ACESSA GUIDANCE SYSTEM

K132744 · Halt Medical, Inc. · HFG · May 27, 2014 · Obstetrics/Gynecology

Device Facts

• Record ID: K132744
• Device Name: ACESSA GUIDANCE SYSTEM
• Applicant: Halt Medical, Inc.
• Product Code: HFG · Obstetrics/Gynecology
• Decision Date: May 27, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4160
• Device Class: Class 2

Indications for Use

The Acessa Guidance System is indicated for enhancing the ultrasonic image of the Acessa Handpiece and for predicting its future path on a computer monitor screen which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system. The device is intended as an optional accessory for use during the Acessa System procedure.

Device Story

Acessa Guidance System uses electromagnetic tracking to visualize surgical instruments during laparoscopic ultrasound-guided procedures. System components include a Guidance Controller, a disposable Guidance Ultrasound Transducer Sleeve, and a Table Top Field Generator (TTFG). The TTFG generates a magnetic field detected by sensors within the transducer sleeve and the Acessa Handpiece. The controller processes these signals to draw virtual representations of the handpiece and transducer on a computer monitor, overlaying the handpiece's predicted path onto the B-scan ultrasound image. This allows the physician to navigate the handpiece accurately relative to anatomical features during radiofrequency ablation. The system is an optional accessory used in clinical settings by physicians. It benefits patients by providing real-time spatial guidance, potentially increasing procedural precision and safety.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including electrical safety (ANSI/AAMI ES 60601-1), EMC (EN/IEC 60601-1-2), and programmable electrical medical systems (IEC 60601-1-4) testing. Biocompatibility was verified per ISO 10993-1, -5, -10, and -11. System performance was validated through Guidance Sleeve end cap tensile testing and worst-case accuracy comparison testing in a simulated clinical environment. Software validation was performed by the predicate device manufacturer.

Technological Characteristics

Electromagnetic tracking system; components include Guidance Controller, disposable Ultrasound Transducer Sleeve, and Table Top Field Generator. Connectivity: Wired (4.5m Field Generator cable, Guidance Handpiece Cable). Power: AC medical grade. Software: Programmable electrical medical system. Biocompatibility: Compliant with ISO 10993 standards. Safety: Compliant with ANSI/AAMI ES 60601-1, EN/IEC 60601-1-2, and IEC 60601-1-4.

Indications for Use

Indicated for enhancing ultrasonic visualization and predicting the path of the Acessa Handpiece during the Acessa System radiofrequency ablation procedure. Intended for use by clinicians in a surgical setting.

Regulatory Classification

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.

Predicate Devices

• AIM System (K121479)

Submission Summary (Full Text)

{0}------------------------------------------------

K132744
MAY 27 2014

Acessa
guidance

## Section 5 - 510(k) Summary

.

As Required By 21 CFR 807.92

| Date of Summary Preparation | May 22, 2014 |
|-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter and Owner's Name and Address | Halt Medical, Inc.<br>131 Sand Creek Road, Suite B<br>Brentwood, CA 94513<br>Main: [phone]<br>Fax: [phone] |
| Contact Person | Clarisa A. Tate<br>VP of RA & QA, Halt Medical, Inc.<br>Office: [phone]<br>e-mail: [e-mail] |
| Trade Name | Acessa Guidance System |
| Common Name | Acessa Guidance System or electromagnetic tracking system |
| Classification Name | Unipolar endoscopic coagulator cutter and accessories |
| Classification | Class II |
| Product Code | HFG, OEW, IYO |
| Classification Panel | Obstetrics and Gynecology |
| Classification Regulation | 21 CFR §884.4160 |
| Legally Marketed Device to which<br>substantial equivalence is claimed | AIM System (K121479) |
| Intended Use | The Acessa Guidance System is indicated for enhancing the ultrasonic image of<br>the Acessa Handpiece and for predicting its future path on a computer monitor<br>screen which also shows the image of a B-scan (or similar display) of a medical<br>ultrasound imaging system. The device is intended as an optional accessory for<br>use during the Acessa System procedure. |
| Device<br>Description | The Acessa Guidance System consists of the following components:<br>Guidance Controller (Model Number 5100): Contains the tracking system and software used to run the system, with attached 4.5m Field Generator cable. Guidance Ultrasound Transducer Sleeve (Model Number 5500): A disposable sleeve that houses the ultrasound transducer, the magnetic guidance sensor and guidance display control buttons. Guidance Field Generator (Model Number 5200): The TTFG (Table Top Field Generator) generates a magnetic field that is picked up by the magnetic guidance sensors in the Handpiece and the Ultrasound Transducer Sleeve. Guidance Handpiece Cable (Model Number 5400): Connects a Guidance Handpiece to the Acessa Generator and the Guidance Controller. Power Cord (Model Number 4110): A medical grade power cord that provides AC power to the Controller. NOTES: |
| | • The Acessa Guidance System must be used with laparoscopic ultrasound.<br>Laparoscopic ultrasound equipment is not included with the Acessa<br>Guidance System.<br>• The Acessa Guidance System may only be used with the Acessa System, a<br>radiofrequency ablation device. |
| | The Acessa Guidance System uses electromagnetic tracking technology to track<br>the positions of the Guidance Ultrasound Transducer Sleeve and the Guidance<br>Handpiece shaft and draws virtual representations of them in their spatial<br>relationship, so that a physician can predict the Guidance Handpiece shaft's<br>future path in relation to the features in the ultrasound slice. The Acessa<br>Guidance System is considered an optional accessory to procedures where<br>ultrasound is currently used for visualization, such as the Acessa System<br>procedure. |
| Technological<br>Characteristics<br>Compared to<br>Predicate<br>Devices | The design features and principal modes of operation of the Acessa Guidance<br>System is the equivalent to the commercially available AIM System. Both<br>products are configured the same and the software is made by the predicate<br>device's company which they based on their cleared device. |
| | Application of electromagnetic tracking technology with both devices within a<br>surgical procedure is completed in the same manner. Substantial equivalence is<br>established with respect to the same indication for use, principal design,<br>software used, performance, and safety requirements. |
| Performance<br>Testing | The Acessa Guidance System was subjected to electrical and safety testing<br>according to risks assessments performed based on the differences with the<br>predicate device. EMC and safety testing were completed on the device as<br>required by ANSI/AAMI ES 60601-1:2005 with A2:2010 3rd edition Medical Device<br>Equipment Part 1 General Requirements for Safety, EN/IEC 60601-1-2:2007 3rd<br>edition Medical Electrical Equipment General Requirements for Basic Safety and<br>Essential Performance Collateral Standard Electromagnetic Compatibility<br>Requirements and Tests, IEC 60601-1-4:2000 1st edition Medical Electrical<br>Equipment Par 1-4: General Requirements for Safety - Collateral Standard:<br>Programmable Electrical Medical Systems. The device passed all testing. |
| | A series of biocompatibility testing also demonstrated that the device with its<br>additional materials are safe, suitable, and appropriate for their intended use<br>and in compliance with ISO 10993-1:2009 4th edition Biological Evaluation of<br>Medical Devices Part 1 Evaluation and Testing within a Risk Management<br>Process, ISO 10993-5:2009 3rd edition Biological Evaluation of Medical Devices<br>Tests for In Vitro Cytotoxicity, ISO 10993-10:2010 2nd edition Biological<br>Evaluation of Medical Devices Tests for Irritation and Delayed-Type<br>Hypersensitivity, and ISO 10993-11:2006 2nd edition Biological Evaluation of<br>Medical Devices Tests for Systemic Toxicity. |
| | The Acessa Guidance System was also subjected to Guidance Sleeve end cap<br>tensile testing as well as system worse-case accuracy comparison testing in a |
| | simulated clinical environment. The device met all criteria. |
| | Software validations were also conducted, which was conducted by the same<br>manufacturer of the predicate device. |
| Conclusion | The Acessa Guidance System is substantially equivalent to the legally marketed<br>medical device as demonstrated by the technological characteristics comparison<br>and performance testing completed for this device. |

{1}------------------------------------------------

.

Image /page/1/Picture/1 description: The image shows the logo for Acessa guidance. The word "Acessa" is written in a cursive font, with the "A" being larger than the other letters. Below "Acessa" is the word "guidance" in a smaller, sans-serif font. The logo is simple and clean, with a focus on the company name.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for Acessa Guidance. The word "Acessa" is written in a cursive font, with the "A" being the largest letter and the other letters gradually decreasing in size. Below "Acessa", the word "guidance" is written in a smaller, sans-serif font. The overall design is simple and professional.

:

.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling an eagle or bird in flight, with three curved lines representing wings or feathers. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.

## DEPARTMENT OF HEALTII & HUMAN SERVICES

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

May 27, 2014

Halt Medical, Inc. Clarisa A. Tate Vice President of Regulatory Affairs & Quality Assurance 131 Sand Creek Road, Suite B Brentwood, CA 94513-2040

Re: K132744

> Trade/Device Name: Acessa Guidance System Regulation Number: 21 CFR§ 884.4160 Regulation Name: Unipolar endoscopic coagulator cutter and accessories Regulatory Class: II Product Code: HFG Dated: April 25, 2014 Received: April 28, 2014

Dear Clarisa A. 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 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.

{4}------------------------------------------------

Page 2 - Clarisa A. 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 (OS) 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/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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/4/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a bold, sans-serif font. The letters "R" and "E" are partially obscured by a decorative, textured design. The name is written in black ink on a white background.

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

{5}------------------------------------------------

## Indications for Use Statement

510(k) Number (if known):

Device Name: Acessa Guidance System

Indications for Use: The Acessa Guidance System is indicated for enhancing the ultrasonic image of the Acessa Handpiece and for predicting its future path on a computer monitor screen which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system. The device is intended as an optional accessory for use during the Acessa System procedure.

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)

Benjamin R. Fisher -S 2014.05.27 16:03:04 -04'00'