(66 days)
Unknown
The description mentions "Auto contouring" which could potentially utilize AI/ML, but the summary provides no further details or explicit mention of AI/ML technologies.
No.
This device is a treatment planning software for medical devices used in brachytherapy, not a therapeutic device itself.
No
This device is a treatment planning system for brachytherapy, which aids in determining the positioning and loading of radioactive sources for cancer treatment. It provides anatomical and dosimetric information and plan evaluation tools, but it does not diagnose a disease or condition.
Yes
The device description explicitly states "SPOT PRO is a software application" and "The software program provides...". While it interacts with imaging modalities and is used in conjunction with brachytherapy hardware (radioactive sources), the device itself, as described in the summary, is the software for planning and analysis. There is no mention of accompanying hardware being part of the device submission.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- SPOT PRO's Function: SPOT PRO is a software application used for treatment planning in brachytherapy. It uses imaging data (ultrasound, CT, MR) to help physicians determine the placement and dosage of radioactive sources for cancer treatment. It does not analyze biological specimens from the patient.
Therefore, SPOT PRO falls under the category of medical device software used for treatment planning, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
SPOT PRO is intended for use with Brachytherapy procedures, i.e. intercavitary, interstitial, intraluminal, involving afterloading radioactive sources.
SPOT PRO is a software application for Brachytherapy Treatment Planning, for the treatment of cancer, i.e. intercavitary, interstitial, intraluminal, involving radioactive sources.
Product codes
90 MUJ
Device Description
SPOT PRO 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 radioactive seeds implant in the prostate of the patient.
The software program provides the physician wih anatomical and dosimetric information, to determine the positioning and loading of the radioactive sources, prior to insertion. The software 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 also provides the treatment time and dose distribution for the specified loading. From this the information the patient can be treated with radioactive sources.
Modifications to SPOT previously cleared K992303, have been made to add functionality for:
- . Post Planning functionality
- Auto activation dwell positions .
- Auto contouring .
- Usage of CT / MR images acquired by Dicom 3 Import/Export .
The Post Planning functionality has been derived from Plato BPS K983343. The Dicom 3 Import/Export has been derived from Plato External Beam K964206.
The software runs on a Windows NT platform.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
3D Ultrasound imaging, CT / MR images (acquired by Dicom 3 Import/Export)
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
§ 892.5050 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.
0
Special 510(k) Nucletron SPOT PRO August 2002
Image /page/0/Picture/1 description: The image shows the word "Nucletron" in bold, black font next to a logo. The logo is a black square with a white border. Inside the square is a black circle with two white circles on either side. The word "Nucletron" is to the right of the logo.
OCT 2 4 2002
Page 7-4
Ko22741
nucletron b.v. Waardgelder 1 3905 TH Veenendaal 3900 AX Veenendaal P.O.Box 930 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):
| 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: | SPOT PRO |
|---|---|
| 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:
SPOT PRO 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
1
Special 510(k) Nucletron SPOT PRO August 2002
KU22741
physician the possibility to update the planning of the radioactive seeds implant in the prostate of the patient.
The software program provides the physician wih anatomical and dosimetric information, to determine the positioning and loading of the radioactive sources, prior to insertion. The software 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 also provides the treatment time and dose distribution for the specified loading. From this the information the patient can be treated with radioactive sources.
Modifications to SPOT previously cleared K992303, have been made to add functionality for:
- . Post Planning functionality
- Auto activation dwell positions .
- Auto contouring .
- Usage of CT / MR images acquired by Dicom 3 Import/Export .
The Post Planning functionality has been derived from Plato BPS K983343. The Dicom 3 Import/Export has been derived from Plato External Beam K964206.
The software runs on a Windows NT platform.
Intended use:
The modified device has the same intended use as the legally marketed predicate device cited:
SPOT PRO is intended for use with Brachytherapy procedures, i.e. intercavitary, interstitial, intraluminal, involving afterloading radioactive sources.
Summary of technological considerations:
SPOT PRO is substantially equivalent to the cleared predicate device, SPOT (Sonographic Planning of Oncology Treatments), 510(k)#: K992303.
ueslue-Q. R
Name: U. Lutz Title: Business Segment Manager Nucletron B.V. Veenendaal, The Netherlands
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 200 Corporate Boulevard ockville MD 20850
Ms. Lisa Cole Dimmick Director of Regulatory Affairs Nucletron Corporation 7080 Columbia Gateway Drive COLUMBIA MD 21046-2133 Re: K022741
Trade/Device Name: Spot Pro Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II Product Code: 90 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. Iisting 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.
Image /page/2/Picture/11 description: The image shows a partial view of a logo or emblem, featuring stylized, curved lines that resemble waves or abstract shapes. To the left of the design, there is text arranged vertically, following the curve of the emblem. The text appears to be part of the organization's name or a related descriptor, and the overall design suggests a connection to water, nature, or a related field.
3
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. Snogdon
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
510(k) Number.
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SPOT PRO
Device Name
Indications for Use
SPOT PRO is a software application for Brachytherapy Treatment Planning, for the treatment of cancer, i.e. intercavitary, interstitial, intraluminal, involving radioactive sources.
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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 | K022741 |
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
OR
Over-The-Counter Use_