(91 days)
No
The summary describes a rigid endoscope for visualization and image processing, but there is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML algorithms. The image processing mentioned is likely standard digital image processing for display.
No
The device is described as an optical instrument used for visualization, examination, and diagnosis. While it mentions therapy, its primary function is imaging and visualization rather than directly delivering a therapeutic effect.
No
The device is described as an optical instrument used to visualize or image a patient's anatomy during minimally invasive procedures. While it can be used for examination or diagnosis, its primary described function is to provide visualization for surgical procedures (therapy), rather than solely for diagnosis. The "Intended Use" also emphasizes visualization in surgery.
No
The device is described as an optical instrument and part of a rigid endoscope product portfolio, indicating it is a physical hardware device. While it mentions image processing, this is part of a system that includes hardware components like the endoscope and camera.
Based on the provided information, the SPY Cystoscopes/Hysteroscopes are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "provide visualization in general urological and gynecological surgery through the minimally invasive approach." This describes a device used in vivo (within the living body) for direct visualization during a surgical procedure.
- Device Description: The description reinforces this by stating it's an "optical instrument used to visualize or image a patient's anatomy during minimally invasive, endoscopic procedures for examination, diagnosis or therapy." Again, this is about direct visualization of internal anatomy.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. The description of the SPY Cystoscopes/Hysteroscopes does not mention any interaction with specimens or analysis of biological samples.
In summary, the SPY Cystoscopes/Hysteroscopes are a surgical endoscope used for direct visualization within the body, which is not the function of an IVD device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
HIH, FAJ, NWB
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical instrument
Anatomical Site
General urological and gynecological surgery through natural orifices.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data were provided in support of the substantial equivalence determination.
Test: Electrical Safety, Method: In accordance with FDA-recognized voluntary consensus standard IEC 60601-1:2020 (19-49), Result: Pass
Test: Electrical Safety, Method: In accordance with FDA-recognized voluntary consensus standard IEC 60601-2-18:2009 (9-114), Result: Pass
Test: Packaging, Method: In accordance with FDA-recognized voluntary consensus standard ASTM D4169:2022 (14-576), Result: Pass
Test: Biocompatibility, Method: In accordance with FDA-recognized voluntary consensus standard ISO 10993-1:2018 (2-258), Result: Pass
Test: Biocompatibility, Method: In accordance with FDA-recognized voluntary consensus standard ISO 10993-5:2009 (2-245), Result: Pass
Test: Biocompatibility, Method: In accordance with FDA-recognized voluntary consensus standard ISO 10993-10:2021 (2-296), Result: Pass
Test: Biocompatibility, Method: In accordance with FDA-recognized voluntary consensus standard ISO 10993-23:2021 (2-291), Result: Pass
Test: Cleaning, Disinfection & Sterilization (Reprocessing), Method: In accordance with AAMI TIR12:2020, Result: Pass
Test: Cleaning, Disinfection & Sterilization (Reprocessing), Method: In accordance with FDA-recognized voluntary consensus standard ANSI AAMI ST98:2022 (14-583), Result: Pass
Test: Cleaning, Disinfection & Sterilization (Reprocessing), Method: In accordance with ISO 15883-1:2009, Result: Pass
Test: Cleaning, Disinfection & Sterilization (Reprocessing), Method: In accordance with FDA-recognized voluntary consensus standard ANSI AAMI ST79:2017 + A1:2020, A2:2020, A3:2020, A4:2020 (14-562), Result: Pass
Test: Cleaning, Disinfection & Sterilization (Reprocessing), Method: In accordance with FDA-recognized voluntary consensus standard ANSI AAMI ST58:2013/(R)2018 (14-432), Result: Pass
Test: Cleaning, Disinfection & Sterilization (Reprocessing), Method: In accordance with FDA-recognized voluntary consensus standard ISO 17664-1:2021 (14-578), Result: Pass
Test: Cleaning, Disinfection & Sterilization (Reprocessing), Method: In accordance with FDA-recognized voluntary consensus standard ISO 17664-2:2021 (14-579), Result: Pass
Test: Cleaning, Disinfection & Sterilization (Reprocessing), Method: In accordance with FDA-recognized voluntary consensus standard ISO 17665-1:2006 (14-333), Result: Pass
Test: Cleaning, Disinfection & Sterilization (Reprocessing), Method: In accordance with FDA-recognized voluntary consensus standard ISO 14937:2009 (14-337), Result: Pass
Test: Performance – Bench, Method: Comparative testing to currently legally marketed predicate device: - Optical verification - Contrast, Result: Pass
Test: Performance – Bench, Method: In accordance with FDA-recognized voluntary consensus standard ISO 8600-1:2015 (9-110), Result: Pass
Test: Performance – Bench, Method: Hardware compatibility testing, Result: Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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February 12, 2024
Stryker Endoscopy Michelle Ross Staff Specialist, Regulatory Affairs 5900 Optical Court San Jose, California 95138
Re: K233635 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 Received: January 29, 2024
Dear Michelle Ross:
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).
1
Your device is also subject to, among other requirements, the Quality System (OS) 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). 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-device-advice-comprehensive-regulatoryassistance/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
2
Indications for Use
510(k) Number (if known) K233635
Device Name SPY Cystoscope/Hysteroscope
Indications for Use (Describe)
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.
| 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)
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3
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510(k) Summary
This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 C.F.R Part 807.92(c)
Submitter:
| Applicant | Stryker Endoscopy
5900 Optical Court
San Jose, CA 95138 |
|----------------|--------------------------------------------------------------------------------------------------------------------|
| Contact Person | Michelle Ross
Staff Regulatory Affairs Specialist
Phone: (408) 677-6491
Email: michelle.ross1@stryker.com |
| Date Prepared | February 7, 2024 |
Subject Device:
| Name of Device | SPY Cystoscopes/Hysteroscopes |
|---|---|
| Common or Usual Name | Hysteroscope and Cystoscope |
| Classification Name | Hysteroscope (and accessories) (21 C.F.R. 884.1690) |
| Regulatory Class | Class II |
| Product Code | HIH |
| Subsequent Product Code: | FAJ |
| NWB |
Predicate Device:
| Predicate Device | Ideal Eyes Autoclavable Cystoscopes and Hysteroscopes | K040390 |
|---|---|---|
| Reference Device | Stryker AIM HD Autoclavable Laparoscope | K210088 |
NOTE: The predicate and reference devices have not been subject to a design-related recall.
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.
Indications for 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.
4
| Feature | Subject Device | Predicate Device |
|---|---|---|
| SPY Cystoscopes/ Hysteroscopes | ||
| (Current Submission) | Ideal Eyes Autoclavable | |
| Cystoscopes and Hysteroscopes | ||
| (K040390) | ||
| Manufacturer | Stryker Endoscopy | Same as subject device |
| Intended Use | Endoscopic illumination and imaging | |
| during endoscopic procedures. | Same as subject device | |
| Indications for Use Statement | 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. | The Stryker Urology and Gynecology | |
| Hardware System is intended to | ||
| provide the user with the means for | ||
| endoscopic diagnostic and therapeutic | ||
| surgical procedures. Examples of use of | ||
| the product include the visualization | ||
| and manipulation of anatomy, ablation, | ||
| biopsy, incision, and resection of tissue, | ||
| and/or as the surgeon deems | ||
| appropriate. The system is intended for | ||
| use in general urological and | ||
| gynecological surgery through the | ||
| minimally invasive approach, by | ||
| utilizing natural orifices to access the | ||
| surgical site. They are intended for use | ||
| in, but not limited to, the following | ||
| types of procedures: | ||
| · Dilation of the urethra, and cold- | ||
| slitting of urethral strictures. | ||
| • Trans-urethral incision and resection | ||
| of the prostate | ||
| • Trans-urethral removal of bladder | ||
| tumors | ||
| • Trans-cervical resection and ablation | ||
| of the endometrium | ||
| · Trans-cervical resection of fibroids | ||
| Image Transmission | Rigid rod lenses | Same as subject device |
| Outer diameter | 4.0mm | 2.7-4.0mm |
| Working Length | 290-300mm | 240-300mm |
| DOV | 0°, 12°, 30°, 70° | 0°-120° |
| FOV | 65°-75° | 60°-90° |
| Working Channel | No | Same as subject device |
| Locking Mechanism | Speed-Lock (with optional O-Adapter), | |
| Karl Storz (KS)-compatible | Speed-Lock | |
| Patient-Contacting Materials | Stainless Steel, Epoxy, Optical Glass, | |
| Glass Fibers | Stainless Steel, Epoxy, glass fiber, | |
| optical glass, German Silver | ||
| Single Use or Reusable | Reusable | Same as subject device |
| Cleaning | Manual and Automated | Same as subject device |
| Disinfection | Automated | Same as subject device |
| Feature | Subject Device | Predicate Device |
| SPY Cystoscopes/ Hysteroscopes | ||
| (Current Submission) | Ideal Eyes Autoclavable | |
| Cystoscopes and Hysteroscopes | ||
| (K040390) | ||
| Sterilization | ||
| Methods | Autoclave, Hydrogen Peroxide (Steris, | |
| Sterrad) | Autoclave, Hydrogen Peroxide (Steris, | |
| Sterrad), Ethylene Oxide (EO) | ||
| Sterility Assurance Level | 10-6 | 10-6 |
Comparison of Technological Characteristics with the Predicate Device:
5
The subject and predicate devices have the same intended use to provide visualization during gynecological and urological surgery. The predicate device included urology and gynecology hardware in addition to cystoscopes and hysteroscopes; therefore, only a subset of the predicate device indications for use are applicable to the subject device. The differences in technological characteristics between the subject and predicate devices do not raise different questions of safety or effectiveness and can be evaluated through performance testing.
Performance Testing:
The following performance data were provided in support of the substantial equivalence determination.
| Test | Method | Result |
|---|---|---|
| Electrical Safety | In accordance with FDA-recognized voluntary consensus | |
| standard IEC 60601-1:2020 (19-49) | Pass | |
| In accordance with FDA-recognized voluntary consensus | ||
| standard IEC 60601-2-18:2009 (9-114) | Pass | |
| Packaging | In accordance with FDA-recognized voluntary consensus | |
| standard ASTM D4169:2022 (14-576) | Pass | |
| Biocompatibility | In accordance with FDA-recognized voluntary consensus | |
| standard ISO 10993-1:2018 (2-258) | Pass | |
| In accordance with FDA-recognized voluntary consensus | ||
| standard ISO 10993-5:2009 (2-245) | Pass | |
| In accordance with FDA-recognized voluntary consensus | ||
| standard ISO 10993-10:2021 (2-296) | Pass | |
| In accordance with FDA-recognized voluntary consensus | ||
| standard ISO 10993-23:2021 (2-291) | Pass | |
| Cleaning, | ||
| Disinfection & | ||
| Sterilization | ||
| (Reprocessing) | In accordance with AAMI TIR12:2020 | Pass |
| In accordance with FDA-recognized voluntary consensus | ||
| standard ANSI AAMI ST98:2022 (14-583) | Pass | |
| In accordance with ISO 15883-1:2009 | Pass | |
| In accordance with FDA-recognized voluntary consensus | ||
| standard ANSI AAMI ST79:2017 + A1:2020, A2:2020, A3:2020, | ||
| A4:2020 (14-562) | Pass | |
| In accordance with FDA-recognized voluntary consensus | ||
| standard ANSI AAMI ST58:2013/(R)2018 (14-432) | Pass | |
| In accordance with FDA-recognized voluntary consensus | ||
| standard ISO 17664-1:2021 (14-578) | Pass |
6
| Test | Method | Result |
|---|---|---|
| In accordance with FDA-recognized voluntary consensus | ||
| standard ISO 17664-2:2021 (14-579) | Pass | |
| In accordance with FDA-recognized voluntary consensus | ||
| standard ISO 17665-1:2006 (14-333) | Pass | |
| In accordance with FDA-recognized voluntary consensus | ||
| standard ISO 14937:2009 (14-337) | Pass | |
| Performance – Bench | Comparative testing to currently legally marketed predicate | |
| device: |
- Optical verification
- Contrast | Pass |
| | In accordance with FDA-recognized voluntary consensus
standard ISO 8600-1:2015 (9-110) | Pass |
| | Hardware compatibility testing | Pass |
Conclusions:
The SPY Cystoscope/Hysteroscope is similar in design, intended use, principles of operation, technological characteristics and safety features to the predicate device. The results of nonclinical performance testing demonstrate that the SPY Cystoscope/Hysteroscope is as safe and effective as the legally marketed predicate device to support a substantial equivalence determination.