The SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (consisting of Camera Control Unit and Camera Head) is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to process signals transmitted from a fiberoptic endoscope that is connected to the Camera Head.

This product may be used on all patients requiring endoscopic examination using SCHOELLY Laparoscopes and FUJIFILM's light source BL-7000X together with monitor, recorder and various peripheral devices. BLI (Blue Light Imaging) and LCI (Linked Color Imaging) are adjunctive tools which can be used to supplement white light endoscopy. BLI and LCI are not intended to replace histopathological sampling as a means of diagnosis.

The SCHOELLY OSI Camera System is further intended for use as an adjunctive monitor of the hemoglobin oxygen saturation of blood in superficial tissue of the endoscopic observation image area in pattents at risk for ischemic states. The prospective clinical value of measurements made with OSI has not been demonstrated in disease states.

Device Description

The proposed SCHOELLY Oxygen Saturation Imaging (OSI) Camera System is comprised of the SCHOELLY OSI Camera Control Unit (CCU) and the SCHOELLY OSI Camera Head (CH). It is intended for real-time endoscopic imaging and may be used on all patients requiring endoscopic examination.

The proposed device is for use with SCHOELLY Laparoscopes - mounted to the SCHOELLY OSI CH, or a videoscope connected to the SCHOELLY OSI CCU, an endoscopic light source and light guide and optional further light guide accessories. Further optional accessories to complete the endoscopic system include a monitor, an image recorder and further peripheral input devices (keyboard, mouse, foot pedal, etc.).

The proposed SCHOELLY OSI Camera System is suitable for real-time endoscopic visible imaging (white light imaging, WLI) as well as for real-time visualization of tissue oxygen saturation (StO2) levels during minimally invasive surgery (oxygen saturation imaging, OSI).

AI/ML Overview

The document provided does not contain a study proving the device meets specific acceptance criteria based on human-in-the-loop performance, nor does it detail a multi-reader multi-case (MRMC) study or standalone algorithm performance with clearly defined acceptance criteria and adjudicated ground truth as typically found in AI/ML device submissions.

Instead, the document is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) for the SCHOELLY Oxygen Saturation Imaging (OSI) Camera System. This type of submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than fulfilling pre-defined performance acceptance criteria for an AI/ML algorithm.

Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, and effect sizes in MRMC studies, are not explicitly present in the provided text in the context of an AI/ML performance study.

However, I can extract information related to the device's technical and non-clinical performance and substantial equivalence:

Acceptance Criteria and Reported Device Performance (based on Non-Clinical Performance Testing):

The document details non-clinical performance testing and a comparison to a predicate device. While not presented as a formal "acceptance criteria table" for an AI/ML model, the comparison to the predicate device and the successful completion of specified tests serve as the basis for demonstrating equivalence.

Acceptance Criteria Category (Implied by Testing)	Reported Device Performance (SCHOELLY OSI Camera System)
Reprocessing Validation	- Cleaning: Successfully passed cleaning validations according to instructions in the user manual, compliant with ANSI/AAMI ST98:2022 and ISO 14937:2009. - Sterilization: Successfully passed sterilization validations according to instructions in the user manual, compliant with ANSI/AAMI ST98:2022 and ISO 14937:2009.
Software Documentation	- Software documentation provided for a Basic Documentation Level per FDA Guidance (June 2023). - Software lifecycle, documentation, and validation managed in accordance with IEC 62304:2006 + A1:2016.
Electrical Safety and EMC Testing	- Assessed for conformity and complied with IEC 60601-1:2005+AM1:2012, IEC 60601-1-2:2014, IEC 60601-1-2:2020, and IEC 60601-2-18:2009.
Imaging Mode Performance (WLI, BLI, LCI)	- Accurately reproduced reference artifacts for image sharpness, depth of field, signal-to-noise ratio, temporal noise, color reproduction, dynamic range, and distortion. - Produced images with similar intensity, color, and contrast compared to the primary predicate device in in-vivo animal and human oral cavity/hand testing.
OSI Performance (Oxygen Saturation Imaging)	- Accuracy: Measurements of oxygen saturation were similar to those produced by the primary predicate device when compared to a reference device (Spectros T-Stat™ 303 Microvascular Tissue Oximeter) on a tissue phantom with controlled oxygen levels. - Effect of Variables: OSI testing included measurements regarding the effect of distance, angle, orientation, temperature, and duration. - 2D Variation: Measurement of two-dimensional StO2 variation was performed. - Image Similarity: Produced similar images of tissue oxygenation compared to the primary predicate device in human oral cavity/hand and in-vivo animal (intestines and stomach) testing.

Regarding the other specific requirements for AI/ML performance studies:

Sample size used for the test set and the data provenance:
- The document mentions "images of the human oral cavity and hand" and "intestines and stomach images from an in-vivo animal study."
- It does not specify the exact number of images, patients, or animals used for these comparative tests.
- The provenance is implied to be both human (oral cavity and hand) and animal (intestines and stomach), likely from a clinical or laboratory setting for in-vivo testing, but the country of origin is not specified, nor is whether the data was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the use of experts to establish "ground truth" for the imaging comparisons in the sense of independent clinical review. The comparisons are stated as being directly between the SCHOELLY device's output and the predicate device's output, and against reference artifacts/tissue phantoms for quantitative measures.
- For the oxygen saturation accuracy, the "reference device" (Spectros T-Stat™ 303 Microvascular Tissue Oximeter) serves as a quantitative reference for the tissue phantom, but this is a device-to-device comparison, not expert-adjudicated ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no expert adjudication process is described for establishing ground truth for an AI/ML model's output. The performance relies on instrumental comparisons and visual similarity to a predicate.
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 MRMC study is mentioned. The device's primary function is imaging and visualization, including adjunctive oxygen saturation monitoring, not necessarily an AI-driven diagnostic aid for human readers. Therefore, an MRMC study demonstrating human reader improvement with AI assistance is not described.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies a "standalone" technical performance evaluation for the imaging capabilities and oxygen saturation measurements, where the device's output is compared directly to reference standards or the predicate device. However, this is for the device's imaging capabilities (hardware and embedded algorithms for image processing), not an independent AI algorithm producing a standalone diagnostic output.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For imaging characteristics (sharpness, color reproduction, etc.), "reference artifacts" were used.
- For oxygen saturation accuracy, a "tissue phantom with controlled oxygen levels" and a "reference device" (Spectros T-Stat™ 303 Microvascular Tissue Oximeter) were used.
- For visual comparisons (intensity, color, contrast, tissue oxygenation), the predicate device's output and in-vivo human/animal images served as the comparison basis, not a an independent "ground truth" established by expert consensus, histology, or outcomes. The substantial equivalence relies on the similarity to the predicate device's output.
The sample size for the training set:
- Not applicable. This is a 510(k) submission for an imaging system, not explicitly an AI/ML device that requires a distinct "training set" for model development as typically understood in AI/ML validation studies. The "algorithms" mentioned are for image processing (BLI, LCI, OSI modes) and are inherent to the camera system, not necessarily a separate AI/ML model trained on a large dataset.
How the ground truth for the training set was established:
- Not applicable for the same reason as above. If the device incorporates learned algorithms, the details of their training and validation are not provided in this 510(k) summary, which focuses on demonstrating substantial equivalence rather than detailing AI/ML model development.

In summary: The provided text is a 510(k) summary demonstrating substantial equivalence for an endoscopic camera system. It highlights non-clinical performance testing comparing the device's output to a predicate device and established technical standards, rather than an AI/ML performance study with a distinct test set, ground truth experts, and reader studies.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out in a sans-serif font below it. The Department of Health and Human Services logo is a stylized human figure.

June 20, 2024

Schoelly Fiberoptic GmbH % Pamela Papineau RAC Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer, Massachusetts 01432

Re: K233225

Trade/Device Name: SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ, FET, PEA, MUD, NWB Dated: September 27, 2023 Received: September 28, 2023

Dear Pamela Papineau:

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 (that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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.

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).

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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/deviceadvice-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).

Sincerely.

Digitally signed by Tanisha L. Digitally signed by Date: 2024.06.20 Hithe -S 14:59:25 -04'00'

Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K233225

Device Name

SCHOELLY Oxygen Saturation Imaging (OSI) Camera System

Indications for Use (Describe)

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)

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13 June 2024

510(k) Summary

A. GENERAL INFORMATION

510(k) Sponsor:	Schoelly Fiberoptic GmbH
Address:	Robert-Bosch-Str. 1 – 379211 DenzlingenGermany
FDA Registration Number:	8043903
Telephone Number:	+49-7666-980-0
Fax Number:	+49-7666-908-380
Contact Person:	Dr. Sandra Baumann
Date Prepared:	13 June 2024

B. DEVICE IDENTIFICATION

The subject device is the SCHOELLY Oxygen Saturation Imaging (OSI) Camera System:

Trade Name	SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)
Common Name	Video Camera (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)
Classification Name	• Laparoscope, General & Plastic Surgery;• Endoscopic Video Imaging System/Component, Gastroenterology-Urology;
Product Code	GCJ
Subsequent Product Codes	FET, PEA, MUD, NWB
Regulation Number	21 CFR 876.1500
Regulation Name	Endoscope and Accessories
Device Classification	Class II
Regulation Medical Specialty	Gastroenterology/Urology
Review Panels	General & Plastic Surgery

Indications for Use

The SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (consisting of Camera Control Unit and Camera Head) is used for endoscopic observation, diagnosis, treatment, and image recording.

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13 June 2024

It is intended to process signals transmitted from a fiberoptic endoscope that is connected to the Camera Head.

BLI (Blue Light Imaging) and LCI (Linked Color Imaging) are adjunctive tools which can be used to supplement white light endoscopy. BLI and LCI are not intended to replace histopathological sampling as a means of diagnosis.

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

C. PREDICATE DEVICES

FUJIFILM's Processor VP-7000, Image Processing Unit EX-0 and Light Source BL-7000X serve as the primary predicate device in this submission:

510(k) Sponsor:	FUJIFILM Corporation
510(k) Number:	K203717

Trade Name	Processor VP-7000 and Image Processing Unit EX-0;Light Source BL-7000X
Common Name	Endoscopic Video Imaging System/Component
Classification Names	• Laparoscope, General & Plastic Surgery• Endoscopic Video Imaging System/Component,Gastroenterology-Urology
Product Codes	GCJ
Subsequent Product Codes	FET, NTN, PEA, MUD, NWB
Regulation Numbers	21 CFR 876.1500
Regulation Name	Endoscope and Accessories
Device Classification	Class II
Regulation Medical Specialty	Gastroenterology/Urology
Review Panels	General & Plastic SurgeryGastroenterology/Urology

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Indications for Use:

Processor VP-7000 and Image Processing Unit EX-0

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 monitor, 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 OSI has not been demonstrated in disease states.

Light Source BL-7000X:

The BL-7000X 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.

The SCHOELLY NIR FI System serves as the secondary predicate device in this submission:

510(k) Sponsor:	Schoelly Fiberoptic GmbH
510(k) Number:	K221591

The secondary predicate device is specifically comprised of the flowing components:

Trade Name	Camera System
	(Camera Control Unit, Camera Head to be coupled to a
	fiberoptic scope)

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13 June 2024

Common Name	Video Camera(Camera Control Unit, Camera Head to be coupled to afiberoptic scope)
Classification Names	• Laparoscope, General & Plastic Surgery• Endoscopic Video Imaging System/Component,Gastroenterology-Urology
Product CodesSubsequent Product Codes	GCJFET, OWN, FCW
Regulation Numbers	21 CFR 876.1500
Regulation Name	Endoscope and Accessories
Device Classification	Class II
Regulation Medical Specialty	Gastroenterology/Urology
Review Panels	General & Plastic SurgeryGastroenterology/Urology

Trade Name	NIR FI Light Source
Common Name	Light Source, Illuminator
Classification Name	Confocal Optical Imaging1
	Light Source, Fiberoptic, Routine2
Product Code	OWN1
	FCW2
Regulation Number	21 CFR 876.1500
Regulation Name	Endoscope and accessories
Device Classification	Class II
Regulation Medical Specialty	Gastroenterology/Urology
Review Panels	General & Plastic Surgery1
	Gastroenterology/Urology2

1 when used for assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extrahepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using NIR Fluorescence Imaging 2 when used to emit light in the visible range of the spectrum to support standard endoscopic imaging

Indications for Use:

Camera System

The Camera System is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery whenever a laparoscope/ arthroscope/ arthroscope is indicated for use. A few examples of the more common endoscope surgeries are Laparoscopic

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13 June 2024

cholecystectorny, Laparoscopic hernia repair, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectomy, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Small joint arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Pleural biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass, Coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement. The users of the Camera System are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.

NIR FI Light Source

The NIR FI Light Source and NIR FI Light Guide are indicated for use to provide real-time endoscopic visible and near-infrared fluorescence imaging. The NIR FI Light Source and NIR FI Light Guide enable surgeons to perform minimally invasive surgery using standard endoscope visual light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct), using near-infrared imaging.

Fluorescence imaging of biliary ducts with the NIR FI Light Source and NIR FI Light Guide is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.

D. REFERENCE DEVICE

The Spectros T-Stat™ 303 Microvascular Tissue Oximeter serves as the reference device in this submission:

510(k) Sponsor:	Spectros Corporation
510(k) Number:	K081233

Trade Name	T-Stat™ 303 Microvascular Tissue Oximeter
Common Name	Tissue Oximeter
Classification Names	Oximeter, Tissue Saturation
Product Codes	MUD
Subsequent Product Codes
Regulation Numbers	21 CFR 870.2700
Regulation Name	Oximeter
Device Classification	Class II
Regulation Medical Specialty	Cardiovascular

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Review Panels	Cardiovascular
---------------	----------------

Indications for Use:

The Spectros T-Stat™ 303 Microvascular Tissue Oximeter is intended for use as an adjunct monitor of the localized hemoglobin oxygen saturation of blood in the microvascular tissue spaces (StO2%) in infants, children, or adults at risk for reduced-flow and no-flow ischemic states. The prospective clinical value of measurements made with the T-Stat™ Oximeter has not been demonstrated in disease states. The T-Stat™ Oximeter should not be used as the sole basis for diagnosis or therapy.

E. DEVICE DESCRIPTION

F. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

A detailed comparison of the proposed SCHOELLY OSI Camera System and the predicate devices, FUJIFILM's Processor VP-7000, Image Processing Unit EX-0 and Light Source BL-7000X (primary predicate) and the SCHOELLY NIR FI System (secondary predicate), is provided in the substantial equivalence table below. The proposed device represents a new design variant of related components (CCU and CH) of the secondary predicate device while having additional OSI capability. It incorporates the same imaging modes (OSI, BLI, LCI) as the primary predicate and is released for its common use with the light source of the primary predicate thereby operating with the same light spectrum. The Spectros T-Stat™ 303 Microvascular Tissue Oximeter cleared for marketing by FDA in K081233 is cited as a reference device as another example of tissue oximetry.

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K233225

Table 15.1: Technological Characteristics Comparison Table

Attribute	Proposed deviceSCHOELLY's OSICamera	Primary predicate deviceFUJIFILM's Processor VP-7000, Image Processing UnitEX-0, Light Source BL-7000X	Secondary predicate deviceSCHOELLY's NIR FI System	Similarities and Differences
	(current submission)	(K203717)	(K221591)
Manufacturer	SCHOELLY Fiberoptic	FUJIFILM Corporation	SCHOELLY Fiberoptic	N/A
Device Name	SCHOELLY OxygenSaturation Imaging (OSI)Camera System	Processor VP-7000 and ImageProcessing Unit EX-0;Light Source BL-7000X	NIR FI System	N/A
510(k) Number	Current submission	K203717	K221591	N/A
Regulation Numberand Name	876.1500Endoscope and Accessories.	876.1500Endoscope and Accessories	876.1500Endoscope and Accessories	Same
Review Panel	Gastroenterology/UrologyGeneral & Plastic Surgery	Gastroenterology/UrologyGeneral & Plastic Surgery	Gastroenterology/UrologyGeneral & Plastic Surgery	Same
Product Codes	GCJ,FET, PEA, MUD, NWB	GCJFET, NTN, PEA, MUD, NWB	GCJFET, OWN, FCW	Similar:Subject device compromises asubset of product codes ofpredicate devices according torespective system components andfeatures
Indications for Use	see Section B	see Section C	see Section C	See predicate device informationsections above
System Components	Camera Control Unit,Camera Head to be coupledto a fiberoptic scope for usewith light source and furtherlight source accessories.	Camera Control Unit, ImageProcessing Unit , Light Sourcefor use with videoscopes andfurther light source accessories.	Camera Control Unit, CameraHead to be coupled to a fiberopticscope, Fiberoptic Scope and LightSource for use with light guide andfurther light guide accessories.	Similar;Subject system comprises a subsetof components as compared topredicate devices
Principles of Operation	Light emitted by an externallight source is transferredvia fiber bundles into thebody and an image	Light emitted by an externallight source is transferred viafiber bundles into the body andan image (transferred back via	Light emitted by an external lightsource is transferred via fiberbundles into the body and animage (transferred back via a	Similar. See Device Descriptionand predicate device informationabove
	(transferred back via afiberoptic system) iscaptured by a camera wherean optical signal changes toan electrical signal. Imagingsensors acquire a continuousstream of image data whichis further processed forproper viewing on displays.	a fiberoptic /electrical system)is captured by a camera.Imaging sensors acquire acontinuous stream of imagedata which is further processedfor proper viewing on displays.	fiberoptic system) is captured by acamera where an optical signalchanges to an electrical signal.Imaging sensors acquire acontinuous stream of image datawhich is further processed forproper viewing on displays.
Power Rating (CCU)	100 - 240 V ~50/60 Hz	100 - 240 V ~50/60 Hz	100 - 240 V ~50/60 Hz	Same
Image Sensor	CMOS image sensor	CMOS image sensor, CCDimage sensor	CMOS image sensor	Similar
Dimensions (CCU)	370 x 140 x 391 mm	390 x 110 x 485 mm	295 x 129.5 x 355 mm (4Kconfiguration)	Similar
Weight (CCU)	9 kg	9 kg	7 kg (4K configuration)	Similar
Imaging Modes	White Light Imaging (WLI)Oxygen Saturation Imaging(OSI)Blue Light Imaging (BLI,BLI-bright)Linked Color Imaging(LCI)	White Light Imaging (WLI)Oxygen Saturation Imaging(OSI)Blue Light Imaging (BLI, BLI-bright)Linked Color Imaging (LCI)Flexible Spectral-ImagingColor Enhancement (FICE)	White Light Imaging(WLI)NIR Fluorescence Imaging	Similar;Subject device comprises a subsetof imaging modes as compared topredicate devices; Subject devicedoes not provide FICE mode andNIR FI
Data record andstorage	Capture images or videorecordings	Capture images	Capture images and videorecordings to USB or recordings toremote device	Similar
Image Processing /Video Output	Digital	Digital	Digital	Same
Resolution	up to 3840 x 2160	up to 1920 x 1080	up to 3840 x 2160	Similar:All devices provide at least FullHD resolution
Safety Standards	IEC 60601-1IEC 60601-2-18	IEC 60601-1IEC 60601-2-18	IEC 60601-1IEC 60601-2-18	Similar;
	IEC 60601-1-2	IEC 60601-1-2	IEC 60601-1-2IEC 60825-1	Subject device comprises a subsetof safety standards compared tothe primary predicate device inaccordance with respective systemcomponents
Use Environment	Hospital, Operating room	Hospital, Operating room	Hospital, Operating room	Same

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K233225

13 June 2024

Differences in technological characteristics do not raise different questions of safety and effectiveness.

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G. PERFORMANCE DATA

The following performance testing has been performed for the subject device:

Reprocessing validation

Reprocessing validations were designed and conducted in accordance with FDA's Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (March 2015, including Appendix E revised June 2017) .

Cleaning and sterilization studies were designed and performed in accordance with ANSI/ AAMI ST98:2022 and ISO 14937:2009. Cleaning and sterilization processes are defined in the device labeling as per ISO 17664:2017.

These tests demonstrated that the device successfully passed cleaning and sterilization validations according to the instructions in the user manual.

Software Documentation

Software documentation for a Basic Documentation Level is provided in support of the proposed device per FDA's Guidance Content of Premarket Submissions for Device Software Functions: Guidance for Industry and FDA Staff (June 2023). The software lifecycle, including software documentation and validation, is managed in accordance with IEC 62304:2006 + A1:2016.

Electrical Safety and Electromagnetic Compatibility Testing

The OSI Camera System was assessed for conformity with, and was found to comply with the relevant requirements of IEC 60601-1:2005+AM1:2012, IEC 60601-1-2:2014, IEC 60601-1-2:2020, and IEC 60601-2-18:2009.

Non-Clinical Performance Testing

Non-clinical testing of the proposed device's imaging modes was conducted with its WLI, BLI and LCI modes to assess image sharpness, depth of field, signal-to noise ratio, temporal noise, color reproduction, dynamic range, distortion, contrast enhancement, and The results showed that the device could accurately reproduce reference artifacts. images used for assessing these image characteristics. OSI testing included measurements regarding oxygen saturation accuracy, the effect of distance, angle and orientation, and the effect of temperature and duration, as well as the measurement of two-dimensional StO2 variation. The proposed SCHOELLY OSI Camera System and the primary predicate device's output were compared to the reference device with measurements on a tissue phantom with controlled oxygen levels. The results showed that the oxygen saturation values produced by the SCHOELLY device were similar to those produced by the primary predicate. Images of the human oral cavity and hand were also acquired to provide a side-by-side comparison of the SCHOELLY OSI mode and the primary predicate device's oximetry mode. The results demonstrated that the SCHOELLY OSI Camera System produced similar images compared to predicate device. In addition, comparisons of intestines and stomach images from an in-vivo animal study were made for the WLI, BLI, LCI, and OSI modes, and the comparisons showed that

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the SCHOELLY device produced images that were similar to those produced by the primary predicate device. The combination of bench testing and results from in-vivo animal and human testing support that the SCHOELLY device can produce images of similar intensity, color, contrast, and tissue oxygenation, compared to those produced by the primary predicate device and the results support substantial equivalence.

H. CONCLUSION

Based on a comparison of the proposed SCHOELLY OSI Camera System and the predicate devices in terms of indications for use, physical and technological characteristics, and performance specifications, the SCHOELLY OSI Camera System raises no new issues of safety and effectiveness and is substantially equivalent to predicate devices.

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.