(83 days)
No
The summary describes image processing and fusion but does not mention AI, ML, or any related techniques.
No.
The device is intended for viewing and visualization during surgical procedures, and for capturing fluorescent images for assessment of blood flow and tissue perfusion. It does not exert a therapeutic effect on the patient.
No
The device is intended for viewing and visualization during surgical procedures, and for capturing fluorescent images for the visual assessment of blood flow and tissue perfusion, which are functions that aid in surgical guidance and assessment rather than providing a diagnosis of a disease or condition. The text also states it is for "visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion." An "adjunctive method" does not fulfill the primary role of a diagnostic device, which is to diagnose.
No
The device description explicitly lists hardware components such as endoscopes, camera blocks, optical transmission systems, PC workstations, external display monitors, and light sources (IR laser and xenon). While it mentions image processing, it is part of a larger hardware system.
Based on the provided information, this device 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The VS3-IR System is an imaging system used during surgical procedures to visualize internal structures and blood flow. It uses visible light and near-infrared fluorescence imaging.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It directly visualizes structures within the body during surgery.
- Intended Use: The intended uses described are for surgical visualization, assessment of blood flow and tissue perfusion in vivo, and guiding surgical procedures. These are not typical IVD applications.
- Device Description: The description focuses on the endoscope, camera system, and light sources used for imaging, not on components for sample handling or analysis.
While the system uses Indocyanine Green (ICG), which is a dye administered to the patient, the device itself is not performing an in vitro test on a sample containing the dye. It is visualizing the fluorescence of the dye within the patient's body.
Therefore, the VS3-IR System falls under the category of a surgical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The 3D Endoscope Module of the VS3-IR System is intended for viewing internal surgical sites during general surgical procedures, for use in visualization of ventricles and structures within the brain during neurological surgical procedures, viewing internal surgical sites during and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy, and shoulder and knee arthroscopic procedures.
The MMS configuration of the Iridium Module of the VS3-IR System is intended for capturing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic. micro- and reconstructive surgical procedures.
The Endoscope configuration of the Iridium Module of the VS3-IR System is intended to provide real-time endoscopic visible and near infrared fluorescence imaging. Iridium Endoscope enables surgeons to perform routine visible light endoscopic procedures as well as further visually assess vessels, blood flow and related tissue perfusion with near infrared imaging during minimally invasive surgery.
Product codes (comma separated list FDA assigned to the subject device)
OWN, GCJ, HRX, GWG
Device Description
The VS3-IR System is made up of the following components:
- VS3 3D Endoscope (K123467, K141002, K131434).
- VS3-IR-MMS & ICG Kit (K150018)
- VS3-IR-Endoscope & ICG Kit (not yet assigned).
The VS3-IR system includes:
- HD3D camera (cleared K123467, K141002, and K131434)
- Laser Light Source (cleared K123467, K141002, K131434, and K150018)
- CCU (cleared K123467, K141002, K131434. and K150018) .
- Display monitor (cleared K123467, K141002, K131434, and K150018)
- MMS-IR (cleared K150018)
- VS3-IR Endoscope (subject of this premarket notification)
- 3rd party Xenon light source (cleared K123467, K141002, K131434, and K150018) .
- 3rd party endoscopic light cable (cleared K123467, K141002, K131434, and K150018)
- Light Integrator for white (Xenon) light and IR light from the LLS (cleared K150018)
- ICG Kit (cleared K150018)
The VS3 3D endoscopes (cleared in K123467, K131434, and K141002) are based on the proximal camera concept with a stereoscopic camera block on the proximal side of the endoscope (the handle). The stereoscopic images are transmitted from the visual field at the distal tip of the endoscope to the proximal camera block through an optical transmission system to PC workstations or external display monitors for enhanced viewing or capturing. VS3 includes reusable endoscopes which are cleaned and sterilized using the same methods and are indicated for the same lifecycle.
In addition to traditional endoscopic procedures, VS3-IR system includes support for Infrared (IR) Fluorescence visualization (hereafter referred to as Iridium utilizes the VS3 system with scopes that support IR fluorescence visualization. VS3 Iridium Miniature Microscope (VS3-IR-MMS) which was cleared in K150018 is positioned 20cm to 45cm above the patient during an open procedure. The proposed Iridium Endoscopes (VS3-R-Endoscope) is used during laparoscopic minimally invasive procedures. VS3 Iridium MMS and Endoscopes are designed to work with an approved IR fluorescence dve (Indocvanine Green or ICG), which has excitation at 805nm and emission band between 825nm and 850nm. VS3 Iridium (VS3-IR) provides excitation light to the surgical field to excite the dye molecules and captures emission from the dye using an IR camera.
Both the Iridium MMS and Iridium Endoscope utilize the left channel of the VS3 imaging system (camera and image processor) for IR fluorescence imaging and the right channel for visible light imaging. This structure allows fluorescence imaging to use the same acquisition and processing pathways as the approved 3D endoscopes (cleared in K123467, K131434, and K141002).
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
Internal surgical sites (general, neurological brain structures/ventricles, anterior and posterior spinal, shoulder and knee arthroscopic procedures).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons performing general, neurological, spinal, or arthroscopic surgical procedures. 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
Bench testing was conducted to verify that the subject device can detect and visualize anatomy and blood flow per the proposed indications for use of the Iridium Module. The Visionsense VS3 system with ICG fluorescence endoscope (VS3 Iridium Endoscope) was bench tested in fluorescence mode so that the endoscope light sources provided both IR (laser light source) and Visible (xenon light source) light to illuminate the simulated surgical field.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Bench testing.
Sample Size: Not specified.
Key Results: In all instances, the VS3-IR System using the VS3-IR-Endoscope functioned as intended and met all performance acceptance criteria.
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.
K123467, K141002, K131434, K150018
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Visionsense Ltd. % Mr. Raymond Kelly Licensale Incorporated 57 Lazy Brook Road Monroe, Connecticut 06468
October 28, 2015
Re: K152204
Trade/Device Name: VS3-IR Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OWN, GCJ, HRX, GWG Dated: August 5, 2015 Received: August 6, 2015
Dear Mr. Kelly:
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. 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 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 and 809]); 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
1
applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. For Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
VS3-IR
Indications for Use (Describe)
The 3D Endoscope Module of the VS3-IR System is intended for viewing internal surgical sites during general surgical procedures, for use in visualization of ventricles and structures within the brain during neurological surgical procedures, viewing internal surgical sites during and posterior spinal procedures, such as nucleotomy, discectomy, and foraminotomy, and shoulder and knee arthroscopic procedures.
The MMS configuration of the Iridium Module of the VS3-IR System is intended for capturing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic. micro- and reconstructive surgical procedures.
The Endoscope configuration of the Iridium Module of the VS3-IR System is intended to provide real-time endoscopic visible and near infrared fluorescence imaging. Iridium Endoscope enables surgeons to perform routine visible light endoscopic procedures as well as further visually assess vessels, blood flow and related tissue perfusion with near infrared imaging during minimally invasive surgery.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary Visionsense VS3-IR System
Submitter's Name, Address, Telephone Number,
Visionsense Ltd. 20 Hamagshimim Street, Petach Tikva 49348 Israel Phone: 972-3-9244339 Facsimile: +972-3-9244-335
Contact Person and Date Prepared
Raymond Kelly 57 Lazy Brook Rd Monroe, CT 06468 USA Phone: (203) 880-4091
Date Prepared: August 11, 2015
Name of Device
VS3-IR System
Common or Usual Name / Classification Name
Endoscopes and Accessories / Infrared Microscope / Angiographic X-ray System
Predicate Device
Novadaq Technologies SPY Imaging System (K063345 / K091515)
Intended Use / Indications for Use
The 3D Endoscope Module of the VS3-IR System is intended for viewing internal surgical sites during general surgical procedures, for use in visualization of ventricles and structures within the brain during neurological surgical procedures, viewing internal surgical sites during anterior and posterior spinal procedures, such as nucleotomy, and foraminotomy, and shoulder and knee arthroscopic procedures.
The MMS configuration of the Iridium Module of the VS3-IR System is intended 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 in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures.
The Endoscope configuration of the Iridium Module of the VS3-IR System is intended to provide real-time endoscopic visible and near infrared fluorescence imaging. Iridium Endoscope enables surgeons to perform routine visible light endoscopic procedures as well as further visually assess yessels, blood flow and related tissue perfusion with near infrared imaging during minimally invasive surgery.
4
Principles of Operation / Conditions of Use
The VS3-IR System is made up of the following components:
- VS3 3D Endoscope (K123467, K141002, K131434) .
- VS3-IR-MMS & ICG Kit (K150018)
- . VS3-IR-Endoscope & ICG Kit (not yet assigned).
The following table summarizes FDA clearance history for the VS3-IR system:
| Component | FDA Clearance # | Indication |
|---|---|---|
| VS3 3D | ||
| Endoscopes | K123467 (Laparoscope) | |
| K141002 (Arthroscope) | ||
| K131434 (Neurological) | Intended for viewing internal surgical | |
| sites during general surgical | ||
| procedures, for use in visualization of | ||
| ventricles and structures within the | ||
| brain during neurological surgical | ||
| procedures, viewing internal surgical | ||
| sites during anterior and posterior | ||
| spinal procedures, such as | ||
| nucleotomy, discectomy, and | ||
| foraminotomy, and shoulder and knee | ||
| arthroscopic procedures. | ||
| VS3-IR-MMS | ||
| & ICG Kit | K150018 | Intended 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 in tissue and free | ||
| flaps used in plastic, micro- and | ||
| reconstructive surgical procedures. | ||
| VS3-IR- | ||
| Endoscope | ||
| & ICG Kit | Not yet assigned | Intended to provide real-time |
| endoscopic visible and near infrared | ||
| fluorescence imaging. Iridium | ||
| Endoscope enables surgeons to | ||
| perform routine visible light | ||
| endoscopic procedures as well as | ||
| further visually assess vessels, blood | ||
| flow and related tissue perfusion with | ||
| near infra-red imaging during | ||
| minimally invasive surgery. |
This premarket notification adds the IR endoscope to the FDA cleared devices in K123467 (Laparoscope), K141002 (Arthroscope), K131434 (Neurological), and K150018 (MMS), and to change the family brand name to VS3-IR system.
5
The VS3-IR system includes:
- . HD3D camera (cleared K123467, K141002, and K131434)
- Laser Light Source (cleared K123467, K141002, K131434, and K150018)
- CCU (cleared K123467, K141002, K131434. and K150018) .
- Display monitor (cleared K123467, K141002, K131434, and K150018)
- MMS-IR (cleared K150018)
- . VS3-IR Endoscope (subject of this premarket notification)
- 3rd party Xenon light source (cleared K123467, K141002, K131434, and K150018) .
- . 3rd party endoscopic light cable (cleared K123467, K141002, K131434, and K150018)
- . Light Integrator for white (Xenon) light and IR light from the LLS (cleared K150018)
- . ICG Kit (cleared K150018)
The VS3 3D endoscopes (cleared in K123467, K131434, and K141002) are based on the proximal camera concept with a stereoscopic camera block on the proximal side of the endoscope (the handle). The stereoscopic images are transmitted from the visual field at the distal tip of the endoscope to the proximal camera block through an optical transmission system to PC workstations or external display monitors for enhanced viewing or capturing. VS3 includes reusable endoscopes which are cleaned and sterilized using the same methods and are indicated for the same lifecycle.
In addition to traditional endoscopic procedures, VS3-IR system includes support for Infrared (IR) Fluorescence visualization (hereafter referred to as Iridium utilizes the VS3 system with scopes that support IR fluorescence visualization. VS3 Iridium Miniature Microscope (VS3-IR-MMS) which was cleared in K150018 is positioned 20cm to 45cm above the patient during an open procedure. The proposed Iridium Endoscopes (VS3-R-Endoscope) is used during laparoscopic minimally invasive procedures. VS3 Iridium MMS and Endoscopes are designed to work with an approved IR fluorescence dve (Indocvanine Green or ICG), which has excitation at 805nm and emission band between 825nm and 850nm. VS3 Iridium (VS3-IR) provides excitation light to the surgical field to excite the dye molecules and captures emission from the dye using an IR camera.
Both the Iridium MMS and Iridium Endoscope utilize the left channel of the VS3 imaging system (camera and image processor) for IR fluorescence imaging and the right channel for visible light imaging. This structure allows fluorescence imaging to use the same acquisition and processing pathways as the approved 3D endoscopes (cleared in K123467, K131434, and K141002).
6
Technological Characteristics
Requirements for the Iridium Endoscope assume that the Iridium Scope is used with the Iridium Camera, CCU, and Laser Light source. Stand-alone functionality of the Iridium Scope is not supported.
| # | Feature/Parameter | Value/Description |
|---|---|---|
| 1 | Able to function with no | |
| camera | No | |
| 2 | Working distance | 2cm – 7cm from tissue |
| 3 | Direction Of View | 0°, 30° |
Performance Data
The subject device conforms to the following recognized standards:
| Standards
No. | Standards
Organization | Standards Title |
|------------------|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 60601-1-2 | IEC | Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance -
collateral standard: electromagnetic compatibility -
requirements and tests (Edition 3). |
| 60601-1 | IEC | Medical electrical equipment - Part 1: General requirements
for basic safety and essential performance. |
| 60601-1-4 | IEC | Medical electrical equipment - Part 1: General requirements
for safety, Collateral standard: Programmable electrical
medical systems. |
| 60601-1-4 | IEC | Safety of laser products - Part 1: equipment classification,
and requirements. |
The system software was validated and performs as intended per the pre-specified requirements.
In addition, bench testing was conducted to verify that the subject device can detect and visualize anatomy and blood flow per the proposed indications for use of the Iridium Module.
The Visionsense VS3 system with ICG fluorescence endoscope (VS3 Iridium Endoscope) was bench tested in fluorescence mode so that the endoscope light sources provided both IR (laser light source) and Visible (xenon light source) light to illuminate the simulated surgical field. The left channel of the 3D endoscope was dedicated to visible light imaging, while the right channel of the scope was dedicated to IR imaging during the testing the laser excitation light triggered IR fluoresce in ICG molecules as intended. The fluorescence light was detected by one of the image sensors in the PHD camera to produce an IR image. The other sensor was used to capture a visible light image of the same scene. The two images were fused together to produce a composite image showing blood flow.
In all instances, the VS3-IR System using the VS3-IR-Endoscope functioned as intended and met all performance acceptance criteria.
7
Substantial Equivalence
The VS3-IR-Endoscope as part of the VS3-IR System is substantially equivalent to other legally marketed surgical endoscopes. Specifically, the VS3-IR-Endoscope is substantially equivalent to the cleared Novadaq SPY Imaging device (K091515). As explained in more detail below, the subject VS3-IR-Endoscope has been added to the cleared VS3 base system and VS3-IR-MMS to create the VS3-IR-Endoscope and has the same indications for use and substantially similar technological characteristics and principles of operation as the identified predicate device. A substantial equivalence chart comparing the similarities and differences between the subject and predicate device is provided below
All the components of the subject device and associated software have been cleared in the original VS3 base system 510(k) notices (K123467, K131434, K141002) and the Infrared Iridium VS3-IR-MMS submissions (K150018) including the ICG Kit (K150018) and are included in this submission by reference for purposes of completeness in describing the updated VS3-IR System that the company plans to market.
| | VS3-IR IR Endoscope
(proposed) | Novadaq Endoscopic SPY
(K091515) |
|---------------------------------------|-----------------------------------------------------|-----------------------------------------------------|
| Manufacturer | Visionsense Ltd. | Novadaq Technologies Inc |
| Sterilization | Steam Autoclave | Steam Autoclave |
| Imaging Agent | IR fluorescence dye (i.e.
Indocyanine Green-ICG) | IR fluorescence dye (i.e.
Indocyanine Green-ICG) |
| Imaging Head | Silicon Image Sensor in the
camera | Silicon Image Sensor in the
camera |
| Light Source | Infrared Laser | Infrared Laser |
| Excitation Wavelength | 805nm | 805nm |
| Scope Diameter | 5.5mm | 10mm |
| Angles of View | 0°, 30° | 0°, 30° |
| Imaging | Fluorescent and White Light
Imaging | Fluorescent and White Light
Imaging |
| Emission Band | 825nm to 850nm | 825nm to 850nm |
| Emission Capture | IR camera | IR camera |
| Display both Visible
and IR images | Yes | Yes |
Conclusions
The VS3-IR System is substantially equivalent to the predicate device. Performance testing demonstrates that the newly added components to the VS3-IR-System performs substantially equivalent to the predicate device, and any differences in technological characteristics do not raise different questions of safety or efficacy compared to the predicate device.