(14 days)
X-ray imaging of whole body - Computerized Tomography Including; Axial Volumetric (Helical) CT Fluoroscopy Respiratory (4D) Gated Scanning. Respiratory Gated (4D) Scanning on the Aquilion LB is a non-invasive software/hardware option that can be used for the evaluation of respiration-induced motion by acquiring and displaying CT images consisting of all respiratory phases during a breathing cycle.
The CKRS-003A Respiratory Gating Option will be added to the previously cleared TSX-201A Aquilion LB CT system. This addition requires hardware and software modifications to the existing device.
The provided text describes a 510(k) submission for a modification to a CT system, specifically adding a Respiratory Gating Option. However, it does not include a detailed study proving the device meets specific acceptance criteria with reported performance metrics. The document focuses on establishing substantial equivalence to predicate devices and adherence to regulatory standards rather than presenting a performance study with numerical results.
Therefore, many of the requested sections below cannot be fully completed based on the provided text.
Here's an attempt to answer based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the given text. The document states that the device "will be met and reported via a supplement to the initial report for the predicate device" regarding performance standards, implying that detailed performance data would be in a separate, unprovided document.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the given text. The document refers to meeting performance standards but does not detail any specific test set or data used for verification of the Respiratory Gating option.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given text. There is no mention of a test set, ground truth establishment, or expert involvement in the provided document.
4. Adjudication Method for the Test Set
This information is not provided in the given text. There is no mention of a test set or adjudication method.
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
This information is not provided in the given text. The device described, a CT system with respiratory gating, is a hardware/software modification to an imaging device, not an AI-assisted diagnostic tool for human readers in the way an MRMC study would typically evaluate. The primary change is to reduce motion artifacts and improve targeting, which indirectly aids human interpretation, but a formal MRMC study as described is not mentioned.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not explicitly provided in the given text. The document describes the Respiratory Gating option as reducing motion artifacts and improving targeting. This implies an algorithmic process, but whether its performance was evaluated purely in a standalone manner (without any human interpretation of the resulting images) is not detailed. The focus is on the output of the images for clinical utility.
7. The Type of Ground Truth Used
This information is not provided in the given text.
8. The Sample Size for the Training Set
This information is not provided in the given text. There's no mention of a training set for the respiratory gating algorithm.
9. How the Ground Truth for the Training Set was Established
This information is not provided in the given text, as no training set is mentioned.
Summary of the Study (Based on Given Text):
The provided text details a 510(k) submission for the Toshiba TSX-201A Aquilion LB CT System with a new Respiratory Gating Option (CKRS-003A). The "study" presented in this document is primarily a regulatory submission aimed at demonstrating substantial equivalence to existing legally marketed devices.
The key points of this submission are:
- Predicate Devices: The device is being compared to the TSX-201A Aquilion LB CT (K050458) and the Varian RPM Respiratory Gating System (K983629).
- Reason for Submission: Modification of the cleared TSX-201A Aquilion LB CT system to include the Respiratory Gating Option.
- Intended Use: To produce cross-sectional images for various diagnoses, with the addition of respiratory gating to "reduce motion artifacts and improve targeting of anatomy for use with other cleared devices."
- Safety and Effectiveness Concerns: The device is designed and manufactured under Quality System Regulations (21 CFR § 820) and complies with Federal Diagnostic Equipment Standards (21 CFR § 1020.30 and 1020.33) and applicable IEC standards (60601-1, 60601-2-32, 60601-2-44).
- Claim of Substantial Equivalence: Toshiba America Medical Systems, Inc. believes the combination of the two predicate devices (the CT system and the respiratory gating system) does not change the intended use of either device.
Crucially, this document does not present specific performance data or a detailed study with acceptance criteria, sample sizes, expert ground truth establishment, or any statistical evaluation of the respiratory gating's performance against defined metrics. It primarily asserts compliance with regulatory standards and substantial equivalence, with detailed performance data implied to be in a "supplement to the initial report for the predicate device."
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MAY 12 2005
510(k) Summary
| Date: | April 10, 2005 |
|---|---|
| Submitter's Name: | Toshiba America Medical Systems, Inc. |
| Submitter's Address: | P.O. Box 2068, 2441 Michelle Drive,Tustin, CA 92781-2068 |
| Submitter's Contact:(714)730-5000 | Paul Biggins, Regulatory Affairs Specialist, |
| Establishment RegistrationNumber: | 2020563 |
| Device Proprietary Name: | TSX-201A Aquilion LB with RespiratoryGating |
| Common Name:90JAK] | Scanner, Computed Tomography, X-Ray[Fed. Reg. No. 892.1750, Pro. Code: |
| Regulatory Class: | II (per 21 CFR 892.1750) |
| Performance Standard:Standard | 21 CFR Subchapter J,Federal Diagnostic X-ray Equipment |
| Predicate Device(s): | TSX-201A Aquilion LB K050458Varian HPM K983629 |
| Reason For Submission | Modification of cleared device |
Description of this Device:
The CKRS-003A Respiratory Gating Option will be added to the previously cleared TSX-201A Aquilion LB CT system. This addition requires hardware and software modifications to the existing device.
Summary of Intended Uses:
This device is designed to produce cross-sectional images of a human body by reconstruction of x-ray transmission data from the same axial plane taken at different angles. These images have been proven to be clinically useful in the diagnosis of spine and head injuries, intracranial tumors, blood clots in the brain, eye trauma, soft tissue lesions in the extremities, gastrointestinal lesions, abdominal and pelvic malignancies, and hepatic metastases. CT is also used to evaluate intestinal obstructions, assess intra-abdominal abnormalities and to
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K06 US87
Page 2 of 2
examine musculoskeletal degeneration. Additionally this device will employ respiratory gating to reduce motion artifacts and improve targeting of anatomy for use with other cleared devices. This device employs no intended uses that are not in cleared devices already found in the marketplace.
Technological Characteristics:
This package is similar in uses and applications as those of the predicate devices. The main difference is in the method used to obtain the final results.
Safety and Effectiveness Concerns:
This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820. All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR § 1020.30 and 1020.33, that apply to this upgrade, will be met and reported via a supplement to the initial report for the predicate device. Additionally this system is in conformance with the applicable parts of the IEC 60601-1 {applicable portions}; IEC 60601-2-32 and IEC 60601-2-44. - Medical Device Safety standards.
Substantial Equivalence:
Toshiba TSX-201A, Aquilion LB CT cleared via K050458 Varian RPM Respiratory Gating System cleared via K983629
Toshiba America Medical Systems, Inc. believes that the combination of the two devices does not change the intended use of either device.
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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 and 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 a human figure embracing or supporting another, with flowing lines suggesting movement or support.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MAY 1 2 2006
Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K061187
Trade/Device Name: Toshiba TSX-201A, Aquilion LB CT System with Respiratory Gating (CKRS-003A)
Regulation Number: 21 CFR 892.1750
Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: April 25, 2006 Received: April 28, 2006
Dear Mr. Job:
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/12 description: The image is a black and white logo for the FDA Centennial, celebrating 1906-2006. The logo is circular with the letters "FDA" in a bold, sans-serif font in the center. Below the letters, the word "Centennial" is written in a cursive font. Three stars are arranged below the word "Centennial". The outer ring of the logo contains text and star symbols.
Preventing and Promoting Public Health
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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 yours,
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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Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known):
K661187
Device Name: Toshiba TSX-201A, Aquilion LB CT System with Respiratory Gating (CKRS-003A
Indications for Use:
X-ray imaging of whole body - Computerized Tomography Including;
Axial Volumetric (Helical) CT Fluoroscopy Respiratory (4D) Gated Scanning
Respiratory Gated (4D) Scanning on the Aquilion LB is a non-invasive software/hardware option that can be used for the evaluation of respiration-induced motion by acquiring and displaying CT images consisting of all respiratory phases during a breathing cycle
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR§801.109)
Over-The-Counter Use
(Optional Format 1-2-96) Division Sign-Off) Division of Reproductive, Abdominal.
OR
and Radiological D C4 M-1 M-1 M-1 M-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.