(454 days)
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.
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.
The provided text describes a 510(k) premarket notification for the Hystero-V Hysteroscope, asserting its substantial equivalence to a predicate device. The information details various non-clinical performance tests but explicitly states that no clinical or animal testing was necessary or performed. Therefore, the following response will be based on the non-clinical testing reported.
Here's an analysis of the acceptance criteria and the study (non-clinical testing) proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test | Performance Demonstrated by Hystero-V Hysteroscope |
|---|---|
| Biocompatibility | Materials identical to Uro-V cystoscope (K17500) and complied with ISO 10993-1:2018 for cytotoxicity, irritation, sensitization, and systemic toxicity. Test data leveraged from K17500. |
| Electrical Safety | Complied with IEC 60601-1. |
| Electromagnetic Compatibility (EMC) | Complied with IEC 60601-1-2. |
| Software Validation & Verification | Software version is identical to Uro-V cystoscope (K171500), with minor UI changes. Considered "moderate" level of concern per FDA guidance. Validated and verified. |
| Thermal Safety of Light Source | Met requirements specified in IEC 60601-2-18. |
| Bending Test | No mechanical damage or degradation of imaging when a weight was applied to bend the cannula. |
| Flow Testing (Working Channel Leaks) | No leaks from the working channel 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. (Note: Predicate device had 120 degrees FOV, Hystero-V has 140 degrees, which is an improvement or at least meets the standard if the standard accommodates this). Hystero-V 30 degrees, Predicate 20 degrees, Reference 30 degrees for Direction of View, meeting criteria. |
| Torque Testing of Cannula | Image quality still met product specification after twisting the cannula, and no visible damage to the cannula. |
| Pull Testing of Cannula | Pulling with two pounds of force did not compromise image quality or damage the cannula. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each individual test. The context implies that the testing was performed on a sample of the Hystero-V Hysteroscope devices/components as part of the validation process.
- Data Provenance: The data comes from bench tests and engineering evaluations performed by the manufacturer, Hysterovue, Inc. It is therefore prospective in nature, as it was conducted specifically for this submission. The origin is implied to be within the company's testing facilities, likely in the US (Bellevue, WA). For biocompatibility, data was leveraged from a previously cleared device (K17500).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. The ground truth for these non-clinical tests is established by objective engineering standards (e.g., ISO, IEC) and the device's own specifications. These are not subjective interpretations requiring expert consensus.
- Qualifications of Experts: Not applicable for establishing ground truth in this context. The testing would have been conducted by engineers and technicians with expertise in medical device testing, regulatory compliance, and relevant standards.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. These were objective pass/fail tests against predefined standards and specifications, not subjective assessments requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No, an MRMC comparative effectiveness study was explicitly stated as not necessary and not performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
- Standalone Performance: Not applicable in the context of an AI algorithm. This device is a hardware hysteroscope. The software component described is for controlling the device and displaying images, not for AI-powered diagnostics or analysis.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the non-clinical tests, the ground truth was established by:
- International Standards: ISO 10993 (biocompatibility), IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-2-18 (thermal safety), ISO 8600-5 (image quality), ISO 8600-3 (field of view/direction of viewing).
- Device Specifications: The manufacturer's internal product specifications for mechanical integrity (bending, torque, pull tests) and functional performance (no leaks in working channel, image quality).
- Predicate Device Data: For biocompatibility, the ground truth was largely established by the prior clearance of the Uro-V cystoscope (K17500), which used identical materials, manufacturing, and sterilization.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. This device does not use machine learning or AI that would require a "training set." The software mentioned is an operating system/control software, not an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for an AI algorithm. The software functionality was verified and validated against its design requirements and specifications, which are based on standard software engineering practices and the functional needs of the hysteroscope.
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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.
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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
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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 SEBellevue, WA 98006 |
| 510k Number | K202445 |
| Correspondence Person | Thomas Lawson, PhD |
| Contact Information | Email: drthomlawson@gmail.comPhone: 510-206-1794 |
| Date Prepared | 19 November 2021 |
Proposed Device
| Trade Name | Hystero-V Hysteroscope |
|---|---|
| Common Name | Hysteroscope |
| Regulation Number andClassification Name | 21 CFR§884.1690, Hysteroscope and Accessories21 CFR§884.4530, Obstetric-GynecologicSpecialized 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. |
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| Reference Device | |
|---|---|
| Trade Name | Uro-V Cystoscope |
| Common Name | Cystoscope |
| Premarket Notification | K171500 |
| Regulation Number andClassification 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.
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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-VhysteroscopeHysterovue, Inc.(This Submission) | U-Scope 8000HSC+EMBEndoSee Corp.(K132384) | Uro-VdisposablecystoscopeUroViu 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 recognizedindications fordiagnostichysteroscopy includeabnormal uterinebleeding, infertility andpregnancy wastage,evaluation of abnormalhysterosalpingogram,intrauterine foreignbody, amenorrhea,pelvic pain. | diagnostichysteroscopy includeabnormal uterinebleeding, infertilityand pregnancywastage, evaluationof abnormalhysterosalpingogram,intrauterine foreignbody, amenorrhea,pelvic pain. | ||
| Intended Use | Viewing of cervicalcanal and uterine cavityand obtaining tissuesamples | Viewing of cervicalcanal and uterinecavity and obtainingtissue samples | Endoscopicdiagnosis andtreatment withinthe bladder andurethra. |
| Route ofAdvancement | Advanced to uterinecavity via the cervicalcanal | Advanced to uterinecavity via the cervicalcanal | Advanced to thebladder via theurethra |
| Site of use | Hospitals and physicianoffices | Same | Same |
| Device Features | |||
| Components | Reusable handle withvideo screenAttachable cannulawith a working channelalong its length and anillumination source andcamera at its tip | Same | Same |
| Cannula OuterDiameter | 4.25 mm | 4.3 mm | 3.9 mm |
| Cannula TotalLength | 254 mm | 276 mm | 254 mm |
| Illuminationlight source | LEDs | Same | Same |
| Imagetransmission | Image transmitted froma video camera at thetip of the cannula to avideo monitor on thehandle | Same | Same |
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| 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
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(≤ 24 hours). Therefore, following ISO 10993-1:2018, the applicable biocompatibility tests are:
-
- Cytotoxicity Test 10993-5:2009;
-
- Irritation Test 10993-10:2010:
-
- Guinea Pig Maximization Sensitization Test 10993-10:2010; and
-
- 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;
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- . 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.
§ 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.