(90 days)
The CT-Guide is a stereotactic accessory for Computed Tomography ("CT") systems. The CT-Guide displays an interventional instrument on a computer monitor that also displays a CT-based model of the target organ(s).
The CT-Guide is intended to be used in clinical interventions in the lung, where CT is currently used for visualizing such procedures.
The CT-Guide System is comprised of four main components: (1) the ActiSensor, a disposable video camera that is mounted onto a holder, which is clipped to a needle; (2) the ActiSticker, a disposable pad, which provides visual and radio-opaque reference markers; (3) a workstation that contains a dedicated computer; and (4) accompanying computer software.
The provided text describes the ActiViews Ltd.'s CT-Guide Needle Guidance System (K110812). Here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Predefined specifications for performance and accuracy | "All results were satisfactory and met the predefined specifications." (bench tests on a custom phantom setup) |
| Software validation and testing | "The CT-Guide software was validated and tested." |
| Biocompatibility of skin-contacting materials | "Skin contacting materials were tested for biocompatibility per ISO 10933-1... All results were satisfactory." |
| Electromagnetic compatibility (EMC) | "The CT-Guide system was tested for electromagnetic compatibility per IEC 60601-1-2... All results were satisfactory." |
| Electrical safety | "The CT-Guide system was tested for... electrical safety per IEC 60601-1... All results were satisfactory." |
| Safety and effectiveness for intended use (clinical) | "A prospective, multi-center clinical study was conducted with CT-Guide system. The results established that the system is safe and effective for its intended use." |
| Functionality | "In all instances, the CT-Guide functioned as intended and the testing results observed were as expected." |
Study Details
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Sample size used for the test set and the data provenance:
The document states a "prospective, multi-center clinical study was conducted," but it does not specify the sample size for the test set (number of patients or procedures). The data provenance is prospective and multi-center, but the specific countries of origin are not mentioned. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the given text. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the given text. -
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:
An MRMC comparative effectiveness study is not explicitly mentioned. The clinical study aimed to establish safety and effectiveness of the system rather than compare human readers with and without AI assistance. Therefore, no effect size for human reader improvement with AI assistance is provided. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is described as a "Needle Guidance System" and an "accessory for Computed Tomography ("CT") systems" that "displays an interventional instrument on a computer monitor." This implies a human-in-the-loop system, as the human operator (clinician) uses the guidance for the interventional procedure. Therefore, a standalone (algorithm-only) performance study would not be applicable or described for this type of device, and is not mentioned. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the clinical study, the text states, "The results established that the system is safe and effective for its intended use." While "safety and effectiveness" are outcomes, the specific type of ground truth used to measure these outcomes (e.g., successful lesion targeting confirmed by follow-up imaging, biopsy results, lack of complications) is not detailed. For the bench tests, predefined specifications were met, implying a ground truth based on engineering or performance metrics. -
The sample size for the training set:
The document does not specify a training set sample size. It mentions "software was validated and tested," but no details on training data. -
How the ground truth for the training set was established:
This information is not provided in the given text.
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510(k) SUMMARY
ActiViews Ltd.'s CT-Guide Needle Guidance System
JUN 2 1 2011
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
ActiViews Ltd. 7 Nahum Haat Street Haifa 31905 Israel Phone: 97248551002 Facsimile: 97248551003
Contact Person: Yuval Zuk Date Prepared: March 22, 2011
Name of Device and Name/Address of Sponsor
CT-Guide Needle Guidance System
ActiViews Ltd. 7 Nahum Haat Street Haifa 31905 lsrael
Common or Usual Name/Classification Name
Computed tomography x-ray system accessory
Predicate Devices
Veran ig4 Image Guided System (K060903) UltraGuide MR Guide 3000 (K011418)
Intended Use / Indications for Use
The CT-Guide is a stereotactic accessory for Computed Tomography ("CT") systems. The CT-Guide displays an interventional instrument on a computer monitor that also displays a CT-based model of the target organ(s).
The CT-Guide is intended to be used in clinical interventions in the lung, where CT is currently used for visualizing such procedures.
Technological Characteristics
The CT-Guide System is comprised of four main components: (1) the ActiSensor, a disposable video camera that is mounted onto a holder, which is clipped to a needle; (2) the ActiSticker, a disposable pad, which provides visual and radio-opaque reference markers; (3) a workstation that contains a dedicated computer; and (4) accompanying computer software.
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Performance Data
CT-Guide Needle Guidance System was tested for its performance and accuracy through several bench tests conducted on a custom phantom setup. All results were satisfactory and met the predefined specifications.
The CT-Guide software was validated and tested.
Skin contacting materials were tested for biocompatibility per ISO 10933-1 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
The CT-Guide system was tested for electromagnetic compatibility and electrical safety per IEC 60601-1 and IEC 60601-1-2
A prospective, multi-center clinical study was conducted with CT-Guide system. The results established that the system is safe and effective for its intended use.
In all instances, the CT-Guide functioned as intended and the testing results observed were as expected.
Substantial Equivalence
The CT-Guide is as safe and effective as the Veran ig4 Image Guided System and the UltraGuide MR Guide 3000. The CT-Guide has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the CT-Guide and its predicate devices raise no new issues of safety or effectiveness. Performance and clinical data demonstrate that the CT-Guide is as safe and effective as Veran ig4 Image Guided System and the UltraGuide MR Guide 3000. Thus, the CT-Guide is substantially equivalent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring. MD 20993-0002
ActiViews, Ltd. % John J. Smith, M.D., L.D. Regulatory Counsel Hogan Lovells US LLP 555 13th Street, NW WASHINGTON DC 20004
JUN 2 1 2011
Re: K110812
Trade/Device Name: CT-Guide Needle Guidance System Regulation Number: 21 CFR 892.1750 1 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: March 23, 2011 Received: March 23, 2011
Dear Dr. Smith:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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/cdrh/industry/support/index.html.
Sincerely Yours,
Mary Patil
Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
KI10812 510(k) Number (if known):
Device Name: CT-Guide Needle Guidance System
Indications for Use:
The CT-Guide is a stereotactic accessory for Computed Tomography ("CT") systems. The CT-Guide displays an interventional instrument on a computer monitor that also displays a CT-based model of the target organ(s).
The CT-Guide is intended to be used in clinical interventions in the lung, where CT is currently used for visualizing such procedures.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Macy S. Padlo
Page 1 of
Office of In Vitro
K110812
510K
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.