Search Results
Found 7 results
510(k) Data Aggregation
(310 days)
RadioMed Corporation
The Visicoil MR Marker and the Pre-Loaded Visicoil MR Marker are indicated for use to radiographically mark soft tissue for future therapeutic procedures.
Device Identification: the Visicoil MR is a helically wound coil of platinum wire. The product is available on a carrier for user-loaded implantation or pre-loaded in a needle.
Device Characteristics: The Visicoil MR is a linear fiducial marker. It is used for marking soft tissue for future therapeutic procedures.
Environment for Use: The Visicoil MR and Pre-Loaded Visicoil MR may be implanted in a healthcare facility, free standing clinic or physician's office.
Description of Device: The Visicoil MR Marker and the Pre-loaded Visicoil MR Marker is a sterile device, in the form of a platinum coil. Visicoil MR comes on a delivery system, packaged in a Mylar/Tyvek pouch, sterilized by gamma sterilization. The Pre-Loaded Visicoil MR comes in a 18, 19, 20, 21, or 22g 304 stainless steel needle and stylet with a beeswax plug at the tip, packaged in a Mylar/Tyvek pouch sterilized by EO sterilization.
The coils ranges in length from 0.3cm to 2cm and have an outside diameter that ranges between 0.3mm and 1.0mm. Platinum has a dense mass which allows for imaging in all x-ray based imaging devices and other electro-magnetic properties help to enhance visibility within Magnetic Resonance Imaging (MRI).
The device is a passive device and is permanently implanted in the patient.
This document describes a 510(k) premarket notification for the Visicoil MR Marker. It demonstrates substantial equivalence to predicate devices, but it does not contain information about an AI-powered device or a study proving that an AI device meets acceptance criteria.
The document is for a physical medical device (a radiographically visible marker for soft tissue) and focuses on changes in material composition (from gold to platinum) and its visibility under MRI, as well as biocompatibility and functional testing of the physical marker.
Therefore, I cannot provide an answer based on the prompt's requirements for acceptance criteria, study details, sample sizes, expert involvement, or AI performance, as this information is not present in the provided text.
Ask a specific question about this device
(28 days)
RADIOMED CORPORATION
Pre-Loaded CK Visicoil Gold Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.
The Pre-Loaded CK Visicoil a sterile device, in the form of two gold coils and a PGLA spacer loaded into a 17, 18 or 19g needle. The coil ranges in OD between 0.35mm and 1.2mm.
The Pre-Loaded CK Visicoil is packaged sterile, for single use. Sterilization is achieved by a validated EO sterilization method.
The Pre-Loaded CK Visicoil will be manufactured, labeled, and packaged in accordance with the current FDA QSR. To ensure compliance to specifications, upon completion of the manufacturing process the device will be inspected and tested in accordance with RadioMed standard operating procedures.
Depending on the coil size (0.35mm, 0.50mm, 0.75mm, or 1.2mm), the Pre-Loaded Visicoil Marker will be delivered using either a 17, 18 or 19 gauge needle. The coils and spacer are supplied loaded and ready for use in the applicable needle.
The provided text describes the 510(k) submission for the RadioMed™ Pre-Loaded CK Visicoil Marker. It focuses on establishing substantial equivalence to predicate devices rather than presenting a study of the device's performance against specific acceptance criteria.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in the provided document. The 510(k) process primarily relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often through comparison of technological characteristics and compliance with recognized standards.
Here's an attempt to answer the questions based on the provided text, indicating when information is not present:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The submission focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics and compliance with general medical device standards. No specific acceptance criteria or quantitative performance metrics for the device itself are reported in this text.
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. The document does not describe a clinical performance study with a distinct test set.
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 described performance study or test set, there's no mention of experts establishing ground truth for such a set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. No adjudication method is mentioned for a test set.
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
This information is not provided. The device is a physical marker and not an AI or imaging system, so an MRMC study related to AI assistance would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. The device is a physical marker; it does not involve algorithms or human-in-the-loop performance in the context of an AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided. The document does not describe a study that would require establishing a ground truth for device performance in the sense of diagnostic accuracy or efficacy. The "ground truth" for this type of device would likely be its physical properties and functionality.
8. The sample size for the training set
This information is not provided. There is no mention of a training set as this is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
This information is not provided. No training set is mentioned.
Summary of available "Performance Testing" information:
The document mentions "Performance Testing" in Section 7, but it refers to compliance with general standards rather than specific device performance criteria:
- Standards Achieved:
- ISO 10993: Biological Evaluation of Medical Devices (This indicates biocompatibility testing was performed, but specific results are not detailed).
- FDA QSR 21 CFR Part 820: Good Manufacturing Practices (This indicates compliance with manufacturing processes and quality systems).
The submission relies on demonstrating that the new device (Pre-Loaded CK Visicoil Gold Marker) shares the "fundamental scientific technology" with and is "identical" in certain design aspects to its predicate devices:
The key modification described is the configuration of loading two gold coils and a PGLA spacer into a needle, which is stated to be identical to one of the predicate products (K103449). The intended use is also stated as "has not changed."
Ask a specific question about this device
(34 days)
RADIOMED CORPORATION
The Pre-Loaded Visicoil is indicated for use to radiographically mark soft tissue for future therapeutic procedures.
The Pre-Loaded Visicoil a sterile device, in the form of a gold coil loaded into a 17, 18 or 19g needle. The coil ranges in OD between 0.35mm and 1.2mm. The Pre-Loaded Visicoil is packaged sterile, for single use. Sterilization is achieved by a validated EO sterilization method. Depending on the coil size (0.35mm, 0.75mm, or 1.2mm), the Pre-Loaded Visicoil Marker will be delivered using either a 17, 18 or 19 gauge needle. The coil is supplied loaded and ready for use in the applicable needle.
This 510(k) submission (K070305) for the RadioMed™ Soft Tissue Marker (Pre-Loaded Visicoil Marker) is a Special 510(k), which implies that the fundamental scientific technology and the intended use of the modified device have not changed from the predicate device (Visicoil™ Marker, K031206). Therefore, the performance testing focuses on demonstrating that the device continues to meet established safety and effectiveness criteria, particularly considering the changes introduced (pre-loading in the needle and sterilization method change).
The provided document does not contain a detailed study report with specific quantitative acceptance criteria or a comprehensive clinical study. Instead, the submission relies on the established substantial equivalence to the predicate device and adherence to regulatory standards.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative acceptance criteria or a "reported device performance" section with metrics like sensitivity, specificity, accuracy, etc., as typically seen in submissions for AI/diagnostic devices.
Instead, it indicates that the device has passed adherence to regulatory and manufacturing standards.
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Functional Equivalence | The modified device (Pre-Loaded Visicoil) maintains the same fundamental scientific technology and intended use as the predicate device (Visicoil™ Marker). This implies that its radiographic marking capabilities remain unchanged. | The "Comparison of Technological Characteristics" states: "The fundamental scientific technology of the modified device has not changed." and "The design of the predicate Visicoil Marker is identical to the Pre-Loaded Marker." The "Intended Use" and "Indications for Use" are also stated as unchanged. This indirectly confirms that the performance in marking soft tissue for future therapeutic procedures is maintained. |
| Sterilization Efficacy | The new sterilization method (Ethylene Oxide - EO) must effectively sterilize the device to ensure patient safety. This implies meeting industry standards for sterility assurance. | "Sterilization is achieved by a validated EO sterilization method." While specific validation data (e.g., Sterility Assurance Level - SAL) is not provided in this summary, the statement indicates that a validated method is used, implying successful performance against sterility criteria. |
| Biocompatibility | The materials used for the device must be biocompatible with human tissue, especially since the change involves pre-loading in a delivery needle. The gold coil material is assumed to be biocompatible, as it's identical to the predicate. The new needle and any associated components must also be biocompatible. (Not explicitly mentioned as a new test but implicitly covered by relying on predicate and QSR). | Not explicitly detailed in the provided text. However, adherence to FDA QSR Part 820 ("Good Manufacturing Practices") implicitly covers material and process controls that ensure biocompatibility. Since the core gold coil material is identical to the predicate, and the needle type (CP Medical, Class I exempt) is standard, new biocompatibility testing might not have been deemed necessary beyond standard QSR compliance. |
| Device Integrity/Stability | The pre-loading of the coil within the needle must not compromise the integrity of the coil (e.g., kinking, damage) or its ability to be deployed effectively. The device must also remain stable throughout its shelf life under the new sterilization and packaging. (Not explicitly mentioned as a new test but implicitly covered by relying on predicate and QSR). | "Pre-Loaded Visicoil is packaged sterile, for single use." "To ensure compliance to specifications, upon completion of the manufacturing process the device will be inspected and tested in accordance with RadioMed standard operating procedures." This implies that the device integrity and functionality for deployment are verified at manufacturing. |
| Manufacturing Quality | Compliance with the FDA Quality System Regulation (QSR) 21 CFR Part 820. | "The Pre-Loaded Visicoil will be manufactured, labeled, and packaged in accordance with the current FDA QSR." "Summary of standards achieved: FDA QSR 21 CFR Part 820 Good Manufacturing Practices." This indicates adherence to established quality and control procedures for manufacturing. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a sample size for a separate "test set" in the context of clinical performance or human reader studies. This submission is for a modified device and relies on showing substantial equivalence, rather than new clinical efficacy data.
- Data Provenance: Not applicable in the context of a new clinical study. The data provenance implicitly stems from the predicate device's established performance and the manufacturer's internal validation of manufacturing and sterilization processes.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not applicable. The document does not describe a study involving expert readers or the establishment of ground truth by experts for a new diagnostic or interpretative purpose.
- Qualifications of Experts: Not applicable.
4. Adjudication Method
- Adjudication Method: Not applicable. There is no mention of a study involving human interpretation or a need for adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not conducted or described in this document. This is not a study about human readers improving with or without AI assistance but rather a device modification submission.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study: No, a standalone performance study (algorithm only) was not conducted or described. This device is a physical marker, not a diagnostic algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: For the purposes of this submission, the "ground truth" is implicitly the established safety and effectiveness of the predicate device and the validated performance of the manufacturing and sterilization processes. There is no new "ground truth" established as part of a diagnostic accuracy study.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This document is not describing an AI/machine learning device that would require a training set.
9. How the Ground Truth for the Training Set Was Established
- Training Set Ground Truth: Not applicable for the reasons stated above.
Ask a specific question about this device
(35 days)
RADIOMED CORP.
RadioMed™ Soft Tissue Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.
The RadioMed™ Soft Tissue Marker is a non-sterile device, in the form of a gold coil that ranges in OD between 0.75mm and 1.2mm.
The RadioMed™ Soft Tissue Marker is packaged non-sterile, single use, and is to be sterilized by the end user in accordance with a validated sterilization process. Sterilization is achieved by exposure to steam autoclave.
The RadioMed™ Soft Tissue Marker will be manufactured, labeled, and packaged in accordance with the current FDA QSR. To ensure compliance to specifications, upon completion of the manufacturing process the device will be inspected and tested in accordance with RadioMed standard operating procedures.
The RadioMed™ Soft Tissue Marker will be delivered using either a 17 gauge or 18 gauge needle and stylet.
This document describes a 510(k) submission for the RadioMed™ Soft Tissue Marker, which is a medical device. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance characteristics against acceptance criteria in a comprehensive study.
Based on the provided text, there is no specific acceptance criteria table or a study proving the device meets distinct performance criteria in terms of accuracy, sensitivity, specificity, etc. This is because 510(k) submissions for devices like markers often rely on demonstrating that the new device is as safe and effective as a legally marketed predicate device. The performance testing mentioned is related to manufacturing standards and visibility, not a clinical effectiveness study with defined performance metrics.
Here's a breakdown of the information that can be extracted or inferred, and what is not present:
Missing Information (Not Applicable to this 510(k) submission):
- 1. A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on substantial equivalence to predicate devices and manufacturing quality, not a comparison against specific clinical performance metrics.
- 2. Sample size used for the test set and the data provenance: Not applicable. There's no "test set" in the context of a clinical performance study as described in the prompt.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth establishment is described.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This is a physical marker, not an AI algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- 8. The sample size for the training set: Not applicable. This is not an AI/algorithm-based device requiring a training set.
- 9. How the ground truth for the training set was established: Not applicable.
Information that is present or can be inferred:
Overview of Evidence Presented:
The submission focuses on comparing the RadioMed™ Soft Tissue Marker to existing predicate devices (RadioMed™ Marker, Implanter/Adjustable/Anderson's Marker, Extracranial Marker) to demonstrate substantial equivalence. The key aspects of this comparison are:
- Intended Use: The intended use and indications for use have not changed from the predicate device.
- Intended Use: "RadioMed™ Soft Tissue Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures."
- Technological Characteristics: The fundamental scientific technology of the modified device has not changed.
- Material: The material (metallic gold) is identical to the Anderson Marker (K940121) and Extracranial Marker, and is widely used in other approved medical devices with a "safe history of use." This obviates the need for additional biocompatibility testing.
- Design: The design is identical to the predicate RadioMed™ Marker (K022326) except for the outside diameter (OD) and material (gold vs. unspecified material in K022326). The new marker ranges in OD between 0.75mm and 1.2mm.
- Performance Testing (Non-Clinical):
- Summary of standards achieved:
- FDA QSR 21 CFR Part 820 Good Manufacturing Practices
- AAMI Standard 11134-1994 Recommended practice for Steam Autoclave
- Visibility Studies: "Visibility Studies (see section H - Performance Testing)" are mentioned, implying that the marker's visibility under radiographic imaging was assessed. However, no specific data, acceptance criteria, or experimental setup for these visibility studies are provided in this summary.
- Summary of standards achieved:
Conclusion from a 510(k) Perspective:
The FDA's letter (K031206) confirms that they have "determined the device is substantially equivalent...to legally marketed predicate devices." This determination is based on the information provided in the 510(k) submission, primarily focusing on the safety and effectiveness as demonstrated through comparison to predicates and adherence to manufacturing and sterilization standards, rather than direct clinical performance against novel acceptance criteria.
In summary, for this specific 510(k) submission, the "acceptance criteria" and "study" are intrinsically linked to demonstrating substantial equivalence through comparison with predicate devices and adherence to established manufacturing and safety standards, rather than a clinical trial proving specific performance metrics of an AI algorithm.
Ask a specific question about this device
(197 days)
RADIOMED CORPORATION
RadioMed™ Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.
The RadioMed™ Marker is a non-sterile, disposable device in the form of a rhodium coil that is 0.35mm in diameter.
The provided text is a 510(k) summary for the RadioMed™ Marker, a medical device. This type of document is a premarket notification to the FDA, demonstrating substantial equivalence to a legally marketed predicate device. It primarily focuses on device description, intended use, and comparison to predicates, along with a summary of performance testing and adherence to standards.
However, the provided text does not contain the detailed information required to fill out all aspects of your request regarding acceptance criteria and the study that proves the device meets them.
Specifically, the document mentions "Visibility Testing (see section V)" and refers to various standards (FDA QSR, ISO 10993-1, AAMI Standard 11134-1994) but does not detail the specific performance acceptance criteria for visibility, a quantitative measure of performance, or the results of the visibility study. It also lacks information on the sample sizes, data provenance, ground truth establishment, or specific details of a comparative effectiveness study.
Therefore, I can only populate the table and answer the questions based on the limited information available in the provided text. Many fields will be marked as "Not provided in the text."
Here's the breakdown of what can and cannot be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Visibility | Visible under fluoroscopy, ultrasound, CT, and x-ray. (No quantitative criteria or specific performance metrics provided in this document excerpt) |
| Biocompatibility | Passes biocompatibility testing per ISO 10993-1 |
| Material (Chemical Composition) | Rhodium (Stated to be identical to a predicate device's material) |
| Manufacturing Standards | Complies with FDA QSR 21 CFR Part 820 Good Manufacturing Practices, AAMI Standard 11134-1994 Recommended Practice for Steam Autoclave |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not provided in the text. The document refers to "Visibility Testing" and "animal and bench studies" but no sample sizes are mentioned.
- Data Provenance: Not provided in the text.
- Retrospective/Prospective: Not provided in the text.
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 provided in the text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided in the text.
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
- No MRMC comparative effectiveness study is described for this device, nor is it an AI-based device. The device is a physical marker.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical marker, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For "Visibility Testing," the ground truth likely involved direct visual confirmation on imaging modalities, possibly by a human observer or sensor, but the specific method (e.g., expert consensus on image quality, quantitative measurement) is not detailed.
- For "Biocompatibility," the ground truth would be established by the results of standardized biological tests as per ISO 10993-1.
8. The sample size for the training set
- Not applicable. This is a physical marker, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This is a physical marker, not a machine learning model.
Ask a specific question about this device
(29 days)
RADIOMED CORPORATION
GENETRA ™ with activities from 0.1 to 5.0 mCi per centimeter length is indicated for temporary or permanent interstitial implantation or surface application to treat selected localized tumors. They can be used as either primary treatment or as treatment for residual disease after excision of primary or recurrent turnors. GENETRA may be used concurrently with or following treatment with other interventions, such as external beam therapy, hyperthermia, or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate and other accessible tumors are commonly treated.
GENETRA ™ utilizes Pd-103 as the radionuclide for brachytherapy. GENETRA™ exists in the form of a coiled rhodium wire. The rhodium matrix also provides the radiopacity of the device. GENETRA™ is a naturally sealed source in the form of a wire. GENETRA™ is packaged non-sterile, single use, and is to be sterilized by the end user in accordance with a validated sterilization process. Sterilization is accomplished by exposure to steam autoclave. GENETRA™ will be manufactured, labeled and packaged under GMP controls. Upon completion of the manufacturing and assembly process the device will be inspected to assure compliance to specifications. The devices will be tested in accordance with Standard Operating Procedures. The sources are delivered using a 19 gauge needle and stylet.
The provided document describes the GENETRA™ brachytherapy radionuclide source and its submission for 510(k) clearance. However, it does not contain a detailed study report with specific acceptance criteria and performance data for a device in the context of diagnostic AI or image analysis.
The document focuses on comparing GENETRA™ to its predicate device (RadioMed™ Source K001070) based on shared technological characteristics and compliance with manufacturing and safety standards. The "Performance Testing" section lists categories of tests but provides no numerical acceptance criteria or performance results.
Therefore, I cannot directly answer most of your detailed questions regarding acceptance criteria, study design, sample sizes, expert qualifications, or comparative effectiveness with AI. The device described is a medical implant (radioactive source), not a diagnostic AI or imaging device that would typically involve such studies.
Here's a breakdown of what can be extracted or inferred from the provided text, addressing your points where possible, and noting where information is missing:
Acceptance Criteria and Device Performance for GENETRA™
The document does not explicitly state numerical acceptance criteria or specific performance results for the GENETRA™ device in the format typically used for diagnostic or AI-based devices. Instead, performance is framed in terms of meeting established industry standards for radioactive sources and being identical in fundamental design and characteristics to a legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Category | Acceptance Criteria (Inferred from standards and predicate comparison) | Reported Device Performance (Inferred from "Summary of standards achieved" and "identical to predicate") |
|---|---|---|
| Material Composition | Identical to predicate RadioMed™ Source (rhodium matrix). Radionuclide: Palladium - 103, identical to predicate. Packaging: modified from original stainless steel cartridge to utilize a glass barrel, but fundamentally similar. | GENETRA™ uses rhodium as did the predicate RadioMed™ Source. Radionuclide for GENETRA™ is Palladium - 103, which is the same as the predicate. |
| Energy Emission | Identical to predicate RadioMed™ Source (20-23 keV x-rays). | Energy emitted for GENETRA™ and the RadioMed™ Source is identical: 20-23 keV x-rays. |
| Physical Design | Identical to predicate RadioMed™ Source. "Sealed source in the form of a wire from which to deliver a therapeutic dosage of radioactive energy." | The design of the predicate RadioMed™ Source is identical to GENETRA™. |
| Sterilization | To be sterilized by the end-user in accordance with a validated sterilization process (exposure to steam autoclave). Complies with AAMI Standard 11134-1994 (Recommended practice for Steam Autoclave). | Device is packaged non-sterile, single use, and is to be sterilized by the end user via steam autoclave. Compliance with AAMI 11134-1994 is listed. |
| Manufacturing Quality | Compliance with FDA QSR 21 CFR Part 820 Good Manufacturing Practices. Devices inspected to assure compliance to specifications and tested in accordance with Standard Operating Procedures. | Manufactured, labeled, and packaged under GMP controls. Inspected to assure compliance to specifications. Tested in accordance with Standard Operating Procedures. |
| Biological Evaluation | Compliance with ISO 10993-1 1992 (E) Biological Evaluation of Medical Devices. | Compliance with ISO 10993-1 1992 (E) listed. |
| Sealed Source Testing | Compliance with ANSI N43.6-1997 (Classification of sealed radioactive sources), ANSI N44.1-1973 (Integrity and Test Specifications for selected Brachytherapy Sources), ANSI N44.2-1973 (Leak testing radioactive brachytherapy sources), and ISO 9978: 1992(E) ("Radiation protection - Sealed radioactive sources - Leakage test methods"). | Compliance with ANSI N43.6-1997, ANSI N44.1-1973, ANSI N44.2-1973, and ISO 9978: 1992(E) listed under "Summary of standards achieved." "Sealed Source Testing" is one of the four performance categories. |
| Needle Gauge | Delivery through a 19 gauge needle and stylet. (Predicate uses 17 or 18 gauge). | GENETRA™ sources are delivered using a 19 gauge needle and stylet. (This is a design modification from the predicate, but is a stated characteristic of GENETRA™). |
| Activity Range | 0.1 to 5.0 mCi per centimeter length. | GENETRA™ produced with activities from 0.1 to 5.0 mCi per centimeter length. |
| Radiation Energy | No specific numerical acceptance criteria provided in the text beyond "identical to predicate". | "Radiation Energy" is listed as a performance category. The energy emitted is 20-23 keV x-rays, identical to the predicate. |
| Source Strength Measurement: Calibration and Calibration Accuracy | No specific numerical acceptance criteria provided in the text. | "Source Strength Measurement: Calibration and Calibration Accuracy" is listed as a performance category. No specific results are reported. |
| Dose Comparison | No specific numerical acceptance criteria provided in the text. | "Dose Comparison" is listed as a performance category. No specific results are reported, but given the identical radionuclide and energy, the dose characteristics are implied to be clinically comparable to the predicate. |
Missing Information (Not applicable or not typically included for this type of device)
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set of clinical cases or patient data is mentioned as this is a device clearance for a radiation source based on substantial equivalence and engineering standards, not a clinical trial of its efficacy with patient outcomes in a diagnostic context.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a clinical diagnosis or image interpretation is not relevant for this type of device submission.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 is not an AI or diagnostic imaging device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for a device quality and safety submission based on substantial equivalence. The "ground truth" here is compliance with engineering, manufacturing, and safety standards for radioactive sources.
- The sample size for the training set: Not applicable. This is not an AI device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
Ask a specific question about this device
(204 days)
RADIOMED CORP.
The RadioMed"10 Source with activities from 0.1 to 5.0mCi per centimeter is indicated for temporary or permanent interstitial implantation or surface application to treat selected localized turnors. They can be used either as primary treatment (such as for prostate cancer or unresectable tumors) or as treatment for residual disease after excision of primary or recurrent tumors. The Pd-103 sources may be used concurrently with or following treatment with other interventions, such as external beam therapy, hyperthermia, or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate and other accessible tumors are commonly treated.
The RadioMed™ source utilizes Pd-103 as the radionuclide for brachytherapy. The RadioMed The Source exists in the form of a coiled rhodium wire. The rhodium matrix also provides the radiopacity of the device. The RadioMed™ Source is a naturally sealed source in the form of a wire.
The RadioMed The Source is packaged non-sterile, single use, and is intended to be sterilized by the end user in accordance with a validated sterilization process. Sterilization is accomplished by exposure to steam autoclave.
The RadioMed" Source will be manufactured. labeled and packaged under GMP controls. Upon completion of the manufacturing and assembly process the device will be inspected to assure compliance to specifications. The devices will be tested in accordance with Standard Operating Procedures.
The sources are delivered in the same manner as brachytherapy seeds currently on the market, i.e. a 17 or 18-gauge needle and stylet.
The provided text describes a 510(k) premarket notification for the "RadioMed™ Source," a brachytherapy radionuclide source. It primarily focuses on demonstrating substantial equivalence to existing predicate devices. Consequently, the document does not detail specific acceptance criteria for performance metrics or present a study proving the device meets those criteria in the way one might expect for a diagnostic or AI-driven device.
Instead, the "Performance Testing" section outlines the standards achieved for different aspects of the device, implying that compliance with these standards serves as the "acceptance criteria" and the "study" is the demonstration of adherence to these standards.
Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided text for certain categories:
Acceptance Criteria and Device Performance Study for RadioMed™ Source
The RadioMed™ Source is a brachytherapy radionuclide source. Its "performance" is subdivided into four categories, and the device's acceptance is based on its compliance with established standards and specifications for these categories and general regulatory requirements.
1. Table of Acceptance Criteria and Reported Device Performance
| Category / Performance Aspect | Acceptance Criteria (Standard / Description) | Reported Device Performance |
|---|---|---|
| General Manufacturing & Quality | FDA QSR 21 CFR Part 820 Good Manufacturing Practices | Manufactured, labeled, and packaged under GMP controls. Device will be inspected to assure compliance to specifications. Devices will be tested in accordance with Standard Operating Procedures. |
| Biocompatibility | ISO 10993-1 1992 (E) Biological Evaluation of Medical Devices | Achieved (Summary states "Summary of standards achieved: ISO 10993-1 1992 (E) Biological Evaluation of Medical Devices") |
| Radioactive Source Classification | ANSI N43.6-1997: Classification of sealed radioactive sources | Achieved (Summary states "Summary of standards achieved: ANSI N43.6-1997: Classification of sealed radioactive sources") |
| Integrity & Test Specifications | ANSI N44.1-1973 Integrity and Test Specifications for selected Brachytherapy Sources | Achieved (Summary states "Summary of standards achieved: ANSI N44.1-1973 Integrity and Test Specifications for selected Brachytherapy Sources") |
| Leak Testing | ANSI N44.2-1973 Leak testing radioactive brachytherapy sources / ISO 9978: 1992(E) "Radiation protection - Sealed radioactive sources - Leakage test methods". | Achieved (Summary states "Summary of standards achieved: ANSI N44.2-1973 Leak testing radioactive brachytherapy sources" and "ISO 9978: 1992(E) "Radiation protection - Sealed radioactive sources - Leakage test methods".") The RadioMed™ Source is described as a naturally sealed source. |
| Sterilization (by end user) | AAMI Standard 11134-1994 Recommended practice for Steam Autoclave | Intended to be sterilized by the end user in accordance with a validated sterilization process (steam autoclave). |
| Radiation Energy | Energy emitted for 103Pd (20-23 keV x-rays) | The energy emitted for the RadioMed™ Source and the Theragenics 103Pd Seed is exactly the same: 20-23 keV x-rays. |
| Source Strength Measurement | Calibration and Calibration Accuracy | Performance is subdivided into this category, implying that established calibration and accuracy standards are met (details not provided in the text). |
| Dose Comparison | (Implicit comparison to predicate devices for therapeutic effect) | Performance is subdivided into this category, implying that dose characteristics are comparable to predicate devices (details not provided in the text). |
| Sealed Source Testing | (Implicit integrity and safety testing for sealed sources) | Performance is subdivided into this category, implying that all necessary tests for sealed sources are conducted (details not provided in the text). The device is described as a "naturally sealed source." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of a typical clinical trial or performance study for a diagnostic device. The performance testing appears to refer to engineering and quality assurance tests conducted on manufactured units.
- No specific sample size for a "test set" is mentioned.
- Data provenance (country of origin, retrospective/prospective) is not applicable or provided, as the testing relates to manufacturing and product specifications rather than clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. The ground truth for this device is based on objective measurements against engineering standards, physical properties of the radionuclide, and established regulatory benchmarks, rather than subjective expert interpretation of data.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on subjective data (e.g., image interpretation). For this device, compliance is determined by objective measurements and adherence to technical standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a brachytherapy source, not a diagnostic imaging or AI-driven device intended to assist human readers. Therefore, an MRMC study is irrelevant to its evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The RadioMed™ Source is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the RadioMed™ Source's performance and safety is:
- Engineering Specifications: Compliance with design blueprints and material properties.
- Physical Standards: Adherence to established physical properties of the radionuclide (Pd-103 energy emission).
- Regulatory Standards: Compliance with national and international standards for medical devices, manufacturing (GMP, QSR), radiation safety (ANSI, ISO), and biocompatibility (ISO).
- Predicate Device Equivalence: The comparison to legally marketed predicate devices serves as a "ground truth" for demonstrating substantial equivalence in function and safety.
8. The Sample Size for the Training Set
Not applicable. This device does not involve machine learning or AI, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set.
Ask a specific question about this device
Page 1 of 1