(163 days)
No
The summary describes a system for visualizing internal surgical sites and fluorescent images for blood flow assessment. It details hardware components and basic imaging functionality but makes no mention of AI, ML, or advanced image processing techniques that would typically indicate the presence of such technology.
No.
The device is described as an imaging system intended for viewing internal surgical sites and assessing blood flow and tissue perfusion, which are diagnostic and visualization functions, not therapeutic ones.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the Iridium Module 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." Visual assessment and evaluation of physiological states like blood flow and tissue perfusion are diagnostic activities.
No
The device description explicitly lists multiple hardware components including an endoscope, camera, CCU, light source, display monitor, IR fluorescence scope, and laser light source. While software is mentioned, 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 outside of the body (in vitro).
- Device Function: The VS3-IR-MMS System is used for in vivo (within the living body) visualization during surgical procedures. It directly images internal structures and blood flow within the patient.
- Intended Use: The intended use clearly describes viewing internal surgical sites, ventricles, spinal structures, joints, and tissue/free flaps during surgery.
- Device Description: The components are designed for surgical visualization (endoscopes, cameras, light sources, monitors).
- Performance Studies: The performance studies involve imaging ICG in vitro for bench testing, but the primary application and evaluation are in vivo on human hands and free flaps.
The device is a surgical imaging system, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The Endoscope Module of the VS3-IR-MMS 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 spinal procedures, such as nucleotomy, discectomy, and foraminotomy, and shoulder and knee arthroscopic procedures. The Iridium Module of the VS3-IR-MMS 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.
Product codes (comma separated list FDA assigned to the subject device)
OWN
Device Description
The VS3-IR-MMS System consists of the cleared base system and the Iridium Module that is the subject of this submission. The currently marketed VS3 system with endoscope functionality was cleared under the following product codes: GCJ (General Surgery Endoscope), GWG (Neurological Endoscope), and HRX (Orthopedic Arthroscope). The cleared base system consists of the following components and accessories: High Definition 3D Endoscope, High Definition 3D Camera with 3 control buttons and a focus adjustment knob, 2D Coupler, CCU, Light Source, and Display Monitor. The VS3-IR-MMS System that is the subject of this submission contains the previously cleared components of the cleared base system listed above, as well as a High Definition IR Fluorescence Scope (MMS), a Laser Light Source (LLS), associated software and VS, Iridium IR Fluorescence Kit. The new Iridium Module, which uses the newly added High Definition IR Fluorescence Scope (MMS) and a Laser Light Source (LLS), as well as the cleared High Definition 3D Camera, Camera Control Unit (CCU), and Display Monitor, is used to generate florescence excitation illumination for external use in 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluorescent Imaging
Anatomical Site
Internal surgical sites, ventricles and structures within the brain, anterior spinal procedures (nucleotomy, discectomy, and foraminotomy), shoulder, knee, tissue and free flaps.
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
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. Specifically, 10mg of ICG was dilated in sterile water to a concentration equal to that of ICG in the blood of a representative human (i.e., 2 ug/ml). Next, the ICG in sterile water diluted to representative human concentration was imaged directly to verify good quality imaging. Then, the sample of ICG in sterile water diluted to representative human concentration was covered with chicken skin and imaged to simulate visualization through skin.
Outside of the United States, a human hand was used in a simulated use testing environment to demonstrate that the Iridium Module has the capability to visualize blood flow corresponding to ICG dye fluorescence of blood vessels in the skin.
Lastly, an evaluation of the device was performed in free flaps in several human subjects outside the US and demonstrated that the device functions as intended with no adverse events reported using the system.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. Specifically, 10mg of ICG was dilated in sterile water to a concentration equal to that of ICG in the blood of a representative human (i.e., 2 ug/ml). Next, the ICG in sterile water diluted to representative human concentration was imaged directly to verify good quality imaging. Then, the sample of ICG in sterile water diluted to representative human concentration was covered with chicken skin and imaged to simulate visualization through skin.
On a related note, outside of the United States, a human hand was used in a simulated use testing environment to demonstrate that the Iridium Module has the capability to visualize blood flow corresponding to ICG dye fluorescence of blood vessels in the skin.
Lastly, an evaluation of the device was performed in free flaps in several human subjects outside the US and demonstrated that the device functions as intended with no adverse events reported using the system.
In all instances, the VS3-IR-MMS System using the Iridium Module 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.
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
June 17, 2015
Visionsense LTD. % Mr. Gerard J. Prud'homme Hogan Lovells US LLP 555 13th Street, North West Washington, District of Columbia 20004
Re: K150018
Trade/Device Name: VS3-IR-MMS System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: OWN Dated: May 19, 2015 Received: May 19, 2015
Dear Mr. Prud'homme:
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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.
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/ResourcesforYou/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 yours.
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150018
Device Name
VS3-IR-MMS System
Indications for Use (Describe)
The Endoscope Module of the VS3-IR-MMS 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 spinal procedures, such as nucleotomy, discectomy, and foraminotomy, and shoulder and knee arthroscopic procedures. The Iridium Module of the VS3-IR-MMS 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.
| 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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510(k) Summary
Visionsense's VS3-IR-MMS System
Submitter's Name, Address. Telephone Number, Contact Person and Date Prepared
Visionsense Ltd. 20 Hamagshimim Street Petach Tikva 49348 lsrael Phone: 972-3-9244339 Facsimile: +972-3-9244-335
Contact Person: Alex Chanin, CEO
Date Prepared: May 19, 2015
Name of Device and Name/Address of Sponsor
VS3-IR-MMS Svstem
Common or Usual Name / Classification Name
Surgical Microscope / Angiographic X-ray System / Endoscopes and Accessories
Predicate Device
Novadaq Technologies SPY Imaging System (K063345)
Intended Use / Indications for Use
The Endoscope Module of the VS3-IR-MMS 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, discectomy, and foraminotomy, and shoulder and knee arthroscopic procedures. The Iridium Module of the VS3-IR-MMS 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.
Technological Characteristics / Principles of Operation
The VS3-IR-MMS System consists of the cleared base system and the Iridium Module that is the subject of this submission. The currently marketed VS3 system with endoscope functionality was cleared under the following product codes: GCJ (General Surgery Endoscope), GWG (Neurological Endoscope), and HRX (Orthopedic Arthroscope). The cleared base system consists of the following components and accessories: High Definition 3D Endoscope, High Definition 3D Camera with 3 control buttons and a focus adjustment knob, 2D Coupler, CCU, Light Source, and Display Monitor. The VS3-IR-MMS System that is the subject of this submission contains the previously cleared components of the cleared base system listed above, as well as a High Definition IR Fluorescence Scope (MMS), a Laser Light Source (LLS), associated software and VS, Iridium IR Fluorescence Kit. The new Iridium Module, which uses the newly added High Definition IR Fluorescence Scope (MMS)
4
and a Laser Light Source (LLS), as well as the cleared High Definition 3D Camera, Camera Control Unit (CCU), and Display Monitor, is used to generate florescence excitation illumination for external use in 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.
In sum, the proposed VS3-IR-MMS System is built on the predicate base VS3 System that has already been cleared for the treatment of viewing internal surgical sites during general surgical procedures and 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 (see K123467. K131434. K141002). The Iridium Module added to the cleared base system results in the following changes to the cleared system:
- . Addition of a new scope ("MMS"), which is intended to provide a view of the surgical field from 20cm to 45cm above the patient.
- . Addition of a Laser Light Source ("LLS") used to generate florescence excitation illumination.
- Software modifications to allow the new MMS with LLS to be used with the cleared system.
- Addition of the VS, Iridium IR Fluorescence Kit which contains the sterile ICG imaging agent used for fluorescence imaging.
- . Additional indications for use with the new Iridium Module, which includes the MMS with LLS and associated software (described above) to include 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 surqical procedures.
The Iridium Module that is the subject of this submission is designed to work with the Indocyanine Green (ICG) IR fluorescence imaging agent supplied in the VSg Iridium IR Fluorescence Kit. Each VS . Iridium IR Fluorescence Kit contains the following:
- o Six 25mg vials of sterile ICG imaging agent.
- o Six 10ml vials of sterile Water for Injection.
ICG in blood has maximum excitation at 805nm and an emission band between 825nm and 850nm. VS, Iridium Module provides excitation light to the surgical field to excite the dye molecules and captures emission from the dye using an IR camera.
The VS3-IR-MMS System permits recording surgical procedures, storing them on removable storage devices, and plaving the procedures back.
5
Performance Data
The subject device conforms to the following recognized standards:
| Standards No. | Standards
Organization | Standards Title |
|---------------|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| 60601-1-2 | | Medical electrical equipment - Part 1-2: General requirements for |
| (19-2) | IEC | basic safety and essential performance - collateral standard:
electromagnetic compatibility - requirements and tests (Edition
3). |
| Standards No. | Standards
Organization | Standards Title |
| 60601-1 | | Medical electrical equipment - Part 1: General requirements for |
| (19-4) | IEC | basic safety and essential performance. |
| Standards No. | Standards | Standards Title |
| | Organization | |
| | | Medical electrical equipment - Part 1: General requirements for |
| 60601-1-4 | IEC | safety, Collateral standard: Programmable electrical medical |
| | | systems. |
| Standards No. | Standards | Standards Title |
| | Organization | |
| 60825-1 | | Safety of laser products - Part 1: Equipment classification, and |
| (12-273) | IEC | 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. Specifically, 10mg of ICG was dilated in sterile water to a concentration equal to that of ICG in the blood of a representative human (i.e., 2 ug/ml). Next, the ICG in sterile water diluted to representative human concentration was imaged directly to verify good quality imaging. Then, the sample of ICG in sterile water diluted to representative human concentration was covered with chicken skin and imaged to simulate visualization through skin.
On a related note, outside of the United States, a human hand was used in a simulated use testing environment to demonstrate that the Iridium Module has the capability to visualize blood flow corresponding to ICG dye fluorescence of blood vessels in the skin.
Lastly, an evaluation of the device was performed in free flaps in several human subjects outside the US and demonstrated that the device functions as intended with no adverse events reported using the system.
In all instances, the VS3-IR-MMS System using the Iridium Module functioned as intended and met all performance acceptance criteria.
Substantial Equivalence
The endoscope functionality of the base VS3-IR-MMS System was previously cleared. The proposed Iridium Module of the VS3-R-MMS has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device (K063345). The minor technological differences between the VS3-IR-MMS System Iridium Module and its predicate device do not raise different questions of safety or effectiveness. Performance data demonstrate that the VS3-IR-MMS System Iridium Module is as safe and effective as the predicate device. Thus,
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the VS3-IR-MMS Iridium Module is substantially equivalent. See the below comparison table of the Iridium Module of the updated VS3-IR-MMS and the Novadaq Spy Imaging device (K063345).
| Attributes | VS3-IR-MMS (proposed) | Spy (K063345) |
|---|---|---|
| Manufacturer | Visionsense Ltd. | Novadaq Technologies Inc |
| Drape Usage | Yes | Yes |
| Imaging Agent | IR fluorescence dye (e.g., | |
| Indocyanine Green-ICG) | IR fluorescence dye (e.g., | |
| Indocyanine Green-ICG) | ||
| Imaging Head | Silicon Image Sensor | Silicon Image Sensor |
| Imaging Device | No direct or indirect patient contact | No direct or indirect patient |
| contact | ||
| Light Source | Infrared Laser | Infrared Laser |
| Excitation Wavelength | 805nm | 805nm |
| Field of View | 19cm x 14cm | |
| (40cm nominal distance) | 19cm x 14cm | |
| (30cm nominal distance) | ||
| Imaging | Fluorescent Imaging | Fluorescent Imaging |
| Emission Band | 825nm to 850nm | 825nm to 850nm |
| Emission Capture | IR camera | IR camera |
Conclusions
The VS3-IR-MMS System Iridium Module is substantially equivalent to the predicate device. Performance and clinical testing demonstrates that the newly added components to the proposed device 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.