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

Device Description

Acessa Guidance Handpiece (Model Number 5300):

The Acessa Guidance Handpiece, when used with the tracking system, is meant to guide the tip of the Handpiece up to the uterine serosa. Once the device is advanced into the uterus, standard ultrasound views are used to guide the tip to the fibroid. Ultrasound visualization for fibroid penetration and treatment remain unchanged.

The Acessa Guidance Handpiece is a single-use only, sterile, radiofrequency (RF) applicator that connects to the Acessa Generator by a custom Cable. The Handpiece consists of a handle with a trocar shaft, active needle tip, and seven deployable needle electrodes each with embedded thermocouple sensors for real-time temperature feedback. The Acessa Guidance Handpiece also has control buttons that allow the user to access the User Interface.

This Acessa Guidance Handpiece also contains the magnetic guidance sensor used to determine spatial location. The embedded sensor and SROM can be used with the electromagnetic tracking technologies to track the positions of an Ultrasound Transducer and the Handpiece shaft, and draws virtual representations of them in their spatial relationship, so that a physician can predict the Handpiece shaft's future path in relation to the features in the ultrasound slice. These electromagnetic tracking technologies are considered optional accessories to Acessa System procedure.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Acessa Guidance Handpiece based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Acceptance Criteria	Reported Device Performance
Electrical and Safety Testing	Compliance with EN/IEC 60601-1:2005/2006 (3rd edition) Medical Electrical Equipment Part 1 General Requirements for Safety; EN/IEC 60601-1-2:2007 (3rd edition) Medical Electrical Equipment General Requirements for Basic Safety and Essential Performance Collateral Standard Electromagnetic Compatibility Requirements and Tests; EN/IEC 60601-2-2:2009 (5th edition) Medical Electrical Equipment Particular Requirements for the Safety of High Frequency Surgical Equipment.	Passed all testing.
Biocompatibility Testing	Compliance with ISO 10993-1:2009 (4th edition) Biological Evaluation of Medical Devices Part 1 Evaluation and Testing within a Risk Management Process; ISO 10993-5:2009 (3rd edition) Biological Evaluation of Medical Devices Tests for In Vitro Cytotoxicity; ISO 10993-10:2010 (2nd edition) Biological Evaluation of Medical Devices Tests for Irritation and Delayed-Type Hypersensitivity; and ISO 10993-11:2006 (2nd edition) Biological Evaluation of Medical Devices Tests for Systemic Toxicity.	Demonstrated safety, suitability, and appropriateness for intended use.
Flexural Strength Testing	Not explicitly stated in terms of specific numeric criteria, but evaluated against established criteria.	Met all criteria.
Compatibility with EM Tracking	Not explicitly stated in terms of specific numeric criteria, but evaluated against established criteria for functionality with an electromagnetic tracking system.	Met all criteria.

2. Sample Size Used for the Test Set and Data Provenance

The provided document describes performance testing of the device itself (electrical, safety, biocompatibility, mechanical, and compatibility with a tracking system), not a clinical study on patient data. Therefore, there isn't a "test set" in the context of patient data, nor is there data provenance in terms of country of origin or retrospective/prospective nature for such a clinical study. The testing was technical in nature, conducted on the device hardware and materials.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. As noted above, this was not a study evaluating performance against a clinical ground truth established by experts.

4. Adjudication Method for the Test Set

Not applicable. This was not a study involving expert adjudication of clinical cases.

5. 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. This document describes the 510(k) submission for a medical device (Acessa Guidance Handpiece) which is a physical instrument, not an AI or software algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant here.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance testing was based on:

Established national and international standards for electrical safety (EN/IEC 60601 series).
Established national and international standards for biocompatibility (ISO 10993 series).
Internal criteria for flexural strength and compatibility with the electromagnetic tracking system.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable.

Summary

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K132184
Page 1 of 2

APR 2 8 2014

As Required By 21 CFR 807.92
Date of Summary Preparation	April 25, 2014
Submitter and Owner's Name andAddress	Halt Medical, Inc.131 Sand Creek Road, Suite BBrentwood, CA 94513Main: (925) 634-7943Fax: (925) 634-7841
Contact Person	Clarisa A. TateVP Director of RA & QA, Halt Medical, Inc.Office: (925) 271-0626e-mail: ctate@haltmedical.com
Trade Name	Acessa Guidance Handpiece
Common Name	Acessa Guidance Handpiece
Classification Name	Unipolar endoscopic coagulator-cutter and accessories
Classification	Class II
Product Code	HFG
Classification Panel	Obstetrics and Gynecology
Classification Regulation	21 CFR §884.4160
Legally Marketed Device to whichsubstantial equivalence is claimed	Acessa System (K121858)
Intended Use	The Acessa Guidance Handpiece is indicated for use in percutaneouslaparoscopic coagulation and ablation of soft tissue, including treatment ofsymptomatic uterine fibroids under laparoscopic ultrasound guidance.
DeviceDescription	Acessa Guidance Handpiece (Model Number 5300):The Acessa Guidance Handpiece, when used with the tracking system, is meant toguide the tip of the Handpiece up to the uterine serosa. Once the device isadvanced into the uterus, standard ultrasound views are used to guide the tip tothe fibroid. Ultrasound visualization for fibroid penetration and treatment remainunchanged.The Acessa Guidance Handpiece is a single-use only, sterile, radiofrequency (RF)applicator that connects to the Acessa Generator by a custom Cable. TheHandpiece consists of a handle with a trocar shaft, active needle tip, and sevendeployable needle electrodes each with embedded thermocouple sensors for real-time temperature feedback. The Acessa Guidance Handpiece also has controlbuttons that allow the user to access the User Interface.This Acessa Guidance Handpiece also contains the magnetic guidance sensorused to determine spatial location. The embedded sensor and SROM can be usedwith the electromagnetic tracking technologies to track the positions of anUltrasound Transducer and the Handpiece shaft, and draws virtual representationsof them in their spatial relationship, so that a physician can predict the Handpieceshaft's future path in relation to the features in the ultrasound slice. Theseelectromagnetic tracking technologies are considered optional accessories to
	Acessa System procedure.
TechnologicalCharacteristicsCompared toPredicateDevices	The design features and principal modes of operation of the Acessa GuidanceHandpiece is the equivalent to the commercially available Acessa System. It isthe same product with the exception of the addition of the embedded sensor andSROM so that the device may also be used, if desired, with electromagnetictracking technologies that can draw a virtual representation of the device.
	Application of radiofrequency energy with both devices within a surgicalprocedure is completed in the same manner. Substantial equivalence isestablished with respect to the same indication for use, principal design, type ofenergy used or delivered, performance and safety requirements. Treatment usingthe Acessa Guidance Handpiece is the same as that of how the predicate would beused.
PerformanceTesting	The Acessa Guidance Handpiece was subjected to electrical and safety testingaccording to risks assessments performed based on the differences with thepredicate device. EMC and safety testing were completed on the device asrequired within EN/IEC 60601-1:2005/2006 3rd edition Medical ElectricalEquipment Part 1 General Requirements for Safety, EN/IEC 60601-1-2:2007 3rdedition Medical Electrical Equipment General Requirements for Basic Safety andEssential Performance Collateral Standard Electromagnetic CompatibilityRequirements and Tests , EN/IEC 60601-2-2:2009 5th edition Medical ElectricalEquipment Particular Requirements for the Safety of High Frequency SurgicalEquipment. The device passed all testing.
	A series of biocompatibility testing also demonstrated that the device with itsadditional materials are safe, suitable, and appropriate for their intended use andin compliance with ISO 10993-1:2009 4th edition Biological Evaluation ofMedical Devices Part 1 Evaluation and Testing within a Risk ManagementProcess, ISO 10993-5:2009 3rd edition Biological Evaluation of Medical DevicesTests for In Vitro Cytotoxicity, ISO 10993-10:2010 2nd edition BiologicalEvaluation of Medical Devices Tests for Irritation and Delayed-TypeHypersensitivity, and ISO 10993-11:2006 2nd edition Biological Evaluation ofMedical Devices Tests for Systemic Toxicity.
	The Acessa Guidance Handpiece was also subjected to flexural strength testing aswell as compatibility testing with an electromagnetic tracking system. The devicemet all the criteria.
Conclusion	The Acessa Guidance Handpiece is substantially equivalent to the legallymarketed medical device as demonstrated by the technological characteristicscomparison and performance testing completed for this device.

510(k) Summary

As Required By 21 CFR 807.92

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Image /page/2/Picture/0 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The image is in black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

April 28, 2014

Halt Medical, Inc. Clarisa Tate VP of Regulatory Affairs & Quality Assurance 131 Sand Creek Road, Suite B Brentwood, CA 94513

Re: K132184

Trade/Device Name: Acessa System Regulation Number: 21 CFR& 884.4160 Regulation Name: Unipolar endoscopic coagulator-cutter and accessories Regulatory Class: II Product Code: HFG Dated: April 4, 2014 Received: April 7, 2014

Dear Clarisa Tate,

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 cither 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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Page 2 - Clarisa Tate

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/deffault.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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Herbert P. Lerner

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 Statement

510(k) Number (if known): K132184

Device Name: Acessa System

Indications for Use: The Acessa 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 System consists of the following components:

Generator (Model Number 1000) ●
Handpiece (Model Number 2000 or 5300) .
Handpiece Cable (Model Number 4200) .
Pads (Model Number 3000)
Pad Cable (Model Number 4300) .
Power Cord (Model Number 4110) �
Foot Pedal (Model Number 4100) ●

Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ,

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert P. Lerner -S 2014.04.28 16:14:03 -04'00'

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).