SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)

K233225 · Schoelly Fiberoptic GmbH · GCJ · Jun 20, 2024 · Gastroenterology, Urology

Device Facts

• Record ID: K233225
• Device Name: SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)
• Applicant: Schoelly Fiberoptic GmbH
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jun 20, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended 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. 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 patients at risk for ischemic states. The prospective clinical value of measurements made with OSI has not been demonstrated in disease states.

Device Story

System consists of Camera Control Unit (CCU) and Camera Head (CH) coupled to fiberoptic endoscope. Inputs: optical signals from endoscope via light source (FUJIFILM BL-7000X). Transformation: optical signals converted to electrical signals by CMOS sensor; processed for real-time display. Outputs: White Light Imaging (WLI), Blue Light Imaging (BLI), Linked Color Imaging (LCI), and Oxygen Saturation Imaging (OSI). Used in hospital operating rooms by surgeons (general, gynecological, cardiac, thoracic, plastic, orthopedic, ENT, urological). OSI provides adjunctive monitoring of hemoglobin oxygen saturation in superficial tissue; assists visualization of tissue perfusion. Healthcare providers use output for real-time intraoperative assessment. Benefits: provides visual feedback on tissue oxygenation status during minimally invasive procedures.

Clinical Evidence

Bench testing assessed image characteristics (sharpness, SNR, color reproduction) and OSI accuracy (effect of distance, angle, temperature). OSI performance compared to primary predicate using tissue phantoms with controlled oxygen levels. In-vivo animal study (intestines/stomach) and human oral cavity/hand imaging provided side-by-side comparisons. Results demonstrated the SCHOELLY device produced images and oxygen saturation values similar to the primary predicate.

Technological Characteristics

Components: CCU and CH. Sensor: CMOS. Imaging modes: WLI, OSI, BLI, LCI. Resolution: up to 3840 x 2160. Power: 100-240V, 50/60Hz. Connectivity: fiberoptic coupling to endoscope, peripheral input devices. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18. Sterilization: per ISO 17664:2017.

Indications for Use

Indicated for all patients requiring endoscopic examination for observation, diagnosis, treatment, and image recording. Includes adjunctive monitoring of hemoglobin oxygen saturation (StO2) in superficial tissue for patients at risk for ischemic states. Not intended to replace histopathological sampling.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Processor VP-7000 and Image Processing Unit EX-0; Light Source BL-7000X (K203717)
• SCHOELLY NIR FI System (K221591)

Reference Devices

• Spectros T-Stat™ 303 Microvascular Tissue Oximeter (K081233)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use ( <i>Select one or both, as applicable</i> ) |
|----------------------------------------------------------|
|----------------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

## A. GENERAL INFORMATION

| 510(k) Sponsor: | Schoelly Fiberoptic GmbH |
|--------------------------|--------------------------------------------------------|
| Address: | Robert-Bosch-Str. 1 – 3<br>79211 Denzlingen<br>Germany |
| FDA Registration Number: | 8043903 |
| Telephone Number: | [phone] |
| Fax Number: | [phone] |
| 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;<br>• 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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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 SCHOELL Y 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 patients at risk for ischemic states.

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;<br>Light Source BL-7000X |
|------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Common Name | Endoscopic Video Imaging System/Component |
| Classification Names | • Laparoscope, General & Plastic Surgery<br>• Endoscopic Video Imaging System/Component,<br>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 Surgery<br>Gastroenterology/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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| Common Name | Video Camera<br>(Camera Control Unit, Camera Head to be coupled to a<br>fiberoptic scope) |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Classification Names | • Laparoscope, General & Plastic Surgery<br>• Endoscopic Video Imaging System/Component,<br>Gastroenterology-Urology |
| Product Codes<br>Subsequent Product Codes | GCJ<br>FET, 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 Surgery<br>Gastroenterology/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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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

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).

# 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 device<br>SCHOELLY's OSI<br>Camera | Primary predicate device<br>FUJIFILM's Processor VP-<br>7000, Image Processing Unit<br>EX-0, Light Source BL-<br>7000X | Secondary predicate device<br>SCHOELLY's NIR FI System | Similarities and Differences |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | (current submission) | (K203717) | (K221591) | |
| Manufacturer | SCHOELLY Fiberoptic | FUJIFILM Corporation | SCHOELLY Fiberoptic | N/A |
| Device Name | SCHOELLY Oxygen<br>Saturation Imaging (OSI)<br>Camera System | Processor VP-7000 and Image<br>Processing Unit EX-0;<br>Light Source BL-7000X | NIR FI System | N/A |
| 510(k) Number | Current submission | K203717 | K221591 | N/A |
| Regulation Number<br>and Name | 876.1500<br>Endoscope and Accessories. | 876.1500<br>Endoscope and Accessories | 876.1500<br>Endoscope and Accessories | Same |
| Review Panel | Gastroenterology/Urology<br>General & Plastic Surgery | Gastroenterology/Urology<br>General & Plastic Surgery | Gastroenterology/Urology<br>General & Plastic Surgery | Same |
| Product Codes | GCJ,<br>FET, PEA, MUD, NWB | GCJ<br>FET, NTN, PEA, MUD, NWB | GCJ<br>FET, OWN, FCW | Similar:<br>Subject device compromises a<br>subset of product codes of<br>predicate devices according to<br>respective system components and<br>features |
| Indications for Use | see Section B | see Section C | see Section C | See predicate device information<br>sections above |
| System Components | Camera Control Unit,<br>Camera Head to be coupled<br>to a fiberoptic scope for use<br>with light source and further<br>light source accessories. | Camera Control Unit, Image<br>Processing Unit , Light Source<br>for use with videoscopes and<br>further light source accessories. | Camera Control Unit, Camera<br>Head to be coupled to a fiberoptic<br>scope, Fiberoptic Scope and Light<br>Source for use with light guide and<br>further light guide accessories. | Similar;<br>Subject system comprises a subset<br>of components as compared to<br>predicate devices |
| Principles of Operation | Light emitted by an external<br>light source is transferred<br>via fiber bundles into the<br>body and an image | Light emitted by an external<br>light source is transferred via<br>fiber bundles into the body and<br>an image (transferred back via | Light emitted by an external light<br>source is transferred via fiber<br>bundles into the body and an<br>image (transferred back via a | Similar. See Device Description<br>and predicate device information<br>above |
| | (transferred back via a<br>fiberoptic system) is<br>captured by a camera where<br>an optical signal changes to<br>an electrical signal. Imaging<br>sensors acquire a continuous<br>stream of image data which<br>is further processed for<br>proper viewing on displays. | a fiberoptic /electrical system)<br>is captured by a camera.<br>Imaging sensors acquire a<br>continuous stream of image<br>data which is further processed<br>for proper viewing on displays. | fiberoptic system) is captured by a<br>camera where an optical signal<br>changes to an electrical signal.<br>Imaging sensors acquire a<br>continuous stream of image data<br>which is further processed for<br>proper viewing on displays. | |
| Power Rating (CCU) | 100 - 240 V ~<br>50/60 Hz | 100 - 240 V ~<br>50/60 Hz | 100 - 240 V ~<br>50/60 Hz | Same |
| Image Sensor | CMOS image sensor | CMOS image sensor, CCD<br>image 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 (4K<br>configuration) | Similar |
| Weight (CCU) | 9 kg | 9 kg | 7 kg (4K configuration) | Similar |
| Imaging Modes | White Light Imaging (WLI)<br>Oxygen Saturation Imaging<br>(OSI)<br>Blue Light Imaging (BLI,<br>BLI-bright)<br>Linked Color Imaging<br>(LCI) | White Light Imaging (WLI)<br>Oxygen Saturation Imaging<br>(OSI)<br>Blue Light Imaging (BLI, BLI-<br>bright)<br>Linked Color Imaging (LCI)<br>Flexible Spectral-Imaging<br>Color Enhancement (FICE) | White Light Imaging<br>(WLI)<br>NIR Fluorescence Imaging | Similar;<br>Subject device comprises a subset<br>of imaging modes as compared to<br>predicate devices; Subject device<br>does not provide FICE mode and<br>NIR FI |
| Data record and<br>storage | Capture images or video<br>recordings | Capture images | Capture images and video<br>recordings to USB or recordings to<br>remote device | Similar |
| Image Processing /<br>Video Output | Digital | Digital | Digital | Same |
| Resolution | up to 3840 x 2160 | up to 1920 x 1080 | up to 3840 x 2160 | Similar:<br>All devices provide at least Full<br>HD resolution |
| Safety Standards | IEC 60601-1<br>IEC 60601-2-18 | IEC 60601-1<br>IEC 60601-2-18 | IEC 60601-1<br>IEC 60601-2-18 | Similar; |
| | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2<br>IEC 60825-1 | Subject device comprises a subset<br>of safety standards compared to<br>the primary predicate device in<br>accordance with respective system<br>components |
| 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.