X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR

K993772 · Terumo Medical Corp. · DTZ · Jun 5, 2000 · Cardiovascular

Device Facts

• Record ID: K993772
• Device Name: X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR
• Applicant: Terumo Medical Corp.
• Product Code: DTZ · Cardiovascular
• Decision Date: Jun 5, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

X-Coated CAPIOX® SX25 and SX18 Hollow Fiber Oxygenators The with/without Detachable Hardshell Reservoirs are used to exchange gases with without and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery for periods up to 6 hours. The integral heat exchanger is used to warm or cool blood or perfusion fluid as it flows through the device. (detachable) hardshell reservoir is used to store blood during The extracorporeal circulation from both the venous line and the cardiotomy line. The reservoir contains a venous section that is comprised of a filter and defoamer to facilitate air bubble removal. The cardiotomy section of the reservoir contains a filter to remove particulate matter and a defoamer to facilitate air bubble removal. The X-Coat is a polymer coating that is applied to blood contacting surfaces of the oxygenator to reduce the adhesion of platelets to the surfaces of the device.

Device Story

X-Coated CAPIOX SX25/SX18 are hollow fiber oxygenators used during cardiopulmonary bypass (CPB) surgery. Device receives venous blood and cardiotomy suction blood; performs gas exchange (oxygenation/CO2 removal) and temperature regulation via integral heat exchanger. Hardshell reservoir stores blood; filters and defoamers remove air bubbles and particulate matter. X-Coat polymer coating applied to blood-contacting surfaces to reduce platelet adhesion. Used in clinical OR settings by perfusionists/surgeons. Output is oxygenated, temperature-controlled blood returned to patient. Benefits include maintenance of patient gas exchange and hemodynamic support during bypass procedures.

Clinical Evidence

No clinical data provided; device evaluation based on safety and effectiveness information regarding oxygenators and defoamers, including literature review and MDR/complaint database analysis.

Technological Characteristics

Hollow fiber oxygenator with integral heat exchanger and optional detachable hardshell reservoir. Blood-contacting surfaces treated with X-Coat polymer coating to reduce platelet adhesion. Includes venous and cardiotomy filters and defoamers. Designed for CPB procedures up to 6 hours.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass surgery requiring gas exchange, blood/fluid temperature regulation, and blood storage/filtration for up to 6 hours.

Regulatory Classification

Identification

A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”

Submission Summary (Full Text)

{0}------------------------------------------------

Kb3772

# SUMMARY OF INFORMATION
GARDING SAFETY AND EFFECTIVENESS ISSUE
FOR OXYGENATORS

re references were obtained through a seath of the Medine database (1988 – October, 1999), and articles inhouse. Other
were Medical Device Reports/Diogenese database (1985-

Vote: A summary of the methods used to address these issues is presented on pp.

| I | |
|-----|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| E | |
| 1 | ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ |
| | |
| AB. | |
| E | T |

| Item | Possible Cause | Reference1 |
|----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| Effect on Blood Components | Contact with foreign surfaces and air, turbulent blood<br>flow/flow pattern, temperature, surgical procedures2,<br>excessive gas flow | 1,2,3,4,5,6,7,8,9,10,<br>11,12,22, 29 |
| Decrease/Poor Gas Exchange | Plasma leakage/plasma breakthrough, improper<br>technique (failure to connect gas line, failure to increase<br>O2 during rewarming, etc.), device design, channeling,<br>water condensation, thrombus in blood phase, improper<br>storage | 13,31 MDR database<br>complaint file |
| Effects on coagulation system | Contact with foreign surfaces, inadequate<br>anticoagulation | 4, MDR database |
| Item | Possible Cause | Reference3 |
| Biocompatibility | Contact with foreign surfaces, manner of<br>oxygenation/vigourous bubbling, aggregation of<br>immunoglobulins, protamine-heparin complex, protein<br>denaturation at blood-polymer interface, constituents of<br>priming solution/wetting agent, anesthesia, tissue<br>damage | 4,5,6,7,8,9,12,14,24,<br>25,26,27,28,30,32 |
| Microemboli | | 15,16,17,18 |
| Gaseous | Suction system, inadequate priming/debubbling,<br>overocclusion of the pumphead setting, manner of<br>oxygenation/vigorous bubbling, technique | |
| Blood component aggregates | Contained in cardiotomy/suction blood and in donor<br>blood, activation of platelets and/or leukocytes due to<br>contacting foreign surfaces, technique | |
| Debris, particulates | Manufacturing process, improper technique, other<br>devices/equipment used in cardiopulmonary bypass,<br>antifoam agents | |
| Absorption/uptake of medications | Absorption by some materials | 19,20,21,23 |
| Item | Possible Cause | Reference4 |
| Foaming/defoamer failure | Inadequate defoaming agent, using flow rates greater than maximum rated flow rate | MDR database, complaint file |
| Macro Air Bolus | Improper technique (e.g. clamping gas outlet line, loose connections)<br>(See also microemboli above) | MDR database |
| Leaks: water, blood, gas, priming solution | Mishandling/damage during shipment, improper technique (e.g. overpressurizing), manufacturing defect | MDR database, complaint file |
| Broken/missing parts, packaging defects/sterility barrier broken | Damage during handling or shipping, manufacturing defect | MDR database, complaint file |
| Poor heat exchange | Heater/cooler malfunction, design<br>Clotting, poor design | MDR database |
| Miscellaneous infrequent items: e.g. venous resistance, high pressure drop | | MDR database, complaint file |
| Contamination | Damage during shment, technique | observation |
| Failure of measuring temperature | Use of inappropriate thermistor | observation |

s refer to references listed in the Bibliography following this Table.
Inon leukocyte counts are also seen in other types of extracorporal circulation such as hemodialysis, l

{1}------------------------------------------------

TABLE 1 (cont.)

3 Numbers refer to references listed in the Bibliography following this Table

!!

{2}------------------------------------------------

TABLE 1 (cont.)

4 Numbers refer to references listed in the Bibliography following this Table

・・

{3}------------------------------------------------

SUMMARY OF INFORMATION
GARDING SAFETY AND EFFECTIVENESS ISSUE
FOR DEFOAMERS

terature references were obtained the Medine database (1988 – October, 1999), and articles inbouse. Other
urces were Medical Device Reports/Diogenes database (1985-Consultat

Note: A summary of the methods used to address these is presented on pp.

| { |
|-------------|
| ਪ੍ਰ<br>0 |
| > |
| t<br>S |
| 4<br>œ<br>イ |
| 1 |

| Item | Possible Cause | References |
|-----------------------------------------------------|------------------------------------------------------------------------|------------------------------|
| Visible foaming | Poor performance,<br>inadequate defoaming agent | MDR Database, complaint file |
| Structural defect | Manufacturing defect,<br>damage during shipment or user handling | MDR Database, complaint file |
| Increase in pressure gradient, slow<br>breakthrough | Inadequate patient anticoagulation, clots/blocking/poor<br>performance | MDR Database |

umbers refer to references listed in the Bibliography following this

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN = 5 2000

Mr. Garry A. Courtney Requlatory Affairs Terumo Medical Corporation 125 Blue Ball Road Elkton, MD 21921

K993772 Re: Trade Name: X-Coated Capiox SX18 and SX25 Hollow Fiber Oxygenators with/without Detachable Hardshell Resevoirs. Regulatory Class: III (Three) Product Code: DTZ Dated: March 4, 2000 March 7, 2000 Received:

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 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket 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.

{5}------------------------------------------------

Page 2 - Garry 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".

Singerely yours,

Sincerely yours,

James E. Dillard III

Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

{6}------------------------------------------------

K 993772/51

# 510(k) Number (if known):

| Device Name: | X-Coated CAPIOX® SX25 and SX18 Hollow Fiber Oxygenators<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | and the control controlled of the consisted on the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of<br>with/without Detachable Hardshell Reservoirs.<br>11, NA SECRECAMENT A CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION<br>I |

### Indications For Use:

## Intended Use Described In The 510(k):

X-Coated CAPIOX® SX25 and SX18 Hollow Fiber Oxygenators The with/without Detachable Hardshell Reservoirs are used to exchange gases with without and a gaseous environment to satisfy the gas exchange needs of a patient during cardiopulmonary bypass surgery for periods up to 6 hours.

The integral heat exchanger is used to warm or cool blood or perfusion fluid as it flows through the device.

(detachable) hardshell reservoir is used to store blood during The extracorporeal circulation from both the venous line and the cardiotomy line. The reservoir contains a venous section that is comprised of a filter and defoamer to facilitate air bubble removal. The cardiotomy section of the reservoir contains a filter to remove particulate matter and a defoamer to facilitate air bubble removal.

The X-Coat is a polymer coating that is applied to blood contacting surfaces of the oxygenator to reduce the adhesion of platelets to the surfaces of the device.

Harriet Caudrix

Regulatory Affairs Terumo Medical Corporation

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

OR

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|-----------------------------------------------------------|
| (Division Sign-Off) |
| sion of Cardiovascular, Respiratory, Neurological Devices |
| 510(k) Number K993772 |

Prescription Use ನ Over-The-Counter Use

(Per 21 CFR 801.109)