a semiconductor diode laser that operates at a single wavelength, 810 mm, with treatment beam power output ranging from 0 to 2 Watts. A red diode laser provides a visible aiming beam. The Novus Varia system is comprised of the following functional components: a laser console; control and display panel; system microprocessor control electronics; a covered footswitch; operating software; an optional remote control unit; and delivery devices with accessories. Compatible delivery devices include: the LaserLink Z and LaserLink Z-1000 Slit Lamp Delivery Adapters, the LaserLink HS Slit Lamp Delivery Adapter, the LaserLink Large Spot Slit Lamp Delivery Adapters HS、LaserLink Z and Universal LaserLink), the Laser (LaserLink Indirect Ophthalmoscope, and the Acculite Endophotocoagulation Probe Delivery System (Acculite EndoOcular Probe/Endokit).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Novus TTx Laser and Delivery Devices based on the provided text:

Important Note: The provided document is a 510(k) Summary Statement from 2003, which is a premarket notification to demonstrate substantial equivalence to legally marketed predicate devices. For this type of submission, the "study" demonstrating performance is primarily a comparison of technological characteristics and intended use to already approved devices, rather than a clinical trial with specific performance metrics against an acceptance criterion in the modern sense of algorithm performance. The "acceptance criteria" here are essentially the demonstration of "substantial equivalence" to the predicates.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by Substantial Equivalence Claim)	Reported Device Performance (Comparison to Predicates)
Intended Use Equivalence: The device shares the same intended uses as the predicate devices.	The Novus TTx Laser and Delivery Devices have the same intended uses as the predicate devices.
Indications for Use Equivalence: The device shares the same indications for use as the predicate devices (treatment of ocular pathology, including various retinal conditions, glaucoma treatments, etc., as detailed in Section V).	The Novus TTx Laser and Delivery Devices have the same indications for use as the predicate devices.
Technological Characteristics Equivalence: The device possesses similar technological characteristics to the predicate devices. This includes aspects like treatment wavelength, laser media, mode of operation, power output, exposure duration, treatment intervals, spot sizes, aiming beam, cooling system, laser energy delivery control (footswitch), and delivery systems.	The Novus TTx Laser and Delivery Devices have similar technological characteristics to the predicate devices (treatment wavelength: 810 nm; laser media: semiconductor diode; power output: 0-2 Watts; aiming beam: red diode laser; and comparable delivery systems).
Safety and Effectiveness: Implied by substantial equivalence to legally marketed devices, demonstrating that the device is as safe and effective as the predicate devices and does not raise new questions of safety or effectiveness. (This is typically evaluated through comparison of design, materials, performance claims, and non-clinical testing if applicable, not necessarily a new clinical trial for 510(k)).	System and software hazard analysis information, software verification and validation information, and (relevant) clinical literature were submitted to support the safety and effectiveness profile, demonstrating that its performance is consistent with the predicates.

Study Information (Based on a 510(k) Submission, which focuses on equivalency)

Sample size used for the test set and the data provenance:
- Test set sample size: Not applicable in the context of a traditional clinical performance study with a "test set" of patients or cases. The "test" here is the comparison of the new device's specifications and intended use against existing predicate devices.
- Data provenance: Not directly applicable to external data sets. The "data" primarily consists of the technical specifications and indications for use of the Novus TTx device itself, compared against the known specifications and indications of the listed predicate devices (e.g., Iris Medical Oculight SL/SLx, Nidek DC-3300, etc.). The provenance would be the manufacturer's own design and engineering data, and publicly available information or marketing materials about the predicate devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept is not relevant for a 510(k) substantial equivalence submission for a laser device. "Ground truth" from experts in this context would imply a diagnostic or interpretive task where human judgment defines the correct answer, which is not the primary assessment for a surgical laser device's equivalence. The "truth" is established by comparing technical specifications and intended uses, typically evaluated by engineering and clinical reviewers at the FDA.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There's no "adjudication" in the sense of resolving discrepancies in expert opinions on cases.
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:
- Not applicable. This is a surgical laser device, not an AI-powered diagnostic tool, and the submission is a 510(k) for substantial equivalence, not a clinical effectiveness trial in this manner.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device (laser) with integrated software for control, not an standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this 510(k) submission is the established regulatory approval and performance characteristics of the predicate devices. The Novus TTx is deemed equivalent if its technical specifications and intended uses fall within the scope and performance demonstrated by these already cleared devices, and it doesn't raise new safety or effectiveness concerns.
The sample size for the training set:
- Not applicable. There is no "training set" in the context of a machine learning model, as this is a traditional medical device submission.
How the ground truth for the training set was established:
- Not applicable, as there is no training set.

In summary: The provided document describes a 510(k) premarket notification. The "study" demonstrating that the Novus TTx Laser meets "acceptance criteria" is a comparative analysis showing that it is "substantially equivalent" to predicate devices already on the market. This means it has the same intended use, indications for use, and similar technological characteristics, and does not raise new questions of safety or effectiveness. This type of submission relies on engineering specifications, software verification and validation, hazard analysis, and comparison with known predicate device data, rather than a clinical trial with a defined patient "test set," expert readers, or AI algorithms.

Summary

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II.

K0323571_JF3 Attachment 10 510(k) Summary Statement for the Novus TTx Laser and Delivery Devices

General Information

Submitter:	Lumenis, Inc.2400 Condensa StreetSanta Clara, California, U. S. A.95051-0901
Contact Persons:	Karen L. Baker
Summary Preparation Date:	October 2, 2003
Names

Device Names: Novus TTx Laser and Delivery Devices Primary Classification Name: 79, General and Plastic Surgery Panel GEX, Laser powered surgical instrument

III. Predicate Devices

Iris Medical Oculight SL/SLx (K020374, K913430, K912918) .
Nidek DC-3300 (K013760) .
Nidek DC-3000 (K903639) .
. BV International Viridis Laser (K960867)
Coherent System 920 Argon/Krypton (K830235) .
Novus Varia Ophthalmic Laser (K022181) ●
. LaserLink Z, LaserLink Z-1000 (K022181)
. LaserLink HS (K973470)
Iridex Large Spot Slit Lamp Delivery Adapters (K020374) .
Nidek Slit Lamp Delivery Adapter for Nidek SL-1600 (K013760) ●
Lumenis Laser Indirect Ophthalmoscope (K022181) ◆
Iris Laser Indirect Ophthalmoscope (K020374) ●
Acculite Endophotocoagulation Probe Delivery System (Acculite . Endoprobe/Endokit) (K022181):
HGM EndoOcular Probe (K840590, K860358) .
Iris Medical Endoprobe (K020374, K96097) .

IV. Product Description

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K032357 2 of 3

aiming beam. The Novus Varia system is comprised of the following functional components: a laser console; control and display panel; system microprocessor control electronics; a covered footswitch; operating software; an optional remote control unit; and delivery devices with accessories. Compatible delivery devices include: the LaserLink Z and LaserLink Z-1000 Slit Lamp Delivery Adapters, the LaserLink HS Slit Lamp Delivery Adapter, the LaserLink Large Spot Slit Lamp Delivery Adapters HS、LaserLink Z and Universal LaserLink), the Laser (LaserLink Indirect Ophthalmoscope, and the Acculite Endophotocoagulation Probe Delivery System (Acculite EndoOcular Probe/Endokit).

V. Indications for Use

. Retinal photocoagulation, panretinal photocoagulation, and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including:
- Diabetic retinopathy (proliferative retinopathy, nonproliferative retinopathy, macular edema):
- Retinal tears, detachments and holes
- Lattice degeneration
- Age-related macular degeneration
- Intraocular tumors (choroidal hemangioma, choroidal melanoma, retinoblastoma)
- Retinopathy of prematurity
- Choroidal neovascularization;
- Central and branch retinal vein occlusion;
. Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma

Laser Indirect Ophthalmoscope

The Laser Indirect Ophthalmoscope is indicated for use in the following ophthalmic treatments: diabetic retinopathy (panretinal photocoagulation); retinopexy; segmental peripheral photocoagulation; segmental photocoagulation; cloudy vitreous carities; and, pediatric retinal repairs (under general anesthesia).

Endophotocoagulation

The Acculite Endoprobe is indicated for use in the following ophthalmic applications: photocoagulation of the anterior and posterior segment, including: anterior segment treatment in the surgical management of glaucoma; endophotocoagulation in vitreoretinal surgery, including panretinal photocoagulation, retinopexy, and treatment of neovascularization.

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K032357 3

VI. Rationale for Substantial Equivalence

The TTx Laser and Delivery Devices with Accessories have the same intended uses and indications for use as the predicate devices, and have similar technological characteristics as the predicate devices - treatment wavelength, laser media, mode of operation, power output, exposure duration, treatment intervals, spot sizes, aiming beam, cooling system, laser energy delivery control (footswitch), and delivery systems - as the predicate devices, and therefore is substantially equivalent to the predicate devices referenced in Section III

VII. Performance Data

System and software hazard analysis information, software verification and validation information, and clinical literature were submitted in conjunction with this Premarket Notification submission. The determination of substantial equivalence was based upon the comparison of the technical characteristics between the Novus TTx Laser and Delivery Devices and the predicate laser systems and the evaluation of the performance data.

VIII. Conclusion

The Novus TTx Laser and Delivery Devices are substantially equivalent to similar predicate laser devices, delivery systems and accessories. The Novus TTx Laser and Delivery Devices share the same intended use, indications for use, and technological characteristics as the predicate laser systems.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three curved lines representing its body and wings. The eagle faces left within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Public Health Service

OCT - 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Karen L. Baker Senior Manager, Regulatory Affairs Lumenis, Inc. 2400 Condensa Street Santa Clara, California 95051-0901

Re: K032357

Trade/Device Name: Novus TTx Laser and Delivery Devices with Accessories Regulation Number: 21 CFR 878.4810, 886.4390 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in Dermatology; Ophthalmic laser Regulatory Class: II Product Code: GEX, HQF Dated: July 28, 2003 Received: July 31, 2003

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 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.

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Page 2 - Ms. Karen L. 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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): K032357

Device Name: Novus TTx Laser and Delivery Devices with Accessories

Indications for Use:

Retinal photocoagulation, panretinal photocoagulation, and intravitreal endophotocoagulation ● of vascular and structural abnormalities of the retina and choroid including:
- Diabetic retinopathy (proliferative retinopathy, nonproliferative retinopathy, macular edema):
- Retinal tears, detachments and holes
- Lattice degeneration
- Age-related macular degeneration
- Intraocular tumors (choroidal hemangioma, choroidal melanoma, retinoblastoma)
- retinopathy of prematurity
- choroidal neovascularization;
- central and branch retinal vein occlusion;
. Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and openangle glaucoma

(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)
Optional Format 1-2-96

Over-The-Counter Use:

Muriam C. Provost

Division of General. Restorative and Neurological Devices

510(k) Number K032357

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Attachment 2, Continued Indications for Use Statement as Requested by FDA

510(K) Number (if Known): K032357

Device Name: Novus TTx Laser and Delivery Devices with Accessories

Indications for Use:

Laser Indirect Ophthalmoscope

The Laser Indirect Ophthalmoscope is indicated for use in the following ophthalmic treatments: diabetic retinopathy (panretinal photocoagulation); retinopexy; segmental peripheral photocoagulation; segmental photocoagulation; cloudy vitreous cavities; and, pediatric retinal repairs (under general anesthesia).

Endophotocoagulation

(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)
Optional Format 1-2-96

Over-The-Counter Use:

Miriam C Provost

(Division Sign-Division of General, Restorative and Neurologi

510(k) Number K032357

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.