(266 days)
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.
The Acessa Guidance System consists of the following components: Guidance Controller (Model Number 5100), Guidance Ultrasound Transducer Sleeve (Model Number 5500), Guidance Field Generator (Model Number 5200), Guidance Handpiece Cable (Model Number 5400), and Power Cord (Model Number 4110). The Acessa Guidance System uses electromagnetic tracking technology to track the positions of the Guidance Ultrasound Transducer Sleeve and the Guidance Handpiece shaft and draws virtual representations of them in their spatial relationship, so that a physician can predict the Guidance Handpiece shaft's future path in relation to the features in the ultrasound slice. The Acessa Guidance System is considered an optional accessory to procedures where ultrasound is currently used for visualization, such as the Acessa System procedure.
The Acessa Guidance System includes the following performance testing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Electrical and Safety | Compliance with ANSI/AAMI ES 60601-1:2005 with A2:2010 (3rd edition), EN/IEC 60601-1-2:2007 (3rd edition), and IEC 60601-1-4:2000 (1st edition) | Device passed all testing. |
| Biocompatibility | Compliance with ISO 10993-1:2009 (4th edition), ISO 10993-5:2009 (3rd edition), ISO 10993-10:2010 (2nd edition), and ISO 10993-11:2006 (2nd edition) | Device demonstrated safety, suitability, and appropriateness for intended use based on additional materials. |
| Mechanical (Guidance Sleeve end cap tensile testing) | Not explicitly stated, but implies meeting a predefined threshold for tensile strength. | Device met all criteria. |
| Accuracy (System worse-case accuracy comparison) | Not explicitly stated, but implies meeting a predefined accuracy threshold. | Device met all criteria in a simulated clinical environment. |
| Software Validation | Not explicitly stated, but implies successful validation of software functionality. | Software validations were conducted and presumably successful. |
2. Sample Size Used for the Test Set and Data Provenance:
- The document does not specify sample sizes for any of the listed performance tests.
- The provenance of the data (e.g., country of origin, retrospective or prospective) is not provided for any of the tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- This information is not provided in the document. The tests described are primarily engineering, biocompatibility, and simulated environment tests, rather than clinical studies requiring expert ground truth for interpretation of patient data.
4. Adjudication Method for the Test Set:
- This information is not applicable as the provided testing is not a clinical study involving human reader interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not conducted or described in this document. The device is a guidance system, and the testing focuses on its engineering and functional performance rather than its impact on human reader performance in a diagnostic context.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- The document describes performance testing that largely functions as "standalone" performance for the device's components (electrical, safety, biocompatibility, mechanical). The "system worse-case accuracy comparison testing in a simulated clinical environment" evaluates the algorithm's accuracy in a controlled setting without explicit mention of human-in-the-loop performance influencing the measurement. However, the device is an "optional accessory" for use during a procedure and is meant to enhance ultrasonic images and predict tool paths, implying human interaction during its intended use. Therefore, while some tests are algorithmic/system performance, it's not a standalone diagnostic algorithm.
7. The Type of Ground Truth Used:
- Electrical and Safety Testing: Ground truth is established by the specified international standards (e.g., ANSI/AAMI ES 60601-1).
- Biocompatibility Testing: Ground truth is established by the specified international standards (e.g., ISO 10993 series).
- Mechanical (Guidance Sleeve end cap tensile testing): Ground truth would be engineered specifications or established industry standards for material strength.
- Accuracy (System worse-case accuracy comparison): Ground truth would be defined reference points or known positional values within the simulated clinical environment.
- Software Validation: Ground truth would be the software requirements specifications and expected functional behavior.
8. The Sample Size for the Training Set:
- The document does not mention a "training set" in the context of machine learning or AI models. The software is noted to be from the manufacturer of the predicate device and based on their cleared device, implying reuse or adaptation of existing software rather than a de novo development requiring a distinct training phase.
9. How the Ground Truth for the Training Set was Established:
- This information is not applicable as no training set for an AI model is described.
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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.131 Sand Creek Road, Suite BBrentwood, CA 94513Main: (925) 634-7943Fax: (925) 634-7841 |
| Contact Person | Clarisa A. TateVP of RA & QA, Halt Medical, Inc.Office: (925) 271-0626e-mail: ctate@haltmedical.com |
| 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 whichsubstantial equivalence is claimed | AIM System (K121479) |
| Intended Use | The Acessa Guidance System is indicated for enhancing the ultrasonic image ofthe Acessa Handpiece and for predicting its future path on a computer monitorscreen which also shows the image of a B-scan (or similar display) of a medicalultrasound imaging system. The device is intended as an optional accessory foruse during the Acessa System procedure. |
| DeviceDescription | The Acessa Guidance System consists of the following components: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.Laparoscopic ultrasound equipment is not included with the AcessaGuidance System.• The Acessa Guidance System may only be used with the Acessa System, aradiofrequency ablation device. | |
| The Acessa Guidance System uses electromagnetic tracking technology to trackthe positions of the Guidance Ultrasound Transducer Sleeve and the GuidanceHandpiece shaft and draws virtual representations of them in their spatialrelationship, so that a physician can predict the Guidance Handpiece shaft'sfuture path in relation to the features in the ultrasound slice. The AcessaGuidance System is considered an optional accessory to procedures whereultrasound is currently used for visualization, such as the Acessa Systemprocedure. | |
| TechnologicalCharacteristicsCompared toPredicateDevices | The design features and principal modes of operation of the Acessa GuidanceSystem is the equivalent to the commercially available AIM System. Bothproducts are configured the same and the software is made by the predicatedevice's company which they based on their cleared device. |
| Application of electromagnetic tracking technology with both devices within asurgical procedure is completed in the same manner. Substantial equivalence isestablished with respect to the same indication for use, principal design,software used, performance, and safety requirements. | |
| PerformanceTesting | The Acessa Guidance System 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 by ANSI/AAMI ES 60601-1:2005 with A2:2010 3rd edition Medical DeviceEquipment 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, IEC 60601-1-4:2000 1st edition Medical ElectricalEquipment Par 1-4: General Requirements for Safety - Collateral Standard:Programmable Electrical Medical Systems. 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 useand in 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 System was also subjected to Guidance Sleeve end captensile 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 samemanufacturer of the predicate device. | |
| Conclusion | The Acessa Guidance System is substantially equivalent to the legally marketedmedical device as demonstrated by the technological characteristics comparisonand performance testing completed for this device. |
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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.
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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.
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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.
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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 (800) 638-2041 or (301) 796-7100 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
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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'
§ 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).