CAPIOX SX10 HARDSHELL RESEVOIR

K991973 · Terumo Medical Corp. · DTN · Sep 3, 1999 · Cardiovascular

Device Facts

• Record ID: K991973
• Device Name: CAPIOX SX10 HARDSHELL RESEVOIR
• Applicant: Terumo Medical Corp.
• Product Code: DTN · Cardiovascular
• Decision Date: Sep 3, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 is also used in the vacuum-assisted venous return technique during cardiopulmonary bypass procedures lasting up to 6 hours.

Device Story

Hardshell reservoir for extracorporeal circulation; stores blood from venous and cardiotomy lines during cardiopulmonary bypass (up to 6 hours). Inputs: venous blood and suctioned cardiotomy blood. Operation: gravity-fed or vacuum-assisted venous return; internal defoamers facilitate air bubble removal; screen filters remove particulate matter/emboli. Output: processed blood ready for return to patient. Used in clinical settings (OR) by perfusionists/surgeons. Benefits: facilitates air/particulate removal and supports vacuum-assisted venous drainage to minimize circuit priming volumes.

Clinical Evidence

Bench testing only. Performance data confirms filtration efficiency >90% for particles ≥20µ. Biocompatibility testing conducted per ISO-10993.

Technological Characteristics

Clear plastic casing; internal screen filter and defoamer elements. 3000 mL capacity. Supports gravity and vacuum-assisted venous return. Sterilized via Ethylene Oxide (SAL 10^-6).

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass procedures lasting up to 6 hours requiring blood storage from venous and cardiotomy lines, including use with vacuum-assisted venous return.

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 (K982223)

Submission Summary (Full Text)

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# SECTION II: SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE

## Proprietary Device Name: CAPIOX® SX10 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® 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 is also used in the vacuum-assisted venous return technique during cardiopulmonary bypass procedures lasting up to 6 hours.

### Description:

CAPIOX® SX10 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 contact with the defoamer. The total capacity of the reservoir is 3000 mL.

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

#### Substantial Equivalence:

The CAPIOX® SX10 Hardshell Reservoir is substantially equivalent to the CAPIOX® SX Hardshell Reservoir (K982223) as follows:

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Substantially Equivalent in 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® SX10 Hardshell Reservoir and the CAPIOX® SX Hardshell Reservoir are substantially equivalent in design, technology and principles of operation.

# Specifications:

Table 1

| Item | CAPIOX® SX10 Hardshell<br>Reservoir | CAPIOX® SX HARDSHELL<br>RESERVOIR |
|--------------------------------------------------|-------------------------------------|-----------------------------------|
| Reservoir Volume | | |
| | Maximum | 3000 mL |
| | Minimum | 100 mL |
| Blood Flow Rate During<br>Cardiopulmonary Bypass | Cardiotomy Inlet: 4.0 L/min Max. | Cardiotomy Inlet: 0.5-5 L/min |
| | Venous Flow: Min: 0.5 L/min | Venous Flow: Min: 0.5 L/min |
| | Max: 4.0 L/min | Max: 7.0 L/min |
| Cardiotomy Filtration<br>Efficiency | Greater than 90% efficiency for | Greater than 90% efficiency for |
| | particles ≥ 20u | particles ≥ 20u |

The difference in specifications between the CAPIOX® SX10 Hardshell Reservoir and the CAPIOX® SX Hardshell Reservoir do not raise new issues of safety and effectiveness.

In summary, the CAPIOX® SX10 Hardshell Reservoir and the CAPIOX® SX Hardshell 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.

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Additional Safety Information:

- Pyrogen Testing ●
- Sterilization conditions have been validated to provide a Sterility Assurance Level . (SAL) of 10 to the negative sixth.
- 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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Section II. Summary of Safety and Effectiveness Information

The Summary of Safety and Effectiveness Information Pertaining to Substantial Equivalence was prepared on May 13, 1999.

- Prepared by: Garry A. Courtney Regulatory Affairs Specialist
- Prepared for: Terumo Medical Corporation 2101 Cottontail Lane Somerset, NJ 08873

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing protection and care.

SEP | 3 1999

Mr. Gary A. Courtney Regulatory Affairs Associate Terumo Medical Corporation Requlatory Affairs Department 125 Blue Ball Road Elkton, MD 21921

Re : K991973 CAPIOX® SX10 HARDSHELL RESERVOIR Requlatory Class: III (Three) Product Code: 74 DPN, 74 DTN Dated: June 6, 1999 Received: June 11, 1999

Dear Mr. Courtney:

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, 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance with 895. 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 Please note: this response to your premarket Federal Register. notification submission does not affect any 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.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

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, "Misbranding by reference to premarket notification" (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. Callehan

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

Enclosure

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510(k) Number (if known):

K.991913

Device Name: CAPIOX® SX10 Hardshell Reservoir

### Indications For Use:

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 is also used with the vacuum-assisted venous return technique during cardiopulmonary bypass procedures lasting up to 6 hours

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Buce L. Rempe le

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K991973

Prescription Use

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

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