(29 days)
Titanium needles are intended for interstitial Brachytherapy procedures involving Nucletron mHDR remote afterloading equipment.
The Titanium Needle Set as described in this submission is designed as an accessory to the Nucletron remote afterloading equipment, mHDR and is intended for interstitial Brachytherapy procedures.
Interstitial needles can be used for treatment of carcinoma where no lumen or cavity is available. More and more brachytherapy treatments are carried out where CT and MR based imaging is used for volume and target delineation. The Titanium Needles are fully CT/MR compatible and can be used in order to have minimal artefacts on the acquired images.
The Titanium Needle is inserted into the treatment area, using standard interstitional insertion techniques. CT markers are inserted into the Titanium Needles for visualisation. Radiographic images are obtained to determine the precise location within the body. This information is then used for Brachytherapy treatment planning purposes.
The Titanium Needle Set is used as an accessory to the Nucletron microSelectron remote afterloaders.
This is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with acceptance criteria for device performance. Therefore, many of the requested elements for a study proving acceptance criteria will not be present in this document.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The provided document (K080871) is a 510(k) summary for "Titanium Needle Sets." In a 510(k) submission for this type of device, the primary "acceptance criterion" is often demonstrating substantial equivalence to a predicate device, particularly for devices like interstitial needles which are accessories to a larger system. Performance is generally assessed through design specifications, material compatibility, and intended use alignment rather than through new clinical outcome studies with predefined statistical acceptance criteria typical of novel therapies or diagnostics.
The document states:
- "The Titanium Needle Set as described in this submission is designed as an accessory to the Nucletron remote afterloading equipment, mHDR and is intended for interstitial Brachytherapy procedures."
- "The Titanium Needles are fully CT/MR compatible and can be used in order to have minimal artefacts on the acquired images."
- "The modified device has the same intended use as the legally marketed predicate device cited."
- "The Titanium Needle Set is substantially equivalent to the cleared predicate device, Interstitial Needle Set, 510(k)#: K953946."
Based on the available text, specific quantitative acceptance criteria and reported device performance metrics (e.g., sensitivity, specificity, accuracy, or a specific range of artifact reduction) are not detailed. The "performance" is implicitly demonstrated through the claim of CT/MR compatibility with minimal artifacts and the overall substantial equivalence to the predicate.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document does not describe a clinical study with a "test set" in the context of diagnostic or interventional performance. The "test" in this submission would likely refer to engineering verification and validation testing (e.g., material compatibility, dimensional accuracy, sterilization efficacy, imaging compatibility) rather than a clinical trial. Therefore, sample sizes for a clinical test set are not applicable here.
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)
Not applicable, as no clinical "test set" requiring ground truth established by experts is described for this type of 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical "test set" requiring adjudication for ground truth 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. This device is an interstitial needle for brachytherapy, not an AI-powered diagnostic or decision support tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable, as no clinical "test set" requiring ground truth is described. For a device like this, the "ground truth" would relate to its physical properties and performance (e.g., actual dimensions matching specifications, material composition, artifact presence in imaging under controlled conditions).
8. The sample size for the training set
Not applicable. This document is not describing a machine learning or AI algorithm development.
9. How the ground truth for the training set was established
Not applicable. This document is not describing a machine learning or AI algorithm development.
In summary:
The provided 510(k) document is for a medical device accessory (Titanium Needle Set) and aims to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission typically relies on comparing design, materials, and intended use, along with non-clinical performance data (e.g., imaging compatibility, mechanical robustness, biocompatibility), rather than extensive human-in-the-loop clinical studies with statistical acceptance criteria. Therefore, most of your requested information related to comprehensive clinical study design and performance metrics is not present in this regulatory submission.
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Nucletron
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
APR 2 9 2008
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION As required by section 807.92(c)
Submitter of 510(k):
Company name: Registration number: Address:
Phone: Fax: Correspondent: Nucletron Corporation 1121753 8671 Robert Fulton Drive Columbia, MD 21046 410-312-4100 410-312-4197 Lisa Dimmick Director Assurance & Regulatory Affairs
Modified Device Name:
| Trade/Proprietary Name: | Titanium Needle Sets |
|---|---|
| Common / Usual name: | JAQ, Remote controlled radionuclide applicator system |
| Classification name: | 90 (Radiology) |
| Classification: | 21CFR892.5700 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 | Interstitial Needle Set | K953046 |
Description:
The Titanium Needle Set as described in this submission is designed as an accessory to the Nucletron remote afterloading equipment, mHDR and is intended for interstitial Brachytherapy procedures.
Interstitial needles can be used for treatment of carcinoma where no lumen or cavity is available. More and more brachytherapy treatments are carried out where CT and MR based
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imaging is used for volume and target delineation. The Titanium Needles are fully CT/MR compatible and can be used in order to have minimal artefacts on the acquired images.
The Titanium Needle is inserted into the treatment area, using standard interstitional insertion techniques. CT markers are inserted into the Titanium Needles for visualisation. Radiographic images are obtained to determine the precise location within the body. This information is then used for Brachytherapy treatment planning purposes.
The Titanium Needle Set is used as an accessory to the Nucletron microSelectron remote afterloaders.
Intended use:
The modified device has the same intended use as the legally marketed predicate device cited.
Titanium needles are intended for interstitial Brachytherapy procedures involving Nucletron mHDR remote afterloading equipment.
Summary of technological considerations:
The Titanium Needle Set is substantially equivalent to the cleared predicate device, Interstitial Needle Set, 510(k)#: K953946.
18-02-2008
Date
Name: Dick van Waes Title: Vice President Nucletron B.V. Veenendaal, The 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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure, composed of three stylized, curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lisa Dimmick Director Regulatory Affairs Nucletron Corporation 8671 Robert Fulton Drive COLUMBIA MD 21046-2133
APR 2 9 2008
Re: K080871
Trade/Device Name: Titanium Needle Sets Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radio-nuclide applicator system Regulatory Class: II Product Code: JAQ Dated: March 31, 2008 Received: March 31, 2008
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 such 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.
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Page 2
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.
This letter will allow you to begin marketing your device as described in your Section 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely vours.
Nancy C. Bugdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use Statement
510(k) Number
Device Name
Indications for Use
Titanium Needle Sets
Titanium needles are intended for interstitial Brachytherapy procedures involving Nucletron mHDR remote afterloading equipment.
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
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
§ 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.