(20 days)
The Veloxion System is intended for intrauterine use by trained gynecologists for endoscopically controlled tissue chip resection and coagulation, and removal of intrauterine polyps and myomas and benign conditions requiring endometrial ablation via suction channel under continious flow conditions following resection using a bipolar resectoscope. It is also intended to distend the uterus by filling with saline to facilitate viewing and to monitor the volume differential between fluid flowing into and out of the uterus.
The Veloxion System consists of the following components:
- Veloxion Controller (with Integrated Fluid Control)
- Footswitch
- Veloxion Resectoscope
- Veloxion Fluid Control Set
- Veloxion Video Control Unit
- Veloxion Roll Stand
The Veloxion System also includes the following Class I accessories for handling of waste collected from the patient (these items only handle waste after it is already outside the patient), which includes: - Waste Management Tubing: To provide a conduit for transfer of aspirated fluids and tissue from the patient and from under the patient's buttocks drape
- Tissue Catch: For collection of gross resected tissue pieces for pathology.
- Waste Management Bags: To provide bags for final collection of outflow.
The Veloxion System provides bipolar resection and coagulation of intrauterine tissue, it distends the uterus by filling with saline, it provides pressure control of the intrauterine cavity for insufflation to facilitate viewing with the integrated hysteroscope and it monitors the fluid deficit (potential fluid absorbed by the patient's body) to the physician established limit.
This document describes the FDA clearance for the Veloxion System, a device used in gynecological procedures. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and study design for performance.
Here's what can be extracted and what is missing:
1. Table of acceptance criteria and the reported device performance:
This document does not provide specific acceptance criteria or reported device performance metrics in a quantifiable way. It states: "Results of tests provided for the predicate were adequate to support the new indication." This implies that the device met certain performance standards, but those standards and the actual performance are not detailed here.
Missing Information: Specific numerical acceptance criteria (e.g., accuracy thresholds, failure rates, precision limits) and the measured performance of the device against these criteria.
2. Sample size used for the test set and the data provenance:
This document does not specify a sample size for a test set or data provenance (country of origin, retrospective/prospective). It refers to "tests provided for the predicate" but does not detail them.
Missing Information: The specific sample size of the test set, the country of origin of the data, and whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This document does not mention the use of experts to establish a ground truth or their qualifications. Given the nature of the device (a hysteroscopic system for tissue resection/coagulation and fluid management), the "ground truth" would likely be related to the device's functional integrity, safety, and effectiveness in performing its intended tasks, rather than image interpretation.
Missing Information: Information on experts used for ground truth establishment and their qualifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This document does not describe any adjudication method.
Missing Information: The adjudication method used for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
This document does not refer to a multi-reader multi-case comparative effectiveness study or AI assistance. The Veloxion System appears to be a surgical device with fluid management and visualization capabilities, not an AI-powered diagnostic tool for human readers.
Missing Information: Information on MRMC studies or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This document does not describe a standalone algorithm performance study. The device is a system with human-in-the-loop operation (trained gynecologists).
Missing Information: Information on standalone algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This document does not explicitly state the type of ground truth used. For a device like the Veloxion System, the "ground truth" for proving effectiveness and safety would likely involve a combination of:
- Pre-clinical testing: Bench testing for mechanical, electrical, fluid management, and energy delivery performance.
- Biocompatibility testing: To ensure materials are safe for human contact.
- Sterilization validation: To confirm the device can be properly sterilized.
- Clinical validation (if applicable and part of the predicate device's data): Observing the device's performance in surgical settings, potentially using outcomes data for the predicate.
The primary predicate (K190113) was cleared previously, and the current submission (K191335) largely relies on the predicate's testing. The specific new indication mentioned is "endometrial ablation," which suggests that the testing would focus on the device's ability to safely and effectively perform ablation, possibly verified through histopathology or visual confirmation of ablation efficacy.
Missing Information: Explicit statement of the type of ground truth used.
8. The sample size for the training set:
This document does not mention a training set sample size. This is because the Veloxion System is a physical medical device, not an algorithm that requires a "training set" in the machine learning sense.
Missing Information: A training set sample size.
9. How the ground truth for the training set was established:
This document does not mention a training set or how its ground truth was established, for the same reasons as point 8.
Missing Information: How ground truth for a training set was established.
Summary of what the document does provide:
- Device Name: Veloxion System
- Indications for Use: Intrauterine use by trained gynecologists for endoscopically controlled tissue chip resection and coagulation, removal of intrauterine polyps and myomas, and benign conditions requiring endometrial ablation via suction channel under continuous flow conditions following resection using a bipolar resectoscope. It also distends the uterus with saline for viewing and monitors fluid volume differential.
- Predicate Device: Veloxion System (K190113) from Corinth MedTech, Inc.
- Basis for Clearance: Substantial equivalence to the predicate device, with an added indication for endometrial ablation. The submission states, "Results of tests provided for the predicate were adequate to support the new indication." This implies that the validation work done for the predicate device, plus any additional testing for the new indication, was sufficient.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
June 6, 2019
Corinth MedTech, Inc. Sandeep Saboo Vice President. Ouality Assurance & Regulatory Affairs 1601 S. De Anza Blvd., Suite 200 Cupertino, CA 95014
K191335 Re: Trade/Device Name: Veloxion System Regulation Number: 21 CFR§ 884.1690 Regulation Name: Hysteroscope and Accessories Regulatory Class: II Product Code: HIH, HIG, GEI Dated: May 15, 2019 Received: May 17, 2019
Dear Sandeep Saboo:
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 (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 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,
Sharon M. Andrews 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) K191335
Device Name Veloxion System
Indications for Use (Describe)
The Veloxion System is intended for intrauterine use by trained gynecologists for endoscopically controlled tissue chip resection and coagulation, and removal of intrauterine polyps and myomas and benign conditions requiring endometrial ablation via suction channel under continious flow conditions following resection using a bipolar resectoscope. It is also intended to distend the uterus by filling with saline to facilitate viewing and to monitor the volume differential between fluid flowing into and out of the uterus.
| 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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K191335: 510(k) Summary
I. Submitter Information
| Submitter name: | Corinth MedTech, Inc.1601 S. De Anza Blvd, Suite 200Cupertino, CA 95014 |
|---|---|
| Contact person: | Sandeep SabooVice President, Regulatory Affairs and Quality AssurancePhone: (408) 996-2517Fax: (408) 996-0621 |
| Date Prepared: | 5 June 2019 |
II. Product Classification
| Device Name: | Veloxion System | |
|---|---|---|
| Common Name: | Resectoscope | Subject Device |
| Regulation: | 21 CFR 884.1690 | |
| Regulation Name: | Hysteroscope and accessories | |
| Class: | II | |
| Product Code: | HIH | |
| Additional Product Codes: | HIG, GEI |
III. Predicate Device
| Predicate | Manufacturer | Predicate Device Names | 510(k)# | Clearance Date |
|---|---|---|---|---|
| Primary Predicate | Corinth MedTech, Inc. | Veloxion System | K190113 | April 24, 2019 |
Predicate device has not been the subject of a design related recall.
IV. Device Description
The Veloxion System consists of the following components:
- · Veloxion Controller (with Integrated Fluid Control)
- 0 Footswitch
- · Veloxion Resectoscope
- · Veloxion Fluid Control Set
- · Veloxion Video Control Unit
- · Veloxion Roll Stand
The Veloxion System also includes the following Class I accessories for handling of waste collected from the patient (these items only handle waste after it is already outside the patient), which includes:
- · Waste Management Tubing: To provide a conduit for transfer of aspirated fluids and tissue from the patient and from under the patient's buttocks drape
- · Tissue Catch: For collection of gross resected tissue pieces for pathology.
- · Waste Management Bags: To provide bags for final collection of outflow.
The Veloxion System provides bipolar resection and coagulation of intrauterine tissue, it distends the uterus by filling with saline, it provides pressure control of the intrauterine cavity for insufflation to facilitate viewing with the integrated hysteroscope and it monitors the fluid deficit (potential fluid
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K191335 Page 2 of 2
absorbed by the patient's body) to the physician established limit. The components of Veloxion System perform the following functions:
- · The Veloxion Controller provides bipolar radiofrequency outputs (for cut and coagulation) and fluid/pressure control through the use of two integrated peristaltic pumps, provides the user interface to establish the desired set pressure, monitors intracavitary pressure using dual independent pressure sensors mechanically connected to the Veloxion Fluid Control Set irrigation lumen. The software then monitors, controls and notifies the user when the limits are reached or when specific conditions are met.
- · The Veloxion Resectoscope is a sterile single use hand held bipolar radiofrequency device configured to provide camera and light for visualization of the anatomy for the resection of tissue and aspiration of resected chips. Fluid inflow and aspiration of the resected chips are controlled by the Controller's peristaltic pumps.
- · The Veloxion Fluid Control Set is a sterile single use device that provides conduits for fluid inflow, aspiration of resected tissue and fluids and a diaphragm (pressure membrane) that provides mechanism for the Controller to measure cavity pressure (through the irrigation lumen) during the procedure thereby facilitating the insufflation function.
- · The Veloxion Video Control Unit provide control of the camera, light, display image to a commercially available monitor, stores image and video selected by the user from a session, and provides a USB connection for a USB Stick download of stored media by the user.
- · The Veloxion Roll Stand enables monitoring of saline remaining in the saline bag and facilitates the fluid deficit function.
V. Indications for Use
When compared to the predicate, the subject device includes the addition of endometrial ablation to the indications for use. This difference in indications for use does not represent a new intended use.
| Device | Indications For Use |
|---|---|
| ModifiedVeloxion System(Subject Device) | The Veloxion System is intended for intrauterine use by trained gynecologists forendoscopically controlled tissue chip resection and coagulation, and removal of intrauterinepolyps and myomas and benign conditions requiring endometrial ablation via suctionchannel under continuous flow conditions following resection using a bipolar resectoscope.It is also intended to distend the uterus by filling with saline to facilitate viewing and tomonitor the volume differential between fluid flowing into and out of the uterus. |
| Veloxion SystemK190113(PrimaryPredicate) | The Veloxion System is intended for intrauterine use by trained gynecologists forendoscopically controlled tissue chip resection and coagulation, and removal of intrauterinepolyps and myomas via suction channel under continuous flow conditions followingresection using a bipolar resectoscope. It is also intended to distend the uterus by fillingwith saline to facilitate viewing and to monitor the volume differential between fluidflowing into and out of the uterus. |
Comparison of Indications for Use
VI. Comparison of Technological Characteristics with the Predicate Device
The subject Veloxion System has the same technological characteristics as the predicate device.
VII. Performance Data
Results of tests provided for the predicate were adequate to support the new indication.
VIII. Conclusions
The subject Veloxion System is as safe and effective as 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.