(13 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.
Yes
The device is used in cardiopulmonary bypass procedures to remove particulate and gaseous microemboli, which is a therapeutic intervention aimed at treating or preventing a medical condition.
No
The device is described as a filter for removing particulate and gaseous microemboli during cardiopulmonary bypass procedures, indicating it is a therapeutic device rather than a diagnostic one.
No
The device description clearly indicates it is a physical filter designed to remove microemboli from blood during cardiopulmonary bypass, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for filtering blood during cardiopulmonary bypass procedures to remove particulate and gaseous microemboli. This is a therapeutic/supportive function performed on blood within the extracorporeal circuit, not a diagnostic test performed on a sample of blood or other biological material outside the body to provide information about a patient's health status.
- Device Description: The description reinforces its function as a filter within an extracorporeal circuit.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
IVD devices are typically used to examine specimens (like blood, urine, tissue) to diagnose diseases, monitor conditions, or screen for health issues. This device's function is purely mechanical filtration within a surgical procedure.
N/A
Intended Use / Indications for Use
The AFFINITY® 38 µ Arterial Filter with Trillium™ Biopassive Surface is indicated for use in cardiopulmonary bypass procedures for the removal of particulate and gaseous microemboli.
Product codes
DTM
Device Description
The AFFINITY® 38 µ Arterial Blood Filter with Trillium™ Biopassive Surface is a single use device designed to filter microemboli from the blood in the extracorporeal circuits during cardiopulmonary bypass surgery.
The AFFINITY® 38 µ Arterial Blood Filter with Trillium™ Biopassive Surface is coated with a non-leaching biopassive surface.
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® 38 µ Arterial Blood Filter with Trillium™ Biopassive Surface does not significantly affect safety and effectiveness and are substantially equivalent to other commercially distributed extracorporeal cardiopulmonary devices. 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.”
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SEP 2 7 2001
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
Marie L. Holm. Associate Product Regulations Manager, Regulatory Affairs
DEVICE NAME
AFFINITY® 38 µ Arterial Blood Filter with Trillium™ Biopassive Surface
NAME OF PREDICATED OR LEGALLY MARKETED DEVICE
AFFINITY® 38 µ Arterial Blood Filter (K952532) AFFINITY® Hollow Fiber Oxygenator with Trillium™ Biopassive Surface (K973760)
DESCRIPTION OF DEVICE
The AFFINITY® 38 µ Arterial Blood Filter with Trillium™ Biopassive Surface is a single use device designed to filter microemboli from the blood in the extracorporeal circuits during cardiopulmonary bypass surgery.
The AFFINITY® 38 µ Arterial Blood Filter with Trillium™ Biopassive Surface is coated with a non-leaching biopassive surface.
STATEMENT OF INTENDED USE
The AFFINITY® 38 µ Arterial Blood Filter with Trillium™ Biopassive Surface is indicated for use in cardiopulmonary bypass procedures for the removal of particulate and gaseous microemboli.
STATEMENT OF INTENDED USE OF PREDICATED/MARKETED DEVICE
The AFFINITY® 38 // Arterial Blood Filter is indicated for use in cardiopulmonary bypass procedures for the removal of particulate and gaseous microemboli.
AFFINITY® 38 µ Arterial Filter with Trillium™ Biopassive Surface
1
STATEMENT OF TECHNOLOGICAL CHARACTERISTICS COMPARISON
Information regarding technological characteristics comparison is provided in the following section, "Determination of Substantial Equivalence".
DETERMINATION OF SUBSTANTIAL EQUIVALENCE
This "SPECIAL 510(k)" is being submitted for a modification to the AFFINITY® 38 u Arterial Blood Filter. The modification to the current AFFINITY® 38 u Arterial Blood Filter is to coat the primary blood contact surfaces with Trillium™.
The AFFINITY® 38 µ Arterial Blood Filter with Trillium™ Biopassive Surface is being compared to the following Marketed Devices:
- . AFFINITY® 38 µ Arterial Blood Filter (K952532)
- AFFINITY® Hollow Fiber Oxygenator with Trillium™ Biopassive Surface . (K973760)
The AFFINITY® 38 u Arterial Blood Filter with Trillium™ Biopassive Surface Trillium™ has the same indications statement and intended uses as the:
-
AFFINITY® 38 u Arterial Blood Filter (K952532) .
The AFFINITY® 38 µ Arterial Blood Filter with Trillium™ Biopassive Surface has "no new technological characteristics (e.g., materials and manufacturing processes)" from the AFFINITY® 38 µ Arterial Blood Filter. The technological characteristic is solely the coating material of the blood pathway: -
Trillium™ .
The technological characteristic of the Trillium™ Biopassive Surface is common to other medical devices (hollow fiber oxygenators) currently in commercial distribution as follows: -
AFFINITY® Hollow Fiber Oxygenator with Trillium™ Biopassive Surface . (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® 38 u Arterial Blood Filter with Trillium™ Biopassive Surface is
AFFINITY® 38 u Arterial Filter with Trillium™ Biopassive Surface
2
substantially equivalent to other marketed extracorporeal cardiopulmonary devices.
The biocompatibility and in vitro bench testing demonstrated that when ompaged The predicate devices, the AFFINITY® 38 // Arterial Blood Filter with Trillium™ to the predicate donooo, the Aignificantly affect safety and effectiveness and are Diopaorro Garraco ent to other commercially distributed extracorporeal Substantially oquivaloritions to othe in vitro bench testing included analysis of:
- Coating Characteristics .
- Physical Characteristics .
- Performance Characteristics .
3
Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
SEP 2 7 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Marie L. Holm Associate Product Regulations Manager Medtronic Perfusion Systems 7611 Northland Drive N Minneapolis, MN 55428-1088
Re: K013084
Trade Name: AFFINITY® 38 µ Arterial Filter with Trillium™ Biopassive Surface Regulation Number: 21 CFR 870.4260 Regulation Name: Cardiopulmonary bypass arterial line blood filter Regulatory Class: II Product Code: DTM Dated: September 11, 2001 Received: September 14, 2001
Dear Ms. Holm:
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 for assumer 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 he 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
4
Page 2 - Ms. Marie L. Holm
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic rorth in also quand byovisions (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) 594-4586. 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,
Valla Tuh
Thomas E. Dillard III
James E. Dillard II Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510 (k) Number if known: _ LO13084
Device Name: AFFINITY® 38 µ Arterial Filter with Trillium™ Biopassive Surface
Indications for Use:
The AFFINITY® 38 µ Arterial Filter with Trillium™ Biopassive Surface is indicated for use in cardiopulmonary bypass procedures for the removal of particulate and gaseous microemboli.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K013084
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter use _________________________________________________________________________________________________________________________________________________________