(90 days)
No
The document does not mention AI, ML, or related concepts like deep learning, neural networks, or image processing for analysis or decision-making. The description focuses on the laser technology and its components.
Yes
The device is intended for the treatment of ocular pathology, including various conditions of the retina, choroid, and glaucoma, which are therapeutic medical interventions.
No
Explanation: The device is described as a "laser system intended for use in the treatment of ocular pathology" and its indications for use are "photocoagulation" and various "treatments" such as iridotomy, iridectomy, and trabeculoplasty. These are all therapeutic procedures, not diagnostic ones.
No
The device description clearly states it is a laser system comprised of multiple hardware components including a laser console, control and display panel, microprocessor control electronics, fiber ports, eye safety filter port, footswitch, and delivery devices. While it includes operating software, it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Novus Varia Ophthalmic Laser and Delivery Devices is a therapeutic device. It uses laser energy to treat ocular pathology directly on the patient's eye. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes treatment procedures (photocoagulation, iridotomy, trabeculoplasty) performed on the patient's eye.
- Device Description: The description details a laser system and delivery devices used to apply the laser energy to the eye. There is no mention of analyzing biological samples.
Therefore, the Novus Varia Ophthalmic Laser and Delivery Devices falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Novus Varia Ophthalmic Laser and Delivery Devices is intended for use in the treatment of ocular pathology. The NovusVaria 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:
- proliferative and nonproliferative diabetic retinopathy; -
- choroidal neovascularization; -
- branch retinal vein occlusion; -
- age-related macular degeneration -
- retinal tears and detachments -
- retinopathy of prematurity -
- 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.
Product codes
GEX
Device Description
The Novus Varia Laser System is an air cooled, diode-pumped, solid state, Nd: Y AG, threecolor laser system (green, yellow and red) intended for use in the treatment of ocular pathology. 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; two fiber ports for delivery systems; eye safety filter port; a covered footswitch; operating software; an optional remote control unit; an optional printer; delivery devices with accessories
Compatible delivery devices include: the LaserLink Z and LaserLink Z-1000 Slit Lamp Delivery Adapters; the Laser Indirect Ophthalmoscope (Heine and Keeler models) and the
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ocular (anterior and posterior segments of the eye), retina, choroid, vitreous cavities
Indicated Patient Age Range
pediatric (for retinal repairs)
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)
System and software hazard analysis information and software verification and validation information was 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 Varia Ophthalmic Laser with Delivery Devices and the predicate laser systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Novus Omni Laser System (K932468), Iris Medical Oculight GL and Delivery Devices (K960971), Ultima 2000/Ultima 2000SE (K913127), Coherent System 920 Argon/Krypton Laser (K837235), LaserLink Z Slit Lamp Laser Delivery Adapter (LaserLink Z & LaserLink Z-1000) (K000498, K991258, K932468)
Reference Device(s)
Acculite Endophotocoagulation Probe Delivery System (K991258, K932468, K913127), Laser Indirect Ophthalmoscope (K991258, K932468, K913127, K885196)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
OCT 01 2002
Attachment 10
510(k) Summary Statement for the
Novus® Varia™ Ophthalmic Laser and Delivery Devices
I. General Information
| Submitter: | Lumenis, Inc.
2400 Condensa Street
Santa Clara, California, U. S. A.
95051-0901 |
|---------------------------|------------------------------------------------------------------------------------------|
| Contact Persons: | 1. Karen L. Baker
2. K. Delane Dale |
| Summary Preparation Date: | June 28, 2002 |
| Device Names: | Novus® Varia™ Ophthalmic Laser and Delivery |
Primary Classification Name:
III. Predicate Devices
II.
- Novus Omni Laser System (K932468) .
- Iris Medical Oculight GL and Delivery Devices (K960971) .
- Ultima 2000/Ultima 2000SE (K913127) .
- Coherent System 920 Argon/Krypton Laser (K837235) .
- LaserLink Z Slit Lamp Laser Delivery Adapter (LaserLink Z & LaserLink Z-1000) . (K000498, K991258, K932468)
Devices
- Acculite Endophotocoagulation Probe Delivery System (K991258, K932468, . K913127)
- Laser Indirect Ophthalmoscope (K991258, K932468, K913127, K885196) .
IV. Product Description
The Novus Varia Laser System is an air cooled, diode-pumped, solid state, Nd: Y AG, threecolor laser system (green, yellow and red) intended for use in the treatment of ocular pathology. 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; two fiber ports for delivery systems; eye safety filter port; a covered footswitch; operating software; an optional remote control unit; an optional printer; delivery devices with accessories
Compatible delivery devices include: the LaserLink Z and LaserLink Z-1000 Slit Lamp Delivery Adapters; the Laser Indirect Ophthalmoscope (Heine and Keeler models) and the
1
V. Indications for Use
The Novus Varia Ophthalmic Laser and Delivery Devices is intended for use in the treatment of ocular pathology. The NovusVaria 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:
- proliferative and nonproliferative diabetic retinopathy; -
- choroidal neovascularization; -
- branch retinal vein occlusion; -
- age-related macular degeneration -
- retinal tears and detachments -
- retinopathy of prematurity -
- 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.
VI. Rationale for Substantial Equivalence
The Novus Varia Ophthalmic Laser with Delivery Devices and Accessories share the same intended use, indications for use and the same or similar technological characteristics (including treatment wavelengths, laser active medium, pumping system, aiming beam, mode of operation, exposure duration, power, treatment intervals, spot sizes, controls and displays, laser energy delivery control (footswitch), and delivery systems), and therefore is substantially equivalent to the predicate devices referenced in Section III.
VII. Performance Data
System and software hazard analysis information and software verification and validation information was 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 Varia Ophthalmic Laser with Delivery Devices and the predicate laser systems.
2
VIII. Conclusion
The Novus Varia Ophthalmic Laser and Delivery Devices are substantially equivalent to similar predicate laser devices, delivery systems and accessories. The Novus Varia Ophthalmic Laser and Delivery Devices share the same intended use, indications for use, and technological characteristics as the predicate ophthalmic laser systems.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of an eagle or bird-like figure, with flowing lines representing its wings and body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 01 2002
Ms. Karen L. Baker Regulatory Consultant Lumenis, Inc. 2400 Condensa Street Santa Clara, CA 95051-0901
Re: K022181
Trade/Device Name: Novus® Varia™ Ophthalmic Laser and Delivery Devices Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: June 28, 2002 Received: July 3, 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 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.
4
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 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" (21CFR 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.
- Stypk Ruede
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
5
Attachment 2 Indications for Use Statement as Requested by FDA
510(K) Number (if Known):
Device Name: Novus Varia Ophthalmic Laser and Delivery Devices
Indications for Use:
The Novus Varia Ophthalmic Laser and Delivery Devices is intended for use in the treatment of ocular pathology. The Lumenis Varia 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:
- proliferative and nonproliferative diabetic retinopathy;
- choroidal neovascularization;
- branch retinal vein occlusion;
- age-related macular degeneration
- retinal tears and detachments
- retinopathy of prematurity
- 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 diabetic retinopathy (panretinal photocoagulation); retinopexy; segmental treatments: 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.
(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 of General, Restorative and Neurological Devices
| Prescription Use: | |
|---|---|
| (Per 21 CFR 801.109) |
Optional Format 1-2-96
| 510(k) Number | K022181 |
|---|---|
| --------------- | --------- |