(145 days)
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.
The HTx Disposable Hysteroscope System is a single use hysteroscope endoscope intended for gynecology procedure applications. It includes a disposable cannula module, a reusable imaging system, a medical grade display and optional software for processing patient management. The disposable cannula contains a miniature complementary metal-oxide-semiconductor (CMOS) camera, a light-emitting diode (LED) illumination module, and a channel for fluid and device. The cannula connects directly to the image system via an image cable. The cannula also contains three (3) buttons for video recording, picture taking, and light-emitting diode (LED) brightness control. The image system connects to a medical grade display module via DVI port. The external patient management software runs on an external PC that connects with the image system via LAN cable.
This document is a 510(k) premarket notification for the AcuVu HTx Disposable Hysteroscope System, indicating that the device is a Class II medical device. The document primarily focuses on demonstrating substantial equivalence to a predicate device (AcuVu GDT-1000, K180096) rather than detailing a clinical study with specific acceptance criteria and performance metrics for an AI-powered device.
Therefore, many of the requested categories for AI-specific studies are not applicable or cannot be extracted from this document, as the HTx Disposable Hysteroscope System, as described, does not appear to be an AI-powered device in the sense of an algorithm for diagnostic or prognostic purposes. It is a traditional medical imaging device (hysteroscope) for viewing the cervical canal and uterine cavity.
Here's an attempt to answer the questions based on the provided text, acknowledging the limitations:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with numerical performance metrics for a diagnostic or AI algorithm. Instead, it lists various non-clinical tests performed to ensure the device meets safety and functional requirements. The "acceptance criteria" can be inferred as compliance with the listed standards and demonstrating acceptable results in the tests.
| Acceptance Criteria Category | Standard/Requirement | Reported Device Performance |
|---|---|---|
| Sterilization | ISO 11135:2014 (Ethylene Oxide Sterilization) | Validation performed in accordance with ISO 11135:2014. (Implies successful sterilization and packaging) |
| Biocompatibility | FDA guidance "Use of International Standard ISO 10993-1," "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Specific tests: Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2010), Irritation (ISO 10993-10:2010), Acute Systemic Toxicity (ISO 10993-11:2017), Material Mediated Pyrogenicity (ISO 10993-11:2017). | Results demonstrated the subject device is non-cytotoxic, non-sensitizing, non-irritating, not systemically toxic, and non-pyrogenetic. |
| Electromagnetic Compatibility/Electrical Safety | IEC 60601-1, IEC 60601-2-18, IEC 60601-1-2 | Device was tested and found to be compliant with these standards. |
| Optical Performance | ISO 8600-1:2015 (General requirements), ISO 8600-3:2019 (Determination of Field of View and Direction of View), IEC 62471:2006 (Photobiological safety), IEC 60601-2-18:2009 (Endoscopic equipment specific requirements). Specific parameters mentioned in comparison table: FOV > 115 degrees, DOV: HTx 60: 12 Degrees, HTx40: 8 degrees, Image resolution: 400x400 (160,000) pixels. | Optical performance (direction of view, field of view, distortion/resolution, luminous flux, color performance, photobiological safety), optical safety, and thermal safety testing were conducted in accordance with the listed standards. The functional comparison table states: FOV>115 degrees (Same as predicate), DOV: HTx 60: 12 Degrees, HTx40: 8 degrees (Different DOV from predicate, which was 0 degree). Image resolution: 400x400 (160,000) pixels (Same as predicate). This implies the performance meets the requirements set by these standards and comparison to the predicate device. |
| Software | FDA's 2005 Guidance for the Content of Premarket Submissions for Software Contained in Medical Device (for a Moderate Level of Concern device) | Software documentation provided in support of the subject device as per the guidance. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes technical and performance testing of a physical medical device (hysteroscope), not a clinical study on a patient population with a "test set" of data in the AI sense. No patient sample sizes or data provenance (country, retrospective/prospective) are mentioned. The testing involves laboratory verification and validation activities.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. As noted above, this is not an AI-powered diagnostic device undergoing a clinical study with ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This document does not describe a clinical study requiring an adjudication method for a test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance. This document concerns a hysteroscope, which is an imaging device, not an AI algorithm assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. For the technical and performance testing described, the "ground truth" is measured against engineering specifications and international standards (e.g., optical properties, sterility, biocompatibility).
8. The sample size for the training set
Not applicable. This device does not use an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device does not use an AI algorithm that requires a training set and associated ground truth.
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September 15, 2021
AcuVu, Inc. Sam Mostafavi Regulatory Affairs 4546 El Camino Real #211 Los Altos, CA 94022
Re: K211227
Trade/Device Name: HTx Disposable Hysteroscope System Regulation Number: 21 CFR§ 884.1690 Regulation Name: Hysteroscope and Accessories Regulatory Class: II Product Code: HIH Dated: August 10, 2021 Received: August 12, 2021
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 (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 Roberts -S
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) K211227
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.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K211227 Page 1 of 5
510(k) Summary
510(k) Number: K211227
Applicant Information:
| Date Prepared: | September 10, 2021 |
|---|---|
| Manufacturer: | AcuVu Inc.4546 El Camino Real #211Los Altos, CA 94022 |
| Contact Person: | Sam Mostafaviipcs11@ymail.com |
| Mobile Number: | 650-670-6972 |
| Office Number: | 650-578-9653 |
| Facsimile Number: | 650-578-9653 |
Device Information:
| Trade/Device Name: | HTx Disposable Hysteroscope System |
|---|---|
| Regulation Number: | 21 CFR § 884.1690 |
| Regulation Name: | Hysteroscope and accessories |
| Regulatory Class: | Class II |
| Product Code | HIH (Hysteroscope and Accessories) |
| Panel: | Obstetrics/Gynecology |
Predicate Device:
AcuVu GDT-1000 (K180096)
The predicate device has not been subject to a design-related recall.
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.
Device Description
The HTx Disposable Hysteroscope System is a single use hysteroscope endoscope intended for gynecology procedure applications. It includes a disposable cannula module, a reusable imaging system, a medical grade display and optional software for processing patient management.
The disposable cannula contains a miniature complementary metal-oxide-semiconductor (CMOS) camera, a light-emitting diode (LED) illumination module, and a channel for fluid and device. The cannula connects directly to the image system via an image cable. The cannula also contains three (3) buttons for video recording, picture taking, and light-emitting diode (LED)
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brightness control. The image system connects to a medical grade display module via DVI port. The external patient management software runs on an external PC that connects with the image system via LAN cable.
Disposable Cannula
The disposable cannula module family includes two models. HTx60 has an outer diameter of 6.2mm and adapts to tools up to 3mm, and HTx40 has an outer diameter of 4.5mm and adapts to tools up to 5Fr. The disposable single-use cannula contains a miniature camera module and an LED illumination module at the tip. The cannula connects to the image system through an image cable for image data transfer, camera control, and power supply.
The disposable cannula has a working length of 240mm, and an overall length is 330mm.
Fluid irrigation is achieved through a tube which is connected to an IV bag and pressured via peristaltic pump. The disposable cannula is sterilized and packaged in a sealed pouch.
Image System Module
The HTx1000 image system Module is reusable. It connects to the disposable cannula through an image cable. Its proximal end has a USB connection interface and power button. It contains the image processing controller and user interface software to check the live video during the procedure.
The Image System Module contains several function buttons for use during a procedure – an LED adjustment button to adjust brightness, an information retrieve button to review the stored images, and a set of navigation buttons to instruct the user on setting functions.
Functional and Technological Comparison
Table below includes a functional and technological comparison between AcuVu HTx System and AcuVu GDT-1000 System (K180096).
| Feature | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| AcuVu Inc. Inc.HTx Disposable HysteroscopeSystem | AcuVu Inc.GDT-1000 System (K180096) | ||
| Classification | Class II | Class II | Same |
| Regulation Name | 21 CFR § 884.1690 | 21 CFR § 884.1690 | Same |
| Product code | HIH | HIH | Same |
| Indications for use | The HTx disposable hysteroscopesystem is intended to permit viewingof the cervical canal and uterinecavity for the purpose of performing | AcuVu GDT-1000 System isused to permit viewing of theadult cervical canal and uterinecavity for the purpose of | Same |
| diagnostic and operative procedure. | performing diagnostic andoperative procedure. | ||
| Site of use | Hospitals and physician's office. | Hospitals and physician'soffice. | Same |
| Intended users | Trained Medical Professionals. | Trained Medical Professionals. | Same |
| Device Features:Components | (1) image-capturing system anddisplay; (2) attachable and disposablecannula with inflow and outflowports. | (1) image-capturing hand pieceand tower; (2) attachablecannula configuration withinflow and outflow ports. | Differenttechnology;similarperformance |
| Cannula outerdiameter | 4.5mm-6.2mm | 4.8 - 5.3 mm (operative)4.8 - 5.3 mm (diagnostic) | Similar topredicate device |
| Cannula length | Working length: 240 mmOverall length: 330 mm | Working length: 220 - 240mmOverall length: 300 - 350 mm | Similar; withinrange ofpredicate |
| Illumination lightsource | LEDs | LEDs | Same |
| Image resolution | The CMOS sensor consists of 400 x400 (160,000) pixels. | The CMOS sensor consists of400 x 400 (160,000) pixels. | Same |
| Optical image | Digital CMOS | Digital CMOS | Same |
| Disposable/ Reusable | Cannula is provided sterile for singleuse and the image system and themonitor is reusable | Cannula is provided sterile forsingle use and the handle andtower is reusable. | Same |
| Battery operated | No | No | Same |
| Duration of use | < 24 hours | < 24 hours | Same |
| Field of View andDirection of Viewing | FOV>115 degrees,DOV: HTx 60: 12 DegreesHTx40: 8 degrees | FOV>115 degrees,DOV 0 degree | Same FOVDifferent DOV |
Table-1: Functional and Technological Comparison
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Differences in technological characteristics do not raise different questions of safety and effectiveness.
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Performance Data
Non-clinical tests were performed in accordance with the applicable requirements of the following areas. Verification and validation activities are performed to ensure that productperformance meets design requirements.
Sterilization
The device is provided sterile via ethylene oxide sterilization validation was performed in accordance with ISO 11135:2014.
Biocompatibility
The biocompatibility evaluation was conducted in accordance with the FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Testing included:
- Cytotoxicity (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2010) ●
- Irritation (ISO 10993-10:2010)
- Acute Systemic Toxicity (ISO 10993-11:2017) ●
- Material Mediated Pyrogenicity (ISO 10993-11:2017) .
The results of testing demonstrated the subject device is non-cytotoxic, non-sensitizing, nonirritating, not systemically toxic, and non-pyrogenetic.
Electromagnetic Compatibility/Electrical Safety
The device was tested and found to be compliant with the following standards for electrical safety and EMC: IEC 60601-1, IEC 60601-2-18, and IEC 60601-1-2
Performance Testing
Optical performance (direction of view, field of view, distortion/resolution, luminous flux, color performance, photobiological safety), optical safety, and thermal safety testing were conducted in accordance with the standards listed below:
- ISO 8600-1:2015 Medical endoscopes and endotherapy devices Part 1: General ● requirements
- ISO 8600-3:2019 Medical endoscopes and endotherapy devices Part 3: Determination of ● Field of View and Direction of View of Endoscopes with Optics
- IEC 62471:2006 (First Edition) Photobiological safety of lamps and lamp systems
- IEC 60601-2-18:2009 Medical electrical equipment, Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
Software
Software documentation for a Moderate Level of Concern device is provided in support of the subject device per FDA's 2005 Guidance for the Content of Premarket Submissions for Software Contained in Medical Device.
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Conclusion:
The performance testing summarized above support a substantial equivalence determination. The performance testing demonstrates that the subject device is as safe and as effective as the legally marketed 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.