(11 days)
Not Found
No
The summary describes a physical blood filter and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
This device is designed for filtering blood during cardiopulmonary bypass procedures, which is a supportive function rather than directly treating a medical condition.
No
Explanation: The device is an arterial blood filter designed to remove particulate and gaseous microemboli during cardiopulmonary bypass procedures. Its stated function is filtration, not diagnosis.
No
The device description clearly states it is a "single use device designed to filter microemboli from the blood," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to filter blood during cardiopulmonary bypass procedures. This is a therapeutic intervention performed on the patient's blood outside the body, but it's not for the purpose of diagnosing a condition.
- Device Description: The device is described as a filter for removing microemboli from blood in an extracorporeal circuit. This aligns with a therapeutic or supportive device used during surgery, not a diagnostic test.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze blood for the presence of specific substances, markers, or conditions to aid in diagnosis.
IVD devices are specifically designed to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is purely mechanical filtration during a surgical procedure.
N/A
Intended Use / Indications for Use
The AFFINITY® 20 µ Arterial Blood Filter with Trillium™ Biosurface is indicated for use in cardiopulmonary bypass procedures up to 6 hours in duration for the removal of particulate and gaseous microemboli.
Product codes (comma separated list FDA assigned to the subject device)
74 DTM
Device Description
The AFFINITY® 20 µ Arterial Blood Filter with Trillium™ Biosurface is a single use device designed to filter microemboli from the blood in the extracorporeal circuits during cardiopulmonary bypass surgery.
The AFFINITY 20 µ Arterial Blood Filter with Trillium" Biosurface is coated with a nonleaching biosurface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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)
The biocompatibility and in vitro bench testing demonstrated that when compared to the predicate devices, the AFFINITY® 20 µ Arterial Blood Filter with Trillium™ Biosurface does not significantly affect safety and effectiveness and are substantially equivalent to other commercially distributed arterial filters. The in vitro bench testing included analysis of:
- Coating Characteristics .
- Physical Characteristics .
- . Performance Characteristics
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.
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
SUMMARY OF SAFETY AND EFFECTIVENESS
COMPANY AND CONTACT PERSON
Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428 Tel: (763) 391-9183 FAX: (763) 391-9603
Michele Pyfferoen, Requlatory Affairs Specialist, Requlatory Affairs
DEVICE NAME
AFFINITY® 20 µ Arterial Blood Filter with Trillium™ Biosurface
NAME OF PREDICATED OR LEGALLY MARKETED DEVICE
AFFINITY® 20 µ Arterial Blood Filter (K994208) AFFINITY® Hollow Fiber Oxygenator with Trillium™ Biosurface (K973760)
DESCRIPTION OF DEVICE
The AFFINITY® 20 µ Arterial Blood Filter with Trillium™ Biosurface is a single use device designed to filter microemboli from the blood in the extracorporeal circuits during cardiopulmonary bypass surgery.
The AFFINITY 20 µ Arterial Blood Filter with Trillium" Biosurface is coated with a nonleaching biosurface.
STATEMENT OF INTENDED USE
The AFFINITY® 20 µ Arterial Blood Filter with Trillium™ Biosurface is indicated for use in cardiopulmonary bypass procedures up to 6 hours in duration for the removal of particulate and gaseous microemboli.
STATEMENT OF INTENDED USE OF PREDICATED/MARKETED DEVICE
The AFFINITY® 20 µ Arterial Blood Filter is indicated for use in cardiopulmonary bypass procedures up to 6 hours in duration for the removal of particulate and gaseous microemboli.
STATEMENT OF TECHNOLOGICAL CHARACTERISTICS COMPARISON
Information regarding technological characteristics comparison is provided in the following section, "Determination of Substantial Equivalence".
1
DETERMINATION OF SUBSTANTIAL EQUIVALENCE
This "SPECIAL 510(k)" is being submitted for a modification to the AFFINITY® 20 µ Arterial Blood Filter. The modification to the current AFFINITY® 20 µ Arterial Blood Filter is to coat the blood contact surfaces with Trillium".
The AFFINITY®20 µ Arterial Blood Filter with Trillium™ Biosurface is being compared to the following Marketed Devices:
- AFFINITY® 20 u Arterial Blood Filter (K994208) .
- AFFINITY® Hollow Fiber Oxygenator with Trillium™ Biosurface (K973760) ●
The AFFINITY® 20 µ Arterial Blood Filter with Trillium™ Biosurface Trillium™ has the same indications statement and intended uses as the:
-
AFFINITY® 20 µ Arterial Blood Filter (K994208) .
The AFFINITY® 20 µ Arterial Blood Filter with Trillium™ Biosurface has "no new technological characteristics (e.g., materials and manufacturing processes)" from the AFFINITY® 20 µ Arterial Blood Filter. The technological characteristic is solely the coating material of the blood contact surface: -
Trillium™ .
The technological characteristic of the Trillium™ Biosurface is common to other medical devices (hollow fiber oxygenators) currently in commercial distribution as follows: -
AFFINITY® Hollow Fiber Oxygenator with Trillium™ Biosurface (K973760) .
This technological characteristic "could affect the safety and effectiveness of the device". However, these "technological characteristics do not raise new types of safety or effectiveness questions". In addition, "there are acceptable scientific methods which exist for assessing effects of these new technological characteristics".
"Performance data to assess the effects of these new technological characteristics" has been performed. These "performance data demonstrate" that the AFFINITY" 20 µ Arterial Blood Filter with Trillium™ Biosurface is substantially equivalent to other marketed arterial filters.
The biocompatibility and in vitro bench testing demonstrated that when compared to the predicate devices, the AFFINITY® 20 µ Arterial Blood Filter with Trillium™ Biosurface does not significantly affect safety and effectiveness and are substantially equivalent to other commercially distributed arterial filters. The in vitro bench testing included analysis of:
- Coating Characteristics .
- Physical Characteristics .
- . Performance Characteristics
| Special 510 (k) Notification | AFFINITY® 20 μ Arterial Filter with | Confidential |
|---|---|---|
| Medtronic, Inc. | Trillium™ Biosurface | Page 17 |
| Medtronic Perfusion Systems |
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal is circular and features the department's name around the perimeter. In the center of the seal is an emblem of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans and provide essential human services.
Public Health Service
NOV 1 4 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtronic Perfusion Systems c/o Ms. Michele Pyfferoen 7611 Northland Drive Minneapolis, MN 55428
Re: K033468
AFFINITY® 20μ Arterial Filter with Trillium™ Biosurface Regulation Number: 21 CFR 870.4260 Regulation Name: Cardiopulmonary Bypass Arterial Line Blood Filter Regulatory Class: Class II (two) Product Code: 74 DTM Dated: October 31, 2003 Received: November 3, 2003
Dear Ms. Pyfferoen:
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.
3
Page 2 - Ms. Michele Pyfferoen
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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Bram D. Zuckernan, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known) K 033468
Device Name:
AFFINITY® 20μ Arterial Filter with Trillium™ Biosurface
Indications for Use:
The AFFINITY® Arterial Filter with Trillium™ Biosurface is indicated for use in cardiopulmonary bypass procedures up to 6 hours in duration for the removal of particulate and gaseous microemboli.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
O.M.
vascular Devices
Ko 33468 510(k) Number
(Optional Format 3-10-98)