Who is the manufacturer of Hystero-V Hysteroscope?

Hysterovue, Inc. filed the 510(k) submission for Hystero-V Hysteroscope (K202445).

What is the FDA product code for Hystero-V Hysteroscope?

HIH. It is classified under 21 CFR 884.1690 as a Class 2 device in the Obstetrics/Gynecology panel.

What is the regulatory pathway for Hystero-V Hysteroscope?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Hystero-V Hysteroscope?

U-Scope 8000 HSC+EMB Cannula Hysteroscope (K132384).

Who can help prepare an FDA 510(k) submission like Hystero-V Hysteroscope?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Hystero-V Hysteroscope

K202445 · Hysterovue, Inc. · HIH · Nov 23, 2021 · Obstetrics/Gynecology

Device Facts

Record ID	K202445
Device Name	Hystero-V Hysteroscope
Applicant	Hysterovue, Inc.
Product Code	HIH · Obstetrics/Gynecology
Decision Date	Nov 23, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.1690
Device Class	Class 2

Intended Use

The Hysteroscope is intended to be 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 diagnosis. Generally recognized indications for diagnostic hysteroscopy include abnormal uterine bleeding, infertility and pregnancy wastage, evaluation of abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea, and pelvic pain.

Device Story

Handheld, battery-operated portable hysteroscope; consists of sterile, single-use cannula and reusable handle with LCD touchscreen. Cannula features distal LED light source and camera; captures video/images of cervical canal and uterine cavity. Physician operates device in outpatient/office settings. Signals transmitted electronically to handle monitor for real-time visualization. Cannula includes fluid channel for infusion or tissue evacuation. Physician uses visual output to guide diagnostic procedures and perform endometrial biopsies. Benefits include portable, integrated visualization and sampling capability for gynecological assessment.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), thermal safety (IEC 60601-2-18), and mechanical performance (bending, torque, pull, flow, and image quality per ISO 8600-3/5).

Technological Characteristics

Materials: stainless steel, nylon, polycarbonate (ISO 10993 compliant). Illumination: LED. Imaging: distal camera, 3.5-inch LCD handle monitor. Dimensions: 465 mm total length, 254 mm working length, 4.25 mm cannula diameter. Connectivity: internal electronic signal transmission. Sterilization: EO (cannula), manual disinfection (handle). Software: moderate level of concern.

Indications for Use

Indicated for patients requiring diagnostic hysteroscopy and endometrial biopsy in outpatient or office settings. Includes patients with abnormal uterine bleeding, infertility, pregnancy wastage, abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea, or pelvic pain.

Regulatory Classification

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.

Predicate Devices

U-Scope 8000 HSC+EMB Cannula Hysteroscope (K132384)

Reference Devices

Uro-V Cystoscope (K171500)

Related Devices

K132384 — U-SCOPE 8000 SYSTEM WITH HSC+EMB CANNULA · Endosec Corporation · Jul 2, 2014
K123151 — ENDOSEE MODEL 8000 U-SCOPE · Endosee Corp · Mar 8, 2013
K171113 — LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module · Lina Medical Aps · Jan 4, 2018
K170660 — Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula · CooperSurgical, Inc. · Jul 13, 2017
K190639 — Endosee System · CooperSurgical, Inc. · May 15, 2019

Submission Summary (Full Text)

{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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 23, 2021 Hysterovue, Inc. Thomas Lawson, Ph.D. Vice President, Regulatory Affairs 5337 14th Place SE Bellevue, WA 98006 Re: K202445 > Trade/Device Name: Hystero-V Hysteroscope Regulation Number: 21 CFR§ 884.1690 Regulation Name: Hysteroscope and Accessories Regulatory Class: II Product Code: HIH, HFF Dated: October 22, 2021 Received: October 25, 2021 Dear Thomas Lawson: 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. 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. 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. {1}------------------------------------------------ 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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 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) K202445 Device Name Hystero-V Hysteroscope #### Indications for Use (Describe) The Hysteroscope is intended to be 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 diagnosis. Generally recognized indications for diagnostic hysteroscopy include abnormal uterine 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) | | |-------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------| | <div> X Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### 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}------------------------------------------------ # General Information | Submitter | Hysterovue, Inc. | |-----------------------|--------------------------------------------------------------| | Address | Hysterovue, Inc. 5337 14th Place SE Bellevue, WA 98006 | | 510k Number | K202445 | | Correspondence Person | Thomas Lawson, PhD | | Contact Information | Email: drthomlawson@gmail.com Phone: 510-206-1794 | | Date Prepared | 19 November 2021 | # Proposed Device | Trade Name | Hystero-V Hysteroscope | |----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------| | Common Name | Hysteroscope | | Regulation Number and Classification Name | 21 CFR§884.1690, Hysteroscope and Accessories 21 CFR§884.4530, Obstetric-Gynecologic Specialized Manual Instrument | | Product Code | HIH, HHF | | Regulatory Class | II | # Predicate Device | Trade Name | U-Scope 8000 HSC+EMB Cannula Hysteroscope | |------------------------------------------------------------------------------|-----------------------------------------------| | Common Name | Hysteroscope | | Premarket Notification | K132384 | | Regulation Number and Classification Name | 21 CFR§884.1690, Hysteroscope and Accessories | | Product Code | HIH | | Regulatory Class | II | | Note: This predicate device has not been subject to a design-related recall. | | {4}------------------------------------------------ | Reference Device | | |----------------------------------------------|--------------------------------------------------------------------| | Trade Name | Uro-V Cystoscope | | Common Name | Cystoscope | | Premarket Notification | K171500 | | Regulation Number and Classification Name | 21 CFR§884.1500, Endoscope and Accessories | | Product Code | FAJ | | Regulatory Class | II | | | Note: This device has not been subject to a design-related recall. | # Device Description The Hystero-V hysteroscope is a handheld, battery operated portable hysteroscope consisting of a sterile, single-use cannula and a reusable handle with an LCD touchscreen monitor. It is intended to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures and endometrial tissue sample (biopsy) in an outpatient or office setting. The disposable cannula has a light source and camera at the distal end that are used for visualization and to capture image and video of the diagnostic area. The image and video signals are transferred electronically from the cannula to the monitor on the handle via an electrical connection so that the physician can view the anatomy during the procedure. The cannula also has a fluid channel that can infuse fluids during the procedure or evacuate tissue. The fully assembled Hystero-V hysteroscope has an overall length of 465 mm (18.3 inches); the working length of the disposable cannula component is 254 mm (10 inches). When assembled, the Hystero-V hysteroscope weighs 0.5 pounds. The materials used in construction of the cannulastainless steel, nylon, and polycarbonate-contact tissue for less than 24 hours. The device has been tested for biocompatibility and was shown to be biocompatible. The handle does not contact the patient. #### Indications for Use The indications for use for the Hystero-V hysteroscope are: The Hystero-V hysteroscope is intended to be 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 uterine bleeding, infertility and pregnancy wastage, evaluation of abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea, and pelvic pain. {5}------------------------------------------------ The Hystero-V hysteroscope has equivalent intended use and indications for use statement as the U-Scope 8000 HSC+EMB, i.e., viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures and facilitating endometrial sample (biopsy). ### Comparison of Technological Characteristics with the Predicate Device Hysterovue, Inc. has identified the U-Scope 8000 HSC hysteroscope +EMB Cannula (EndoSee Corp., K132384) as the predicate device. The Uro-V cystoscope (UroViu Corp., K171500) is a reference device. The Hysteroscope is equivalent to the U-Scope 8000 HSC+EMB Cannula in terms of intended use, cannula tip configuration to facilitate tissue collection, and EM compatibility and safety. The Hysteroscope is identical to the Uro-V cystoscope in terms of shape of the handle, materials used in its construction, biocompatibility of materials, sterilization method, packaging, and software. Comparison of the Hystero-V hysteroscope (subject device) to the U-Scope 8000 HSC+EMB Cannula (predicate device) and the Uro-V cystoscope (reference device). | | Subject Device | Predicate device | Reference Device | |------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------| | | Hystero-V hysteroscope Hysterovue, Inc. (This Submission) | U-Scope 8000 HSC+EMB EndoSee Corp. (K132384) | Uro-V disposable cystoscope UroViu Corp. (K171500) | | Indication for use | To permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures and to obtain an endometrial sample (biopsy) in an outpatient or an office setting. The sample is used for cytologic and histologic diagnosis. | To permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures and to obtain an endometrial sample (biopsy) in an outpatient or an office setting. Generally recognized indications for | For endoscopic diagnosis and treatment within the bladder and urethra. | | | Hystero-v Hysteroscope | | | | | Generally recognized indications for diagnostic hysteroscopy include abnormal uterine bleeding, infertility and pregnancy wastage, evaluation of abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea, pelvic pain. | diagnostic hysteroscopy include abnormal uterine bleeding, infertility and pregnancy wastage, evaluation of abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea, pelvic pain. | | | Intended Use | Viewing of cervical canal and uterine cavity and obtaining tissue samples | Viewing of cervical canal and uterine cavity and obtaining tissue samples | Endoscopic diagnosis and treatment within the bladder and urethra. | | Route of Advancement | Advanced to uterine cavity via the cervical canal | Advanced to uterine cavity via the cervical canal | Advanced to the bladder via the urethra | | Site of use | Hospitals and physician offices | Same | Same | | | | | | | Device Features | | | | | Components | Reusable handle with video screen Attachable cannula with a working channel along its length and an illumination source and camera at its tip | Same | Same | | Cannula Outer Diameter | 4.25 mm | 4.3 mm | 3.9 mm | | Cannula Total Length | 254 mm | 276 mm | 254 mm | | Illumination light source | LEDs | Same | Same | | Image transmission | Image transmitted from a video camera at the tip of the cannula to a video monitor on the handle | Same | Same | {6}------------------------------------------------ {7}------------------------------------------------ | K202445 | | | |-------------|--|--| | Page 5 of 7 | | | | LCD display size | 3.5 inches (diagonal) on the handle | Same | Same | |-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|-------------| | Field of View | 140 degrees | 120 degrees | 140 degrees | | Focal Length | 5 to 50 mm | 5 to 50 mm | 5 to 25 mm | | Direction of View from Center Axis | 30 degrees | 20 degrees | 30 degrees | | Adjust brightness of illumination | Adjust by depressing a button on the handle to change settings | Same | Same | | Capture still images or video images during the procedure | Capture still images or video during procedure by depressing a camera button on the handle | Same | Same | | Duration of use | < 24 hours | Same | Same | | Sterilization | The handle is not provided sterile. The handle is cleaned and disinfected following company instructions. Disposable cannula is sterile following exposure to ethylene oxide (EO) and is single use; it is disposed after the procedure following the institution's procedures. | Same | Same | | Frequency of use | Handle is reusable. Cannula is single patient use. | Same | Same | | Tissue contact materials | Compliant with ISO 10993 | Same | Same | ### Non-Clinical Performance Testing # Biocompatibility testing The cannula of the Hystero-V hysteroscope is the only part that is in contact with the patient. The cannula is an externally communicating device with limited contact duration {8}------------------------------------------------ (≤ 24 hours). Therefore, following ISO 10993-1:2018, the applicable biocompatibility tests are: - 1. Cytotoxicity Test 10993-5:2009; - 2. Irritation Test 10993-10:2010: - 3. Guinea Pig Maximization Sensitization Test 10993-10:2010; and - 4. Systemic Toxicity Study 10993-11:2006. The cannula materials are identical to those used in the cannula of the Uro-V cystoscope reference device that was reviewed and cleared in K17500. In addition, the subject device has identical manufacturing and processing (including sterilization). Therefore. biocompatibility test data (as outlined in above) can be leveraged from K17500 to support the biocompatibility of the subject device. # Electrical safety and electromagnetic compatibility (EMC) The subject device was evaluated for electrical safety and EMC and found to comply with IEC 60601-1 and IEC 60601-1-2 respectively. # Software testing The software version running the Hysteroscope is the same as that which runs the Uro-V cystoscope (reviewed and cleared in K171500), with the minor difference that "Hystero-V" and "Hysterovue, Inc." logos are shown on the screen when the device is powered up. As with the Uro-V cystoscope, according to the FDA's Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, the software for this device is considered to have a "moderate" level of concern. The software was validated and verified. # Mechanical Testing The mechanical testing of the subject device included: - . Thermal safety of the light source on the distal tip of the cannula meets requirements specified in IEC 60601-2-18; - Bending test demonstrated that attaching a weight to the cannula to bend it . resulted in no mechanical damage to the cannula or degradation of imaging; - Flow testing demonstrated no leaks from the working channel in the cannula ● when flow was set at 120 mL/min at a pressure of 300 mmHg; - Image quality met requirements of ISO 8600-5; - Field of view and Direction of Viewing accuracy met requirements of ISO 8600-3; {9}------------------------------------------------ - . Torque testing of the cannula demonstrated that image quality still met product specification after twisting the cannula and that no damage was visible to the cannula; and - Pull testing of the cannula with two pounds of force did not compromise the . image quality or damage the cannula. ## Animal Testing No preclinical testing of the subject device was necessary. The bench tests are sufficient. # Clinical Studies No clinical testing of the subject device was necessary. The bench tests are sufficient. ### Conclusion The Hystero-V hysteroscope indications for use and technology do not raise no different questions of safety and effectiveness as compared to the predicate device. Performance testing demonstrated that the Hystero-V hysteroscope is as safe and effective as the Therefore, the subject device is substantially equivalent to the predicate predicate. device.