(67 days)
No
The description focuses on traditional treatment planning functionalities, image processing, and database management. There is no mention of AI, ML, or related terms, nor is there any description of training or test sets which are typical for AI/ML devices. The modifications mentioned are related to specific functionalities like post-planning and auto activation of dwell positions, which are not inherently AI/ML.
No
The device is a software application for brachytherapy treatment planning, assisting in determining the positioning and loading of radioactive sources for cancer treatment, rather than directly treating the disease.
No
This device is a treatment planning system for brachytherapy and provides tools for planning and evaluating dose distribution for cancer treatment, not for diagnosing cancer or other conditions.
Yes
The device is described as a "software application" and a "software program" that runs on a Windows platform. While it is an accessory to a hardware device (microSelectron-HDR), the 510(k) summary focuses solely on the software's functionality for treatment planning and does not describe any hardware components of the device itself.
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: Real Time HDR is a software application used for treatment planning in brachytherapy. It uses imaging data (3D Ultrasound) and anatomical/dosimetric information to help physicians determine the positioning and loading of radioactive sources for cancer treatment.
- Lack of Sample Analysis: The description does not mention any analysis of samples taken from the patient's body. The software processes imaging data and treatment parameters, not biological samples.
Therefore, Real Time HDR falls under the category of a medical device used for treatment planning, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Real Time HDR is a software application for Brachytherapy Treatment Planning, for the treatment of cancer, i.e. intercavitary, interstitial, intraluminal, involving radioactive sources.
Product codes
90 JAQ, MUJ
Device Description
Real Time HDR (RT HDR) is a "real time" treatment planning system for brachytherapy especially meant for treatment of cancer in the prostate. Direct 3D Ultrasound imaging of the treatment gives the physician the possibility to update the planning of the dwell positions of the source in the prostate of the patient.
The program provides a variety of plan evaluation tools to assist in generating the most optimal dose distribution, i.e. dose volume histograms, dose verification points and dose profiles. The software program provides the physician wih anatomical and dosimetric information, to determine the positioning and loading of the radioactive sources, prior to radiation treatment. The program also provides the treatment time and dose distribution for the specified loading. From this the information the patient can be treated with the dwell positions of the source.
Modifications to SPOT previously cleared K992303, have been made to add functionality for:
- Post Planning
- Auto activation dwell positions
The Ultrasound acquisitation has been changed form longitidinal to transversal.
The Post Planning functionality has been derived from Plato BPS K983343. The Dicom 3 Import/Export has been derived from Plato External Beam K964206.
Real Time HDR (RT HDR) is an accessory to the microSelectron-HDR (V2). The program constists of two modules: - Treatment Planning Software: Real Time HDR
- Database: Smoothbase
The software runs on a Windows 2000 platform.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
3D Ultrasound imaging
Anatomical Site
prostate
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.
0
Special 510(k) Nucletron Real Time HDR August 2002
OCT 2 5 2002
Page 7-4
Image /page/0/Picture/3 description: The image shows the word "Nucletron" in bold, black font. To the left of the word is a square containing a black circle with two white circles inside. The white circles are positioned on opposite sides of the black circle.
NUCLETRON B.V.
Waardgelder 1 3905 TH Veenendaal P.O.Box 930 3900 AX Veenendaal The Netherlands Phone +31 318 557133 Fax +31 318 550485
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):
(
f
| Company name: | Nucletron Corporation |
|---|---|
| Registration number: | 1121753 |
| Address: | 7080 Columbia Gateway Drive |
| Columbia, MD 21046-2133 | |
| Phone: | 410-312-4100 |
| Fax: | 410-312-4197 |
| Correspondent: | Lisa Dimmick |
| Director Assurance & Regulatory Affairs |
Modified Device Name:
| Trade/Proprietary Name: | Real Time HDR |
|---|---|
| Common/Usual Name: | Radiation Therapy Planning System |
| Classification Name: | Acessory to Radiotherapy Device |
| Classification: | 21Cfr892.5050 Class II |
Legally Marketed Device(s)
Our device is substantially equivalent to the legally marketed predicate device cited in the table below:
| Manufacturer | Device | 510(k) # |
|---|---|---|
| Nucletron BV | SPOT (Sonographic Planning of Oncology | |
| Treatments) | K992303 |
Description:
Real Time HDR (RT HDR) is a "real time" treatment planning system for brachytherapy especially meant for treatment of cancer in the prostate. Direct 3D Ultrasound imaging of the
1
Special 510(k) Nucletron Real Time HDR August 2002
treatment gives the physician the possibility to update the planning of the dwell positions of the source in the prostate of the patient.
The program provides a variety of plan evaluation tools to assist in generating the most optimal dose distribution, i.e. dose volume histograms, dose verification points and dose profiles. The software program provides the physician wih anatomical and dosimetric information, to determine the positioning and loading of the radioactive sources, prior to radiation treatment. The program also provides the treatment time and dose distribution for the specified loading. From this the information the patient can be treated with the dwell positions of the source.
Modifications to SPOT previously cleared K992303, have been made to add functionality for:
-
o Post Planning
, ----- -
. Auto activation dwell positions
The Ultrasound acquisitation has been changed form longitidional to transversal.
The Post Planning functionality has been derived from Plato BPS K983343. The Dicom 3 Import/Export has been derived from Plato External Beam K964206.
Real Time HDR (RT HDR) is an accessory to the microSelectron-HDR (V2). The program constists of two modules:
- Treatment Planning Software: Real Time HDR ●
- Database: Smoothbase ●
The software runs on a Windows 2000 platform.
Intended use:
The modified device has the same intended use as the legally marketed predicate device cited:
Real Time HDR is intended for use with Brachytherapy procedures, i.e. intercavitary, interstitial, intraluminal, involving afterloading radioactive sources.
Summary of technological considerations;
Real Time HDR is substantially equivalent to the cleared predicate device, SPOT (Sonographic Planning of Oncology Treatments), 510(k)#: K992303.
Name: J. W. M. Meiis Title: a.i. Business Segment Manager Nucletron B.V. Veenendaal. The Netherlands
8/8/2002
Date
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is a symbol of medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 0 Corporate Boulevard kville MD 20850
Ms. Lisa Cole Dimmick Director of Regulatory Affairs Nucletron Corporation 7080 Columbia Gateway Drive COLUMBIA MD 21046-2133
Re: K022739
Trade/Device Name: Real Time HDR Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II
Product Code: 90 JAQ and MUJ Dated: October 4, 2002 Received: October 7, 2002
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 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 (PMA), it may be subject to 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.
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,
3
Page 2
This letter will allow you to begin marketing your device as described in your 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:
| 8xx.1xxx. | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancv C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number K022739
Device Name
Real Time HDR
Indications for Use
Real Time HDR is a software application for Brachytherapy Treatment Planning, for the treatment of cancer, i.e. intercavitary, interstitial, intraluminal, involving radioactive sources.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
Elaine R. Ingram
(Division Sign-Off) Division of Reproductive Abdomi and Radiological Davings 510(k) Number __