(136 days)
No
The document describes image processing and software changes, but there is no mention of AI, ML, or related concepts like training or test sets for such algorithms.
No
The device is primarily for viewing/diagnostic purposes and image processing. While it can be used with another device for therapeutic procedures, it does not perform therapeutic actions itself.
Yes
The "Intended Use / Indications for Use" section states that the device is "used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures."
No
The device description explicitly states it includes hardware components: the Aveta Disposable Hysteroscope (with camera and LED light) and the Aveta Controller. While there is a software change mentioned, the device is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures." This describes a device used for direct visualization and intervention within the body, not for examining specimens in vitro (outside the body).
- Device Description: The description details a hysteroscope with a camera and light, used for viewing and potentially surgical procedures within the uterus. It also mentions fluid management and a resecting device, all of which are consistent with an in-vivo procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, tissue, etc.) or performing tests on samples outside the body. The device is used for direct observation and manipulation within the patient.
IVD devices are specifically designed to perform tests on specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Aveta Disposable Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
Product codes
HIH
Device Description
The Aveta Disposable Hysteroscope is used by physicians in an office or operating room setting. The subject device includes the Aveta Disposable Hysteroscope and Aveta Controller. Like the Aveta Disposable Hysteroscope cleared under K190372, the modified Aveta Disposable Hysteroscope includes a camera and LED light. The Aveta Disposable Hysteroscope is connected to the Aveta Controller to provide the camera and light functions and to process and store the image obtained from the Aveta Disposable Hysteroscope.
For fluid management, the Aveta Disposable Hysteroscope can be used with gravity fed pressurized saline bag or the fluid management system cleared under K190372. For therapeutic procedures, the Aveta Disposable Hysteroscope is used with the cleared Aveta Disposable Resecting Device (K190372). The only functional buttons on the Aveta Disposable Hysteroscope handle are the image capture and the image transfer buttons. For the modified device, when other buttons on the handle are pressed, the Aveta Controller does not take any action.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical canal and the uterine cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
used by physicians in an office or operating room 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)
The following summary results of design control activities have been provided in support of the substantial equivalence determination.
- . Software verification
- . Simulated Use with gravity fed pressurized saline bag (Regulation of cavity pressure was demonstrated in a model uterine system, flow rate tests and tissue resection) was performed utilizing the Aveta Disposable Hysteroscope. Results demonstrate the subject device met specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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December 19, 2019
Meditrina, Inc. Csaba Truckai President & CEO 1190 Saratoga Avenue, Suite 180 San Jose. CA 95129
Re: K192100
Trade/Device Name: Aveta Disposable Hysteroscope Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope And Accessories Regulatory Class: II Product Code: HIH Dated: November 18, 2019 Received: November 21, 2019
Dear Csaba Truckai:
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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the 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,
for Sharon M. Andrews 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) K192100
Device Name Aveta Disposable Hysteroscope
Indications for Use (Describe)
The Aveta Disposable Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical 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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K192100: 510(k) Summary
I. Submitter Information
| Submitter name: | Meditrina, Inc.
1190 Saratoga Avenue, Suite 180
San Jose, CA 95129 | |
|-----------------|----------------------------------------------------------------------------------------------------------------------|---------------------|
| Contact person: | Csaba Truckai
President & CEO
Mobile: (415) 215-7233
Office: (408) 471-4877
csabat@hermesinnovations.com | Fax: (408) 418-4815 |
| Date Prepared: | 18 December 2019 | |
II. Product Classification
| Device Name: | Aveta Disposable Hysteroscope | |
|---|---|---|
| Common Name: | Hysteroscope | Subject Device |
| Regulation: | 21 CFR 884.1690 | |
| Regulation Name: | Hysteroscope and accessories | |
| Class: | II | |
| Product Code: | HIH |
III. Predicate Device Information
| Predicate Devices | Manufacturer | Predicate Device Names | 510(k)# | Clearance Date |
|---|---|---|---|---|
| Predicate Device | Meditrina, Inc. | Aveta System | K190372 | May 16, 2019 |
Predicate has not been the subject of a design related recall.
IV. Device Description
The Aveta Disposable Hysteroscope is used by physicians in an office or operating room setting. The subject device includes the Aveta Disposable Hysteroscope and Aveta Controller. Like the Aveta Disposable Hysteroscope cleared under K190372, the modified Aveta Disposable Hysteroscope includes a camera and LED light. The Aveta Disposable Hysteroscope is connected to the Aveta Controller to provide the camera and light functions and to process and store the image obtained from the Aveta Disposable Hysteroscope.
For fluid management, the Aveta Disposable Hysteroscope can be used with gravity fed pressurized saline bag or the fluid management system cleared under K190372. For therapeutic procedures, the Aveta Disposable Hysteroscope is used with the cleared Aveta Disposable Resecting Device (K190372). The only functional buttons on the Aveta Disposable Hysteroscope handle are the image capture and the image transfer buttons. For the modified device, when other buttons on the handle are pressed, the Aveta Controller does not take any action.
Other than minor change to the Aveta Controller software to disable fluid management related buttons on the Aveta Disposable Hysteroscope, there is no change to the components of the cleared Aveta
4
System (K190372). Provided in Table 1 are additional details on the modified Aveta Disposable Hysteroscope.
| Aveta Disposable
Hysteroscope and
Accessory | Device
Characteristics &
Packaging | Materials; Patient
Contact and Contact
Duration | Functions Performed |
|---------------------------------------------------|--------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Aveta Disposable
Hysteroscope | Sterile (EO), single
use, used in the sterile
field. Tyvek/Film
Pouch | Polymers (PVC, ABS);
Stainless Steel, direct
patient contact for
limited duration. | • Visualization of uterine cavity.
• Provides conduits/lumens for inflow,
outflow.
• Provides conduit for mechanical Resecting
Device for operative hysteroscopy.
• Provides controls to the user to record
images.
• Provides controls to the user to perform
image transfer |
| Aveta Controller
(accessory) | Non-sterile, reusable,
used outside the
sterile field | No patient contact | • Camera, light, image processing and image
storing. |
Table 1. Modified Aveta Disposable Hysteroscope and accessory
V. Indications for Use
The indications for use of the modified Aveta System is a subset of the indications for use of the predicate Aveta System.
| Device | Indications For Use |
|---|---|
| Aveta Disposable Hysteroscope | |
| (Subject Device) | The Aveta Disposable Hysteroscope is used to permit viewing of the |
| cervical canal and the uterine cavity for the purpose of performing | |
| diagnostic and surgical procedures. | |
| Aveta System | |
| (Predicate) | |
| (K190372) | The Aveta System is intended for intrauterine use by trained gynecologists |
| to permit viewing of the cervical canal and the uterine cavity, provide | |
| liquid distension of the uterus and monitor the volume differential between | |
| the irrigation fluid flowing into and out of the uterus during diagnostic and | |
| surgical procedures to resect and remove tissue such as submucous | |
| myomas. endometrial polyps and retained products of conception. |
Comparison of Indications for Use
This difference does not represent a new intended use.
VI. Comparison of Technological Characteristics with the Predicate Device
The subject Aveta Disposable Hysteroscope and the cleared Aveta Disposable Hysteroscope (cleared as a component of Aveta System K190372) have similar technological characteristics in terms of basic operating principle and basic design features with minor differences in compatible fluid sources and software of the Aveta Controller. The different technological characteristics of the subject devices do not raise different types of safety and effectiveness questions. The table below compares the subject device with the predicate device.
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| Attribute | Subject Device | PREDICATE Device |
|---|---|---|
| 510k# | K192100 | K190372 |
| Manufacturer: | Meditrina Inc. | Meditrina Inc. |
| Device Names | Aveta Disposable Hysteroscope | Aveta System |
| Class: | II | II |
| Regulation Name: | Hysteroscope and Accessories | Hysteroscope and Accessories / Hysteroscopic Insufflator |
| Regulation Number: | 884.1690 | 884.1690 / 884.1700 |
| Product Code: | HIH | HIH / HIG |
| Intended Use: | Intended to permit viewing of the cervical canal | |
| and the uterine cavity. | Intended for the distention and visualization of the cervical | |
| canal and the uterine cavity and for endoscopic resection and | ||
| removal of tissue chips via suction while monitoring volume | ||
| differential between the irrigation fluid flowing into and out | ||
| of the uterus. | ||
| Indications for Use: | The Aveta Disposable Hysteroscope is used to | |
| permit viewing of the cervical canal and the | ||
| uterine cavity for the purpose of performing | ||
| diagnostic and surgical procedures. | The Aveta System is intended for intrauterine use by trained | |
| gynecologists to permit viewing of the cervical canal and | ||
| the uterine cavity, provide liquid distension of the uterus | ||
| and monitor the volume differential between the irrigation | ||
| fluid flowing into and out of the uterus during diagnostic | ||
| and surgical procedures to resect and remove tissue such as | ||
| submucous myomas, endometrial polyps and retained | ||
| products of conception. | ||
| Materials of | ||
| Construction: | Stainless Steel, | |
| ABS, | ||
| Silicone elastomer, | ||
| PVC, | ||
| Polycarbonate | Stainless Steel, | |
| ABS. | ||
| Silicone elastomer, | ||
| PVC, | ||
| Polycarbonate | ||
| Working Length: | 224mm | 224mm |
| Outer Diameter: | 5.5mm | 5.5mm |
| Working Channel | ||
| Diameter: | 3.5mm | 3.5mm |
| Working Channel | ||
| Closure: | Silicone valve | Silicone valve |
| Recommended Light | ||
| Source: | Integrated LED | Integrated LED |
| Focal Length: | 5 to 25mm | 5 to 25mm |
| Working Distance: | 10mm | 10mm |
| Field of View: | 90° | 90° |
| Direction of View: | 0° | 0° |
| Optics | Fixed focus lens with CMOS sensor | Fixed focus lens with CMOS sensor |
| Attribute | Subject Device | PREDICATE Device |
| 510k# | K192100 | K190372 |
| Manufacturer: | Meditrina Inc. | Meditrina Inc. |
| Device Names | Aveta Disposable Hysteroscope | Aveta System |
| Resolution @ | ||
| Working Distance: | 3.4 lp/mm at 25mm Working Distance | 3.4 lp/mm at 25mm Working Distance |
| Image Processing: | Image generated by the CMOS sensor in Aveta | |
| Disposable Hysteroscope is processed and sent | ||
| to Aveta Controller for further processing and | ||
| displayed on a monitor | Image generated by the CMOS sensor in Aveta Disposable | |
| Hysteroscope is processed and sent to Aveta Controller for | ||
| further processing and displayed on a monitor | ||
| How provided: | Sterile, single-use | Sterile, single-use |
| Sterilization | ||
| Method: | Ethylene oxide gas | Ethylene oxide gas |
| SAL: | 10-6 | 10-6 |
| Fluid Management | ||
| System: | · Use with gravity fed pressurized saline bag. | |
| · Use with The Aveta Fluid Management | ||
| System cleared in K190372. | Used in combination with Aveta Fluid Management System | |
| Tissue Resection: | • Used in combination with Aveta Disposable | |
| Resecting Device cleared in K190372 | Used in combination with Aveta Disposable Resecting | |
| Device |
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The differences outlined above were evaluated to demonstrate safety and effectiveness of the Aveta Disposable Hysteroscope.
VII. Non-Clinical Performance Testing
The following summary results of design control activities have been provided in support of the substantial equivalence determination.
- . Software verification
- . Simulated Use with gravity fed pressurized saline bag (Regulation of cavity pressure was demonstrated in a model uterine system, flow rate tests and tissue resection) was performed utilizing the Aveta Disposable Hysteroscope. Results demonstrate the subject device met specifications.
VIII. Conclusions
The results of the non-clinical testing described above demonstrate that the subject device is as safe and effective as the predicate device and support the subject device is substantially equivalent to the predicate device.