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).

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.

AI/ML Overview

This document describes a medical device, the Linac Collimator Assembly Housing (LCAH), and its 510(k) summary for substantial equivalence review. This type of regulatory submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device.

Therefore, the document does not contain specific acceptance criteria, performance data from a clinical study, or details about ground truth establishment, expert review, or statistical methodologies like MRMC studies typically found in submissions for novel devices or those requiring clinical performance validation.

Based on the provided text, the following information is either not applicable or not available:

A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on substantial equivalence to predicate devices, not performance against specific criteria.
Sample size used for the test set and the data provenance: Not applicable as no clinical test set or performance study is detailed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
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: Not applicable. This device is a physical accessory for a LINAC, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no clinical performance study is detailed.
The sample size for the training set: Not applicable as this is not an AI/algorithm-based device requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary of Device and Regulatory Context (from the provided text):

Device Name: Linac Collimator Assembly Housing (LCAH)
Intended 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)."
Regulatory Mechanism: 510(k) Premarket Notification, seeking substantial equivalence.
Predicate Devices: XKnife Radiosurgery System (K912630) and the ARTISTE MV SA (K072485).
Conclusion for Equivalence: The 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."

In the context of a 510(k) for a device like the LCAH, the "acceptance criteria" are primarily met through demonstrating equivalence to existing legally marketed devices, often through engineering analysis, mechanical testing, and comparison of specifications, rather than clinical performance studies with specific statistical endpoints. The study proving it meets criteria would be the submission itself, detailing how its design and function compare to the predicates.

Summary

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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:

...

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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.

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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

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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:

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

Page 1 of 1

Regulation Number and Section

§ 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.