The Dideco D735 MICRO 20 with 20 micron screen and the Dideco D736 MICRO 40 with 40 micron screen 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 D735 MICRO 20 and D736 MICRO 40 are sterile, non-pyrogenic disposable filters for use in arterial line of the cardiopulmonary bypass circuit with the flow rate not exceeding 2.5 liters/minute. The D735 MICRO 20 and D736 MICRO 40 are Newborn-Infant 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 bypass connector has been eliminated in the modified versions of the D736 predicate devices resulting in enhanced ergonomics. In addition, the maximum blood flow rate has been increased to 2.5 liters/minute, in order to be consistent with the maximum flow rate of the cleared D736 MICRO Ph.I.S.I.O. modified device (K002493).

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not specify exact sample sizes for each in-vitro test. However, it states that "all tests were performed on sterilized aged devices" comparing the D735 MICRO 20 (operated at 2.5 LPM) against its D735 predicate device (operated at 2.0 LPM), and the D736 MICRO 40 (operated at 2.5 LPM) against its D736 predicate device (operated at 2.0 LPM).

The data provenance is retrospective, as the testing was performed on aged devices, and the entire document is a 510(k) submission, which is a premarket notification process based on demonstrating substantial equivalence to a legally marketed predicate device. The country of origin for the submitter is Italy (Dideco S.p.A., Mirandola, MO, Italy).

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

Not applicable. This device is a medical filter, and its performance is evaluated through objective physical and biological in-vitro tests, not through expert-based assessment of diagnostic images or clinical outcomes. Therefore, there is no "ground truth" established by experts in the typical sense of a clinical study.

4. Adjudication Method for the Test Set

Not applicable. As described above, the evaluation relies on objective in-vitro test results against established specifications, not human adjudication of subjective data.

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 is not a diagnostic device involving human readers or AI.

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

Not applicable. This is not an algorithmic device. The device itself is a physical filter.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation of this medical device is based on pre-defined, objective experimental specifications for physical and biocompatibility characteristics, aligned with relevant guidance documents (e.g., "Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submission" and ISO 10993-1:1995). The comparison is against the performance of legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."

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

Not applicable, as there is no training set.

Summary

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IAN = 8 2004

133987

510(k) SUMMARY

SUBMITTER:

CONTACT PERSON:

DATE PREPARED:

DEVICE TRADE NAME:

COMMON NAME:

CLASSIFICATION NAME:

PREDICATE DEVICES:

Dideco S.p.A. 86, Via Statale 12 Nord 41037 Mirandola (MO) Italy

Luigi Vecchi Phone: 011 39 0535 29811 Fax: 011 39 0535 25229

December 23, 2003

D735 MICRO 20: Dideco D735 Micro 20 Newborn-Infant Arterial Filter with 20 micron screen (hereafter referred to as D735 MICRO 20) and

D736 MICRO 40: Dideco D736 MICRO 40 Newborn-Infant Arterial Filter with 40 micron screen (hereafter referred to as D736 MICRO 40)

Arterial Filter

Cardiopulmonary Bypass Arterial Line Blood Filter

D735 MICRO 20: Dideco D735 Micro 20 Newborn-Infant Arterial Filter with 20 micron screen and D736 MICRO 40: Dideco D736 MICRO 40 Newborn-Infant Arterial Filter with 40 micron screen (hereafter referred to as D735 and D736 respectively) (K961869), and modified for the D736 MICRO 40 Ph.J.S.J.O .: Dideco Newborn-Infant Arterial Filter with Ph.I.S.1.O. coating (Phosphorilcholine coating) as described in K002493.

DEVICE DESCRIPTION:

INDICATION FOR USE:

The Dideco D735 MICRO 20 with 20 micron screen and the Dideco D736 MICRO 40 with 40 micron screen 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 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.

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TECHNOLOGICAL CHARACTERISTICS:

The D735 MICRO 20 and the D736 MICRO 40 have the same operating principles and control mechanisms when compred to the D735/D736 predicate devices. The D735 MICRO 20 and the D736 MICRO 40 utilize when compared to the same filtering media, the same main blood flow path and the same filtering pore size (20 and 40 micron respectively) as the predicate devices.

(2) and 40 micron reopedition) as the productions as a mith the exception of the exception of the rille design fouter of the enchor, identical to those of the current MICRO Newborn-Infant series predicate devices. Furthermore, no change of the intended use has been made as result of the extension of the maximum blood flow rate up to 2.5 LPM for both the D735 MICRO 20 and D736 MICRO 40. Both devices share the identical manufacturing process. The arterial filters are ethylene oxide sterilized and have a nonpyrogenic fluid path. They are for single use only.

BIOCOMPATIBILITY 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 D735 MICRO 20 and of the D736 MICRO 40 (accelerated aging). The devices were aged up to five years and tested for Hemolysis, 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. No new materials are used in the newborn/infant arterial filter as compared to the predicate devices. This 510(k) cross references biocompatibility data previously submitted in D735 MICRO 20 Dideco Newborn-Infant Arterial Filter with 20 micron screen and D736 MICRO 40 Dideco Newbom-Infant Arterial Filter with 40 micron screen 510(k) (K961869).

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. These data demonstrate both substantial equivalence with the predicate device and show that the device is compliant with safety and effectiveness requirements. The device was aged up to 5 years and tested for priming volume, filter integrity test, pull strength, blood side pressure drop, in vitro hemolysis/cell depletion, filtration efficiency and air handling characteristics. For comparative purposes all tests were performed on sterilized aged devices comparing the D735 MICRO 20 operated at 2.5 LPM vs. the D735 predicate device operated at 2.0 LPM and D736 MICRO 40 operated at 2.5 LPM vs. D736 predicate device operated at 2.0 LPM. The results of these tests met established specifications.

The results of the study showed that the device characteristics of the D735 MICRO 20 vs. D735 predicate device and D736 MICRO 40 vs. D736 predicate device were comparable.

CONCLUSIONS:

The results of in vitro studies demonstrate that the D735 MICRO 20 and D736 MICRO devices perform in a manner substantially equivalent to the predicate devices. Biocompatibility and functional tests demonstrate that their performance is equivalent to the D735 and D736 predicate 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or a stylized human figure, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

'JAN - 8 2004

Dideco S.P.A. c/o Mr. Barry Sall Parexel International Corp. 195 West Street Waltham, MA 02451-1163

Re: K033987

D735 MICRO 20, Dideco D735 Micro 20 Newborn-Infant Arterial Filter with 20 micron 55 MICRO 20, Dideco 40, Dideco D736 Micro 40 Newborn-Infant Arterial Filter with 40 micron screen Regulation Number: 21 CFR 870.4260 Regulation Name: Cardiopulmonary Bypass Arterial Line Blood Filter Regulatory Class: Class II (two) Product Code: DTM Dated: December 23, 2003 Received: December 23, 2003

Dear Mr. Sall:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becared the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surved in the encreately 776, 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, devices that have been require approval of a premarket approval application (PMA). and Cosmetic Fore, market the device, subject to the general controls provisions of the Act. The r ou may, mererory, mans of the Act include requirements for annual registration, listing of general controls provision gractice, labcling, and prohibitions against misbranding and adulteration.

If your device is classified (scc 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 may be subject to sable additions, 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 r loase of actives and i revious that your device complies with other requirements of the Act that I Dri has intact a and regulations administered by other Federal agencies. You must of any I vith 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 form in the quiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product taxill allow you to begin marketing your device as described in your Section 510(k) r mo let notification. The FDA finding of substantial equivalence of your device to a legally premaince routineation - cesults 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. Also, please note the regulation entifled, "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 Mace Eacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address.

Sincerely yours,

C. Meparlmayer

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: D735 MICRO 20, Dideco D735 Micro 20 Newborn-Infant Arterial Filter with 20 micron screen and for the D736 MICRO 40, Dideco D736 Micro 40 Newborn-Infant Arterial Filter with 40 micron screen

Indications for Use:

The Dideco D735 MICRO 20 with 20 micron screen and the Dideco D736 MICRO 40 with 40 micron screen are recommended for use in the arterial line the extracorporeal circuit during any procedure that requires of 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.

Prescription Use
(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)

esles Mye
(Division Sign Off)

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.”

Test	Acceptance Criteria	Reported Device Performance
Hemolysis	Met established specifications	Met established specifications
Cytotoxicity	Met established specifications	Met established specifications
Irritation	Met established specifications	Met established specifications
Acute Systemic Toxicity	Met established specifications	Met established specifications
Mutagenicity	Met established specifications	Met established specifications
Sterility	Met established specifications	Met established specifications
Pyrogenicity	Met established specifications	Met established specifications
ETO Residuals	Met established specifications	Met established specifications
Package Integrity	Met established specifications	Met established specifications
Priming Volume	Met established specifications	Met established specifications
Filter Integrity	Met established specifications	Met established specifications
Pull Strength	Met established specifications	Met established specifications
Blood Side Pressure Drop	Met established specifications	Met established specifications
In vitro Hemolysis/Cell Depletion	Met established specifications	Met established specifications
Filtration Efficiency	Met established specifications	Met established specifications
Air Handling Characteristics	Met established specifications	Met established specifications