CAPIOX RX HARDSHELL RESERVOIR

K013526 · Terumo Cardiovascular Systems Corp. · DTN · Nov 15, 2001 · Cardiovascular

Device Facts

• Record ID: K013526
• Device Name: CAPIOX RX HARDSHELL RESERVOIR
• Applicant: Terumo Cardiovascular Systems Corp.
• Product Code: DTN · Cardiovascular
• Decision Date: Nov 15, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4400
• Device Class: Class 2

Intended Use

The CAPIOX® RX 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 Story

Hardshell reservoir for blood storage during/after cardiopulmonary bypass; accepts venous blood via gravity or vacuum-assisted return; accepts suctioned blood from cardiotomy field. Internal defoamers and screen filters remove air and particulates. Features X-Coating to reduce platelet adhesion. Used in clinical settings by perfusionists/medical staff. Output is filtered, defoamed blood returned to patient circuit for volume replacement. Supports procedures up to 6 hours.

Clinical Evidence

Bench testing only. Performance evaluations included filter defoaming (venous and cardiotomy sections), pressure drop/flow rate, filtration efficiency, effects on cellular blood components, pressure integrity, and tubing connection strength. Biocompatibility testing conducted per ISO 10993; in-vivo animal study performed for X-Coating polymer.

Technological Characteristics

Hardshell reservoir, 4000 mL capacity. Materials: polycarbonate, polypropylene, PET, PVC, polyurethane, nylon, stainless steel, ceramic, and X-Coating polymer. Features rotatable venous inlet. Sterilization: Ethylene Oxide (SAL 10^-6). No software or electronic components.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass, post-operative chest drainage, or autotransfusion procedures requiring blood storage, air bubble removal, and particulate filtration during extracorporeal circulation.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• CAPIOX® SX Hardshell Reservoir (K002238)

Submission Summary (Full Text)

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# CAPIOX® RX Hardshell Reservoir

K013526

#### Submitter Information:

This premarket notification is submitted by:

Garry A. Courtney Terumo Cardiovascular Systems Regulatory Affairs Specialist Telephone: [phone], Ext. 7420

Date of Preparation: October 12, 2001

#### Device Names:

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

#### Predicate Device:

The CAPIOX® RX Hardshell Reservoir is substantially equivalent in intended use, materials, design, technology and principles of operation, and performance to the CAPIOX® SX Hardshell Reservoir (K002238).

#### Intended Use:

The CAPIOX® RX 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.

### Principles of Operation and Technology:

The CAPIOX® RX Hardshell Reservoir is used as a blood storage device 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.

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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.

Blood may also be suctioned into the reservoir from the cardiotomy field. This blood enters the device through the cardiotomy blood suction ports. As with the venous blood, the blood passes through a defoamer to remove air and through a filter for removal of particulates.

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

## Design and Materials:

The design of the CAPIOX® RX Reservoir consist of a hard casing reservoir. 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 4000 mL.

The CAPIOX® RX 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 RX reservoir contains a defoamer and a 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, PET, polyvinyl chloride, polyurethane, nylon, stainless steel and ceramic. The device also contains Terumo's X-Coating polymer solution.

## Performance Evaluations:

The performance of the CAPIOX® RX Hardshell Reservoir is substantially equivalent to the performance of the predicate devices. The following tests were conducted to demonstrate equivalence in performance:

- Filter Defoaming Venous Section ●
- Filter Defoaming - Cardiotomy Section
- Pressure Drop/Flow Rate Testing Venous Section .
- Pressure Drop Cardiotomy Section .
- Filtration Efficiency Cardiotomy Section .
- Effects Upon Cellular Blood Components .
- Pressure Integrity Testing ●
- Tubing Connection Strength ●

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## Substantial Equivalence Comparison:

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

The RX Reservoir and the predicate SX Reservoirs share the same Intended Use: intended uses. Each is used to store blood during extracorporeal circulation from both the venous line and the cardiotomy line. The reservoirs contain filters to remove particulate matter and defoamers to facilitate air bubble removal.

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

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

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

The CAPIOX RX® Hardshell Reservoir and the predicate SX Reservoir may be used in procedures lasting up to 6 hours.

Principles of Operation and Technology: The RX 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.

Design and Materials: The design and the materials of the RX Reservoir and the SX Reservoir is essentially the same. The generic materials used in the two devices are comparable.

Performance: Comparisons of the performance of the RX Reservoir and the predicate SX Reservoirs were conducted. The comparisons demonstrated that there were no clinically significant performance differences between the devices.

## Substantial Equivalence Summary:

In summary, the RX Reservoir and the predicate SX 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.
- The polymer coating material that is applied to the blood-contacting surfaces of the . device was also evaluated in an in-vivo animal study. No adverse conditions were noted.

## Conclusion:

In summary, the CAPIOX® RX Hardshell Reservoir is substantially equivalent in intended use, principles of operation and technology, design and materials, and performance to the predicate SX Hardshell Reservoir (K002238).

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 5 2001

Mr. Garry A. Courtney Regulatory Affairs Terumo Cardiovascular Systems Corporation 125 Blue Ball Road Elkton, MD 21921

Re: K013526

Trade Name: CAPIOX® RX Hardshell Reservior Regulation Number: 21 CFR 870.4400 Regulation Name: Cardiopulmonary bypass blood reservoir Regulatory Class: Class II (two) Product Code: DTN Dated: October 22, 2001 Received: October 23, 2001

Dear Mr. Courtney:

We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your Section 310(t) premaint in substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the clerosule) to regarly manage and commerce prior to May 26, 1976, the enaounters with the provisions of the Federal Food, Drug, devices that have been recassined in accessor wl of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval applic and Cosmetic Ac. (Act) that do not request of the general controls provisions of the Act. The You may, ulerclore, market the devices, becjocher to the more
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the Fiel 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 If your device is classified (500 a0070) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations of may oc subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found interests concerning your device in the Federal Register.

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#### Page 2 - Mr. Garry A. Courtney

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); 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

y

James E/ Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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NOV 1 5 2001

510(k) Number (if known):

K013526

CAPIOX® RX Hardshell Reservoir Device Name:

### Indications For Use:

The CAPIOX® RX 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.

Reservoir is also used for post-operative chest drainage and The Hardshell 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.

Harry A. Courtney 10/19/01
Garry A. Courtney

Regulatory Affairs Terumo Cardiovascular Systems

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number: K013526

Prescription Use

OR

Over-The-Counter Use

(Per 21 CFR 801.109)