(91 days)
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 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.
The provided text describes a 510(k) premarket notification for the Stryker Endoscopy SPY Cystoscope/Hysteroscope. It focuses on demonstrating substantial equivalence to a predicate device, rather than a standalone study proving specific clinical performance metrics with a test set, ground truth, or human reader involvement for an AI/ML device.
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device with details like sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable to this document.
This document details:
- Device Type: A traditional medical device (optical instrument for visualization in surgery), not explicitly an AI/ML powered device.
- Regulatory Pathway: 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to an existing legally marketed predicate device.
- Performance Testing: Primarily non-clinical bench testing and compliance with recognized voluntary consensus standards.
Here's a breakdown of what is provided, framed as closely as possible to your request, but highlighting the absence of AI/ML specific criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various performance tests and their "Pass" results, indicating that the device met the criteria set by the respective standards or comparative testing. The acceptance criteria themselves are implicitly defined by compliance with these standards (e.g., "In accordance with FDA-recognized voluntary consensus standard IEC 60601-1:2020").
| Test Category | Specific Test / Standard | Acceptance Criteria (Implicit from Standard Compliance) | Reported Device Performance |
|---|---|---|---|
| Electrical Safety | IEC 60601-1:2020 (19-49) | Compliance with standard | Pass |
| IEC 60601-2-18:2009 (9-114) | Compliance with standard | Pass | |
| Packaging | ASTM D4169:2022 (14-576) | Compliance with standard | Pass |
| Biocompatibility | ISO 10993-1:2018 (2-258) | Compliance with standard | Pass |
| ISO 10993-5:2009 (2-245) | Compliance with standard | Pass | |
| ISO 10993-10:2021 (2-296) | Compliance with standard | Pass | |
| ISO 10993-23:2021 (2-291) | Compliance with standard | Pass | |
| Cleaning, Disinfection & Sterilization (Reprocessing) | AAMI TIR12:2020 | Compliance with standard | Pass |
| ANSI AAMI ST98:2022 (14-583) | Compliance with standard | Pass | |
| ISO 15883-1:2009 | Compliance with standard | Pass | |
| ANSI AAMI ST79:2017 + A1:2020, A2:2020, A3:2020, A4:2020 (14-562) | Compliance with standard | Pass | |
| ANSI AAMI ST58:2013/(R)2018 (14-432) | Compliance with standard | Pass | |
| ISO 17664-1:2021 (14-578) | Compliance with standard | Pass | |
| ISO 17664-2:2021 (14-579) | Compliance with standard | Pass | |
| ISO 17665-1:2006 (14-333) | Compliance with standard | Pass | |
| ISO 14937:2009 (14-337) | Compliance with standard | Pass | |
| Performance – Bench | Comparative testing to currently legally marketed predicate device: Optical verification, Contrast | Equivalence to predicate device for optical verification and contrast | Pass |
| ISO 8600-1:2015 (9-110) | Compliance with standard | Pass | |
| Hardware compatibility testing | Compatibility with relevant hardware | Pass |
2. Sample size used for the test set and the data provenance: Not applicable. This document describes non-clinical testing of a physical medical device, not a performance study on a test set of data (e.g., images for an AI algorithm).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML algorithm is not relevant to the described testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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. The device is a direct visualization tool, not an AI-assisted diagnostic or interpretative system for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" here is compliance with established engineering and safety standards, and equivalence to a predicate device's performance.
8. The sample size for the training set: Not applicable. The device does not involve a training set as it's not an AI/ML product.
9. How the ground truth for the training set was established: Not applicable.
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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).
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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
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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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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 Endoscopy5900 Optical CourtSan Jose, CA 95138 |
|---|---|
| Contact Person | Michelle RossStaff Regulatory Affairs SpecialistPhone: (408) 677-6491Email: 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: | FAJNWB |
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.
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| Feature | Subject Device | Predicate Device |
|---|---|---|
| SPY Cystoscopes/ Hysteroscopes(Current Submission) | Ideal Eyes AutoclavableCystoscopes and Hysteroscopes(K040390) | |
| Manufacturer | Stryker Endoscopy | Same as subject device |
| Intended Use | Endoscopic illumination and imagingduring endoscopic procedures. | Same as subject device |
| Indications for Use Statement | The SPY Cystoscopes/Hysteroscopes areintended to provide visualization ingeneral urological and gynecologicalsurgery through the minimally invasiveapproach, by utilizing natural orifices toaccess the surgical site. | The Stryker Urology and GynecologyHardware System is intended toprovide the user with the means forendoscopic diagnostic and therapeuticsurgical procedures. Examples of use ofthe product include the visualizationand manipulation of anatomy, ablation,biopsy, incision, and resection of tissue,and/or as the surgeon deemsappropriate. The system is intended foruse in general urological andgynecological surgery through theminimally invasive approach, byutilizing natural orifices to access thesurgical site. They are intended for usein, but not limited to, the followingtypes of procedures:· Dilation of the urethra, and cold-slitting of urethral strictures.• Trans-urethral incision and resectionof the prostate• Trans-urethral removal of bladdertumors• Trans-cervical resection and ablationof 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 AutoclavableCystoscopes and Hysteroscopes(K040390) | |
| SterilizationMethods | 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:
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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 consensusstandard IEC 60601-1:2020 (19-49) | Pass |
| In accordance with FDA-recognized voluntary consensusstandard IEC 60601-2-18:2009 (9-114) | Pass | |
| Packaging | In accordance with FDA-recognized voluntary consensusstandard ASTM D4169:2022 (14-576) | Pass |
| Biocompatibility | In accordance with FDA-recognized voluntary consensusstandard ISO 10993-1:2018 (2-258) | Pass |
| In accordance with FDA-recognized voluntary consensusstandard ISO 10993-5:2009 (2-245) | Pass | |
| In accordance with FDA-recognized voluntary consensusstandard ISO 10993-10:2021 (2-296) | Pass | |
| In accordance with FDA-recognized voluntary consensusstandard ISO 10993-23:2021 (2-291) | Pass | |
| Cleaning,Disinfection &Sterilization(Reprocessing) | In accordance with AAMI TIR12:2020 | Pass |
| In accordance with FDA-recognized voluntary consensusstandard ANSI AAMI ST98:2022 (14-583) | Pass | |
| In accordance with ISO 15883-1:2009 | Pass | |
| In accordance with FDA-recognized voluntary consensusstandard ANSI AAMI ST79:2017 + A1:2020, A2:2020, A3:2020,A4:2020 (14-562) | Pass | |
| In accordance with FDA-recognized voluntary consensusstandard ANSI AAMI ST58:2013/(R)2018 (14-432) | Pass | |
| In accordance with FDA-recognized voluntary consensusstandard ISO 17664-1:2021 (14-578) | Pass |
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| Test | Method | Result |
|---|---|---|
| In accordance with FDA-recognized voluntary consensusstandard ISO 17664-2:2021 (14-579) | Pass | |
| In accordance with FDA-recognized voluntary consensusstandard ISO 17665-1:2006 (14-333) | Pass | |
| In accordance with FDA-recognized voluntary consensusstandard ISO 14937:2009 (14-337) | Pass | |
| Performance – Bench | Comparative testing to currently legally marketed predicatedevice:- Optical verification- Contrast | Pass |
| In accordance with FDA-recognized voluntary consensusstandard 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.
§ 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.