Predicate Devices

K933496, K891230, K932254, K922799, K936003

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical components and filtration capabilities of a blood reservoir, with no mention of AI or ML technologies.

Therapeutic

No
This device is a blood storage and filtration system used during cardiopulmonary bypass and for autotransfusion, not a device directly applying treatment to a patient or affecting the structure or function of the body.

Diagnostic

No

The device is a Hardshell Venous Reservoir used for blood storage and filtration during cardiopulmonary bypass and for blood collection and autotransfusion. Its function is to manage blood physically, not to diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly details a physical, single-use, disposable hardware device made of polycarbonate and other materials, designed for filtering and storing blood. There is no mention of software as a component or the primary function.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes a device used in an extracorporeal circuit during cardiopulmonary bypass and for collecting and returning blood to the patient. This is a therapeutic and supportive function performed directly on the patient's blood outside the body, but not for the purpose of diagnosing a condition.
Device Description: The description details a device for collecting, defoaming, and filtering blood. These are physical processes applied to the blood, not analytical tests performed on a sample to gain diagnostic information.
Lack of Diagnostic Purpose: There is no mention of analyzing blood components, detecting markers, or providing information for diagnosis.

IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is entirely focused on managing blood flow and quality during and after surgery, which is a therapeutic and supportive intervention.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The MAXIMA FORTÉ™ Hardshell Venous Reservoir is intended for use in procedures requiring the storage and filtration of blood in the extracorporeal circuit during cardiopulmonary bypass. The MAXIMA FORTE™ Hardshell Venous Reservoir is also intended for use after open heart surgery to collect autologous blood from the chest and to aseptically return the blood to the patient for volume replacement.

Product codes

Not Found

Device Description

The Medtronic MAXIMA FORTÉ™ Hardshell Venous Reservoir is a single use, disposable, sterile and nonpyrogenic fluid path device. Venous blood is collected and defoamed while cardiotomy blood is collected, defoamed and filtered prior to mixing with the venous blood.

The Medtronic MAXIMA FORTE™ Hardshell Venous Reservoir consists of a polycarbonate housing which incorporates a filter/defoamer assembly. The filter/defoamer assembly, which consists of polyurethane defoamers, a 20 micron (nominal) polyester filter and a styrene frame, is designed to defoam and filter cardiotomy blood and defoam venous blood.

The maximum capacity of the MAXIMA FORTE™ Hardshell Venous Reservoir is approximately 4,000 ml. The reservoir housing tapers toward the blood outlet port. The hardshell venous reservoir operates at venous blood flow rates from 1 to 7 liters per minute and cardiotomy blood flow rates from 1 to 5 liters per minute. Following intraoperative use, these reservoirs are used for the collection and autotransfusion of shed blood.

Venous blood enters the top of the reservoir through the venous inlet port. The venous blood flows downward through a central tube to the bottom of the filter/defoamer frame where it passes through the venous defoamer and outer defoamer into the main chamber of the reservoir.

Cardiotomy blood enters through any of the six (6) inlet cardiotomy ports. The intrathoracic suctioned cardiotomy blood flows downward through the center chamber of the cardiotomy filter/defoamer assembly, and passes through the defoamers and filter into the main chamber of the reservoir. The center chamber is separate from and surrounds the central tube through which the venous blood flows.

The venous and cardiotomy blood are mixed outside the filter/defoamer assembly, in the main chamber of the reservoir and in the low-volume, tapered arca at the bottom of the reservoir. The filtered, defoamed and mixed blood then exits through the outlet port at the reservoir.

The lid of the MAXIMA FORTE" Hardshell Venous Reservoir contains various access ports, which include:

one (1) 1/2" venous inlet port with temperature probe and luer port .
six (6) cardiotomv suction inlet ports.
- three (3) 1/4"
- two (2) - 3/8"
- one (1) combination 1/4-3/8"
. two (2) filtered lucr ports,
. two (2) unfiltered lucr ports,
. one (1) recirculation inlet port, and
. one (1) vent port

The venous inlet port and cardiotomy inlet ports are mounted on a rotatable turret that allows the clinician optimal positioning during set-up and use. In addition, for case of use the venous inlet 1/2" port may be converted to a 3/8" port by using a molded adaptor. The reservoir lid also has a;

three-way stopcock sampling manifold, onc-way check valve, and venous blue)/arterial (red) . coiled sampling lines,
a 3/8" recirculation line, and ●
a built-in two-way pressure relief valve that is designed to relieve either high positive or low . negative pressures.

A 3/8" blood outlet port is located at the bottom of the device.

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

The in-vitro testing demonstrated that when compared to a predicate device the MAXIMA FORTÉ" Hardshell Venous Reservoirs do not significantly affect safety and effectiveness and are substantially equivalent to other commercially distributed hardshell venous reservoirs. The testing included analysis of:

Breakthrough Volume Testing .
. Blood Trauma Testing
Static Hold-Up Volume Testing .
Pressurization Testing .
Filtration Efficiency Testing .
Dynamic Hold-Up Volume Testing ●
Cleanliness .

Key Metrics

Not Found

Predicate Device(s)

Medtronic MAXIMA® Hardshell Venous Reservoir (K933496), Medtronic MAXIMA® Filtered Hardshell Venous Reservoir (K891230 and K932254), Terumo Medical Corporation CAPIOX SX Hardshell Venous Reservoir (K922799), Avecor Cardiovascular AFFINITY CVR Cardiotomy/Venous Hardshell Reservoir (K936003)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.4400 Cardiopulmonary bypass blood reservoir.

(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Summary

0

NOV - 1 1996

(Summary of Information Respecting Safety and Effectiveness) K961836

COMPANY AND CONTACT PERSON

Medtronic, Inc. Cardiopulmonary Division 4633 E. La Palma Avenue Anaheim, CA 92807 714-779-3700 (phone) 714-779-7964 (fax)

Debra J. Kridner, Manager Regulatory Affairs

DEVICE NAME

MAXIMA FORTÉ™ Hardshell Venous Reservoir (FT-HSVR)

CLASSIFICATION NAME

Reservoir, Blood, Cardiopulmonary Bypass

NAME OF PREDICATE OR LEGALLY MARKETED DEVICE

Medtronic MAXIMA® Hardshell Venous Reservoir (K933496) .
Medtronic MAXIMA® Filtered Hardshell Venous Reservoir (K891230 and K932254) .
. Terumo Medical Corporation CAPIOX SX Hardshell Venous Reservoir (K922799)
Avecor Cardiovascular AFFINITY CVR Cardiotomy/Venous Hardshell Reservoir (K936003) .

1

DESCRIPTION OF DEVICE

The Medtronic MAXIMA FORTÉ™ Hardshell Venous Reservoir is a single use, disposable, sterile and nonpyrogenic fluid path device. Venous blood is collected and defoamed while cardiotomy blood is collected, defoamed and filtered prior to mixing with the venous blood.

The Medtronic MAXIMA FORTE™ Hardshell Venous Reservoir consists of a polycarbonate housing which incorporates a filter/defoamer assembly. The filter/defoamer assembly, which consists of polyurethane defoamers, a 20 micron (nominal) polyester filter and a styrene frame, is designed to defoam and filter cardiotomy blood and defoam venous blood.

The maximum capacity of the MAXIMA FORTE™ Hardshell Venous Reservoir is approximately 4,000 ml. The reservoir housing tapers toward the blood outlet port. The hardshell venous reservoir operates at venous blood flow rates from 1 to 7 liters per minute and cardiotomy blood flow rates from 1 to 5 liters per minute. Following intraoperative use, these reservoirs are used for the collection and autotransfusion of shed blood.

Venous Blood Flow

Venous blood enters the top of the reservoir through the venous inlet port. The venous blood flows downward through a central tube to the bottom of the filter/defoamer frame where it passes through the venous defoamer and outer defoamer into the main chamber of the reservoir.

Cardiotomy Blood Flow

Cardiotomy blood enters through any of the six (6) inlet cardiotomy ports. The intrathoracic suctioned cardiotomy blood flows downward through the center chamber of the cardiotomy filter/defoamer assembly, and passes through the defoamers and filter into the main chamber of the reservoir. The center chamber is separate from and surrounds the central tube through which the venous blood flows.

The venous and cardiotomy blood are mixed outside the filter/defoamer assembly, in the main chamber of the reservoir and in the low-volume, tapered arca at the bottom of the reservoir. The filtered, defoamed and mixed blood then exits through the outlet port at the reservoir.

The lid of the MAXIMA FORTE" Hardshell Venous Reservoir contains various access ports, which include:

one (1) 1/2" venous inlet port with temperature probe and luer port .
six (6) cardiotomv suction inlet ports.
- three (3) 1/4"
- two (2) - 3/8"
- one (1) combination 1/4-3/8"
. two (2) filtered lucr ports,
. two (2) unfiltered lucr ports,
. one (1) recirculation inlet port, and
. one (1) vent port

2

The venous inlet port and cardiotomy inlet ports are mounted on a rotatable turret that allows the clinician optimal positioning during set-up and use. In addition, for case of use the venous inlet 1/2" port may be converted to a 3/8" port by using a molded adaptor. The reservoir lid also has a;

three-way stopcock sampling manifold, onc-way check valve, and venous blue)/arterial (red) . coiled sampling lines,
a 3/8" recirculation line, and ●
a built-in two-way pressure relief valve that is designed to relieve either high positive or low . negative pressures.

A 3/8" blood outlet port is located at the bottom of the device.

STATEMENT OF INTENDED USE

The MAXIMA FORTÉ™ Hardshell Venous Reservoir is intended for use in procedures requiring the storage and filtration of blood in the extracorporeal circuit during cardiopulmonary bypass. The MAXIMA FORTE™ Hardshell Venous Reservoir is also intended for use after open heart surgery to collect autologous blood from the chest and to aseptically return the blood to the patient for volume replacement.

STATEMENT OF INTENDED USE OF PREDICATE/MARKETED DEVICES

Medtronic MAXIMA® Hardshell Venous Reservoir (MHR-T) - in procedures requiring the storage and filtration of blood in the extracorporeal circuit during cardiopulmonary bypass.

Medtronic MAXIMA® Filtered Hardshell Venous Reservoir (1315) - in procedures requiring the storage and filtration of blood in the extracorporeal circuit during cardiopulmonary bypass and for use after open heart surgery to collect autologous blood from the chest and to aseptically return the blood to the patient for volume replacement..

Terumo Medical Corporation CAPIOX SX Hardshell Venous Reservoir - to be used during open heart surgical procedures requiring cardiopulmonary bypass for periods up to 6 hours.

Avecor Cardiovascular AFFINITY CVR Cardiotomy/Venous Hardshell Reservoir - To be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.

STATEMENT OF TECHNOLOGICAL CHARACTERISTICS COMPARISON

A table comparing the intended use and technological characteristics of the Medtronic Cardiopulmonary MAXIMA FORTE™ Hardshell Venous Reservoirs with the four noted substantially equivalent devices is provided in Attachment 1.

510(k) Notification	MAXIMA FORTE™ Hardshell Venous Reservoir	Confidential
Medtronic, Inc.	Appendix V
Medtronic Cardiopulmonary	April 29, 1996	Page 4

3

A table comparing the intended use and technological characteristics of the Medtronic Cardiopulmonary MAXIMA FORTE™ Hardshell Venous Reservoirs with the four noted substantially equivalent devices is provided in Attachment I.

DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The Medtronic Cardiopulmonary MAXIMA FORTÉ™ Hardshell Venous Reservoirs are substantially equivalent to other hardshell venous reservors currently in commercial distribution. These predicate/marketed devices include:

Medtronic MAXIMA® Hardshell Venous Reservoir (K933496) .
Medtronic MAXIMA® Filtered Hardshell Venous Reservoir (K891230 and K932254) .
. Terumo Medical Corporation CAPIOX SX Hardshell Venous Reservoir (K922799)
Avecor Cardiovascular AFFINITY CVR Cardiotomy/Venous Hardshell Reservoir . (K936003)

The Medtronic Cardiopulmonary MAXIMA FORTÉ™ Hardshell Venous Reservoirs have an intended use which is substantially equivalent to other hardshell venous reservoirs currently in commercial distribution These predicate/marketed devices include:

Medtronic MAXIMA® Hardshell Venous Reservoir (K933496) indicated for only . intraoperative use.
Medtronic MAXIMA® Filtered Hardshell Venous Reservor (K891230 and K932254) . indicated for intraoperative and postoperative use.
. Terumo Medical Corporation CAPIOX SX Hardshell Venous Reservoir (K922799) - indicated for only intraoperative use.
. Avecor Cardiovascular AFFINITY CVR Cardiotomy/Venous Hardshell Reservoir (K936003) - indicated for only intraoperative use.

The Medtronic Cardiopulmonary MAXIMA FORTÉ™ Hardshell Venous Reservoirs have technological characteristics which are substantially equivalent to other hardshell venous reservoirs currently in commercial distribution. These predicate/marketed devices include:

. Medtronic MAXIMA® Hardshell Venous Reservoir (K933496)
Medtronic MAXIMA® Filtered Hardshell Venous Reservoir (K891230 and K932254) .
Terumo Medical Corporation CAPIOX SX Hardshell Venous Reservoir (K922799)
Avecor Cardiovascular AFFINITY CVR Cardiotomy/Venous Hardshell Reservoir . (K936003)

The design, construction, materials and nominal specifications of the Medtronic Cardiopulmonary MAXIMA FORTE™ Hardshell Venous Reservoirs are either identical or substantially equivalent to other hardshell venous reservoirs currently in commercial distribution. These predicate/marketed devices include:

MAXIMA FORTE™ Hardshell Venous Reservoir Addendum I September 5, 1996

4

Medtronic MAXIMA® Hardshell Venous Reservoir (K K933496) .
Medtronic MAXIMA® Filtered Hardshell Venous Reservoir (K891230 and K932254) .
Terumo Medical Corporation CAPIOX SX Hardshell Venous Reservoir (K922799) .
Avecor Cardiovascular AFFINITY CVR Cardiotomy/Venous Hardshell Reservoir . (K936003)

In addition, the in-vitro testing demonstrated that when compared to a predicate device the MAXIMA FORTÉ" Hardshell Venous Reservoirs do not significantly affect safety and effectiveness and are substantially equivalent to other commercially distributed hardshell venous reservoirs. The testing included analysis of:

Breakthrough Volume Testing .
. Blood Trauma Testing
Static Hold-Up Volume Testing .
Pressurization Testing .
Filtration Efficiency Testing .
Dynamic Hold-Up Volume Testing ●
Cleanliness .

5

Attachment I

DEVICE COMPARISONS -- GENERAL CHARACTERISTICS AND NOMINAL SPECIFICATIONS

| | Medtronic, Inc.
MAXIMA FORTE™
Hardshell Venous Reservoir | Medtronic, Inc.
MAXIMA®
Hardshell Venous Reservoirs | Terumo Medical Corporation
CAPIOX SX
Hardshell Venous Reservoir | Avecor Cardiovascular
AFFINITY CVR Cardiotomy
Venous Hardshell Reservoir |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number: | This submission | K891230 and K932254
K933296 | K922799 | K936003 |
| Catalog Number(s): | FT-HSVR | 1315 (K891230 and K932254)
MHR-T (K933496) | CX*SXXX | CVR |
| Intended Use: | In procedures requiring the
storage and filtration of blood in
the extracorporeal circuit during
cardiopulmonary bypass. For use
after open heart surgery to collect
autologous blood from the chest
and to aseptically return the blood
to the patient for volume replacement. | 1315 and MHR-T
In procedures requiring the
storage and filtration of blood in
the extracorporeal circuit during
cardiopulmonary bypass.
1315
For use after open heart surgery to collect
autologous blood from the chest
and to aseptically return the blood
to the patient for volume replacement. | To be used during open heart surgical
procedures requiring cardiopulmonary
bypass for periods up to 6 hours. | To be used in an extracorporeal
perfusion circuit to collect venous and
cardiotomy suctioned blood during routine
cardiopulmonary bypass procedures up to
6 hours in duration. |
| Performance Characteristics: | | | | |
| Duration of Use (Maximum) | 6 hours | 6 hours | 6 hours | 6 hours |
| Blood Flow Rate (Maximum)
Venous (lpm)
Cardiotomy (lpm) | 7
5 | 7
6 | 4
4 | 7
6 |
| Filtration
Cardiotomy Filter | 20 micron depth filter | 20 micron depth filter | 20 micron depth filter | 30 micron depth filter |

| 510(k) Notification (K961836)
Medtronic, Inc
Medtronic Cardiopulmonary | MAXIMA FORTE™ Hardshell Venous Reservoir
Addendum I
September 5, 1996 | Confidential
Appendix V
Revised - Page 7 |

------------------------------------------------------------------------------	-----------------------------------------------------------------------------	------------------------------------------------

6

Attachment I

DEVICE COMPARISONS -- GENERAL CHARACTERISTICS AND NOMINAL SPECIFICATIONS

| | Medtronic, Inc.
MAXIMA FORTE™
Hardshell Venous Reservoir | Medtronic, Inc.
MAXIMA®
Hardshell Venous Reservoirs | Terumo Medical Corporation
CAPIOX SX
Hardshell Venous Reservoir | Avecor Cardiovascular
AFFINITY CVR Cardiotomy
Venous Hardshell Reservoir |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|------------------------------------------------------------|-----------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Technological Characteristics: | | | | |
| Filter/Defoamer Assembly
Filter
Material
Type
Defoamer
Material | Polyester
Depth
Polyurethane Foam | Polyester
Depth
Polyurethane Foam | Polyester
Depth
Polyurethane Foam | Polyester
Depth
Polyurethane Foam |
| Reservoir | | | | |
| Design and Construction | | | | |
| System
Volume Capacity (ml)
Minimum Operating Level (ml)
Filter/Defoamer | Open Circuit
4000
500
Integrated within reservoir | Open Circuit
3800
300
Integrated within reservoir | Open Circuit
3000
100
Integrated within reservoir | Open Circuit
4000
500
Integrated within reservoir |
| Materials | Polycarbonate | Polycarbonate | Polycarbonate | Not stated |
| Ports/Inlets | | | | |
| Venous Blood Inlet
Blood Outlet
Cardiotomy Suction Inlet/Ports
Prime Ports
Luer and Vent Ports
Rotatable Turret/Venous Inlet
Sample Manifold - 3 Gang | Yes
Yes
Yes
Yes
Yes
Yes
Yes | Yes
Yes
Yes
Yes
Yes
No
No | Yes
Yes
Yes
Yes
Yes
Yes
Yes | Yes
Yes
Yes
Yes
Yes
Yes
Yes |

510(k) Notification	MAXIMA FORTE™ Hardshell Venous Reservoir
Medtronic, Inc.
Medtronic Cardiopulmonary	April 29, 1996

Confidential
Appendix V
Page 8

7

Attachment I

DEVICE COMPARISONS -- GENERAL CHARACTERISTICS AND NOMINAL SPECIFICATIONS

	Medtronic, Inc.	Medtronic, Inc.	Terumo Medical Corporation	Avecor Cardiovascular
	MAXIMA FORTE™	MAXIMA®	CAPIOX SX	AFFINITY CVR Cardiotomy
	Hardshell Venous Reservoir	Hardshell Venous Reservoirs	Hardshell Venous Reservoir	Venous Hardshell Reservoir
Technological Characteristics:
Oxygenator/Hardshell Venous
Reservoir May Be Coupled	Yes	Yes	Yes	Yes
Hardshell Venous Reservoir
Mode of Operation	To collect and defoam venous blood
while cardiotomy blood is collected,
defoamed and filtered prior to mixing
with the venous blood. The defoamed/
filtered blood is then returned to the
patient.	To collect and defoam venous blood
while cardiotomy blood is collected,
defoamed and filtered prior to mixing
with the venous blood. The defoamed/
filtered blood is then returned to the
patient.	To collect and defoam venous blood
while cardiotomy blood is collected,
defoamed and filtered prior to mixing
with the venous blood. The defoamed/
filtered blood is then returned to the
patient.	To collect and defoam venous blood
while cardiotomy blood is collected,
defoamed and filtered prior to mixing
with the venous blood. The defoamed/
filtered blood is then returned to the
patient.

510(k) Notification Medtronic, Inc. Medtronic Cardiopulmonary MAXIMA FORTE™ Hardshell Venous Reservoir

Confidential Appendix V Page 9

April 29, 1996