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The Interstitial Needles and their corresponding obturators are indicated for use for interstitial irradiation treatments of soft tissues such as breast, head and neck, tongue.

The Interstitial Needles and their corresponding Obturators/Mandrins are intended for interstitial irradiation treatments of soft tissues including breast, head and neck, and tongue using HDR or PDR brachytherapy and are compatible with the following afterloaders: VariSource iX™, VariSource 200™, GammaMedplus iX™ and GammaMedplus™ and can be used in combination with the appropriate accessories.
The devices are intended to be used by trained and qualified personnel such as Radiation Oncologists, Physicians, Radiologists, Dosimetrists, Medical Physicists, and Nurses/MTRAs/Radiology Technicians/Radiographers in a hospital environment.
There are two versions of the needle included in this submission: titanium and stainless steel.

The provided text describes a 510(k) Premarket Notification for "Interstitial Needles" by Varian Medical Systems, Inc. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the performance of an AI/ML-driven medical device against specific acceptance criteria through a study involving human readers or standalone algorithm performance.

Therefore, many of the requested details about acceptance criteria, study design (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance), and training set ground truth are not applicable to this document. The device in question appears to be a physical medical instrument (needles for brachytherapy), not a software or AI-based diagnostic tool.

However, I can extract information related to the non-clinical testing performed to demonstrate the device's basic functionality and safety.

Here's a breakdown of what can be inferred from the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines various "Non Clinical Tests" and states that "All the tests that were performed met the applied pass criteria." However, it does not explicitly list the quantitative acceptance criteria or detailed numerical results. Instead, it describes general functionalities that were tested.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not specified. The document refers to "Bench Testing" but does not detail the number of units or test repetitions.
• Data Provenance: Not applicable in the context of clinical data for AI/ML. The tests are non-clinical, likely performed in a lab setting by the manufacturer.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:

• Not applicable. This is a physical device, and performance is assessed through engineering and material tests, not expert interpretation of outputs like in an AI/ML study.

4. Adjudication Method for the Test Set:

• Not applicable. Performance determined by instrument measurements and material tests, not expert consensus or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. The document explicitly states: "No clinical tests have been included in this pre-market submission." An MRMC study would be a clinical test.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of Ground Truth Used:

• Engineering specifications and material standards: For example, compliance with ISO10993 for biocompatibility and IEC 62366:2007 for usability. The "ground truth" for these tests would be established by the defined parameters and expected outcomes of the specific engineering and materials tests.

8. The Sample Size for the Training Set:

• Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established:

• Not applicable (no training set for a physical device).

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The Varian Remote High Dose Rate Afterloader system, including the applicators and accessories included in this notification, is a device intended to be used by properly trained and licensed medical personnel to provide radiation brachytherapy with a high specific activity radioisotope source to reduce the exposure times required to achieve a prescribed dose. Remote operation of the Afterloader eliminates the necessity of hand placement of radioactive sources on or within the body of a patient. The radioactive source is Iridium-192, encapsulated in the end of a wire stored in the Afterloader and mechanically driven from it to a precisely described position for a specified dwell time during treatments the wire is retracted into the Afterloader so that the source end resides in a tungsten-shielded safe to limit personnel exposures to an acceptable, safe level. The Afterloader contains a radiation detector which signals whenever the source is not in the safe.

The Interstitial Needles are used with Varian High Dose Rate Afterloaders.

The device is a family of closed-ended, interstitial needles and associated obturators to be used in conjunction with a high dose rate (HDR) brachytherapy afterloading device. The needles are available in either 17 gauge O.D. or 18 gauge O.D. and in lengths of 113mm, 200mm, 250mm, and 320mm. The associated obturators are inserted into needles to stiffen the needles during implantation of the needles into the patient and to stiffen the needles between radiation therapy fractions. The obturators are available in lengths of 113mm, 200mm, 250mm, and 320mm. The needles are provided unsterile with instructions for steam sterilization and have been qualified for 25 uses. The obturators are provided unsterile with instructions for steam sterilization and have been qualified for 100 uses.

The provided text is a 510(k) summary for Varian Interstitial Needles. It describes the device, its intended use, and its classification, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on establishing "substantial equivalence" to a predicate device, which is a regulatory pathway for medical devices. This pathway often relies on demonstrating that the new device has the same intended use and similar technological characteristics as an already legally marketed device, rather than requiring extensive clinical performance studies to prove specific acceptance criteria.

Therefore, I cannot populate the table or answer the questions as the requested information is not present in the provided text.

Here's a breakdown of why the information isn't available:

• Acceptance Criteria & Device Performance: These are usually defined in testing protocols and reports for performance validation. The 510(k) summary provided here is a high-level regulatory document, not a detailed test report.
• Sample Size, Data Provenance, Expert Ground Truth, Adjudication, MRMC, Standalone Performance, Ground Truth Type, Training Set Sample Size, Training Set Ground Truth: All these items relate to the specifics of a performance study, which is not detailed or even referenced as existing in this 510(k) summary. The document states a "Substantial Equivalence Comparison Chart provides a comparison of the technological characteristics to those of the predicate device" is in Tab 7 of the submission, but this chart's content is not provided. This chart is likely comparing specifications, materials, and design, not clinical performance metrics.

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