SPY Cystoscope/Hysteroscope

K252012 · Stryker Endoscopy · HIH · Jul 18, 2025 · Obstetrics/Gynecology

Device Facts

• Record ID: K252012
• Device Name: SPY Cystoscope/Hysteroscope
• Applicant: Stryker Endoscopy
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Jul 18, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.1690
• Device Class: Class 2

Intended Use

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 Story

Rigid endoscope for visualization during minimally invasive urological and gynecological procedures. Device transmits visible light to illuminate anatomy; forms and relays images of surgical site to external camera system for processing and display. Used in clinical settings by physicians. Provides real-time visualization to assist in examination, diagnosis, or therapy. Benefits include minimally invasive access to surgical sites.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including optical performance (MTF, distortion, FOV, transmission, chromatic aberration) and mechanical attribute evaluations.

Technological Characteristics

Rigid endoscope; optical instrument for visualization. Features include smaller outer diameter and increased field-of-view compared to predicates. Transmits visible light; relays images to external camera system. Bench testing evaluated optical performance (MTF, FOV, AFOV, distortion, transmission) and hardware compatibility with Stryker and Karl Storz models.

Indications for Use

Indicated for patients undergoing general urological and gynecological surgery via minimally invasive natural orifice access for examination, diagnosis, or therapy.

Regulatory Classification

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.

Predicate Devices

• SPY Cystoscope/Hysteroscope (K233635)
• Ideal Eyes Autoclavable Cystoscopes and Hysteroscopes (K040390)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

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).

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

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K252012 - Irina Glazkova
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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
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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 ([e-mail]) or phone [phone] 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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SPY Cystoscope/Hysteroscope
Page 11 of 28

| 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. | | ? |
| 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. | | |
| 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) | ? |

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K252012, Page 1 of 2

| 510(k) #: | 510(k) Summary | Prepared on: 2025-06-27 |
| --- | --- | --- |
| Contact Details | | 21 CFR 807.92(a)(1) |
| 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 | [e-mail] | |
| Device Name | | 21 CFR 807.92(a)(2) |
| 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) |
| 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. | | |
| Intended Use/Indications for Use | | 21 CFR 807.92(a)(5) |
| 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. | | |
| 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.