(50 days)
Pre-1976 Neutron Therapy Device
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on hardware and software upgrades for a radiation therapy system, without mentioning any AI/ML functionalities.
Yes
The device is described as a "medical neutron radiation therapy system that provides a therapeutic neutron beam for clinical treatment," indicating its purpose is to treat medical conditions.
No
The device is described as a medical device designed to produce and deliver a neutron beam for the treatment of patients, and it is referred to as a "radiation therapy system." While it uses a CT scanner, this component is for "Patient Treatment Simulation" and not for diagnosis.
No
The device description explicitly mentions modifications to hardware subsystems (Patient Treatment Chair, Patient Treatment Platform, GE CT/T 8800 Scanner) in addition to a software subsystem. This indicates it is a system with both hardware and software components, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "produce and deliver a neutron beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation." This describes a therapeutic device that acts directly on the patient's body.
- Device Description: The description confirms it's a "medical neutron radiation therapy system that provides a therapeutic neutron beam for clinical treatment." This further reinforces its therapeutic nature.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such examination of specimens.
Therefore, the NIUINT at Fermilab NTS is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NIUINT at Fermilab NTS is a preamendments medical device designed to produce and deliver a neutron beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Product codes (comma separated list FDA assigned to the subject device)
IWL
Device Description
The modified NTS is a medical neutron radiation therapy system that provides a therapeutic neutron beam for clinical treatment. Modifications include upgrades to the Patient Treatment Chair Subsystem, the Patient Treatment Platform Subsystem, the GE CT/T 8800 Scanner Subsystem, and the Patient Treatment Simulation Software Subsystem.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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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)
The modified NTS Patient Treatment Chair and Patient Treatment Platform Subsystems have been in clinical use for approximately two years. The GE CT/T 8800 Scanner Subsystem has been in clinical use for approximately five vears and the Patient Treatment Simulation Software Subsystem has been in clinical use for approximately twenty-five years. All subsystems demonstrate that the post-1976 modifications meet performance specifications. Performance specifications and testing information are described in Sections XVIII-XX.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Pre-1976 Neutron Therapy Device, Northern Illinois University Institute for Neutron Therapy at Fermilab.
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
§ 892.5300 Medical neutron radiation therapy system.
(a)
Identification. A medical neutron radiation therapy system is a device intended to generate high-energy neutrons for radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment support, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows a handwritten text string. The string appears to be "KD63691". The text is written in a bold, somewhat messy style, with the characters closely spaced together. The background is plain white.
510(k) SUMMARY
NIUINT at Fermilab's Neutron Therapy System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Northern Illinois University Institute for Neutron Therapy at Fermilab 307 Lowden Hall DeKalb, Illinois 60115 (815) 753-0936 Phone: Facsimile: (815) 753-0666
Contact Person: John L. Lewis, Ph.D.
JAN 3 1 2007
Date Prepared: December 12, 2006
Name of Device and Name/Address of Sponsor
Neutron Therapy Device
Northern Illinois University Institute for Neutron Therapy at Fermilab 307 Lowden Hall DeKalb, Illinois 60115
Common or Usual Name
Neutron Therapy System ("NTS")
Classification Name
Medical Neutron Radiation Therapy System Classification Code: IWL, 21 C.F.R. § 892.5300
Predicate Devices
Pre-1976 Neutron Therapy Device, Northern Illinois University Institute for Neutron Therapy at Fermilab.
1
Intended Use / Indications for Use
The NIUINT at Fermilab NTS is a preamendments medical device designed to produce and deliver a neutron beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Technological Characteristics
The modified NTS is a medical neutron radiation therapy system that provides a therapeutic neutron beam for clinical treatment. Modifications include upgrades to the Patient Treatment Chair Subsystem, the Patient Treatment Platform Subsystem, the GE CT/T 8800 Scanner Subsystem, and the Patient Treatment Simulation Software Subsystem.
Performance Data
The modified NTS Patient Treatment Chair and Patient Treatment Platform Subsystems have been in clinical use for approximately two years. The GE CT/T 8800 Scanner Subsystem has been in clinical use for approximately five vears and the Patient Treatment Simulation Software Subsystem has been in clinical use for approximately twenty-five years. All subsystems demonstrate that the post-1976 modifications meet performance specifications. Performance specifications and testing information are described in Sections XVIII-XX.
Substantial Equivalence
The modified NTS is substantially equivalent to the preamendments NTS. The modified NTS has the same intended uses and similar indications, technological characteristics and principles of operation. The minor technological differences between the modified NTS and its predicate device raise no new issues of safety or effectiveness. Thus, the modified NTS is substantially equivalent to its predicate device.
2
Image /page/2/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized graphic in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The central graphic consists of three curved lines that resemble a stylized human figure or abstract design. The image is in black and white.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Northern Illinois University Outreach % Mr. Jonathan S. Kahan, Esq. Regulatory Counsel Hogan & Hartson L.L.P. 555 Thirteenth Street, NW WASHINGTON DC 20004
JAN 3 1 2007
Re: K063691
Trade/Device Name: Neutron Therapy System Regulation Number: 21 CFR 892.5300 Regulation Name: Medical neutron radiation therapy system Regulatory Class: II Product Code: IWL Dated: December 12, 2006 Received: December 12, 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 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/2/Picture/10 description: The image is a circular logo with the letters "FDA" in large, bold font in the center. Above the letters, the years "1906-2006" are printed. Below the letters, the word "Centennial" is written in a cursive font. The logo is surrounded by a dotted border with stars.
Protecting and Promoting Public Health
3
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loast be advised that i Driv based.
that FDA has made a determination that your device complies with other requirements of the Act that I Dri her made a and regulations administered by other Federal agencies. You must of any I coclar statutes and regaratents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI'N I all 607), labeling (21 OF N Part 820); and if applicable, the electronic forul in the quality by stells (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) This leter with and in Jourse Sogal finding of substantial equivalence of your device to a legally premaired predicated 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 11 you desire 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 (210) It For 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 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 IV.
The NTS is a preamendments medical device designed to produce and deliver a neutron beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
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)
Page _ of _
David A. Segura
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
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