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.

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.

AI/ML Overview

D130 Ph.I.S.I.O. Dideco Kids Neonatal Arterial Filter Study Summary

This document describes the acceptance criteria and the study performed to demonstrate the substantial equivalence of the D130 Ph.I.S.I.O. Dideco Kids Neonatal Arterial Filter to its predicate device, the D736 Ph.I.S.I.O. The study focused on in vitro evaluations and biocompatibility testing.

1. Table of Acceptance Criteria and Reported Device Performance

The device performance was evaluated against established specifications, primarily demonstrating equivalence or improvement compared to the predicate device, the D736 Ph.I.S.I.O.

Acceptance Criteria Category	Specific Test/Characteristic	Acceptance Criteria (implied, relative to predicate)	Reported Device Performance (D130 Ph.I.S.I.O.)
Biocompatibility	Hemolysis	Meet ISO 10993-1:2002 and FDA 1995 Memo requirements for raw materials and aged device.	Met established specifications. Performance was equivalent to the D736 Ph.I.S.I.O. unmodified device.
	Hemocompatibility	Meet ISO 10993-1:2002 and FDA 1995 Memo requirements for raw materials and aged device.	Met established specifications. Performance was equivalent to the D736 Ph.I.S.I.O. unmodified device.
	Cytotoxicity	Meet ISO 10993-1:2002 and FDA 1995 Memo requirements for raw materials and aged device.	Met established specifications. Performance was equivalent to the D736 Ph.I.S.I.O. unmodified device.
	Irritation	Meet ISO 10993-1:2002 and FDA 1995 Memo requirements for raw materials and aged device.	Met established specifications. Performance was equivalent to the D736 Ph.I.S.I.O. unmodified device.
	Acute Systemic Toxicity	Meet ISO 10993-1:2002 and FDA 1995 Memo requirements for raw materials and aged device.	Met established specifications. Performance was equivalent to the D736 Ph.I.S.I.O. unmodified device.
	Mutagenicity	Meet ISO 10993-1:2002 and FDA 1995 Memo requirements for raw materials and aged device.	Met established specifications. Performance was equivalent to the D736 Ph.I.S.I.O. unmodified device.
	Sterility	Sterile, non-pyrogenic (demonstrated via ETO sterilization techniques).	Demonstrated effectiveness of sterilization techniques, assuring the device is sterile and non-pyrogenic.
	Pyrogenicity	Non-pyrogenic.	Demonstrated effectiveness of sterilization techniques, assuring the device is sterile and non-pyrogenic.
	ETO residuals	Acceptable levels of Ethylene Oxide residuals.	Met established specifications.
	Package integrity	Maintain sterility and device integrity.	Met established specifications.
In Vitro Performance	Operating Blood Volume	Reduced compared to predicate D736 Ph.I.S.I.O.	Reduced priming volume compared to the D736 Ph.I.S.I.O. unmodified device.
	Structural Integrity	Comparable to predicate D736 Ph.I.S.I.O., integrity when pressurized over maximum recommended pressure.	Comparable structural integrity to the D736 Ph.I.S.I.O. unmodified device. Demonstrated integrity when pressurized over the maximum recommended pressure.
	Pressure Integrity	Comparable to predicate D736 Ph.I.S.I.O.	Met established specifications.
	Pressure Drop	Reduced compared to predicate D736 Ph.I.S.I.O.	Reduced pressure drop compared to the D736 Ph.I.S.I.O. unmodified device.
	Filter Flow Rate Capacity	Effective at all blood flow rates (up to 0.7 L/min).	Effective filter flow rate capacity at all blood flow rates (up to 0.7 L/min).
	In Vitro Hemolysis/Cell Depletion	Comparable to predicate D736 Ph.I.S.I.O.	Comparable hemolysis/cell depletion to the D736 Ph.I.S.I.O. unmodified device.
	Filtration Efficiency	Comparable to predicate D736 Ph.I.S.I.O., overall mean percent removal greater than 80% for 40µ particles.	Comparable filtration efficiency to the D736 Ph.I.S.I.O. unmodified device, with an overall mean percent removal greater than 80% for particles equal to the nominal pore size of the filter (40µ). Removal capability of microbubbles as well as air bolus was comparable.
	Leaching of Coating	No analytical evidence of leaching of phosphorylcholine coating.	No analytical evidence of the possibility of leaching of phosphorylcholine coating from the D130 Ph.I.S.I.O. was evidenced in the leaching test.
	Air Handling Characteristics	Comparable to predicate D736 Ph.I.S.I.O. (specifically, removal capability of microbubbles and air bolus).	Removal capability of microbubbles as well as air bolus introduced in the circuit was comparable to the D736 Ph.I.S.I.O. unmodified device.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical sample size for the test set. However, it indicates that "A complete battery of tests were carried out" and "Testing was performed on the D130 Ph.I.S.I.O." and "all tests, when applicable, were performed on sterilized aged devices comparing the D130 Ph.I.S.I.O. vs. the D736 Ph.I.S.I.O." This implies a sufficiently representative number of devices were tested to draw conclusions on performance, aging, and comparison.

The data provenance is from in vitro testing and laboratory experiments conducted by Sorin Group Italia S.r.l. in Italy. The results likely represent prospective data generation specifically for this 510(k) submission, as these tests were carried out to meet current regulatory guidance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of medical device (arterial filter) relies on objective, measurable physical and chemical properties rather than subjective interpretation of diagnostic images or clinical assessments by human experts. Therefore, the concept of "experts establishing ground truth" in the traditional sense (e.g., radiologists interpreting images) is not directly applicable here. The "ground truth" or "established specifications" were likely based on:

Engineering and Biomedical Scientists: Professionals with expertise in fluid dynamics, materials science, biocompatibility, and medical device design.
Regulatory Standards: ISO 10993-1:2002 and FDA 1995 Memorandum, and "Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submission" Final Guidance for Industry, dated November 29, 2000. These standards themselves are developed through expert consensus and scientific validation.
Predicate Device Performance: The established performance of the D736 Ph.I.S.I.O. served as a benchmark for substantial equivalence.

No specific number or qualifications of individual human experts for ground truth establishment are provided because the evaluation method is primarily objective testing against predefined technical standards.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective measurements (e.g., flow rate, pressure drop, particle count, chemical analysis) that do not require human adjudication in the typical sense of a clinical or image-based study. The results are compared directly to pre-established specifications or the predicate device's performance.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical medical device (an arterial filter) and not an AI or software-as-a-medical-device (SaMD) that involves human readers interpreting data.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is an arterial filter and does not involve an algorithm.

7. The Type of Ground Truth Used

The ground truth used was a combination of:

Quantitative measurements and physical properties: Measured values for operating blood volume, pressure drop, flow rate, filtration efficiency, and integrity tests.
Biological and chemical assays: Results from biocompatibility tests (hemolysis, cytotoxicity, etc.), sterility tests, pyrogenicity, and leaching tests.
Established Regulatory Standards: Compliance with ISO 10993-1:2002, FDA Guidance documents, and the D736 Ph.I.S.I.O. 510(K) (K002493) data.

This represents objective scientific and technical data, often rooted in established scientific principles and regulatory benchmarks.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set. The device is a physical product designed through engineering principles.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set was used.

Summary

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	510(k) SUMMARY
SUBMITTER:	Sorin Group Italia S.r.l.86, Via Statale 12 Nord41037 Mirandola (MO) Italy
CONTACT PERSON:	Luigi VecchiPhone: 011 39 0535 29811Fax: 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 40micron screen phosphorilcholine coated (hereafter referredto 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 ArterialFilter with Ph.I.S.I.O. coating (Phosphorilcholine coating) asdescribed in K002493 and modified in K033987.

DEVICE DESCRIPTION:

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.

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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.

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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.

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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 (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

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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:

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

Regulation Number and Section

§ 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.”