D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTER

K052717 · Dideco S.R.L. · DTM · Oct 20, 2005 · Cardiovascular

Device Facts

• Record ID: K052717
• Device Name: D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTER
• Applicant: Dideco S.R.L.
• Product Code: DTM · Cardiovascular
• Decision Date: Oct 20, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4260
• Device Class: Class 2

Intended Use

The Dideco D732 MICRO 27 Ph.I.S.I.O. with 27 micron screen with phosphorylcholine coating 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 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 Story

D732 MICRO 27 Ph.I.S.I.O. is a sterile, single-use arterial blood filter for cardiopulmonary bypass circuits; flow rate ≤7.0 L/min. Device features a 27-micron pleated polyester screen and phosphorylcholine-coated blood-contact surfaces to improve biocompatibility. Operates by trapping gaseous emboli and particulate debris >27 microns from the arterial line perfusate. Used in clinical settings (e.g., OR) by perfusionists or surgeons. Output is filtered blood returned to the patient; clinical benefit includes reduced gaseous/particulate emboli delivery and improved hemocompatibility (reduced pressure drop/hemolysis) compared to uncoated filters. Device is ethylene oxide sterilized.

Clinical Evidence

Bench testing only. In vitro testing per FDA guidance (Nov 2000) and ISO 10993-1:1995. Evaluated structural/mechanical integrity, pressure drop, flow capacity, hemolysis/cell depletion, and air handling. Results showed 80% particle removal efficiency (AAMI standard). Phosphorylcholine coating demonstrated statistically significant improvements in pressure drop and hemolysis compared to the unmodified D732 MICRO 20. Biocompatibility testing (hemolysis, cytotoxicity, irritation, systemic toxicity, mutagenicity) performed on aged devices.

Technological Characteristics

Arterial line blood filter; 27-micron pleated polyester screen; phosphorylcholine-coated blood-contact surfaces. Single-use; ethylene oxide sterilized; non-pyrogenic. Flow rate capacity ≤7.0 L/min. Mechanical filtration principle. No software or electronic components.

Indications for Use

Indicated for patients undergoing procedures requiring cardiopulmonary bypass. Used in the arterial line of the extracorporeal circuit to remove gaseous emboli and particulate debris >27 microns. Contraindicated for use longer than 6 hours.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• D736 Micro 40 Ph.I.S.I.O. (K002493)

Reference Devices

• D732 MICRO 20 (K952270)

Submission Summary (Full Text)

{0}------------------------------------------------

K 052717

්‍රි. 2 0 2005

# APPENDIX I

# 510(K) SUMMARY

{1}------------------------------------------------

| 510(k) SUMMARY | |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTER: | Dideco S.r.l.<br>86, Via Statale 12 Nord<br>41037 Mirandola (MO) Italy |
| CONTACT PERSON: | Luigi Vecchi<br>Phone: [phone]<br>Fax: [phone] |
| DATE PREPARED: | September 28, 2005 |
| DEVICE TRADE NAME: | D732 MICRO 27 Ph.I.S.I.O.: Dideco<br>D732 Micro 27 Adult Arterial Filter with<br>27 micron screen with phosphorylcholine<br>coating (hereafter referred to as D732<br>MICRO 27 Ph.I.S.I.O.) |
| COMMON NAME: | Arterial Filter |
| CLASSIFICATION NAME: | Cardiopulmonary Bypass Arterial Line<br>Blood Filter |
| UNMODIFIED DEVICE | D732 MICRO 20: Dideco D732 Micro 20<br>Adult Arterial Filter with 20 micron screen<br>(hereafter referred to as D732 MICRO<br>20) (K952270). |
| PREDICATE DEVICE: | D736 Micro 40 Ph.I.S.I.O.: Dideco Micro<br>40 Ph.I.S.I.O. Newborn-Infant Arterial<br>Filter with 40 micron screen with<br>biocompatible treatment surface<br>(K002493) (hereinafter referred to as the<br>D736 MICRO Ph.I.S.I.O) |

# DEVICE DESCRIPTION:

The D732 MICRO 27 Ph.I.S.I.O. is sterile, non-pyrogenic disposable filter for use in the arterial line of the cardiopulmonary bypass circuit with the flow rate not exceeding 7.0 liters/minute. The D732 MICRO 27 Ph.I.S.I.O. is an Adult Arterial Filter with 27 micron filter screen designed to remove potentially harmful gaseous emboli, aggregated blood constituents, and particulate debris greater than 27 microns from the arterial line perfusate. The D732 MICRO 27 Ph.I.S.I.O. is a modified version of the currently marketed D732 MICRO 20. The modification

{2}------------------------------------------------

consists of coating all blood contact surfaces with phosphoryicholine additive that improves the blood compatibility of the substrate materials and change of the pleated polyester filter screen pore size from 20 to 27 micron. Other than this change the D 732 MICRO 27 Ph.I.S.I.O. and the D 732 MICRO 20 are identical in design, materials, and manufacturing processes.

#### INDICATION FOR USE:

The Dideco D732 MICRO 27 Ph.I.S.I.O. with 27 micron screen with phosphorylcholine coating is recommended for use in the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass. The fitter is 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 D732 Micro 27 Ph.I.S.I.O. has the same design features, operating principles and control mechanisms when compared to the D732 predicate devices. The D732 Micro 27 Ph.I.S.I.O. utilize the same materials (with the exception of addition of the phosphoryicholine coating), filtering media with the exception of the different filter pore size (27 micron instead of 20 micron) and the same main blood flow path as the unmodified devices.

The D732 MICRO 27 Ph.1.S.I.O. are identical to the current MICRO Adult 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 phosphoryIcholine coating to all blood contact surfaces and of the change of the filter screen pore size. Both devices share the identical manufacturing process. The Ph.I.S.I.O. coating solutions used for the D732 MICRO 27 Ph.1.S.I.O. as well as manufacturing process for applying the coating, is identical to that used for the D736 MICRO 40 Ph.I.S.I.O. (K002493) predicate device. There are no differences in packaging type and material between the D732 MICRO 27 Ph.I.S.I.O. and the MICRO undmodified device. 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

{3}------------------------------------------------

ISO 10993 standard for biocompatibility testing on the raw materials. Testing was performed on the D736 MICRO 40 Ph.I.S.I.O. (accelerated aging). The devices were aged up to three 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. As no new materials are used in the D732 MICRO 27 Ph.I.S.I.O. adult arterial filter with respect to the D736 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 "Guidance for Cardiopulmonary Bypass Arterial Line 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, blood side pressure drop, filter flow rate capacity, in vitro hemolysis/cell depletion and air handling characteristics. For comparative purposes all tests were performed on sterilized aged devices comparing the D732 MICRO 27 Ph.I.S.I.O. vs. the D732 MICRO 20 non aged unmodified device operated at 7.0 LPM when applicable. The results of these tests met established specifications. The modifications being made to the MICRO Ph.I.S.I.O. arterial filter due to the presence of the Ph.I.S.I.O. coating affect the performance of the device in a statistically significant manner; therefore the performance characteristic demonstrated by the D732 MICRO 27 Ph.I.S.I.O. in terms of pressure drop andhemolysis are improved with respect to the D732 unmodified device. There is no statistically significant difference in the air handling characteristics between the D732 MICRO 27 Ph.1.S.I.O and the D732 unmodified device. The filtration efficiency of the D 732 MICRO 27 Ph.I.S.I.O. meets the 80% particles removal requirement as per AAMI Standard.

The results of the study showed that the device characteristics of the D732 MICRO 27 Ph.I.S.I.O. vs. D732 MICRO 20 unmodified device are equivalent.

# CONCLUSIONS:

The results of in vitro studies demonstrate that the D732 MICRO 27 Ph.I.S.I.O. device performs in a manner substantially equivalent to the unmodified device. The presence of the coating is advantageous in terms of reduced pressure drop and hemolysis. Biocompatibility and functional tests demonstrate that its performance is equivalent to the D732 unmodified devices, according to their intended use. Additional testing has demonstrated the effectiveness of production techniques assuring that the adult arterial filters are sterile and nonpyrogenic.

{4}------------------------------------------------

Image /page/4/Picture/2 description: The image shows a logo with a stylized bird figure on the right and text on the left. The bird figure is composed of three curved lines that resemble wings or feathers. The text is arranged in a circular pattern around the bird figure, and it appears to be the name of an organization or department. The logo has a simple, clean design with a focus on the bird figure and the text.

OCT 2 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dideco S.R.L. c/o Mr. Barry Sall Parexel International 200 West Street Waltham, MA 02451

Re: K052717

K052717
D732 MICRO 27 Ph.1.S.I.O.: Dideco D732 Micro 27 Adult Arterial Filter with 27 micron screen with phosphorylcholine coating Regulation Number: 21 CFR 870.4260 Regulation Name: Cardiopulmonary Bypass Arterial Line Blood Filter Regulatory Class: Class II (Two) Product Code: DTM Dated: September 28, 2005 Received: September 29, 2005

Dear Mr. Sall:

We have reviewed your Section 510(k) premarket notification of intent to market the undication We have reviewed your Section 310(x) premaince institutially equivalent (for the indications
referenced above and have determined the devices marketed in interstate relerenced and nave determined the device to the devices marketed in interstate for use stated in the enclosure) to regary manced producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Edgeral Food. Drug commerce prior to May 28, 1970, the chance with the provisions of the Federal Food. Drug, devices that have been reclassified in accordance while tapproval application (PMA).
and Cosmetic Act (Act) that do not require approval approval approvisions of the Act . Th and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The You may, therefore, market the device, subject to the general misbranding and general controls provisions of the 7tet merade requirem.
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 If your device is classified (see above) inly child be regulations affecting your device can
may be subject to such additional controls. Existing major regulation EDA IT may be subject to such additional controlis. Lansing major of 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. be found in the Code of Federal Regations, concerning your device in the Federal Register.

{5}------------------------------------------------

Page 2 - Mr. Barry Sall

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be devisou that i Drimination that your device complies with other requirements of the Act that I 127 than interes and regulations administered by other Federal agencies. You must or any I edetar butther 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 ETR Part 607); adoming (2 (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. product laulation of to begin marketing your device as described in your Section 510(k) I ms letter will and in yourse of substantial equivalence of your device to a legally premairce notifications "The 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 rryou don't the Office of Compliance at [phone]. 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 other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mepere Ray

ckerman. M Bram D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for "dideco", which is written in a stylized, bold, sans-serif font. Below the logo, in a smaller font, it says "A SORIN GROUP COMPANY". The logo is black and the background is white.

510(k) Number (if known): __

Device Name: D732 MICRO 27 Ph.I.S.I.O., Dideco D732 Micro 27 Adult Arterial Filter with 27 micron screen with phosphoryIcholine coating

Indications for Use:

The Dideco D732 MICRO 27 Ph.I.S.I.O. with 27 micron screen with phosphoryIcholine coating is The Dideco D732 MICNO 27 Thireston War 27 Micror of the extract during any procedure that requires recommented for use in the artenal line of the black on the bland remove gaseous emboli as well as particulate Cardiopumbliary bypass. The life it is assure should not be used longer than 6 hours. Contact with blood for longer periods is not advised.

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)

sTyeer Aor

510(k) Number_K052717