(136 days)
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 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 System (K190372).
This document is a 510(k) premarket notification for the "Aveta Disposable Hysteroscope" (K192100). The request is a submission to demonstrate substantial equivalence to a legally marketed predicate device (Aveta System, K190372). The provided text describes the device, its intended use, and a comparison to the predicate device. It also briefly mentions non-clinical performance testing.
However, the document does not contain information about acceptance criteria, clinical study design, sample sizes for test or training sets, expert qualifications, ground truth establishment methods, or whether MRMC or standalone performance studies were conducted.
Therefore, I cannot fulfill your request for details on the acceptance criteria and the study that proves the device meets those criteria using only the provided text for the Aveta Disposable Hysteroscope (K192100).
The provided text focuses on demonstrating substantial equivalence through non-clinical performance testing and a comparison of technological characteristics and indications for use to a predicate device. This type of submission (510(k)) typically relies on comparisons to demonstrate safety and efficacy, rather than extensive new clinical studies with detailed acceptance criteria as one might see for a PMA or novel AI/ML device where clinical performance is the primary assessment.
Based on the provided document, the only "study" mentioned is "Non-Clinical Performance Testing," which includes:
- Software verification
- Simulated Use with gravity fed pressurized saline bag: This involved demonstrating regulation of cavity pressure in a model uterine system, flow rate tests, and tissue resection.
Here's what I can extract and what is explicitly missing based on your request categories:
1. A table of acceptance criteria and the reported device performance
- Missing from the document. The document only states that "Results demonstrate the subject device met specifications" for the simulated use testing, but it does not list those specifications or acceptance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Missing from the document. The non-clinical testing appears to be primarily benchtop and simulated use; therefore, there isn't a "test set" in the context of patient data.
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)
- Missing from the document. This is a non-clinical evaluation, so expert adjudication of patient data for ground truth is not applicable here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Missing from the document. Not applicable for this type of non-clinical submission.
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
- Missing from the document. This device is a hysteroscope, not an AI/ML diagnostic tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Missing from the document. Not applicable, as this is a medical device, not an AI algorithm. Its performance is evaluated in conjunction with human use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Missing from the document. For non-clinical testing, "ground truth" would typically refer to established engineering and performance specifications validated through physical measurements and simulations, rather than clinical ground truth from patients. The document does not specify these.
8. The sample size for the training set
- Missing from the document. Not applicable, as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
- Missing from the document. Not applicable.
Summary of available information related to performance:
- Device Name: Aveta Disposable Hysteroscope (K192100)
- Predicate Device: Aveta System (K190372)
- Type of Evaluation: Non-Clinical Performance Testing to demonstrate substantial equivalence to a predicate device.
- Tests Performed:
- Software verification
- Simulated Use with gravity-fed pressurized saline bag (demonstrated: regulation of cavity pressure in a model uterine system, flow rate tests, tissue resection).
- Conclusion: "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."
To obtain the specific details requested in your prompt, you would need access to the full 510(k) submission (e.g., test reports) which is not typically made public in this summarized format.
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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.
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
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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 180San Jose, CA 95129 | |
|---|---|---|
| Contact person: | Csaba TruckaiPresident & CEOMobile: (415) 215-7233Office: (408) 471-4877csabat@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
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System (K190372). Provided in Table 1 are additional details on the modified Aveta Disposable Hysteroscope.
| Aveta DisposableHysteroscope andAccessory | DeviceCharacteristics &Packaging | Materials; PatientContact and ContactDuration | Functions Performed |
|---|---|---|---|
| Aveta DisposableHysteroscope | Sterile (EO), singleuse, used in the sterilefield. Tyvek/FilmPouch | Polymers (PVC, ABS);Stainless Steel, directpatient contact forlimited duration. | • Visualization of uterine cavity.• Provides conduits/lumens for inflow,outflow.• Provides conduit for mechanical ResectingDevice for operative hysteroscopy.• Provides controls to the user to recordimages.• Provides controls to the user to performimage transfer |
| Aveta Controller(accessory) | Non-sterile, reusable,used outside thesterile field | No patient contact | • Camera, light, image processing and imagestoring. |
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 thecervical canal and the uterine cavity for the purpose of performingdiagnostic and surgical procedures. |
| Aveta System(Predicate)(K190372) | The Aveta System is intended for intrauterine use by trained gynecologiststo permit viewing of the cervical canal and the uterine cavity, provideliquid distension of the uterus and monitor the volume differential betweenthe irrigation fluid flowing into and out of the uterus during diagnostic andsurgical procedures to resect and remove tissue such as submucousmyomas. 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 canaland the uterine cavity. | Intended for the distention and visualization of the cervicalcanal and the uterine cavity and for endoscopic resection andremoval of tissue chips via suction while monitoring volumedifferential between the irrigation fluid flowing into and outof the uterus. |
| Indications for Use: | The Aveta Disposable Hysteroscope is used topermit viewing of the cervical canal and theuterine cavity for the purpose of performingdiagnostic and surgical procedures. | The Aveta System is intended for intrauterine use by trainedgynecologists to permit viewing of the cervical canal andthe uterine cavity, provide liquid distension of the uterusand monitor the volume differential between the irrigationfluid flowing into and out of the uterus during diagnosticand surgical procedures to resect and remove tissue such assubmucous myomas, endometrial polyps and retainedproducts of conception. |
| Materials ofConstruction: | 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 ChannelDiameter: | 3.5mm | 3.5mm |
| Working ChannelClosure: | Silicone valve | Silicone valve |
| Recommended LightSource: | 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 AvetaDisposable Hysteroscope is processed and sentto Aveta Controller for further processing anddisplayed on a monitor | Image generated by the CMOS sensor in Aveta DisposableHysteroscope is processed and sent to Aveta Controller forfurther processing and displayed on a monitor |
| How provided: | Sterile, single-use | Sterile, single-use |
| SterilizationMethod: | Ethylene oxide gas | Ethylene oxide gas |
| SAL: | 10-6 | 10-6 |
| Fluid ManagementSystem: | · Use with gravity fed pressurized saline bag.· Use with The Aveta Fluid ManagementSystem cleared in K190372. | Used in combination with Aveta Fluid Management System |
| Tissue Resection: | • Used in combination with Aveta DisposableResecting Device cleared in K190372 | Used in combination with Aveta Disposable ResectingDevice |
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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.
§ 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.