(27 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 CT-Guide Needle Guidance System underwent performance and accuracy testing through several bench tests conducted on a custom phantom setup. All results were reported as satisfactory and met predefined specifications. The CT-Guide modified software was validated and tested. Additionally, the system was retested for electromagnetic compatibility and electrical safety per IEC 60601-1 and IEC 60601-1-2. In all instances, the CT-Guide functioned as intended, and testing results were as expected. This submission is a Special 510(k) for modifications to a previously cleared device (K110812), and thus primarily relies on showing that the modified device remains as safe and effective as the predicate.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance (Accuracy) | "All results were satisfactory and met the predefined specifications." |
| Software Validation | "The CT-Guide modified software was validated and tested." |
| Electromagnetic Compatibility (EMC) | "retested for electromagnetic compatibility per IEC 60601-1-2. testing results observed were as expected." |
| Electrical Safety | "retested for ... electrical safety per IEC 60601-1. testing results observed were as expected." |
| Functionality | "In all instances, the CT-Guide functioned as intended." |
2. Sample Size Used for the Test Set and the Data Provenance
The study was conducted using "several bench tests conducted on a custom phantom setup."
- Sample Size: Not explicitly stated as a numerical sample size of cases or images, but rather described as "several bench tests." The phantom setup implies a controlled, non-human testing environment.
- Data Provenance: The data is from bench tests using a custom phantom, not from human subjects or clinical data (retrospective or prospective). Country of origin is not specified for the phantom tests, but the device manufacturer is based in Israel.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The ground truth for bench tests on a phantom is typically based on the known physical properties and measurements of the phantom itself, not on expert clinical judgment.
4. Adjudication Method for the Test Set
Not applicable, as ground truth was established through physical measurements on a phantom, not expert review requiring adjudication.
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
No MRMC comparative effectiveness study was mentioned. The study described focuses on technical performance of the device itself rather than human reader improvement with AI assistance. This device is a "Needle Guidance System," implying a tool that assists during interventions rather than an AI for diagnostic image interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The performance testing described ("bench tests conducted on a custom phantom setup") would generally be considered a form of standalone performance assessment for the device's accuracy and functionality in a controlled environment, separate from human-in-the-loop clinical use.
7. The Type of Ground Truth Used
The ground truth was established using a "custom phantom setup," implying objective physical measurements and known properties of the phantom.
8. The Sample Size for the Training Set
Not applicable. The description provided is for performance testing of a device's modifications, not for the training of an AI algorithm from a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of an AI training set in the document.
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510(k) SUMMARY
NOV 1 0 2011
ActiViews's CT-Guide Needle Guidance System
Submitter's Name, Address. Telephone Number. Contact Person and Date Prepared
ActiViews Ltd. 7 Nahum Haat St. Haifa 31905 lsrael Phone: (972) 48551002 Facsimile: (972) 48551003
Contact Person: Yuval Zuk
Date Prepared: October 14. 2011
Name of Device and Name/Address of Sponsor
CT-Guide Needle Guidance System ActiViews Ltd 7 Nahum Haat St. Haifa 31905 Israel
Common or Usual Name/ Classification Name
Computed Tomography X-ray System Accessory
Predicate Device
ActiViews Ltd.'s CT-Guide Needle Guidance System (K110812)
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.
Purpose of the Special 510(k) Notice
The purpose of this Special 510(k) notice is to address hardware and software design modifications to the cleared CT-Guide Needle Guidance System cleared via K110812. The device modifications include:
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- Modification of the ActiSticker design to include 3 entry holes instead of 1 entry hole . in the previous version of the system, as well as to the system software to support this change in the ActiSticker.
- . Various software modifications implemented to provide improved user interface and additional information to the user during the procedure.
- System level changes that include the following: new version of the computer, the . cart, the monitor and a change in the operating system. The computer, cart and the monitor have been updated to a newer version and meet or exceed the predefined specifications in the originally cleared version of the device.
Performance Data
The modified 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 modified software was validated and tested. In addition, the CT-Guide system was retested for electromagnetic compatibility and electrical safety per IEC 60601-1 and IEC 60601-1-2. In all instances, the CT-Guide functioned as intended and the testing results observed were as expected.
Substantial Equivalence
The modified CT-Guide Needle Guidance System has the same intended use and indications, and similar principles of operation, and technological characteristics as the previously cleared CT-Guide Needle Guidance System. The minor differences in the modified CT-Guide Needle Guidance System's technological characteristics do not raise any new questions of safety or effectiveness. Performance data demonstrates that the modified CT-Guide Needle Guidance System is as safe and effective as the predicate CT-Guide Needle Guidance System. Thus, the modified CT-Guide Needle Guidance System is substantially equivalent to its identified predicate device.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, composed of three curved lines.
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
NOV 1 0 2011
ActiViews, Ltd. % John J. Smith , M.D., J.D. Regulatory Counsel Hogans Lovells. US LLP 555 13th Street, NW WASHINGTON DC 20004
Re: K113063
Trade/Device Name: CT-Guide Needle Guidance System Regulation Number: 41 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: October 14, 2011 Received: October 14, 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 Pastel
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
510(k) Number (if known):
CT-Guide Needle Guidance System Device Name:
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 X (Per 21 C.F.R. 801.109)
AND/OR
Over-The-Counter Use (Per 21 C.F.R. 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)
n Sian-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number K113063
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§ 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.