Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. November 18, 2019 Reed Medical (Zhejiang) Co., Ltd. % Daniel Qiu Project Manager Shanghai Qisheng Business Consulting Co., Ltd. Room 1301, Bld 46, Jing Gu Zhong Rd. No. 58, Min Hang District, Shanghai, CN Shanghai, Shanghai 200240 CHINA Re: K190797 Trade/Device Name: Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01) Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope And Accessories Regulatory Class: II Product Code: HIH Dated: October 15, 2019 Received: October 15, 2019 Dear Daniel Oiu: 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. 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 located 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. 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Sincerely, for Sharon Andrews 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) K190797 Device Name Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01) Indications for Use (Describe) The Reedgyn disposable hysteroscope RH-2D-01 is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures in an outpatient or office setting. Generally recognized indications for diagnostic hysteroscopy include: abnormal bleeding, infertility and pregnancy wastage, evaluation of abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea, and pelvic pain. The Reedgyn disposable hysteroscope RH-2S-01 is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures and to obtain an endometrial tissue sample (biopsy) in an outpatient or office setting. The sample is used for cytologic and histologic diagnosis. Generally recogmized indications for diagnostic hysteroscopy include: abnormal bleeding, infertility and pregnancy wastage, evaluation of abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea, and pelvic pain. | 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary ### l. Submitter's information Name: Reed Medical (Zhejiang) Co., Ltd. Address: 8th floor, 10th building, No.988 of Xinxing two road, EDZ of Pinghu, Pinghu, Zhejiang, China Contact person: Lu Zhong Zhong Telephone: +86-573-85135876 Fax: +86-573-85135876 Date prepared: November 17, 2019 ## II.Device Device trade name: Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01) Classification name: Hysteroscope and Accessories Regulation class: II Regulation number: 21CFR 884.1690 Panel: Obstetrics/Gynecology Product code: HIH # III.Predicative device K132384, U-scope 8000 System With Hsc+emb Cannula. #### IV.Device description The Reedgyn disposable hysteroscopes, which include models RH-2S-01 and RH-2D-01, are used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures (both RH-2S-01 and RH-2D-01) and to obtain an endometrial tissue sample (biopsy) in an outpatient or office setting (RH-2S-01 only). RH-2S-01 and RH-2D-01 are similar in design. The only difference between RH-2S-01 and RH-2D-01 is: RH-2S-01 is intended for performing diagnostic procedures and obtaining an endometrial tissue sample (biopsy), while the RH-2D-01 is intended for performing diagnostic procedures only. Key performance specifications and device characteristics are listed in the table below. {4}------------------------------------------------ The Reedgyn disposable hysteroscopes consist of a lightweight handle, a cannula integrated with a camera and a light source at the distal end to illuminate the area for visualizing images. The distal end of the cannula is equipped with a camera module including a camera and LED lightling. LED irradiates the surface of the object, and the reflected light enters the image processor through a lens and converts it into electrical signals, and then converted into a digital image signal , which is transmitted to the digital signal processing chip. After chip processing, the signal is transmitted to PC through USB interface. The Reedgyn disposable hysteroscopes should be operated together with Reedgyn hysteroscope imaging software which was installed to a Microsoft Windows PC station. (Note: the Windows PC station is not included in the product configuration.) | Parameter | Specification | |-------------------|---------------------------------------------------------------------------------------------------------------------------| | Cannula length | 270mm | | Outer diameter | RH-2D-01: 4.9mm<br>RH-2S-01: 7.8mm | | Inner diameter | RH-2D-01:<br>-Fluid channel (In & out): 1.3mm<br>RH-2S-01:<br>-Fluid channel (In & out): 1.2mm<br>-Accessory channel: 2mm | | Handle width | 28 mm | | Handle height | 25 mm | | Direction of view | 20° ± 5° | | Field of view | 100° ± 5° | | Number of pixels | 1280 x 720 | | Depth of field | 5-50mm | | Light Source | LED | The Reedgyn disposable hysteroscope is provided sterilea sealed pouch. It is for single use. The Reedgyn disposable hysteroscope operates on 5V DC working voltage. The general type of materials in the device are РЕВАХ® thermoplastic elastomers {5}------------------------------------------------ (Cannula) and polycarbonate (Connector). The The Reedgyn disposable hysteroscope components are part of an external communicating device (Tissue/bone/dentin) in direct tissue contact for a duration ≤24 hours. . The biocompatibility of the Reedgyn disposable hysteroscope was established via testing of the final, finished product (see performance testing section below). The Reedgyn disposable hysteroscopes are intended to be used in hospitals and physician offices. ## V.Indication for use The Reedgyn disposable hysteroscope RH-2D-01 is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures in an outpatient or office setting. Generally recognized indications for diagnostic hysteroscopy include: abnormal bleeding, infertility and pregnancy wastage, evaluation of abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea, and pelvic pain. The Reedgyn disposable hysteroscope RH-2S-01 is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures and to obtain an endometrial tissue sample (biopsy) in an outpatient or office setting. The sample is used for cytologic and histologic diagnosis. Generally recognized indications for diagnostic hysteroscopy include: abnormal bleeding, infertility and pregnancy wastage, evaluation of abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea, and pelvic pain. The indications for use of Reedgyn disposable hysteroscopes are similar to that of predicate device. The indications for the RH-2D-01 falls within the indications of the predicate, but does not include biopsy. | Attribute | Subject device | Predicative device<br>U-Scope 8000 Hsc+emb<br>Cannula | |----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) number | K190797 | K132384 | | Indication for use | The Reedgyn disposable hysteroscope RH-2D-01 is<br>used to permit viewing of the cervical canal and<br>uterine cavity for the purpose of performing<br>diagnostic procedures in an outpatient or office<br>setting. Generally recognized indications for<br>diagnostic hysteroscopy include: abnormal<br>bleeding, infertility and pregnancy wastage, | The predicative device is used<br>to permit viewing of the<br>cervical canal and uterine<br>cavity for the purpose of<br>performing diagnostic<br>procedures and to obtain an<br>endometrial tissue sample | | Attribute | Subject device | Predicative device<br>U-Scope 8000 Hsc+emb<br>Cannula | | | evaluation of abnormal hysterosalpingogram,<br>intrauterine foreign body, amenorrhea, and pelvic<br>pain. | (biopsy) in an outpatient or<br>office setting. The sample is<br>used for cytologic and<br>histologic diagnosis. Generally<br>recognized indications for<br>diagnostic hysteroscopy<br>include: abnormal bleeding,<br>infertility and pregnancy<br>wastage, evaluation of abnormal<br>hysterosalpingogram,<br>intrauterine foreign body,<br>amenorrhea, and pelvic pain. | | | The Reedgyn disposable hysteroscope RH-2S-01 is<br>used to permit viewing of the cervical canal and<br>uterine cavity for the purpose of performing<br>diagnostic procedures and to obtain an<br>endometrial tissue sample (biopsy) in an<br>outpatient or office setting. The sample is used for<br>cytologic and histologic diagnosis. Generally<br>recognized indications for diagnostic hysteroscopy<br>include: abnormal bleeding, infertility and<br>pregnancy wastage, evaluation of abnormal<br>hysterosalpingogram, intrauterine foreign body,<br>amenorrhea, and pelvic pain. | diagnostic hysteroscopy<br>include: abnormal bleeding,<br>infertility and pregnancy<br>wastage, evaluation of abnormal<br>hysterosalpingogram,<br>intrauterine foreign body,<br>amenorrhea, and pelvic pain. | | Procedures | Uterine diagnostic for RH-2D-01, Uterine<br>diagnostic and endometrial biopsy for RH-2S-01 | Uterine diagnostic and<br>endometrial biopsy | | Environment of use | Hospitals and physician offices | Hospitals and physician offices | | Intended user | Physicians with adequate training in hysteroscopy | For use only by physicians<br>with adequate training in<br>hysteroscopy. | | Device features:<br>-Components | CMOS camera semi-rigid cannula USB interface electronics USB cable | Image-capturing hand tower; attachable cannula with outflow and inflow ports<br>in which suction can be created and with a curette<br>near its tip. | | -Cannula outer<br>diameter | RH-2S-01: 7.8 mm<br>RH-2D-01: 4.9 mm | 4.3mm | | -Accessory channel | RH-2D-01: N/A<br>RH-2S-01: 2mm | N/A | | -Cannula | Flexible | Flexible | | Attribute | Subject device | Predicative device<br>U-Scope 8000 Hsc+emb<br>Cannula | | -Cannula length | 270mm | 276mm | | -Illumination light<br>source | LEDs | LEDs | | -Hysteroscope field<br>of view | $100° ±5°$ | $100° ±5°$ | | -Hysteroscope<br>direction of view | $20° ±5°$ | $20° ±3°$ | | -Depth of field | 5-50mm | 4-45mm | | -Imaging<br>transmission | Over USB interface to a viewing station | Image transmitted from a<br>video camera to a video<br>monitor on the handle | | -Number of pixels | 1280 x 720 | 400*400 | | -Optical image | Digital CMOS | Digital CMOS technology | | Disposable/Reusable | Disposable/ only single usage | Reusable handle and a sterile<br>disposable diagnostic cannula | | Battery charge<br>indication | n/a - no battery | Charge indication as an icon on<br>the LCD monitor | | Battery<br>power | n/a - no battery | 3.7V | | Adjust<br>brightness of LEDs | n/a - brightness is managed by camera exposure<br>and gain | Adjust by depressing a button<br>on the hand tower | | Capture still or video<br>images during<br>procedure | Controlled by keyboard and foot switch interfaces | Capture still or video during<br>procedure by depressing a<br>camera button on the hand<br>tower | | Enter<br>patient ID<br>information prior to<br>procedure | User interface allows physician to add patient<br>information | User interface on monitor<br>allows physician to add patient<br>information. | | Duration<br>of use | $≤$ 2 hours | $≤$ 24 hours | | Sterilization | Entire product is sterile following exposure to<br>ethylene oxide (EO). | Hand tower is not sterile. The<br>U-scope 8000 HSC+EMB<br>cannula is sterile following<br>exposure to ethylene<br>oxide(EO). | | Frequency of use | Disposable for a single usage | Hand tower is reusable. The | | Attribute | Subject device | Predicative device | | | | U-Scope 8000 Hsc+emb<br>Cannula | | | | U-scope 8000 HSC+EMB<br>cannula is single patient use. | | Tissue contact<br>material | Compliant with ISO 10993 | Compliant with ISO 10993 | # VI. Comparison of Technological Characteristics {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ The subjective device and predicative device have the same intended use. The subject and predicative device have different technological characteristics as evidenced by the table above. The differences in technological characteristics do not raise different questions of safety or effectiveness. # VII.Summary of non-clinical testing The following performance data were provided to verify that the subject device met all design specifications. The results demonstrated that the subject device is as safe and effective as the predicate device.. - Risk Analysis developed in accordance with ISO 14971:2007. - Electrical Safety Testing in accordance with IEC 60601-1:2005 (3rd Edition). - The subject device was demonstrated to meet applicable sections of the standard. - . Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2014. - The subject device was demonstrated to be electromagnetically compatible । in its intended environment of use. - . Medical electrical equipment - Part 2-18: "Particular requirements for the basic essential performance of of endoscopic safety and a equipment" (IEC60601-2-18:2009). - -The subject device met the requirements of the standard. - . Biocompatibility Tests in accordance with ISO 10993, including cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2010),irritation (ISO 10993-10:2010) and acute systemic toxicity (ISO 10993-11:2017). - i The subject device was demonstrated to be non-cytotoxic, non-irritating, non-sensitizing, and not acutely toxic. - Software Validation - Software Life Cycle Processes in accordance with IEC 62304:2015, and Guidance for Industry and FDA staff-Guidance for the content of premarket submissions for software contained in medical devices.Document issued on:May 11,2005. - -The software of the subject device was demonstrated to function as intended per specification. - Endoscopes-medical endoscopes and endotherapy devices-Part 1:General requirements-(ISO 8600-1:2015). - The subject device was demonstrated to meet the requirements of the । {9}------------------------------------------------ standard. - Optics and optical instruments - Medical endoscopes and endoscopic accessories —Part 3: Determination of field of view and direction of view of endoscopes with optics AMENDMENT 1.(ISO 8600-3:2003). - The subject device was demonstrated to meet the requirements of the । standard. - Endoscopes — Medical endoscopes and endotherapy devices —Part 4: Determination of maximum width of insertion portion.(ISO 8600-4:2014). - The subject device was demonstrated to meet the requirements of the standard. - Optics and photonics - Medical endoscopes and endotherapy devices -Part 5:Determination of optical resolution of rigid endoscopes with optics.(ISO 8600-5:2005). - । The subject device was demonstrated to meet the requirements of the standard. Due to its labeling as sterile, the Reedgyn disposable hysteroscope underwent sterilization validation and shelf life testing to confirm the label shelf life and was found in compliance with the following: - Sterilization of health-care products - Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices. (ISO 11135:2014). - . Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems. (ISO 11607-1:2006). - . Standard guide for accelerated aging of sterile barrier systems for medical devices (ASTM F1980-16). - . Sterilization of medical devices-Microbiological methods-Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process(ISO 11737-2:2009). - Standard test method for determination of leaks in flexible packaging by bubble emission(ASTM D3078-02(2013)). - . Standard test method for detecting seal leaks in porous medical packaging by dye penetration(ASTM F1929-15). - . Sterilization-sterile supply -Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized(DIN 58953-6:2016). - . Standard test method for seal strength of flexible barrier materials(ASTM F88/F88M-15). {10}------------------------------------------------ Results from testing demonstrate assurancethe device is sterile and remains sterile throughout the proposed shelf life. ### VIII.Conclusion The Reedgyn disposable hysteroscopes have similar indications to that of the predicate. The RH-2D-01 indications fall within those of the predicate, and the difference does not alter the intended use. The technological differences between Reedgyn disposable hysteroscopes and the predicate device do not raise different questions of safety and effectiveness. Performance testing as described above has demonstrated that the subject device is as safe and effective as the predicate device. Therefore, the subject device is substantially equivalent to the predicate device.