(30 days)
Not Found
No
The summary describes a radiation therapy afterloading system with treatment planning software, but there is no mention of AI or ML capabilities in the device description, intended use, or specific sections for AI/ML details.
Yes
This device is intended to apply a radionuclide source for radiation therapy, which is a medical treatment.
No
The device is intended for radiation therapy by applying a radionuclide source, which is a treatment function, not a diagnostic one.
No
The device description explicitly states it is an "Afterloading System" which includes hardware components like a PC running software, but also implies a system for applying a radionuclide source, which is a physical process requiring hardware beyond just software. It also mentions "Applicators and Transfer Tubes" which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy." This describes a therapeutic device used for treating patients, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a system for delivering radiation therapy, including a console, software for treatment planning and control, and components for source delivery (applicators and transfer tubes). This aligns with a therapeutic radiation delivery system.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, the Nucletron microSelectron HDR - GENIE Afterloading System is a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Nucletron microSelectron®HDR - GENIE Afterloading System has the same intended use as the legally marketed predicate device cited: This device is 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.
Product codes (comma separated list FDA assigned to the subject device)
90 JAQ
Device Description
The entry-level microSelectron®HDR - GENIE Afterloading System concerns a microSelectron-HDR (V2) with only three treatment channels. The operators console of the microSelectron®HDR - GENIE Afterloading System concerns a PC running dedicated Treatment Console Software which is similar as in the predicate device microSelectron-HDR (V2). In the microSelectron®HDR - GENIE Afterloading System there is on the operators console a second completely independent software program for radiotherapy treatment planning. Treatment plans are transferred from the radiotherapy treatment planning software to the Treatment Console Software by file transfer. It is the same as in the predicate device where treatment plans are transferred to the Treatment Console Software from radiotherapy treatment planning software running on a separate computer. The radiotherapy treatment planning software is covered by a separate 510(k) submission. Applicators and Transfer Tubes as available for microSelectron-HDR (V2) are also applicable for the microSelectron®HDR - GENIE Afterloading System. The entry-level microSelectron®HDR - GENIE Afterloading System is a standalone device. Connection to a LAN is only for the purpose of File Transfer of Treatment Plan Files.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body or to the surface of the body
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): 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.
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
§ 892.5700 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
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K021286
Page 1 of 2
MAY 2 3 2002 Special 510(k) Nucletron microSelectron®HDR - GENIE Afterloading System April 2002
Image /page/0/Picture/3 description: The image shows the word "Nucletron" in bold, black font next to a square logo. The logo contains a black circle with two white circles on either side of it. The logo is enclosed in a black square.
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: | 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: | microSelectron®HDR - GENIE Afterloading System |
|---|---|
| Common/Usual Name: | Remote Controlled Afterloading System |
| Classification Name: | Radiotherapy Device |
| Classification: | Class II |
Legally Marketed Device(s)
Our device is substantially equivalent to the legally marketed predicate device cited in the table below:
| . Manufacturer | ||
|---|---|---|
| l Nucletron BV | ||
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ' K953946 microSelectron-HDR V2 | |
| Comments of the first of the property would with the will and the comments of the first of the may be and | ||
| and the more of the completed of the first to the first and the first for the first and the many and the comments of the comments of the comments of the comments of the comme | ||
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | K953946 |
1
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K021286
Page 2 of 2
Special 510(k) Nucletron microSelectron®HDR - GENIE Afterloading System April 2002 Description:
The entry-level microSelectron®HDR - GENIE Afterloading System concerns a microSelectron-HDR (V2) with only three treatment channels. The operators console of the microSelectron®HDR - GENIE Afterloading System concerns a PC running dedicated Treatment Console Software which is similar as in the predicate device microSelectron-HDR (V2). In the microSelectron®HDR - GENIE Afterloading System there is on the operators console a second completely independent software program for radiotherapy treatment planning. Treatment plans are transferred from the radiotherapy treatment planning software to the Treatment Console Software by file transfer. It is the same as in the predicate device where treatment plans are transferred to the Treatment Console Software from radiotherapy treatment planning software running on a separate computer.
The radiotherapy treatment planning software is covered by a separate 510(k) submission.
Applicators and Transfer Tubes as available for microSelectron-HDR (V2) are also applicable for the microSelectron®HDR - GENIE Afterloading System.
The entry-level microSelectron®HDR - GENIE Afterloading System is a standalone device. Connection to a LAN is only for the purpose of File Transfer of Treatment Plan Files.
Intended use:
The Nucletron microSelectron®HDR - GENIE Afterloading System has the same intended use as the legally marketed predicate device cited:
This device is 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.
Summary of technological considerations:
The Nucletron microSelectron®HDR - GENIE Afterloading System is substantially equivalent to the cleared predicate device, microSelectron-HDR V2, 510(k)#: K953946.
Signature
10 APRIL 2002
Date
Name: F. van Krieken Title: Business Segment Manager Nucletron B.V. Veenendaal, The Netherlands
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard . Rockville MD 20850
MAY 2 3 2002
Ms. Lisa Dimmick Director Quality Assurance and Regulatory Affairs Nucletron Corporation 7080 Columbia Gateway Drive COLUMBIA MD 21046-2133
Re: K021286
Trade/Device Name: MicroSelectron® HDR - GENIE Afterloading System Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system
Regulatory Class: II Product Code: 90 JAQ Dated: April 10, 2002 Received: April 23, 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.
Image /page/2/Picture/12 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized image of an eagle with three lines representing its wings and legs.
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. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
NUMBER (IF KNOWN): K021286 510 (k)
MICROSELECTRON HDR-GENIE AFTERLOADING SYSTEM DEVICE NAME :
INDICATIONS FOR USE:
The Nucletron microSelectron HDR - GENIE Afterloading System has the same intended use as the legally marketed predicate device cited.
This device is 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.
(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)
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