(99 days)
No
The device description and intended use focus on mechanical positioning and alignment of collimators, with no mention of AI/ML technologies or related concepts like image processing, training/test sets, or performance metrics typically associated with AI/ML devices.
No
The device is described as an accessory housing that positions and aligns collimators for radiation beam shaping during radiosurgery and radiation therapy procedures. It is not directly therapeutic but rather an accessory to a therapeutic device (the LINAC).
No
This device is described as an accessory for a LINAC (Linear Accelerator) system used to position and align radiation beam shaping collimators during radiosurgery and radiation therapy procedures. Its function is to facilitate treatment delivery, not to diagnose a condition or disease.
No
The device description clearly states it is a physical assembly consisting of a collimator sliding tray, baseplate, and tube, designed to be mounted on a LINAC. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a mechanical accessory for a linear accelerator (LINAC) used in radiotherapy and radiosurgery. It is designed to hold and position collimators to shape radiation beams for treating patients.
- Device Description: The description details the physical components of the device (sliding tray, baseplate, tube) and its function in aligning radiation beam shaping collimators.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in laboratory settings or point-of-care testing to analyze biological samples.
This device is a medical device used in the delivery of radiation therapy, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Integra Radionics™ Linac Collimator Assembly Housing (LCAH) is intended to be mounted as an Accessory tray for a LINAC to attach Integra Radionics collimators.
The Integra Radionics™ Linac Collimator Assembly Housing (LCAHART) is indicated to be mounted on the Siemens Artiste MV linac with MLC-160 Accessory Hollder as an Accessory tray to attach Integra Radionics collimators for treatment modalities such as stereotactic radiosurgery (SRS) and radiotherapy (SRT).
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
The Linac Collimator Assembly Housing (LCAH) consisting of a collimator sliding tray, collimator baseplate, and collimator tube. It is designed as a slide-in attachment for the Siemens MLC-160 LINAC Accessory Holder. The LCAH positions and aligns Radionics radiation beam shaping collimators to the Siemens ARTISTE LINAC (K072485) internal collimator and radiation source during radiosurgery and radiation therapy procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intended Users of the LCAH are medical physicists, radiation oncologists, and appropriate radiation technicians.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
K/00096
Confidential
Integra Radionics, Inc. Premarket Notification Traditional 510(k) Linac Collimator Assembly Housing (LCAH)
Linac Collimator Assembly Housing (LCAH) 510(k) Summary
Submitter's name and address:
APR 2 2 2010
Integra Radionics, Inc. 22 Terry Avenue Burlington, MA 01803 USA
Contact person and telephone number:
Helder A. Sousa Regulatory Affairs Project Manager Integra Radionics, Inc. 22 Terry Avenue Burlington, MA 01803 USA Phone: (781) 565-1235 Fax: (781) 238-0645
Date prepared:
December 11, 2009
Name of device:
| Trade Name: | Linac Collimator Assembly Housing (LCAH) |
|---|---|
| Common Name: | Collimator Assembly |
| Classification Name: | Accelerator, Linear, Medical |
| Regulation Number: | 21 CFR 892.5050 |
| Product Code: | IYE |
Substantial Equivalence:
The Linac Collimator Assembly Housing (LCAH) is substantially equivalent in function and intended use with the XKnife Radiosurgery System (K912630) and the ARTISTE MV SA (K072485).
Indications Use:
The Integra Radionics™ Linac Collimator Assembly Housing (LCAH) is intended to be mounted as an Accessory tray for a LINAC to attach Integra Radionics collimators.
Device Description:
...
The Linac Collimator Assembly Housing (LCAH) consisting of a collimator sliding tray, collimator baseplate, and collimator tube. It is designed as a slide-in attachment for the Siemens MLC-160 LINAC Accessory Holder. The LCAH positions and aligns Radionics radiation beam shaping collimators to the Siemens ARTISTE LINAC (K072485) internal collimator and radiation source during radiosurgery and radiation therapy procedures.
1
Intended Users of the LCAH are medical physicists, radiation oncologists, and appropriate radiation technicians.
Conclusion:
The Linac Collimator Assembly Housing (LCAH) is substantially equivalent to the XKnife Radiosurgery System (K912630) and the Siemens ARTISTE MV SA (K072485). The Linac Collimator Assembly Housing (LCAH) is similar to the predicate devices in the intended use, the fundamental scientific technology of the device, and does not raise new issues of safety and effectiveness.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized caduceus, which is a symbol often associated with healthcare, overlaid on a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Helder A. Sousa Regulatory Affairs Project Manager Integra Radionics, Inc. 22 Terry Avenue BURLINGTON MA 01803
APR 2 2 2010
Re: K100096
Trade/Device Name: Linac Collimator Assembly Housing (LCAHART) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: March 15, 2010 Received: March 16, 2010
Dear Mr. Sousa:
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 200). This letter will allow you to begin marketing your device as described in your Section 510(l) memarket notification. The FDA finding of substantial equivalence of your device to a logally 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 tolloffre ne (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Donald J. Trump
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K100096
Device Name:
Linac Collimator Assembly Housing (LCAHART)
Indications For Use:
The Integra Radionics™ Linac Collimator Assembly Housing (LCAHART) is indicated to be mounted on the Siemens Artiste MV linac with MLC-160 Accessory Hollder as an Accessory tray to attach Integra Radionics collimators for treatment modalities such as stereotactic radiosurgery (SRS) and radiotherapy (SRT).
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Blod Becker
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K100096
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