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510(k) Data Aggregation
(263 days)
MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER
The Medtronic ARES™ Antibiotic-Impregnated Catheters are intended for use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.
The Medtronic ARES™ Antibiotic-Impregnated Catheters are manufactured using barium sulfate-filled silicone elastomer and are impregnated with clindamycin hydrochloride and rifampicin.
ARES Antibiotic-Impregnated Ventricular Catheter
The ARES ventricular catheter measures 23 cm in length, 0.13 cm in inner diameter, and 0.25 cm in outer diameter. Lengths are marked in 1 cm intervals starting from 3 cm to 15 cm from the catheter tip, thus enabling the surgeon to gauge the depth of penetration of the catheter into the lateral ventricle. The proximal end of the catheter has 32 flow holes—four lines of eight holes spaced at 90° intervals around the catheter circumference. Components supplied with the ARES Ventricular Catheter include a pre-loaded stainless steel stylet and a Right Angle Clip, which is included to facilitate placement and use of the ventricular catheter.
ARES Antibiotic-Impregnated Peritoneal Catheter
The ARES peritoneal catheter measures 120 cm in length, 0.13 cm in inner diameter, and 0.25 cm in outer diameter. There are no length markers or wall slits on the catheter, and the tip is open ended. The catheter may be trimmed to the proper length.
This 510(k) summary describes the Medtronic ARES™ Antibiotic-Impregnated Catheters and their substantial equivalence to the BACTISEAL® Catheter. The submission primarily relies on non-clinical performance and biocompatibility data, rather than clinical studies involving human patients or complex AI algorithms. Therefore, many of the requested elements pertaining to clinical studies, AI performance, ground truth, and expert evaluation are not applicable or cannot be extracted from this document.
Here's the information that can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Requirement) | Reported Device Performance (ARES™) |
|---|---|---|
| Performance Testing | Meet requirements outlined in ISO 7197: Neurosurgical implants - Sterile, single use hydrocephalus shunts and components and ASTM 647-94 Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application. | Successfully tested to meet the applicable requirements outlined in ISO 7197 and ASTM 647-94. Additionally, non-clinical tests were conducted for specific characteristics. |
| Sterilization Testing | Sterility assurance level (SAL) of 10-6 according to ISO 17665: Sterilization of health care products - Moist heat. | Validated using the Half Cycle method as outlined in ISO 17665 to a sterility assurance level (SAL) of 10-6. |
| Pyrogen Testing | Conform to FDA standards concerning pyrogen levels for devices in contact with cerebrospinal fluid, meeting a 2.15 EU/device specification. | Meets a 2.15 EU/device specification utilizing the Kinetic-Chromogenic LAL method. |
| Biocompatibility Testing (General) | Considered an implant device with tissue/bone contact and permanent contact duration of greater than 30 days, tested in accordance with ISO 10993-1:2009 and FDA Blue Book Memo, G95-1. | A series of tests were conducted to demonstrate biocompatibility with the following specific results: |
| Cytotoxicity | No biological reactivity. | No biological reactivity (Grade 0) observed at 48 hours post exposure to the test article extract. (Conclusion: Non-cytotoxic) |
| Sensitization | No reaction at challenge following induction phase. | Extracts elicited no reaction at the challenge (0% sensitization), following an induction phase. (Conclusion: Non-sensitizing) |
| Intracutaneous Irritation/Reactivity | Test article extract sites not significantly greater biological reaction than control. | Test article extract sites did not show a significantly greater biological reaction than the sites injected with the control article extract. (Conclusion: Non-irritant) |
| Acute Systemic Toxicity | Test article extracts not significantly greater biological reaction than control. | Test article extracts did not induce a significantly greater biological reaction than the control extracts. (Conclusion: Non-toxic (acute)) |
| Bacterial Reverse Mutation Study (Non-antibiotic impregnated catheter) | Non-mutagenic. | DMSO and saline test article extracts were considered to be non-mutagenic to Salmonella typhimurium tester strains TA98, TA100, TA1535, and TA1537 and to Escherichia coli tester strain WP2uvrA. (Conclusion: Non-genotoxic) |
| Bacterial Reverse Mutation Assay (Mock-impregnated catheter) | Non-mutagenic. | DMSO and saline test article extracts were considered to be non-mutagenic to Salmonella typhimurium tester strains TA98, TA100, TA1535, and TA1537 and to Escherichia coli tester strain WP2uvrA. (Conclusion: Non-genotoxic) |
| In Vitro Mouse Lymphoma Assay | Mutant frequencies and cloning efficiencies within limits for negative response. | Mutant frequencies and cloning efficiencies of preparations treated with test article were within the limits defined for a negative response. (Conclusion: Non-genotoxic) |
| Mouse Peripheral Blood Micronucleus Study | No induction of micronuclei. | The test article extracts did not induce micronuclei in mice. (Conclusion: Non-genotoxic) |
| Implantation - 13 week brain and subcutaneous implant & Sub-Chronic / Chronic Toxicity | No systemic signs of toxicity and no local adverse event. | The test article does not appear to demonstrate any systemic signs of toxicity when implanted in the brain and subcutaneous tissue of New Zealand White rabbits for a period of 13 weeks. (Conclusion: No local adverse event, Non-toxic (sub-chronic)) |
| Comparative Performance (Predicate Device) | ||
| Drug release kinetics | Demonstration that antibiotics release kinetics over a 38-day period is the same for ARES and BACTISEAL. | Antibiotic release kinetics measured over a 38-day period demonstrated the same as BACTISEAL antibiotic release rates. |
| Zone of Inhibition Testing | Demonstration of antimicrobial activity for at least 31 days with statistically equivalent zones of inhibition for ARES and BACTISEAL. | Antimicrobial activity demonstrated for at least 31 days. Measured ZOIs statistically equivalent to those of BACTISEAL. |
| Catheter Crush Resistance | ARES catheter mean value must not be significantly lower than control group (BACTISEAL) mean using a two-sample t-test at 95% confidence. | Pass |
| Drug Content | Clindamycin: 0.150 ± 45%; Rifampicin: 0.054 ± 60%. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document primarily details non-clinical (bench and in-vitro/in-vivo animal) tests. Therefore, the concept of a "test set" in the context of clinical data or AI performance (which would typically involve patient cases) is not directly applicable.
- Bench tests: No specific sample sizes are provided within the summary for tests like performance testing or sterilization testing, although these would involve multiple units for validation.
- Biocompatibility tests: Sample sizes are implicit in the descriptions of animal studies (e.g., "All animals increased in weight" implies multiple animals were used, but specific numbers are not given for each test). The studies used Salmonella typhimurium and Escherichia coli tester strains, mice, and New Zealand White rabbits.
- Data Provenance: The data originates from internal testing conducted by Medtronic as part of their 510(k) submission. It's prospective in the sense that these tests were conducted specifically to support this submission. The origin is implied to be within controlled laboratory settings, likely in the US, given the submission is to the FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not Applicable. This submission relies on objective, measurable physical, chemical, and biological endpoints from non-clinical tests (bench, in-vitro, and in-vivo animal studies) rather than human expert interpretation of clinical data or images. Therefore, no experts were used to establish "ground truth" in the clinical AI sense.
4. Adjudication Method for the Test Set
Not Applicable. Since no human expert evaluation or clinical data interpretation was involved for establishing a "ground truth" or test set, no adjudication method was used.
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 submission is for a physical medical device (antibiotic-impregnated catheter) and does not involve AI algorithms or human reading of medical cases.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not Applicable. This submission is for a physical medical device and does not involve an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" or reference standards used are established scientific and regulatory standards and validated test methodologies. These include:
- Engineering Standards: ISO 7197, ASTM 647-94 for performance.
- Sterilization Standards: ISO 17665.
- Pyrogen Standards: ANSI/AAMI/ST72.
- Biocompatibility Standards: ISO 10993-1, ISO 10993-3, ISO 10993-5, ISO 10993-6, ISO 10993-10, ISO 10993-11, and FDA Blue Book Memo, G95-1.
- Quantitative Measurements: Drug release kinetics (mg/day), Zone of Inhibition (mm), Drug content (weight %), mechanical strength (crush resistance).
- Biological Endpoints: Cytotoxicity (cellular response), Sensitization (immune response), Irritation (tissue reaction), Systemic Toxicity (organism-wide effects), Genotoxicity (DNA damage), Implantation responses (local tissue reaction in vivo).
Comparisons were also made directly against the predicate device (BACTISEAL® Catheter) for key performance characteristics to demonstrate "sameness."
8. The Sample Size for the Training Set
Not Applicable. This submission is for a physical medical device and does not involve AI algorithms that require a "training set."
9. How the Ground Truth for the Training Set was Established
Not Applicable. As there is no AI algorithm, there is no training set or ground truth for one.
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