(106 days)
The Integrated Brachytherapy Unit (IBU) is intended to be used for the visualization, localization and confirmation of the volume and size of the Brachy radiation therapy irradiation field(s), using a fluoroscopic and/or radiographic system. Localization and simulation for Brachy radiation therapy can be performed more effectively on the IBU than on a standard radiation treatment simulator. The additional L-arm allows the user to visualize under many angles easier for the operator than with the predicate device. The IBU will not be used for the simulation of external beam radiation treatments.
The IBU integrated Brachy therapy imaging unit is a localization and simulation device for a radiation therapy department especially for Brachy therapy treatments. 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 an image intensifier with optional rotatable cassette holder. The movements of the IBU are manually driven, after the relevant electrical locks are lifted. The mobile IBU patient couch has mechanical motions which can be controlled from a hand pendant affixed to the table.
The provided documentation for the Nucletron IBU (K973848) is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with detailed acceptance criteria and results. Therefore, the document does not contain the specific information requested about acceptance criteria, a study proving device performance against those criteria, sample sizes, expert qualifications, or ground truth establishment.
A 510(k) submission typically compares the new device to a predicate device in terms of technological characteristics and intended use, asserting that any differences do not raise new questions of safety or effectiveness. It does not generally include a prospective clinical trial or a formal performance study against predefined numerical acceptance criteria in the way envisioned by the prompt.
Here's what can be extracted and what information is not present based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in numerical or statistical terms. The acceptance criteria for a 510(k) submission are generally that the device is "substantially equivalent" to predicate devices and does not raise new issues of safety or effectiveness.
- Reported Device Performance: Not provided in terms of specific metrics or quantitative results from a performance study. The document describes the device's technical capabilities and intended use.
2. Sample sized used for the test set and the data provenance
- Not applicable/Not provided. The submission does not describe a performance study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. No test set or ground truth establishment process is described in the context of a performance study.
4. Adjudication method for the test set
- Not applicable/Not provided. No test set or adjudication process is described.
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
- Not applicable/Not provided. This device is an imaging unit (Image-intensified fluoroscopic RT simulation system), not an AI-assisted diagnostic tool. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This is a hardware imaging device, not an algorithm.
7. The type of ground truth used
- Not applicable/Not provided. No ground truth is established for a performance study. The device is intended for visualization, localization, and confirmation of irradiation fields, implying that its output (images) would be interpreted by clinicians.
8. The sample size for the training set
- Not applicable/Not provided. This is a hardware device; there is no mention of a training set as would be found in an AI/machine learning context.
9. How the ground truth for the training set was established
- Not applicable/Not provided.
Summary based on the provided text:
The Nucletron IBU (K973848) is an imaging unit for Brachytherapy simulation. Its premarket notification focused on demonstrating substantial equivalence to existing predicate devices (Nucletron Simulix-HP and Philips Integris). The core "acceptance criteria" for this specific submission type is meeting the FDA's requirements for substantial equivalence, primarily by showing that its intended use and technological characteristics are similar to predicate devices and that any differences do not raise new questions of safety or effectiveness.
The document highlights the following about the device:
- Intended Use: Visualization, localization, and confirmation of volume and size of Brachytherapy irradiation field(s) using fluoroscopic and/or radiographic systems.
- Technological Considerations: Substantially equivalent to predicate devices, allowing visualization under various angles. Features a mobile table for patient preparation in a separate room.
- Standards: Subject to Federal Performance standard 21 CFR 1020.30 and voluntary safety standards like UL 187 and IEC 601. Compliance with these standards would be an implicit "acceptance criterion" for safety and basic functionality.
There is no mention of a clinical performance study with specific quantitative acceptance criteria or results as typically seen for diagnostic algorithms or new treatment modalities requiring efficacy data.
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Premarket Notification Nucletron IBU Date :29 August 1997
JAN 2 2 1998
Image /page/0/Picture/2 description: The image shows the word "Nucletron" in a bold, sans-serif font. To the left of the word is a square logo. The logo contains a black circle with two white circles on opposite sides of the black circle. The logo and the word "Nucletron" are both in black.
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 3900 AX Veenendaal P.O.Box 930 The Netherlands Phone +31 318 557133 Fax +31 318 550485
FBN MKT IBU 510K 70819.4.doc 29 August 1997
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 Requlatory Affairs Manager 410-312-4100 Phone:. 410-312-4197 Fax:
Device Name: b.
Trade/Proprietary Name: Common/Usual Name: Classification Name:
IBU. Integrated Brachy therapy Unit Image-intensified fluoroscopic RT simulation system Radiation therapy simulation system, 21 CFR 892.5840 Class II.
Legally Marketed Predicate Device(s) C.
Our Device is substantially equivalent to the legally marketed predicate devices cited in the table below.
| Manufacturer | Device |
|---|---|
| Nucletron | Simulix-HP |
| Philips | Integris |
.
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Premarket Notification
Nucletron IBU
Date :29 August 1997
Description d. .
The IBU integrated Brachy therapy imaging unit is a localization and simulation device for a radiation therapy department especially for Brachy therapy treatments. 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 an image intensifier with optional rotatable cassette holder. The movements of the IBU are manually driven, after the relevant electrical locks are lifted. The mobile IBU patient couch has mechanical motions which can be controlled from a hand pendant affixed to the table.
Intended use e.
The IBU is intended to be used for the visualization, localization and confirmation of the volume and size of the Brachy therapy irradiation field(s), using a fluoroscopic and/or radiographic system.
Summary of technological considerations f.
The IBU is substantially equivalent to the predicate devices. It allows visualization of volumes to be irradiated under a variety of angles. The IBU uses X-Ray imaging for diagnostic and treatment planning purposes, where by the patient is supported by a patient table which can be moved vertical, lateral and longitudinal to position the relevant anatomy in the isocenter for visualization.
To optimize the use for Brachy therapy simulation. The IBU has a mobile table operated from internal batteries, so that the patient could possibly be prepared in a separate room.
Standards ਹੈ
The IBU system is subject to Federal Performance standard 21 CFR 1020.30. The IBU system will be manufactured in accordance with voluntary safety standards, such as UL 187 and IEC 601;
Talvini
28 Aug '97
Date
Name Frank de Bruin Product Manager Simulation products Title Nucletron bv Veenendaal Netherlands
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 22 1998
Ralph Shuping, Sc.D. Regulatory Affairs Manager Nucletron Corporation 7080 Columbia Gateway Drive Columbia, MD 21046-2133
Re:
K973848 IBU, Integrated Brachy Therapy Unit Dated: October 6, 1997 Received: October 8, 1997 Regulatory class: II 21 CFR 892.5840/Procode: 90 KPQ
Dear Mr. Shuping:
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 intenstated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical 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 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 (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 requirement, 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 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 question 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/dsmamain.html".
Sincerely yours
h7liau Yu
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Statement of indications for use
510(k) Number (if known): __ K 9 7 3 8 4 8
Device Name: IBU (Integrated Brachytherapy Unit)
Indications for Use: The Integrated Brachytherapy Unit (IBU) is intended to be used for the visualization, localization and confirmation of the volume and size of the Brachy radiation therapy irradiation field(s), using a fluoroscopic and/or radiographic system. Localization and simulation for Brachy radiation therapy can be performed more effectively on the IBU than on a standard radiation treatment simulator. The additional L-arm allows the user to visualize under many angles easier for the operator than with the predicate device. The IBU will not be used for the simulation of external beam radiation treatments.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | OR | Over the Counter Use | |
|---|---|---|---|---|
| (Per 21 CFR 801.109) |
| (Optional Format 1-2-96) | |
|---|---|
| -- | -------------------------- |
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number
§ 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.