(196 days)
Not Found
No
The summary describes a laser photocoagulator with integrated imaging capabilities and software for image manipulation and treatment planning. There is no mention of AI, ML, or any related concepts like automated analysis, diagnosis support beyond aiding the physician, or learning algorithms. The focus is on combining existing technologies for imaging and treatment.
Yes
The device is indicated for "retinal photocoagulation," which is a treatment method for ocular pathology. It also explicitly mentions "aiding in the diagnosis and treatment of ocular pathology."
Yes
The device is indicated for "aiding in the diagnosis and treatment of ocular pathology" and integrates imaging technologies for capture, display, storage, and manipulation of retinal images, which are essential functions for diagnostic purposes.
No
The device description explicitly states that the NAVILAS Laser System is comprised of a laser photocoagulation module, digital imaging camera, computer hardware, and a software platform. It is a system that includes both hardware and software components for imaging and treatment.
Based on the provided information, the NAVILAS Laser System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- NAVILAS Function: The NAVILAS Laser System is a medical device used for retinal photocoagulation (treatment) and imaging of the retina (diagnosis and treatment planning). It interacts directly with the patient's eye, not with samples taken from the body.
The device description and intended use clearly indicate that the NAVILAS is an ophthalmic medical device used for both diagnostic imaging and therapeutic laser treatment of the eye. It does not perform tests on biological samples.
N/A
Intended Use / Indications for Use
The NAVILAS is indicated for use in retinal photocoagulation, as well as for the imaging (capture, display, storage and manipulation) of the retina of the eye, including via color, fluorescein angiography and red-free imaging; and for aiding in the diagnosis and treatment of ocular pathology in the posterior segments of the eye.
The NAVILAS Laser System is a retinal photocoagulator integrated with a digital fundus camera. The NAVILAS is indicated for use in retinal photocoagulation, as well as for the imaging (capture, display, storage and manipulation) of the retina of the eye, including via color, fluorescein angiography and infra-red imaging; and for aiding in the diagnosis and treatment of ocular pathology in the posterior segments of the eye.
Product codes
CFX, HKI, NEE, NEG, HOF
Device Description
The NAVILAS Laser System is a retinal laser photocoagulator with an integrated digital fundus camera. The NAVILAS Laser System combines imaging technologies (fundus live imaging, infra-red imaging and fluorescein angiography) with established retinal laser photocoagulation treatment methods by providing the doctor a system for imaging and treatment planning prior to the photocoagulation.
The NAVILAS Laser System is comprised of a laser photocoagulation module, digital imaging camera, computer hardware, and a software platform intended to be used to capture display, store and manipulate images captured by the fundus camera.
Like the predicate devices, laser photocoagulation with the NAVILAS is performed using single shot (Single Spot Mode), repeated shots (Repeat Mode), and scanned patterns (Pattern Mode). All treatment-related information and images are continuously displayed on the monitor to provide the physician an optimal platform for the photocoagulation procedure.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fundus live imaging, infra-red imaging, fluorescein angiography, color, red-free imaging
Anatomical Site
retina of the eye, posterior segments of the eye
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)
Performance verification and validation testing was completed to demonstrate that the device performance complies with specifications and requirements identified for the NAVILAS Laser System. This was accomplished by software and hardware verification & validation testing, along with system level bench testing of the NAVILAS Laser System. All criteria for this testing were met and results demonstrate that laser photocoagulation performed with the NAVILAS Laser System meets all performance specifications and requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K072823, K043486, K053044, K052268, K011877
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.
0
091064
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS 00 OCT 2009
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT: | OD-OS GmbH
Warthestr. 21
14513 Teltow
Germany
Phone: +49 3328 312 82-100
Fax: +49 3328 312 82-999 |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| OFFICIAL
CORRESPONDENT: | Judy F. Gordon, D.V.M.
Regulatory Consultant to OD-OS GmbH
733 Bolsana Drive
Laguna Beach, CA 92563
Tel: (949) 715-0609
Fax: (949) 715-0610
judy@clinregconsulting.com |
| DATE PREPARED: | April 10, 2009 |
| TRADE NAME: | NAVILAS Laser System |
| COMMON NAME: | Retinal Photocoagulator with a Digital Fundus Camera |
| DEVICE
CLASSIFICATION: | Laser Instrument, Surgical, Powered
(Class II, per 21 CFR §878.4810) |
| | Camera, Ophthalmic
Class II, per 21 CFR §886.1120 |
| | Device, Storage, Images, Ophthalmic
Class I per 21 CFR §892.2010 |
| | Device, Communication, Images, Ophthalmic
Class I per 21 CFR §892.2020 |
| | CFX, HKI, NEE, NEG |
ﺎﺯ
1
SUBSTANTIAL EQUIVALENCE
The NAVILAS Laser System is substantially equivalent to the following devices listed in Table 1.
| 510(k) # | TRADE NAME | MANUFACTURER |
|---|---|---|
| Laser Photocoagulation | ||
| K072823 | MERILAS 532nm Laser | Meridian AG |
| K043486 | Pascal Photocoagulator | Optimedica Corporation |
| Retinal Imaging | ||
| K053044 | OPTO Global Digital Fundus | |
| Camera System | OPTO Global, Inc. | |
| K052268 | VISUCAM PR NM Digital Camera | Carl Zeiss Meditec AG |
| K011877 | FF450 Plus VISUPAC System | Carl Zeiss Jena GmbH |
| TABLE 1 | |||
|---|---|---|---|
| PREDICATE DEVICES FOR THE NAVILAS LASER SYSTEM |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION
The NAVILAS Laser System is a retinal laser photocoagulator with an integrated digital fundus camera. The NAVILAS Laser System combines imaging technologies (fundus live imaging, infra-red imaging and fluorescein angiography) with established retinal laser photocoagulation treatment methods by providing the doctor a system for imaging and treatment planning prior to the photocoagulation.
The NAVILAS Laser System is comprised of a laser photocoagulation module, digital imaging camera, computer hardware, and a software platform intended to be used to capture display, store and manipulate images captured by the fundus camera.
Like the predicate devices, laser photocoagulation with the NAVILAS is performed using single shot (Single Spot Mode), repeated shots (Repeat Mode), and scanned patterns (Pattern Mode). All treatment-related information and images are continuously displayed on the monitor to provide the physician an optimal platform for the photocoagulation procedure.
INDICATION FOR USE
The NAVILAS is indicated for use in retinal photocoagulation, as well as for the imaging (capture, display, storage and manipulation) of the retina of the eye, including via color, fluorescein angiography and red-free imaging; and for aiding in the diagnosis and treatment of ocular pathology in the posterior segments of the eye.
2
BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The NAVILAS Laser System has the same intended use, indications, and very similar principles of operation as for the cleared predicate devices, the MERILAS 532nm Laser System (K072823) and the Optimedica Pascal Photocoagulator (K043486) for laser photocoagulation. Imaging functionalities are similar to those of the OPTO Digital Fundus Camera (K053044), the Visucam PR NM Digital Camera (K052268), and the FF450 Visupac System (K011877), which are also indicated for use for the capture, display and storage of digital images of the retina and fundus. The minor differences between the NAVILAS Laser System and the listed predicate devices do not raise any new questions of safety or of effectiveness in comparison to the predicate devices.
PERFORMANCE DATA
, r
Performance verification and validation testing was completed to demonstrate that the device performance complies with specifications and requirements identified for the NAVILAS Laser System. This was accomplished by software and hardware verification & validation testing, along with system level bench testing of the NAVILAS Laser System. All criteria for this testing were met and results demonstrate that laser photocoagulation performed with the NAVILAS Laser System meets all performance specifications and requirements.
CONCLUSIONS
As described in this 510(k) Summary, all testing deemed necessary was conducted on the NAVILAS Laser System to ensure that the device is safe and effective for its intended use and is substantially equivalent to legally marketed devices intended for laser photocoagulation and retinal imaging to aid in the diagnosis and treatment of diseases of the eve.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
ClinReg Consulting Services, Inc. c/o Judy F. Gordon, D.V.M. Regulatory Consultant to OD-OS 733 Bolsana Dr. Laguna Beach, CA 92651
OCT 2 7 2009
Re: K091064
Trade/Device Name: NAVILAS Laser System Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: II Product Code: HOF Dated: October 14, 2009 Received: October 16, 2009
Dear Ms. Gordon:
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. Ilsting 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 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); medical device reporting (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.
4
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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Elkham
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): K09 | 064
Device Name: NAVILAS Laser System
Indications for Use:
The NAVILAS Laser System is a retinal photocoagulator integrated with a digital fundus camera. The NAVILAS is indicated for use in retinal photocoagulation, as well as for the imaging (capture, display, storage and manipulation) of the retina of the eye, including via color, fluorescein angiography and infra-red imaging; and for aiding in the diagnosis and treatment of ocular pathology in the posterior segments of the eye.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bruce Drum
Page 1 of 1
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear,
Nose and Throat Devices
510(k) Number K091064