The Veloxion System is intended for endoscopically controlled tissue chip resection and coagulation, and removal of prostate adenomas via suction channel under continuous flow conditions following resection using a bipolar resecting device.

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 Controller provides bipolar radiofrequency outputs (cut and coagulation) and fluid control through the use of two integrated peristaltic pumps. The Resecting Device is a disposable, hand held bipolar radiofrequency device configured for the resection and aspiration of resected chips. Fluid inflow and aspiration of the resected chips are controlled by the Controller's peristaltic pumps, in conjunction with the disposable Fluid Control Set, which provides continuous inflow and aspiration during the procedure.

AI/ML Overview

The provided text is a 510(k) premarket notification from the FDA, and it describes a medical device called the "Veloxion System" for endoscopically controlled tissue chip resection and coagulation, specifically for prostate adenomas.

However, it does not contain any information regarding acceptance criteria, device performance metrics, or study details (like sample size, number of experts, ground truth, or MRMC studies) related to the clinical performance or efficacy of the device.

The "Performance Data" section (VII) lists various types of engineering and safety tests (e.g., Sterility, Biocompatibility, Software, EMC, Mechanical Integrity, Functional Testing, Dimensional Testing, Simulated Use, Thermal effect, Usability). These are primarily focused on the device's technical specifications, safety, and manufacturing quality, rather than its clinical efficacy or diagnostic accuracy.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text. The document does not contain this type of information.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 24, 2017

Corinth MedTech, Inc. Sandeep Saboo Vice President, Regulatory Affairs and Quality Assurance 1601 S. De Anza Blvd., Suite 221 Cupertino, CA 95014

Re: K162979

Trade/Device Name: Veloxion System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FJL, KQT, GEI Dated: February 14, 2017 Received: February 15, 2017

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Joyce M. Whang -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) K162979

Device Name Veloxion System

Indications for Use (Describe)

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 Subpart C)

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Section 5: 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:	07 December 2016

II. Product Classification

Device Name:	Veloxion System
Common Name:	Endoscope and accessories
CFR Classification:	21 CFR 876.1500
Device Class:	II
Product Code:	FJL
Common Name:	Gastroenterology-urology evacuator
CFR Classification:	21 CFR 876.4370
Device Class:	II
Product Code:	KQT
Common Name:	Electrosurgical cutting and coagulation device and accessories
CFR Classification:	21 CFR 878.4400
Device Class:	II
Product Code:	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 Resection Pump and Resectoscope for Chip Aspiration
	(K042523)
Predicate:	ERBE, USA Inc., ERBE ESU Model VIO 300D with Accessories
	(K023886)

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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 ●

V. Indications for Use

VI. Comparison of Intended Use, Indications for Use and Technological Characteristics with the Predicate Device

The Veloxion System shares the same intended use as the predicate devices used as a system: Endoscopically controlled coagulation, resection and removal of tissue chips via suction channel under continuous flow conditions following resection using a high-frequency electrode with a resectoscope.

The indications for use are substantially the same as those of the primary predicate as it applies to prostate adenomas. The indications for use of the subject device is a subset of the indications for use of the primary predicate device. The narrower indication of the subject device does not raise any new or different issues of safety or effectiveness.

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Comparison of Indications for Use

Comparison of Indications for Use
Veloxion System(Subject)	The Veloxion System is intended for endoscopically controlled tissue chip resection and coagulation, and removal of prostate adenomas via suction channel under continuous flow conditions following resection using a bipolar resecting device.
Resection Pump andResectoscope forChip Resection(Primary Predicate,K042523)	The Resection Pump 2228 with Resectoscope 8659.xxx is used for endoscopically controlled tissue chip resection and removal of intrauterine polyps, intrauterine myoma or prostate adenomas via suction channel under continuous flow conditions following resection using a high-frequency electrode with a Resectoscope.
ERBE ESU ModelVIO 300 D withAccessories(Predicate,K023886)	The ERBE ESU Model VIO 300 D with Accessories is intended to deliver High Frequency (HF) electrical current for the cutting and/or coagulation of tissue.

The subject and predicate systems are based on the following similar technological features:

Both systems endoscopically control coagulation, resection and removal of tissue chips ● via suction using a radiofrequency electrode.
Both systems are designed for resection and removal of prostate adenomas
Both systems enable continuous flow for irrigation and aspiration.
Both systems include a Resectoscope.
. Both systems include a radiofrequency generator/controller with a footswitch.
Both systems include a pump to provide suction for removal of the resected tissue.
Both systems include Resectoscope compatible with 30degree Endoscope ●
Both systems include Resectoscope that cut and coagulate tissue using bipolar RF energy.

VII. Performance Data

The following performance data were provided in support of the substantial equivalence determination:

Sterility, Shelf Life and Packaging Testing
Biocompatibility testing performed to ISO 10993-1 ●
Software Testing performed to IEC 62304 ●
Electromagnetic Compatibility and Electrical Safety Testing performed to IEC 60601-1 ● and 60601-1-2
Mechanical Integrity: System withstands operating pressures ●
Functional Testing: Cut and coagulation, aspiration, irrigation, pressure sensing ●
Dimensional Testing
. Simulated Use: Tissue resection and spot coagulation, regulation of cavity pressure
Thermal effect on tissue: Ex-vivo thermal damage study
Usability Evaluation ●

VIII. Conclusions

Based on the results of performance testing demonstrating the safety and effectiveness of the subject device to be as good as the predicate device, the Veloxion System is substantially equivalent to the predicate system.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.