(31 days)
Not Found
No
The document describes a physical blood filter and does not mention any computational or algorithmic components, let alone AI/ML.
No.
The device is an arterial filter used in an extracorporeal circuit to remove emboli and particulate debris, which is a supportive function during a medical procedure, not a direct treatment for a disease or condition.
No
This device is an arterial filter designed to remove emboli and particulate debris from the blood during cardiopulmonary bypass. It is used to purify blood, not to diagnose a condition.
No
The device description clearly indicates it is a physical arterial blood filter with a 40 µm screen, designed to trap and remove emboli and particulate debris. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Dideco Micro 40 Ph.I.S.I.O. Adult Arterial Filter is a physical filter designed to remove gaseous emboli and particulate debris from blood during a medical procedure (cardiopulmonary bypass). It is not analyzing a sample to provide diagnostic information.
- Intended Use: The intended use clearly states it's for use in the arterial line of an extracorporeal circuit during cardiopulmonary bypass. This is a therapeutic/supportive function, not a diagnostic one.
Therefore, this device falls under the category of a medical device used in a therapeutic procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Dideco Micro 40 Ph.I.S.I.O. Adult Arterial Filter is recommended for use in the arterial line of extracorporeal circuit during any procedure that requires cardiopulmonary bypass, for periods up to six hours of use. The filters are effective in trapping and removing gaseous emboli as well as particulate debris that may be introduced through the arterial line.
Product codes
DTM
Device Description
The Dideco Micro 40 Ph.I.S.I.O Adult Arterial Filter is an arterial blood filter with a 40 µm screen. The fitter is designed to permit the effective separation of gaseous emboli and remove blood components aggregates present in the arterial line. The blood contact surfaces of the arterial filter have been modified to improve blood compatibility.
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
Adult
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
In-vitro tests were performed to demonstrate that the Dideco Micro 40 Ph.I.S.I.O. Adult Arterial Filter described in this submission is substantially equivalent to the unmodified version, the Dideco Micro 40 Adult Arterial Filter.
Key Metrics
Not Found
Predicate Device(s)
Dideco Micro 40 Adult Arterial Filter
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.”
0
K040184
Pg 1 OF 2
FEB 26 2004
X. 510(k) SUMMARY
| SUBMITTER: | COBE Cardiovascular
14401 W 65th Way
Arvada, CO 80004. USA |
|-------------------------|------------------------------------------------------------------|
| CONTACT PERSON: | Lynne Leonard
E-mail: lynne.leonard@cobecv.com |
| | Phone: 303-467-6194 |
| | Fax: 303-467-6429 |
| DATE PREPARED: | January 23, 2004 |
| DEVICE TRADE
NAME: | Dideco Micro 40 Ph.I.S.I.O. Adult Arterial Filter |
| COMMON/USUAL
NAME: | Arterial Filter |
| CLASSIFICATION
NAME: | Cardiopulmonary Bypass Arterial Line Blood Filter |
| PREDICATE DEVICE: | Dideco Micro 40 Adult Arterial Filter |
DEVICE DESCRIPTION:
The Dideco Micro 40 Ph.I.S.I.O Adult Arterial Filter is an arterial blood filter with a 40 µm screen. The fitter is designed to permit the effective separation of gaseous emboli and remove blood components aggregates present in the arterial line. The blood contact surfaces of the arterial filter have been modified to improve blood compatibility.
INDICATIONS FOR USE:
The Dideco Micro 40 Ph.I.S.I.O Adult Arterial Filter is recommended for use in the arterial line of extracorporeal circuit during any procedure that requires cardiopulmonary bypass, for periods up to six hours. The filters are effective in trapping and removing gaseous emboli as well as particulate debris that may be introduced through the arterial line.
1
STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON:
The Dideco Micro 40 Ph.I.S.I.O. Adult Arterial Filter described in this submission is substantially equivalent to the unmodified version, the Dideco Micro 40 Adult Arterial Filter. The devices are identical in design, method of operation, and fundamental scientific technology. Both devices are intended to be used in adult surgical procedures requiring cardiopulmonary bypass for periods up to six hours. The devices differ in that the Dideco Micro 40 Ph.I.S.I.O Adult Arterial Filter contains a surface coating that improves the blood compatibility of the device.
TESTING TO DETERMINE SUBSTANTIAL EQUIVALENCE:
In-vitro tests were performed to demonstrate that the Dideco Micro 40 Ph.I.S.I.O. Adult Arterial Filter described in this submission is substantially equivalent to the unmodified version, the Dideco Micro 40 Adult Arterial Filter.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 26 2004
COBE Cardiovascular, Inc. c/o Ms. Lynne Leonard Regulatory Affairs, Submission 14401 W. 65th Way Arvada. CO 80004-3599
Re: K040184
Dideco Micro 40 Adult Arterial Filter Regulation Number: 21 CFR 870.4260 Regulation Name: Cardiopulmonary Bypass Arterial Line Blood Filter Regulatory Class: Class II (two) Product Code: DTM Dated: January 23, 2004 Received: January 27, 2004
Dear Ms. Leonard:
Wc 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. Lynne Leonard
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), 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) you may obtain. 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,
Dmar R. Lochner
ABram 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):
Dideco Micro 40 Ph.I.S.I.O. Adult Arterial Filter Device Name:
Indications For Use: The Dideco Micro 40 Ph.I.S.I.O. Adult Arterial Filter is recommended for use in the arterial line of extracorporeal circuit during any procedure that requires cardiopulmonary bypass, for periods up to six hours of use. The filters are effective in trapping and removing gaseous emboli as well as particulate debris that may be introduced through the arterial line.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DQ NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna D. Holmes
(Division Sign-Off) Division of Cardiovascular Devices
Page 1 of 1
510(k) Number KU40184