(90 days)
The Medtronic CardioTherm™ Blood Cardioplegia System is intended for mixing, cooling, warming, and delivery of oxygenated blood and/or asanguineous cardioplegia solution.
Each Medtronic CardioTherm™ Blood Cardioplegia System is a single use, disposable device designed to mix arterial blood from an oxygenator with asanguineous cardioplegia solution in specific ratios devending on the tubing set configurations. The blood/cardioplegia solution is then cooled/warmed and delivered to the patient. The Medtronic CardioTherm™ Cardioplegia Heat Exchanger consists of a polycarbonate housing which incorporates a bubble chamber. A stopcock is attached to the upper luer port of the housing lid allowing for air venting through a purge line during priming and pressure monitoring through a vented or nonvented pressure monitoring line throughout the procedure. A temperature probe port is located adjacent to the blood outlet port at the bottom of the device, allowing for temperature monitoring of the blood/cardioplegia solution prior to patient delivery. The heat exchanger housing contains nonporous polypropylene hollow fibers, which are supported on their exterior by a polyethylene screen. These polypropylene fibers run longitudinally through the polycarbonate chamber. Blood/cardioplegia solution flows through the polypropylene hollow fibers. The walls of these fibers provide a barrier between the blood/cardioplegia solution and the cooling/warming water.
The provided document is a 510(k) summary for the Medtronic CardioTherm™ Blood Cardioplegia Delivery Systems. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria in the manner one might expect for a novel diagnostic or AI-driven device.
Therefore, many of the requested points regarding acceptance criteria, study design, expert ground truth, and AI performance metrics are not applicable to this type of regulatory submission. This document details a comparison of general characteristics and nominal specifications to establish substantial equivalence.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the format of defined metrics and thresholds for a specific performance study. Instead, it presents a comparison of the Medtronic CardioTherm™ Blood Cardioplegia System's characteristics and specifications against four predicate devices to demonstrate substantial equivalence. The "performance characteristics" listed are:
| Characteristic | Medtronic CardioTherm™ | Predicate 1 (Medtronic/Electromedics) | Predicate 2 (Gish Biomedical) | Predicate 3 (Avecor Cardiovascular) | Predicate 4 (Sorin Biomedical) |
|---|---|---|---|---|---|
| Heat Exchanger Priming Volume | 46 mL | 55 mL | 83 mL | 68 mL | 55 mL |
| Maximum Flow Rate | 1 LPM | 3 LPM | not rated | not rated | 0.5 LPM |
| Fluid Path Pressure (maximum) | $\le 500$ mmHg | not rated | $\le 300$ mmHg | $\le 500$ mmHg | not rated |
| Water Path Pressure (maximum) | 45 psi | 45 psi | 65 psi | 40 psi | 80 psi |
The "acceptance criteria" for this type of submission are implicitly that the new device's characteristics and performance are comparable to, or within the established safety and effectiveness profile of, the predicate devices. The document argues that this is the case, stating, "The design, construction, materials and nominal specifications of the Medtronic Cardiopulmonary CardioTherm™ Blood Cardioplegia Systems are either identical or substantially equivalent to other These predicate/marketed Blood Cardioplegia Systems currently in commercial distribution."
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 in the document. The submission is a comparison of product specifications and intended use, not a clinical trial or performance study on a test set of data.
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 applicable as there is no mention of a test set requiring expert-established ground truth. The "ground truth" for this submission would be the established safety and effectiveness of the predicate devices based on their prior regulatory approvals and market history.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as there is no test set or adjudication process 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
This information is not applicable. The device described is a medical instrument (blood cardioplegia delivery system), not an AI-driven diagnostic tool. Therefore, there are no "human readers" or AI assistance involved in its function or evaluation in the context of this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the established safety and effectiveness of the predicate devices as previously cleared by regulatory bodies. The submission aims to demonstrate that the new device is "substantially equivalent" to these already-marketed devices, implying it meets similar safety and performance standards.
8. The sample size for the training set
This information is not applicable as the device is not an AI system that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as above.
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Image /page/0/Picture/0 description: The image shows the date May 23 1996. The text is written in a bold, sans-serif font. The date is written in a clear and legible manner. The image is likely a scan or photograph of a document or other printed material.
SUMMARY OF SAFETY AND EFFECTIVENESS
COMPANY AND CONTACT PERSON
Medtronic, Inc. Cardiopulmonary Division 4633 E. La Palma Avenue Anaheim. CA 92807 714-779-3700
Debra J. Kridner, Manager Regulatory Affairs
DEVICE NAME
CardioTherm™ Blood Cardioplegia Delivery Systems (CTXXX Series and CTXXXBR Series)
NAME OF PREDICATE OR LEGALLY MARKETED DEVICE
- Medtronic Electromedics. Inc. Blood Cardioplegia Delivery Systems (K934355) .
- Gish Biomedical, Inc. Single Pass Blood Cardioplegia (SPBC) Systems (K896807/ K944219) .
- . Avecor Cardiovascular - MYOtherm™ Cardioplegia Delivery Systems (K904171)
- Sorin Biomedical BCD ADVANCED Blood Cardioplegia System (K925369) .
DESCRIPTION OF DEVICE
Each Medtronic CardioTherm™ Blood Cardioplegia System is a single use, disposable device designed to mix arterial blood from an oxygenator with asanguineous cardioplegia solution in specific ratios devending on the tubing set configurations. The blood/cardioplegia solution is then cooled/warmed and delivered to the patient.
The Medtronic CardioTherm™ Cardioplegia Heat Exchanger consists of a polycarbonate housing which incorporates a bubble chamber. A stopcock is attached to the upper luer port of the housing lid allowing for air venting through a purge line during priming and pressure monitoring through a vented or nonvented pressure monitoring line throughout the procedure. A temperature probe port is located adjacent to the blood outlet port at the bottom of the device, allowing for temperature monitoring of the blood/cardioplegia solution prior to patient delivery.
The heat exchanger housing contains nonporous polypropylene hollow fibers, which are supported on their exterior by a polyethylene screen. These polypropylene fibers run longitudinally through the polycarbonate chamber. Blood/cardioplegia solution flows through the polypropylene hollow
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fibers. The walls of these fibers provide a barrier between the blood/cardioplegia solution and the cooling/warming water.
The flow of solution through the Medronic CardioTherm™ Blood Cardioplegia Heat Exchanger is as follows:
Blood/Cardioplegia
The blood and/or cardioplegia solution enters the bottom of the device, flows up through the polypropylene hollow fibers, flows back down a center collecting tube, and exits the from the bottom of the device.
Water
The cooling/warming water enters a side port, passes around the outside walls of the polypropylene fibers, then exits through a parallel side port.
Heat exchange occurs as the blood/cardioplegia solution passes through the hollow fibers, while the temperature regulated cooling/warming water passes around the outside walls of the same fibers. The blood/cardioplegia solution is cooled/ warmed as it flows through the heat exchanger.
By connecting tubing of specific inner diameters to the heat exchanger, a predetermined approximate ratio of blood to cardioplegia solution may be delivered to the patient. The tubine sets are manufactured with polyvinyl chloride tubing and polycarbonate/polyvinyl chloride connectors which are currently used as components in the commercially distributed Medtronic Extracorporeal InterSept™ Custom Tubing Packs (K800178) and Medtronic InterSept™ Crystalloid Cardioplegia Delivery System (K885154). Four of the various delivery ratios available are:
- 1 . a tubing set for 1:1 ratio of blood to asanguineous cardioplegia.
-
- a tubing set for 2:1 ratio of blood to asanguineous cardioplegia.
-
- a tubing set for 4:1 ratio of blood to asanguineous cardioplegia.
-
- a tubing set for 9:1 ratio of blood to asanguineous cardioplegia.
These tubing ratios are commercially available blood cardioplegia systems; including the Medtronic Electromedics, Inc. Blood Cardioplegia Delivery Systems, the Gish Biomedical, Inc. Single Pass Blood Cardioplegia (SPBC) Systems, the Avecor Cardiovascular MYOtherm™ Cardioplegia Delivery Systems and the Sorin Biomedical BCD ADVANCED Blood Cardioplegia System.
Tubing inner diameters for commercially available tubing sets generally range from 3/32" (2.4 mm) to 17/64" (6.7mm).
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STATEMENT OF INTENDED USE
The Medtronic CardioTherm™ Blood Cardioplegia System is intended for mixing, cooling, warming, and delivery of oxygenated blood and/or asanguineous cardioplegia solution.
STATEMENT OF INTENDED USE OF PREDICATE/MARKETED DEVICES
The Medtronic Electromedics, Inc. - Blood Cardioplegia Delivery Systems are intended to mix, cool, and deliver oxygenated blood/cardioplegia solution in a predetermined ratio.
The Gish Biomedical, Inc. - Single Pass Blood Cardioplegia (SPBC) Systems are intended to mix, cool/warm, and deliver oxygenated blood/cardioplegia solution.
The Avecor Cardiovascular - MYOtherm™ Cardioplegia Delivery Systems are intended to mix, cool, and deliver oxygenated blood/cardioplegia solution in a predetermined ratio.
The Sorin Biomedical - BCD ADVANCED Blood Cardioplegia System are intended to mix, cool/warm, and deliver oxygenated blood/cardioplegia solution.
STATEMENT OF TECHNOLOGICAL CHARACTERISTICS COMPARISON
A table comparing the intended use and technological characteristics of the Medtronic Cardiopulmonary CardioTherm™ Blood Cardioplegia Systems with the four noted substantially equivalent devices is provided in Attachment I.
DETERMINATION OF SUBSTANTIAL EQUIVALENCE
This premarket notification submission provides substantial equivalence information and rationale which addresses the introduction to commercial distribution of the Medtronic Cardiopulmonary CardioTherm™ Blood Cardioplegia System.
The Medtronic Cardiopulmonary CardioTherm™ Blood Cardioplegia Systems are substantially equivalent to other Blood Cardioplegia Systems currently in commercial distribution. These predicate/marketed devices include:
- Medtronic Electromedics, Inc. - Blood Cardioplegia Delivery Systems (K934355)
- . Gish Biomedical, Inc. - Single Pass Blood Cardioplegia (SPBC) Systems (K896807/ K944219)
- . Avecor Cardiovascular - MYOtherm™ Cardioplegia Delivery Systems (K904171)
- Sorin Biomedical BCD ADVANCED Blood Cardioplegia System (K925369) ●
The Medtronic Cardiopulmonary CardioTherm™ Blood Cardioplegia Systems have an intended use which is substantially equivalent to other Blood Cardioplegia Systems currently in commercial distribution. These predicate/marketed devices include
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- Medtronic Electromedics, Inc. Blood Cardioplegia Delivery Systems (K934355) .
- Gish Biomedical, Inc. Single Pass Blood Cardioplegia (SPBC) Systems (K896807/ K944219) .
- Avecor Cardiovascular MYOtherm™ Cardioplegia Delivery Systems (K904171) .
- Sorin Biomedical BCD ADVANCED Blood Cardioplegia System (K925369) .
The Medtronic Cardiopulmonary CardioTherm™ Blcod Cardioplegia Systems have technological characteristics which are substantially equivalent to other Blood Cardioplegia Systems currently in commercial distribution. These predicate/marketed devices include:
- Medtronic Electromedics, Inc. Blood Cardioplegia Delivery Systems (K934355) .
- Gish Biomedical, Inc. Single Pass Blood Cardioplegia (SPBC) Systems (K89680/ K944219) .
- Avecor Cardiovascular MYOtherm™ Cardioplegia Delivery Systems (K904171) .
- Sorin Biomedical BCD ADVANCED Blood Cardioplegia System (K925369) .
The design, construction, materials and nominal specifications of the Medtronic Cardiopulmonary CardioTherm™ Blood Cardioplegia Systems are either identical or substantially equivalent to other These predicate/marketed Blood Cardioplegia Systems currently in commercial distribution. devices include:
- Medtronic Electromedics, Inc. Blood Cardioplegia Delivery Systems (K934355) .
- Gish Biomedical, Inc. Single Pass Blood Cardioplegia (SPBC) Systems (K896807/K944219) .
- Avecor Cardiovascular MYOtherm™ Cardioplegia Delivery Systems (K904171) .
- Sorin Biomedical BCD ADVANCED Blood Cardioplegia System (K925369) .
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DEVICE COMPARISONS -- GENERAL CHARACTERISTICS AND NOMINAL SPECIFICATIONS
| Medtronic, Inc.CardioTherm™Blood Cardioplegia System | Medtronic, Inc./Electromedics Inc.Blood Cardioplegia.Delivery Systems | Gish Biomedical, Inc.SPBCBlood Cardioplegia Systems | Avecor CardiovascularMYOTherm™Cardioplegia Delivery Systems | Sorin BiomdicalBCD ADVANCEDBlood Cardioplegia System | |
|---|---|---|---|---|---|
| 510(k) Number: | This submission | K934355 | K896807 | K904171 | K925369 |
| Catalog Number(s): | CT-XXX SeriesCT-XXXBR Series | D1081A, D1080A, D1082A | SPBC-XX SeriesSPBC-XXBR Series | MYOtherm™ XX SeriesMYOtherm™ XX BR Series | BCD ADV X Series(includes bridge/shunt system) |
| Intended Use: | To mix, cool, warm and deliveroxygenated blood/cardioplegiasolution. | To mix, cool, and deliveroxygenated blood/cardioplegiasolution in a predetermined ratio. | To mix, cool/warm, and deliveroxygenated blood/cardioplegiasolution. | To mix, cool, and deliveroxygenated blood/cardioplegiasolution in a predetermined ratio. | To mix, cool/warm, and deliveroxygenated blood/cardioplegiasolution. |
| Performance Characteristics: | |||||
| Heat ExchangerPriming Volume (mL)Maximum Flow Rate (LPM)Fluid Path Pressure (maximum)Water Path Pressure (maximum) | 461$500 mmHg$45 psi | 553not rated45 psi | 83not rated$300 mmHg$65 psi | 68not rated$500 mmHg$40 psi | 55.5not rated80 psi |
| Technological Characteristics: | |||||
| Configuration | Heat Exchanger | Heat Exchanger | Heat Exchanger | Heat Exchanger | Heat Exchanger |
| Heat ExchangerVent PortBubble ChamberTemperature WellPressure Monitoring LinePatient Delivery Line | YesYesYesYesYes | YesYesYesYesYes | YesYesYesYesYes | YesYesYesYesYes | YesYesYesYesYes |
| Various Tubing Sets | Various Tubing Sets | Various Tubing Sets | Various Tubing Sets | Various Tubing Sets | |
| Medtronic, Inc.CardioTherm™Blood Cardioplegia System | Medtronic, Inc./Electromedics Inc.Blood Cardioplegia.Delivery Systems | Gish Biomedical, Inc.SPBCBlood Cardioplegia Systems | Avecor CardiovascularMYOTherm™Cardioplegia Delivery Systems | Sorin BiomdicalBCD ADVANCEDBlood Cardioplegia System | |
| Materials | |||||
| Heat ExchangerHousingHeat Exchanger | PolycarbonatePolypropylene | PolycarbonateStainless steel | PolycarbonateAluminum | PolycarbonateStainless steel | PolycarbonateAluminum |
| Tubing Sets | Polyvinyl chloridePolycarbonate | Polyvinyl chloridePolycarbonate | Polyvinyl chloridePolycarbonate | Polyvinyl chloridePolycarbonate | Polyvinyl chloridePolycarbonate |
| Specifications | |||||
| Tubing Set Ratios | Separate sets(1:1, 2:1, 4:1 and 9:1) | Separate sets(1:1, 2:1 and 4:1) | Separate sets(1:1, 2:1, 4:1 and 9:1) | Separate sets(1:1, 2:1, 4:1 and 9:1) | Separate sets(1:1, 2:1, 4:1 and 8:1) |
| Tubing Inner Diameter | 1/12 inch to 1/4 inch | 1/8 inch to 1/4 inch | 3/32 inch to 17/64 inch | 1/8 inch to 1/4 inch | 3/32 inch to 17/64 inch |
| Ratio Capability | Variable (w/bridge clamps)(all blood. 1:1, 2:1, 4:1, 9:1and all crystalloid withvarious tubing sets) | Variable(1:1, 2:1 and 4:1) | Variable (w/bridge clamps)(all blood, 1:1, 2:1, 4:1, 9:1,and all crystalloid withvarious tubing sets) | Variable (w/bridge clamps)(all blood, 1:1, 2:1, 4:1, 9:1,and all crystalloid withvarious tubing sets) | Variable (w/bridge clamps)(all blood, 1:1, 2:1, 4:1, 8:1,and all crystalloid withvarious tubing sets) |
| Mode of Operation | This blood/cardioplegia systemis used in the extracorporealcircuit for mixing, cooling,warming and delivery ofoxygenated blood and/orcardioplegia solution. Themultiple configurations allowthe clinician the capability ofproviding varying ratios ofblood to cardioplegia solutionbased on the patients' clinicalneed. | This blood/cardioplegia systemis used in the extracorporealcircuit for mixing, cooling,warming and delivery ofoxygenated blood and/orcardioplegia solution. Themultiple configurations allowthe clinician the capability ofproviding varying ratios ofblood to cardioplegia solutionbased on the patients' clinicalneed. | This blood/cardioplegia systemis used in the extracorporealcircuit for mixing, cooling,warming and delivery ofoxygenated blood and/orcardioplegia solution. Themultiple configurations allowthe clinician the capability ofproviding varying ratios ofblood to cardioplegia solutionbased on the patients' clinicalneed. | This blood/cardioplegia systemis used in the extracorporealcircuit for mixing, cooling,warming and delivery ofoxygenated blood and/orcardioplegia solution. Themultiple configurations allowthe clinician the capability ofproviding varying ratios ofblood to cardioplegia solutionbased on the patients' clinicalneed. | This blood/cardioplegia systemis used in the extracorporealcircuit for mixing, cooling,warming and delivery ofoxygenated blood and/orcardioplegia solution. Themultiple configurations allowthe clinician the capability ofproviding varying ratios ofblood to cardioplegia solutionbased on the patients' clinicalneed. |
510(k) Notification - CardioTherm™ Medtronic, Inc. Medtronic Cardiopulmonary
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DEVICE COMPARISONS -- GENERAL CHARACTERISTICS AND NOMINAL SPECIFICATIONS
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§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.