The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures.

Device Description

The Affinity Fusion® Cardiotomy/Venous Reservoir (CVR) with Balance® Biosurface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures.

The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface 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 blood volume replacement. The inside of the jar is coated with Balance Biosurface to reduce platelet activation and adhesion and preserve platelet function. This product is single-use, nontoxic, nonpyrogenic, supplied STERILE in individual packaging. The Affinity Fusion Cardiotomy/Venous Reservoir is sterilized by ethylene oxide.

AI/ML Overview

The provided document describes the Medtronic Affinity Fusion® Cardiotomy/Venous Reservoir with Balance® Biosurface (K122914) which is a Class II device intended for use in extracorporeal perfusion circuits. The submission is a 510(k) premarket notification, which establishes substantial equivalence to a predicate device rather than requiring a full clinical trial for novel device approval.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative acceptance criteria with corresponding performance metrics in a readily extractable table format. Instead, it lists various performance tests conducted. The implicit acceptance criterion for this 510(k) submission is that the device performs functionally and safely when compared to the predicate device, or adheres to established industry standards for such performance characteristics.

Since specific numerical targets and results are not provided for each test, a direct comparison table cannot be generated from the given text. However, the list of performance tests indicates the areas where the device's performance was evaluated to ensure safety and effectiveness.

Key Performance Tests Conducted (implicit acceptance criteria is equivalence/satisfactory performance):

Performance Test	Reported Device Performance
Blood Damage	Not explicitly quantified, assumed to be acceptable/equivalent to predicate.
Pressure Integrity	Not explicitly quantified, assumed to be acceptable/equivalent to predicate.
Pressure Drop	Not explicitly quantified, assumed to be acceptable/equivalent to predicate.
Leak Testing	Not explicitly quantified, assumed to be acceptable/equivalent to predicate.
Defoaming	Not explicitly quantified, assumed to be acceptable/equivalent to predicate.
Cardiotomy Filtration Efficiency	Not explicitly quantified, assumed to be acceptable/equivalent to predicate.
Burst Pressure	Not explicitly quantified, assumed to be acceptable/equivalent to predicate.
Coating Integrity	Not explicitly quantified, assumed to be acceptable/equivalent to predicate.
Temperature Probe Accuracy	Not explicitly quantified, assumed to be acceptable/equivalent to predicate.
Positive and negative pressure check valve function	Not explicitly quantified, assumed to be acceptable/equivalent to predicate.
Minimum operating level	Not explicitly quantified, assumed to be acceptable/equivalent to predicate.
Level sensor pull-off force	Not explicitly quantified, assumed to be acceptable/equivalent to predicate.
Dynamic holdup	Not explicitly quantified, assumed to be acceptable/equivalent to predicate.
Reliable fluid delivery	Not explicitly quantified, assumed to be acceptable/equivalent to predicate.
Venous inlet prime	Not explicitly quantified, assumed to be acceptable/equivalent to predicate.
Cap particulate shedding	Not explicitly quantified, assumed to be acceptable/equivalent to predicate.
Device Particulate Shedding	Not explicitly quantified, assumed to be acceptable/equivalent to predicate.

2. Sample Size for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify the sample sizes used for each of the pre-clinical bench tests. The tests themselves are generally performed on a defined number of device units or components to ensure statistical relevance, but these details are not present in the summary.
Data Provenance: The studies were pre-clinical bench testing.
- Country of Origin: Not specified, but likely performed in the facilities of Medtronic, Inc. (Minneapolis, MN, USA, as per applicant address).
- Retrospective or Prospective: These were prospective bench tests conducted specifically for this submission.

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

This information is not applicable and not provided in the context of this 510(k) submission. Bench testing for a device like a cardiotomy/venous reservoir does not typically involve human experts establishing "ground truth" through interpretation. The "ground truth" for such tests is derived from quantifiable physical or chemical measurements performed by trained laboratory personnel following established protocols.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or image-based diagnostic evaluations where human interpretation or consensus is required. Bench tests rely on objective measurements and predefined pass/fail criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical testing was not required to establish substantial equivalence with the predicate devices." Therefore, there is no discussion of human reader improvement with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This device is a physical medical device (a reservoir), not an AI/software algorithm, so "standalone algorithm performance" is not relevant here.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests conducted (e.g., Blood Damage, Pressure Integrity, Leak Testing, etc.) would be established through objective physical and chemical measurements and adherence to validated engineering and materials science principles. It is based on the inherent physical properties and functional performance of the device under controlled laboratory conditions, as measured against predefined specifications or comparison to the predicate.

8. The Sample Size for the Training Set

This information is not applicable and not provided. This device is a physical medical device, not an AI/machine learning model, so "training set" is not a relevant concept.

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

This information is not applicable and not provided for the same reason as point 8.

Summary

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K122914

510(k) Summary of Safety and Effectiveness

Date Prepared:

September 21, 2012

Applicant:

Medtronic, Inc. Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428 Establish Registration Number: 2184009

Contact Person:

Julia A. Nelson Principal Regulatory Affairs Specialist Phone: (763) 514-9844 (763) 367-8361 Fax: E-mail:julia.a.nelson@medtronic.com

Trade Name:

Common Name: Classification Name: Classification:

Affinity Fusion® Cardiotomy/Venous Reservoir with Balance® Biosurface Cardiotomy Venous Reservoir Cardiopulmonary bypass blood reservoir Class II, 21 870.4400

Product Code:

DTN

Name of Predicate Device: Affinity® NT Cardiotomy/Venous Reservoir with Filter Model 540 (K936003)

Device Description:

JAN 0 9 2013

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Intended Use:

Contraindications:

Do not use this device for any purpose other than indicated.

Do not use if air leaks are observed during priming and/or operation; this may result in air embolism to the patient and/or fluid loss.

The Affinity Fusion Cardiotomy/Venous Reservoir is contraindicated for use in postoperative chest drainage and autotransfusion procedures when:

There is an air leak in the lung or gross perforations to the chest wall exist.
Pericardial, mediastinal, pulmonary or systemic infection or malignancy is present. .
. Gross contamination or a lymphatic failure is present or suspected.
Suctioned blood is obtained from a site where a topical hemostatic agent has been used. .
. The chest is open and vacuum is applied.
. Protamine has been administered prior to the reservoir being removed from the bypass circuit.
. The patient is returned to surgery for any reason.
. Vented chest tubes not incorporating vent flow regulation, such as a stopcock, are used. Caution: An assessment should be made of the quality and suitability of the blood that has been collected before re-infusion begins.

Comparison to Predicate Devices:

A comparison of Affinity Fusion® Cardiotomy/Venous Reservoir with Balance® Biosurface to the predicate device indicates the following similarities:

. Same intended use
. Same technological characteristics
Same operating principle .
Same design features .
Similar materials with the exception of the housing material of the device. The Affinity . Fusion CVR housing is made of a Bisphenol A-free (BPA-free) copolyester material, which differs from the polycarbonate material used in the predicate device.

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. Same shelf life

Summary of Performance Data

Pre-clinical bench testing was used to verify the performance characteristics of this device. Clinical testing was not required to establish substantial equivalence with the predicate devices.

The following performance tests were conducted:

. Blood Damage
. Pressure Integrity
Pressure Drop .
Leak Testing .
· · Defoaming
Cardiotomy Filtration Efficiency .
Burst Pressure .
. Coating Integrity
. Temperature Probe Accuracy
Positive and negative pressure check valve function
Minimum operating level
Level sensor pull-off force ●
. Dynamic holdup
Reliable fluid delivery .
Venous inlet prime ●
Cap particulate shedding ●
Device Particulate Shedding .

Conclusion:

The data included in this submission is sufficient to provide reasonable assurance of the safety and effectiveness of the device and the Affinity Fusion® Cardiotomy/Venous Reservoir with Balance® Biosurface is substantially equivalent to the legally marketed predicate device, the Affinity® NT Cardiotomy/Venous Reservoir with Filter Model 540 (K936003).

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

JAN 0 9 2013

Medtronic CardioVascular c/o Julia A. Nelson, MS, RAC Principal Regulatory Affairs Specialist 8200 Coral Street NE Mailstop MVS83 Mounds View, MN 55112

Re: K122914

Trade Name: Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface Model BB841 Regulation Number: 21 CFR 870.4400 Regulation Name: Cardiopulmonary Bypass Blood Reservoir Regulatory Class: Class II (two) Product Code: DTN Dated: January 2, 2013 Received: January 3, 2013

Dear Ms. Nelson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be

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Page 2 - Julia A. Nelson, MS, RAC

found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Matthew G. Hillebrenner

for-

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

4122914 510(k) Number (if known):

Device Name:

Affinity Fusion® Cardiotomy/Venous Reservoir with Balance® Biosurface

Indications for Use:

Prescription Use	X
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number_k122914

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.