The Dideco D731 MICRO 20 Ph.I.S.I.O., with 20 micron screen with phosphorylcholine coating and the Dideco D733 MICRO 40 Ph.I.S.I.O., with 40 micron screen with phosphorylcholine coating are recommended for use in the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass. The filters are 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.

Device Description

The D731 MICRO 20 Ph.I.S.I.O. and D733 MICRO 40 Ph.I.S.I.O. are sterile, non-pyrogenic disposable filters for use in the arterial line of the cardiopulmonary bypass circuit with the flow rate not exceeding 5.0 liters/minute. The D731 MICRO 20 Ph.I.S.I.O. and D733 MICRO 40 Ph.I.S.I.O. are Pediatric Arterial Filters with 20 and 40 micron filter screens designed to remove potentially harmful gaseous emboli, aggregated blood constituents, and particulate debris greater than 20 and 40 microns respectively from the arterial line perfusate. The D731 MICRO 20 Ph.J.S.I.O. and D733 MICRO 40 Ph.I.S.I.O. are a modified version of the currently marketed D731/D733 MICRO. The modification consists of coating all blood contact surfaces with phosphoryIcholine additive that improves the blood compatibility of the substrate materials. Other than this change the D 731/D733 MICRÓ Ph.I.S.I.O. and the D 731/D733 MICRO are identical in design, materials, and manufacturing processes.

AI/ML Overview

The provided document is a 510(k) summary for a medical device modification, specifically for the D731 MICRO 20 Ph.I.S.I.O. and D733 MICRO 40 Ph.I.S.I.O. Pediatric Arterial Filters. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study where a device's performance is measured against specific acceptance criteria.

Therefore, the requested information categories regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness studies are largely not applicable or explicitly detailed in this type of regulatory submission.

Here's an breakdown of what can be extracted or inferred from the provided text, and what cannot:

1. Table of acceptance criteria and reported device performance:

This document does not provide a table of acceptance criteria with numerical targets. Instead, it states that "The results of the testing met established specifications" for various tests. The performance is reported in terms of "comparable" or "substantially equivalent" to the unmodified predicate devices.

Acceptance Criterion	Reported Device Performance (D731/D733 MICRO Ph.I.S.I.O.)
Biocompatibility:
Hemolysis	Met established specifications (tested on D733 MICRO Ph.I.S.I.O., applicable to both)
Cytotoxicity	Met established specifications (tested on D733 MICRO Ph.I.S.I.O., applicable to both)
Irritation	Met established specifications (tested on D733 MICRO Ph.I.S.I.O., applicable to both)
Acute Systemic Toxicity	Met established specifications (tested on D733 MICRO Ph.I.S.I.O., applicable to both)
Mutagenicity	Met established specifications (tested on D733 MICRO Ph.I.S.I.O., applicable to both)
Sterility	Met established specifications (tested on D733 MICRO Ph.I.S.I.O., applicable to both)
Pyrogenicity	Met established specifications (tested on D733 MICRO Ph.I.S.I.O., applicable to both)
ETO residuals	Met established specifications (tested on D733 MICRO Ph.I.S.I.O., applicable to both)
Material/Product Integrity:
Package integrity	Met established specifications (conducted on D733 MICRO Ph.I.S.I.O., applicable to both)
Structural integrity	Met established specifications (compared to D731/D733 unmodified devices)
Mechanical integrity	Met established specifications (compared to D731/D733 unmodified devices)
Pressure drop	Met established specifications (compared to D731/D733 unmodified devices)
Filter flow rate capacity	Met established specifications (compared to D731/D733 unmodified devices)
In vitro hemolysis/cell depletion	Met established specifications (compared to D731/D733 unmodified devices)
Filtration efficiency	Not affected by modification; applies from D731/D733 unmodified devices
Air handling characteristics	Not affected by modification; applies from D731/D733 unmodified devices
Overall performance	Substantially equivalent to unmodified devices; comparable characteristics

2. Sample size used for the test set and the data provenance:

Sample size: Not explicitly stated as a numerical count of devices tested. The document mentions "A complete battery of tests" and "Tests were performed on sterilized aged devices comparing the D731 MICRO 20 Ph.I.S.I.O. vs. the D733 non aged unmodified device and D731 MICRO 40 Ph.I.S.I.O vs. D733 non aged unmodified device". The testing for biocompatibility was performed on the D733 MICRO Ph.I.S.I.O. (accelerated aging) and the data was considered applicable to D731 MICRO 20 Ph.I.S.I.O. There's no specific "test set" size quantified for each parameter.
Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This is a regulatory submission, so the data would have been generated internally by the manufacturer or by a contracted lab. It's laboratory-based testing, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The "ground truth" in this context is based on objective, standardized laboratory measurements against established specifications for device performance, not expert human interpretation (like in imaging studies).

4. Adjudication method for the test set:

Not applicable. See point 3. Testing involves objective measurements, not human adjudication.

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 document describes a medical device (arterial filter) for mechanical function and biocompatibility, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies and "human readers" are irrelevant.

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

Not applicable. See point 5. This is not an algorithm.

7. The type of ground truth used:

Objective Laboratory Specifications and Predicate Device Performance: The "ground truth" for the test results is adherence to pre-established scientific/engineering specifications (e.g., ISO 10993 standards for biocompatibility) and performance comparability to the unmodified predicate devices.

8. The sample size for the training set:

Not applicable. This is not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established:

Not applicable. See point 8.

Summary

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K651232

Special 510(k): Device Modification May 12, 2005

APPENDIX I

MAY 2 0 2005

510(K) SUMMARY

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510(k) SUMMARY Dideco S.r.l. SUBMITTER: 86, Via Statale 12 Nord 41037 Mirandola (MO) Italy Luigi Vecchi CONTACT PERSON: Phone: 011 39 0535 29811 Fax: 011 39 0535 25229 May 12, 2005 DATE PREPARED: D731 MICRO 20 Ph.I.S.I.O.: Dideco DEVICE TRADE NAME: D731 Micro 20 Pediatric Arterial Filter screen with micron with 20 phosphoryIcholine coating (hereafter referred to as D731 MICRO 20 Ph.I.S.I.O.) and D733 MICRO 40 Ph.I.S.I.O.: Dideco D733 MICRO 40 Pediatric Arterial Filter micron screen with 40 with coating coating coating of (hereafter phopshorilcoline D733 MICRO 40 referred to as Ph.I.S.I.O) Arterial Filter COMMON NAME: Cardiopulmonary Bypass Arterial Line CLASSIFICATION NAME: Blood Filter D731 MICRO 20: Dideco D731 Micro 20 UNMODIFIED DEVICES Pediatric Arterial Filter with 20 micron screen and D733 MICRO 40: Dideco D733 MICRO 40 Pediatric Arterial Filter with 40 micron screen (hereafter referred to as D731 and D733 respectively) (K945198 and K041061). D736 MICRO 40 Ph.I.S.I.O.: Dideco PREDICATE DEVICES: Ph.I.S.I.O. D736 Micro 40 -Newborn/Infant Arterial Filter with 40 biocompatible screen with micron treatment surface (K002493) (hereafter referred to as D736 MICRO Ph.I.S.I.O.

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DEVICE DESCRIPTION:

INDICATION FOR USE:

The Dideco D731 MICRO 20 Ph.I.S.I.O. with 20 micron screen with phosphorylcholine coating and the Dideco D733 MICRO 40 Ph.I.S.I.O. with 40 micron screen with phosphoryIcholine coating are recommended for use in the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass. The filters are 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 D731 Micro 20 Ph.I.S.I.O. and the D733 MICRO 40 Ph.I.S.I.O. have the same design features, operating principles and control mechanisms when compared to the D731/D733 predicate devices. The D731 Micro 20 Ph.I.S.I.O. and the D733 MICRO 40 Ph.I.S.I.O. utilize the same materials (with the exception of addition of the phosphorylcholine coating), filtering media with the same filter pore size (20 and 40 micron respectively) and the same main blood flow path as the unmodified devices.

The D731 MICRO 20 Ph.I.S.I.O. and of the D733 MICRO 40 Ph.I.S.I.O. are identical to the current MICRO Pediatric series unmodified devices in design, operating principles, control mechanisms and fundamental scientific technology. No change to the intended use has been made as result of the addition of the

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phosphoryIcholine coating to all blood contact surfaces. Both devices share the identical manufacturing process. The Ph.I.S.I.O. coating solutions used for the D731 MICRO 20 Ph.I.S.I.O. and the D733 MICRO 40 Ph.I.S.I.O. as well as manufacturing process for applying the coating, is identical to that used for the manalableming 40 Ph.I.S.I.O. (K002493) predicate device. There are no differences in packaging type and material between the D731/D733 MICRO Ph.I.S.I.O. and the MICRO unmodified devices. The arterial filters are ethylene oxide sterilized and have a nonpyrogenic fluid path. They are for single use only.

NON CLINICAL TEST RESULTS:

A complete battery of tests were carried out in accordance with the requirements of ISO 10993-1:1995 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 733 MICRO Ph.I.S.I.O. (accelerated aging). The devices were aged up to three years and tested for Hemolysis, Cytotoxicity, Irritation, Acre Systemic Toxicity and Mutagenicity, Sterility, Pyrogenicity and ETO residuals. Package integrity testing was also conducted. The results of the testing met established specifications. As no new materials are used in the D731 MICRO 20 Ph.I.S.I.O. pediatric arterial filter with respect to the D733 MICRO 40 Ph.I.S.I.O data collected are considered applicable to both MICRO Ph.I.S.I.O filters.

IN VITRO TEST RESULTS:

In vitro testing was carried out in accordance with the relevant requirements of in viro couling was carterial Line Blood Filter Blood Filter 510(K) Submission" Final Guidance for Industry, dated November 29, 2000. These data demonstrate substantial equivalence with the unmodified devices and show that the devices are compliant with safety and effectiveness requirements. The device was aged up to 3 years and tested for structural integrity, mechanical integrity, was aged ap te syre drop, filter flow rate capacity, in vitro hemolysis/cell depletion. For comparative purposes all tests were performed on sterilized aged devices comparing the D731 MICRO 20 Ph.I.S.I.O. vs. the D733 non aged unmodified device and D731 MICRO 40 Ph.I.S.I.O vs. D733 non aged unmodified device operated at 5.0 LPM when applicable. The results of these tests met established specifications. The modifications being made to the MICRO Ph.I.O. arterial filter do not affect the performance of the device; therefore the filtration efficiency and air handling characteristics exhibited by the D731/D733 MICRO unmodified device apply also to the MICRO Ph.I.S.I.O. arterial filters.

The results of the study showed that the device characteristics of the D731 MICRO 20 Ph.I.S.I.O. vs. D731 unmodified device and D733 MICRO 40 Ph.I.S.I.O. vs. D733 unmodified device were comparable.

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CONCLUSIONS:

The results of in vitro studies demonstrate that the D731 MICRO 20 Ph.I.S.I.O. and D733 MICRO Ph.I.S.I.O. devices perform in a manner substantially equivalent to the unmodified devices. Biocompatibility and functional tests demonstrate that their performance is equivalent to the D731 and D733 unmodified devices, according to their intended use. Additional testing has demonstrated the effectiveness of production techniques assuring that the newborn-infant arterial filters are sterile and non-pyrogenic.

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Image /page/5/Picture/11 description: The image shows a logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles a person embracing another person.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 0 2005

Dideco S.R.L. c/o Mr. Barry Sall Senior Regulatory Consultant Parexel International 195 West Street Waltham, MA 02451-1163

Re: K051232

R051232
D731 Micro 20 Ph.I.S.I.O. Pediatric Arterial Filter, D733M Regulation Number: 21 CFR 870.4260 Regulation Name: Cardiopulmonary Bypass Arterial Blood Filter Regulatory Class: Class II (Two) Product Code: DTM Dated: May 12, 2005 Received: May 13, 2005

Dear Mr. Sall:

く

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Securit >10(x) promation is substantially equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced above and nave determined the article predicate devices marketed in interstate for use stated in the enclosure) to legally marketed produced Device Amendments. Or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1976, the enactinent and of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the PMA devices that have been reclassified in accordance while approval application (PMA).
and Cosmetic Act (Act) that do not require approval as traisions of the Act . The and Cosmetic Act (Act) that do not require approvate or a provisions of the Act. The Act. The
You may, therefore, market the device, subject to the general consussion, lis You may, therefore, market the device, subject to the gentralion, listing of
general controls provisions of the Act include requirements for annual registration, and general controls provisions of the Act mendo roquilibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). in If your device is classified (see above) mo chiler cass if expering your device can
may be subject to such additional controls. Existing major regulation FDA may may be subject to such additional controlis. Exibling migres of to 898. In addition. FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 Register be found in the Code of Federal Regarities 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 Please be advised that FDA 3 issuance of a successions in ther requirements of the Act that FDA has made a determination that your access of other Federal agencies. You must or any Federal statutes and regulanents and united to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as school and as a control leadly also alsot CPK Fatt 607), labeling (21 CFR Part 820); and if applicable, the clectronic Torth in the quality systems (QS) regulations (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Doctors vour device as described in your Section 510(k) I mis letter witi anow you to ocgin manening your and equivalence of your device to a legally premarket notification. The PDA mining of basification 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 If you desire specific acvice for Jour do Novel 2011-01-20120. Also, please note the regulation entitled. Contact the Office of Comphalled at (210) 21 CFR Part 807.97). You may obtain Misoralluming by reference to premaritoritibilities under the Act from the Division of Small other general Information on your responsive Assistance at its toll-free number (800) 638-2041 or by J Manufacturers, International and Octisal http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Blommarfor

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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: D731 MICRO 20 Ph.I.S.I.O., Dideco D731 Micro 20 Pediatrio Device Name. Droom screen with phosphorylcholine coating and for the D733 MICRO 40 Ph.I.S.I.O., Dideco D733 Micro 40 Pediatric Arterial Filter with 40 micron screen with phosphorylcholine coating

Indications for Use:

The Dideco D731 MICRO 20 Ph.I.S.I.O., with 20 micron screen with The Dideco Drow and the Dideco D733 MICRO 40 Ph.I.S.I.O., with proophorylondine obating and with the coating are recommended for use in the arterial line of the extracorporeal circuit during any procedure that requires the arenanials of the oxtraosiported. Inc. used to trap and remove gaseous emboli as well as particulate debris that maybe introduced through the arterial emooil as well as well as well longer than 6 hours. Contact with blood for longer periods is not advised.

Prescription Use X (Part 21 CFR 801 Subpart D) Over-the-Counter Use_ (21 CFR 807 Subpart C) AND/OR

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

05 1232 Bloomington

Division of Cardiovascular Devices 510(k) Number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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.”