(210 days)
Remote Afterloading Brachytherapy Unit for interstitial, intracavitary, intraluminal, including bronchial, endovascular (PARIS IDE), intraoperative and surface applicator treatments.
The Treatment Control Station (TCS) described in this submission is a software and hardware package which replaces the current Treatment Control Unit (TCU) for the microSelectron-HDR classic. The TCS is windows based software and runs on a PC based computer system. TCS will allow the user to program a treatment and monitor a treatment in progress. TCS will come together with a Treatment Control Panel, which takes care of the secondary timing and providing hardware independent "Start", "Interrupt" button and source location indicators. The TCS user obtains authorization for parts of the functionality depending on the user name and password. Treatment data can either be entered manually, based on a standard plan, based on a previously fraction or Imported from the Nucletron Treatment Planning System (PLATO). Prior and after treatment completion an extensive report is generated providing full details of how the patient will be and is treated.
The provided text describes a Premarket Notification (510(k)) for the Nucletron microSelectron-HDR classic with TCS (Treatment Control Station). This submission focuses on software and hardware upgrades to an existing remote afterloading brachytherapy system.
Based on the provided document, the submission is a 510(k) for device approval, which primarily demonstrates substantial equivalence to predicate devices. It does not contain information about a dedicated clinical study with specific acceptance criteria, performance metrics, ground truth establishment, or human reader effectiveness as would typically be found for novel diagnostic AI devices.
The document states that "Our Device is substantially equivalent to the legally marketed predicate devices cited in the table below," implying that performance is assumed to be similar to legally marketed devices rather than being proven through a separate study with specific acceptance criteria.
Therefore, many of the requested details are not present in this type of regulatory submission. I will answer based on the information available and note where information is not provided.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
No explicit acceptance criteria or reported device performance metrics (e.g., accuracy, sensitivity, specificity for diagnostic devices) are provided in this regulatory submission. The submission is focused on demonstrating "substantial equivalence" to existing, legally marketed devices for a software and hardware upgrade. The "performance" being assessed here is the device's ability to fulfill its intended use in a similar manner to its predicate.
| Acceptance Criteria (Explicit) | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of performance metrics. The implicit acceptance criterion is "substantial equivalence" to predicate devices as defined by the FDA. | The device (TCS) "allows the use of an enhanced user interface to program a treatment and monitor a treatment in progress," replacing the current Treatment Control Unit (TCU). It is deemed "substantially equivalent" to the predicate devices: Nucletron microSelectron-HDR classic (K864210) and Nucletron microSelectron-HDR (K953946). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. This type of 510(k) submission for a software/hardware upgrade to a therapeutic device often relies on engineering verification and validation, rather than a clinical "test set" with patient data in the way a diagnostic AI device would.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. As there's no mention of a clinical "test set" involving patient data and diagnostic outcomes, the concept of establishing ground truth by medical experts in this context is not applicable from the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided, as there is no described test set or ground truth establishment by experts in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This device is a treatment control station for brachytherapy, not a diagnostic AI device intended to assist human readers in image interpretation. Therefore, this type of study would not be relevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided, and the concept of "standalone performance" for a treatment control station (which is inherently a human-in-the-loop system) would not directly apply. The TCS is an interface and control system for a medical device, requiring operator input and monitoring.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided. The regulatory submission focuses on the technical specifications and safety/effectiveness equivalence to predicate devices, rather than clinical performance against a medical ground truth (like pathology or outcomes data). The "ground truth" in this context would likely relate to the correct and safe execution of treatment plans and control of the brachytherapy unit, which would be assessed through engineering and software validation.
8. The sample size for the training set
This information is not provided. The device is a software and hardware upgrade to control a therapeutic device. It is not an AI/ML model that would have a traditional "training set" of data in the sense of learning from patient images or diagnostic outcomes.
9. How the ground truth for the training set was established
This information is not provided, as there is no traditional "training set" described for a machine learning model.
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4/2/99
Premarket Notification Nucletron mlcroSelectron-HDR classic with TCS Date : 31 August, 1998
Image /page/0/Picture/5 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, all within a black square border. The word "Nucletron" is positioned to the right of the logo.
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 Center of Devices and Radiological Health Office of Device Evaluation Pre-Market Notification section
PKG MKT mHDR 510k
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
as required by section 807.92(c)
Submitter of 510(k) a.
Company name: Registration # Address:
Nucletron Corporation 1121753 7080 Columbia Gateway Drive Columbia, MD 21046-2133
Contact Person:
Ralph E. Shuping Regulatory Affairs Manager 410-312-4100 Phone: Fax: 410-312-4197
b. Device Name:
| Trade/Proprietary Name: | Treatment Control Station - microSelectron-HDR classicUpgrade, Remote Afterloading System |
|---|---|
| Classification Name: | Remote Control Radionuclide Applicator System |
| 21 CFR 892.5700 Class II. |
Legally Marketed Predicate Device(s) C.
Our Device is substantially equivalent to the legally marketed prodicate devices cited in the table below.
Appendix 5, page 2
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Premarket Notification Nucletron microSelectron-HDR classic with TCS Date : 31 August, 1998
| Manufacturer | Device | 510(k) # |
|---|---|---|
| Nucletron | microSelectron-HDR classic | K864210 |
| Nucletron | microSelectron-HDR | K953946 |
DescriptIon d.
The Treatment Control Station (TCS) described in this submission is a software and hardware package which replaces the current Treatment Control Unit (TCU) for the microSelectron-HDR classic.
The TCS is windows based software and runs on a PC based computer system. TCS will allow the user to program a treatment and monitor a treatment in progress. TCS will come together with a Treatment Control Panel, which takes care of the secondary timing and providing hardware independent "Start", "Interrupt" button and source location indicators.
The TCS user obtains authorization for parts of the functionality depending on the user name and password.
Treatment data can either be entered manually, based on a standard plan, based on a previously fraction or Imported from the Nucletron Treatment Planning System (PLATO). Prlor and after treatment completion an extensive report is generated providing full details of how the patient will be and is treated.
A detailed description including principles of operation and other information necessary to understand the device is provided in Section 3.
Intended use e.
The indications for use for the Treatment Control Station - microSelectron-HDR classic Upgrade are:
Remote Afterloading Brachytherapy Unit for interstitial, intracavitary, intraluminal, including bronchial, endovascular (PARIS IDE), intraoperative and surface applicator treatments.
Summary of technological considerations f.
The Treatment Control Station - microSelectron-HDR classic Upgrade Is substantially equivalent to the predicate devices. It allows the use of an enhanced user interface to program a treatment and monitor a treatment in progress.
g
31-08-98
Date
Name: P.Krechting Title Product Manager Nucletron bv Veenendaal Netherlands
Appendix 5, page 3
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 1995
Ralph E. Shuping, Sc.D. Regulatory Affairs Manger Nucletron Corporation 7080 Columbia Gateway Drive Columbia, Maryland 21046
Re: K983115
Treatment Control Station (TCS) MicroSelectron HDR Classic Upgrade Dated: January 14, 1999 Received: January 19, 1999 Regulatory Class: II 21 CFR 892.5700/Procode: 90 JAQ
Dear Dr. Schuping:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controis 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
CART Daniel O. Schultz, M.D.
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Premarket Notification Nucletron microSelectron-HDR classic with TCS Date : 31 August, 1998
Image /page/3/Picture/4 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 shape with two white circles inside.
Department of Health and Human Services Center of Devices and Radiological Health Office of Device Evaluation Pre-Market Notification section
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
PKG MKT mHDR 510k
Statement of intended use
Device Name: Treatment Control Station - microSelectron-HDR classic Upgrade, remote afterloading system
Intended use
The indications for use for the Treatment Control Station - microSelectron-HDR classic Upgrade are:
Remote Afterloading Brachytherapy Unit for interstitial, intracavitary, intraluminal, including bronchial, endovascular (PARIS IDE), intraoperative and surface applicator treatments.
Prescription use
The Treatment Control Station - microSelectron-HDR classic Upgrade is intended to be used for medical procedures on patients to be prescribed and performed by a suitably trained and certified medical professional.
Name
P. Krechting
31-08-98
Date
Title
Product Manager Nucletron BV
Veenendaal
Netherlands
David b. Stypman
Division Sign-Off) Division of Reproductive, Abdominal, E and Radiological 510(k) Number
Appendix 5, page 4
§ 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.