(38 days)
The ig4™ Image Guided System is a stereotactic accessory for Computed Tomography (CT) Systems. The ig4 System displays an interventional instrument, such as a biopsy needle, an aspiration needle, or an ablation needle, on a computer monitor that also displays a CT-based model of the target organ(s). The ig4 System compensates for the patient's respiratory phases.
The ig4 System is intended to be used in clinical interventions and for anatomical structures where computed tomography is currently used for visualizing such procedures.
The ig4TM Image Guided System is an accessory for a CT System that utilizes electromagnetic tracking technology to locate and navigate instruments relative to a CT-based model of the patient anatomy. Because the system is used to assist in locating structures in soft tissue, the system incorporates a method of gating the location information on soft tissue to the patient's respiration. The ig4™ System consists of an EM tracking accessory for rigid needles, a matrix of thoracic reference markers, an EM field generator and tracking system, software, and a computer system.
The provided text does not contain detailed information about specific acceptance criteria, a dedicated study proving these criteria, or the statistical aspects of such a study (sample sizes, ground truth establishment for test/training sets, expert qualifications, or MRMC studies). The document is a 510(k) summary for the ig4™ Image Guided System, primarily focusing on its intended use and substantial equivalence to predicate devices.
However, it does state: "In addition, bench and animal tests demonstrated that the ig4™ Image Guided System meets the performance requirements for its intended use." This indicates that some form of testing was performed to verify performance, but the details are not provided in this summary.
Therefore, most of the requested information cannot be extracted directly from the provided text.
Here's a breakdown of what can and cannot be answered based on the input:
1. A table of acceptance criteria and the reported device performance
- Cannot be extracted. The document mentions "performance requirements" but does not define them or report specific performance metrics against them.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be extracted. The document mentions "bench and animal tests" but does not provide sample sizes, and there's no mention of human test sets or data provenance (country, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be extracted. There is no information about expert involvement in establishing ground truth for any test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be extracted. No information on adjudication methods is present.
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
- Cannot be extracted. The document does not describe any MRMC studies or a comparison of human readers with or without AI assistance. The device is for image-guided intervention, not primarily for diagnostic interpretation by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Partially inferable, but specific performance data is absent. The "bench and animal tests" would likely evaluate the standalone performance of the system's navigation and tracking accuracy. However, no specific performance metrics are provided. The device concept is inherently "human-in-the-loop" as it displays information for an interventionalist.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Cannot be extracted. The document mentions "bench and animal tests" but does not specify how ground truth (e.g., actual needle tip position vs. displayed position) was established during these tests.
8. The sample size for the training set
- Cannot be extracted. There is no mention of a "training set," as the device appears to be primarily an electromagnetic tracking and navigation system, not a machine learning model that requires explicit training data in the same sense.
9. How the ground truth for the training set was established
- Cannot be extracted. No training set is mentioned.
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SECTION 5-510(k) Summary
MAY 11 2006
ig4TM Image Guided System
I. Submitter Information
Veran Medical Technologies 2409 21st Avenue South Suite 205 Nashville, TN 37212 Telephone: (303) 594-3666 Telefax: (615) 297-0911
Contact: Torsten M. Lyon Date Prepared: March 31, 2006
II. Device Information
Trade name: ig4TM Image Guided System Common name: CT stereotactic accessory Classification Name: Computed Tomography X-ray System Product Code: JAK
III. Device Description
The ig4TM Image Guided System is an accessory for a CT System that utilizes electromagnetic tracking technology to locate and navigate instruments relative to a CT-based model of the patient anatomy. Because the system is used to assist in locating structures in soft tissue, the system incorporates a method of gating the location information on soft tissue to the patient's respiration. The ig4™ System consists of an EM tracking accessory for rigid needles, a matrix of thoracic reference markers, an EM field generator and tracking system, software, and a computer system.
IV. Intended Use
The ig4TM Image Guided System is a stereotactic accessory for Computed Tomography (CT) Systems. The ig4 System displays an interventional instrument, such as a biopsy needle, an aspiration needle, or an ablation needle, on a computer monitor that also displays a CT-based model of the target organ(s). The ig4 System compensates for the patient's respiratory phases.
The ig4 System is intended to be used in clinical interventions and for anatomical structures where computed tomography is currently used for visualizing such procedures.
V. Substantial equivalence
The ig4™ Image Guided System was demonstrated to be substantially equivalent to the UltraGuide CT-1010 (K002258), the Medtronic Navigation GoldenEye
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System (K001284) and conventional soft tissue navigation with CT images. In addition, bench and animal tests demonstrated that the ig4™ Image Guided System meets the performance requirements for its intended use. Dissimilarities between the ig4™ System and the predicate devices do no affect the safety or effectiveness of this device.
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: 上一篇:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes, positioned to the right of the department's name. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the upper portion of the logo.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MAY 11 1 2006
Mr. Torsten M. Lyon Vice President of Engineering Veran Medical Technologies. Inc. 2409 21st Avenue South Suite 205 NASHVILLE TN 37212
Re: K060903
Trade/Device Name: ig4TM Image Guided System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: March 31, 2006 Received: April 3, 2006
Dear Mr. Lyon:
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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/2/Picture/10 description: The image is a black and white circular logo. The logo has the text "1906-2006" at the top, and the letters "FDA" in the center. Below the letters, the word "Centennial" is written in cursive. The logo is surrounded by stars and the words "U.S. Department of Commerce".
Protecting and Promoting Public Lands
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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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely vours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 4 - Indications for Use
Page 1 of 1
510(k) Number (if known): 长 0 6 0 9 0 3
Device Name: ig4TM Image Guided System
Indications for Use:
The ig4™ Image Guided System is a stereotactic accessory for Computed Tomography (CT) Systems. The ig4 System displays an interventional instrument, such as a biopsy needle, an aspiration needle, or an ablation needle, on a computer monitor that also displays a CT-based model of the target organ(s). The ig4 System compensates for the patient's respiratory phases.
The ig4 System is intended to be used in clinical interventions and for anatomical structures where computed tomography is currently used for visualizing such procedures.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Posted November 13, 2003)
David A. Ingram
(Division Sian-Off Division of Reproductive. and Radiological Devices 510(k) Number
Page 15
Page / of /
§ 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.