The Dideco D731 MICRO 20 with 20 micron screen and the Dideco D733 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 intrough 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 and D733 MICRO 40 are sterile, non-pyrogenic disposable filters for use in arterial line of the cardiopulmonary bypass circuit with the flow rate not exceeding 5.0 liters/minutes. The D731 MICRO 20 and D733 MICRO 40 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 maximum blood flow rate has been increased to 5.0 liters/minute.

AI/ML Overview

The provided document describes the Dideco D731 MICRO 20 and D733 MICRO 40 Pediatric Arterial Filters. Based on the information, here's an analysis of the acceptance criteria and the study performed:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria in a table format. Instead, it states that "The results of the testing met established specifications" and "The results of these tests met established specifications." The reported device performance is described as comparable or substantially equivalent to the predicate devices.

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	Met established specifications; equivalent to predicate devices.
Hemolysis	Met established specifications.
Cytotoxicity	Met established specifications.
In Vitro Studies:**
Structure Integrity	Met established specifications; comparable to predicate devices.
Mechanical Integrity	Met established specifications; comparable to predicate devices.
Blood Side Pressure Drop	Met established specifications; comparable to predicate devices.
Filter Flow Rate Capacity	Met established specifications; comparable to predicate devices.
In vitro Hemolysis/Cell Depletion	Met established specifications; comparable to predicate devices.
Filtration Efficiency	Met established specifications; comparable to predicate devices.
Air Handling Characteristics	Met established specifications; comparable to predicate devices.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not provide a specific sample size for the "in vitro test results." It mentions that "Testing was performed on the D731 MICRO 20 and of the D733 MICRO 40 (accelerated aging)" and that "all tests were performed on sterilized aged devices." The provenance of the data is not explicitly stated, but the submission is from Dideco S.p.A. in Italy, suggesting the primary data generation might have occurred there. The testing described is prospective, as it involves evaluating the new devices against established protocols.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This section is not applicable. The study is an in vitro and biocompatibility assessment of a physical medical device (arterial filter), not an AI or diagnostic device that requires expert ground truth establishment for patient data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This is not applicable since the study is not based on human judgment or interpretation of data needing adjudication. Performance is assessed through objective laboratory measurements.

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

This is not applicable. The device is an arterial filter, not an AI-assisted diagnostic tool.

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

This is not applicable. The device is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's evaluation is based on pre-established specifications and validated laboratory test methods for physical and mechanical properties (e.g., structural integrity, flow rates, filtration efficiency) and ISO 10993 standards for biocompatibility. The new device's performance is then compared to these specifications and to the predicate devices.

8. The sample size for the training set

This is not applicable. The device is a physical medical device, not an AI algorithm requiring a training set.

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

This is not applicable for the reasons mentioned in point 8.

Summary

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MAY - 6 2004

SUBMITTER:

CONTACT PERSON:

DATE PREPARED:

DEVICE TRADE NAME:

510(k) SUMMARY

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

April 23, 2004

D731 MICRO 20: Dideco D731 Micro 20 Pediatric Arterial Filter with 20 micron screen (hereafter referred to as D731 MICRO 20) and

D733 MICRO 40: Dideco D733 MICRO 40 Pediatric Arterial Filter with 40 micron screen (hereafter referred to as D733 MICRO 40)

COMMON NAME:

CLASSIFICATION NAME:

PREDICATE DEVICES:

Arterial Filter

Cardiopulmonary Bypass Arterial Line Blood Filter

D731 MICRO 20: Dideco D731 Micro 20 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).

DEVICE DESCRIPTION:

INDICATION FOR USE:

The Dideco D731 MICRO 20 with 20 micron screen and the Dideco D733 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 b hours. Contact with blood for longer periods is not advised.

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TECHNOLOGICAL CHARACTERISTICS:

The D731 MICRO 20 and the D733 MICRO 40 have the same design features, operating principles and control mechanisms when compared to the D731/D733 predicate devices. The D731 MICRO 20 and the D733 MICRO 40 utilize the same materials, filtering media with the same filter pore size (20 and 40 micron respectively) and the same main blood flow path as the predicate devices.

The D731 MICRO 20 and of the D733 MICRO 40 are, with the exception of the increase of the maximum blood flow rate up to 5.0 LPM, identical to the current MICRO Pediatric series predicate devices. No change of the intended use has been made as result of the extension of the maximum blood flow rate up to 5.0 LPM for both the D731 MICRO 20 and D733 MICRO 40. Both devices share the identical manufacturing process. The arterial filters are ethylene oxide sterilized and have a nonpyrogenic fluid path. They are tor 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 D731 MICRO 20 and of the D733 MICRO 40 (accelerated aging). The devices were aged up to five years and tested for Hemolysis, Cytotoxicity, In taxes Systemic Toxicity and Mutagenicity, Sterlily, 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 Pediatric arterial filter as compared to the predicate devices. This 510(k) cross references biocompatibility data previously submitted in D731 MICRO 20 Dideco Pediatric Arterial Filter with 20 micron screen and D733 MICRO 40 Dideco Pediatric Arterial Filter with 40 micron screen 510(k) (K945198).

IN VITRO TEST RESULTS:

In viro 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 Cated November 29, 2000. These data demonstrate substantial equivalence with the predicate devices and show that the devices are compliant with safety and effectiveness requirements. The device was aged up to 5 years and tested for structural integrity, mechanical integrity, blood side pressure drop, filter flow rate capacity, in vitro hemolysis/cell depletion, filtration efficiency and air handling characteristics. For comparative purposes all tests were performed on sterilized aged devices comparing the D731 MICRO 20 operated at 3.0 LPM vs. the D733 predicate device operated at 5.0 LPM and D731 MCRO 40 operated at 3.0 LPM vs. D733 predicate device operated at 5.0 LPM when applicable. The results of these person net established specifications.

The results of the study showed that the device characteristics of the D731 MICRO 20 vs. D731 predicate device and D733 MICRO 40 vs. D733 predicate device were comparable.

CONCLUSIONS:

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

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem that features a stylized eagle-like bird with three curved lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 6 2004

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

Re: K041061

D731 Micro 20 and D733 Micro 40 Pediatric Arterial Filters Regulation Number: 21 CFR 870.4260 Regulation Name: Filter, Blood, Cardiopulmonary, Arterial Line Regulatory Class: Class II (two) Product Code: DTM Dated: April 23, 2004 Received: April 23, 2004

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 enclesure) to legally marketed predicate devices marketed in interstatc 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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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,

Myximay-

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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Image /page/4/Picture/0 description: The image shows the word "dideco" in a bold, sans-serif font. The letters are all lowercase and connected to each other. The color of the text is black, and the background is white. The overall impression is a simple, modern logo.

DIDECO S.p.A.

KO4106 510(k) Number (if known): __

Device Name: D731 MICRO 20, Dideco D731 Micro 20 Pediatric Arterial Filter with 20 micron screen and for the D733 MICRO 40, Dideco D733 Micro 40 Pediatric Arterial Filter with 40 micron screen

Indications for Use:

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)

CMoMarlyn fac BDZ
Digital Sign Off

(Division Sign-Off)
Division of Cardiovascular Device

510(k) Number K041661

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.”