The venous hardshell cardiotomy reservoir is used to collect, store and filter blood in extracorporeal circulation, in cardiopulmonary bypass operations on pediatric patients for up to 6 hours. The reservoir can also be employed postoperatively as drainage and autotransfusion reservoir (e.g., for thorax drainage) to return the autologous blood to the patient which was removed from the thorax for the volume exchange.

Device Description

The Neonatal and Pediatric Venous Hardshell Cardiotomy Reservoirs with and without SOFTLINE Coating are developed for surgical procedures requiring cardiopulmonary bypass for pediatric patients. They are used as a blood buffer in the extracorporeal circuit and are used as a collecting and defoaming device for sucked blood. The device is supplied sterile and non-pryogenic.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical device modification, specifically for Neonatal and Pediatric Venous Hardshell Cardiotomy Reservoirs. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device's absolute safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval) submission.

Therefore, the document does not contain the acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/ML medical device submission. The provided information details design verification tests, which are engineering-focused assessments, not clinical performance studies with acceptance criteria as typically understood in the context of AI/ML performance metrics (e.g., sensitivity, specificity).

Here's why the requested information cannot be fully provided from this document:

Device Type: The device is a "Venous Hardshell Cardiotomy Reservoir," which is a physical medical device used in cardiopulmonary bypass operations, not an AI/ML algorithm.
Study Type: The submission is a 510(k) for a "device modification," which relies on demonstrating substantial equivalence through non-clinical (i.e., laboratory/benchtop) design verification tests rather than clinical studies.
Focus: The focus of the 510(k) is on the safety and performance of the modified physical components (defoamer coating, flow rates, volumes), not on the diagnostic or predictive accuracy of an algorithm.

However, I can extract the relevant information regarding the design verification tests performed, which serve a similar function to "proving the device meets acceptance criteria" within the context of hardware modifications:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with numerical targets for each test, nor does it provide a detailed "reported device performance" table with precise quantitative results. Instead, it indicates that the tests were performed to show the modified device is "as safe and effective as the originally cleared devices" and that the "evaluation and test results do not show any kind of risk potential."

Test Performed	Implied Acceptance Criteria (Based on "as safe and effective as originally cleared devices" and "no risk potential")	Reported Device Performance
Air handling	Device effectively handles air to prevent patient harm; performance is equivalent to the predicate device.	Evaluation and test results "do not show any kind of risk potential for the health or security of the patient or user." "Safe and effective for their intended use."
Defoaming	Device effectively removes foam from blood; performance is equivalent to the predicate device.	Evaluation and test results "do not show any kind of risk potential for the health or security of the patient or user." "Safe and effective for their intended use."
Break Through Volume, cardiotomy part and venous part	The volume of blood required to "break through" the defoaming mechanism meets established safety and performance thresholds, equivalent to the predicate.	Evaluation and test results "do not show any kind of risk potential for the health or security of the patient or user." "Safe and effective for their intended use."
Dynamic Priming Volume, cardiotomy part	The volume of blood needed to fill the cardiotomy part during dynamic operation meets established safety and performance thresholds, equivalent to the predicate.	Evaluation and test results "do not show any kind of risk potential for the health or security of the patient or user." "Safe and effective for their intended use."
Functional Test, cardiotomy part	The cardiotomy part operates as intended across its specified functionality, equivalent to the predicate.	Evaluation and test results "do not show any kind of risk potential for the health or security of the patient or user." "Safe and effective for their intended use."
BioBurden	Level of microbial contamination meets sterility requirements.	Evaluation and test results "do not show any kind of risk potential for the health or security of the patient or user." "Safe and effective for their intended use."
LAL	Endotoxin levels meet safety requirements.	Evaluation and test results "do not show any kind of risk potential for the health or security of the patient or user." "Safe and effective for their intended use."
Biocompatibility	Material compatibility with blood and tissues meets safety standards.	Evaluation and test results "do not show any kind of risk potential for the health or security of the patient or user." "Safe and effective for their intended use."

Regarding the specific questions tailored for AI/ML device studies:

2. Sample size used for the test set and the data provenance: Not applicable. This is a physical device. The "tests" were design verification tests (benchtop/laboratory), not clinical studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's performance often comes from engineering specifications, established testing protocols, and physical measurements, rather than expert consensus on medical images or clinical outcomes.

4. Adjudication method for the test set: Not applicable. There is no mention of expert review or adjudication in the context of these engineering design verification tests.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical device, not an AI/ML algorithm used for image interpretation or diagnosis by human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the design verification tests listed, the "ground truth" would be established by predefined engineering specifications, performance standards, biological safety standards (e.g., ISO standards for biocompatibility), and comparison to the predicate device's known performance characteristics.

8. The sample size for the training set: Not applicable. This device does not involve machine learning and therefore has no training set.

9. How the ground truth for the training set was established: Not applicable. This device does not involve machine learning and therefore has no training set.

In conclusion: The provided document is for a traditional medical device modification (physical product) and uses design verification testing to demonstrate substantial equivalence, not a clinical study to establish performance metrics for an AI/ML device. Therefore, many of the requested fields are not applicable to this submission type.

Summary

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JUL 0 7 2014 Premarket Notification Special 510(k) - Device Modification; Modified Neonatal and Pediatric Venous Hardshell Cardiotomy Reservoirs with and without SOFTLINE Coating

510(k) Summary

[As required by 21 CFR 807.92(c)]

Submitter Information

MAQUET Cardiopulmonary AG

Kehler Strasse 31 76437 Rastatt

Germany

Contact Person:

Katrin Schwenkglenks

Phone: 011 49 7471 9973 151

011 49 7471 9973 8667 Fax:

e-mail: Katrin.Schwenkglenks@maquet.com

Summary Date:

May 23, 2014

Device Name

Proprietary name: Neontal Venous Hardshell Cardiotomy Reservoir with and without SOFTLINE Coting Pediatric Venous Hardshell Cardiotomy Reservoir with and without SOFTLINE Coating

Common/Usual name:Venous Hardshell Reservoir

Classification: Class II

CFR Sections: 21 CFR 870.4400; 21 CFR 870.4230; 21 CFR 870.4270

Predicate Device: Neonatal and Pediatric Venous Hardshell Cardiotomy Reservoirs with and without SOFTLINE Coating (K102919).

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Premarket Notification Special 510(k) - Device Modification;

Modified Neonatal and Pediatric Venous Hardshell Cardiotomy Reservoirs with and without SOFTLINE Coating

Device Modification

ﺘﺮﺗ

The modifications subject of this submission comprise the material change of the defoamer coating from ASC to MACE coating combined with a change of the specifications - the increase of the maximum blood flow of the cardiotomy part and thus an increase in the dynamic hold-up volume of the cardiotomy part, as well as a change of the specifications of the break through volume of the venous and of the cardiotomy part.

Device Description

The Neonatal and Pediatric Venous Harshell Cardiotomy Reservoirs with and without SOFTLINE Coating are developed for surgical procedures requiring cardiopulmonary bypass for pediatric patients. They are used as a blood buffer in the extracorporeal circuit and are used as a collecting and defoaming device for sucked blood. The device is supplied sterileand non-pryogenic.

Intended Use

The venous hardshell cardiotomy reservoir is used to collect, store and filter blood in extracorporeal circulation, in cardiopulmonary bypass operations on pediatric for up to 6 hours.

The reservoir can also be employed postoperatively as drainàge and autotransfusion reservoir (e.g., for thorax drainage) to return the autologous blood to the patient which was removed from the thorax for the volume exchange.

Comparison of Technological Characteristics to Predicate Device

The modified Venous Hardshell Cardiotomy Reservoirs have the following similarities to the Venous Hardshell Cardiotomy Reservoirs, which previously received 510(k) clearance:

have the same intended use,
use the same operating principle,

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Premarket Notification Special 510(k) - Device Modification: Modified Neonatal and Pediatric Venous Hardshell Cardiotomy Reservoirs with and without SOFTLINE Coating

. incorporate the same reservoir design,
have the same shelf life, .
. are packaged and sterilized using the same processes and
have the same SOFTLINE Coating

There is no change in the fundamental scientific technology and the product change does not affect the intended use.

In summary, the Neonatal and Pediatric Venous Hardshell Cardiotomy Reservoirs with and without SOFTLINE Coating described in this submission are, in our opinion, substantially equivalent to the predicate devices.

Nonclinical Data

The modified devices were subjected to design verification tests which are based on the risk assessment. The tests are designed to show that the Neonatal and Pediatric Venous Hardshell Cardiotomy Reservoirs with and without SOFTLINE Coating with the proposed modifications are as safe and effective as the originally cleared devices.

The following design verification tests / evaluations were performed:

Air handling

Defoaming

Break Through Volume, cardiotomy part and venous part .

· Dynamic Priming Volume, cardiotomy part -

Functional Test, cardiotomy part -

BioBurden -

LAL

Biocompatibility

The evaluation and test results do not show any kind of risk potential for the health or security of the patient or user. Based on the test results and evaluation, the Neonatal and

06-4

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Premarket Notification Special 510(k) - Device Modification; Modified Neonatal and Pediatric Venous Hardshell Cardiotomy Reservoirs with and without SOFTLINE Coating

Pediatric Venous Hardshell Cardiotomy Reservoirs with and without SOFTLINE Coating are safe and effective for their intended use.

Clinical Data

Clinical results were not submitted to support substantial equivalence.

Conclusions

Based on the risk analysis, MAQUET Cardiopulmonary AG has conducted the appropriate . design verification activities and believes that the modified devices are substantially equivalent to the cleared MAQUET predicate devices.

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.

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

July 7, 2014

MAQUET Cardiopulmonary, AG Katrin Schwenkglenks Regulatory Affairs Manager Neue Rottenburger Strasse 37 72379 Hechingen, Germany

Re: K141432

Trade/Device Name: Neonatal and Pediatric Venous Hardshell Cardiotomy Reservoir with and without SOFTLINE Coating Regulation Number: 21 CFR 870.4400 Regulation Name: Cardiopulmonary Bypass Blood Reservoir Regulatory Class: Class II Product Code: DTN, DTP Dated: May 23, 2014 Received: June 9, 2014

Dear Ms. Schwenkglenks:

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 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

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Page 2 - Ms. Schwenkglenks

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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda,gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

M.A.D.A.

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

510(k) Number (if known): K141432

Device Name: Neonatal Venous Hardshell Cardiotomy Reservoir and Pediatric Venous Hardshell Cardiotomy Reservoir with and without SOFTLINE Coating

Indications for Use:

The venous hardshell cardiotomy reservoir is used to collect, store and filter blood in extracorporeal circulation, in cardiopulmonary bypass operations on pediatric palients for up to 6 hours.

The reservoir can also be employed postoperatively as drainage and autotransfusion reservoir (e.g., for thorax drainage) to return the autologous blood to the patient which was removed from the thorax for the volume exchange.

Over-The-Counter Use Prescription Use × AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M. Zeller

Page __ of ___

(Posted November 13, 2003)

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.