← Product Code [HIH](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIH) · K040390 # STRYKER UROLOGY AND GYNECOLOGY HARDWARE SYSTEM (K040390) _Stryker Endoscopy · HIH · May 17, 2004 · Obstetrics/Gynecology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIH/K040390 ## Device Facts - **Applicant:** Stryker Endoscopy - **Product Code:** [HIH](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIH.md) - **Decision Date:** May 17, 2004 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 884.1690 - **Device Class:** Class 2 - **Review Panel:** Obstetrics/Gynecology - **Attributes:** Therapeutic ## Indications for Use 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. The system's use is intended for, 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 ## Device Story System comprises endoscopes, sheaths, electrodes, and surgical accessories for minimally invasive urological and gynecological procedures. Device provides visualization and manipulation of anatomy; enables ablation, biopsy, incision, and resection of tissue. Operated by surgeons in clinical settings via natural orifices. System facilitates procedures including urethral dilation, prostate resection, bladder tumor removal, and endometrial/fibroid resection. Output is direct visualization and mechanical/electrosurgical tissue interaction. Benefits include minimally invasive access to surgical sites. ## Clinical Evidence No clinical data. Substantial equivalence based on bench testing and adherence to voluntary safety and performance standards including IEC 60601-1, IEC 60601-2-2, IEC 60601-2-18, ANSI/AAMI HF-18, and ISO 10993. ## Technological Characteristics System includes endoscopes, sheaths, electrodes, and mechanical accessories. Materials evaluated per ISO 10993. Electrosurgical components comply with ANSI/AAMI HF-18. Electrical safety per IEC 60601-1, 60601-2-2, and 60601-2-18. Connectivity: None (mechanical/optical/electrosurgical). ## Regulatory 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. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Stryker Endoscopy Mr. Christopher L. Cook Quality Engineer 5900 Optical Court San Jose, CA 95138 JUL 27 2015 Re: K040390 Trade/Device Name: Stryker Urology and Gynecology Hardware System Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH, FAJ, FAS and KQT Dated (Date on orig SE ltr): February 10, 2004 Received (Date on orig SE ltr): February 17, 2004 Dear Mr. Cook, This letter corrects our substantially equivalent letter of May 17, 2004. 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 (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. 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 {1} 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*. 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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH’s Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Benjamin R. Fisher -S Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2} Device Name: Stryker Urology and Gynecology Hardware System Indications for Use: 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. The system's use is intended for, 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 (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use ☑ (Per 21 CFR 801.109) Over-The-Counter-Use ☐ (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number K040390 Stryker Urology and Gynecology Hardware System 510(k) submission 3 of 15 {3} MAY 17 2004 K040390 Page 1 of 2 # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ## Device Name Proprietary Name: Stryker Urology and Gynecology Hardware System Common and Usual Name: Scope, Obturator, Working Element, Sheath, Bridge, Electrode, Albarran Deflector, Timberlake Obturator, Cutting Loop, Roller Ball, Cold Knives, Dilator/Sound/Bougie, Bladder Syringe, Ellik Evacuator, Forceps Classification Name: Endoscope and accessories, Cystoscopes, Hysteroscope, Resectoscope, Sheaths, Electrode, Urethrotome, Dilators, Evacuator, Non-Electric Biopsy Forceps, G-U, Surgical Instruments The Stryker Urology and Gynecology Hardware System is substantially equivalent in terms of safety and effectiveness to many currently marketed devices and surgery systems currently marketed by Henke Sass Wolf, Omnitech Systems, GIMMI, and ACMI. The Stryker Urology and Gynecology Hardware System is an extension of the Hystero-Resectoscope and Accessories as currently marketed by Stryker and OEM suppliers Henke Sass Wolf and Omnitech Systems. The Stryker Urology and Gynecology Hardware System is composed of endoscopes, sheaths, accessories, and applied parts which provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. 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. The system's use is intended for, 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 ## Contraindications: - Acute Pelvic Inflammatory Disorder (PID) Hysteroscopy may be contraindicated by the following conditions, depending on their severity or extent: - Inability to distend the uterus - Cervical stenosis - Cervical/vaginal infection - Uterine bleeding or menses - Known pregnancy - Invasive carcinoma of the cervix - Recent uterine perforation The Stryker Urology and Gynecology Hardware System conforms to the following voluntary safety and performance standards: IEC 60601-1 Medical Electrical Equipment – General Requirements for Safety, IEC 60601-2-2 Medical Electrical Equipment – General Requirements for Safety, Collateral Standard, Electromagnetic Compatibility, IEC 60601-2-18 Particular Requirements for the Safety of Endoscopic Equipment, ANSI/AAMI HF-18 Electrosurgical Devices, ISO 10993 Biological Evaluation of Medical Devices. {4} K'04039c Page 242 There are no significant technological or performance differences between the Stryker Urology and Gynecology Hardware System and the identified predicate devices and surgery systems, nor are there any new questions raised regarding safety or effectiveness, therefore, the Stryker Urology and Gynecology Hardware System is substantially equivalent to the identified predicate devices and surgery systems. Contact: Christopher L. Cook Date: Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 Phone: 408-754-2288 Fax: 408-754-2521 Email: chris.cook@stryker.com --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIH/K040390](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIH/K040390) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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