(145 days)
Yes.
The document explicitly states multiple times that the device is "an artificial intelligence (AI) / machine learning (ML) enabled device" and mentions its use of a "deep learning approach for super-resolution and reconstruction".
No.
The device is a diagnostic tool that provides information (tissue oxygenation) to help identify patients at risk of tissue ischaemia. It does not provide therapy or treatment.
Yes
The device is intended to be used as an adjunctive monitor to provide tissue oxygenation information, which helps identify patients at risk of tissue ischemia. This function directly relates to assessing a medical condition or health status, classifying it as a diagnostic device.
No
The device is not a software-only medical device because its description explicitly lists several hardware components, including a "hyperspectral camera, the HyperSnap Camera, a computational workstation, the Camera Control Unit (CCU), the Camera Electrical Isolator and Camera Electrical Isolator Power Supply." These components indicate it is a system with significant hardware, even though it heavily relies on software and AI/ML for its functionality.
No
The device directly measures tissue parameters (haemoglobin oxygen saturation) through optical imaging of the superficial tissue in the surgical field, which is considered an in vivo measurement rather than an in vitro diagnostic test performed on samples outside the body.
No
The provided input states "PCCP authorized (PCCP) and relevant text: Not Found.", which indicates that the clearance letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this device.
Intended Use / Indications for Use
The HyperSnap Surgical System is a real-time video camera system utilising computational hyperspectral imaging in the visible spectrum. The system is intended to be used intraoperatively to relay a standard RGB video feed used for visualisation alongside corresponding tissue oxygenation information presented as a corresponding two-dimensional real-time video feed.
The system is intended for use as an adjunctive monitor of the haemoglobin oxygen saturation of blood (StO2) in the superficial tissue in the surgical field of view.
The HyperSnap Surgical System may help identify patients at risk of tissue ischaemia. The system is indicated for use in all populations for open and minimally invasive general surgical applications utilising compatible surgical telescopes (exoscopes and rigid endoscopes).
The prospective clinical value of measurements made with StO2 has not been demonstrated in disease states.
Product codes
SFE, FET, MUD
Device Description
Hyperspectral imaging (HSI) is an optical imaging modality that carries information about tissue properties, facilitating objective tissue characterisation without the need for any exogenous contrast agent. HSI is non-invasive, non-contact, and does not make use of ionising radiation.
The HSS is an HSI system that seamlessly integrates into surgical workflows to provide critical, but currently unavailable, tissue property information during surgery. The HSS provides for visualisation of real-time tissue oxygenation saturation (StO2) information alongside conventional red-green-blue (RGB) visualisation. Additionally, the mean StO2 value within a user-defined ROI is reported.
Imaging is displayed at video rate ensuring instant surgeon feedback and intra-operative tissue assessment to facilitate surgical guidance and decision making.
The HSS is an artificial intelligence (AI) / machine learning (ML) enabled device. Training data for the deep learning algorithm comprises high resolution medical imaging datasets which collectively offer representative spatial and spectral variation across the intended target tissues and surfaces.
The core components of the HSS include, amongst others, a hyperspectral camera, the HyperSnap Camera, a computational workstation, the Camera Control Unit (CCU), the Camera Electrical Isolator and Camera Electrical Isolator Power Supply. The HyperSnap Camera is a lightweight surgical camera with a snapshot hyperspectral imaging sensor. Our surgical imaging technology exploits highly optimised algorithms and software to leverage snapshot HSI hardware for the extraction of advanced optical properties of observed tissues.
The camera can be securely mounted but is easily manoeuvrable, allowing for controlled mobilisation and immobilisation of the imaging system by a single operator without the need for an assistant. The CCU runs the HyperSnap Software which implements a deep learning approach for super-resolution and reconstruction of acquired snapshot hyperspectral images.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Computational hyperspectral imaging in the visible spectrum
Anatomical Site
Superficial tissue in the surgical field of view
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intended Users: The HSS is intended to be used by surgeons. Operating theatre staff, i.e., medical assistants with relevant specialist qualifications like a scrub nurse or circulating nurse, may optionally assist the surgeon.
Operating Environment: The HSS is intended to be used in a professional healthcare environment, i.e. operating room or operating theatre.
Description of the training set, sample size, data source, and annotation protocol
Training data for the deep learning algorithm comprises high resolution medical imaging datasets which collectively offer representative spatial and spectral variation across the intended target tissues and surfaces.
Description of the test set, sample size, data source, and annotation protocol
Reconstruction fidelity metric was validated against previously unseen representative in-vivo performance data. No further details provided.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Performance Testing
- Tissue Oxygenation: StO2 measurement performance of the subject and reference devices was compared with a dissolved oxygen meter as a gold standard using 12 different blood-based phantoms, simulating the optical properties of different tissues that may be monitored by the subject device. Results demonstrated that the subject device performs comparably to the reference device, K112826, with respect to monitoring StO2 levels.
- Spatial Resolution: The spatial resolution performance of the subject device was assessed using a USAF-1951 resolution test target and an ISO 12233 e-SFR test target, in line with the ISO 8600-5 and ISO 12233 standards. Results demonstrated that the subject device achieved good spatial resolution performance, displaying satisfactory repeatability and reproducibility against predetermined acceptance criteria across repeated acquisitions and varying HSS configurations. All predetermined and objective acceptance criteria were met.
- Colourimetry: The RGB reconstruction performance of the subject device was assessed on a range of Spectralon diffuse colour standards. Results demonstrated that the subject device achieved satisfactory colour reconstruction performance across the range of Spectralon diffuse colour standards. All predetermined and objective acceptance criteria were met.
Animal Performance Testing
- Three GLP compliant animal studies were conducted using a laparoscopic approach and subsequent conversion to open surgery to evaluate safety, performance, and usability of the subject device in a representative in-vivo model according to the predefined endpoints.
- Safety profile assessment: showed that the subject device met all predefined criteria and was safe to use.
- Performance profile assessment: All endpoints were met, including laparoscopic vs open small bowel StO2; detection of qualitative and quantitative changes in StO2 visualised/measured laparoscopically during clamping of small and large bowel mesentery; repeatability and reproducibility of StO2 quantification; and adequate RGB visualisation and detection of qualitative changes in RGB visualised during clamping of small and large bowel.
- Usability assessment: favourable, all usability criteria met, device successfully positioned for imaging and focusing.
AI/ML Technical Validation
- Technical validation of the deep learning-based super-resolution and reconstruction algorithm confirmed that all predefined technical performance criteria were met. Evaluation across benchmark datasets demonstrated superior image reconstruction performance relative to baseline methods, as indicated by improvements in peak signal-to-noise ratio (PSNR), structural similarity index measure (SSIM), and reconstruction fidelity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
FDA 510(k) Clearance Letter - HyperSnap Surgical System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID # 04017.07.05
Silver Spring, MD 20993
www.fda.gov
June 24, 2025
Hypervision Surgical
Jaco Jacobs
Chief Operating Officer
London Institute for Healthcare Engineering
100 Lambeth Palace Road
London, SE1 7AR
United Kingdom
Re: K250268
Trade/Device Name: HyperSnap Surgical System (HSS)
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: SFE, FET, MUD
Dated: January 24, 2025
Received: January 30, 2025
Dear Jaco Jacobs:
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/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.
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"
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K250268 - Jaco Jacobs Page 2
(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 820.30 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 (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-reporting-combination-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 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-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
Page 3
K250268 - Jaco Jacobs Page 3
Sincerely,
YAN FU -S
Digitally signed by YAN FU -S
Date: 2025.06.24 17:58:03 -04'00'
for 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
Page 4
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K250268
Device Name: HyperSnap Surgical System (HSS)
Indications for Use (Describe)
The HyperSnap Surgical System is a real-time video camera system utilising computational hyperspectral imaging in the visible spectrum. The system is intended to be used intraoperatively to relay a standard RGB video feed used for visualisation alongside corresponding tissue oxygenation information presented as a corresponding two-dimensional real-time video feed.
The system is intended for use as an adjunctive monitor of the haemoglobin oxygen saturation of blood (StO2) in the superficial tissue in the surgical field of view.
The HyperSnap Surgical System may help identify patients at risk of tissue ischaemia. The system is indicated for use in all populations for open and minimally invasive general surgical applications utilising compatible surgical telescopes (exoscopes and rigid endoscopes).
The prospective clinical value of measurements made with StO2 has not been demonstrated in disease states.
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)
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:
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"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."
Page 5
K250268 - HYPERSNAP® SURGICAL SYSTEM
1. Submitter's Information
| Manufacturer | Hypervision Surgical Ltd |
|---|---|
| Address | London Institute for Healthcare Engineering, 100 Lambeth Palace Road, London, SE1 7AR |
| Contact | regulatory@hypervisionsurgical.com |
| Company Contact Person | Dr Jaco Jacobs |
| Date Prepared | 24th June 2025 |
2. Subject Device
| Device Trade Name | HyperSnap Surgical System (HSS) |
|---|---|
| Device Common Name | Video Imaging System |
| Classification Regulation Number | 21 CFR 876.1500 |
| Classification Regulation Name | Endoscope and Accessories |
| Device Classification | Class II |
| Device Product Code | SFE, FET, MUD |
3. Predicate and Reference Devices
Herein we will make use of the following devices. Our strategy for demonstrating substantial equivalence to our predicate device will be via a comparison of performance of the subject device to that of the reference device. The chosen predicate device used a similar approach to gain marketing authorisation.
| Device Type | Device | Marketing Authorisation | Product Code |
|---|---|---|---|
| Predicate | FUJIFILM EX-0, VP-7000 | K203717 | GCJ, FET, NTN, PEA, MUD, NWB |
| Reference | Moor VMS-OXY Tissue Oxygenation and Temperature Monitor | K112826 | MUD |
Page 6
4. Device Description
4.1. Safer Technologies Program Designation
The HSS was granted a Safer Technologies Program (STeP) designation by the US Food and Drug Administration (FDA) in 2024, a voluntary program for certain medical devices that are reasonably expected to significantly improve the safety of currently available treatments.
4.2. General Description
Hyperspectral imaging (HSI) is an optical imaging modality that carries information about tissue properties, facilitating objective tissue characterisation without the need for any exogenous contrast agent. HSI is non-invasive, non-contact, and does not make use of ionising radiation.
The HSS is an HSI system that seamlessly integrates into surgical workflows to provide critical, but currently unavailable, tissue property information during surgery. The HSS provides for visualisation of real-time tissue oxygenation saturation (StO2) information alongside conventional red-green-blue (RGB) visualisation. Additionally, the mean StO2 value within a user-defined ROI is reported.
Imaging is displayed at video rate ensuring instant surgeon feedback and intra-operative tissue assessment to facilitate surgical guidance and decision making.
The HSS is an artificial intelligence (AI) / machine learning (ML) enabled device. Training data for the deep learning algorithm comprises high resolution medical imaging datasets which collectively offer representative spatial and spectral variation across the intended target tissues and surfaces.
4.3. Core Components of the HyperSnap Surgical System
The core components of the HSS include, amongst others, a hyperspectral camera, the HyperSnap Camera, a computational workstation, the Camera Control Unit (CCU), the Camera Electrical Isolator and Camera Electrical Isolator Power Supply. The HyperSnap Camera is a lightweight surgical camera with a snapshot hyperspectral imaging sensor. Our surgical imaging technology exploits highly optimised algorithms and software to leverage snapshot HSI hardware for the extraction of advanced optical properties of observed tissues.
The camera can be securely mounted but is easily manoeuvrable, allowing for controlled mobilisation and immobilisation of the imaging system by a single operator without the need for an assistant. The CCU runs the HyperSnap Software which implements a deep learning approach for super-resolution and reconstruction of acquired snapshot hyperspectral images.
4.4. Supported Accessories
Supported accessories include the Insufflator, Light Source and Light Guide. Peripheral input/output devices include the Surgical Display, Foot Control and Surgical Keyboard.
Page 7
The HSS is compatible with different Surgical Telescopes allowing for use in both open and laparoscopic surgical procedures for general surgical specialities. Surgical Telescopes connect to the HyperSnap Camera via a Coupler.
Sterility in the surgical field is maintained by using a Surgical Drape; a sterile surgical gauze is used as a Calibration Target prior to the surgical procedure.
Finally, a Surgical Trolley and mandatory Isolating Transformer are used to securely house the system components and supported accessories.
4.5. Surgical Stack
The HyperSnap Surgical System comprises the core components and accessories. When fully configured with all necessary accessories, it forms a surgical stack capable of supporting both laparoscopic and open surgical procedures.
5. Statement of Intended Use
5.1. Indications for Use
The HyperSnap Surgical System is a real-time video camera system utilising computational hyperspectral imaging in the visible spectrum. The system is intended to be used intraoperatively to relay a standard RGB video feed used for visualisation alongside corresponding tissue oxygenation information presented as a corresponding two-dimensional real-time video feed.
The system is intended for use as an adjunctive monitor of the haemoglobin oxygen saturation of blood (StO2) in the superficial tissue in the surgical field of view.
The HyperSnap Surgical System may help identify patients at risk of tissue ischaemia. The system is indicated for use in all populations for open and minimally invasive general surgical applications utilising compatible surgical telescopes (exoscopes and rigid endoscopes).
The prospective clinical value of measurements made with StO2 has not been demonstrated in disease states.
5.2. Contraindications
The HSS has no known contraindications.
5.3. Intended Patient Population
The HSS is indicated for use in all populations indicated for general surgical applications (laparoscopic or open surgery).
Page 8
5.4. Intended Users
The HSS is intended to be used by surgeons. Operating theatre staff, i.e., medical assistants with relevant specialist qualifications like a scrub nurse or circulating nurse, may optionally assist the surgeon.
5.5. Operating Environment
The HSS is intended to be used in a professional healthcare environment, i.e. operating room or operating theatre.
6. Comparison of Technological Characteristics
6.1. Similarities
Both devices relay real-time imaging information to be used intraoperatively. Both devices are intended to be used by trained physicians to visually assess vessels and other critical structures of interest. Both devices relay additional tissue property information, namely the haemoglobin oxygen saturation of blood in superficial tissue in an area under observation in patients at risk of ischaemic states.
6.2. Differences
The subject device uses hyperspectral imaging to non-invasively quantify tissue oxygenation metrics. The subject device uses snapshot hyperspectral technology that enables the capture of hyperspectral information in real-time. However, while snapshot hyperspectral cameras enable real-time imaging, this is achieved by spatial multiplexing of spectral information. The subject device employs highly optimised algorithms for real time reconstruction and recovery of spatio-spectral information, reconstruction of RGB information, and estimation of tissue properties such as tissue oxygen saturation, StO2. The predicate device provides additional optical imaging modes: blue light imaging, linked colour imaging, white light imaging, in addition to oxygen saturation imaging information. When in oxygen saturation imaging mode, StO2 images are quantified from the differences in the absorption coefficient in the visible light region between oxy- and deoxy-haemoglobin using a small number of wavelengths. The unit alternately emits select wavelengths of light synchronously, from which images are acquired with an RGB colour charge coupled device mounted at the tip of the endoscope. An StO2 image is subsequently created by performing a nonlinear transformation on the images acquired that correspond to the illumination induced by the different wavelength LEDs. The StO2 images are displayed by assigning the StO2 level to the RGB display colour of the monitor in 1% increments, with the StO2 level of 100% as red, 50% as yellowish green, and 0% as dark blue. The subject device is a hyperspectral surgical camera whilst the predicate is an endoscopic video imaging camera.
6.3. Substantial Equivalence Comparison
This table compares the subject and predicate devices.
Page 9
| Property | Subject Device | Predicate Device |
|---|---|---|
| Premarket Notification | K250268 | K203717 |
| Manufacturer | Hypervision Surgical Ltd | FUJIFILM Corporation |
| Device Name | HyperSnap Surgical System | FUJIFILM EX-0, VP-7000 |
| Generic Name | Video imaging system | Endoscopic video imaging system |
| Codified Regulation | 21 CFR 876.1500 | 21 CFR 876.1500 |
| Product Codes | SFE, FET, MUD | GCJ, FET, NTN, PEA, MUD, NWB |
| Use Environment | Operating room (operating theatre) | Operating room (operating theatre) |
| Intended User | Surgeon | Surgeon |
| Indications for Use | The HyperSnap Surgical System is a real-time video camera system utilising computational hyperspectral imaging in the visible spectrum. The system is intended to be used intraoperatively to relay a standard RGB video feed used for visualisation alongside corresponding tissue oxygenation information presented as a corresponding two-dimensional real-time video feed. |
The system is intended for use as an adjunctive monitor of the haemoglobin oxygen saturation of blood (StO2) in the superficial tissue in the surgical field of view.
The HyperSnap Surgical System may help identify patients at risk of tissue ischaemia. The system is indicated for use in all populations for open and minimally invasive general surgical applications utilising compatible surgical telescopes (exoscopes and rigid endoscopes).
The prospective clinical value of measurements made with StO2 has not been demonstrated in disease states. | The VP-7000 unit is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to process electronic signals transmitted from a video endoscope (a video camera in an endoscope). This product may be used on all patients requiring endoscopic examination and when using a FUJIFILM medical endoscope and light source together with monitor, recorder, and various peripheral devices.
The Image Processing Unit EX-0 is an optional module intended for use as an adjunctive monitor of the haemoglobin oxygen saturation of blood in superficial tissue of the endoscopic observation image area in patients at risk for ischaemic states.
This product may be used on all patients requiring endoscopic examination when using a FUJIFILM medical endoscope, video processor and light source together with monitor, recorder, and various peripheral devices.
The prospective clinical value of measurements made with OXEI has not been demonstrated in disease states. |
Page 10
| Property | Subject Device | Predicate Device |
|---|---|---|
| Patient Population | All patients indicated for laparoscopic or open surgery | All patients requiring endoscopic examination |
| Surgical Telescopes | Compatible exoscopes and rigid endoscopes | Endoscope with flexibility adjuster |
| Imaging Modes | White light imaging (RGB) and StO2 | Different modes are supported: blue light imaging, linked colour imaging, white light imaging, and oxygen saturation imaging |
| White Light Imaging | Yes | Yes |
| FICE Mode | No | Yes |
| BLI Mode | No | Yes |
| BLI Bright Mode | No | Yes |
| LCI Mode | No | Yes |
| StO2 | Two-dimensional colour coded images of StO2% of the endoscopic observation imaging area | Two-dimensional colour coded images of StO2% of the endoscopic observation imaging area |
| Image Sensor | Mosaic CMOS hyperspectral imaging sensor on HyperSnap Camera | RGB colour charge coupled device mounted at the tip of the endoscope |
| Power Rating | Camera Control Unit | |
| 100–240V AC | ||
| 50/60Hz | ||
| 10–5A |
Camera Electrical Isolator Power Supply
100–240V AC
50/60Hz
0.4A/115V AC – 0.25A/230V AC | EX-0, VP-7000
100–240V AC
50/60Hz
1.2–0.7A |
| Light Source | Compatible broad band white light | 5 LED lights are controlled independently. Blue LED creates short wavelength light, red/green/blue LEDs are combined as white light |
| Calibration | Compatible sterile gauze | As per manufacturer's instructions |
Page 11
| Property | Subject Device | Predicate Device |
|---|---|---|
| Cybersecurity | Cybersecurity in line with FDA consensus standard TIR 57 | FDA guidance documents Content of Premarket Submissions for Management of Cybersecurity in Medical Devices |
| Software | Software in line with FDA consensus standard IEC 62304 | IEC 62304 and FDA guidance documents Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices |
| Artificial Intelligence / Machine Learning | Evaluated as per Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations | Not an AI/ML-enabled device |
| Risk | Risk management per FDA consensus standard ISO 14971 | Information not publicly available |
| Human Factors | Usability engineering per FDA consensus standard IEC 62366-1 | Information not publicly available |
| Photobiological Safety | Evaluated as per FDA consensus standard IEC 62471 | Information not publicly available |
| Electromagnetic Compatibility | Evaluated as per FDA consensus standards IEC 60601-1-2 and AIM 7351731 |
Additional performance testing to demonstrate compatibility with common electromagnetic emitters | Evaluated as per FDA consensus standard IEC 60601-1-2 |
| Electrical, Mechanical, Thermal | Evaluated as per FDA consensus standards IEC 60601-1, IEC 60601-1-6 and IEC 60601-2-18 | Evaluated as per FDA consensus standards IEC 60601-1, IEC 60601-1-6, IEC 60601-2-18, and IEC 60825-1 |
| Interoperability | Interoperability evaluation in line with Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices | Information not publicly available |
Page 12
| Property | Subject Device | Predicate Device |
|---|---|---|
| Bench Testing | StO2 measurement performance of the subject and reference devices was compared with a dissolved oxygen meter as a gold standard using 12 different blood-based phantoms, simulating the optical properties of different tissues and surface types that may be monitored by the subject device. |
The spatial resolution of the subject device was assessed using a USAF-1951 resolution test target and an ISO 12233 e-SFR test target, in line with the ISO 8600-5 and ISO 12233 standards.
The RGB reconstruction performance of the subject device was assessed on a range of Spectralon diffuse colour standards. | StO2 measurement performance of the subject and reference devices was compared with a dissolved oxygen meter as a gold standard using 7 different blood-based phantoms, simulating the optical properties of different tissues that may be monitored by the subject device. |
| Animal Testing | Three GLP animal studies were conducted using a laparoscopic approach and subsequent conversion to open surgery to evaluate safety, performance, and usability of the subject device in a representative in-vivo model according to the predefined endpoints. The StO2 outputs reported by the subject device were compared against a reference device. | Three animal studies were conducted: one laparoscopic, one endoscopic and one for open surgery. The StO2 outputs reported by the predicate device were compared against a reference device. |
Page 13
7. Consensus Standards
HVS has identified the following standards which are applicable to the product realisation process. We list process as well as product-based standards utilised and include the recognition number for FDA consensus standards.
| Standard | Consensus Recognition Number | Conformity Assessment |
|---|---|---|
| IEC 62304 | 13-79 | Declaration of conformity |
| ISO 14971 | 5-125 | Declaration of conformity |
| TIR 57 | 13-83 | Declaration of conformity |
| CVSS 3.0 | 13-116 | Declaration of conformity |
| ANSI/NEMA HN 1-2019 (MDS2) | 13-123 | Declaration of conformity |
| IEC 62366-1 | 5-129 | Declaration of conformity |
| IEC 62471 | 12-249 | Declaration of conformity |
| IEC 60601-1 | 19-4 | Declaration of conformity |
| IEC 60601-1-2 | 19-36 | Declaration of conformity |
| IEC 60601-1-6 | 5-132 | Declaration of conformity |
| IEC 60601-2-18 | 9-114 | Declaration of conformity |
| AIM 7351731 | 19-45 | Declaration of conformity |
| IEC TR 60601-4-2 | 19-19 | Declaration of conformity |
| ISO/CIE 11664-6 | 9-148 | General use |
| ISO 8600-5 | 9-131 | General use |
8. Performance Data
In this section we include a brief discussion of the nonclinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence. The StO2 measurement function was evaluated via extensive and comparative bench testing and animal testing. Performance testing established that the subject device may be used as a conventional RGB visualisation system as well as an adjunctive monitor of the haemoglobin oxygenation saturation of blood in superficial tissue.
8.1. AI/ML Technical Validation
Technical validation of the deep learning-based super-resolution and reconstruction algorithm confirmed that all predefined technical performance criteria were met. Evaluation across benchmark datasets demonstrated superior image reconstruction performance relative to baseline methods, as indicated by improvements in peak signal-to-noise ratio (PSNR), structural similarity index measure (SSIM), and reconstruction fidelity. Furthermore, the reconstruction fidelity metric was validated against previously unseen representative in-vivo performance data, supporting the algorithm's generalisability and robustness in clinically representative settings.
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8.2. Bench Performance Testing
8.2.1. Tissue Oxygenation
StO2 measurement performance of the subject and reference devices was compared with a dissolved oxygen meter as a gold standard using 12 different blood-based phantoms, simulating the optical properties of different tissues that may be monitored by the subject device. The subject device was used, with supported accessories, as labelled, to quantify the StO2 level. Results demonstrated that the subject device performs comparably to the reference device, K112826, with respect to monitoring StO2 levels.
8.2.2. Spatial Resolution
The spatial resolution performance of the subject device was assessed using a USAF-1951 resolution test target and an ISO 12233 e-SFR test target, in line with the ISO 8600-5 and ISO 12233 standards. Results demonstrated that the subject device achieved good spatial resolution performance, displaying satisfactory repeatability and reproducibility against predetermined acceptance criteria across repeated acquisitions and varying HSS configurations (i.e., different supported Surgical Telescopes).
All predetermined and objective acceptance criteria were met to confirm the validity of the technical performance of the spatial resolution of the RGB output of the subject device.
8.2.3. Colourimetry
The RGB reconstruction performance of the subject device was assessed on a range of Spectralon diffuse colour standards. Results demonstrated that the subject device achieved satisfactory colour reconstruction performance across the range of Spectralon diffuse colour standards.
All predetermined and objective acceptance criteria were met to confirm the validity of the technical performance in terms of colourimetry of the RGB output of the subject device.
8.3. Animal Performance Testing
Three GLP compliant animal studies were conducted to evaluate safety, performance, and usability of the subject device in a representative in-vivo model according to the predefined endpoints.
Overall, the safety profile assessment showed that the subject device met all predefined criteria and that the subject device was safe to use when applying the usual principles of laparoscopic surgery.
All endpoints for evaluation of the performance profile were met, notably: the laparoscopic vs open small bowel StO2; detection of qualitative changes in StO2 visualised laparoscopically with the subject device during clamping of small and large bowel mesentery; the detection of quantitative changes in StO2 measured laparoscopically with the subject device during clamping of small bowel and large bowel mesentery; repeatability and reproducibility of StO2 quantification metrics reported by the subject device as well as demonstration of
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adequate RGB visualisation of predefined anatomical structures; and detection of qualitative changes in RGB visualised laparoscopically with the subject device during clamping of small and large bowel.
The usability assessment was favourable as all usability criteria were met and the device could be successfully positioned to enable imaging and focusing to achieve a sharp image of the target tissue.
9. Conclusion
The subject device shares the same intended use and substantially similar indications to the chosen predicate. Any differences herein raise no additional risks, nor do these differences bring up new questions of safety and efficacy of the subject device in relation to the predicate.
The subject device was developed under a quality management system (QMS) in conformity with ISO 13485 and the FDA's own Quality System Regulation (QSR). Furthermore, the FDA has determined that the requirements in ISO 13485 are, when taken in totality, substantially similar to the requirements of the QSR, providing a similar level of assurance in the quality management system and ability to consistently manufacture devices that are both safe and effective.
HVS cites conformity to FDA recognised consensus standards IEC 62366-1 and ISO 14971 for human factors and safety risk management activities, respectively.
External conformity assessments by certification body (CB) scheme accredited and nationally recognised test laboratories (NRTL) per the following consensus standards demonstrated acceptable basic safety and essential performance of the subject device: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-18 and AIM 7351731. Additional electromagnetic compatibility (EMC) testing, specifically focussed on common electromagnetic emitters, was conducted and demonstrated that there was no degradation in the performance of the subject device.
Photobiological safety evaluation of the supported high intensity Light Source demonstrated a favourable safety profile.
Technical validation of the deep learning-based super-resolution and reconstruction algorithm confirmed that all predefined technical performance criteria were met.
Software was developed and verified under FDA's recognised consensus standard IEC 62304 with additional considerations provided in TIR 57 implemented for a secure software development lifecycle that consistently produces devices and software that provide reasonable assurance of cybersecurity.
Extensive bench and GLP compliant animal performance testing, with predefined endpoints and acceptance criteria, demonstrated that the performance profile of the subject device is satisfactory.
The subject device successfully met all acceptance criteria and passed validation against user needs.
The aforementioned, when taken in totality, supports the notion that the subject device is at least as safe and at least as effective as the predicate. HVS considers the devices substantially equivalent.