(90 days)
No
The description focuses on the mechanical and physical components of the device for mixing, cooling, warming, and delivering solutions, with no mention of AI or ML capabilities for analysis, decision-making, or control.
Yes.
The device is used to mix, cool, warm, and deliver cardioplegia solution to a patient, which directly contributes to a medical treatment.
No
The device is designed to mix, cool, warm, and deliver fluids during a medical procedure; it does not diagnose a medical condition.
No
The device description clearly details physical components like polycarbonate housing, stopcocks, luer ports, temperature probe ports, and hollow fibers, indicating it is a hardware device with a physical mechanism for mixing, cooling, warming, and delivering solutions.
Based on the provided information, the Medtronic CardioTherm™ Blood Cardioplegia System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "mixing, cooling, warming, and delivery of oxygenated blood and/or asanguineous cardioplegia solution." This describes a system used during a medical procedure (likely cardiac surgery) to prepare and deliver a solution directly to the patient's heart.
- Device Description: The description details a system for processing and delivering fluids to the patient, including a heat exchanger and components for mixing and temperature control. This is consistent with a device used in a surgical or interventional setting.
- Lack of IVD Characteristics: IVD devices are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The CardioTherm system is used to prepare and deliver a solution to the body, not to analyze specimens from it.
Therefore, the Medtronic CardioTherm™ Blood Cardioplegia System is a medical device used in a clinical setting for patient treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Medtronic CardioTherm™ Blood Cardioplegia System is intended for mixing, cooling, warming, and delivery of oxygenated blood and/or asanguineous cardioplegia solution.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
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 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K934355, K896807/K944219, K904171, K925369
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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).
2
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
Confidential
3
- 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) .
4
DEVICE COMPARISONS -- GENERAL CHARACTERISTICS AND NOMINAL SPECIFICATIONS
| | Medtronic, Inc.
CardioTherm™
Blood Cardioplegia System | Medtronic, Inc./Electromedics Inc.
Blood Cardioplegia.
Delivery Systems | Gish Biomedical, Inc.
SPBC
Blood Cardioplegia Systems | Avecor Cardiovascular
MYOTherm™
Cardioplegia Delivery Systems | Sorin Biomdical
BCD ADVANCED
Blood Cardioplegia System |
|------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number: | This submission | K934355 | K896807 | K904171 | K925369 |
| Catalog Number(s): | CT-XXX Series
CT-XXXBR Series | D1081A, D1080A, D1082A | SPBC-XX Series
SPBC-XXBR Series | MYOtherm™ XX Series
MYOtherm™ XX BR Series | BCD ADV X Series
(includes bridge/shunt system) |
| Intended Use: | To mix, cool, warm and deliver
oxygenated blood/cardioplegia
solution. | To mix, cool, and deliver
oxygenated blood/cardioplegia
solution in a predetermined ratio. | To mix, cool/warm, and deliver
oxygenated blood/cardioplegia
solution. | To mix, cool, and deliver
oxygenated blood/cardioplegia
solution in a predetermined ratio. | To mix, cool/warm, and deliver
oxygenated blood/cardioplegia
solution. |
| Performance Characteristics: | | | | | |
| Heat Exchanger
Priming Volume (mL)
Maximum Flow Rate (LPM)
Fluid Path Pressure (maximum)
Water Path Pressure (maximum) | 46
1
$500 mmHg$
45 psi | 55
3
not rated
45 psi | 83
not rated
$300 mmHg$
65 psi | 68
not rated
$500 mmHg$
40 psi | 55
.5
not rated
80 psi |
| Technological Characteristics: | | | | | |
| Configuration | Heat Exchanger | Heat Exchanger | Heat Exchanger | Heat Exchanger | Heat Exchanger |
| Heat Exchanger
Vent Port
Bubble Chamber
Temperature Well
Pressure Monitoring Line
Patient Delivery Line | Yes
Yes
Yes
Yes
Yes | Yes
Yes
Yes
Yes
Yes | Yes
Yes
Yes
Yes
Yes | Yes
Yes
Yes
Yes
Yes | Yes
Yes
Yes
Yes
Yes |
| | 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.
SPBC
Blood Cardioplegia Systems | Avecor Cardiovascular
MYOTherm™
Cardioplegia Delivery Systems | Sorin Biomdical
BCD ADVANCED
Blood Cardioplegia System |
| Materials | | | | | |
| Heat Exchanger
Housing
Heat Exchanger | Polycarbonate
Polypropylene | Polycarbonate
Stainless steel | Polycarbonate
Aluminum | Polycarbonate
Stainless steel | Polycarbonate
Aluminum |
| Tubing Sets | Polyvinyl chloride
Polycarbonate | Polyvinyl chloride
Polycarbonate | Polyvinyl chloride
Polycarbonate | Polyvinyl chloride
Polycarbonate | Polyvinyl chloride
Polycarbonate |
| 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, 9:1
and all crystalloid with
various 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 with
various tubing sets) | Variable (w/bridge clamps)
(all blood, 1:1, 2:1, 4:1, 9:1,
and all crystalloid with
various tubing sets) | Variable (w/bridge clamps)
(all blood, 1:1, 2:1, 4:1, 8:1,
and all crystalloid with
various tubing sets) |
| Mode of Operation | This blood/cardioplegia system
is used in the extracorporeal
circuit for mixing, cooling,
warming and delivery of
oxygenated blood and/or
cardioplegia solution. The
multiple configurations allow
the clinician the capability of
providing varying ratios of
blood to cardioplegia solution
based on the patients' clinical
need. | This blood/cardioplegia system
is used in the extracorporeal
circuit for mixing, cooling,
warming and delivery of
oxygenated blood and/or
cardioplegia solution. The
multiple configurations allow
the clinician the capability of
providing varying ratios of
blood to cardioplegia solution
based on the patients' clinical
need. | This blood/cardioplegia system
is used in the extracorporeal
circuit for mixing, cooling,
warming and delivery of
oxygenated blood and/or
cardioplegia solution. The
multiple configurations allow
the clinician the capability of
providing varying ratios of
blood to cardioplegia solution
based on the patients' clinical
need. | This blood/cardioplegia system
is used in the extracorporeal
circuit for mixing, cooling,
warming and delivery of
oxygenated blood and/or
cardioplegia solution. The
multiple configurations allow
the clinician the capability of
providing varying ratios of
blood to cardioplegia solution
based on the patients' clinical
need. | This blood/cardioplegia system
is used in the extracorporeal
circuit for mixing, cooling,
warming and delivery of
oxygenated blood and/or
cardioplegia solution. The
multiple configurations allow
the clinician the capability of
providing varying ratios of
blood to cardioplegia solution
based on the patients' clinical
need. |
510(k) Notification - CardioTherm™ Medtronic, Inc. Medtronic Cardiopulmonary
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5
DEVICE COMPARISONS -- GENERAL CHARACTERISTICS AND NOMINAL SPECIFICATIONS
Confidential