(90 days)
Not Found
No
The summary does not mention AI, ML, or related concepts like deep learning, neural networks, or training/test sets for algorithmic models. The performance studies focus on traditional device functionalities and safety standards.
Yes
The device is used for "tissue chip resection and coagulation" and "removal of intrauterine polyps and myomas," which are direct therapeutic interventions.
No
The device is described as being used for "tissue chip resection and coagulation, and removal of intrauterine polyps and myomas," which are interventional procedures, not diagnostic ones. It also facilitates viewing and monitors fluid volume, which are supportive functions for an interventional procedure.
No
The device description explicitly lists multiple hardware components (Controller, Footswitch, Resectoscope, Fluid Control Set, Video Control Unit, Roll Stand, and accessories) and performance studies include hardware-related testing (dimensional inspection, thermal effects, electrical safety, etc.).
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 system for surgical intervention (tissue chip resection and coagulation, removal of polyps and myomas) and visualization within the uterus. This is a direct medical procedure performed on a patient's body.
- Device Description: The components listed (resectoscope, fluid control, video control, etc.) are all consistent with a surgical and visualization system used in vivo (within the living body).
- Lack of Diagnostic Function: The system's functions are focused on surgical manipulation, fluid management for visualization, and monitoring fluid deficit during the procedure. It does not perform any tests on biological samples (like blood, urine, tissue samples outside the body) to diagnose a disease or condition.
- Anatomical Site: The device is used intrauterine, directly within the patient's body. IVDs typically analyze samples taken from the body.
In summary, the Veloxion System is a surgical and visualization device used directly on a patient, not a device that performs diagnostic tests on biological samples in vitro.
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 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.
Product codes
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)
The following performance data have been provided in support of the substantial equivalence determination.
- Software Verification and Validation Testing performed per IEC 62304 and documentation provided per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- Other Tests were performed per approved test protocols which included:
- Integrity: System withstands operating pressures
- Functional Testing: Cut and coagulation, aspiration, irrigation, pressure control
- Dimensional Inspection and Testing
- Functional Testing for all components of the system
- Maximum LED Tip Temperature
- Comparative visualization testing in a simulated model
- Simulated Use: Tissue resection and spot coagulation of cavity pressure, imaging
- Durability Testing: Electrode durability testing for tissue resection and coagulation.
- Comparative testing to predicate for electrode durability, pressure control, fluid deficit, fluid control, resolution per ISO 8600-5, distortion and photobiologic safety per IEC 62471:2006.
- Thermal effects evaluation.
- Biocompatibility Testing per ISO 10993-1.
- Sterilization Validation per ISO 11135 and ISO 11137-1/-2/-3.
- Packaging Validation per ASTM D4169.
- Accelerated Aging per ASTM F1980
- Electrical Safety & EMC: In accordance with IEC 60601-1:2005, IEC 60601-1-2:2014, IEC 60601-2-18:2009 and IEC 60601-2-2:2009.
- Usability Testing: Use related risk evaluation
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.
April 24, 2019
Corinth MedTech, Inc. Sandeep Saboo Vice President, Quality Assurance & Regulatory Affairs 1601 S. De Anza Blvd., Suite 200 Cupertino, CA 95014
Re: K190113
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: January 22, 2019 Received: January 24, 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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
1
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.
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190113
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 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.
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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3
K_190113__: 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: | 21 January 2019 |
II. Product Classification
| Device Name: | Veloxion System | |
|---|---|---|
| Common Name: | Resectoscope | |
| Regulation: | 21 CFR 884.1690 | |
| Regulation Name: | Hysteroscope and accessories | |
| Class: | II | |
| Product Code: | HIH | |
| Additional Product Codes: | HIG, GEI | |
| Subject Device |
III. Predicate Devices
The predicate device is the system comprised of the following legally marketed devices as used in combination to which substantial equivalence is claimed:
Primary Predicate: Veloxion System (cleared per K180752) Predicate: Hysteroscope A22002A Olympus Corp. (cleared per K897003)
Predicate devices have not been a 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.
4
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.
V. Indications for Use
There is no difference in the indications for use for the modified Veloxion System (subject device) when compared to the predicate device (cleared Veloxion System, per K180752)
| 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 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 | |
| K180752 | |
| (Predicate 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 via suction channel under continuous flow conditions | |
| following resection using a bipolar resecting device. It is also intended to distend the | |
| uterus by filling with saline to facilitate viewing with a hysteroscope 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 and the previously cleared Veloxion System (K180752) and Olympus Hysteroscope (K897003) have the same or similar technological characteristics (see Table 1 and Table 2) in terms of basic operating principle and basic design features with a key difference being that the subject Veloxion System includes a sterile, single use camera and light while the predicate uses a commercially available reusable endoscope.
5
Veloxion System Traditional 510(k) Premarket Notification
| Technological Characteristics | VELOXION SYSTEM
(Subject) | VELOXION SYSTEM
(Predicate) |
|---------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Monopolar or Bipolar | Bipolar | Bipolar |
| Energy Type: | Radiofrequency, Bipolar | Radiofrequency, Bipolar |
| Optics: | Integrated, Sterile, 10° Endoscope | Compatible with reusable 30° marketed Endoscope |
| Set Fluid Deficit Range: | From 250 to 2500ml | From 250 to 2500ml |
| Fluid Deficit Rate ≥ 300ml/min notification to user? | YES | YES |
| Notification to user when Actual fluid deficit is 1000ml? | YES (no pause, notification only) | YES |
| Notification to user with pause when Actual fluid deficit is 2000ml? | YES | NO |
| Notification when Actual fluid deficit is within 250ml of Set Limit? | YES | YES |
| Device Stops when Set Limit or 2500ml is reached? | YES | YES |
| Set Pressure Range: | 35 to 120mmHg | 35 to 125mmHg |
| Positive Action to Increase Above 100mmHg: | YES | YES |
| Pressure Sensor: | Dual, independent sensing of cavity pressure | Dual, independent sensing of cavity pressure |
| Over-pressure condition detection: | YES | YES |
| Maximum Allowable Actual Cavity Pressure | 135mmHg for 5 seconds | 135mmHg for 5 seconds |
| Primary mitigation for risk of over-pressurization of uterus: | • Reverse rotation of irrigation wheel | • Reverse rotation of irrigation wheel |
| Ultimate mitigation for risk of over-pressurization of uterus if all
designed mitigations are unsuccessful | • Non-defeatable, continuous notification tone
• Notification displayed:
"Remove device from cavity. Check for Clog." | • Non-defeatable, continuous notification tone
• Notification displayed:
• "Remove device from cavity. Check for Clog." |
| Continuous Flow?: | YES | YES |
| Irrigation fluid: | Saline | Saline |
| Maximum # of saline bag(s) hung on saline load cell: | Four (4) | One (1) |
| Load cells: | Separate load cells to weigh the saline bags and the waste
bags | One load cell to weigh the combined saline and waste bag
load |
| Pump? | Dual Pump (Irrigation, Aspiration) | Dual Pump (Irrigation, Aspiration) |
| Irrigation Flow Rate: | Programmed irrigation flow rate constant for each mode:
Steady State = 100ml/min, Cut = 380ml/min,
Coag = 100ml/min, ASPIRATE = 650ml/min | Programmed irrigation flow rate constant for each mode:
Steady State = 100ml/min, Cut = 380ml/min,
Coag = 100ml/min, ASPIRATE = 400ml/min |
| Suction for aspiration of waste from patient drape: | Facility Suction | Waste Accessory Pump |
| Able to Monitor saline remaining?: | YES | YES |
| Shaft OD (Sheath): | With Sheath Assembled: 25Fr (8.3mm) | With Sheath Assembled: 26Fr (8.6mm) |
| Technological Characteristics | VELOXION SYSTEM
(Subject) | VELOXION SYSTEM
(Predicate) |
| Electrode (Dimension/Material/ Insulation/Actuation): | OD: 0.019"
Material: Tungsten (99.95% purity)
Insulation: FEP
Actuation: Linear Oscillating Loop | OD: 0.015"
Material: Tungsten (99.95% purity)
Insulation: FEP
Actuation: Circumferential Oscillating Wire |
| How Supplied (Sterility): | Sterile, Single Use
(Veloxion Resectoscope, Veloxion Fluid Control Set) | Sterile, Single Use
(Veloxion Resecting Device Kit, Veloxion Fluid Control Set) |
Table 1: Comparison of subject Veloxion System and predicate Veloxion System:
6
Veloxion System Traditional 510(k) Premarket Notification
Table 2: Comparison of subject Veloxion System and predicate Olympus Hysteroscope:
| Technological Characteristics | VELOXION SYSTEM
(Subject) | Olympus Hysteroscope
(K897003) |
|-------------------------------|------------------------------|-----------------------------------|
| OD: | Inner Sheath: 6.5mm | 4.0mm |
| Working Length: | 220mm | 280mm |
| DOV: | 10° | 30° |
| FOV: | 85° | 57° |
| Working Distance: | 5 to 50mm | 20mm |
| Light Source: | LED light | Xenon, Halogen, LED |
| Imaging: | Integrated CMOS sensor | External CCD camera |
| Total # Pixels: | 160,000 | Unknown |
| Pixels/mm2: | 160,000 | Unknown |
| Active Area of CCD Chip: | 714 $\mu$ m x 707 $\mu$ m | Unknown |
7
The main technological differences between the subject Veloxion System and the predicate Veloxion System are the following:
- The subject Veloxion System includes a sterile, single-use camera and light system while the predicate Veloxion System uses a commercially available reusable Endoscope.
- The subject Veloxion System includes programmed flow rates that are slightly different than the predicate Veloxion System as a result of an integrated passive flow mechanism.
The differences outlined were evaluated through performance testing to demonstrate safety and effectiveness of the subject Veloxion System.
VII. Performance Data
The following performance data have been provided in support of the substantial equivalence determination.
- Software Verification and Validation Testing performed per IEC 62304 and . documentation provided per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- . Other Tests were performed per approved test protocols which included:
- Integrity: System withstands operating pressures o
- Functional Testing: Cut and coagulation, aspiration, irrigation, pressure control o
- Dimensional Inspection and Testing O
- Functional Testing for all components of the system O
- Maximum LED Tip Temperature O
- Comparative visualization testing in a simulated model O
- Simulated Use: Tissue resection and spot coagulation of cavity pressure, O imaging
- Durability Testing: Electrode durability testing for tissue resection and coagulation. O
- o Comparative testing to predicate for electrode durability, pressure control, fluid deficit, fluid control, resolution per ISO 8600-5, distortion and photobiologic safety per IEC 62471:2006.
- Thermal effects evaluation. O
- Biocompatibility Testing per ISO 10993-1. O
- Sterilization Validation per ISO 11135 and ISO 11137-1/-2/-3. O
- Packaging Validation per ASTM D4169. O
- Accelerated Aging per ASTM F1980 O
- O Electrical Safety & EMC: In accordance with IEC 60601-1:2005, IEC 60601-1-2:2014, IEC 60601-2-18:2009 and IEC 60601-2-2:2009.
- Usability Testing: Use related risk evaluation O
- Integrity: System withstands operating pressures o
VIII. Conclusions
Based on the results of performance tests, the subject Veloxion System is considered to be substantially equivalent and as safe and effective as the predicate Veloxion System (K180752).