(20 days)
Not Found
No
The summary describes a system for intrauterine tissue resection and fluid management, focusing on hardware components and basic control functions like pressure monitoring and fluid deficit calculation. There is no mention of AI, ML, image processing, or any features that would suggest the use of such technologies for analysis, decision-making, or advanced control.
Yes
The device is intended for endoscopically controlled tissue chip resection and coagulation, and removal of intrauterine polyps and myomas and benign conditions requiring endometrial ablation, which are therapeutic interventions.
No
Explanation: The device description and intended use focus on tissue removal, coagulation, and uterine distension for surgical procedures, not on the identification or analysis of diseases or conditions for diagnosis. While it monitors fluid deficit, this is for safety during the procedure, not for diagnostic purposes.
No
The device description explicitly lists multiple hardware components, including a controller, footswitch, resectoscope, fluid control set, video control unit, and roll stand.
Based on the provided information, the Veloxion System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical procedures within the uterus (tissue resection, coagulation, removal of polyps and myomas, endometrial ablation). It also facilitates viewing and monitors fluid balance during these procedures. This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The components listed (resectoscope, fluid control, video control, etc.) are consistent with surgical and endoscopic equipment used for direct intervention and visualization within the body.
- Lack of Diagnostic Function: There is no mention of the device analyzing biological samples (blood, tissue, etc.) to provide diagnostic information about a patient's condition. The "Tissue Catch" component is for collecting tissue after it has been resected for potential pathology, which is a separate process, not a function of the Veloxion System itself.
- No Mention of Diagnostic Output: The description focuses on controlling the surgical environment (distension, pressure, fluid monitoring) and performing surgical actions (resection, coagulation). There is no indication of the device producing a diagnostic result or interpretation.
In summary, the Veloxion System is a surgical device used for therapeutic and procedural purposes within the uterus, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HIH, HIG, GEI
Device Description
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intrauterine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained gynecologists
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)
Results of tests provided for the predicate were adequate to support the new indication.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
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.
1
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
2
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 200
Cupertino, CA 95014 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Sandeep Saboo
Vice President, Regulatory Affairs and Quality Assurance
Phone: (408) 996-2517
Fax: (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
4
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 |
|---|---|
| Modified | |
| Veloxion System | |
| (Subject Device) | 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 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 to | |
| monitor the volume differential between fluid flowing into and out of the uterus. | |
| Veloxion System | |
| K190113 | |
| (Primary | |
| Predicate) | 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 via suction channel 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 to monitor the volume differential between fluid | |
| flowing 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.