(454 days)
No
The description focuses on the hardware components, visualization capabilities, and basic image/video transfer. There is no mention of any analytical or interpretive functions that would typically involve AI/ML, nor are there details about training or test sets which are characteristic of AI/ML development.
No
The device is primarily used for diagnostic purposes, such as viewing and obtaining tissue samples, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to be used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures." It also mentions "Generally recognized indications for diagnostic hysteroscopy."
No
The device description clearly states it is a handheld, battery-operated portable hysteroscope consisting of a sterile, single-use cannula and a reusable handle with an LCD touchscreen monitor. It includes hardware components like a camera, light source, and fluid channel.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Hystero-V hysteroscope is a medical device used to visualize the cervical canal and uterine cavity and to obtain a tissue sample (biopsy).
- Purpose of the Sample: While the sample obtained is used for cytologic diagnosis (which is an in vitro process), the device itself is used for the collection of the sample and for direct visualization within the body. It does not perform the diagnostic test on the sample itself.
The device is an endoscope used for diagnostic and biopsy procedures within the body, not a device that performs diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
HIH, HFF
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 cannula-stainless 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical canal and uterine cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
outpatient or office setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing including:
Biocompatibility testing: 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. The software was validated and verified.
Mechanical Testing:
- 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;
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 |