(26 days)
Not Found
No
The summary describes a physical filter device and its performance characteristics, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
Explanation: The device is used to trap and remove gaseous emboli and particulate debris from the arterial line during cardiopulmonary bypass, which directly contributes to the treatment and prevention of adverse effects during a medical procedure.
No
The device is described as a filter used to trap and remove gaseous emboli and particulate debris from the arterial line during cardiopulmonary bypass. It is a therapeutic device, not a diagnostic one, as it directly intervenes to remove harmful substances rather than to identify a condition or provide information about a medical state.
No
The device description clearly describes a physical filter with a screen and housing, intended for use in a cardiopulmonary bypass circuit. This is a 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 in the arterial line of an extracorporeal circuit during cardiopulmonary bypass. This is a therapeutic/surgical intervention performed directly on the patient's blood flow, not a test performed on a sample of blood or other biological material outside the body to diagnose a condition.
- Device Description: The description details a physical filter designed to remove particles and air from blood flowing through it. This aligns with a medical device used in a procedure, not a diagnostic test.
- Performance Studies: The performance studies focus on the physical and functional characteristics of the filter (filtration efficiency, pressure drop, hemolysis, etc.) in the context of blood flow, not on the accuracy or reliability of a diagnostic measurement.
IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device operates in vivo (within the body's circulating blood) as part of a medical procedure.
N/A
Intended Use / Indications for Use
The D131 Dideco Kids with 40 micron screen phosphorilcholine (Ph.I.S.I.O.) coated is recommended for use in the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass. The filter is used to trap and remove gaseous emboli as well as particulate debris that maybe introduced through the arterial line. The device should not be used longer than 6 hours. Contact with blood for longer periods is not advised.
Product codes
DTM
Device Description
The D131 Ph.I.S.I.O. is a sterile, non-pyrogenic disposable filter for use in arterial line of the cardiopulmonary bypass circuit with the flow rate not exceeding 2.5 liters/minute. The D131 Ph.I.S.I.O. is a Infant Arterial Filter with a 40 micron filter screen designed to remove potentially harmful gaseous emboli, aggregated blood constituents, and particulate debris greater than 40 microns from the arterial line agground blood been reduced in the modified in the modified version of the D736 Ph.I.S.I.O. unmodified device resulting in decreased priming volume and surface area of the filtering material. The internal modifications which mainly involve the filter screen geometry, make the new filter essentially a downscaled and simplified version of the D736 Ph.I.S.I.O.. The modifications to some of the external features result in enhanced ergonomics.
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
Infant Arterial Filter, Newborn Arterial Filter
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 testing was carried out in accordance with the relevant requirements of "Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submission" Final Guidance for Industry, dated November 29, 2000 for providing the data necessary to demonstrate both substantial equivalence with the unmodified device and show that the device is compliant with safety and effectiveness requirements. The device was aged up to 3 years (+ 1 additional year of aging in order to test a truly worst case) and tested for operating blood volume, structural integrity test, pressure integrity test, pressure drop, filter flow rate capacity, in vitro hemolysis/cell depletion, filtration efficiency, leaching and air handling characteristics. For comparative purposes all tests, when applicable, were performed on sterilized aged devices comparing the D131 Ph.I.S.I.O. vs. the D736 Ph.I.S.I.O. operated at same max blood flow. The results of these tests met established specifications.
The results of in vitro studies demonstrate that the design modifications result in reduced priming volume and pressure drop with an effective filter flow rate capacity at all blood flow rates as compared to the D736 Ph.I.S.I.O. unmodified device. Both filters demonstrated a comparable structural integrity, hemolysis/cell depletion at the maximum blood flow. Both devices share similar removal capability for microbubbles as well as air bolus introduced in the circuit at minimum, mean and maximum blood flow tested. Likewise both filters demonstrated comparable filtration efficiency with an overall mean percent removal greater than 80% for particles equal to the nominal pore size of the filter (40p). The D131 Ph.l.S.I.O. filter demonstrated integrity when pressurized over the maximum recommended pressure and no analytical evidence of the possibility of leaching of phosphoriylcholine coating from the D131 Ph.l.S.I.O. was evidenced during the leaching test. The results are in line with expectations because the D131 Ph.I.S.I.O. is smaller in overall size, has a more compact design, and contains a different filter screen design as compared to the unmodified device. The smaller size offers theoretical advantages in terms of reduced priming volume and consequently less hemodilution. A lower priming volume is desirable as it results in advantageous patient hemodynamics, reduced exposure of the blood cells and plasma proteins to large surface areas.
Biocompatibility tests demonstrate that its performance is equivalent to the D736 Ph.I.S.I.O. unmodified device, according to its intended use. Additional testing has demonstrated the effectiveness of production techniques assuring that the newborn arterial filter is sterile and non-pyrogenic.
Key Metrics
filtration efficiency with an overall mean percent removal greater than 80% for particles equal to the nominal pore size of the filter (40p)
Predicate Device(s)
D130 Dideco Kids Newborn Arterial Filter with 40 micron screen phosphorylcholine (Ph.I.S.I.O.) coated (hereinafter referred to as D130 Ph.I.S.I.O.) originally cleared for use with a maximum blood flow rate of 0.7 l/min under K063255 is manufactured by Sorin group Italia S.r.l.
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
510(k) SUMMARY
| SUBMITTER: | Sorin Group Italia S.r.l.
86, Via Statale 12 Nord
41037 Mirandola (MO) Italy | SEP 12 2007 |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| CONTACT PERSON: | Luigi Vecchi
Phone: 011 39 0535 29811
Fax: 011 39 0535 25229 | |
| DATE PREPARED: | August 16, 2007 | |
| DEVICE TRADE NAME: | D131 Dideco Kids Infant Arterial Filter with 40 micron screen
phosphorylcholine (Ph.I.S.I.O.) coated (hereafter referred to
as D131 Ph.I.S.I.O.) | |
| COMMON NAME: | Arterial Filter | |
| CLASSIFICATION NAME: | Cardiopulmonary Bypass Arterial Line Blood Filter | |
| LEGALLY MARKETED UNMODIFIED DEVICE | D736 MICRO 40 Ph.I.S.I.O.: Dideco Newborn-Infant Arterial
Filter with Ph.I.S.I.O. coating (Phosphorilcholine coating) as
described in K002493 and modified in K033987 | |
| PREDICATE DEVICE: | D130 Dideco Kids Newborn Arterial Filter with 40 micron
screen phosphorylcholine (Ph.I.S.I.O.) coated (hereinafter
referred to as D130 Ph.I.S.I.O.) originally cleared for use with
a maximum blood flow rate of 0.7 l/min under K063255 is
manufactured by Sorin group Italia S.r.l. | |
DEVICE DESCRIPTION:
The D131 Ph.I.S.I.O. is a sterile, non-pyrogenic disposable filter for use in arterial line of the cardiopulmonary bypass circuit with the flow rate not exceeding 2.5 liters/minute. The D131 Ph.I.S.I.O. is a Infant Arterial Filter with a 40 micron filter screen designed to remove potentially harmful gaseous emboli, aggregated blood constituents, and particulate debris greater than 40 microns from the arterial line agground blood been reduced in the modified in the modified version of the D736 Ph.I.S.I.O. unmodified device resulting in decreased priming volume and surface area of the filtering material. The internal modifications which mainly involve the filter screen geometry, make the new filter essentially a downscaled and simplified version of the D736 Ph.I.S.I.O.. The modifications to some of the external features result in enhanced ergonomics.
INDICATION FOR USE:
The D131 Dideco Kids with 40 micron screen phosphorilcholine (Ph.I.S.I.O.) coated is recommended for use in the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass. The filter is used to trap and remove gaseous emboli as well as particulate debris that maybe introduced through the arterial line. The device should not be used longer than 6 hours. Contact with blood for longer periods is not advised.
TECHNOLOGICAL CHARACTERISTICS:
The D131 Ph.I.S.I.O. has the same operating principles and control mechanisms when compared to the D736 Ph.I.S.I.O. unmodified device and D130 Ph.I.S.I.O. predicate device. The D131 Ph.I.S.I.O. utilizes the
1
same materials, the same filtering media, the same main blood flow path and the same filtering pore size (40 micron) as both the unmodified and predicate devices.
million) as both the unitiounce and products and seen updated with respect to those of the current D736 The Gesign leatures of the D101 Ph.I.S.I.O. shares essentially the D131 Ph.I.S.I.O. shares essentially the same PIT.C.S.C. Newbon-mail diffindined act not not hose in actuate device. No change of the intended basic design philosophy and goornely with the fevice. Both devices share the identical manufacturing use has been made for the modified torolor or the active and has a nonpyrogenic fluid path. It is for single use only.
BIOCOMPATIBILITY TEST RESULTS:
As no new materials are used into the D131 Ph..S.I.O. infant arterial filter as compared to the D130 Ph.I.S.I.O. predicate device, data collected on aged D130 Ph.I.S.I.O. samples (K063255) are considered applicable also to the D131 Ph.I.S.I.O. modified device. A complete battery of tests were conducted in applicance with the requirements of ISO 10993-12002 and the FDA May 1, 1995 Memorandum on the use of the ISO 10993 standard for biocompatibility testing on the raw materials. Testing was performed on the D 130 Ph.I.S.I.O. (accelerated aging). The results of the testing met established specifications.
IN VITRO TEST RESULTS:
In vitro testing was carried out in accordance with the relevant requirements of "Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submission" Final Guidance for Industry, dated November 29, 2000 for providing the data necessary to demonstrate both substantial equivalence with the unmodified device and show that the device is compliant with safety and effectiveness requirements. The device was aged up to 3 years (+ 1 additional year of aging in order to test a truly worst case) and tested for operating blood volume, structural integrity test, pressure integrity test, pressure drop, filter flow rate capacity, in vitro hemolysis/cell depletion, filtration efficiency, leaching and air handling characteristics. For comparative purposes all tests, when applicable, were performed on sterilized aged devices comparing the D131 Ph.I.S.I.O. vs. the D736 Ph.I.S.I.O. operated at same max blood flow. The results of these tests met established specifications..
CONCLUSIONS:
The results of in vitro studies demonstrate that the design modifications result in reduced priming volume and pressure drop with an effective filter flow rate capacity at all blood flow rates as compared to the D736 Ph.I.S.I.O. unmodified device. Both filters demonstrated a comparable structural integrity, hemolysis/cell depletion at the maximum blood flow. Both devices share similar removal capability for microbubbles as well as air bolus introduced in the circuit at minimum, mean and maximum blood flow tested. Likewise both filters demonstrated comparable filtration efficiency with an overall mean percent removal greater than 80% for particles equal to the nominal pore size of the filter (40p). The D131 Ph.l.S.I.O. filter demonstrated integrity when pressurized over the maximum recommended pressure and no analytical evidence of the possibility of leaching of phosphoriylcholine coating from the D131 Ph.l.S.I.O. was evidenced during the leaching test. The results are in line with expectations because the D131 Ph.I.S.I.O. is smaller in overall size, has a more compact design, and contains a different filter screen design as compared to the unmodified device. The smaller size offers theoretical advantages in terms of reduced priming volume and consequently less hemodilution. A lower priming volume is desirable as it results in advantageous patient hemodynamics, reduced exposure of the blood cells and plasma proteins to large surface areas.
Biocompatibility tests demonstrate that its performance is equivalent to the D736 Ph.I.S.I.O. unmodified device, according to its intended use. Additional testing has demonstrated the effectiveness of production techniques assuring that the newborn arterial filter is sterile and non-pyrogenic
In conclusion test result of this study suggests the D131 Ph.I.S.I.O. arterial filter is equivalent to the D736 Ph.I.S.I.O. arterial filter with respect to device function.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and head. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850
Sorin Group Italia S.R.L c/o Mr. Barry Sall Principal Consultant Parexel Consulting 200 West Street Waltham. MA 02451
SEP 1 2 2007
K072308 Re:
D131 Ph.I.S.I.O. Dideco Kids Infant Arterial Filter Regulation Number: 21 CFR 870.4260 Regulation Name: Cardiopulmonary bypass arterial line blood filter Regulatory Class: Class II Product Code: DTM Dated: August 16, 2007 Received: August 17, 2007
Dear Mr. Sall:
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.
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Page 2- Mr. Barry Sall
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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SORIN GROUP
AT THE HEART OF MEDICAL TECHNOLOGY
Sorin Group Italia S.r.l.
510(k) Number (if known):
14072308
Device Name: D131 Dideco Kids Infant Arterial Filter with 40 micron screen phosphorycholine (Ph.J.S.I.O.) coated
Indications For Use:
D131 Dideco Kids with 40 micron screen phosphorylcholine (Ph.I.S.I.O.) coated is recommended for use in the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass. The filter is used to trap and remove gaseous emboli as particulate debris that maybe introduced through the arterial line. The device should not be used longer than 6 hours. Contact with blood for longer periods is not advised.
Prescription Use X (Part 21 CFR 801 Subpart D) and/or Over-The-Counter Use (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)
Division of Bro