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510(k) Data Aggregation
(86 days)
The Retrograde Cardioplegia Cannula with Duratio Treatment is indicated for use in the delivery of blood or cardioplegic solution intraoperatively.
Extracorporeal circuit components with the Duraflo treatment are indicated for use in cardiopulmonary surgery when a heparin-treated blood path is desired.
This device is for short-term use only (
The Baxter Research Medical Retrograde Cardioplegia Cannula with Duratio Treatment is a dual lumen cannula. The distal tip contains multiple infusion holes and an opening into the separate pressure monitoring lumen. A soft, low-pressure, self-inflating balloon surrounds the distal body (proximal to the flow holes). Inflation is accomplished via the differential pressure that occurs within the cannula during influsion. The balloon will deflate spontaneously when flow is stopped. The cannula is furnished with an introducer stylet. Each device is Individually packaged sterile and non-pyrogenic in a sealed, peed-type pouch.
The device is treated with Baxter Healthcare Corporation's proprietary Heparin coating, Duraflo.
Here's an analysis of the provided text regarding the Retrograde Cardioplegia Cannula with Duraflo Treatment, focusing on acceptance criteria and supporting studies.
It's important to note that the provided 510(k) summary (K991170) does not contain the detailed information typically associated with acceptance criteria and studies demonstrating device performance against those criteria as would be expected for an AI/ML or diagnostic device. This document is for a physical medical device (a catheter) and relies on substantial equivalence to predicate devices, rather than primary performance studies in the way you might be expecting.
Therefore, I will interpret your request within the context of what information is available in this 510(k) submission for a non-AI device.
Acceptance Criteria and Study for Retrograde Cardioplegia Cannula with Duraflo Treatment (K991170)
Given that this 510(k) is for a physical medical device (a cannula) rather than a software or diagnostic device, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" is framed differently. The primary mechanism for clearance in this case is demonstrating substantial equivalence to existing legally marketed predicate devices. The "performance" being evaluated is whether the new device functions similarly and is as safe and effective as the predicates.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence Review) | Reported Device Performance (Summary) |
|---|---|
| Intended Use Equivalence: Device indicates for same clinical purpose. | Indicated for "delivery of blood or cardioplegic solution intraoperatively" and "use in cardiopulmonary surgery when a heparin-treated blood path is desired." Matches or is consistent with predicate devices. |
| Technological Equivalence: Same fundamental technology. | "The proposed device consists of a device identical to the device cited as predicate Device A, which has been treated with the Duraflo treatment included in Predicate Device B." Uses established cannula design with an existing heparin coating. |
| Material Equivalence: Made of similar, safe, and biocompatible materials. | Materials are considered equivalent or safe, given its "identical" nature to Predicate A and the known safety of the Duraflo treatment (from Predicate B). |
| Design Equivalence: Similar structural and functional design. | "The proposed device consists of a device identical to the device cited as predicate Device A..." (RC-014 cannula design). The added Duraflo treatment is a surface modification, not a fundamental design change to the cannula's physical structure. |
| Safety and Effectiveness Equivalence: No new safety or effectiveness concerns. | The FDA granted clearance, indicating that the device is deemed "substantially equivalent" in safety and effectiveness to the predicate devices. No new questions of safety or effectiveness are raised. |
| Short-term Use: Device is acceptable for short-term use. | Indicated for "short-term use only ( |
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(227 days)
The Peripheral Retrograde Cardioplegia Cannula is indicated for use in the delivery of blood or cardioplegic solution. Placement of the cannula may be performed either through the jugular vein or intraoperatively.
The BRMI Peripheral Retrograde Cannula is a triple lumen radiopaque cannula. The distal tip contains multiple infusion holes and a separate pressure monitoring lumen that terminates at a 3-way stopcock. A soft, low-pressure, manually inflated and deflated silicone occlusion balloon surrounds the distal body (proximal to the flow holes). The cannula has approximately 50cm of usable lumen length. Each Peripheral Retrograde Cannula is individually packaged sterile and non-pyrogenic in a sealed, peel-type pouch.
This document is a 510(k) summary for a medical device (Peripheral Retrograde Cardioplegia Cannula). It does not contain information about studies to prove acceptance criteria, as this type of device (a cannula) is typically cleared based on substantial equivalence to predicate devices rather than clinical performance studies with acceptance criteria.
Therefore, I cannot provide the requested information. The document focuses on:
- Device Description: What the device is and its components.
- Intended Use: How the device is meant to be used.
- Predicate Devices: Comparison to similar devices already on the market to demonstrate substantial equivalence.
- Regulatory Classification: The FDA's classification of the device.
There is no mention of:
- Acceptance criteria for performance.
- Any studies (clinical or otherwise) with sample sizes, data provenance, ground truth establishment, expert adjudication, or MRMC/standalone performance.
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(77 days)
The NMI Retrograde Cardioplegia Cannulae-RCCS are intended for use in perfusing blood or Cardioplegia solutions via the coronary sinus during cardiopulmonary surgery.
The NMI Retrograde Cardioplegia Cannulae are fabricated with polyvinyl chloride bodies (PVC) and polyurethane balloon cuffs, polycarbonate/polyethylene stopcocks, polypropylene clamps, PVC female luer connectors, and stainless steel guidewires. The features of the device include: self-inflating cuff, pressure monitoring port with 3-way stopcock on jumen extension, suture ing. and 14 French size. The cannulae are placed in the coronary sinus in order to infuse cardioplegia in a retrograde fashion to the myocardium. This practice both arrests the heart and preserves metabolic function during surgery.
The provided document, K961717, describes the NMI Retrograde Cardioplegia Cannula-RCCS and its substantial equivalence to the Research Medical, Inc. Retrograde Cardioplegia Cannula # K880103. The study detailed is primarily focused on bench testing and material performance rather than clinical efficacy involving human readers or sophisticated algorithms. Therefore, many of the requested fields related to clinical studies, human readers, ground truth, and AI performance are not applicable.
Here's the information derived from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally demonstrated by the NMI cannulae's performance being comparable to or better than the RMI cannulae or by meeting specific physical/material standards.
| Acceptance Criteria (What is considered acceptable) | Reported Device Performance (NMI Retrograde Cardioplegia Cannula-RCCS) |
|---|---|
| Pressure Drop / Saline (4°C): Consistent performance compared to predicate at varying flow rates (100-500 ml/min). | NMI cannulae average pressure drops range at flow rates between 100 and 500 ml/min = 11 to 76 mmHg at 4°C (Predicate: 7 to 97 mmHg) |
| Pressure Drop / Saline (40°C): Consistent performance compared to predicate at varying flow rates (100-500 ml/min). | NMI cannulae average pressure drops range at flow rates between 100 and 500 ml/min = 6 to 60 mmHg at 40°C (Predicate: 6 to 97 mmHg) |
| Pressure Drop / Bovine Blood (25% Hematocrit, 4°C): Consistent performance compared to predicate at varying flow rates (100-500 ml/min). | NMI cannulae average pressure drops range at flow rates between 100 and 500 ml/min = 22 to 121 mmHg at 4°C (Predicate: 14 to 127 mmHg) |
| Pressure Drop / Bovine Blood (25% Hematocrit, 40°C): Consistent performance compared to predicate at varying flow rates (100-500 ml/min). | NMI cannulae average pressure drops range at flow rates between 100 and 500 ml/min = 11 to 77 mmHg at 40°C (Predicate: 12 to 91 mmHg) |
| Pressure Monitoring Port: Accurate pressure readings (0.5 to 0.9 mmHg) for downstream pressures of 10 to 80 mmHg. | NMI cannulae 0.5 to 0.9 mmHg for downstream pressures of 10 to 80 mmHg (Predicate: 0.6 to 0.9 mmHg) |
| Balloon Burst: Greater than 130 mmHg. | Greater than 130 mmHg |
| Guide Collapse: Less than predicate device. | Less than predicate device |
| Balloon Device (Performance): Greater than predicate device. | Greater than predicate device |
| Leak Test Requirements: No leaks at 10 psi air on NMI Device @ 4°C and 40°C. | No leaks at 10 psi air on NMI Device @ 4°C and 40°C |
| Tubing Bond Strength: Exceeds 0.4 lb tensile strength @ 4°C and 40°C. | Exceeds 0.4 lb tensile strength @ 4°C and 40°C |
| Luer Connections: Meets ANSI/HIMA MD70.1-1983 for Medical Materials Luer Taper Fittings. | Meets ANSI/HIMA MD70.1-1983 for Medical Materials Luer Taper Fittings |
| Package Integrity: Passed burst test in accordance with ASTM F1140-88. | Tyvek/Mylar passed burst test in accordance with ASTM F1140-88 |
| Shipping & Distribution Testing: Passed Distribution Simulation Test per ASTM 40169 Standard. | Passed Distribution Simulation Test per ASTM 40169 Standard |
| Accelerated Aging: No affects on performance after one year. | One year - No affects on performance |
| Biocompatibility: Fluid contact materials comply with Tripartite Biocompatibility Guidance for external devices, blood path direct, short term use. | Fluid contact materials of construction comply with Tripartite Biocompatibility Guidance for external devices, blood path direct, short term use |
| Sterilization: Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL 10⁻⁶. | Validated 100% Ethylene Oxide sterilization cycle (Overkill Method) SAL 10⁻⁶ |
| Pyrogenicity: Non-Pyrogenic per USP Pyrogen test (LAL). | Non-Pyrogenic per USP Pyrogen test (LAL) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as a numerical sample size. The testing appears to involve a limited number of manufactured devices for functional testing and material analysis.
- Data Provenance: The data is generated from retrospective bench testing of manufactured devices, comparing the NMI cannulae to a predicate device (Research Medical, Inc. Retrograde Cardioplegia Cannula # K880103). The country of origin of the data is not specified but is implicitly associated with Naltiac Medical, Inc. in Dallas, TX, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This study does not involve human expert interpretation of data to establish a ground truth. It focuses on physical and material performance metrics evaluated through laboratory testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. There is no adjudication method described as the study involves objective physical measurements and material tests, not subjective interpretations.
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 is not a study involving human readers or AI assistance. It's a medical device bench testing and substantial equivalence submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. There is no algorithm or AI component to this medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Objective Measurement Standards / Predicate Device Performance: The "ground truth" or reference for performance is established by objective engineering and safety standards (e.g., ANSI/HIMA MD70.1-1983, ASTM F1140-88, ASTM 40169, USP Pyrogen test, Tripartite Biocompatibility Guidance) and by the functional performance ranges observed in the predicate device.
8. The sample size for the training set
- Not Applicable. There is no "training set" in the context of an algorithm or AI. The device is a physical medical instrument.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an algorithm, there is no ground truth established for one.
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(91 days)
The FoamSeal Retrograde Cardioplegia Catheter is intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus by means of transatrial introduction.
The proposed modified FoamSeal Retrograde Cardioplegia Catheter is identical to the original FoamSeal Retrograde Cardioplegia Catheter (marketed under 510(k) # K941916), with the exception of a more rigid guide stylet.
The provided text is a 510(k) summary for the FoamSeal Retrograde Cardioplegia Catheter. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria in the context of a machine learning or AI-powered medical device.
The document describes a physical device, a catheter, and the "study" mentioned is a mechanical engineering test to compare the rigidity of a stylet. It's a non-clinical, bench-top test of a physical characteristic, not a clinical study or a performance evaluation of a device with "acceptance criteria" in the way that would apply to an AI system.
Therefore, I cannot fulfill your request for the specific information points as they relate to AI/ML device performance. The information you're asking for (sample size, data provenance, experts, adjudication, MRMC, standalone performance, ground truth, training set size) is relevant to AI/ML device validation, which is not what this 510(k) describes.
The document states:
- Study: "Stylet guide collapse testing was performed on the stylet guide from the proposed modified FoamSeal Retrograde Cardioplegia Catheter, and was compared to collapse values from the stylet guide used in the Research Medical retrograde cardioplegia catheter..."
- Purpose of Study: "The purpose of this test was to evaluate the force that can be generated by the stylet before buckling occurs, thereby providing a means for comparing stylet rigidity."
- Outcome/Finding: "Test results demonstrate that the modified FoamSeal Retrograde Cardioplegia Catheter stylet is less rigid than the Research Medical stylet, thereby presenting less of a potential for damage to the coronary sinus."
This is a physical test result, not an AI/ML performance metric.
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