(28 days)
Not Found
No
The description focuses on the mechanical movement of lasers based on pre-calculated coordinates from external systems (RTPS). There is no mention of the device itself performing calculations, analysis, or learning from data, which are characteristic of AI/ML.
No.
The device is used in the simulation stage of radiation therapy to prepare a patient for treatment by precisely marking a patient, not for direct treatment.
No
The device is used to precisely mark a patient for radiation therapy by defining the isocenter based on pre-calculated coordinates. It does not diagnose any condition or disease.
No
The device description explicitly lists hardware components such as "movable lasers, a handheld keypad, a power/control box, and a PC controller" that are operated by the software.
Based on the provided information, the CT Sim Laser System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- CT Sim Laser System's Function: The CT Sim Laser System is used to physically mark a patient's body based on coordinates derived from imaging data. It does not analyze any biological specimens.
- Intended Use: The intended use clearly states its purpose is for the "simulation stage of radiation therapy to prepare a patient for treatment" and to "precisely mark a patient for radiation therapy." This is a physical alignment and marking process, not an in vitro diagnostic test.
The device's function is to translate imaging-derived coordinates into physical laser positions on the patient's body for treatment planning and setup. This is a crucial step in radiation therapy but falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The CT Sim Laser System is used in the simulation stage of radiation therapy to prepare a patient for treatment. The lasers can be moved to a point that defines the isocenter in the CT suite. The Gammex CT Sim is intended to read laser positioning coordinates in a Gammex specified software format from a file in a shared folder. Typically the coordinates were calculated by a Radiation Therapy Treatment Planning System (RTPS) using CT images and sent to the Hospital Information System (HIS), Oncology System (OIS) or other system, by the RTPS.
Product codes
IWE
Device Description
The CT Sim Laser System allows the radiation oncologist, medical physicist and oncology technician to precisely mark a patient for radiation therapy. CT Sim provides the ability to move the lasers to particular coordinates for alignment/marking purposes on the patient. The coordinates that the lasers are to move to may be manually input through the software graphical user interface (GUI) or through a data file with a specific format (or DICOM).
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT images
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiation oncologist, medical physicist and oncology technician / CT suite
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The CT Sim Laser System has been tested using appropriate bench testing methods. Test results of the modified device have demonstrated that the device performs within its design specifications and equivalently to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5780 Light beam patient position indicator.
(a)
Identification. A light beam patient position indicator is a device that projects a beam of light (incoherent light or laser) to determine the alignment of the patient with a radiation beam. The beam of light is intended to be used during radiologic procedures to ensure proper positioning of the patient and to monitor alignment of the radiation beam with the patient's anatomy.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 892.9.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 11, 2015
Gammex, Inc. % Mr. James Luker Regulatory Affairs Manager Sun Nuclear Corporation 3275 Suntree Boulevard MELBOURNE FL 32940
Re: K152303
Trade/Device Name: CT Sim Laser Alignment System Regulation Number: 21 CFR 892.5780 Regulation Name: Light beam patient position indicator Regulatory Class: II Product Code: IWE Dated: August 14, 2015 Received: August 14, 2015
Dear Mr. Luker:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael O'Hara For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K152303
Device Name CT Sim Laser Alignment System
Indications for Use (Describe)
The CT Sim Laser System is used in the simulation stage of radiation therapy to prepare a patient for treatment. The lasers can be moved to a point that defines the isocenter in the CT suite. The Gammex CT Sim is intended to read laser positioning coordinates in a Gammex specified software format from a file in a shared folder. Typically the coordinates were calculated by a Radiation Therapy Treatment Planning System (RTPS) using CT images and sent to the Hospital Information System (HIS), Oncology System (OIS) or other system, by the RTPS.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Section 5 - 510(k) Summary
Provided in accordance with 21 CFR 807.92 (c)
General Provisions 1
Date Prepared:
August 27, 2015
Submitted by:
Gammex Inc. 7600 Discovery Drive Middleton WI, 53562 Ph: 608 828-7000 Fax: 608-828-7500 Web: www.gammex.com
Contact Person:
Ken Windisch KRW@Gammex.com
Phone: 608 828 7276
Classification Name:
Light beam patient position indicator
Common Name:
Laser alignment system
Proprietary Names:
CT Sim Laser System
Establishment Registration Number:
2181970
Classification:
Regulation Number: 21 CFR 892.5780 Name: Light beam patient position indicator Product code: IWE
Class 2
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Predicate Device(s):
| Model Name: | Philips Laser Alignment Tool |
|---|---|
| Common Name: | Laser alignment system |
| 510(k) # | K943381 |
| Manufacturer: | Philips Medical Systems |
| Submitted: | July 13, 1994 |
| Model Name: | Centralite |
| Common Name: | Laser alignment system |
| 510(k) # | K872489 |
| Manufacturer: | Diacor Inc. |
| Submitted: | June 23, 1987 |
To our knowledge, these predicate devices have not been subject to a design-related recall.
2 Description and Use:
The CT Sim Laser System allows the radiation oncologist, medical physicist and oncology technician to precisely mark a patient for radiation therapy. CT Sim provides the ability to move the lasers to particular coordinates for alignment/marking purposes on the patient. The coordinates that the lasers are to move to may be manually input through the software graphical user interface (GUI) or through a data file with a specific format (or DICOM). CT Sim is in no way integrated with the third party Radiation Therapy Treatment Planning System (RTPS) or imaging/radiological device.
3 Intended Use Statement:
The CT Sim Laser System is used in the simulation stage of radiation therapy to prepare a patient for treatment. The lasers can be moved to a point that defines the isocenter in the CT suite. The Gammex CT Sim is intended to read laser positioning coordinates in a Gammex specified software format from a file in a shared folder. Typically the coordinates were calculated by a Radiation Therapy Treatment Planning System (RTPS) using CT images and sent to the Hospital Information System (HIS), Oncology System (OIS) or other system, by the RTPS.
বা Technological Characteristics
The primary technological characteristics of the CT Sim Laser System is usage of movable lasers, a handheld keypad, a power/control box, and a PC controller, which are operated by the CT Sim software to indicate isocenter in the CT suite. These technological characteristics are believed to be substantially equivalent to the predicate device and where differences exist, do not raise new questions of safety and/or effectiveness.
5 Performance Data and Comparison with Predicate
The CT Sim Laser System has been tested using appropriate bench testing methods. Test results of the modified device have demonstrated that the device
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performs within its design specifications and equivalently to the predicate devices.
6 Summary
The CT Sim Laser System is believed to be substantially equivalent to the predicate Philips Laser Alignment Tool (K943381) and Diacor Inc. Centralite (K872489) device due to the similarities in function, technology, and performance. The intended use, performance testing, safety and effectiveness reviews demonstrate CT Sim Laser System is as safe, as effective, and performs as well as the predicate device. Where differences exist, they are not believed to raise new questions of safety and/or effectiveness.