Indiana University Cyclotron Facility's Proton Therapy System is a medical device intended to deliver proton radiation treatment to patients with solid tumors or other diseases susceptible to radiation.

Device Description

IUCF's PTS is a charged particle radiation therapy system. The PTS contains three major systems: the Cyclotron System (CYS), JUSTIS, and the Treatment Systems (TS). The TS is divided into seven subsystems to carry out the proton treatment process: the Treatment Room Control System (TRCS); the Kicker Enable System (KES); the Beam Delivery System (BDS); the Dose Delivery System (DDS); the Patient Positioning System (PPS); the MPRI Radiation Interlock System (MIRS); and the Emergency Stop System (ESS). These subsystems work together to generate the desired dose level and distribution at the target site. Treatment System 2 (TS2) of the PTS, the subject of this 510(k) notice, employs a rotating gantry, which allows the proton radiation beam to be delivered to the target site from any direction in a plane. The gantry includes the gantry structure; retractable gantry floor; Digital Radiography panel positioning systems; gantry safety mechanisms; and gantry rotation controls. Computer control of the gantry is provided by the PPS.

AI/ML Overview

The provided text describes the Indiana University Cyclotron Facility's Proton Therapy System (IUCF PTS) as a medical device intended to deliver proton radiation treatment. However, it does not include a table of acceptance criteria or a detailed study proving the device meets specific performance criteria.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices (Loma Linda Medical Center Proton Beam Therapy System (K872369) and Ion Beam Applications, SA's, Proton Therapy Systems (K983024, K060695)).

Here's a breakdown of what is recoverable from the text, and what is not:

1. A table of acceptance criteria and the reported device performance:

Not provided. The text states: "Extensive performance testing conducted at the system and subsystem (hardware and software) levels, and electromagnetic compatibility, electromagnetic interference ("EMC/EMI") and electrical safety demonstrated that the system and subsystems met or exceeded design specifications, clinical performance requirements and EMC/EMI and electrical safety applicable standards."
This indicates that internal design specifications and clinical performance requirements existed and were met, but the specific criteria and results are not detailed in this 510(k) summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not provided. The document does not describe a clinical study with a "test set" in the context of patient data or outcomes. The "performance testing" mentioned refers to engineering and system-level validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable / Not provided. Since there's no clinical "test set" with ground truth established by experts, this information is not present.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable / Not provided. (See point 3)

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:

No. This is a system for delivering radiation therapy, not an imaging or diagnostic AI device. Therefore, an MRMC study and AI assistance effect size are not relevant or discussed. The device is for treatment delivery, not interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable / Not provided. The device is a treatment system, not a standalone algorithm. Its performance is demonstrated through its ability to deliver the intended proton radiation, which involves hardware and software working together. The "Performance Data" section indicates system-level testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable / Not provided for clinical ground truth. The "ground truth" for this device would be its adherence to engineering specifications and its ability to accurately deliver a specified dose of proton radiation. The document states it "met or exceeded design specifications" and "functioned as intended."

8. The sample size for the training set:

Not applicable / Not provided. This is a proton therapy system, not a machine learning model that requires a distinct "training set" of data in the typical AI sense.

9. How the ground truth for the training set was established:

Not applicable / Not provided. (See point 8)

Summary of Device Acceptance Information Present in the Document:

The acceptance of the IUCF PTS is based on demonstrating substantial equivalence to existing legally marketed predicate devices rather than proving performance against specific quantitative acceptance criteria in a detailed clinical study.

Acceptance Criteria and Reported Device Performance (as inferred from the text):

Acceptance Criterion	Reported Device Performance
Design Specifications	"met or exceeded design specifications"
Clinical Performance Requirements	"met or exceeded clinical performance requirements"
EMC/EMI and Electrical Safety Standards	"met or exceeded EMC/EMI and electrical safety applicable standards"
Intended Functionality	"In all instances, the IUCF PTS functioned as intended."
Safety and Effectiveness (relative to predicates)	"The IUCF PTS is as safe and effective as the Loma Linda Medical Center Proton Beam Therapy System (K872369) and Ion Beam Applications, SA's, Proton Therapy Systems (K983024, K060695)."
Technological Characteristics	"The IUCF PTS has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices."
New Questions of Safety or Effectiveness	"The minor technological differences... raise no new questions of safety or effectiveness."

Study Information:

Type of Study: Not a typical clinical study with patient cohorts, but rather a technical performance testing and substantial equivalence argument.
Test Set Sample Size: Not applicable as no patient-specific test set is described. Performance testing was conducted at "system and subsystem levels."
Data Provenance: Not applicable for a clinical test set. The testing was likely conducted in a controlled engineering environment.
Ground Truth Establishment for Test Set: Not applicable in the clinical sense. Ground truth was adherence to engineering design specifications and regulatory standards.
Adjudication Method: Not applicable.
MRMC Study: No.
Standalone Performance Study: Performance testing was done at system/subsystem levels, which represents the device's standalone capability in delivering radiation according to design.
Type of Ground Truth: Adherence to engineering "design specifications," "clinical performance requirements," and "EMC/EMI and electrical safety applicable standards."
Training Set Sample Size: Not applicable.
Ground Truth for Training Set: Not applicable.

In essence, the document serves as a regulatory filing (510(k) summary) to demonstrate that the device is "substantially equivalent" to already approved devices, rather than a detailed report of a new clinical trial or performance validation against explicit, public acceptance criteria.

Summary

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KDb289v

510(k) SUMMARY

Indiana University Cyclotron Facility's Proton Therapy System

DEC 1 4 2006

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Indiana University Cyclotron Facility 2401 Milo B. Sampson Lane Bloomington, Indiana 47408

Phone: (812) 855-2881 Facsimile: (812) 855-6645

Paul E. Sokol, IUCF Director Contact Person:

September 26, 2006 Date Prepared:

Name of Device and Name/Address of Sponsor

Proton Therapy System (PTS)

Indiana University Cyclotron Facility 2401 Milo B. Sampson Lane Bloomington, Indiana 47408-1398

Common or Usual Name

Proton Beam Therapy System (PBTS)

Classification Name

Medical Charged-Particle Radiation Therapy System

Predicate Devices

The Indiana University Cyclotron Facility PTS is substantially equivalent to the Loma Linda Medical Center Proton Beam Therapy System (K872369) and Ion Beam Applications, SA's, Proton Therapy Systems (K983024, K060695).

Intended Use / Indications for Use

The IUCF PTS is intended to deliver proton radiation treatment to patients with solid tumors or other diseases susceptible to radiation.

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K062891

Technological Characteristics

Performance Data

Extensive performance testing conducted at the system and subsystem (hardware and software) levels, and electromagnetic compatibility, electromagnetic interference ("EMC/EMI") and electrical safety demonstrated that the system and subsystems met or exceeded design specifications, clinical performance requirements and EMC/EMI and electrical safety applicable standards. In all instances, the IUCF PTS functioned as intended.

Substantial Equivalence

The IUCF PTS is as safe and effective as the Loma Linda Medical Center Proton Beam Therapy System (K872369) and Ion Beam Applications, SA's, Proton Therapy Systems (K983024. K060695). The IUCF PTS has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the IUCF PTS and its predicate devices raise no new questions of safety or effectiveness. Performance data demonstrate that the IUCF PTS is as safe and effective as the predicate devices listed above. Thus, the IUCF PTS is substantially equivalent.

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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 stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Indiana University Cyclotron Facility c/o Jonathan S. Kahan Hogan & Hartson LLP Columbia Square 555 Thirteenth Street, N.W. WASHINGTON DC 20004

DEC 1 4 2006

Re: K062891

Trade/Device Name: Proton Therapy System 、シ Regulation Number: 21 CFR §892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN Dated: December 1, 2006 Received: December 4, 2006

Dear Mr. Kahan:

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 arior 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/10 description: The image shows a circular logo with the text "1906 - 2006" at the top. The letters "FDA" are prominently displayed in the center of the logo. Below the letters, the word "Centennial" is written in a cursive font. Three stars are arranged in a horizontal line beneath the word "Centennial".

rotecting and Promoting Puthic 9

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Page 2 --

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.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.

Sincercly yours,

Nancy C. Hogdon

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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Indications for Use Statement

510(k) Number (if known):___

Device Name: Proton Therapy System

Indications for Use:

Prescription Use _X (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use_ (21 C.F.R. 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

5 : 0(k) Number ______________________________________________________________________________________________________________________________________________________________

Page _ of

IUCF0027

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.