(71 days)
Not Found
No
The device description and performance studies focus on the laser technology and its delivery systems, with no mention of AI or ML capabilities.
Yes
The device is explicitly described as being "intended for use in the treatment of ocular pathology" and lists numerous medical conditions it treats, such as diabetic retinopathy and glaucoma.
No
The device is described as a laser system intended for the treatment of ocular pathology, not for diagnosis.
No
The device description explicitly states it is a laser system comprised of hardware components like a laser console, control panel, footswitch, and delivery devices, in addition to operating software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the treatment of ocular pathology through photocoagulation. This is a therapeutic intervention performed directly on the patient's eye.
- Device Description: The description details a laser system designed to deliver energy for treatment. It does not mention any components or processes related to analyzing samples (like blood, tissue, or other bodily fluids) in vitro (outside the body).
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information based on sample analysis.
- Reagents, calibrators, or controls used for testing.
The device is a therapeutic medical device used for surgical procedures on the eye.
N/A
Intended Use / Indications for Use
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.
Product codes
GEX, HQF
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ocular (anterior and posterior segments, retina, choroid)
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K020374, K913430, K912918, K013760, K903639, K960867, K830235, K022181, K973470
Reference Device(s)
Not Found
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
II.
K0323571_JF3 Attachment 10 510(k) Summary Statement for the Novus TTx Laser and Delivery Devices
General Information
| Submitter: | Lumenis, Inc.
2400 Condensa Street
Santa 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
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
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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
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 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.
3
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:
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 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
OR
Over-The-Counter Use:
Muriam C. Provost
Division of General. Restorative and Neurological Devices
510(k) Number K032357
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2 of 2
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
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)
Prescription Use:
(Per 21 CFR 801.109)
Optional Format 1-2-96
OR
Over-The-Counter Use:
Miriam C Provost
(Division Sign-Division of General, Restorative and Neurologi
510(k) Number K032357