(125 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 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 into and out of the uterus.
The Veloxion System consists of the following components:
- Veloxion Controller (with Integrated Fluid Control)
- Footswitch
- Veloxion Resecting Device Kit:
- Veloxion Resecting Device
- Sheath
- Continuous Flow Optical Obturator
- Veloxion Fluid Control Set
- Veloxion Saline Pole
The Veloxion System also includes the following Class I accessories for handling of waste collected from the patient (these items apply no aspiration to the patient, they only handle waste after it is already outside the patient), which includes: - Waste Accessory Bag for collection of waste aspirated form the patient and from under patient's buttocks,
- Waste Accessory Tubing for collection of waste from under the patient's buttocks
- Waste Management Pump for moving the waste to the Waste Bag.
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 a hysteroscope and it monitors the fluid deficit (potential fluid absorbed by the patient's body) to the physician established limit.
The provided text describes a 510(k) premarket notification for the Veloxion System, a hysteroscopy device, and compares it to predicate devices. However, the document does not contain information related to acceptance criteria or a study proving the device meets specific performance metrics in the format requested, particularly for an AI/algorithm-based device.
The "Performance Data" section (Page 8 of the original document) lists various tests performed, but these are general engineering and functional validation tests for the hardware components of the hysteroscope system (e.g., software V&V, integrity, functional testing of aspiration/irrigation, dimensional inspection, simulated use, durability, electrical safety, usability). These tests are typical for a medical device's safety and effectiveness but do not detail specific acceptance criteria for device performance in a clinical context (e.g., sensitivity, specificity, accuracy for a diagnostic task), nor do they describe a study comparing the device's diagnostic or assistive capabilities against a specific ground truth, as would be expected for an AI/algorithm.
Therefore, many of the requested data points cannot be extracted from this document as they are not present. The document focuses on establishing substantial equivalence based on technological characteristics and general performance testing of the physical system, not on the performance of a specific algorithm or AI component in a diagnostic or interpretive task.
If the "Veloxion System" refers to a device with an AI component for interpretation, that information is not detailed within this 510(k) summary. The summary describes fluid control, tissue resection, and coagulation functions.
Based on the information provided in the document:
-
A table of acceptance criteria and the reported device performance: Not available in a format detailing clinical performance metrics (e.g., sensitivity, specificity, accuracy) for an AI or algorithm. The document lists general performance data for the physical device, such as "Software Verification and Validation Testing," "Integrity: System withstands operating pressures," "Functional Testing: Cut and coagulation, aspiration, irrigation, pressure control," etc. These are not quantifiable metrics that can be presented in a table against acceptance criteria for an AI's diagnostic or interpretive performance.
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable or not provided. The testing described is for the hardware system's functionality and safety, not for an algorithm's diagnostic performance on a dataset.
-
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): Not applicable or not provided, as there is no mention of a diagnostic performance study with ground truth establishment.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or not provided.
-
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: Not applicable or not provided. The document describes a medical device for hysteroscopy, not an AI-assisted diagnostic tool for interpretation by human readers.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable or not provided. The device described performs physical actions (resection, coagulation, fluid control) and monitoring, not standalone image analysis or diagnostic tasks.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable or not provided, as there is no diagnostic performance study described.
-
The sample size for the training set: Not applicable or not provided. This would be relevant for an AI/machine learning model, which is not the focus of this 510(k) summary.
-
How the ground truth for the training set was established: Not applicable or not provided.
Summary of available performance data (from section VII "Performance Data") related to the device's functional performance:
The document indicates that the following performance data were provided in support of substantial equivalence:
- Software Verification and Validation Testing performed per IEC 62304 and FDA guidance.
- Integrity testing (system withstands operating pressures).
- Functional Testing (Cut and coagulation, aspiration, irrigation, pressure control).
- Dimensional Inspection and Testing.
- Simulated Use (Tissue resection and spot coagulation, regulation of cavity pressure).
- Durability Testing (Electrode durability for tissue resection and coagulation).
- Fluid deficit testing.
- Comparative testing to predicate for electrode durability, pressure control, and fluid control.
- Electrical Safety & EMC per 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).
Conclusion from the document:
Based on these performance tests, the Veloxion System is considered substantially equivalent, safe, and effective as the predicate systems. The document confirms that the differences between the Veloxion System and predicate devices (e.g., dual pump system, programmed flow rates, single-use patient-contacting components) were evaluated through performance testing to demonstrate safety and effectiveness.
In essence, the document confirms the device meets acceptance criteria related to its mechanical, electrical, software, and functional performance, but not for AI/algorithm-based diagnostic or interpretive capabilities, as those are not described as functions of this device.
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July 25, 2018
Corinth MedTech, Inc. Sandeep Saboo Vice President, Regulatory Affairs and Quality Assurance 1601 S. De Anza Blvd., Suite 221 Cupertino. CA 95014
Re: K180752
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: June 22, 2018 Received: June 25, 2018
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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,
Sharon M. Andrews -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
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Indications for Use
510(k) Number (if known)
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 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 into and out of the uterus.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subnart C) |
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K180752: 510(k) Summary
I. Submitter Information
| Submitter name: | Corinth MedTech, Inc.1601 S. De Anza Blvd, Suite 221Cupertino, CA 95014 |
|---|---|
| Contact person: | Sandeep SabooVice President, Regulatory Affairs and Quality AssurancePhone: (408) 996-2517Fax: (408) 996-0621 |
| Date Prepared: | 23 July 2018 |
II. Product Classification
| Device Name: | Veloxion System | |
|---|---|---|
| Common Name: | Resectoscope | |
| Regulation: | 21 CFR 884.1690 | |
| Regulation Name: | Hysteroscope and accessories | Subject Device |
| Class: | II | |
| Product Code: | HIH | |
| Additional Product Codes: | HIG, GEI |
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: Richard Wolf Medical Instruments Corporation:
- · Resection Pump and Resectoscope for Chip Aspiration (K042523)
- · Hystero Pump II 2222 and Fluid Monitoring 2223 (K022449)
Predicate: ERBE, USA Inc., ERBE ESU Model VIO 300D with Accessories (K023886) Predicate: Veloxion System (cleared per K162979)
None of the predicates have been subject of a design related recall.
IV. Device Description
The Veloxion System consists of the following components:
- · Veloxion Controller (with Integrated Fluid Control)
- o Footswitch
- · Veloxion Resecting Device Kit:
- o Veloxion Resecting Device
- o Sheath
- 0 Continuous Flow Optical Obturator
- · Veloxion Fluid Control Set
- · Veloxion Saline Pole
The Veloxion System also includes the following Class I accessories for handling of waste collected from the patient (these items apply no aspiration to the patient, they only handle waste after it is already outside the patient), which includes:
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- · Waste Accessory Bag for collection of waste aspirated form the patient and from under patient's buttocks,
- · Waste Accessory Tubing for collection of waste from under the patient's buttocks
- · Waste Management Pump for moving the waste to the Waste Bag.
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 a hysteroscope and it monitors the fluid deficit (potential fluid absorbed by the patient's body) to the physician established limit. Therefore:
- · 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 and the fluid deficit limits. The software then monitors, controls and notifies the user when the limits are reached or when specific conditions are met.
- The Veloxion Resecting Device is a sterile single use hand held bipolar radiofrequency device configured 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 pressure sensor that provides two independent intrauterine pressure measurement (for redundancy) for monitoring cavity pressure during the procedure thereby facilitating the insufflation function.
- · The Veloxion Saline Pole enables monitoring of saline remaining in the saline bag and facilitates the fluid deficit function.
V. 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 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 the irrigation fluid flowing into and out of the uterus.
There are minor differences in the indications for use for the subject device when compared to the predicate system when the devices that comprise the predicate system are used together per their labeling to perform a hysteroscopy procedure. The predicate system is comprised of the following devices:
- Richard Wolf Resectoscope and Resection Pump for Chip Aspiration ●
- Richard Wolf Hystero Pump II (Model 2222) and Fluid Monitoring Display (Model 2223)
- ERBE ESU Model VIO 300 D with Accessories ●
The indications for use for the subject device when compared to the predicate Veloxion System differ with respect to the tissue type.
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Veloxion System
Traditional 510(k) Premarket Notification
| Comparison of Indications for Use | |
|---|---|
| Device | Indications For Use |
| Veloxion System(Subject Device) | The Veloxion System is intended for intrauterine use by trainedgynecologists for endoscopically controlled tissue chip resection andcoagulation, and removal of intrauterine polyps and myomas via suctionchannel under continuous flow conditions following resection using abipolar resecting device. It is also intended to distend the uterus by fillingwith saline to facilitate viewing with a hysteroscope and to monitor thevolume differential between fluid flowing into and out of the uterus. |
| Richard Wolf FluidManager(Predicate K022449)Fluid MonitoringDisplay (Model 2223)and Hystero Pump II(Model 2222) | The Hysteroscopy Fluid Management System is indicated for liquiddistension of the uterus for diagnostic and operative hysteroscopicprocedures, and monitoring the volume differential between the irrigationfluid flowing into and out of the uterus. |
| Resection Pump andResectoscope for ChipResection(Primary Predicate,K042523) | The Resection Pump 2228 with Resectoscope 8659.xxx is used forendoscopically controlled tissue chip resection and removal of intrauterinepolyps, intrauterine myoma or prostate adenomas via suction channelunder continuous flow conditions following resection using a high-frequency electrode with a Resectoscope. |
| ERBE ESU Model VIO300 D with Accessories(Predicate, K023886) | The ERBE ESU Model VIO 300 D with Accessories is intended to deliverHigh Frequency (HF) electrical current for the cutting and/or coagulationof tissue. |
| Veloxion SystemK162979(Predicate Device) | The Veloxion System is intended for endoscopically controlled tissue chipresection and coagulation and removal of prostate adenomas via suctionchannel under continuous flow conditions following resection using abipolar resecting device. |
The differences in indication statements do not represent a new intended use.
VI. Comparison of Technological Characteristics with the Predicate Device
The Veloxion System (subject device for hysteroscopy) and the predicate system (Richard Wolf Resectoscope and Resection Pump for Chip Aspiration (K042523), ERBE ESU Model VIO 300 D with Accessories (K023886) and Fluid Monitoring Display Model 2223 and Hystero Pump II Model 2222 (K022449)) and the previously cleared Veloxion System (K162979) have the same or similar technological characteristics in terms of basic operating principle and basic design features with one key difference being that Veloxion System includes dual, balanced pump system while the predicate system includes single pump for irrigation only. Both systems include roller peristaltic pumps and are to be used with specifically designed fluid monitoring unit and tube sets.
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Veloxion System Traditional 510(k) Premarket Notification
| Technological Characteristics | VELOXION SYSTEM(Subject and Predicate) | PREDICATE SYSTEM DevicesERBE ESU Model VIO 300 D with Accessories [K023886]Richard Wolf Resection Pump [K042523]Richard Wolf Fluid Manager [K022449] | |
|---|---|---|---|
| Monopolar or Bipolar | Bipolar | Bipolar or Monopolar | |
| Energy Type: | Radiofrequency, Bipolar | Radiofrequency, Bipolar or Monopolar Resection | |
| Optics: | Compatible with commercially available 30degree Endoscopes. | Compatible with 30degree Richard Wolf Endoscope | |
| Able to Set & Monitor Fluid Deficit? | YES | YES | |
| Able to Set Cavity Pressure on the Device? | YES | YES | |
| Continuous Flow? : | YES | YES | |
| Irrigation fluid: | Saline | Saline | |
| Pump? | Dual Pump (Irrigation, Aspiration) | Single Pump (Irrigation only) | |
| Able to Monitor saline remaining?: | YES | NO | |
| Irrigation Flow Rate: | Programmed irrigation flow rate constant for each modeSteady State = 100ml/min, Cut=380ml/min, Coag=100ml/min forSubject & PredicateASPIRATE=400ml/min for subject and 750ml/min for predicate. | Max. Irrigation flow rate is Set by the User from 150 to500ml/min. However, actual flow rate depends on the actualcavity pressure and outflow stopcock opening. | |
| Set Pressure Range: | 35 to 125mmHg (subject)15 to 60mmHg (predicate) | 15 to 150mmHg | |
| Positive Action to Increase Above 100mmHg: | YES (subject)40mmHg (predicate) | YES | |
| Pressure Sensor: | Dual, independent, direct sensing of cavity pressure | Dual, independent, pressure sensing of Irrigation tube (indirectmeasurement) | |
| Over-pressure condition detection: | YES | YES | |
| Maximum Allowable Actual Cavity Pressure | 135mmHg for 5 seconds (subject)75mmHg (predicate) | 200mmHg for 5 seconds | |
| Ultimate mitigation for risk of over-pressurization ofuterus if all designed mitigations are unsuccessful | • Non-defeatable, continuous notification tone• Notification displayed:"Remove device from cavity. Check for Clog." | • Continuous notification tone• Over-pressure display icon is illuminated and PressureDisplay flashes | |
| Set Fluid Deficit Range: | From 250 to 2500ml. Device stops when limit is reached (subjectonly) | From 0 to 2000ml but user can exceed 2500ml, if needed afterreaching 2000ml limit. | |
| Fluid Deficit Rate ≥ 300ml/min notification to user? | YES (subject only) | YES | |
| Notification to user with pause when Actual fluiddeficit is 1000ml? | YES (subject only) | NO | |
| Notification to user when Actual fluid deficit is 250mlless than Set fluid deficit? | YES (subject only) | NO | |
| Shaft OD (Sheath): | With Sheath Assembled: 26Fr (8.6mm) | With Sheath Assembled: 27Fr (9.0mm) | |
| Technological Characteristics | VELOXION SYSTEM(Subject and Predicate) | PREDICATE SYSTEM DevicesERBE ESU Model VIO 300 D with Accessories [K023886]Richard Wolf Resection Pump [K042523]Richard Wolf Fluid Manager [K022449] | |
| Working Length: | Sheath Working Length: 193mm | Sheath Working Length: 186mm | |
| Materials (Electrode/ Insulation): | Electrode: Tungsten (99.95% purity)Insulation: FEP | Electrode: TungstenElectrode Insulation: PTFE | |
| How Supplied (Sterility): | Sterile, Single Use(Veloxion Resecting Device Kit) | Sterile component:Non-Sterile, Reusable Components: | ElectrodeWorking ElementOuter SheathObturator |
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Veloxion System Traditional 510(k) Premarket Notification
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The main technological differences between the subject Veloxion System and the predicate system are the following:
- . The Veloxion System includes a dual, balanced pump system for a more controlled cavity pressure.
- The Veloxion System includes programmed flow rates that are equivalent to flow rate delivered using the predicate system which also varies based on user adjustment of outflow stopcock.
- . The patient contacting components of the Veloxion System are sterile, single use while the predicate system components are sterile, single use for some components and reusable for other components.
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
- Simulated Use: Tissue resection and spot coagulation, regulation of cavity pressure O
- Durability Testing: Electrode durability testing for tissue resection and coagulation. o
- Fluid deficit testing O
- o Comparative testing to predicate for electrode durability, pressure control and fluid control.
- Electrical Safety & EMC: In accordance with IEC 60601-1:2005, IEC 60601-1-O 2:2014, IEC 60601-2-18:2009 and IEC 60601-2-2:2009.
- Usability Testing: Use related risk evaluation 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 system:
- · Richard Wolf Resectoscope and Resection Pump for Chip Aspiration,
- · ERBE ESU Model VIO 300 D with Accessories, and
- · Richard Wolf Fluid Manager (Fluid Monitoring Display (Model 2223) and Hystero Pump II (Model 2222)).
as well as the previously cleared Veloxion System (K162979).
§ 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.