(30 days)
The Arterial Filter is indicated for use in cardiopulmonary bypass procedures for the removal of particulate and gaseous microemboli.
The 20 u arterial blood filter is a single use device designed to filter microemboli from the blood in the extracorporeal circuits during cardiopulmonary bypass surgery.
Acceptance Criteria and Study for AFFINITY® 20u Arterial Blood Filter
The provided document describes the submission of a "SPECIAL 510(k)" for the AFFINITY® 20u Arterial Blood Filter, which is a modification of an existing device (AFFINITY® 38u Arterial Blood Filter) with a change only in the filter pore size. The review focuses on demonstrating substantial equivalence to predicate devices, specifically the AFFINITY® 38u Arterial Blood Filter and the INTERSEPT® 20 µ Arterial Blood Filter.
No Acceptance Criteria or Device Performance Table Provided:
The provided text does not explicitly state specific acceptance criteria with quantifiable targets for each characteristic (e.g., "Prime volume must be less than X mL"). Instead, it states that the in vitro bench testing demonstrated that the AFFINITY® 20µ Arterial Blood Filter "does not significantly affect safety and effectiveness and are substantially equivalent to other commercially distributed arterial filters" when compared to predicate devices. Therefore, a table of acceptance criteria and reported device performance cannot be created from the given information.
The study aimed to demonstrate that the new device, despite a change in a technological characteristic (pore size), does not raise new types of safety or effectiveness questions and that its performance is substantially equivalent to legally marketed predicate devices.
Study Details:
-
Acceptance Criteria and Reported Device Performance:
As noted above, no specific quantitative acceptance criteria or reported performance values are provided. The general acceptance criterion was "does not significantly affect safety and effectiveness and are substantially equivalent to other commercially distributed arterial filters" compared to predicate devices.The in vitro bench testing included analysis of the following characteristics to demonstrate substantial equivalence:
- I. Physical Characteristics:
- Prime volume
- Pressure integrity
- II. Performance Characteristics:
- Pressure drop
- Ease of prime
- Filtration efficiency
- Microemboli removal
- Bolus air management
- Blood trauma
- I. Physical Characteristics:
-
Sample Size used for the test set and the data provenance:
The document does not specify the exact sample size for the test set used in the in vitro bench testing. It only states that "Performance data to assess the effects of these new technological characteristics has been performed." The data provenance is also not specified; however, given it's an in vitro bench test, it would have been conducted in a laboratory setting. It is inherently prospective as it involves new testing of the modified device. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the study appears to be entirely in vitro bench testing of physical and performance characteristics, not an evaluation requiring expert interpretation or human "ground truth" establishment in the typical clinical sense. The "ground truth" for these tests would be established by validated measurement techniques and comparison against established performance benchmarks of predicate devices. -
Adjudication method for the test set:
This information is not applicable as the study involves in vitro bench testing, not an evaluation requiring independent adjudication of clinical findings or expert consensus. -
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. The study described is an in vitro bench testing comparison of a device's physical and performance characteristics to predicate devices. It does not involve human readers or AI assistance. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, a standalone algorithm-only performance study was not done. This device is a physical medical device (an arterial blood filter), not an algorithm or AI system. -
The type of ground truth used:
The "ground truth" for this in vitro bench testing would be derived from objective measurements obtained through standard scientific methods for each physical and performance characteristic (e.g., precise volume measurements for prime volume, pressure sensors for pressure drop, various measurement techniques for filtration efficiency and microemboli removal). The performance of the predicate devices would serve as the comparative ground for demonstrating substantial equivalence. -
The sample size for the training set:
This information is not applicable. The device is a physical medical device and does not involve machine learning or AI, and therefore does not have a "training set" in the context of data-driven models. -
How the ground truth for the training set was established:
This information is not applicable, as there is no "training set" for this physical device.
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K 994208
SUMMARY OF SAFETY AND EFFECTIVENESS
COMPANY AND CONTACT PERSON
Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428 Tel: 612-391-9000 FAX: 612-391-9603
Marie Holm, Associate Product Regulations Manager, Regulatory/Clinical Affairs Debra Kridner, Director of Regulatory/Clinical Affairs
DEVICE NAME
AFFINITY® 20u Arterial Blood Filter
NAME OF PREDICATED OR LEGALLY MARKETED DEVICE
AFFINITY® 38 u Arterial Blood Filter (K952532) INTERSEPT® 20 µ Arterial Blood Filter (K926413)
DESCRIPTION OF DEVICE
The 20 u arterial blood filter is a single use device designed to filter microemboli from the blood in the extracorporeal circuits during cardiopulmonary bypass surgery.
STATEMENT OF INTENDED USE
The Arterial Filter 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 Arterial Filter is indicated for use in cardiopulmonary bypass procedures for the removal of particulate and gaseous microemboli.
The INTERSEPT® and Medtronic arterial blood filter is indicated for use in all cardiopulmonary bypass procedures for the removal of particulate and gaseous microemboli from the arterial line.
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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® Arterial Blood Filter. The modification is to change only the filter pore size and market both a 38 u and 20 u Arterial Blood Filter.
The AFFINITY® 20 u Arterial Blood Filter is being "compared to the following Marketed Devices":
The AFFINITY® 20 u Arterial Blood Filter has the "same indications statement and intended uses" as the:
The AFFINITY® 20 u Arterial Blood Filter has "new technological characteristics (e.g., design)" from the AFFINITY" 38 u Arterial Blood Filter. The new technological characteristic is solely the pore size of the micron filter:
-
. 20 μ
The technological characteristic of the 20 u screen is common to other arterial blood filters currently in commercial distribution as follows: -
· INTERSEPT® 20 µ Arterial Blood Filter (K926413)
This technological characteristic "could affect the safety and effectiveness of the device". However, these "new technological characteristics do not raise new types of safety or effectiveness questions". In addition, "there are accepted 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 u Arterial Blood Filter is substantially equivalent to other marketed arterial filters.
| SPECIAL 510(k) NotificationMedtronic, Inc.Medtronic Perfusion Systems | AFFINITY® 20μ Arterial Blood FilterDecember 13, 1999 | ConfidentialAppendix IIPage 3 |
|---|---|---|
| ------------------------------------------------------------------------------- | ---------------------------------------------------------- | --------------------------------------- |
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The in vitro bench testing demonstrated that when compared to the predicate devices, the AFFINITY® 20 u Arterial Blood Filter 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:
I. Physical Characteristics
- a. Prime volume
- b. Pressure integrity
II. Performance Characteristics
- a. Pressure drop
- b. Ease of prime
- c. Filtration efficiency
- d. Microemboli removal
- Bolus air management e.
- ﻧﺖ Blood trauma
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized symbol consisting of three curved lines that resemble a person. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. The text is in all capital letters.
'JAN 1 3 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Marie Holm Associate Product Regulation Manager Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428
Re: K994208 AFFINITY® 20 Micron Arterial Blood Filter Regulatory Class: III Product Code: DTM Dated: December 13, 1999 Received: December 14, 1999
Dear Ms. Holm:
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 general controls provisions of the Act include the Act. 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 Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General (QS) requlation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Please note: this response to your premarket Register. 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.
This letter will allow you to continue marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed
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Page 2 - Ms. Marie Holm
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Acting Director Division of Cardiovascular Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number if known: メタウイコ0 8
Device Name: AFFINITY® 20 µ Arterial Blood Filter
Indications for Use:
The Arterial Filter is indicated for use in cardiopulmonary bypass procedures for the removal of particulate and gaseous microemboli.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sate L. Campbell
Division of Cardiovascular, Respiratory, and Neurological Device 510(k) Number
Prescription Use
(Per 21 CFR 801.109) X
OR
Over-The-Counter use
§ 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.”