(15 days)
K03347
No
The description focuses on hardware modifications (replacing an image intensifier with a flat panel detector) and standard image processing and management functionalities. There is no mention of AI, ML, or related concepts in the intended use, device description, or other sections.
No
The device is described as a "localization and simulation device" for brachytherapy. Its intended use is for "visualization, localization and confirmation of the volume and the size of the brachytherapy irradiation field(s)," which are diagnostic and procedural guidance functions, not direct treatment.
No
The device is described as a "localization and simulation device" for brachytherapy. Its purpose is to visualize, localize, and confirm the volume and size of the irradiation field, which is part of treatment planning and delivery, not diagnosing a medical condition.
No
The device description clearly outlines multiple hardware components including a gantry, L-arm, C-arm, X-ray tube housing assembly, collimator, flat panel image detector, patient table, and a PC based workstation. While it uses specialized software, it is an integral part of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Integrated Brachytherapy - Digital (IBU-D) is a medical imaging and simulation device used in brachytherapy. Its purpose is to visualize, localize, and confirm the radiation field within the patient's body using fluoroscopy and radiography. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states its function is for visualization, localization, and confirmation of the brachytherapy irradiation field using imaging systems. This is an in-vivo (within the living body) application, not in-vitro (in glass/outside the body).
- Device Description: The description details a gantry, C-arm, X-ray tube, flat panel detector, and patient table – all components of an imaging and positioning system used directly on a patient.
Therefore, the IBU-D falls under the category of a medical imaging device used for treatment planning and verification, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Integrated Brachytherapy - Digital (IBU-D) is intended to be used for the visualization, localization and confirmation of the volume and the size of the brachytherapy irradiation field(s), using a fluoroscopic and/or radiographic system.
Product codes
KPQ
Device Description
Integrated Brachytherap Unit - Digital (IBU-D) is a modification to the Integrated Brachytherapy Unit (IBU) in which the Image Intensifier of the IBU is replaced by a Flat Panel image detector. The Flat Panel image detector used in the IBU-D is the same Flat Panel image detector as used in Nucletron's Simulix Evolution product (K03347).
The Integrated Brachytherpay Unit – Digital (IBU-D) is a localization and simulation device for a Brachy radiation therapy department. It consists of a gantry that supports an L-arm and a C-arm which can rotate isocentrically. The C-arm houses an X-ray tube housing assembly with collimator on one side and a flat panel image detector. The movements of the IBU-D are manually driven, after the relevant electrical locks are lifted. The mobile IBU patient table has mechanical motions which can be controlled from a hand pendant affixed to the table. Images are displayed and managed by a PC based workstation running specialized software.
The system makes also use of the same third party X-ray tube and X-ray high tension generator as used in the Simulix Evolution system.
The Flat Panel image detector which replaces the current Image intensifier is a Amorphous silicon, digital detector, with a square image area of 41 x 41 cm.
The PC based workstation runs the same software as the workstation of the Simulix Evolution system. It supports the following functionality:
- . Image acquisition
- Image display .
- Image annotation .
- Database and DICOM Import / Export functionality
- Position read out and display of the IBU-D gantry. .
- Control of the IBU-D beam limiting device. .
The last two items in this list are specific for the IBU-D.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopic and/or radiographic system
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
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)
Reference Device(s)
K03347
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5840 Radiation therapy simulation system.
(a)
Identification. A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. 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.
0
Image /page/0/Picture/1 description: The image shows the word "Nucletron" in bold, black font. To the left of the word is a square logo. The logo contains a black circle with two white circles on either side of it.
NUCLETRON B.V. Waardgelder 1 3905 TH Veenendaal P.O.Box 930 3900 AX Veenendaal The Netherlands Phone +31 318 557133 +31 318 550485 Fax
Department of Health and Human Services Centre of Device and Radiological Health Office of Device Evaluation Special 510(k) section
.
・・
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as required by section 807.92(c)
Submitter of 510(k):
| Company name: | Nucletron Corporation |
|---|---|
| Registration number: | 1121753 |
| Address: | 8671 Robert Fulton Drive |
| Columbia, MD 21046 | |
| Phone: | 410-312-4100 |
| Fax: | 410-312-4197 |
| Correspondent: | Lisa Dimmick |
| Director Assurance & Regulatory Affairs |
Modified Device Name:
| Trade/Proprietary Name: | Integrated Brachytherapy Unit - Digital |
|---|---|
| Common/Usual Name: | Fluoroscopic / radiographic radiation treatment simulation system |
| Classification Name: | System, Simulation, Radiation Therapy |
| Classification: | 21Cfr892.5840 Class II |
| Product Code | KPQ |
Legally Marketed Device(s)
Our device is substantially equivalent to the legally marketed predicate device cited in the table below:
|
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Description:
Integrated Brachytherap Unit - Digital (IBU-D) is a modification to the Integrated Brachytherapy Unit (IBU) in which the Image Intensifier of the IBU is replaced by a Flat Panel image detector. The Flat Panel image detector used in the IBU-D is the same Flat Panel image detector as used in Nucletron's Simulix Evolution product (K03347)
1
The Integrated Brachytherpay Unit – Digital (IBU-D) is a localization and simulation device for a Brachy radiation therapy department. It consists of a gantry that supports an L-arm and a C-arm which can rotate isocentrically. The C-arm houses an X-ray tube housing assembly with collimator on one side and a flat panel image detector. The movements of the IBU-D are manually driven, after the relevant electrical locks are lifted. The mobile IBU patient table has mechanical motions which can be controlled from a hand pendant affixed to the table. Images are displayed and managed by a PC based workstation running specialized software.
The system makes also use of the same third party X-ray tube and X-ray high tension generator as used in the Simulix Evolution system.
The Flat Panel image detector which replaces the current Image intensifier is a Amorphous silicon, digital detector, with a square image area of 41 x 41 cm.
The PC based workstation runs the same software as the workstation of the Simulix Evolution system. It supports the following functionality:
- . Image acquisition
- Image display .
- Image annotation .
- � Database and DICOM Import / Export functionality
- Position read out and display of the IBU-D gantry. .
- Control of the IBU-D beam limiting device. .
The last two items in this list are specific for the IBU-D.
Intended use:
The modified device has the same intended use as the legally marketed predicate device cited:
The Integrated Brachytherapy - Digital (IBU-D) is intended to be used for the visualization, localization and confirmation of the volume and the size of the brachytherapy irradiation field(s), using a fluoroscopic and/or radiographic system.
Summary of technological considerations:
Integrated Brachytherapy Unit - Digital is substantially equivalent to the cleared predicate device, Integrated Brachytherapy Unit, 510(k)#: K973848.
Signature
13 AUG 2007
Date
Name: Dick van-Waes Title: Business Director Brachytherapy & Imaqing Nucletron B.V. Veenendaal, The Netherlands
2
Image /page/2/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, arranged in a vertical stack. The profiles are depicted with flowing lines, giving a sense of movement or continuity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." is arranged in a circular fashion around the image.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
2007 SEP 14
Ms. Lisa Dimmick Director, Regulatory Affairs and Quality Assurance Nucletron Corporation 8671 Robert Fulton Drive COLUMBIA MD 21046
Re: K072445
Trade/Device Name: Integrated Brachytherapy Unit - Digital Regulation Number: 21 CFR 892,5840 Regulation Name: Radiation therapy stimulation system Regulatory Class: II Product Code: KPO Dated: August 13, 2007 Received: August 30, 2007
Dear Ms. Dimmick:
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 indived on for use stated in the enclosure) to legally marketed predicate devices marketed in ior un mically in 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 most therefore, market the device, subject to the general controls provisions of the Act, TTo general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adultervition.
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. Below the text is a large "FDA" in bold letters. Underneath "FDA" is the word "Centennial" in a cursive font. At the bottom of the logo are three small stars.
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3
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 not 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 se( forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the ed ecronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1150
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 logal/v marketed predicate device results in a classification for your device and thus, perceits your evice 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" (21 CFR Part 807.97). You may obtain other general information on vour responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistances at the 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 Chrogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use Statement
510(k) Number
Device Name
Indications for Use
Integrated Brachytherapy Unit - Digital
The Integrated Brachytherapy - Digital (IBU-D) is intended to be used for the visualization, localization and confirmation of the volume and the size of the brachytherapy irradiation field(s), using a fluoroscopic and/or radiographic system.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, and | |
| Radiological Devices | |
| 510(k) Number | K072445 |
| Prescription Use | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) |