CAPIOX SX HARDSHELL RESEVOIR

K982223 · Terumo Medical Corp. · DTN · Sep 10, 1998 · Cardiovascular

Device Facts

• Record ID: K982223
• Device Name: CAPIOX SX HARDSHELL RESEVOIR
• Applicant: Terumo Medical Corp.
• Product Code: DTN · Cardiovascular
• Decision Date: Sep 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CAPIOX SX 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 CAPIOX SX Hardshell Reservoir is also used for post-operative chest drainage and autotransfusion procedures to aseptically return the blood to the patient for blood volume replacement. The Hardshell Reservoir is also used with vacuum assisted venous return during cardiopulmonary bypass.

Device Story

Hardshell reservoir for extracorporeal circulation; collects blood from venous and cardiotomy lines. Features rotatable venous inlet to minimize tubing length/priming volume. Internal components include defoamers and screen filters for air bubble and particulate removal. Operates via gravity or external vacuum (vacuum-assisted venous return) to facilitate blood collection. Used in clinical settings (e.g., OR) by perfusionists or clinicians. Output is stored blood returned to patient via autotransfusion. Benefits include air/particulate removal and blood volume management during bypass or post-op drainage.

Clinical Evidence

Bench testing only. Includes pyrogen testing, sterilization validation (SAL 10^6), ethylene oxide residual limits, and biocompatibility testing per ISO-10993. Performance specifications (volume, flow rates, filtration efficiency >90% for particles ≥20u) compared to predicate.

Technological Characteristics

Clear plastic casing; internal defoamer and screen filter elements. 4,000 mL capacity. Gravity or vacuum-assisted operation. Sterilized via ethylene oxide. Biocompatibility tested per ISO-10993.

Indications for Use

Indicated for patients undergoing extracorporeal circulation, cardiopulmonary bypass, or requiring post-operative chest drainage and autotransfusion for blood volume replacement.

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

• Baxter Bentley HSR4000 (K915573)
• Bentley BMR Venous Reservoir (K971455)

Submission Summary (Full Text)

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# SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE

## Proprietary Device Name: CAPIOX® SX Hardshell Reservoir

## Classification Name: Cardiopulmonary bypass blood reservoir, defoamer, cardiotomy suction line filter

## Reason for Submission:

Addition of the use of vacuum assisted venous drainage to the intended use of the hardshell reservoir.

## Intended Use:

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

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

### Description

CAPIOX® SX hardshell reservoir has a rotatable venous blood inlet port to permit minimizing tubing lengths which could result in lower circuit priming volumes.

The 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 permitting blood to reside in the lower section of the reservoir while not in constant contact with the defoamer. The total capacity of the reservoir is 4,000 mL.

The cardiotomy section of the hardshell reservoir contains a defoamer and a cardiotomy filter to facilitate gas bubble removal of particulates/emboli from suctioned blood entering the reservoir.

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- II Summary and Certification Summary of Safety and Effectiveness
#### Substantial Equivalence

The CAPIOX® SX Reservoir is substantially equivalent to the Baxter Bentley HSR4000 (K915573) and Bentley BMR Venous Reservoir (K971455) # as follows:

Intended use: same as described on previous page.

#### Design

These devices are constructed from a clear plastic casing containing filter and defoamer elements.

### Technology and Principles of Operation

- Both devices utilize gravity and/or external vacuum (cardiotomy) for blood collection into the reservoir. Air removal is facilitated by defoamers and the tendency of air to rise through liquid. Particulate removal is facilitated by the blood flow pathway through filters contained in the reservoirs. Vacuum can be applied to the reservoirs to increase venous return.

The CAPIOX SX Hardshell Reservoir and the Baxter Bentley HSR4000 and Bentley BMR Venous Reservoir are substantially equivalent in design, technology and principles of operation.

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#### II - Summary and Certification Summary of Safety and Effectiveness

Specifications

| Table 1 | | |
|--------------------------|-----------------------------|------------------------------|
| Item | CAPIOX SX18/25 Reservoir | Bentley HSR Reservoir |
| Reservoir volume | | |
| Maximum | 4,000 mL | 4,500 mL |
| Minimum operating volume | 200 mL | 300 mL |
| Blood flow rate during | Cardiotomy inlet: 0.5-5LPM | 1-5 LPM |
| cardiopulmonary bypass | Venous flow: 0.5-7 LPM | 1-7 LPM |
| Cardiotomy Filtration | Greater than 90% efficiency | 80% efficiency for particles |
| Efficiency | for particles ≥20u | > 20u |

The specifications of the CAPIOX SX Hardshell Reservoir and the Baxter Bentley HSR4000 and are substantially equivalent.

In summary, the CAPIOX® SX Reservoir and the Baxter Bentley HSR4000 and Bentley BMR Venous Reservoir are substantially equivalent in intended use, design and materials, technology/principles of operation, specifications and performance. Differences as described above do not raise new issues of safety or effectiveness.

Terumo's statement that this device is substantially equivalent to any other device is done solely to comply with the requirements of the Federal Food, Drug and Cosmetic Act and is not intended whatsoever to be the basis for a patent infringement action.

#### Additional Safety Information

·Pyrogen Testing

·Sterilization conditions have been validated to provide a Sterility Assurance Level (SAL) of 106.

· Ethylene oxide residuals 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).

· Manufacturing control testing

· Blood contacting materials were tested in accordance with 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 contact duration).

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- II Summary and Certification Summary of Safety and Effectiveness
Date Prepared June 17, 1998

Prepared by: Sandi Hartka, Manager Regulatory Affairs

> for: Terumo Medical Corporation 2101 Cottontail Lane Somerset, NJ 08873

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 1998

Ms. Sandi Hartka Manager, Requlatory Affairs Terumo Medical Corporation 125 Blue Ball Road Elkton, MD 21921

Re : K982223 CAPIOX® SX Harshell Reservoir Regulatory Class: II (two) Product Code: DTN Dated: June 22, 1998 - ------Received: June 24, 1998

Dear Ms. Hartka:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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, qood 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 (Premarket Approval) , it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any

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obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 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, 2 Misbranding by reference to premarket notification² (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance.at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahar Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K 982223 510(k) Number (if known):

CAPIOX® SX Hardshell Reservoir Device Name:

Indications For Use:

The CAPIOX SX 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 the blood to the patient for blood volume replacement

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

Bee G. Campbell

(Division Sign-Off) Division of Cardiovascular. Respiratory, and Neurological Devices 510(k) Number_K 98222

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)