The Capiox® Advance Hardshell Reservoir is a hardshell reservoir used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line. The reservoir contains filters to remove particulate matter and defoamers to facilitate air bubble removal.

The Hardshell Reservoir is also used for post-operative chest drainage and autotransfusion procedures to aseptically return blood to the patient for blood volume replacement.

The Hardshell Reservoir is also used with the vacuum-assisted venous return technique during cardiopulmonary bypass.

The Hardshell Reservoir contains X-Coating, which is intended to reduce platelet adhesion on the surfaces of the device.

The device may be used for procedures lasting up to 6 hours.

Device Description

The Capiox® Advance Hardshell Reservoir device and the predicate Capiox® RX Hardshell Reservoir device are both used as a blood storage devices during and after cardiopulmonary bypass procedures. Venous blood enters the reservoir via gravity, or by way of external vacuum that may be applied to the reservoir.

Venous blood that is drawn from the patient enters the device via the venous blood inlet port. The blood passes through a defoamer to remove air bubbles from the blood and through a filter to remove particulates from the blood.

Blood may also be suctioned into the reservoir from the cardiotomy field. This blood enters the device through the cardiotomy blood suction ports. The blood passes through a defoamer to remove air bubbles from the blood and through a filter to remove particulates from the blood.

Blood exits the device via gravity through the blood outlet port and is subsequently pumped through the remainder of the cardiopulmonary bypass circuit.

The design of the Capiox® Advance Hardshell Reservoir is comprised of a hardshell casing that serves as a blood containment system within the bypass circuit. The upper portion of the reservoir consists of a hardshell lid assembly that contains the necessary inlet ports and vent ports. It contains a rotatable venous blood inlet port. The total capacity of the reservoir is 4000mL.

The venous section of the reservoir contains a filter for particulate matter removal and a defoamer to facilitate air bubble removal. The cardiotomy section of the reservoir contains a filter for particulate matter removal and a defoamer to facilitate air bubble removal.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Capiox® Advance Hardshell Reservoir (K153143). This is an administrative document for a medical device and, as such, it does not contain the detailed data from clinical studies with acceptance criteria, sample sizes, or ground truth establishment that would be present in a research paper.

However, I can extract the relevant information that is available about the performance evaluations and what they aim to show for the device:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists "Performance Evaluations" that were conducted to establish substantial equivalence to a predicate device (Capiox® RX Hardshell Reservoir; K130359). However, it does not provide specific numerical acceptance criteria or the reported device performance for each evaluation. It simply lists the types of tests performed.

Performance Evaluation Type	Acceptance Criteria (Not provided in source)	Reported Device Performance (Not provided in source)
Air Handling Performance	Not specified	Not specified
Hemolysis	Not specified	Not specified
Venous Filter Dynamic Hold Up and/or Pressure Drop	Not specified	Not specified
Vacuum Testing (Product Integrity, Large Venous Port-O-Ring Seal)	Not specified	Not specified
Burst, Leak, Circulation, and/or Pull Testing to Evaluate Venous Port and Tubing Connection Integrity	Not specified	Not specified
Pre-Connect Evaluation	Not specified	Not specified
Package Testing	Not specified	Not specified

The document states that "Clinical studies involving patients are not necessary to demonstrate substantial equivalence... Substantial equivalence is demonstrated with the following in-vitro performance evaluations." This indicates that the evaluations listed above are the studies that demonstrate the device meets the necessary criteria for substantial equivalence, implying their results were favorable and met internal company-defined specifications, even if those are not explicitly detailed here.

2. Sample size used for the test set and the data provenance

The document explicitly states: "Clinical studies involving patients are not necessary to demonstrate substantial equivalence of the Capiox® Advance Hardshell Reservoir to the predicate device." Therefore, there was no test set with human patient data used for this 510(k) submission.

The provenance of the data for the in-vitro performance evaluations is not specified, but it would typically be internal laboratory testing conducted by Terumo Cardiovascular Systems Corporation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no clinical studies with human patient data were conducted that would require expert-established ground truth. The evaluations were in-vitro tests, likely with predefined physical or chemical standards.

4. Adjudication method for the test set

Not applicable, as no test set with human patient data was used.

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 device is a cardiopulmonary bypass hard-shell reservoir, not an AI-powered diagnostic tool. No MRMC study or AI assistance is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical device, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the in-vitro performance evaluations would be the established scientific and engineering standards and specifications for devices of this type, as well as the performance of the predicate device. For example:

Air Handling Performance: Likely measured against predefined thresholds for air bubble removal efficiency.
Hemolysis: Measured against acceptable levels of blood cell damage according to ISO standards or industry best practices.
Venous Filter Dynamic Hold Up and/or Pressure Drop: Measured against specifications ensuring adequate blood flow and minimal retention.
Product Integrity/Seal, Burst, Leak, Circulation, Pull Testing: Measured against engineering specifications for mechanical strength and leak resistance.
Pre-Connect Evaluation: Likely assessed for ease of connection and secure fit.
Package Testing: Assessed against standards for maintaining sterility and integrity during shipping and storage.

These "ground truths" are based on engineering principles, industry standards (e.g., ISO), and the performance characteristics of the legally marketed predicate device.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary:

The provided document describes a 510(k) premarket notification for a Class II medical device, the Capiox® Advance Hardshell Reservoir. The submission relies on demonstrating "substantial equivalence" to a predicate device through in-vitro performance evaluations rather than clinical studies with human patients. As such, information typically found in detailed studies evaluating diagnostic algorithms (like acceptance criteria, sample sizes for human readers/patients, ground truth establishment by experts, or AI-specific studies) is not present. The "studies" in this context are a series of laboratory-based engineering and performance tests designed to confirm that the modified device functions comparably and safely to its predicate.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing right, layered on top of each other. The profiles are black and have a flowing, abstract design. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in black, uppercase letters.

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

December 02, 2015

Terumo Cardiovascular Systems Corporation Tierra Brown Regulatory Affairs Specialist 125 Blue Ball Road Elkton, Maryland 21921

Re: K153143

Trade/Device Name: Capiox Advance Hardshell Reservoir Regulation Number: 21 CFR 870.4400 Regulation Name: Cardiopulmonary Bypass Blood Reservoir Regulatory Class: Class II Product Code: DTN, DTP Dated: October 22, 2015 Received: October 30, 2015

Dear Tierra Brown:

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 of medical devicerelated 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.

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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" (21 CFR 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 yours,

M.A. Hillebrand

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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piox Advance Hardshell Reser U CLION 4 - Indications for U TERUM

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TERUMO® SECTION 5 – 510(k) Summary Capiox® Advance Hardshell Reservoir

Submitter Information
Date of Preparation	October 22, 2015
Name	Terumo Cardiovascular Systems Corporation
Address	125 Blue Ball RoadElkton, MD 21921
Establishment Registration Number	1124841
Name of Contact Person	Tierra A. Brown, MSRA, RAC
Contact Person's Title	Regulatory Affairs Specialist
Phone Number	(800) 262-3304 (x7021)
Fax Number	410-392-7171
Email	tierra.brown@terumomedical.com

Device Information
Device Classification Type	Cardiopulmonary Bypass Blood Reservoir (Code DTN)Cardiopulmonary Bypass Defoamer (Code DTP)
Device Common Name	Blood ReservoirDefoamer
Device Trade Name	Capiox® Advance Hardshell Reservoir
Predicate Device	Capiox® RX Hardshell Reservoir; Cleared by FDA withK130359
Classification Regulation	Cardiopulmonary Bypass Reservoir 21 CFR § 870.4400Cardiopulmonary Bypass Defoamer 21 CFR § 870.4230
Device Risk Classification	Cardiopulmonary Bypass Reservoir - Class IICardiopulmonary Bypass Defoamer – Class II
Reason for 510(k) Submission	Modification to Hardshell Reservoir
Substantial Equivalence Statement	The device submitted in this 510(k) maintainscharacteristics that are substantially equivalent inintended use, design, technology/principles of operation,materials and specifications to the predicate device.

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Capiox® Advance Hardshell Reservoir

Intended Use:

The intended use remains the same as the intended use for the predicate device cleared with submission K130359. There have been no changes to the indications or intended use of the subject device as a result of the modifications.

The Hardshell Reservoir is also used for post-operative chest drainage and autotransfusion procedures to aseptically return blood to the patient for blood volume replacement.

The Hardshell Reservoir is also used with the vacuum-assisted venous return technique during cardiopulmonary bypass.

The Hardshell Reservoir contains X-Coating, which is intended to reduce platelet adhesion on the surfaces of the device.

The device may be used for procedures lasting up to 6 hours.

Principles of Operation and Technology:

The principles of operation and technological characteristics remain the same as that of the predicate device cleared with submission K130359. There have been no changes to the fundamental scientific technology of the subject device.

Blood exits the device via gravity through the blood outlet port and is subsequently pumped through the remainder of the cardiopulmonary bypass circuit.

Design and Materials:

The design of the Capiox® Advance Hardshell Reservoir is comprised of a hardshell casing that serves as a blood containment system within the bypass circuit. The upper portion of the

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SECTION 5-510(k) Summary Capiox® Advance Hardshell Reservoir

reservoir consists of a hardshell lid assembly that contains the necessary inlet ports and vent ports. It contains a rotatable venous blood inlet port. The total capacity of the reservoir is 4000mL.

Differences in the design of the two Reservoirs are as follows:

The design of the Capiox® Advance Hardshell Reservoir device will include a curved ● venous inlet port and flared venous inlet drop tubes. The design of the predicate Capiox® RX Hardshell Reservoir device has an angled venous inlet port and straight venous inlet drop tubes. The intent of the curved venous inlet port is to improve air handling performance of the port. A curved design is more conducive to smooth flow than an angled design. The intent of the flared venous inlet drop tubes modification is to help minimize air emboli generation in the venous section of the reservoir.
o The Capiox® Advance Hardshell Reservoir device has a full-length graduated side scale label (decal). The predicate Capiox® RX Hardshell Reservoir device has a half-length graduated side scale label (decal). The full-length graduated side scale label (decal) enhancement offers greater visibility of blood volume during cardiopulmonary bypass.
. The Capiox® Advance Hardshell Reservoir device has a minimum operating volume of The predicate Capiox® RX Hardshell Reservoir device has a minimum 150mL. operating volume of 200mL. The minimum operating volume is lowered to 150mL to facilitate lower blood volumes during cardiopulmonary bypass.

Difference in the materials of the two Reservoirs are as follows:

The materials used in the construction of the Capiox® Advance Hardshell Reservoir include, but are not limited to, nylon, polycarbonate, silicone, polyvinyl chloride, polyurethane, polyester, polypropylene, polymethyl methacrylate, polyhydroxyethyl methacrylate, polyethylene, and X-Coating™. PVC tubing with TOTM plasticizer has been cleared for use with Terumo's FX15 Advance Oxygenator with Integrated Filter and Hardshell Reservoir, K151389.

The material used in the construction of the Capiox® Advance Hardshell Reservoir o device's venous inlet drop tubes and auxiliary tubing (blood-contacting) will be PVC tubing with Tris-(2-Ethylhexyl) Trimellitate, identified as TOTM plasticizer'. The material used in the construction of the predicate Capiox® RX Hardshell Reservoir device's venous inlet drop tubes and auxiliary tubing (blood-contacting) is PVC tubing with Di-(2-ethylhexyhl) phthalate, identified as DEHP plasticizer.
. The intent of the PVC tubing plasticizer change to TOTM plasticizer is to address growing potential safety concerns associated with DEHP and to address increasing concerns related to the use of DEHP.

Terumo Cardiovascular Systems concludes that the differences between the subject device and the predicate device do not affect the intended use of the device nor do they affect safety and effectiveness of the device when used as labeled.

1 PVC tubing with Tris-(2-Ethylhexyl) Trimellitate, identified as TOTM plasticizer, is used with Terumo's Capiox® FX15 Advance Oxygenator with Integrated Filter and Hardshell Reservoir, K151389.

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Capiox® Advance Hardshell Reservoir

Performance Evaluations:

Clinical studies involving patients are not necessary to demonstrate substantial equivalence of the Capiox® Advance Hardshell Reservoir to the predicate device. Substantial equivalence is demonstrated with the following in-vitro performance evaluations:

Air Handling Performance ●
Hemolysis .
Venous Filter Dynamic Hold Up and/or Pressure Drop .
Vacuum Testing (Product Integrity, Large Venous Port-O-Ring Seal) .
Burst, Leak, Circulation, and/or Pull Testing to Evaluate Venous Port and Tubing ● Connection Integrity
Pre-Connect Evaluation ●
. Package Testing

Substantial Equivalence Comparison:

In demonstrating substantial equivalence of the Capiox® Advance Hardshell Reservoir to the predicate Capiox® RX Hardshell Reservoir, Terumo has considered the following aspects to ensure equivalence between the predicate and the subject devices:

Intended use .
. Target Population
Duration of use ●
Product labeling .
Product design ●
Materials .
Principles of Operation and Technology ●
Device Performance .

Substantial Equivalence Statement:

The Capiox® Advance Hardshell Reservoir is substantially equivalent to the predicate Capiox® RX Hardshell Reservoir in intended use, duration of use, design, materials, principles of operation and technology, and performance and specifications. Any noted differences between the subject device and the predicate device do not raise new issues of safety and/or effectiveness.

Conclusion:

Based upon the comparative studies and analyses, Terumo Cardiovascular Systems concludes that the Capiox® Advance Hardshell Reservoir is substantially equivalent in intended use, duration of use, design, materials, principles of operation and technology, and performance and specifications to the predicate Capiox® RX Hardshell Reservoir. It is further concluded that any recognized differences noted during the assessments do not raise new issues of patient/user safety or product effectiveness.

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.