The CAPIOX® SX10 Hardshell Reservoir is a hardshell reservoir used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line during cardiopulmonary bypass procedures lasting up to 6 hours. The reservoir contains filters to remove particulate matter and defoamers to facilitate air bubble removal.

The Hardshell Reservoir may also be used with vacuum-assisted venous return procedures during cardiopulmonary bypass procedures lasting up to 6 hours.

Device Description

The design of the CAPIOX® SX10 Reservoir consists of a hard casing reservoir containing blood filters. It has a rotatable venous blood inlet port that permits minimizing tubing lengths, which could result in lower circuit priming volumes. The total capacity of the reservoir is 3000 mL.

The CAPIOX® SX10 Hardshell Reservoir contains a defoamer and a screen filter in the venous blood inlet section. The defoamer resides in the upper part of the reservoir, thus permitting blood to reside in the lower-section of the reservoir.

The cardiotomy section of the SX10 Reservoir contains a defoamer and a "sock-like" filter to facilitate air removal and the removal of particulates from suctioned blood entering the reservoir.

The generic materials used in the CAPIOX® RX Hardshell Reservoir are polycarbonate. polypropylene, polyethylene terephthalate, silicone, polyvinyl chloride, polyurethane, nylon, stainless steel, ceramic, and polymer coating solutions.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the CAPIOX® SX10 Hardshell Reservoir, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Test	Acceptance Criteria (Implied/Compared To Predicate)	Reported Device Performance
Filter Defoaming	Substantially equivalent to predicate device (K991973)	Performance comparison studies demonstrated no clinically significant differences, indicating similar defoaming capabilities.
Pressure Drop	Substantially equivalent to predicate device (K991973)	Performance comparison studies demonstrated no clinically significant differences, implying similar pressure drop profiles.
Filtration Efficiency	Substantially equivalent to predicate device (K991973)	Performance comparison studies demonstrated no clinically significant differences, suggesting equivalent particulate removal.
Effects Upon Cellular Blood Components	Substantially equivalent to predicate device (K991973), maintaining similar blood compatibility.	Performance comparison studies demonstrated no clinically significant differences. Additionally, biocompatibility studies (ISO 10993) on blood-contacting materials found them to be biocompatible, and an in-vivo animal study of the polymer coating noted no adverse conditions, implying no adverse effects on cellular blood components.
Pressure Integrity Testing	Substantially equivalent to predicate device (K991973)	Performance comparison studies demonstrated no clinically significant differences, implying equivalent structural integrity under pressure.
Fluid Breakthrough Time	Substantially equivalent to predicate device (K991973)	Performance comparison studies demonstrated no clinically significant differences, indicating similar performance in preventing fluid breakthrough.
Sterilization Conditions	AAMI guidelines, Sterility Assurance Level (SAL) of 10-6	Validated in accordance with AAMI guidelines to provide a SAL of 10-6.
Ethylene Oxide Residues	Not to exceed maximum residue limits proposed for Part 821 of Title 21 in the Federal Register of June 23, 1978 (or as finalized or amended).	Will not exceed the maximum residue limits.
Biocompatibility	Recommended by FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing." [External Communicating Devices, Circulating Blood, Limited Exposure (≤ 24 hours) Contact Duration].	Blood contacting materials were found to be biocompatible.
Material Stability	Stable over the expiry of the product.	Material characterization studies (physico-chemical profiles of aged and non-aged devices) demonstrated stability of the materials over the product's expiry.
Polymer Coating Safety	No adverse conditions in-vivo.	Evaluated in an in-vivo animal study; no adverse conditions were noted.

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

The document does not explicitly state the specific sample sizes used for the performance comparison tests (Filter Defoaming, Pressure Drop, Filtration Efficiency, Effects Upon Cellular Blood Components, Pressure Integrity Testing, Fluid Breakthrough Time). It generically refers to "comparison studies of the performance."

The data provenance is not specified. It can be inferred that the testing was conducted by Terumo Corporation, likely at their Ashitaka Factory in Japan, as this is the submitter's location. The studies are retrospective in the sense that they are comparing a new device against an existing, cleared predicate device, but the tests themselves were performed anew for the modified device.

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

This information is not provided in the document. The performance tests are laboratory or bench tests, not clinical studies involving expert interpretation of medical images or data. Therefore, the concept of "experts establishing ground truth" in the diagnostic sense is not applicable here. The "ground truth" for these tests would be the established scientific or engineering methods for measuring the stated parameters (e.g., standard methods for measuring pressure drop or filtration efficiency).

4. Adjudication Method for the Test Set

This information is not applicable as the studies are technical performance tests, not studies requiring human adjudication of clinical outcomes or interpretations.

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

No, an MRMC comparative effectiveness study was not done. This device is a blood reservoir for cardiopulmonary bypass, and its evaluation focuses on physical and biological performance characteristics rather than diagnostic accuracy or human reader performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable as the device is a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance evaluations (Filter Defoaming, Pressure Drop, etc.) would be established through scientific and engineering measurements performed using standardized laboratory protocols. For biocompatibility, the ground truth relies on established international standards (ISO 10993) and in-vivo animal study observations. For sterilization and ethylene oxide residues, the ground truth is based on regulatory guidelines (AAMI, FDA regulations).

8. The Sample Size for the Training Set

This question is not applicable as this is a physical medical device and not an AI algorithm that requires a training set.

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

This question is not applicable as there is no training set for this type of device submission.

Summary

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K030449

CAPIOX® SX10 Hardshell Reservoir

MAR 0 5 2003

Submitter Information:

This Premarket Notification is submitted by:

Garry A. Courtney, MBA, RAC Telephone: 1-800-283-7866, Ext. 7420

This Premarket Notification is submitted on behalf of:

Ashitaka Factory of Terumo Corporation 150 Maimaigi-cho Fujinomiya city, Shizuoka Pref. Japan 418-0015

Device Names:

Proprietary Name:	CAPIOX® SX10 Hardshell Reservoir
Common Name:	Blood Reservoir
Classification:	CPB Reservoirs are classified as Class II devices

Predicate Device:

The CAPIOX® SX10 Hardshell Reservoir is substantially equivalent in intended use, materials, design, technology and principles of operation, and performance to the CAPIOX® SX 10 Hardshell Reservoir that was cleared for marketing under Premarket Notification K991973.

Intended Use:

The CAPIOX® SX10 Hardshell Reservoir is a hardshell reservoir used to store blood during extra-corporeal circulation from both the venous line and the cardiotomy line during cardiopulmonary bypass procedures lasting up to 6 hours. The reservoir contains filters to remove particulate matter and defoamers to facilitate air bubble removal.

The Hardshell Reservoir may also be used with vacuum-assisted venous return procedures during cardiopulmonary bypass procedures lasting up to 6 hours.

Principles of Operation and Technology:

The CAPIOX® SX Hardshell Reservoir is used as a blood storage device during 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 through the venous blood inlet port. The blood passes through a defoamer to remove air from the blood and through a filter for removal of particulates.

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Blood may also be suctioned into the reservoir from the cardiotomy field. This blood enters the device through the cardiotomy blood suction ports that are located on the lid assembly. As with the venous blood, the cardiotomy blood passes through a defoamer to facilitate air removal, and then through a filter for removal of particulates. Air is also removed from the blood due to its tendency to rise within a liquid medium.

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

Design and Materials:

The cardiotomy section of the SX10 Reservoir contains a defoamer and a "sock-like" filter to facilitate air removal and the removal of particulates from suctioned blood entering the reservoir.

Performance Evaluations:

The performance of the CAPIOX® SX10 Hardshell Reservoir is substantially equivalent to the performance of the predicate (unmodified) device. The following tests were conducted to demonstrate equivalence in performance:

Filter Defoaming ●
Pressure Drop .
Filtration Efficiency ●
. Effects Upon Cellular Blood Components
Pressure Integrity Testing ●
Fluid Breakthrough Time .

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Substantial Equivalence Comparison:

The CAPIOX® SX10 Hardshell Reservoir is substantially equivalent to the predicate SX10 Hardshell Reservoir device as follows:

Intended Use: The modified SX10 Hardshell Reservoir and the predicate (unmodified) SX10 Hardshell Reservoir share the same exact intended uses. Each is used to store blood during extra-corporeal circulation from both the venous line and the cardiotomy line during cardiopulmonary bypass procedures lasting up to 6 hours.

Fach of the reservoirs (modified and unmodified) contains filters to remove particulate matter and defoamers to facilitate air bubble removal.

The (modified) SX10 Hardshell Reservoir and the (unmodified) SX10 Hardshell Reservoir each may also be used with vacuum-assisted venous return procedures during cardiopulmonary bypass procedures lasting up to 6 hours.

Principles of Operation and Technology: The (modified) SX10 Reservoir and the predicate SX Reservoirs each utilize gravity and/or vacuum to draw blood into the device. and each has filters and defoamers that facilitate the removal of particulate and air, respectively. Air is also removed from the circulating blood within both devices due to the tendency of air to rise within a liquid medium.

Design and Materials: The design and the materials of the (modified) SX10 Reservoir and the (unmodified) SX10 Reservoir are essentially the same. Differences include a "socklike" cardiotomy filter in the modified device vs. a "pleated" filter design in the predicate device; and the addition of channeling groves at the base of the reservoir in the modified device that are not present in the unmodified predicate device.

The materials used in the two devices are identical except that the modified device contains Terumo's X-Coating polymer, which is not present on the unmodified SX10 Hardshell Reservoir. The X-Coating polymer has been applied to multiple Terumo products that have been reviewed and cleared for marketing by the United States Food and Drug Administration.

Performance: Comparison studies of the performance of the (modified) SX10 Hardshell Reservoir and the predicate SX10 Reservoir were conducted. The comparisons demonstrated that there were no clinically significant performance differences between the devices.

Substantial Equivalence Summary:

In summary, the (modified) CAPIOX® SX10 Hardshell Reservoir and the predicate (unmodified) CAPIOX® SX10 Reservoir are substantially equivalent in intended use, principles of operation and technology, design and materials, and performance. Any noted differences between the devices do not raise new issues of safety and effectiveness.

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Additional Safety Information:

Sterilization conditions have been validated in accordance with AAMI guidelines to . provide a Sterility Assurance Level (SAL) of 10-6.
Ethylene Oxide residues will not exceed the maximum residue limits proposed for . Part 821 of Title 21 in the Federal Register of June 23, 1978 (or as finalized or amended).
Biocompatibility studies were conducted as recommended in the FDA General . Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing." [External Communicating Devices, Circulating Blood, Limited Exposure (≤ 24 hours) Contact Duration]. The blood contacting materials were found to be biocompatible.
Terumo has conducted material characterization studies including physico-chemical ● profiles of aged and non-aged devices to demonstrate stability of the materials, and found the materials to be stable over the expiry of the product.
The polymer coating materials that are applied to the blood-contacting surfaces of the . device were also evaluated in an in-vivo animal study. No adverse conditions were noted.

Conclusion:

In summary, the CAPIOX® SX10 Hardshell Reservoir is substantially equivalent in intended use, principles of operation and technology, design and materials, and performance to the predicate (unmodified) CAPIOX® SX10 Hardshell Reservoir (K991973).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of three people.

Public Health Service

MAR 0 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Terumo Medical Corporation c/o Mr. Gary A. Courtney 125 Blue Ball Road Elkton, MD 21921

Re: K030449 CAPIOX SX10 Hardshell Reservoir Regulation Number: 21 CFR 870.4400 Regulation Name: Cardiopulmonary Bypass Blood Reservoir Regulatory Class: Class II (two) Product Code: DTN Dated: February 7, 2003 Received: February 11, 2003

Dear Mr. Courtney:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

KalaTum

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

Enclosure

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510(k) Number (if known):

Device Name: CAPIOX® SX10 Hardshell Reservoir

Indications For Use:

The Hardshell Reservoir may also be used with vacuum-assisted venous return procedures during cardiopulmonary bypass procedures lasting up to 6 hours.

Larry A. Coutlay 02/07/03
Charles A. Coutlay, MBA, R.S.

Garry/A. Courtney, MBA, RAC Sr. Regulatory Affairs Specialist Terumo Cardiovascular Systems

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
OR
Over-The-Counter Use

(Per 21 CFR 801.109)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K030449

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.