Processor VP-7000:
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 Fujinon/FUJIFILM medical endoscope and light source together with montor, recorder and various peripheral devices. BLI (Blue Light Imaging), LCI (Linked Color Imaging) and FICE (Flexible spectral-Imaging Color Enhancement) are adjunctive tools for gastrointestinal endoscopic examination which can be used to supplement Fujifilm white light endoscopy. BLI, LCI and FICE are not intended to replace histopathological sampling as a means of diagnosis.

The Image Processing Unit EX-0 is an optional module intended for use as an adjunctive monitor of the hemoglobin oxygen saturation of blood in superficial tissue of the endoscopic observation image area in patients at risk for ischemic states.

This product may be used on all patients requiring endoscopic examination when using a Fujinon/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.

Light Source BL-7000X:
The BL-700X Light Source is used for endoscopic observation, diagnosis, treatment, and image recording, It is intended to provide illumination to an endoscope. The light source also functions as a pump to supply air through the endoscope while inside the body to assist in obtaining clear visualization to facilitate diagnostic examination.

This product may be used on all patients requiring endoscopic examination and when using a Fujinon/FUJIFILM medical endoscope and video processor together with monitor, recorder and various peripheral devices.

Device Description

Processor VP-7000 relays the image from the endoscope to a video monitor. Projection can be either analog or digital at the user's preference. VP-7000 also incorporates internal digital storage capacity. VP-7000 controls the light projected to the body cavity. VP-7000 provides for optional structural enhancement through user modes FICE (Flexible spectral-Imaging Color Enhancement), BLI (Blue Light Imaging), BLI-brt (Blue Light Imaging-Bright) and LCI (Linked Color Imaging) at the user's option. Spectral and structural enhancements are achieved through proprietary software. The device is AC operated at a power setting of 120V/60Hz, 0.8A. VP-7000 is housed in a steel-polycarbonate case measuring 390x485x110mm. Optional Image Processing Unit EX-0 receives image data from the VP-7000, and displays an OXEI image on a LCD monitor. The OXEI image is a color-coded digital image showing tissue oxygen saturation (StO2). EX-0 incorporates an internal digital storage capacity. The device is AC-operated at a power setting of 120V/60Hz, 1.0A. EX-0 is housed in a steel-polycarbonate case measuring 320x165x340 mm.

The Fujifilm endoscopes employ fiber bundles to transmit light from Light Source BL-7000X and subsequently to the body cavity. BL-7000X employs five LED lamps. Brightness control is performed by the user. The device is AC operated at a power setting of 120V / 60Hz 1.2A. BL-7000X is housed in a steel polycarbonate case measuring 395x485x155mm.

Processor VP-7000, Light Source BL-7000X, and Image Processing Unit EX-0 are used as a system in conjunction with a compatible video laparoscope or endoscope for visualization of tissue oxygen saturation (StO2) levels.

AI/ML Overview

The provided document describes the Fujifilm Processor VP-7000, Light Source BL-7000X, and Image Processing Unit EX-0. The Image Processing Unit EX-0 is an optional module intended for use as an adjunctive monitor of hemoglobin oxygen saturation of blood in superficial tissue of the endoscopic observation image area in patients at risk for ischemic states.

Based on the provided information, the acceptance criteria and the study proving the device meets them can be summarized as follows:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Software	Compliance with IEC 62304:2015 and FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)".	Evaluated according to IEC 62304:2015 and the FDA quidance mentioned.
Cybersecurity	Compliance with FDA guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (October 2, 2014)".	Developed according to the FDA guidance mentioned.
Electrical Safety/EMC	Compliance with ANSI/AAMI ES 60601-1: 2005/(R)2012 and A1:2012, IEC 60601-1-2:2014, IEC 60601-1-6:2013, IEC 60601-2-18:2009, and IEC 60825-1:2007.	Electrical safety, electromagnetic compatibility, and laser safety were evaluated using these standards. (Implicitly met as no issues stated).
Photobiological Safety	Compliance with IEC 62471:2006, ensuring no realistic optical hazard and meeting exposure limits.	Evaluated according to IEC 62471:2006. The subject device met all exposure limits and was found to not pose a realistic optical hazard.
StO2 Measurement Performance (Bench)	Subject device performs comparably to the reference device (T-Stat K081233) with a dissolved oxygen meter as a gold standard, using 7 different blood-based phantoms.	Results demonstrated that the subject device performs comparably to the reference device, T-Stat (K081233), with respect to monitoring StO2 levels when compared against a dissolved oxygen meter as a gold standard using 7 blood-based phantoms.
StO2 Measurement Performance (Animal - Laparoscopic Visualization)	Adequate images showing visualization of the device and StO2 overlay. Acknowledge variability in StO2 measurements (up to ~29.8% between subject and reference devices) while demonstrating adequate visualization.	Study 1 showed variability between subject and reference devices of approximately 29.8%, potentially due to StO2 variability within observed tissues. However, adequate images were provided to show visualization of the device, as well as the StO2 overlay, which were considered acceptable.
StO2 Measurement Performance (Animal - Endoscopic Monitoring)	Subject device can monitor/measure StO2 levels in a clinically relevant setting (e.g., in a large animal model under controlled conditions of decreasing arterial oxygen saturation). Correlation of results with the reference device should be demonstrated.	Study 2 demonstrated that the subject device could monitor/measure StO2 levels in a clinically relevant setting (endoscopically in 4 minipigs with SpO2 decreased from 100% to 60%). A correlation of results with the reference device was compared for performance evaluation (results implicitly acceptable as the conclusion states the device monitors StO2 comparably).
StO2 Measurement Performance (Animal - Open Surgery Comparability)	Subject device measures/monitors StO2 comparably to the reference device under controlled conditions (e.g., in an open surgery setting with minimized tissue movement), with acceptable differences in StO2 readings. Maximum difference in StO2 readings should be within an acceptable range (e.g., up to ~11.4%).	Study 3 demonstrated that the subject device measures/monitors the StO2 comparably to the reference device, with differences in StO2 readings up to 11.4%. This finding was similar to the bench testing results, establishing that EX-0 may be used as an adjunctive monitor of hemoglobin oxygenation.

2. Sample size used for the test set and the data provenance:

Bench Testing: 7 different blood-based phantoms. Data provenance is not explicitly stated but implies laboratory (benchtop) testing.
Animal Testing:
- Study 1 (Laparoscopic): Number of animals not specified, but involved "a visualization study."
- Study 2 (Endoscopic): 4 female Göttingen minipigs.
- Study 3 (Open Surgery): 3 swine.
Data Provenance (Animal Studies): Live animal studies, likely conducted in a controlled laboratory environment. No specific country of origin is mentioned for the animal studies, but the entire submission is to the U.S. FDA. The details provided (e.g., "female Göttingen minipigs at 11 months of age") suggest prospective data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Bench Testing: A "dissolved oxygen meter" was used as the "gold standard" for StO2 measurements. This is an objective measurement tool, not human experts.
Animal Testing: The document does not specify the use of human experts to establish ground truth for the StO2 measurements. The reference device (T-Stat 303 Microvascular Tissue Oximeter) served as a comparator, and the study focused on the comparability of the subject device's measurements to the reference device and, implicitly, to the physiological changes induced (e.g., decreased arterial oxygen saturation).

4. Adjudication method for the test set:

Not applicable. The ground truth for StO2 measurement was established by an objective "gold standard" (dissolved oxygen meter in bench testing) or by comparison to a legally marketed predicate/reference device and physiological changes in animal models. No human adjudication is mentioned for the StO2 measurements.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. The device (Image Processing Unit EX-0) acts as an "adjunctive monitor" of StO2. The studies described focus on the device's ability to measure StO2 accurately and comparably to a reference device, not on improving human reader performance in interpreting images with AI assistance versus without it. This device itself is an "adjunctive tool," not specifically an AI assisting human interpretation of images for diagnosis, but rather providing a quantifiable physiological parameter (StO2).

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, the performance testing of the StO2 measurement function appears to be a standalone evaluation of the device's capability to measure and display StO2 levels. The bench testing directly compared the device's output to a gold standard, and the animal studies evaluated the device's measurements against a reference device's measurements and induced physiological states. The language suggests the device outputs StO2 values or color-coded images autonomously, without direct human intervention in the measurement process itself, though a human interprets the displayed information.

7. The type of ground truth used:

Bench Testing: Dissolved oxygen meter (objective measurement, considered a "gold standard").
Animal Testing:
- Comparison to a legally marketed reference device (T-Stat 303 Microvascular Tissue Oximeter).
- Induced physiological states (e.g., decreasing arterial oxygen saturation (SpO2) to simulate ischemic states). These physiological changes and the measurements from the reference device serve as the de-facto ground truth for evaluating the subject device's performance in a living system.

8. The sample size for the training set:

Not applicable. The document describes performance testing for a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device. This typically involves verification and validation testing, not the development and training of an AI algorithm from a training set. The Image Processing Unit EX-0 processes existing endoscopic image data to display StO2; it is not presented as a machine learning or AI-driven diagnostic tool that requires a training set in the conventional sense.

9. How the ground truth for the training set was established:

Not applicable, as no training set is described for this device in the provided document.

Summary

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June 30, 2021

FUJIFILM Corporation % Jeffrey Wan Senior Regulatory Affairs Specialist Fujifilm Medical Systems U.S.A., Inc. 81 Hartwell Avenue, Suite 300 Lexington, Massachusetts 02421

Re: K203717

Trade/Device Name: Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ, FET, NTN, PEA, MUD, NWB Dated: June 29, 2021 Received: June 29, 2021

Dear Jeffrey Wan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdth/cfdocs/cfpmn/pmn.cfm 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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) CDRH Leam (https://www.fda.gov/training-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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE website 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).

Sincerely.

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203717

Device Name

FUJIFILM Processor VP-7000, Light Source BL-7000X, and Image Processing Unit EX-0

Indications for Use (Describe) Processor VP-7000:

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).

The prospective clinical value of measurements made with OXEI has not been demonstrated in disease states.

Light Source BL-7000X:

The BL-700X Light Source is used for endoscopic observation, diagnosis, treatment, and image recording, It is intended to provide illumination to an endoscope. The light source also functions as a pump to supply air through the endoscope while inside the body to assist in obtaining clear visualization to facilitate diagnostic examination.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) SUMMARY FUJIFILM Corporation Processor VP-7000, Light Source BL-7000X, and Image Processing Unit EX-0

Date: June 30, 2021

Submitter's Information:

FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-Gun, Kanagawa, Japan 258-8538

Contact Person:

Jeffrey Wan Manager, Regulatory Affairs Telephone: (201) 675-8947 E-Mail: jeffrey.wan@fujifilm.com

ldentification of the Subject Device:

Device Name:	Processor VP-7000, Light Source BL-7000X, ImageProcessing Unit EX-0
Common Name:	Endoscopic Video Imaging System/Component
Review Panel:	General & Plastic Surgery
Regulation Number:	21 CFR 876.1500
Device Class:	Class II
Classification Product Code:	GCJ
Subsequent Product Codes:	MUD, FET, NTN, NWB, PEA

Predicate Device:

FUJIFILM Video Processor VP-7000 and Light Source BL-7000 (K192918)

Reference Device:

T-Stat 303 Microvascular Tissue Oximeter (K081233)

Intended Use / Indications for Use

VP-7000

This product may be used on all patients requiring endoscopic examination and when using a Fujinon/FUJIFILM medical endoscope and light source together with monitor, recorder and various

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peripheral devices. BLI (Blue Light Imaging), LCI (Linked Color Imaging) and FICE (Flexible spectral-Imaging Color Enhancement) are adjunctive tools for gastrointestinal endoscopic examination which can be used to supplement Fuiifilm white light endoscopy. BLL LCI and FICE are not intended to replace histopathological sampling as a means of diagnosis.

The prospective clinical value of measurements made with OXEI has not been demonstrated in disease states.

BL-7000X

The BL-700X Light Source is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to provide illumination to an endoscope. The light source also functions as a pump to supply air through the endoscope while inside the body to assist in obtaining clear visualization to facilitate diagnostic examination.

Device Description

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Comparison of Technological Characteristics

A comparison of the technological characteristics between the subject and predicate devices is provided below, as well as a comparison of the technological characteristics of the subject device to a reference device:

	Subject Device	Predicate Device	Equivalence
Manufacturer	FUJIFILM Corporation	FUJIFILM Corporation
Device Name	Processor VP-7000	FUJIFILM Processor VP-7000
510(k) Number	K203717	K192918
Indications for Use	The VP-7000 unit is used for endoscopicobservation, diagnosis, treatment, andimage recording. It is intended to processelectronic signals transmitted from a videoendoscope (a video camera in anendoscope).This product may be used on all patientsrequiring endoscopic examination andwhen using a Fujinon/FUJIFILM medicalendoscope and light source together withmonitor, recorder and various peripheraldevices. BLI (Blue Light Imaging), LCI(Linked Color Imaging) and FICE (Flexiblespectral-Imaging Color Enhancement) areadjunctive tools for gastrointestinalendoscopic examination which can beused to supplement Fujifilm white lightendoscopy. BLI, LCI and FICE are notintended to replace histopathologicalsampling as a means of diagnosis.The Image Processing Unit EX-0 is anoptional module intended for use as anadjunctive monitor of the hemoglobinoxygen saturation of blood in superficialtissue of the endoscopic observationimage area in patients at risk for ischemicstates.This product may be used on all patientsrequiring endoscopic examination whenusing a Fujinon/FUJIFILM medicalendoscope, video processor and lightsource together with monitor, recorderand various peripheral devices.The prospective clinical value of	The VP-7000 unit is used forendoscopic observation, diagnosis,treatment, and image recording. It isintended to process electronic signalstransmitted from a video endoscope(a video camera in an endoscope).This product may be used on allpatients requiring endoscopicexamination and when using aFujinon/FUJIFILM medicalendoscope and light source togetherwith monitor, recorder and variousperipheral devices. BLI (Blue LightImaging), LCI (Linked Color Imaging)and FICE (Flexible spectral-ImagingColor Enhancement) are adjunctivetools for gastrointestinal endoscopicexamination which can be used tosupplement Fujifilm white lightendoscopy. BLI, LCI and FICE arenot intended to replacehistopathological sampling as ameans of diagnosis.	Both of thesubject andpredicate VP-7000 arespecificallyindicated forobservation,diagnosis,treatment andimagerecording.The additionof ability toadjunctivelymonitorhemoglobinoxygensaturation ofblood insuperficialissue of theendoscopicobservationimage area inpatients atrisk forischemicstates isconsistentwith theobservationalanddiagnosticintended useand does notraise differentquestions ofsafety oreffectiveness.
	been demonstrated in disease states.
Power Rating	100-240V AC;	100-240V AC;	Identical
	50/60Hz; 0.8-0.5A;	50/60Hz; 0.8-0.5A;
FICE mode	Yes	Yes	Identical
BLI mode	Yes	Yes	Identical
BLI-brightmode	Yes	Yes	Identical
LCI mode	Yes	Yes	Identical
OXEI(OxygenSaturationInformation)	Two-dimensional, color-coded images ofStO2% of the endoscopic observationimage area	Not available	Equivalent
DimensionsWxHxD mm	390x110x485 mm	390x110x485 mm	Identical
Weight	9 kg	9 kg	Identical

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	Subject Device	Predicate Device	Equivalence
Manufacturer	FUJIFILM Corporation	FUJIFILM Corporation
Device Name	Light Source BL-7000X	FUJIFILM Light source BL-7000
510(k)Number	K203717	K192918
Indicationsfor Use	The BL-7000X Light Source is used forendoscopic observation, diagnosis,treatment, and image recording. It isintended to provide illumination to anendoscope. The light source alsofunctions as a pump to supply air throughthe endoscope while inside the body toassist in obtaining clear visualization tofacilitate diagnostic examination.This product may be used on all patientsrequiring endoscopic examination andwhen using a Fujinon/FUJIFILM medicalendoscope and video processor togetherwith monitor, recorder and variousperipheral devices	The BL-7000 Light Source is used forendoscopic observation, diagnosis,treatment, and image recording. It isintended to provide illumination to anendoscope. The light source alsofunctions as a pump to supply airthrough the endoscope while insidethe body to assist in obtaining clearvisualization to facilitate diagnosticexamination.This product may be used on allpatients requiring endoscopicexamination and when using aFujinon/FUJIFILM medicalendoscope and video processortogether with monitor, recorder andvarious peripheral devices.	Equivalent
Power Rating	100-240V AC;	100-240V AC;	Identical
	50/60Hz; 1.2-0.7A;	50/60Hz; 1.2-0.7A;
Lamp	5 LED lamps	4 LED lamps	Equivalent
DimensionsWxHxD mm	395x485x155 mm	390x485x155 mm	Identical
Weight	16 kg	12 kg	Equivalent

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Performance Data

Software:

Software of the subject device was evaluated according to IEC 62304:2015 and the FDA quidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," published May 11, 2005. Cybersecurity controls were developed according to the FDA guidance, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices," published October 2, 2014.

Electrical Safety/Electromagnetic Compatibility:

Electrical safety, electromagnetic compatibility, and laser safety of the subject device were evaluated using the following standards: ANSI/AAMI ES 60601-1: 2005/(R)2012 and A1:2012, IEC 60601-1- 2:2014, IEC 60601-1-6:2013, IEC 60601-2-18:2009, and IEC 60825-1:2007.

Photobiological safety of the subject device was evaluated according to IEC 62471:2006. The subject device met all exposure limits and was found to not pose a realistic optical hazard.

Performance Testing:

The StO2 measurement function was evaluated via comparative bench testing and animal testing.

Bench testing: .
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. The subject device was used in combination with the Video Laparoscope EL-R740M, Endoscope EC-740T/L and EG-740N to measure the StO2 level. Results demonstrated that the subject device performs comparably to the reference device, T-Stat (K081233), with respect to monitoring StO2 levels.
. Animal Testing: Three animal studies were conducted: one laparoscopic (Study 1), one endoscopic (Study 2) and one for open surgery (Study 3).
Study 1: A visualization study was conducted to measure the tissue oxygenation saturation (StO2). This study used the subject and reference devices in a laparoscopic manner to look at the serosal surface of the stomach, small intestine, and large intestine. The variability between the subject and reference devices was approximately 29.8%, potentially due to the StO2 variability within the observed tissues. Variability in these measurements has also been reported in the literature. Additionally, limited images were provided to be able to assess the visualization of the device. However, adequate images were provided from this study to show visualization of the device, as well as the StO2 overlay, which were considered acceptable.

Two additional animal studies addressed this variability in oxygenation.

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Study 2: Tissue oxygen saturation (StO2) in the large intestine and stomach for mucosal tissue was measured endoscopically in 4 female Göttingen minipigs at 11 months of age under general anesthesia with decreased arterial oxygen saturation (SpO2) from 100% to 60%. A correlation of the results with the reference device was compared for performance evaluation. Comparative StO2 measurement performance was evaluated in the swine to simulate clinically-relevant usage of the subject and reference devices. The results of this study demonstrated that the subject device could monitor/measure StO2 levels in a clinically relevant setting.

Study 3: Comparative StO2 measurement performance was evaluated when the subject and reference devices measured StO2 at the same locations under controlled conditions in the open surgery setting where the abdomen was incised and the tissues were exposed and fixed to minimize tissue movement. The StO2 measurement was performed at five parts of the GI tract of each of the three swine including the serosal surface of the stomach, small intestine, and large intestine and the mucosal surface of the stomach and large intestine. Difference in the StO2 readings between the subject and reference devices were analyzed at each part. Measurements of the StO2 were evaluated by the subject and reference devices, which has differences up to 11.4%. The results of this study demonstrated that the subject device measures/monitors the StO2 comparably to the reference device, similar to the bench testing.

The combination of these three studies established that the EX-0 device may be used as an adjunctive monitor of the hemoglobin oxygenation of blood in superficial tissue.

Conclusions

The subject devices FUJIFILM Processor VP-7000, Light Source BL-7000X, and Image Processing Unit EX-0 share the same intended use and substantially similar indications to the predicate device. Bench and animal testing demonstrate that the subject devices are as safe and effective as the predicate device. Thus, FUJIFILM Processor VP-7000, Light Source BL-7000X, and Image Processing Unit EX-0 are substantially equivalent to the listed predicate device.

Regulation Number and Section

§ 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.