(56 days)
The GateCT-RT system is used to obtain tracking of the subject's respiratory pattern for respiratory synchronized image acquisition, and radiation therapy treatment. It can be also used, either independently or in conjunction with Vision RT's AlignRT (K052682), to monitor the patient position during the image acquisition, simulation and treatment and to disable the radiation beam automatically.
The GateCT-RT device is an attachment to radiation therapy treatment systems, simulators and image acquisition devices used for diagnostics and radiation therapy. The GateCT-RT system senses and records the respiratory motion and respiratory state of a patient using real time 3D surface tracking of the patient without the need of any externally positioned markers. Regions to be tracked are selected remotely in a location indicated by the physician on the GateCT-RT workstation. These may be automatically detected during subsequent sessions. GateCT tracks the patient's breathing CT acquisition in order to facilitate 4DCT reconstruction. GateRT tracks respiratory motion during treatment or imaging and automatically disables the beam when the breathing signal moves outside the user defined gating window. GateCT-RT may also be employed within the monitoring mode of AlignRT to disable the beam automatically if any patient movement is detected which exceeds a user defined tolerance. The Vision RT camera unit is connected to a PC workstation and is used for surface tracking of the patient.
The provided 510(k) summary for the GateCT-RT Respiratory Gating System does not contain specific details about acceptance criteria, a standalone study, or a multi-reader multi-case (MRMC) comparative effectiveness study with human readers. The information focuses on device description, intended use, and technological characteristics compared to predicate devices for substantial equivalence.
Therefore, many of the requested sections regarding study specifics cannot be extracted from this document, as this type of information is generally not included in a 510(k) summary, which primarily establishes substantial equivalence to predicate devices.
However, based on the provided text, I can infer some aspects related to the purpose of such a device, and answer what info is available.
Here's the breakdown of what can and cannot be answered from the provided text:
Acceptance Criteria and Device Performance
The document does not explicitly state quantitative acceptance criteria or report specific performance metrics from a study (e.g., accuracy, precision of respiratory tracking). It focuses on technological characteristics and intended use for substantial equivalence.
| Acceptance Criteria (Inferred from Intended Use) | Reported Device Performance (Not present in document) |
|---|---|
| Obtain tracking of subject's respiratory pattern | (No specific performance metrics reported in this summary) |
| Facilitate 4DCT reconstruction | (No specific performance metrics reported in this summary) |
| Track respiratory motion during treatment/imaging | (No specific performance metrics reported in this summary) |
| Automatically disable beam when breathing signal moves outside user-defined gating window | (No specific performance metrics reported in this summary) |
| Monitor patient position during image acquisition, simulation, and treatment | (No specific performance metrics reported in this summary) |
Sample Size and Data Provenance
The document does not describe any specific clinical or performance studies with sample sizes. It is a 510(k) summary primarily focused on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use.
Number of Experts and Qualifications for Ground Truth
The document does not describe any study involving experts to establish ground truth.
Adjudication Method
The document does not describe any study, and therefore, no adjudication method is mentioned.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned in the provided text. The submission focuses on device characteristics, not on comparative effectiveness with human readers.
Standalone Performance Study
The document does not explicitly describe a standalone performance study with quantitative results. While the device itself performs tracking, the submission does not include a study demonstrating its standalone accuracy or precision against a gold standard.
Type of Ground Truth Used
The document does not describe any study, and therefore, no ground truth type is mentioned.
Sample Size for Training Set
The document does not refer to any training set or machine learning model, and thus no sample size for a training set is provided.
How Ground Truth for Training Set was Established
The document does not refer to any training set, and thus no method for establishing its ground truth is provided.
Summary of what is available from the 510(k) Summary:
The provided document is a 510(k) summary, which is a submission to the FDA for medical device clearance based on substantial equivalence to predicate devices. It typically describes the device, its intended use, and compares its technological characteristics to existing legally marketed devices. It generally does not include detailed clinical study data, performance metrics, or information about training/test sets, expert adjudication, or MRMC studies, unless these were part of specific tests needed to prove substantial equivalence for unique characteristics. In this case, the clearance seems to be based on comparison of technological characteristics rather than a new standalone clinical efficacy study.
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510(k) Summary
The following information is provided following the format of 21 CFR §807.92 for the GateCT-RT Respiratory Gating System.
| 1. Submitter: Vision RT Ltd |
|---|
| Daws House |
| 33-35 Daws Lane |
| London NW7 4SD |
| United Kingdom |
| Contact Name: Dr Norman Smith |
| Phone: +44 20 89066620 |
| Fax: +44 20 89066621 |
| Email: nsmith@visionrt.com |
| Date summary was prepared: 26th July 2007 |
OCT 1 2007
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- Name of the Device: GateCT-RT GateCT, GateRT Trade/Proprietary Name: Common or Usual Name: Respiratory Gating System Classification Name: Medical Charged-particle radiation therapy system accessory.
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Predicate Devices: Varian RPM Respiratory Gating (K063270); Vision RT's AlignRT (K052682).
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Description of the Device: The GateCT-RT device is an attachment to radiation therapy treatment systems, simulators and image acquisition devices used for diagnostics and radiation therapy. The GateCT-RT system senses and records the respiratory motion and respiratory state of a patient using real time 3D surface tracking of the patient without the need of any externally positioned markers. Regions to be tracked are selected remotely in a location indicated by the physician on the GateCT-RT workstation. These may be automatically detected during subsequent sessions. GateCT tracks the patient's breathing CT acquisition in order to facilitate 4DCT reconstruction. GateRT tracks respiratory motion during treatment or imaging and automatically disables the beam when the breathing signal moves outside the user defined gating window. GateCT-RT may also be employed within the monitoring mode of AlignRT to disable the beam automatically if any patient movement is detected which exceeds a user defined tolerance. The Vision RT camera unit is connected to a PC workstation and is used for surface tracking of the patient.
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Intended Use Statement: The GateCT-RT system is used to obtain tracking of the subject's respiratory pattern for respiratory synchronized image acquisition, and radiation therapy treatment. It can be also used, either independently or in conjunction with Vision RT's AlignRT (K052682), to monitor the patient position during the image acquisition, simulation and treatment and to disable the radiation beam automatically.
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Summary of the Technological Characteristics: The Substantial Equivalence Comparison Chart provides a comparison of the technological characteristics to those of the predicate devices. The comparison chart demonstrates that the device is substantially equivalent to its predicate devices cited in the table. The chart is located in Tab 8 of the submission.
Vision RT Limited DAWS HOUSE 33-35 DAWS LANE LONDON NW7 4SD T +44 (0)20 8906 6620 F +44 (0)20 8906 6621 www.visionrt.com
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Image /page/1/Picture/0 description: The image is a black and white circular logo. The logo contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of three lines that resemble a person.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Vision RT Ltd. % Mr. Robert J. Morton, M.S. Quality and Regulatory Services. Inc. 1244 Fairway Valley Court LINCOLN CA 95648
OCT 1 2007
Re: K072171
Trade/Device Name: GateCT-RT Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product*Code: IYE Dated: August 1, 2007 Received: August 6, 2007
Dear Mr. Morton:
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/1/Picture/10 description: The image shows a logo with the text "1906-2006" at the top and "Centennial" in the middle. Below the logo, the text "Proloting and Promoting Public Health" is written in a decorative font. The logo appears to be a commemorative emblem, possibly for an organization's 100th anniversary.
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Enclosure
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 (2) 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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely vours.
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): _
Device Name:
GateCT-RT
Indications for Use:
The GateCT-RT system is used to obtain tracking of the subject's respiratory pattern for respiratory synchronized image acquisition, and radiation therapy treatment. It can be also used, either independently or in conjunction with Vision RT's AlignRT (K052682), to monitor the patient position during the image acquisition, simulation and treatment and to disable the radiation beam automatically.
Prescription 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)
Arqui To Nhan
(Division Sian-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.