(31 days)
Not Found
Not Found
No
The summary describes a blood filter, a mechanical device, and contains no mention of AI, ML, image processing, or software that would typically incorporate such technologies.
Yes
The device is intended to filter non-biologic particles within a bypass circuit, which is a therapeutic intervention aimed at improving patient outcomes during medical procedures.
No
Explanation: The device is an arterial blood filter, intended to filter non-biologic particles from blood in a bypass circuit. An arterial blood filter is a therapeutic device, not a diagnostic one, as it treats a condition by removing particles rather than identifying or characterizing a disease or condition.
No
The device description and intended use clearly describe a physical arterial blood filter, which is a hardware component, not software.
Based on the provided information, the Capiox® AF125X Arterial Blood Filter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "filter non-biologic particles" within a bypass circuit. This describes a device used during a medical procedure on a patient, not a device used to test samples outside the body to diagnose or monitor a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Measuring analytes or biomarkers
- Being used in a laboratory setting
The device is clearly intended for use within a surgical or medical procedure to filter blood in a bypass circuit. This falls under the category of a medical device used for treatment or support, not for in vitro diagnosis.
N/A
Intended Use / Indications for Use
The Capiox® AF125X Arterial 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.
Product codes (comma separated list FDA assigned to the subject device)
DTM
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.4260 Cardiopulmonary bypass arterial line blood filter.
(a)
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.(b)
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.”
0
Section I: General Information Terumo Cardiovascular Systems Capiox® AF125X Arterial Filter
SEP 1 2 2005
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:
Contact Person: | Garry A. Courtney, MBA, RAC
Terumo Cardiovascular Systems Corp.
125 Blue Ball Road
Elkton, MD 21921
Registration No. 1124841
Phone: 1-800-283-7866, Extension 7420
(410) 398-6079
Fax: |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer/Sterilizer: | Ashitaka Factory of Terumo Corporation
150 Maimaigi-cho
Fujinomiya city, Shizuoka Pref.
Japan 418-0015
Registration No. 9681834 |
| Owner Operator: | Terumo Corporation
44-1, 2-chome, Hatagaya,
Shibuya-ku, Tokyo
Japan 151-0072
Registration No. 8010026 |
| Distributor (in U.S.): | Terumo Medical Corporation
2101 Cottontail Lane
Somerset, NJ 08873
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 (240) 276-0120. 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 (800) 638-2041 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.
(301) 443-6597 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