The SPY Cystoscopes/Hysteroscopes are intended to provide visualization in general urological and gynecological surgery through the minimally invasive approach, by utilizing natural orifices to access the surgical site.

Device Description

The SPY Cystoscope/Hysteroscope is part of Stryker's rigid endoscope product portfolio. The SPY Cystoscope/Hysteroscope is an optical instrument used to visualize or image a patient's anatomy during minimally invasive, endoscopic procedures for examination, diagnosis or therapy. The SPY Cystoscope/Hysteroscope transmits light in the visible spectrum to illuminate the anatomy, then forms and relays the image of the surgical site to a camera system for image processing and display.

AI/ML Overview

Based on the provided FDA 510(k) clearance letter for the SPY Cystoscope/Hysteroscope (K252012), here's a description of the acceptance criteria and the study that proves the device meets them:

Important Note: The provided document is a 510(k) clearance letter, which summarizes the information submitted by the manufacturer. It does not contain the full details of the testing performed. Therefore, some of the requested information (especially regarding specific test methodologies, exact sample sizes for training/test sets, expert qualifications, and ground truth establishment details) is not explicitly stated in this summary. I will highlight what is present and what is inferred based on standard regulatory practices for this type of device.

Study Proving Device Meets Acceptance Criteria

The study performed to demonstrate the device meets acceptance criteria was a non-clinical performance and safety evaluation, primarily involving bench testing. This approach is common for optical, non-diagnostic devices like endoscopes, where functionality can be objectively measured. The submission explicitly states, "The subject device does not require clinical studies to support the determination of substantial equivalence."

1. Table of Acceptance Criteria and Reported Device Performance

The letter outlines the types of non-clinical tests performed, implying these are the areas for which performance criteria were established. While the letter doesn't provide specific numerical acceptance thresholds or the exact measured values, it states that the testing "demonstrates the device conforms with design input requirements, user needs and intended uses."

Acceptance Criteria Category (Implied)	Reported Device Performance Summary
Optical Performance Characteristics:	• Demonstrates conformity with design input requirements, user needs, and intended uses. • Comparative bench top testing shows subject and reference device's optical performance are equivalent.
Optimal Object Distance (Depth of Field)	Testing performed.
Fiber Transmission	Testing performed.
Optical Transmission	Testing performed.
Distortion	Testing performed.
Modulated Transfer Function (MTF) Center and Fringes	Testing performed.
Vignetting	Testing performed.
Field of View (FOV)	Testing performed.
Apparent Field of View (AFOV)	Testing performed.
Image Runout	Testing performed.
Chromatic Aberration	Testing performed.
Contrast Testing	Testing performed.
Mechanical Attributes:	• Demonstrates conformity with design input requirements, user needs, and intended uses.
Hardware Compatibility (Stryker and Karl Storz series models)	Testing performed.
Safety & Risk Assessment:	• Risk management activities concluded that the benefits associated with the use of the device outweigh the residual risk; the overall residual risk is acceptable.
Packaging Qualification:	• A summary of packaging qualification is provided.

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

Sample Size: The document does not specify the exact sample sizes (e.g., number of devices tested) for the non-clinical bench tests. For most bench testing, typically a representative sample or a statistically significant number of production units are tested to ensure consistency and meet specifications.
Data Provenance: This was non-clinical bench testing, not human data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" do not directly apply to the primary performance testing.

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

Not Applicable: Since this device is an optical instrument for visualization (not an AI/diagnostic algorithm interpreting images), and the testing was non-clinical bench testing, "experts" in the sense of clinical reviewers establishing ground truth for a test set (e.g., radiologists reading images) were not involved in the direct performance evaluation of the device's optical properties. The "ground truth" for these tests would be the established engineering and optical performance specifications.

4. Adjudication Method for the Test Set

Not Applicable: Given that the performance evaluation was based on objective, quantitative bench testing (e.g., measuring MTF, FOV, transmission), there was no need for human adjudication of test results in the way one would adjudicate case labels for diagnostic AI. The results are based on instrumental measurements compared against specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No: The document explicitly states: "The subject device does not require clinical studies to support the determination of substantial equivalence." An MRMC study is a clinical study involving human readers. Therefore, no MRMC study was performed or required for this 510(k) clearance.
Effect Size: Not applicable as no MRMC study was conducted.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not Applicable: This device is a physical optical instrument (cystoscope/hysteroscope), not an AI algorithm. Therefore, the concept of "standalone algorithm performance" does not apply. Its performance is its ability to transmit light and form an image according to specifications, which was evaluated via bench testing.

7. The Type of Ground Truth Used

Engineering/Optical Specifications: The ground truth for this device's performance evaluation was established through pre-defined engineering and optical specifications (design input requirements) that the device must meet (e.g., a specific MTF value, a defined FOV range, acceptable levels of distortion, etc.). These specifications are typically derived from industry standards, predicate device performance, and user needs.

8. The Sample Size for the Training Set

Not Applicable: This is a hardware device; thus, it does not have a "training set" in the context of machine learning. The design and manufacturing processes are refined through engineering, prototyping, and iterative testing, not through training on data.

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

Not Applicable: As there is no "training set," this question is not relevant for this device. Ground truth for hardware development is established through engineering design principles, materials science, and manufacturing tolerances.

Summary of Approach:

The clearance for the SPY Cystoscope/Hysteroscope relied on a "Comparison to Predicate" approach, underpinned by extensive non-clinical bench testing to demonstrate that the new device's different technological characteristics (specifically smaller outer diameter and increased field-of-view) "do not raise different questions of safety or effectiveness" compared to the predicate devices. The safety and effectiveness were established by confirming the device met its design specifications for various optical and mechanical parameters.

Summary

FDA 510(k) Clearance Letter - SPY Cystoscope/Hysteroscope

Page 1

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

Doc ID # 04017.08.00

July 18, 2025

Stryker Endoscopy
Irina Glazkova
Staff, Regulatory Affairs Specialist
5900 Optical Court
San Jose, California 95138

Re: K252012
Trade/Device Name: SPY Cystoscope/Hysteroscope
Regulation Number: 21 CFR 884.1690
Regulation Name: Hysteroscope and accessories
Regulatory Class: II
Product Code: HIH, FAJ, NWB
Dated: June 27, 2025
Received: June 27, 2025

Dear Irina Glazkova:

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" (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).

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K252012 - Irina Glazkova Page 2

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

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K252012 - Irina Glazkova Page 3

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).

Sincerely,

Jason Roberts -S

Jason R. Roberts, Ph.D.
Assistant Director
DHT3B: Division of Reproductive,
Gynecology, and Urology Devices
OHT3: Office of Gastrorenal, ObGyn,
General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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Indications for Use

Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.

K252012

Please provide the device trade name(s).

SPY Cystoscope/Hysteroscope

Please provide your Indications for Use below.

Please select the types of uses (select one or both, as applicable).

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

SPY Cystoscope/Hysteroscope Page 11 of 28

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K252012, Page 1 of 2

510(k) Summary

510(k) #: K252012
Prepared on: 2025-06-27

Contact Details

21 CFR 807.92(a)(1)

Field	Value
Applicant Name	Stryker Endoscopy
Applicant Address	5900 Optical Court San Jose CA 95138 United States
Applicant Contact Telephone	650-382-9617
Applicant Contact	Mrs. Irina Glazkova
Applicant Contact Email	irina.glazkova@stryker.com

Device Name

21 CFR 807.92(a)(2)

Field	Value
Device Trade Name	SPY Cystoscope/Hysteroscope
Common Name	Hysteroscope and accessories
Classification Name	Hysteroscope (And Accessories)
Regulation Number	884.1690
Product Code(s)	HIH, FAJ, NWB

Legally Marketed Predicate Devices

21 CFR 807.92(a)(3)

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K233635	SPY Cystoscope/Hysteroscope	HIH
K040390	Ideal Eyes Autoclavable Cystoscopes and Hysteroscopes	HIH

Device Description Summary

21 CFR 807.92(a)(4)

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

Indications for Use Comparison

21 CFR 807.92(a)(5)

The subject device has the same indications for use and intended use as the predicate device.

Technological Comparison

21 CFR 807.92(a)(6)

The different technological characteristics of the device, specifically smaller outer diameter and increased field-of-view, do not raise different questions of safety or effectiveness. Testing summarized within this submission demonstrates the device conforms with design input requirements, user needs and intended uses. Comparative bench top testing demonstrates the subject and reference device's

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K252012, Page 2 of 2

optical performance are equivalent. Risk management activities concluded that the benefits associated with the use of the device outweigh the residual risk; the overall residual risk is acceptable. The combination of this data demonstrates that the subject device is substantially equivalent with respect to safety and effectiveness to the legally marketed predicate device.

Non-Clinical and/or Clinical Tests Summary & Conclusions

21 CFR 807.92(b)

Non-clinical testing was designed and developed in accordance with applicable requirements and standards to establish performance and safety of the subject device. These include performance bench testing to evaluate the optical performance characteristics and mechanical attributes including: Optimal Object Distance (Depth of Field), Fiber Transmission, Optical Transmission, Distortion, Modulated Transfer Function (MTF) Center and Fringes, Vignetting, Field of View (FOV), Apparent Field of View (AFOV), Image Runout, Chromatic Aberration, Contrast Testing, Hardware Compatibility for Stryker and Karl Storz series models. A summary of packaging qualification is also provided.

The subject device does not require clinical studies to support the determination of substantial equivalence.

The SPY Cystoscope/Hysteroscope has the same intended use and indications for use, and fundamental technology as the predicate device. In summary, SPY Cystoscope/Hysteroscope is the same or similar with respect to safety and effectiveness to the legally marketed predicate device.

Regulation Number and Section

§ 884.1690 Hysteroscope and accessories.

(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.