(73 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 and liver, 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.
Here's an analysis of the provided text regarding the CT-Guide Needle Guidance System's acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific numerical acceptance criteria for the device's performance (e.g., target accuracy in millimeters, success rate percentage). Instead, it uses qualitative statements about the studies' outcomes.
Since specific acceptance criteria are not provided, the table below will reflect the general statements made in the document about performance.
| Acceptance Criteria (Not explicitly quantified in source) | Reported Device Performance |
|---|---|
| Device functions as intended. | "The CT-Guide functioned as intended" |
| Satisfactory performance. | "All results were satisfactory" |
| Met predefined specifications. | "met the predefined specifications" |
| Safe and effective for intended use. | "The results demonstrate that the system is safe and effective for its intended use." |
| Testing results were as expected. | "the testing results observed were as expected." |
| Biocompatibility requirements met (ISO 10993-1). | "Skin contacting materials were tested for biocompatibility per ISO 10993-1." |
| Electromagnetic compatibility met (IEC 60601-1-2). | "The CT-Guide System was tested for electromagnetic compatibility... per IEC 60601-1 and IEC 60601-1-2." |
| Electrical safety met (IEC 60601-1). | "The CT-Guide System was tested for... electrical safety per IEC 60601-1 and IEC 60601-1-2." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document only states "a prospective, multi-center clinical study was conducted."
- Data Provenance: Prospective, multi-center clinical study. The country of origin is not explicitly stated for the clinical study data itself, although the submitter is based in Israel and the FDA clearance is for the US market. The bench tests were done on a "custom phantom setup," implying laboratory testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. The document only mentions a "prospective, multi-center clinical study" but does not detail how outcomes were assessed or adjudicated.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the provided text. The study described is an evaluation of the device's performance in clinical use, not a comparison of human readers with and without AI assistance.
- Effect Size: Not applicable, as an MRMC study was not described.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: The core function of the CT-Guide is a guidance system that displays instruments on a CT-based model for a human operator. The "Performance Data" section discusses "bench tests conducted on a custom phantom setup" and "The CT-Guide software was validated and tested." These could be interpreted as standalone tests of the system's accuracy and software functionality prior to human interaction within the clinical study. However, the document doesn't explicitly separate "algorithm only" performance from the overall system's performance, as the system's purpose is to guide human intervention. The clinical study implicitly includes human interaction.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the clinical study, the ground truth or outcome measure is implied to be related to the successful and safe conduct of "clinical interventions in the lung and liver." The document states, "The results demonstrate that the system is safe and effective for its intended use." This suggests clinical outcomes and safety profiles served as the ground truth. For the bench tests, the ground truth would have been derived from the "custom phantom setup" with known geometrical properties or reference points.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The document describes a medical device (hardware and software) that assists in procedures, not a machine learning or AI model that requires a "training set" in the conventional sense. The "CT-Guide software was validated and tested," which likely refers to traditional software verification and validation, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as no machine learning training set is described.
{0}------------------------------------------------
APR 1 3 2012 -
510(k) SUMMARY ActiViews Ltd.'s CT-Guide Needle Guidance System
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: January 31, 2012
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
CT-Guide Needle Guidance System (K110812) CT-Guide Needle Guidance System (K113063)
Intended Use / Indications for Use
The CT-Guide is a sterectactic 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 and liver, 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.
{1}------------------------------------------------
Performance Data
The CT-Guide Needle Guidance System was tested for its performance and accuracy through 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 10993-1. The CT-Guide System was tested for electromagnetic compatibility and electrical safety per IEC 60601-1 and IEC 60601-1-2.
Lastly, a prospective, multi-center clinical study was conducted with the CT-Guide System. The results demonstrate 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 System is safe and effective for lung and liver indications. The CT-Guide has the same intended use, technological characteristics, and principles of operation as its predicate device. Clinical data shows that the use of the system in the new indication for use does not raise any new questions of safety or effectiveness. Performance and clinical data demonstrate that the CT-Guide for a liver indication is as safe and effective as it is for a lung indication. Thus, the CT-Guide system for a liver indication is substantially equivalent to the existing CT-Guide system cleared for use in the lung.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font.
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
APR 1 3 2012
ActiViews Ltd. % John J. Smith. M.D., J.D. Regulatory Counsel Hogan Lovells US LLP 555 13th Street, NW WASHINGTON DC 20004
Re: K120300
Trade/Device Name: CT-Guide Needle Guidance System Regulation Number: CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: January 31, 2012 Received: January 31, 2012
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
{3}------------------------------------------------
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,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
K120300 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 and liver, where CT is currently used for visualizing such procedures.
Prescription Use _ X
AND/OR
Over-The-Counter Use
(Per 21 C.F.R. 807 Subpart C)
(Per 21 C.F.R. 801.109).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) (Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number K120308
Page 1 of 1
§ 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.