(152 days)
Not Found
No
The summary describes standard image processing for fluorescence and color imaging, but there is no mention of AI, ML, or related concepts like training or test sets for algorithmic development.
No.
The device is an imaging system used for diagnostic purposes (visual assessment of blood flow, tissue perfusion, and the lymphatic system), not for providing therapy.
No
Explanation: The device is described as an imaging system used for visual assessment of blood flow and tissue perfusion during surgery. While it provides adjunctive information, it does not directly diagnose conditions but rather aids in visualizing physiological processes. The indications state "fluorescence imaging of blood flow and tissue perfusion" and "fluorescence imaging and visualization of the lymphatic system," which are functions of imaging and visualization, not diagnosis. The system helps surgeons see physiological processes, but the surgeon makes the diagnosis.
No
The device description explicitly states that the system consists of hardware components including an Imaging Head and an Image Processing Unit, in addition to software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a physiological state, health, or disease. This testing happens outside the body (in vitro).
- Device Function: The FloNavi Open Field Fluorescence Imaging System is used for intraoperative imaging. This means it is used during surgical procedures, directly on the patient's body, to visualize blood flow, tissue perfusion, and the lymphatic system. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for "intraoperative fluorescence angiography" and "intraoperative fluorescence imaging and visualization of the lymphatic system." This is a direct imaging technique performed on the living patient.
Therefore, based on the provided information, the FloNavi Open Field Fluorescence Imaging System is an in vivo imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Upon intravenous administration and use of an ICG consistent with its approved labeling, the FloNavi Open Field Fluorescence Imaging System is used to perform intraoperative fluorescence angiography.
The FloNavi Open Field Fluorescence Imaging System is indicated for fluorescence imaging of blood flow and tissue perfusion before, during, and after: vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgical procedures.
Upon interstitial administration and use of an ICG consistent with its approved labeling, the FloNavi Open Field Fluorescence Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Product codes
OWN, IZI, GCJ
Device Description
The FloNavi Open Field Fluorescence Imaging System is an imaging system used in hospitals for capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue transfer circulation for use in imaging during various surgical procedures.
The FloNavi Open Field Fluorescence Imaging System has two system models: HD system and 4K system. Each system consists of the following main components: Imaging Head, Image Processing Unit, power supply cord and video cables.
The Imaging Head may be either handheld or attached to a mechanical arm and provides illumination of the regions of a patient's body to be observed with near infrared light to excite ICG fluorescence. Alternatively, the Imaging Head provides white light illumination of the regions of a patient's body to be observed for color imaging. The cameras in the Imaging Head capture the fluorescent image under near infrared illumination or a color image under white light illumination. The Image Processing Unit receives the video signal from the Imaging Head and processes and outputs the video image to a medical grade video monitor and/or video recorder. Adjustments to the operation of the FloNavi Open Field Fluorescence Imaging System are possible through switches at either the Imaging Head or the Image Processing Unit.
The FloNavi Open Field Fluorescence Imaging System is a reusable device and provided nonsterile. Its components should be cleaned and low-level disinfected prior to the first use and after every subsequent use.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluorescence imaging, full color visible light, NIR fluorescence video imaging
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital
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)
Non clinical tests were conducted to verify that the proposed device met all design specifications as is Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- . IEC 60601-1:2005+A1:2012; ANSI/AAMI ES60601-1:2005+A2 (R2012) +A1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance (HD system)
- . IEC 60601-1:2005+A1:2012+A2:2020; ANSI/AAMI ES60601-1:2005 + A2:2010 (R2012) + A 1:2012+A2:2021 Medical electrical equipment Part 1: General requirements for basic safety and essential performance (4K system)
- . IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
- . IEC 60601-2-57:2011 Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
- . IEC 62471:2006 Photobiological safety of lamps and lamp systems
The software of the proposed device was validated as Moderate level of concern (LoC) in accordance with the following guidance documents: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff
Performance testing and animal testing were also conducted on the subject device and demonstrate that the proposed system performs according to specifications and functions as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 17, 2023
Guangdong OptoMedic Technologies, Inc. Alice Lau Regulatory Affairs Engineer Suite 503, Building A, Golden Valley Intellicreation Community, No. 2 Yonganbei Street, Daxu, Guicheng, Nanhai Foshan, Guangdong 528200 China
Re: K230407
Trade/Device Name: FloNavi Open Field Fluorescence Imaging System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OWN, IZI, GCJ Dated: July 15, 2023 Received: July 17, 2023
Dear Alice Lau:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Carr -S
Jessica Carr, PhD Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230407
Device Name
FloNavi Open Field Fluorescence Imaging System
Indications for Use (Describe)
Upon intravenous administration and use of an ICG consistent with its approved labeling, the FloNavi Open Field Fluorescence Imaging System is used to perform intraoperative fluorescence angiography.
The FloNavi Open Field Fluorescence Imaging System is indicated for fluorescence imaging of blood flow and tissue perfusion before, during, and after: vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgical procedures.
Upon interstitial administration and use of an ICG consistent with its approved labeling, the FloNavi Open Field Fluorescence Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for OptoMedic. The logo consists of a green and yellow circular graphic on the left, followed by the text "OptoMedic" in a bold, black font. The text is slightly glossy, giving it a three-dimensional appearance.
K230407 510(k) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Date Prepared: June 9, 2023
I. General Information
| 510(k) Submitter/Owner: | Guangdong OptoMedic Technologies, Inc.
Suite 503, Building A, Golden Valley Intellicreation Community
No. 2 Yonganbei Street, Daxu, Guicheng, Nanhai, Foshan
Guangdong, 528200, P.R. China
Establishment Registration Number: Not yet registered |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact Person: | Alice Lau
Regulatory Affairs Engineer |
| Regulatory Affairs Engineer |
|---|
| Tel: +86 (757) 8670 2920 |
| Email: liuli@optomedic.com |
II. Device Identification
| Device Trade Name: | FloNavi Open Field Fluorescence Imaging System |
|---|---|
| Model: | HD system: Image Processing Unit (OPTO-CAM2100), |
| Imaging Head (OPTO-CHD3100H; OPTO-CHD3100E) |
4K system: Image Processing Unit (OPTO-CAM214K),
Imaging Head (OPTO-CHD314KE) |
| Common or Usual Name: | Fluorescence Angiographic System |
| Regulation Name: | Endoscopes and accessories |
| Regulation Number: | 21 CFR § 876.1500 |
| Regulatory Class: | Class II |
| Product Code: | OWN, IZI, GCJ |
4
Image /page/4/Picture/0 description: The image shows the logo for OptoMedic. The logo consists of a green and yellow circle on the left, followed by the word "OptoMedic" in black. The word "Opto" is in a smaller font than the word "Medic". The logo is simple and modern.
III. Predicate Device
| 510(k) Number: | K200737 |
|---|---|
| Product Name: | SPY Portable Handheld Imaging (SPY-PHI) System |
The predicate device has not been subject to a design-related recall.
IV. Device Description
The FloNavi Open Field Fluorescence Imaging System is an imaging system used in hospitals for capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue transfer circulation for use in imaging during various surgical procedures.
The FloNavi Open Field Fluorescence Imaging System has two system models: HD system and 4K system. Each system consists of the following main components: Imaging Head, Image Processing Unit, power supply cord and video cables.
The Imaging Head may be either handheld or attached to a mechanical arm and provides illumination of the regions of a patient's body to be observed with near infrared light to excite ICG fluorescence. Alternatively, the Imaging Head provides white light illumination of the regions of a patient's body to be observed for color imaging. The cameras in the Imaging Head capture the fluorescent image under near infrared illumination or a color image under white light illumination. The Image Processing Unit receives the video signal from the Imaging Head and processes and outputs the video image to a medical grade video monitor and/or video recorder. Adjustments to the operation of the FloNavi Open Field Fluorescence Imaging System are possible through switches at either the Imaging Head or the Image Processing Unit.
The FloNavi Open Field Fluorescence Imaging System is a reusable device and provided nonsterile. Its components should be cleaned and low-level disinfected prior to the first use and after every subsequent use.
V. Indications for Use
Upon intravenous administration and use of an ICG consistent with its approved labeling, the FloNavi Open Field Fluorescence Imaging System is used to perform intraoperative fluorescence angiography.
The FloNavi Open Field Fluorescence Imaging System is indicated for fluorescence imaging of blood flow and tissue perfusion before, during, and after: vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgical procedures.
Upon interstitial administration and use of an ICG consistent with its approved labeling, the FloNavi Open Field Fluorescence Imaging System is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Image /page/4/Figure/15 description: The image contains a single digit, specifically the number 2. The number is written in a simple, sans-serif font. The digit is black and stands out against a white background.
5
Image /page/5/Picture/0 description: The image shows the word "OptoMedic" in a stylized font. The "Opto" portion of the word is green, while the "Medic" portion is black. To the left of the word is a green circle that is not fully connected.
.
VI. Comparison of Technological Characteristics with The Predicate Device
Table 1 General Comparison
| Table 1 General Comparison | ||
|---|---|---|
| Description | Subject Device | Predicate device |
| FloNavi Open Field Fluorescence Imaging System | SPY Portable Handheld Imaging (SPY-PHI) System | |
| 510(k) Holder / | ||
| Manufacturer | Guangdong OptoMedic Technologies, Inc. | Novadaq Technologies ULC. (now a part |
| of Stryker) | ||
| Submission Reference | K230407 | K200737 |
| Combination Product | No | No |
| Product Code | OWN, IZI, GCJ | OWN, IZI, GCJ |
| Regulation Number | 21 CFR 876.1500 | 21 CFR 876.1500 |
| Device Classification | ||
| Name | Confocal Optical Imaging | Confocal Optical Imaging |
| Indications for Use | Upon intravenous administration and use of | |
| an ICG consistent with its approved labeling, | ||
| the FloNavi Open Field Fluorescence | ||
| Imaging System is used to perform | ||
| intraoperative fluorescence angiography. |
The FloNavi Open Field Fluorescence
Imaging System is indicated for fluorescence
imaging of blood flow and tissue perfusion
before, during, and after: vascular,
gastrointestinal, organ transplant, and plastic,
micro- and reconstructive surgical
procedures.
Upon interstitial administration and use of
an ICG consistent with its approved labeling,
the FloNavi Open Field Fluorescence
Imaging System is used to perform
intraoperative fluorescence imaging and
visualization of the lymphatic system,
including lymphatic vessels and lymph
nodes. | Upon intravenous administration of SPY
AGENTTM GREEN (indocyanine green for
injection, USP) the SPY-PHI System is
used with SPY AGENTTM GREEN to
perform intraoperative fluorescence
angiography. The SPY-PHI System is
indicated for use in adult and pediatric
patients one month of age and older.
The SPY-PHI System is indicated for
fluorescence imaging of blood flow and
tissue perfusion before, during, and after:
vascular, gastrointestinal, organ transplant,
and plastic, micro- and reconstructive
surgical procedures.
Upon interstitial administration of SPY
AGENTTM GREEN, the SPY-PHI System
is used to perform intraoperative
fluorescence imaging and visualization
of the lymphatic system, including
lymphatic vessels and lymph nodes. |
| Operating Principle | Full color visible light and NIR fluorescence
video imaging. The cameras (VIS+NIR) in
the Imaging Head capture the fluorescent
image under near infrared light illumination
or a color image under white light
illumination. The Image Processing Unit | Full color visible light and NIR
fluorescence video imaging. The CMOS
camera in the Imaging Head captures the
fluorescent image under near infrared light
illumination or a color image under white
light illumination. The VPI receives the |
| | | |
| | Head and processes and outputs the video
image to a medical grade video monitor
and/or video recorder. | processes and outputs the video image to a
medical grade video monitor and/or video
recorder. |
| Major Components | HD system:
Image Processing Unit (OPTO-CAM2100),
Imaging Head (OPTO-CHD3100E/OPTO-
CHD3100H)
4K system:
Image Processing Unit (OPTO-CAM214K),
Imaging Head (OPTO-CHD314KE) | Imaging Head/Imager (HH9030), Video
Processor/Illuminator (PC9001) |
| Image modes | White light image - White light image is
displayed in full color.
GF image - NIR fluorescence is
superimposed in pseudo-color (green) on a
white light image
SF image – In Segmented Fluorescence (SF)
image, a high-definition white light image is
displayed in full color with NIR fluorescence
overlaid in on a color scale. The pseudo-color
of fluorescence will change according to the
fluorescence brightness.
Parallel display image - The white light
image, GF image, SF image, grayscale
fluorescent image are displayed on the same
screen, with the small image on the left side
and the large image as the main image. The
default main image is the white light image
and can be changed through the menu to the
image of other display modes. | White Light Mode - White light image is
displayed in full color.
Overlay Mode - an NIR fluorescence
image is superimposed in pseudo-color
(green) on a white light image.
Color Segmented Fluorescence (CSF) -
white light image is displayed in grayscale
with NIR fluorescence overlaid in a color
scale. Increasing fluorescence levels
transition from blue to yellow to red.
SPY mode - an NIR fluorescence image is
displayed in grayscale. |
| Prescription/
Over-the-counter
use | Prescription | Prescription |
| Environment of Use | Hospital | Hospital |
| Video Output Signals | HD system: SDI, DVI, CVBS, S-VIDEO
4K system: DVI, HDMI, 4×3G-SDI, 12G-
SDI | HD-SDI, 3G-SDI, DVI |
| Image Resolution | HD system: 1920×1080p
4K system: 1920×1080p / 3840×2160p /
4096×2160p | 1920×1080p |
| Sensor Type | CMOS | CMOS |
| Light source | Visible (VIS): Light-emitting diodes
Near infrared (NIR): Light-emitting diodes,
wavelength 785nm | Visible (VIS): Light-emitting diode array
Near infrared (NIR): NIR laser diode,
wavelength 805 nm |
| Power supply | Mains powered | Mains powered |
| | | |
| Safety Standards | IEC 60601-1
IEC 60601-1-2
IEC 62471
IEC 60601-2-57 | IEC 60601-1
IEC 60601-1-2
IEC 60825-1 |
| Design | The light source of the subject device is
located in the Imaging Head itself. | The light source is located in the VPI and
transmits light through a light guide cable. |
6
Image /page/6/Picture/0 description: The image shows the logo for OptoMedic. The logo consists of a green circular design on the left, followed by the word "OptoMedic" in bold, black letters. The circular design is made up of three curved lines that start with a yellow color and transition to green.
0
.
1
7
Image /page/7/Picture/0 description: The image shows the logo for OptoMedic. The logo consists of a green circular graphic on the left, followed by the word "OptoMedic" in black font. The "Opto" part of the word is in a lighter shade of black, while the "Medic" part is in a darker, more glossy shade of black.
The differences technological characteristics do not raise different questions of safety and effectiveness.
VII. Performance data
Non clinical tests were conducted to verify that the proposed device met all design specifications as is Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- . IEC 60601-1:2005+A1:2012; ANSI/AAMI ES60601-1:2005+A2 (R2012) +A1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance (HD system)
- . IEC 60601-1:2005+A1:2012+A2:2020; ANSI/AAMI ES60601-1:2005 + A2:2010 (R2012) + A 1:2012+A2:2021 Medical electrical equipment Part 1: General requirements for basic safety and essential performance (4K system)
- . IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
- . IEC 60601-2-57:2011 Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
- . IEC 62471:2006 Photobiological safety of lamps and lamp systems
The software of the proposed device was validated as Moderate level of concern (LoC) in accordance with the following guidance documents: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff
Performance testing and animal testing were also conducted on the subject device and demonstrate that the proposed system performs according to specifications and functions as intended.
VIII. Conclusions
The performance testing and animal testing summarized above supports a substantial equivalence determination. The performance testing and animal testing demonstrate that the subject device is as safe and as effective as the legally marketed predicate device.