CAPIOX AF125X ARTERIAL FILTER

K052205 · Terumo Cardiovascular Systems Corp. · DTM · Sep 12, 2005 · Cardiovascular

Device Facts

• Record ID: K052205
• Device Name: CAPIOX AF125X ARTERIAL FILTER
• Applicant: Terumo Cardiovascular Systems Corp.
• Product Code: DTM · Cardiovascular
• Decision Date: Sep 12, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4260
• Device Class: Class 2

Intended Use

The Capiox® AF125X Arterial Blood Filter is intended to filtere non-biologic particles and The Capiox® AFT25X Arterial Blood Finer is Interior is Interior of the only of the bypass circuit for up to 6 hours.

Device Story

The Capiox® AF125X Arterial Blood Filter is a component of a cardiopulmonary bypass circuit. It functions to remove non-biologic particles from blood during extracorporeal circulation. The device is intended for use for up to 6 hours. It is used in clinical settings by healthcare professionals during surgical procedures requiring cardiopulmonary bypass. The device operates as a passive filter within the bypass circuit; it does not involve electronic processing, software, or active sensing. By filtering particulate matter, it aims to reduce the risk of embolic events for the patient during bypass.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Cardiopulmonary bypass arterial line blood filter. Class II device per 21 CFR 870.4260. Passive filtration mechanism. Materials and specifications are consistent with the predicate device.

Indications for Use

Indicated for use in a cardiopulmonary bypass circuit for up to 6 hours to filter non-biologic particles.

Regulatory Classification

Identification

A cardiopulmonary bypass arterial line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (blood clots or pieces of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. It is used in the arterial return line.

Special Controls

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

Predicate Devices

• Capiox® AF200X Arterial Filter (K002768)

Submission Summary (Full Text)

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

Section I: General Information Terumo Cardiovascular Systems Capiox® AF125X Arterial Filter

SEP 1 2 2005

K052205

### Capiox® AF125X Arterial Filter

Device Name: Capiox® AF125X Arterial Filter Proprietary Name: CPB Arterial Line Blood Filter Common Name:

Device Classifications: Device Classification Name: Device Classification:

Cardiopulmonary Bypass Arterial Line Blood Filter Cardlopumionary Bypass Fridal Filter is classified as a Class II device per 21 CFR § 870.4260 21 CFR § 870.4260

Regulation Number:

#### Device Product Code(s):

Device Product Code(s):
The Capiox® AF125X Arterial Filter is identified by Terumo Cardiovascular Systems as product code CX*AF125X.

The FDA product code for Arterial Line Blood Filters is DTM.

Review Panel: Cardiovascular (74)

#### Device Intended Use:

Device Intended Use:
The Capiox® AF125X Arterial Blood Filter is intended to filtere non-biologic particles and The Capiox® AFT25X Arterial Blood Finer is Interior is Interior of the only of the bypass circuit for up to 6 hours.

## Reason For Premarket Notification:

Reason For Premarket Nottjication:
The Capiox® AF125X Arterial Filter is submitted as required by the United States Food and The Capiox® AF125X Arterial Filter is submitted by and Onits Artistian Filter is a
Drug Administration when marketing a tina Santa modification of Any existing, Jegally Drug Administration when marketing a new product. The Capital of any existing, legally marketable products offered by Terumo.

## Statement of Equivalence to Predicate Device:

Statement of Equivalence to Predicale Device - Substantially equivalent in intended use, design, The device submitted in this STO(K) is substantaily "operations to the Capics" AF200X Arterial
technology/principles of operation, materials and specifications to the Clapic technology/principles of operation, materials and specifications of any appear of any was cleared by FDA on September 6, 2000.

A comparison of the similarities and differences is presented in this submission. The differences of safety and A comparison of the similarities and differences is presented in also and issues of safety and effectiveness.

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

## Section 514, Special Controls:

Section 514, Special Controls:
To the best of our knowledge, no performance standards have been established for Arterial Line To the best of our knowledge, no performance statualus inate been beach and of the best of the best of the following genered, in
Blood Filters. The following guidance documen Blood Finers. The forewing garation of this submission:

- Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions. FDA
1000 . Guidance Jor Caratopain February 21, 2000
- FDA Blue Book Memorandum G95-1 (Biocompatibility Evaluations) .

#### Establishment Registrations:

| Establishment Registrations:<br>Contact Person: | Garry A. Courtney, MBA, RAC<br>Terumo Cardiovascular Systems Corp.<br>125 Blue Ball Road<br>Elkton, MD 21921<br>Registration No. 1124841<br>Phone: [phone], Extension 7420<br>[phone]<br>Fax: |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer/Sterilizer: | Ashitaka Factory of Terumo Corporation<br>150 Maimaigi-cho<br>Fujinomiya city, Shizuoka Pref.<br>Japan 418-0015<br>Registration No. 9681834 |
| Owner Operator: | Terumo Corporation<br>44-1, 2-chome, Hatagaya,<br>Shibuya-ku, Tokyo<br>Japan 151-0072<br>Registration No. 8010026 |
| Distributor (in U.S.): | Terumo Medical Corporation<br>2101 Cottontail Lane<br>Somerset, NJ 08873<br>Registration No. 2243441 |

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three curved lines representing the wings and two curved lines representing the tail feathers.

Public Health Service

SEP 1 2 2005

Food and Drug Administratic 9200 Corporate Boulevard Rockville MD 20850

Mr. Garry A. Courtney, MBA, RAC Sr. Regulatory Affairs Specialist Terumo Cardiovascular Systems Corp. 125 Blue Ball Road Elkton, MD 21921

K052205 Re:

> Trade/Device Name: CAPIOX® AF125X Arterial Filter Regulation Number: 21 CFR 870.4260 Regulation Name: Cardiopulmonary Bypass Arterial Line Blood Filter Regulatory Class: II Product Code: DTM Dated: August 1, 2005 Received: August 12, 2005

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.

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

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

Page 2 - Mr. Garry A. Courtney, MBA, RAC

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
s (21 CFR 100 (2006) (2006) (21 consisted on 521-542 of the Act); 21 CFR 100 forth in the quality systems (QS) regulation (2 - CFR 1 a ct the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 53 -542 of the Action Section 5 product radiation control provisions (Sections 35 device as described in your Section 510(k)
This letter will allow you to begin marketing your device of your device to a leg This letter will allow you to begin marketing your device of your device of your device to a legally
premarket notification. The FDA inning if your device and his permits y premarket notification. The FDA finding of substantial equive 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), please
rs the register and and and 101 - Alge - Alge - Alge - plasse note the regu If you desire specific advice for your ue vice on our nooning nease note the regulation entitled,
contact the Office of Compliance at [phone]. Also, please note the r contact the Office of Compliance at (240) 270 - 1200 Part 807.97). You may obtain
"Misbranding by reference to premarket notification of Small "Misbranding by reterence to prematicalities under the Act from the Division of Small
other general information on your responsibilities under the Acc from the Division of Sm other general information on your responsibilities and its toll-free mumber [phone] or
Manufacturers, International and Consumer Assistance at its toll-free number (fi Manufacturers, International and Consumer Assistance at lo con in o an in e a.
[phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Oma R. Holmes

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

Enclosure

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

#### Indications for Use

# 510(k) Number (if known): Unkown at time of Submission K0 5 22 6 S

#### CAPIOX® AF125X Arterial Filter _______________________________________________________________________________________________________________________________________________ Device Name:

#### Indications For Use:

The Capiox® AF125X Arterial Blood Filter is intended to filtere non-biologic particles and The Capiox" AFT25X Arterial Blood Thich is Interior is Intended to Theath a cardiopulmonary bypass circuit for up to 6 hours.

Larry A. Courtney, MBA, RAC 8/01/2005

Terumo Cardiovascular Systems

XX Prescription Use _ (Part 21 CFR 801 Subpart D) OR

Over-The-Counter Use (Part 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Vc lanes

(Division Sign-Off) Division of Cardiovascular Devices

510(k) number k052205