The Acessa Pro Vu System is indicated for use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance.

The Acessa ProVu System includes optional electromagnetic guidance for enhancing the ultrasonic image of the Acessa ProVu Handpiece and for predicting its future path on a computer monitor screen which also shows the ultrasound B-scan image.

Device Description

The Acessa ProVu System provides radiofrequency (RF) ablation, ultrasound visualization and guidance within a single console and includes additional accessories. The Acessa ProVu System consists of a console with push buttons to control menu functionality. The console contains the following hardware and electronic components:

RF Ablation System
Ultrasound Visualization System
Guidance System

The following accessories connect to the console:

Dual Foot pedal (one for RF ablation and one for coagulation)
Video Cable
Power Cord
Acessa Pads and Acessa Pad Cable
Acessa ProVu Handpiece and Acessa ProVu Handpiece Cable
Acessa Transducer, either:
- Acessa ProVu Transducer used with Acessa ProVu Transducer Sleeve (embedded with sensor), or
- Acessa ProVu Transducer with (embedded) sensor
Acessa Table Top Field Generator or Acessa ProVu Planar Field Generator
Monitor (hospital-owned accessory monitor, not provided by Acessa)

The Acessa ProVu System is designed to deliver up to 200 W of RF power at 460 kHz in three operational modes: Temperature Control, Power Control and Coagulation Mode. The graphical user interface (GUI) is displayed on a hospital-owned monitor. The system enables selection of operational parameters such as the mode of operation, the ablation time, the target temperature, and the power delivery level. With the Acessa ProVu Handpiece placed in the tissue to be ablated and its electrodes deployed, RF power can be turned on. The system parameters are continuously monitored and displayed on the monitor. If the measured parameters are outside the acceptable limits, the RF energy delivery automatically stops and a message appears on the graphical user interface. RF energy during an ablation or coagulation can also be stopped at any time by the user by pressing the foot pedal.

The Acessa ProVu System uses electromagnetic tracking technology to track the positions of the Acessa ProVu Transducer used with Acessa ProVu Transducer Sleeve (or the Acessa ProVu Transducer with embedded sensor) and the Acessa ProVu Handpiece shaft and draws virtual representations of them in their spatial relationship, so that a physician can predict the Acessa ProVu Handpiece shaft's future path in relation to the features in the ultrasound slice. The use of the guidance functionality is considered an optional accessory to procedures where ultrasound is currently used for visualization, such as the Acessa System procedure.

AI/ML Overview

The provided text describes the Acessa ProVu System and its premarket notification to the FDA. However, it does not contain a study to prove the device meets acceptance criteria, nor does it define specific acceptance criteria with quantitative performance metrics for the device. The document primarily focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and a summary of non-clinical bench testing.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, sample size used for the test set, data provenance, number of experts for ground truth, adjudication methods, MRMC study details, standalone performance, type of ground truth, training set sample size, and how training ground truth was established. This information is not present in the provided text.

The closest relevant information is a general statement that "The performance data demonstrate that the subject device is substantially equivalent to the predicate devices" and a list of non-clinical bench tests performed:

Biocompatibility Testing
Use Life Testing of Transducers
Electrical Safety and Electromagnetic Compatibility testing per various IEC/ANSI standards
Software Validation and Verification Testing per FDA guidance (software considered "major" level of concern)
Acessa ProVu Console and Guidance System Level Testing
Benchtop Ablation Testing to validate substantial equivalence to the predicate
Acessa ProVu Handpiece Performance Testing
Acessa Pads Performance Testing
Acessa ProVu Transducer Performance Testing (Acoustical and Thermal Measurement, in conformance with IEC 60601-2-37)
Acessa ProVu Transducer Sleeve Testing

The document states that the Acessa ProVu System includes optional electromagnetic guidance with an accuracy of ±10 mm. This is the only quantitative performance metric mentioned in relation to the device's functionality. It does not, however, present this as an "acceptance criterion" that was tested in a "study" with specific results.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and 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.

September 28, 2018

Acessa Health, Inc. Kim Rodriguez President & CEO 7004 Bee Cave Road, Bldg. 3, Suite 200 Austin, TX 78746

Re: K181124

Trade/Device Name: Acessa ProVu System Regulation Number: 21 CFR§ 884.4160 Regulation Name: Unipolar endoscopic coagulator-cutter and accessories Regulatory Class: II Product Code: HFG, OEW, IYO, ITX Dated: August 31, 2018 Received: August 31, 2018

Dear Kim Rodriguez:

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 mav, 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 avare 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 mediation-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) K181124

Device Name Acessa ProVu System

Indications for Use (Describe)

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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510(K) SUMMARY

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Acessa ProVu System is provided below.

	Primary	Secondary
Submitter's Name:	Acessa Health Inc.	Acessa Health Inc.
Submitter's Address:	7004 Bee Cave Rd,Bldg. 3, Suite 200,Austin, TX 78746	7004 Bee Cave Rd,Bldg. 3, Suite 200,Austin, TX 78746
Submitter's Telephone:	(877) 412-3828	(877) 412-3828
Submitter's Fax:	(925) 605-0327	(925) 605-0327
Contact Name:	Kim Rodriguez	Brian J. Bergeron
Date Summary was Prepared:	September 27, 2018
Trade or Proprietary Name:	Acessa ProVu System
Common or Usual Name:	Radiofrequency Ablation System
Primary Product Code:	HFG (coagulator, laparoscopic, unipolar (andaccessories))
Regulation Name and Number:	Class II per 21 CFR 884.4160: Unipolar EndoscopicCoagulator-Cutter and Accessories
Secondary Product Codes:	OEW, IYO, ITX
Classification Panel:	Obstetrics and Gynecology
Legally Marketed(Unmodified) Devices toWhich Substantial Equivalenceis Claimed:	Primary Predicate:K132744 Acessa Guidance SystemSecondary Predicates:K121858 The Acessa SystemK163121 Telemed SmartUS Ultrasound SystemThe predicate devices have not been subject to a designrelated recall.

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DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

RF Ablation System 1.
Ultrasound Visualization System 2.
1. Guidance System

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The following accessories connect to the console:

Dual Foot pedal (one for RF ablation and one for coagulation) O
Video Cable O
Power Cord O
Acessa Pads and Acessa Pad Cable O
O Acessa ProVu Handpiece and Acessa ProVu Handpiece Cable
O Acessa Transducer, either:
- Acessa ProVu Transducer used with Acessa ProVu Transducer Sleeve ● (embedded with sensor), or
- Acessa ProVu Transducer with (embedded) sensor
Acessa Table Top Field Generator or Acessa ProVu Planar Field Generator O
Monitor (hospital-owned accessory monitor, not provided by Acessa) O

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INTENDED USE/INDICATIONS FOR USE

The Acessa ProVu System is indicated for use in percutaneous, laparoscopic coagulation and ablation of soft tissue, including treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance.

The subject and predicate device have the same intended use.

	Acessa ProVuSystem(K181124)	Acessa GuidanceSystem(K132744)	The AcessaSystem(K121858)	SmartUS EXT-1M/3M(K163121)
General Information
ClassificationRegulation	21 CRF §884.4160	21 CRF §884.4160	21 CRF §884.4160	21 CRF §892.1550
Classification Name	Unipolar endoscopiccoagulator cutter andaccessories	Unipolar endoscopiccoagulator cutter andaccessories	Unipolar endoscopiccoagulator cutter andaccessories	Ultrasonic pulseddoppler imagingsystem
Product Code	HFG - coagulator,laparoscopic, unipolar(and accessories)	HFG - coagulator,laparoscopic, unipolar(and accessories)	HFG - coagulator,laparoscopic, unipolar(and accessories)	IYN
Secondary ProductCodes	OEW, IYO, ITX	OEW, IYO	N/A	ITX, IYO
Product Class	II	II	II	II
Intended Users	Health CareProfessionals	Health CareProfessionals	Health CareProfessionals	Health CareProfessionals
Classification Panel	Obstetrics andGynecology	Obstetrics andGynecology	Obstetrics andGynecology	Radiology
System Accessories	Field GeneratorUltrasound TransducerRF HandpieceDual foot pedalSingle use padsHandpiece CablePad CablePower Cord	Field GeneratorUltrasound TransducerRF HandpieceDual foot pedalSingle use padsHandpiece CablePad CablePower Cord	Field GeneratorUltrasound TransducerRF HandpieceDual foot pedalSingle use padsHandpiece CablePad CablePower Cord
RF Functionality
Operating Principle	Monopolar	Monopolar	Monopolar
Max PowerDelivery	200 W into 50-80 Ω	200 W into 50-80 Ω	200 W into 50-80 Ω
Frequency	460 kHz	460 kHz	460 kHz
Wave Form	Sinusoidal	Sinusoidal	Sinusoidal
TemperatureDisplay Range	15 - 125°C	15 - 125°C	15 - 125°C
Impedance Range	0-511 Ohms	0-511 Ohms	0-511 Ohms
Duration Range	0.1 to 12 minutes	0.1 to 12 minutes	0.1 to 12 minutes
TemperatureDisplay	Handpiece and Padthermocouples	Handpiece and Padthermocouples	Handpiece and Padthermocouples
	Acessa ProVuSystem(K181124)	Acessa GuidanceSystem(K132744)	The AcessaSystem(K121858)	SmartUS EXT-1M/3M(K163121)
Set Power Display	Yes, coagulation only	Yes, coagulation only	Yes, coagulation only
Duration of EnergyDelivery Displayed	Yes	Yes	Yes
Control Modes	Temperature, Manual,Coagulation	Temperature, Manual,Coagulation	Temperature, Manual,Coagulation
Power LevelControls	Yes, coagulation only	Yes, coagulation only	Yes, coagulation only
Ablation DurationControls	Yes	Yes	Yes
Maximum AblationDuration	12 minutes at targettime	12 minutes at targettime	12 minutes at targettime
Power Supply (PS)	100-240 V, 50/60 Hzswitchable PS	100-240 V, 50/60 Hzswitchable PS	100-240 V, 50/60 Hzswitchable PS
Peak Voltage	230 V	230 V	230 V
Manual ModePower Limit	15 W	10-15 W	10-15 W
Number of SerialCommunicationPorts	Single USB port	Single USB Port	Single USB Port
Pump used withGenerator	None	None	None
Display	Hospital-providedMonitor	LCD/Touch Screen	LCD/Touch Screen
User ControlInterface	System settingscontrolled at theConsole.	System settingscontrolled with thehandpiece buttons andat the RF GeneratorLCD/Touch Screen.	System settingscontrolled with thehandpiece buttons andat the RF GeneratorLCD/Touch Screen.
Guidance Functionality
TrackingTechnology	Electromagnetic	Electromagnetic
Accuracy	±10 mm	±10 mm
Views	Provide ageometrically accurate"3D" representation ofthe Transducer andHandpiece.Display a 2D insetview of the ultrasoundvideo, with the addedfeature of the targetzone overlaid on it andthe laparoscopicultrasound transducer	Provide ageometrically accurate"3D" representation ofthe Transducer andHandpiece.Display a 2D insetview of the ultrasoundvideo and thelaparoscopicultrasound transducer
Tracking System	NDI V3	NDI V2
Ultrasound Functionality
Ultrasound System	Ultrasound beamformers and drivers	Ultrasound beamformers and drivers(Off the shelf Aloka 6Ultrasound systemK093488)	Ultrasound beamformers and drivers(Off the shelf Aloka 6Ultrasound systemK093488)	Ultrasound beamformers and drivers
UltrasoundTransducer	Acessa ProVuTransducer (ModelNumber: 7500 or7700)	Aloka UST 5526L-75Transducer(K040719)	Aloka UST 5526L-75Transducer(K040719)	Aloka UST 5526L-75Transducer(K040719)

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

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The subject device is a combination system of the previously cleared devices that includes an RF ablation system (K121858), guidance control (K132744) and an OEM ultrasound component (K163121). As evidenced by the table above, there are differences in technological characteristics between the subject and predicate device. These differences do not raise different questions of safety and effectiveness.

SUMMARY OF PERFORMANCE DATA

To further support a determination of substantial equivalence, non-clinical bench testing was conducted to support the subject device. The specific types of non-clinical testing conducted are listed below.

Biocompatibility Testing O
Use Life Testing of Transducers o
Electrical Safety and Electromagnetic Compatibility testing per: O
- ANSI/AAMI/ES 60601-1:2005 + A2:2010 + A1:2012 .
- IEC 60601-2-2: 2017 ●
- IEC 60601-1-2: 2014
- . IEC 60601-2-37: 2015
Software Validation and Verification Testing per FDA's Guidance for Industry and O FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
Acessa ProVu Console and Guidance System Level Testing O
Benchtop Ablation Testing to validate that the ablations created by the subject device O are substantially equivalent to the predicate.
Acessa ProVu Handpiece Performance Testing to qualify and quantify the O mechanical and functional properties of the Handpiece.
Acessa Pads Performance Testing to qualify and quantify the mechanical and O functional properties of the Pads.
Acessa ProVu Transducer Performance Testing, including Acoustical and Thermal O Measurement, in conformance with IEC 60601-2-37
Acessa ProVu Transducer Sleeve Testing to qualify and quantify the mechanical and O functional properties of the Transducer Sleeve.

CONCLUSION

The performance data demonstrate that the subject device is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 884.4160 Unipolar endoscopic coagulator-cutter and accessories.

(a)
Identification. A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.(b)
Classification. Class II (performance standards).