(91 days)
Not Found
No
The summary describes a light source and imaging system for fluorescence imaging, focusing on hardware components and imaging capabilities. There is no mention of AI, ML, or advanced image processing beyond basic illumination and visualization.
No
The device is used to perform intraoperative fluorescence imaging and visualization, which is a diagnostic rather than therapeutic function.
No
The document describes the device as an endoscopic light source used for real-time imaging during surgery, aiding surgeons in visualization rather than providing diagnostic information.
No
The device description explicitly states that the OPTOVISION is an endoscopic light source largely composed of a power circuit, a control circuit, and a lighting lamp (light source). This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This includes reagents, calibrators, control materials, kits, instruments, apparatus, equipment, or systems.
- OPTOVISION's Function: The OPTOVISION is an endoscopic light source that provides real-time imaging during surgery. It uses light (visible and near-infrared) to visualize structures within the body. It does not analyze specimens outside the body.
- Intended Use: The intended use clearly describes its function as an imaging tool for surgeons during minimally invasive procedures to visualize vessels, bile ducts, and the lymphatic system. This is an in vivo application, not in vitro.
Therefore, the OPTOVISION falls under the category of a surgical imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Upon intravenous administration of ICG(Indocyanine green for injection) consistent with its approved label, the OPTOVISION provides real-time endoscopic visible and near-infrared fluorescence imaging. The OPTOVISION enable surgeons to perform minimally invasive surgery using standard endoscope visual light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the OPTOVISION is intended for use with standard-of-care white light and, when indicated, intraoperative cholangioaraphy. The device is not intended for standalone use for biliary duct visualization.
Upon interstitial administration and use of ICG consistent with its approved label, the OPTOVISION is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
Product codes
OWN
Device Description
OPTOVISION is an endoscopic light source that enables real-time endoscopic visible and nearinfrared fluorescence imaging minimally invasive surgical procedures. Near-infrared illumination is used for fluorescence imaging using indocyanine green (ICG). This device is largely composed of a power circuit, a control circuit, and a lighting lamp (light source). A power circuit provides power to the lighting lamp and cuts off the power in an emergency, a control circuit controls the light output (intensity)/other settings of light rays, and a light source unit irradiates light directly to the Light Guide Cable (K111342) for observation of the affected area. With the configuration above, the power input from the initial power source is transmitted to the light source unit and the main body, and rays of white light and near-infrared light are directly irradiated through the Light Guide Cable to the affected area for observation. This device is designed for use in the following applications: standard endoscopic visible-light imaging and near-infrared fluorescence imaging.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
real-time endoscopic visible and near-infrared fluorescence imaging
Anatomical Site
vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), lymphatic system, including lymphatic vessels and lymph nodes.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons to perform minimally invasive surgery
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)
The following performance data were provided in support of the substantial equivalence determination.
| Testing | Method | Result |
|---|---|---|
| Electrical Safety | ES60601-1:2005/(R)2012 & A1:2012 C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] IEC 60601-2-18: Edition 3.0 2009-08 IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION | PASS |
| Electromagnetic Compatibility (EMC) test | IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION | PASS |
| Usability | IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION | PASS |
| Photobiological Safety | IEC 62471 First edition 2006-07 | PASS |
| Software Validation & Verification | IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION | PASS |
| Performance - Bench | In accordance with device input specifications | PASS |
All conducted tests demonstrated compliance with applicable standards, and no safety concerns were identified.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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 contains 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.
February 19, 2025
Optosurgical LLC Yoseph Kim Chief Executive Officer and R&D Administrator 6751 Columbia Gateway Dr, Suite 300 Office 313 Columbia, Maryland 21046
Re: K243591
Trade/Device Name: OPTOVISION Endoscopic Light Source Unit Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OWN Dated: October 31, 2024 Received: November 20, 2024
Dear Yoseph Kim:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
1
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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
For comprehensive regulatory information about mediation-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,
Digitally signed by TANISHA TANISHA L. HITHE -S L. HITHE -> Date: 2025.02.19
16:05:57 -05'00'
Tanisha Hithe 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
3
Indications for Use
Submission Number (if known)
Device Name
OPTOVISION Endoscopic Light Source Unit
Indications for Use (Describe)
Upon intravenous administration of ICG(Indocyanine green for injection) consistent with its approved label, the OPTOVISION provides real-time endoscopic visible and near-infrared fluorescence imaging. The OPTOVISION enable surgeons to perform minimally invasive surgery using standard endoscope visual light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the OPTOVISION is intended for use with standard-of-care white light and, when indicated, intraoperative cholangioaraphy. The device is not intended for standalone use for biliary duct visualization.
Upon interstitial administration and use of ICG consistent with its approved label, the OPTOVISION 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)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
l. 510(k) Submitter
Applicant: OPTOSURGICAL LLC. 6751 Columbia Gateway Drive Suite 300, Office 313, Columbia, MD 21046
Contact Person: Yoseph Kim / Chief Executive Officer and R&D Administrator Phone: +1-203-675-7089 Email: voseph.kim@optosurqical.com Date Prepared: February 17, 2025
II. Subject Device
- Name of Device: OPTOVISION Endoscopic Light Source Unit ●
- Common or Usual Name: Light Source, Illuminator ●
- Classification Name: Confocal Optical Imaging ●
- Regulation Name: Endoscope and accessories (21 CFR 876.1500) ●
- Regulatory Class: II
- Product Code: OWN ●
III. Predicate Device
- Proprietary Name: AIM Light Source and SafeLight™ Cable ●
- 510(k) Number: K192292 ●
- Common Name: Light Source, Illuminator ●
- Classification Name: Confocal Optical Imaging & Fiberoptic light ureteral catheter .
- & Light Source. Fiberoptic. Routine
- Regulation Name: Endoscope and accessories & Fiberoptic light ureteral catheter ●
- Regulation: 21 CFR 876.1500 & 21 CFR 876.4020 & 21 CFR 876.4020
- Product Code: OWN, FSC, FCW ●
IV. Description
OPTOVISION is an endoscopic light source that enables real-time endoscopic visible and nearinfrared fluorescence imaging minimally invasive surgical procedures. Near-infrared illumination is used for fluorescence imaging using indocyanine green (ICG). This device is largely composed of a power circuit, a control circuit, and a lighting lamp (light source). A power circuit provides power to the lighting lamp and cuts off the power in an emergency, a control circuit controls the light output (intensity)/other settings of light rays, and a light source unit irradiates light directly to the Light Guide Cable (K111342) for observation of the affected area. With the configuration above, the power input from the initial power source is transmitted to the light source unit and the main body, and rays of white light and near-infrared light are directly irradiated through the Light Guide Cable to the affected area for observation. This device is designed for use in the following applications: standard endoscopic visible-light imaging and near-infrared fluorescence imaging.
V. Indications for Use
Upon intravenous administration of ICG (Indocyanine green for injection) consistent with its
5
approved label, the OPTOVISION provides real-time endoscopic visible and near-infrared fluorescence imaging. The OPTOVISION enables surgeons to perform minimally invasive surgery using standard endoscope visual light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct), using near-infrared imaging. Fluorescence imaging of biliary ducts with the OPTOVISION is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.
Upon interstitial administration and use of ICG consistent with its approved label, the OPTOVISION is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.
VI. Comparison of Technological Characteristics with the Predicate Device
The subject device is substantially equivalent to AIM Light Source and SafeLight™ Cable (K192292). The subject device has the same indications for use and technological characteristics as the predicate device. It also has identical specifications as the predicate device in almost all parameters. The imaging mode is a minor difference between the subject and predicate device [AIM Light Source and SafeLight™ Cable (K192292)]. However, these differences do not raise a question in substantial equivalence.
| Subject device | Predicate Device | Comment | ||
|---|---|---|---|---|
| Manufacturer | OPTOSURGICAL LLC. | Stryker Endoscopy | ||
| Common or Usual Name | Light Source, Illuminator | Light Source, Illuminator | ||
| Classification Name | Confocal Optical Imaging | Confocal Optical Imaging | ||
| Brand Name | OPTOVISION Endoscopic | |||
| Light Source Unit | AIM Light Source and | |||
| SafeLight™ Cable | ||||
| Model Name | OPSFI2241 | L10 & L11 | ||
| Regulatory Class | II | II | ||
| CFR Regulation | 21 CFR 876.1500 | 21 CFR 876.1500 | ||
| Product Code | OWN | OWN, FSC, FCW | ||
| 510(k) Number | K243591 | K192292 | ||
| Intended Use | Endoscopic white light and | |||
| near-infrared illumination | ||||
| and imaging during | ||||
| endoscopic procedures. | Endoscopic white light and | |||
| near-infrared illumination | ||||
| and imaging during | ||||
| endoscopic procedures. | Same as predicate | |||
| Indications for Use | NOTE 1 | NOTE 2 | Similar to predicate | |
| Although the predicate | ||||
| device includes the | ||||
| additional intended use of | ||||
| transilluminating the ureter, | ||||
| the subject device shares | ||||
| the same intended use as | ||||
| the predicate device in using | ||||
| ICG fluorescence imaging | ||||
| for real-time endoscopic | ||||
| visible and near-infrared | ||||
| fluorescence imaging of | ||||
| vessels, blood flow, related | ||||
| tissue perfusion, and bile | ||||
| ducts. | ||||
| This difference does not | ||||
| raise different questions of | ||||
| safety and effectiveness. | ||||
| Subject device | ||||
| An electronic driver controls | Predicate Device | |||
| An electronic driver controls | Comment | |||
| Principles of Operation | near-infrared laser diode | |||
| which are combined through | ||||
| dichroic mirrors and | ||||
| projected onto an output | ||||
| light collimator. A fiber | ||||
| output bundle can be | ||||
| inserted into the light source | ||||
| to couple light to the distal | ||||
| end and into an endoscope. | Red/Green/Blue LEDs and a Red/Green/Blue LEDs and a | |||
| near-infrared laser diode | ||||
| which are combined through | ||||
| dichroic mirrors and | ||||
| projected onto an output | ||||
| light collimator. A fiber | ||||
| output bundle can be | ||||
| inserted into the light source | ||||
| to couple light to the distal | ||||
| end and into an endoscope. | Same as predicate | |||
| Similar to predicate | ||||
| Components | Light Source Unit | |||
| Light Guide Cable | Light Source and SafeLight | |||
| Cable | ||||
| Camera System | ||||
| Laparoscopes | ||||
| IRIS Ureteral Kit | ||||
| Imaging Agent | The OPTOVISION consists | |||
| of a Light Source Unit and | ||||
| offers a light guide cable | ||||
| (K111342). This light guide | ||||
| cable is universally | ||||
| manufactured by a third | ||||
| party, and thus follows the | ||||
| reprocessing procedures | ||||
| established by the | ||||
| respective manufacturer. | ||||
| This difference does not | ||||
| raise different questions of | ||||
| safety and effectiveness, as | ||||
| discussed above. | ||||
| Safety Standards | IEC 60601-1 | |||
| IEC 60601-2-18 | ||||
| IEC 60601-1-2 | ||||
| IEC 62471 | IEC 60601-1 | |||
| IEC 60601-2-18 | ||||
| IEC 60601-1-2 | ||||
| IEC 60825-1 | Similar to predicate | |||
| Safety related to | ||||
| OPTOVISION's light source | ||||
| has been evaluated and | ||||
| demonstrated in compliance | ||||
| with IEC 62471. | ||||
| This difference does not | ||||
| raise different questions of | ||||
| safety and effectiveness, as | ||||
| discussed above. | ||||
| Light Source / Laser | RGB LEDs | RGB LEDs | Same as predicate | |
| Infrared Laser | Infrared Laser | Similar to predicate | ||
| Infrared Wavelengths | 808nm (used for NIR | |||
| fluorescence) | 806nm (used for NIR | |||
| fluorescence) | ||||
| 830nm (used for NIR | ||||
| transillumination) | Both the 808nm and 806nm | |||
| wavelengths are used for | ||||
| NIR fluorescence imaging | ||||
| with ICG, and the difference | ||||
| between these wavelengths | ||||
| is substantially the same in | ||||
| terms of the functionality | ||||
| provided by the subject | ||||
| device and the predicate | ||||
| device. | ||||
| This difference does not | ||||
| raise different questions of | ||||
| safety and effectiveness, as | ||||
| discussed above. | ||||
| Subject device | Predicate Device | Comment | ||
| White Light | Manual | |||
| Autolight | Manual | |||
| Autolight | Same as predicate | |||
| Imaging | ||||
| Mode | NIR | |||
| Fluorescence | NIR | |||
| ખાટ | ||||
| FUSION | ENV | |||
| Contrast | ||||
| Overlay | Similar to predicate | |||
| Both the subject device and | ||||
| predicate device passed the | ||||
| bench test criteria according | ||||
| to the recognized consensus | ||||
| standard EN/IEC 60601-1-2. | ||||
| The "NIR" mode of the | ||||
| subject device is functionally | ||||
| equivalent to the "Contrast" | ||||
| mode of the predicate | ||||
| device, and the "FUSION" | ||||
| mode of the subject device | ||||
| is functionally equivalent to | ||||
| the "Overlay" mode of the | ||||
| predicate device. While the | ||||
| subject device does not | ||||
| support the "ENV" mode, | ||||
| this does not result in any | ||||
| technical differences in the | ||||
| primary function of providing | ||||
| NIR fluorescence imaging | ||||
| using ICG between the two | ||||
| devices. | ||||
| This difference does not | ||||
| raise different questions of | ||||
| safety and effectiveness, as | ||||
| discussed above. | ||||
| Light Guide | ||||
| Cable | Single-Use/ | |||
| Reusable | Reusable | Reusable | Same as predicate | |
| Type of Use | Prescription Use | Prescription Use | Same as predicate |
6
7
NOTE 1: Upon intravenous administration of ICG (Indocyanine green for injection) consistent with its approved label, the OPTOVISION provides real-time endoscopic visible and near-infrared fluorescence imaging. The OPTOVISION enables surgeons to perform minimally invasive surgery using standard endoscope visual light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging of billiary ducts with the OPTOVISION is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.
Upon interstitial administration and use of ICG consistent with its approved label, the OPTOVISION is used to perform intraoperative fluorescence imaging and visualization of the lymphatic vessels and lymphatic vessels and lymph nodes.
NOTE 2: Upon intravenous administration of SPY AGENT™ GREEN (Indocyanine green for injection, USP), the AIM Light Source and SafeLight™ Cable is used with SPY AGENT GREEN to provide real-time endoscopic visible and near-infrared fluorescence imaging. The AlM Light Source and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscope visual light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic duct, common bile duct and common hepatic duct), using near-infrared imaging.
Fluorescence imaging of biliary ducts with the AIM Light Source and SafeLight Cable is intended for use with standardof-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.
Upon interstitial administration of SPY AGENT GREEN (ICG drug product), the AIM Light Source and SafeLight Cable is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic
8
vessels and lymph nodes.
The AIM Light Source is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.
VII. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
| Testing | Method | Result |
|---|---|---|
| Electrical Safety | ES60601-1:2005/(R)2012 & A1:2012 | |
| C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) | ||
| [Incl. AMD2:2021] | ||
| IEC 60601-2-18: Edition 3.0 2009-08 | ||
| IEC 60601-1-6 Edition 3.2 2020-07 | ||
| CONSOLIDATED VERSION | PASS | |
| Electromagnetic Compatibility | ||
| (EMC) test | IEC 60601-1-2 Edition 4.1 2020-09 | |
| CONSOLIDATED VERSION | PASS | |
| Usability | IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED | |
| VERSION | PASS | |
| Photobiological Safety | IEC 62471 First edition 2006-07 | PASS |
| Software Validation & | ||
| Verification | IEC 62304 Edition 1.1 2015-06 CONSOLIDATED | |
| VERSION | PASS | |
| Performance - Bench | In accordance with device input specifications | PASS |
All conducted tests demonstrated compliance with applicable standards, and no safety concerns were identified.
VIII. Conclusions
Based on the information provided in this premarket notification, OPTOVISION Endoscopic Light Source Unit is substantially equivalent to the predicate device as described herein in safety and effectiveness. The OPTOVISION Endoscopic Light Source Unit has the same intended use and similar indications for use as its predicate device, AIM Light Source and SafeLight™ Cable (K192292). Further, the OPTOVISION Endoscopic Light Source Unit has very similar technological characteristics and principles of operation as its predicate device. AIM Light Source and SafeLight™ Cable (K192292). The minor technological differences between the subject and the predicate devices do not raise different questions of safety or effectiveness. Performance testing of the device has demonstrated that the device performs as intended and thus, is substantially equivalent.