Endoscopic Camera System is a camera control unit (CCU) for use with camera heads and video endoscopes for visualization, image recording and documentation during general endoscopic and microscopic procedures.

Device Description

The device consists of a camera control unit (CCU) and a camera head.

The device is intended to be used to connect with an optical endoscope during the endoscopic diagnosis and/or treatment/surgery, and to capture, process and transmit images in the human body cavity under the field of view observed by the endoscope to the monitor.

There are 4 models of the device. The hardware configuration of the device of 4 models are same, and difference is different functions which opened up through software.

AI/ML Overview

The provided FDA 510(k) clearance letter describes an Endoscopic Camera System (K250204) and its substantial equivalence to a predicate device (Image1 SPIES System, K160044). However, it does not provide detailed acceptance criteria or the specific results of a study (e.g., clinical study) that quantitatively proves the device meets strict performance thresholds.

The letter primarily focuses on the device's technical specifications and compliance with non-clinical performance tests relevant to the safety and fundamental function of an endoscopic camera system. It highlights that the device "met all its specifications" and that bench tests demonstrated the device's characteristics have been met, but it does not specify what those specifications or characteristics are in measurable terms related to clinical performance.

Based on the provided text, here's an attempt to answer your questions, highlighting what is available and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "The bench test data for the Endoscopic Camera System demonstrates that the design characteristics used as the basis for the comparison have been met. The results show that the subject device has met all its specifications." and "The bench testing performed verified and validated that the Endoscopic Camera System has met all its design specification and is substantially equivalent to the predicate device, Image1 SPIES System."

However, the specific acceptance criteria (measurable thresholds) and the quantitative reported device performance for these specifications are NOT detailed in this public FDA 510(k) clearance letter.

The letter mentions "minor technology differences" in:

Horizontal resolution
Spatial frequency response
Field of view
Focal length
Dimensions
Weight of camera head
Image delay
Video output
USB port of CCU

For these parameters, the letter ambiguously states that these differences "does not raise new issues of safety and effectiveness." It implies that the new device's performance for these characteristics is either equivalent or acceptably different without introducing new risks compared to the predicate, but specific numbers are not provided.

Acceptance Criteria (Example/Inferred)	Reported Device Performance (Not Provided Quantitatively in Letter)
Horizontal Resolution = [X]	Met specification, equivalent to predicate K160044
Spatial Frequency Response = [Y]	Met specification, equivalent to predicate K160044
Field of View = [Z]	Met specification, equivalent to predicate K160044
Focal Length = [A]	Met specification, equivalent to predicate K160044
Image Delay < [B] ms	Met specification, equivalent to predicate K160044
Electrical Safety (IEC 60601-1)	Compliant
EMC (IEC 60601-1-2)	Compliant
Reprocessing Validation (AAMI TIR 12:2020)	Validated
Software Verification Tests (FDA Guidance)	Verified
Service Life Evaluation	Evaluated (results not public)
System Level Function Tests	Met design specifications

Crucially, the document explicitly states: "The performance validation test report can be provided upon request." This means the detailed quantitative data is part of the full 510(k) submission but not typically released in the public clearance letter.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified in the clearance letter. The testing mentioned (bench testing, software verification) would imply testing of the device units and their software, but the "sample size" in terms of patient data or clinical cases (which is what your question typically refers to for AI/diagnostic devices) is not applicable or not disclosed for this type of device and submission pathway based on the provided text. This device is a general endoscopic camera system, not an AI-powered diagnostic device trained on patient data itself, but rather a visualization tool. Its performance is typically assessed through technical specifications and bench testing for image quality, safety, and functionality.
Data Provenance: Not applicable in the context of patient data for a clinical test set. The data would originate from the bench tests conducted by the manufacturer.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable / Not disclosed. For an endoscopic camera system, the "ground truth" for its performance is typically based on objective physical measurements (e.g., resolution charts, light intensity, color accuracy) and engineering test standards, rather than expert human interpretation of medical images for diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable / Not disclosed. Adjudication is relevant for studies involving human interpretation or multi-expert review, which is not described for this device's performance validation.

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

Not applicable. This device is an "Endoscopic Camera System" for visualization and documentation. The provided information does not indicate that it includes AI or that an MRMC study was performed. The evaluation focuses on the camera system's fundamental performance characteristics, not its impact on human diagnostic accuracy with or without AI assistance.

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

Not applicable. This device is a hardware camera system, not an algorithm, and the provided text does not indicate any standalone algorithm performance testing.

7. The Type of Ground Truth Used

Objective Technical Measurements and Engineering Standards. The "ground truth" for an endoscopic camera system's performance would be established through:
- Metrological standards: Measuring resolution, contrast, brightness, color accuracy, distortion, etc., using calibrated test targets and equipment.
- Compliance with industry standards: Such as IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), and AAMI TIR 12:2020 (reprocessing).
- Design specifications: The device is tested against its predefined engineering design specifications to ensure it meets them.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware camera system, not an AI model, so there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set was Established

Not applicable. As above, there is no "training set" for this device.

In summary, the provided 510(k) clearance letter details a regulatory approval for an endoscopic camera system based on substantial equivalence to a predicate device and compliance with applicable non-clinical safety, EMC, reprocessing, and software verification standards. It emphasizes that the device met its design specifications and passed bench tests, but it does NOT provide the granular quantitative details of "acceptance criteria" or a "study proving it meets those criteria" in the way one would expect for a diagnostic AI device requiring clinical performance validation. The specific numerical performance data would be part of the full 510(k) submission, not typically included in the public clearance letter.

Summary

FDA 510(k) Clearance Letter - Endoscopic Camera System

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

July 1, 2025

Shenzhen Sophway Technology Co., Ltd.
℅ Eva Li
Consultant
Shanghai SUNGO Management Consulting Co., Ltd.
Room 1401, Dongfang Building, 1500# Century Ave.
Shanghai, 200122
China

Re: K250204
Trade/Device Name: Endoscopic Camera System
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: FET
Dated: June 20, 2025
Received: June 20, 2025

Dear Eva Li:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

July 1, 2025

Shenzhen Sophway Technology Co., Ltd.
℅ Eva Li
Consultant
Shanghai SUNGO Management Consulting Co., Ltd.
Room 1401, Dongfang Building, 1500# Century Ave.
Shanghai, 200122
China

Dear Eva Li:

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K250204 - Eva Li Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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K250204 - Eva Li Page 3

Sincerely,

James H. Jang -S Digitally signed by James H. Jang -S Date: 2025.07.01 22:11:06 -04'00'

James Jang, Ph.D.
Acting 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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FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.

510(k) Number (if known)
K250204

Device Name
Endoscopic Camera System

Indications for Use (Describe)
Endoscopic Camera System is a camera control unit (CCU) for use with camera heads and video endoscopes for visualization, image recording and documentation during general endoscopic and microscopic procedures.

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(K) Summary

K250204 Page 1 / 2

1. General Information

Applicant: Shenzhen Sophway Technology Co.,Ltd.
Contact person: Shuting Chen
Tel No. +86 755 36368352
Address 7th Floor, Building 9#, Zhongyuntai Technology Industrial Park, Songbai Rd., Shiyan Avenue, Bao'an, Shenzhen, 518108 Guangdong, P.R. China

Submitter: Eva Li
Address: Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China
Tel No. : 008618101897399
Date of preparation: June 30, 2025

Device Identification:
Common Name: Endoscopic Video Imaging System/Component
Trade Name: Endoscopic Camera System
Device Classification: Class II
Regulation 21 CFR 876.1500
Product Code FET

2. Indication for Use

3. Device Description

The device consists of a camera control unit (CCU) and a camera head.

There are 4 models of the device. The hardware configuration of the device of 4 models are same, and difference is different functions which opened up through software.

4. Technology

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K250204 Page 2 / 2

Predicate Device: Product Code FET, Image1 SPIES System, cleared under K160044

The predicate and subject devices are both camera systems used for the visualization and documentation of endoscopic and microscopic procedures. They have the same operational principals and indications for use.

The subject device and the predicate devices have some minor technology differences: Horizontal resolution, Spatial frequency response, Field of view, Focal length, Dimensions, Weight of camera head, Image delay, Video output, USB port of CCU.

The bench test data for the Endoscopic Camera System demonstrates that the design characteristics used as the basis for the comparison have been met. The results show that the subject device has met all its specifications. The performance validation test report can be provided upon request. The minor difference in specifications when compared to the predicate device under K160044, does not raise new issues of safety and effectiveness and the devices are substantially equivalent for the visualization and documentation of endoscopic and microscopic procedures.

5. Non-Clinical performance tests:

The Endoscopic Camera System undergone bench testing for performance verification and validation purposes.

Electrical safety testing according to IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION
EMC testing according 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION
Reprocessing validation according to AAMI TIR 12:2020, Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A guide for Device Manufactures
Service Life Evaluation
Software Verification Tests according to the Guidance of Content of Premarket Submissions for Device Software Functions
Bench performance for camera, CCU and system level function tests.

The bench testing performed verified and validated that the Endoscopic Camera System has met all its design specification and is substantially equivalent to the predicate device, Image1 SPIES System.

6. Conclusion

The subject device is substantially equivalent to its predicate devices. The nonclinical testing demonstrates that the device is as safe, as effective as well as the legally marketed devices under K160044.

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.