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.

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.

AI/ML Overview

The Medtronic MAXIMA FORTÉ™ Hardshell Venous Reservoir (FT-HSVR) is a medical device intended for use in extracorporeal circulation during cardiopulmonary bypass procedures. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than providing detailed acceptance criteria or a comprehensive study report for standalone performance.

Therefore, many of the requested details regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, and AI-related studies are not available in this document. The document primarily highlights comparative testing against a predicate device to affirm similar safety and effectiveness.

Here's the information that can be extracted or reasonably inferred from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for each test. Instead, it states that "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." This implies the performance of the MAXIMA FORTÉ™ was comparable to or within acceptable variations of the predicate device.

Test Category	Reported Device Performance (Compared to Predicate Device)
Breakthrough Volume Testing	Did not significantly affect safety and effectiveness; substantially equivalent.
Blood Trauma Testing	Did not significantly affect safety and effectiveness; substantially equivalent.
Static Hold-Up Volume Testing	Did not significantly affect safety and effectiveness; substantially equivalent.
Pressurization Testing	Did not significantly affect safety and effectiveness; substantially equivalent.
Filtration Efficiency Testing	Did not significantly affect safety and effectiveness; substantially equivalent.
Dynamic Hold-Up Volume Testing	Did not significantly affect safety and effectiveness; substantially equivalent.
Cleanliness	Did not significantly affect safety and effectiveness; substantially equivalent.
Key Performance Characteristics (Nominal Specifications)	MAXIMA FORTÉ™ Hardshell Venous Reservoir
Duration of Use (Maximum)	6 hours
Blood Flow Rate (Maximum)	Venous: 7 lpm, Cardiotomy: 5 lpm
Cardiotomy Filter	20 micron depth filter
System Volume Capacity	4000 ml
Minimum Operating Level	500 ml

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample sizes used for each of the in-vitro tests (Breakthrough Volume, Blood Trauma, etc.). It only mentions that "in-vitro testing" was performed.

Sample Size (Test Set): Not specified.
Data Provenance: The tests were "in-vitro testing," suggesting laboratory-based studies. The country of origin of the data is not specified, but the company is Medtronic, based in the USA. The data is likely retrospective in the context of the submission, but the tests themselves would have been prospective experiments designed to evaluate the new device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not Applicable. This device is a physical medical component, not an AI or diagnostic system that relies on expert interpretation for ground truth. The "ground truth" for its performance would be established through physical and chemical measurements during in-vitro testing.

4. Adjudication Method for the Test Set

Not Applicable. As mentioned above, this device's performance is assessed through objective in-vitro measurements, not through subjective expert opinions requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not Applicable. This is a physical medical device, not a diagnostic tool or AI system that involves human readers interpreting cases. Therefore, a MRMC comparative effectiveness study is irrelevant to this submission.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, in the sense of a physical device. The "in-vitro testing" described is essentially the standalone performance evaluation of the device itself, without human intervention affecting its inherent filtration, defoaming, or blood-handling characteristics. It's not an "algorithm" in the computational sense, but the device's functional performance was assessed independently.

7. Type of Ground Truth Used

For the in-vitro tests, the "ground truth" would be established by:

Direct Physical Measurements: For parameters like volume capacity, flow rates, and hold-up volumes.
Laboratory Assays: For blood trauma (e.g., hemolysis markers), filtration efficiency (e.g., particle count after filtration), and cleanliness (e.g., particulate analysis).
Engineered Test Conditions: For breakthrough volume and pressurization testing.

8. Sample Size for the Training Set

Not Applicable. This is a physical device, not an AI model that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As no training set is relevant for this type of device, ground truth establishment for a training set is not applicable.

Summary

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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) .

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DESCRIPTION OF DEVICE

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

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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

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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

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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 .

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Attachment I

DEVICE COMPARISONS -- GENERAL CHARACTERISTICS AND NOMINAL SPECIFICATIONS

	Medtronic, Inc.MAXIMA FORTE™Hardshell Venous Reservoir	Medtronic, Inc.MAXIMA®Hardshell Venous Reservoirs	Terumo Medical CorporationCAPIOX SXHardshell Venous Reservoir	Avecor CardiovascularAFFINITY CVR CardiotomyVenous 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 thestorage and filtration of blood inthe extracorporeal circuit duringcardiopulmonary bypass. For useafter open heart surgery to collectautologous blood from the chestand to aseptically return the bloodto the patient for volume replacement.	1315 and MHR-TIn procedures requiring thestorage and filtration of blood inthe extracorporeal circuit duringcardiopulmonary bypass.1315For use after open heart surgery to collectautologous blood from the chestand to aseptically return the bloodto the patient for volume replacement.	To be used during open heart surgicalprocedures requiring cardiopulmonarybypass for periods up to 6 hours.	To be used in an extracorporealperfusion circuit to collect venous andcardiotomy suctioned blood during routinecardiopulmonary bypass procedures up to6 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)	75	76	44	76
FiltrationCardiotomy Filter	20 micron depth filter	20 micron depth filter	20 micron depth filter	30 micron depth filter

510(k) Notification (K961836)Medtronic, IncMedtronic Cardiopulmonary	MAXIMA FORTE™ Hardshell Venous ReservoirAddendum ISeptember 5, 1996	ConfidentialAppendix VRevised - Page 7
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Attachment I

DEVICE COMPARISONS -- GENERAL CHARACTERISTICS AND NOMINAL SPECIFICATIONS

	Medtronic, Inc.MAXIMA FORTE™Hardshell Venous Reservoir	Medtronic, Inc.MAXIMA®Hardshell Venous Reservoirs	Terumo Medical CorporationCAPIOX SXHardshell Venous Reservoir	Avecor CardiovascularAFFINITY CVR CardiotomyVenous Hardshell Reservoir
Technological Characteristics:
Filter/Defoamer AssemblyFilterMaterialTypeDefoamerMaterial	PolyesterDepthPolyurethane Foam	PolyesterDepthPolyurethane Foam	PolyesterDepthPolyurethane Foam	PolyesterDepthPolyurethane Foam
Reservoir
Design and Construction
SystemVolume Capacity (ml)Minimum Operating Level (ml)Filter/Defoamer	Open Circuit4000500Integrated within reservoir	Open Circuit3800300Integrated within reservoir	Open Circuit3000100Integrated within reservoir	Open Circuit4000500Integrated within reservoir
Materials	Polycarbonate	Polycarbonate	Polycarbonate	Not stated
Ports/Inlets
Venous Blood InletBlood OutletCardiotomy Suction Inlet/PortsPrime PortsLuer and Vent PortsRotatable Turret/Venous InletSample Manifold - 3 Gang	YesYesYesYesYesYesYes	YesYesYesYesYesNoNo	YesYesYesYesYesYesYes	YesYesYesYesYesYesYes

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

Confidential
Appendix V
Page 8

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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 VenousReservoir May Be Coupled	Yes	Yes	Yes	Yes
Hardshell Venous ReservoirMode of Operation	To collect and defoam venous bloodwhile cardiotomy blood is collected,defoamed and filtered prior to mixingwith the venous blood. The defoamed/filtered blood is then returned to thepatient.	To collect and defoam venous bloodwhile cardiotomy blood is collected,defoamed and filtered prior to mixingwith the venous blood. The defoamed/filtered blood is then returned to thepatient.	To collect and defoam venous bloodwhile cardiotomy blood is collected,defoamed and filtered prior to mixingwith the venous blood. The defoamed/filtered blood is then returned to thepatient.	To collect and defoam venous bloodwhile cardiotomy blood is collected,defoamed and filtered prior to mixingwith the venous blood. The defoamed/filtered blood is then returned to thepatient.

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

Confidential Appendix V Page 9

April 29, 1996

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.