(76 days)
No
The device description and performance studies focus on the physical characteristics and filtration capabilities of a blood filter, with no mention of AI or ML technologies.
No
This device is a filter used in an extracorporeal circuit to remove harmful substances from blood during cardiopulmonary bypass, which is a supportive function rather than a direct therapeutic treatment that addresses a disease or condition.
No
The device is a filter designed to remove particulate debris from blood during cardiopulmonary bypass, which is a therapeutic function, not a diagnostic one. It does not analyze patient data or provide information for diagnosis.
No
The device description clearly describes a physical filter with a screen, dimensions, and material coating, indicating it is a hardware device.
Based on the provided text, 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 and procedural use, not a diagnostic one.
- Device Description: The device is a filter designed to remove particulate debris and air from blood. This is a physical process applied to blood outside the body during a medical procedure, not a test performed on a sample of blood to diagnose a condition.
- No mention of diagnostic testing: The text describes the device's function in filtering blood and its performance in terms of filtration efficiency and structural integrity. There is no mention of analyzing blood components, detecting biomarkers, or providing information for diagnosis.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not perform such a function.
N/A
Intended Use / Indications for Use
The D130 Ph.I.S.I.O. Dideco Kids with 40 micron screen phosphorilcholine 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.
Product codes
DTM
Device Description
The D130 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 0.7 liters/minute. The D130 Ph.I.S.I.O. is a Neonatal Arterial Filters with 40 micron filter screen designed to remove potentially harmful gaseus embeli, aggregated blood constituents, and particulate debris greater than 40 microns from the arterial line perfusate. The overall dimensions have been reduced in the modified version of the D736 Ph.I.S.I.O. unmodified device resulting in decreased priming volume and maximum blood flow to 0.7 liters/minute. The internal modifications which mainly involve the filter screen geometry, make the new filter esently 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
Neonatal
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)
BIOCOMPATIBILITY TEST RESULTS: A complete battery of tests were carried out in accordance with the requirements of ISO 10993-1:2002 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 D130 Ph.I.S.I.O. (accelerated aging). The devices were aged up to three years and tested for Hemolysis, Hemocompatibility, Cytotoxicity, Irritation, Acute Systemic Toxicity and Mutagenicity, Sterility, Pyrogenicity and ETO residuals. Package integrity testing was also conducted. 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 Fitter 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 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 of the coating and air handling characteristics. For comparative purposes all tests, when applicable, were performed on sterilized aged devices comparing the D130 Ph.I.S.I.O. vs. the D736 Ph.J.S.I.O. operated at their related max blood flow. The results of these tests met established specifications. Since the D 736 Ph.I.S.I.O should be considered as a worst case with respect to the overall surface area in blood contact, blood compatibility characterization data presented in D 736 Ph.I.S.I.O. 510(K) (K002493) can be referenced.
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 and removal capability of microbubbles as well as air bolus introduced in the circuit. Likewise both filters demonstrated a comparable filtration efficiency with an overall mean percent removal greater than 80% for particles equal to the nominal pore size of the filter (40μ). The D130 Ph.I.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 D130 Ph.I.S.I.O. was evidenced the leaching test. The results are in line with expectations because the D130 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 hemodynamic, 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 aronuction techniques assuring that the newborn arterial filter is sterile and non-pyrogenic. In conclusion test result of this study suggests the D130 Ph.I.S.I.O. arterial filter is equivalent to the D736 Ph.I.S.I.O. arterial filter with respect to device function.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Overall mean percent removal greater than 80% for particles equal to the nominal pore size of the filter (40μ).
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.”
0
| 510(k) SUMMARY | ||
|---|---|---|
| SUBMITTER: | Sorin Group Italia S.r.l. | |
| 86, Via Statale 12 Nord | ||
| 41037 Mirandola (MO) Italy | ||
| CONTACT PERSON: | Luigi Vecchi | |
| Phone: 011 39 0535 29811 | ||
| Fax: 011 39 0535 25229 | JAN 11 2007 | |
| DATE PREPARED: | October 26, 2006 | |
| DEVICE TRADE NAME: | D130 Ph.I.S.I.O. Dideco Kids Neonatal Arterial Filter with 40 | |
| micron screen phosphorilcholine coated (hereafter referred | ||
| to as D130 Ph.I.S.I.O.) | ||
| COMMON NAME: | Arterial Filter | |
| CLASSIFICATION NAME: | Cardiopulmonary Bypass Arterial Line Blood Filter | |
| PREDICATE 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. |
DEVICE DESCRIPTION:
The D130 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 0.7 liters/minute. The D130 Ph.I.S.I.O. is a Neonatal Arterial Filters with 40 micron filter screen designed to remove potentially harmful gaseus embeli, aggregated blood constituents, and particulate debris greater than 40 microns from the arterial line perfusate. The overall dimensions have been reduced in the modified version of the D736 Ph.I.S.I.O. unmodified device resulting in decreased priming volume and maximum blood flow to 0.7 liters/minute. The internal modifications which mainly involve the filter screen geometry, make the new filter esently 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 D130 Ph.I.S.I.O. Dideco Kids with 40 micron screen phosphorilcholine 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.
TECHNOLOGICAL CHARACTERISTICS:
The D130 Ph.I.S.I.O. has the same operating principles and control mechanisms when compared to the D736 Ph.I.S.I.O. unmodified devices. The D130 Ph.I.S.I.O. utilize the same materials, the same filtering media, the same main blood flow path and the same filtering pore size (40 micron) as the unmodified evice The design features of the D130 Ph.I.S.I.O. have been renewed with respect to those of the current D736 Ph.I.S.I.O. Newborn-Infant unmodified device. Futhermore, no change of the intended use has been made for the downscaled and simplified version of the device as result of the design changes with consequent decrease in priming volume and maximum blood flow rate to 0.7. Both devices share the identical manufacturing process. The arterial filter is ethylene oxide sterilized and has a nonpyrogenic fluid path. It is for single use only.
1
BIOCOMPATIBILITY TEST RESULTS:
A complete battery of tests were carried out in accordance with the requirements of ISO 10993-1:2002 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 D130 Ph.I.S.I.O. (accelerated aging). The devices were aged up to three years and tested for Hemolysis, Hemocompatibility, Cytotoxicity, Irritation, Acute Systemic Toxicity and Mutagenicity, Sterility, Pyrogenicity and ETO residuals. Package integrity testing was also conducted. 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 Fitter 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 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 of the coating and air handling characteristics. For comparative purposes all tests, when applicable, were performed on sterilized aged devices comparing the D130 Ph.I.S.I.O. vs. the D736 Ph.J.S.I.O. operated at their related max blood flow. The results of these tests met established specifications. Since the D 736 Ph.I.S.I.O should be considered as a worst case with respect to the overall surface area in blood contact, blood compatibility characterization data presented in D 736 Ph.I.S.I.O. 510(K) (K002493) can be referenced.
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 and removal capability of microbubbles as well as air bolus introduced in the circuit. Likewise both filters demonstrated a comparable filtration efficiency with an overall mean percent removal greater than 80% for particles equal to the nominal pore size of the filter (40μ). The D130 Ph.I.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 D130 Ph.I.S.I.O. was evidenced the leaching test. The results are in line with expectations because the D130 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 hemodynamic, 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 aronuction techniques assuring that the newborn arterial filter is sterile and non-pyrogenic
In conclusion test result of this study suggests the D130 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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 1 2007
Sorin Group Italia S.R.L. c/o Mr. Barry Sall Principal Consultant 200 West Street Waltham, MA 02451-1163
Re: K063255
D130 PH.I.S.I.O. Dideco Kids Neonatal Arterial Filter Regulation Number: 21 CFR 870.4260 Regulation Name: Cardiopulmonary Bypass Arterial Blood Line Filter Regulatory Class: II Product Code: DTM Dated: December 20, 2006 Received: December 21, 2006
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.
3
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 (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 (240) 276-0120. 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 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,
FoR Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Sorin Group Italia S.r.l.
510(k) Number (if known):- ككك32 حكومك
Device Name: D130 Ph.L.S.I.O. Dideco Kids Neonatal Arterial Filter with 40 micron screen phosphorylcholine coated
Indications For Use:
D130 Ph.I.S.I.O. Dideco Kids with 40 micron screen phosphoryIcholine coated is recommended for use in the arterial line of the extracorporeal circuit during any procedure that requires cardidpulmony in the altenal life of the extraction of our dailing any processions particulate debrish 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_ V (Part 21 CFR 801 Subpart D)
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ and/or (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)
510(k) Numb