CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS
Device Facts
| Record ID | K960755 |
|---|---|
| Device Name | CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS |
| Applicant | Medtronic Cardiac Surgery, Medtronic, Inc. |
| Product Code | DQX · Cardiovascular |
| Decision Date | May 23, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1330 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The Medtronic CardioTherm™ Blood Cardioplegia System is intended for mixing, cooling, warming, and delivery of oxygenated blood and/or asanguineous cardioplegia solution.
Device Story
Single-use disposable device; integrates into extracorporeal circuit. Inputs: arterial blood from oxygenator; asanguineous cardioplegia solution. Mechanism: polycarbonate housing with nonporous polypropylene hollow fibers; blood/cardioplegia flows through fibers; temperature-regulated water flows around fibers for heat exchange. Output: temperature-controlled blood/cardioplegia mixture delivered to patient. Clinician-operated; used in surgical settings. Tubing sets with specific inner diameters determine blood-to-cardioplegia mixing ratios (e.g., 1:1, 2:1, 4:1, 9:1). Device includes bubble chamber, vent port, temperature probe port, and pressure monitoring line. Facilitates myocardial protection during cardiac surgery by providing precise temperature and composition control of cardioplegic solution.
Clinical Evidence
No clinical data provided. Substantial equivalence is based on bench testing, design analysis, and comparison of technological characteristics and nominal specifications against legally marketed predicate devices.
Technological Characteristics
Heat exchanger with polycarbonate housing; nonporous polypropylene hollow fibers; polyethylene screen support. Tubing sets: polyvinyl chloride (PVC) with polycarbonate/PVC connectors. Dimensions: tubing inner diameters 3/32" to 17/64". Connectivity: standalone extracorporeal circuit component. Sterilization: not specified. Sensing: temperature probe port, pressure monitoring line. Energy: external water-based cooling/warming source.
Indications for Use
Indicated for patients undergoing procedures requiring extracorporeal circulation where mixing, cooling, warming, and delivery of oxygenated blood and/or asanguineous cardioplegia solution is required.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- 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)
Reference Devices
- Medtronic Extracorporeal InterSept™ Custom Tubing Packs (K800178)
- Medtronic InterSept™ Crystalloid Cardioplegia Delivery System (K885154)
Related Devices
- K973475 — CARMEDA COATED CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS (CBCTXXX SERIES AND CBCTXXXBR SERIES) · Medtronic Vascular · Nov 20, 1997
- K991137 — ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER · Minntech Corp. · Jun 8, 2000
- K012898 — MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM · Cobe Cardiovascular, Inc. · Sep 17, 2001
- K011864 — TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B · Medtronic Vascular · Jul 9, 2001
- K201984 — MPS 3 ND Myocardial Protection System · Quest Medical, Inc. · Nov 20, 2020
Submission Summary (Full Text)
{0}
MAY 23 1996
K960755
# 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 depending 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
510(k) Notification - CardioTherm™
Medtronic, Inc.
Medtronic Cardiopulmonary
February 22, 1996
Confidential
Page 144
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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 Medtronic 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 tubing 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.
2. a tubing set for 2:1 ratio of blood to asanguineous cardioplegia.
3. a tubing set for 4:1 ratio of blood to asanguineous cardioplegia.
4. a tubing set for 9:1 ratio of blood to asanguineous cardioplegia.
These tubing ratios are common to 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).
510(k) Notification - CardioTherm™
Medtronic, Inc.
Medtronic Cardiopulmonary
February 22, 1996
Confidential
Page 145
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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:
510(k) Notification - CardioTherm™
Medtronic, Inc.
Medtronic Cardiopulmonary
February 22, 1996
Confidential
Page 146
{3}
- Medtronic Electromedics, Inc. - Blood Cardioplegia Delivery Systems (K934355)
- Gish Biomedical, Inc. - Single Pass Blood Cardioplegia (SPBC) Systems (K896807/K944219)
- Avecor Cardiovascular - MYOther™ Cardioplegia Delivery Systems (K904171)
- Sorin Biomedical - BCD ADVANCED Blood Cardioplegia System (K925369)
The Medtronic Cardiopulmonary CardioTherm™ Blood 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 - MYOther™ 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 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 - MYOther™ Cardioplegia Delivery Systems (K904171)
- Sorin Biomedical - BCD ADVANCED Blood Cardioplegia System (K925369)
510(k) Notification - CardioTherm™
Medtronic, Inc.
Medtronic Cardiopulmonary
February 22, 1996
Confidential
Page 147
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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.
SPBC
Blood Cardioplegia Systems | Avecor Cardiovascular
MYOtherm™
Cardioplegia Delivery Systems | Sorin Biomedical
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) | 46 | 55 | 83 | 68 | 55 |
| Maximum Flow Rate (LPM) | 1 | 3 | not rated | not rated | .5 |
| Fluid Path Pressure (maximum) | 500 mmHg | not rated | 300 mmHg | 500 mmHg | not rated |
| Water Path Pressure (maximum) | 45 psi | 45 psi | 65psi | 40 psi | 80 psi |
| Technological Characteristics: | | | | | |
| Configuration | Heat Exchanger | Heat Exchanger | Heat Exchanger | Heat Exchanger | Heat Exchanger |
| Heat Exchanger | | | | | |
| Vent Port | Yes | Yes | Yes | Yes | Yes |
| Bubble Chamber | Yes | Yes | Yes | Yes | Yes |
| Temperature Well | Yes | Yes | Yes | Yes | Yes |
| Pressure Monitoring Line | Yes | Yes | Yes | Yes | Yes |
| Patient Delivery Line | Yes | Yes | Yes | Yes | Yes |
| | Various Tubing Sets | Various Tubing Sets | Various Tubing Sets | Various Tubing Sets | Various Tubing Sets |
510(k) Notification - CardioTherm™
Medtronic, Inc.
Medtronic Cardiopulmonary
February 22, 1996
Confidential
Page 148
{5}
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 Biomedical
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. |
10(k) Notification - CardioTherm™
Medtronic, Inc.
Medtronic Cardiopulmonary
February 22, 1996
Confidential
Page 149
