HTx Disposable Hysteroscope System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom. March 5, 2024 Suzhou AcuVu Medical Technology Co., Ltd. Sam Mostafavi Regulatory Affairs B1-212, Bio-Nano Park, 218 Xinghu Street, Suzhou Industrial Park Suzhou, Jiangsu 215125 CHINA Re: K231260 > Trade/Device Name: HTx Disposable Hysteroscope System Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH Received: January 30, 2024 Dear Sam Mostafavi: 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" {1}------------------------------------------------ (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). 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 OS 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 medical devices and radiation-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 {2}------------------------------------------------ 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, # Reginald K. Avery -S for Jason 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 {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K231260 Device Name HTx Disposable Hysteroscope System #### Indications for Use (Describe) HTx Disposable Hysteroscope System is intended to be used for viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures. Note: Hysteroscopes are used as tools for access to the uterine cavity and are not, in and of themselves a method of surgery. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------| | <span style="font-size:120%">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:120%">☐</span> 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." {4}------------------------------------------------ # 510(k) Summary This summary of 510(k) is submitted in accordance with the requirements of 21 CFR 807.92. #### 1. Submitter Information: | Manufacturer: | Suzhou AcuVu Medical Technology Co., Ltd. | |-----------------|---------------------------------------------------------------------------| | | B1-212, Bio-Nano Park, 218 Xinghu Street, Suzhou Industrial Park, Suzhou, | | | Jiangsu, China 215125 | | Contact Person: | Sam Mostafavi | | | Email: ipcs11@ymail.com | | | Office Number: 650-670-6972 | | | Facsimile Number: 650-578-9653 | | Date Prepared: | March 1, 2024 | #### 2. Device Information: | Trade/Device Name: | HTx Disposable Hysteroscope System | |--------------------|--------------------------------------| | Common Name: | Hysteroscope | | Model: | HTx1000 and HTx2000 | | Regulation Number: | 21 CFR § 884.1690 | | Regulation Name: | Hysteroscope and accessories | | Regulatory Class: | Class II | | Product Code: | HIH (Hysteroscope (And Accessories)) | | Panel: | Obstetrics/Gynecology | #### 3. Predicate Device: HTx Disposable Hysteroscope System (K211227). This predicate device has not been subject to a designrelated or safety recall. #### 4. Device Description The HTx Disposable Hysteroscope System is a single use hysteroscope endoscope intended for gynecology procedure applications. It includes a single-use, disposable hysteroscope cannula (HTx40 or HTx60), a reusable imaging system (HTx1000/Htx2000), and optional accessories (medical keyboard, barcode reader and IV pole mounting rack). {5}------------------------------------------------ Image /page/5/Picture/1 description: This image shows a white medical device with a long, thin probe extending from the top. The device has a handle with a button on it, and a blue, flower-shaped attachment at the top. The device is likely used for medical procedures, such as biopsies or tissue sampling. The background is a plain gray color. (a) HTx40/HTx60 hysteroscope Image /page/5/Picture/3 description: The image shows an HTx1000 image processor. The processor is white and light blue. The image processor has a variety of buttons and knobs on the front. Image /page/5/Picture/4 description: The image shows a tablet device with a stand. The tablet has a gray screen and a white frame. The stand is attached to the back of the tablet and allows it to be propped up on a flat surface. There are also ports on the side of the tablet. (c) HTx2000 image processor Figure 1: HTx Disposable Hysteroscope System The disposable hysteroscopes (HTx40 or HTx60) were cleared under K211227. The disposable hysteroscope contains a miniature CMOS camera, a light-emitting diode (LED) illumination module, and channels for fluid in/out flow as well as for instrument insertion. HTx60 has a cannula outer diameter of 6.2 mm and adapts to tools up to 3 mm (9 Fr), while HTx40 has an outer diameter of 4.5 mm and adapts to tools up to 5 Fr. The cannula connects directly to the image processor via an image cable. The image processor processes the raw image signal from the cannula and outputs the video on a display for real-time visualization. The image processor includes input/output ports for interfacing with different peripherals such as a keyboard or a USB flash disk. Fluid irrigation is achieved through a tube which is connected to an IV bag and pressured via peristaltic pump (not included in the subject device). The fluid inflow channel shares the same with the working channel. AcuVu has designed a new image processor HTx2000 as an alternative to the existing HTx1000 cleared under K211227 and modified HTx1000 since the clearance under K211227. #### Changes made to the subject device compared to the predicate device are as follows: - A new image processor, HTx2000, is added to the system as an alternative option to the existing ● HTx1000. - Portable O O - an external monitor is optional for display O - I HDMI port is available for an optional external monitor (2x DVI for HTx1000) - A new power source (Li-ion battery) is available in addition to an AC adapter. - Touch screen (no keyboard is needed) O - Input interface: to connect the hysteroscope image cable and receive raw signal input, a 38-pin gold O finger design (a 14-pin aviation socket for HTx2000) - LAN port is disabled O - Software is revised for HTx2000 to incorporate the changes, O - Polycarbonate/acrylonitrile, butadiene, styrene (PC/ABS) plastic housing material O - Design changes of HTx1000 since K211227 clearance . - Magnetic ring: removed O - Cable connector: a new connector of the hysteroscope and cable has been redesigned O - Power cord: the power cord is changed O - Power adapter: a new power adapter has been changed O - ISP board: the image signal processor (ISP) board layout has been redesigned O - An optional mounting rack is added as a new accessory for attaching the HTx2000 onto a metical o IV pole. - Package and device labels are revised O The HTx2000 is a portable version of the HTx1000 in that it comes with a built-in touch screen, eliminating the necessity of attaching a keyboard and an external monitor as user interface for information entry and display. The HTx2000 will not supersede the legally marketed HTx1000, but is an alternative option for users. The HTx1000 will continue to be available as a component of the HTx Disposable Hysteroscope System. The following table provides an overview of all key components of the subject device and explains which are {6}------------------------------------------------ legacy modules inherited from the predicate device and which are newly developed ones. | Component | Model | Manufacturer | Notes | |-------------------------|---------|--------------|-------------------------------------| | Disposable hysteroscope | HTx40 | AcuVu | | | | HTx60 | AcuVu | Inherited from the predicate device | | Image processor | HTx1000 | AcuVu | | | | HTx2000 | AcuVu | New item for submission | | | | | Table 1: List of major components of the subject device | |--|--|--|---------------------------------------------------------| |--|--|--|---------------------------------------------------------| Table 2 below gives a comprehensive comparison between the existing HTx1000 and the newly developed HTx2000. | | HTx1000 | HTx2000 | |----------------------------------------|---------------------------------------|------------------------------------------------| | Appearance | Image: HTx1000 | Image: HTx2000 | | Compatible cannula | HTx40<br>HTx60 | HTx40<br>HTx60 | | Power supply | 100-240V AC | (1) 100-240V AC<br>(2) Lithium battery | | Peripheral interface | USB2.0×3<br>LAN×1 (disabled)<br>DVI×2 | USB2.0×2<br>LAN×1 (disabled)<br>HDMI×1 | | Image display | External monitor | (1) 13.3" touch screen<br>(2) External monitor | | Main board | Model: E611 | Model: E661 | | Operation software | IPC | UterView | | Protection against<br>Electrical shock | Class I | Class I | | Dimension<br>(L×W×H in mm) | 365 × 262 × 144 | 324 × 203 × 46 | | Weight (Kg) | 5.3 | 1.9 | #### Table 2: HTx1000 versus HTx2000 image processor {7}------------------------------------------------ The subject device also offers optional accessories, as summarized in Table 3 below. | Accessory | Model | Manufacturer | Notes | |-----------------------------|------------|--------------|----------------------------------------------------------------------------------| | Keyboard | KSI-U10200 | Gett | Inherited from the predicate device and works with HTx1000 only. | | Patient management software | PIMC | AcuVu | device and works with HTx1000<br>only. | | Barcode scanner | 14952 | Deli | Inherited from the predicate<br>device and works with both<br>HTx1000 & HTx2000. | | IV pole mounting rack | RD1851L20 | AcuVu | Used to mount the HTx2000<br>onto a medical IV pole | | Table 3: List of accessories of the subject device | | |----------------------------------------------------|--| |----------------------------------------------------|--| Note: - The display (Jusha E240A) previously available as an optional accessory of the predicate device has now a) been removed from the accessory list of the subject device. - b) The IV pole mounting rack is a newly developed accessory for mounting the HTx2000 on an IV pole (see the drawings below). Image /page/7/Picture/7 description: The image shows two different views of a monitor mount. The mount consists of a VESA plate, an arm, and a clamp. The clamp is designed to attach to a pole or other cylindrical object and is tightened with a knob. Figure 2: The IV pole mounting rack for HTx2000 ### 5. Indications for Use HTx disposable hysteroscope system is intended to be used for viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures. Note: Hysteroscopes are used as tools for access to the uterine cavity and are not, in and of themselves a method of surgery. {8}------------------------------------------------ ## 6. Comparison of Technological Characteristics Table below includes functional and technological comparison between the subject device and predicate device. | Table 4: Functional and Technology substantial equivalency comparison | | | |-----------------------------------------------------------------------|--|--| | | | | | Feature | Subject Device | Predicate Device | Subject Device Comparison | |----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Suzhou AcuVu Medical Technology<br>Co. Ltd.<br>HTx Disposable Hysteroscope System | Suzhou AcuVu Medical Technology<br>Co. Ltd.<br>HTx Disposable Hysteroscope<br>System (K211227) | | | Classification | Class II | Class II | Same as the predicate device | | Regulation Name | 21 CFR § 884.1690 | 21 CFR § 884.1690 | Same as the predicate device | | Classification Panel | Obstetrics and Gynecology | Obstetrics and Gynecology | Same as the predicate device | | Product code | HIH | HIH | Same as the predicate device | | Indications for use | HTx disposable hysteroscope system is<br>intended to be used for viewing of the<br>cervical canal and uterine cavity for the<br>purpose of performing diagnostic and<br>operative procedures.<br>Note: Hysteroscopes are used as tools<br>for access to the uterine cavity and are<br>not, in and of themselves a method of<br>surgery. | HTx disposable hysteroscope system is<br>intended to be used for viewing of the<br>cervical canal and uterine cavity for the<br>purpose of performing diagnostic and<br>operative procedures. | Same as the predicate device | | Procedures | Viewing of the adult cervical canal and<br>uterine cavity for the purpose of<br>performing diagnostic or operative<br>procedures | Viewing of the adult cervical canal and<br>uterine cavity for the purpose of<br>performing diagnostic or operative<br>procedures | Same as the predicate device | | Environment of use | Hospitals and physician's office | Hospitals and physician's office | Same as the predicate device | | | | | | | Intended users | Trained Medical Professionals | Trained Medical Professionals | Same as the predicate device | | Disposable/ Reusable | Cannula is single use;<br>The image processor and other<br>modules are reusable | Cannula is single use;<br>The image processor and other<br>modules are reusable | Same as the predicate device | | Sterilization | Cannula is provided sterile;<br>The image processor and other<br>modules are provided non-sterile. | Cannula is provided sterile;<br>The image processor and other<br>modules are provided non-sterile. | Same as the predicate device | | Clinical application | Diagnostic and operative hysteroscopy. | Diagnostic and operative hysteroscopy. | Same as the predicate device | | Patient contacting materials<br>(Biocompatibility) | ISO 10993 compliant | ISO 10993 compliant | Same as the predicate device | | Components:<br>- cannula | (1) HTx40 hysteroscope<br>(2) HTx60 hysteroscope | (1) HTx40 hysteroscope<br>(2) HTx60 hysteroscope | Same as the predicate device | | Components:<br>- image processor | HTx1000 image processor<br>HTx2000 image processor | HTx1000 image processor | Different.<br>Subject device offers a second<br>image processor HTx2000, but<br>the difference does not raise<br>different questions of safety and<br>effectiveness for the device. | | Accessories | HTx1000: a barcode scanner or keyboard<br>can be connected through USB interfaces<br>HTx2000: a barcode scanner and an IV<br>pole mounting rack | HTx1000: a barcode scanner or keyboard<br>can be connected through USB interfaces,<br>a medical-grade display (Jusha E240A) | Different. | | AC power supply | 100-240V AC converted to 12V DC by<br>a power adapter | 100-240V AC converted to 12V DC by<br>a power adapter | Same as the predicate device | | Battery-powered mode | Yes (HTx2000) | No | Different.<br>The HTx2000 image processor of<br>the subject device can also be<br>powered by batteries. The<br>difference does not raise different<br>questions of safety and<br>effectiveness for the device. | | Mode of operation | Continuous video | Continuous video | Same as the predicate device | | Cannula outer diameter | 4.5mm-6.2mm | 4.5mm-6.2mm | Same as the predicate device | | Cannula length | Working length: 240 mm<br>Overall length: 330 mm | Working length: 240 mm<br>Overall length: 330 mm | Same as the predicate device | | Field of view and direction of view | FOV: >115°,<br>DOV: 12° (HTx60) and 8° (HTx40) | FOV: >115°,<br>DOV: 12° (HTx60) and 8° (HTx40) | Same as the predicate device | | Light source | LEDs at cannula tip | LEDs at cannula tip | Same as the predicate device | | Image sensor | CMOS sensor 400 x 400 pixels | CMOS sensor 400 x 400 pixels | Same as the predicate device | | Image cable connection | (1) Cable with 38-pin gold-finger connector (for HTx2000)<br>(2) Cable with 14-pin aviation connector (for HTx1000) | Cable with 14-pin aviation connector (for HTx1000) | Different.<br>The HTx2000 image processor<br>uses an image cable with 38-pin<br>gold-finger connector. This<br>difference does not raise different<br>questions of safety or effectiveness<br>for the device. | | Connectivity to customer computer | No (for HTx2000)<br>Yes (for HTx1000) | Yes (for HTx1000) | Different.<br>The LAN port on HTx2000 image<br>processor is currently disabled for<br>any connection to external<br>computer or network, which<br>mitigates cyber security risks when<br>compared to HTx1000. | | Live video output port | (1) HDMI (for HTx2000)<br>(2) DVI (for HTx1000) | DVI | Different.<br>The HTx2000 image processor<br>uses an HDMI rather than DVI<br>port for video output. This<br>difference does not raise different<br>questions of safety or effectiveness<br>for the device. | | Built-in touch screen | Yes (for HTx2000) | No | Different.<br>The HTx2000 image processor<br>has a touch screen for both<br>displaying and user input. This<br>difference does not raise different<br>questions of safety or effectiveness<br>for the device. | | Adjust brightness of LEDs<br>during procedure | By pressing a LED button on the<br>cannula | By pressing a LED button on the<br>cannula | Same as the predicate device | | Capture image or video<br>during procedure | By pressing a camera button on the<br>cannula | By pressing a camera button on the<br>cannula | Same as the predicate device | | Shelf life | ≥ 2 years (cannula)<br>≥ 5 years (image processor) | ≥ 2 years (cannula)<br>≥ 5 years (image processor) | Same as the predicate device | | Operation software | IPC (for HTx1000): accepts user input<br>via panel buttons or keyboard.<br>UterView (for HTx2000): accepts user<br>input via the touch screen. | IPC (for HTx1000): accepts user input<br>via panel buttons or keyboard. | Different.<br>The HTx2000 software is more<br>suited for touch screen operation<br>and is renamed as UterView. This<br>difference does not raise different<br>questions of safety or effectiveness<br>for the device. | {9}------------------------------------------------ {10}------------------------------------------------ {11}------------------------------------------------ The differences in technological characteristics do not raise different questions of safety and effectiveness. {12}------------------------------------------------ #### 7. Summary of Non-clinical Performance Testing Non-clinical tests were conducted to verify that the proposed device met all design specifications. No additional testing for HTx40 or HTx60 alone were necessary. However, the hysteroscope's compatibility with the image processors was assessed. The results demonstrated compliance with all design requirement specifications or statutory standards. - a) Bench-top test - 1) Color performance for HTx2000 utilizing the HTx40 and HTx 60 hysteroscopes assess the following specifications: - Ground truth measurements using a spectrophotometer a) - b) Working distance - c) color contrast enhancement (CCE) - 2) Basic electric safety (electrical, thermal, mechanical, etc.) IEC 60601-1:2005+AMD1:2012 Medical Electrical Equipment- Part 1: General requirements for basic safety and essential performance. - 3) Electromagnetic compatibility IEC 60601-1-2:2020, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests. - 4) Software testing The software of the subject device was validated as Basic Documentation Level in accordance with FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions", issued on June 14, 2023. - 5) Battery safety The lithium-ion battery safety was verified in compliance with the applicable requirements of IEC 62133-2:2017/AMD1:2021 and UN38.3. #### 8. Conclusions The performance testing summarized above support that the subject device is as safe and effective as the predicate device. Therefore, the subject device is substantially equivalent to the predicate device.