ADVANCED MEMBRANCE GAS EXCHANGE PMP STERILE (A.M.G PMP STERILE)

K141492 · Eurosets S.R.L · DTZ · Feb 6, 2015 · Cardiovascular

Device Facts

• Record ID: K141492
• Device Name: ADVANCED MEMBRANCE GAS EXCHANGE PMP STERILE (A.M.G PMP STERILE)
• Applicant: Eurosets S.R.L
• Product Code: DTZ · Cardiovascular
• Decision Date: Feb 6, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Advanced Membrane Gas Exchange PMP STERILE (A.M.G. PMP STERILE) is intended for use in adult Surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours. The Advanced Membrane Gas Exchange PMP STERILE (A.M.G. PMP STERILE) for extracorporeal circulation is a microporous hollow-fiber oxygenator with an integral heat exchanger used to perform cardiopulmonary bypass. It includes a detachable 4.5 liter blood reservoir.

Device Story

Microporous hollow-fiber oxygenator with integral heat exchanger and detachable 4.5L blood reservoir; performs cardiopulmonary bypass by substituting lung function (oxygenation/CO2 removal) and controlling blood temperature. Utilizes polymethyl pentene (PMP) fibers for improved hydrophobicity compared to polyethylene. Used in surgical settings by clinical staff. Device provides gas exchange and thermal regulation during extracorporeal circulation; supports patient physiological stability during procedures up to 6 hours.

Clinical Evidence

Bench testing only. Evaluated gas transfer, pressure drop, fiber hydrophilization, coating uniformity, plasma hemoglobin, heat exchanger efficiency, structural integrity, and biocompatibility (ISO 10993). Sterilization validated per EN ISO 10993-7. No clinical data presented.

Technological Characteristics

Microporous hollow-fiber oxygenator with integral heat exchanger; polymethyl pentene (PMP) fibers; detachable 4.5L reservoir. Sterilized via Ethylene Oxide (EtO). Complies with ISO 7199:2009 and EN 12022:1998 standards.

Indications for Use

Indicated for adult patients undergoing surgical procedures requiring extracorporeal gas exchange support and blood temperature control for up to 6 hours, including cardiopulmonary bypass.

Regulatory Classification

Identification

A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”

Predicate Devices

• A.M.G. advanced membrane gas exchange and accessories (K102109)
• MEDOS HILITE 7000 & 7000 LT Hollow Fiber Oxygenator (K082403)

Submission Summary (Full Text)

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

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the left side of the logo.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 6, 2015

EUROSETS s.r.1. % Mario Gennari Official Correspondent, Gemar s.r.1. Via G. Puccini, 1 Medolla, Modena, IT I-43036

Re: K141492

> Trade/Device Name: Advanced Membrane Gas Exchange PMP Sterile (A.M.G. PMP Sterile) Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ Dated: December 4, 2014 Received: January 14, 2015

Dear Mario Gennari,

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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

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

with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M.A. Hillebrenner

for

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

Enclosure

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

## Indications for Use

510(k) Number (if known) K141492

Device Name

Advanced Membrane Gas Exchange PMP (A.M.G. PMP STERILE)

Indications for Use (Describe)

The Advanced Membrane Gas Exchange PMP STERILE (A.M.G. PMP STERILE) is intended for use in adult Surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours.

The Advanced Membrane Gas Exchange PMP STERILE (A.M.G. PMP STERILE) for extracorporeal circulation is a microporous hollow-fiber oxygenator with an integral heat exchanger used to perform cardiopulmonary bypass. It includes a detachable 4.5 liter blood reservoir.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

# 510(K) SUMMARY, AS REQUIRED BY 21 CFR 807.92

| Submitter's Name | Eurosets s.r.l. |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address | Strada Statale 12, nº143<br>41036 Medolla (MO) Italy |
| Establishment<br>Registration Number | 3003752502 |
| Summary<br>Preparation Date | Feruary 05, 2015 |
| Contact Person<br>Telephone Number<br>Fax Number | Dr. Katia Vescovini, Regulatory Affairs Manager<br>0039 0535660334<br>0039 0535 51248 |
| Name of the Device | Advanced Membrane Gas Exchange PMP STERILE (A.M.G.<br>PMP STERILE) |
| Name of the<br>Oxygenating module | A.M.G. MODULE PMP STERILE<br>A.M.G. MODULE PMP NO T.P. STERILE |
| Name of the<br>Cardiotomy<br>reservoir | VCR 4500 PMP STERILE |
| Common name of<br>the device | Advanced Membrane Gas Exchange and Accessories A.M.G.<br>PMP STERILE |
| Common name of<br>the Oxygenating<br>module | A.M.G. MODULE PMP STERILE<br>A.M.G. MODULE PMP NO T.P. STERILE |
| Common name of<br>the Cardiotomy<br>reservoir | Venous Cardiotomy Reservoir 4500 PMP STERILE |
| Classification Name | Cardiopulmunary device<br>Classification Name: Advanced membrane gas exchange<br>Device Class: II<br>Product Code: DTZ<br>Regulation Number: 21 CFR §870.4350 |
| Performance<br>Standards | No performance standards applicable to Advanced Membrane<br>Gas Exchange PMP STERILE (A.M.G. PMP STERILE) have<br>been established by the FDA |

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

## 510(k) SUMMARY, continued

| DESCRIPTION: | The Advanced Membrane Gas Exchange and accessories PMP<br>STERILE (A.M.G. PMP STERILE) is a microporous hollow-fiber<br>oxygenator with an integral heat exchanger, used to perform<br>cardiopulmonary bypass or surgical procedures requiring<br>extracorporeal gas exchange support and blood temperature<br>control for periods of up to 6 hours. It includes a detachable 4.5<br>liter blood reservoir.<br>The A.M.G. PMP STERILE is equipped with polymethyl pentene<br>fibres, more hydrophobic than the polyethylene used for the<br>predicate device and so considered a more reliable barrier<br>between the blood pathway and gas pathway of the oxygenator.<br>The A.M.G. PMP STERILE is provided in different configurations:<br>- microporous hollow-fiber oxygenator with temperature probe<br>and pre-connected venous cardiotomy reservoir (“A.M.G. PMP<br>STERILE”),<br>- microporous hollow-fiber oxygenator with temperature probe<br>and without pre-connected venous cardiotomy reservoir<br>(“A.M.G. MODULE PMP STERILE”),<br>- microporous hollow-fiber oxygenator without temperature<br>probe and without pre-connected venous cardiotomy reservoir<br>(“A.M.G. MODULE PMP NO TP STERILE”),<br>- Venous Cardiotomy Reservoir 4500 PMP (“VCR 4500 PMP<br>STERILE”).<br>The device is used to temporarily substitute the functions of the |
|-----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | lung as it supplies oxygen and removes carbon dioxide from the<br>blood. The device can be use with adult patients. |
| Indications for Use | The Advanced Membrane Gas Exchange PMP STERILE (A.M.G.<br>PMP STERILE) is intended for use in adult Surgical procedures<br>requiring extracorporeal gas exchange support and blood<br>temperature control for periods of up to 6 hours.<br>The Advanced Membrane Gas Exchange PMP STERILE (A.M.G.<br>PMP STERILE) for extracorporeal circulation is a microporous<br>hollow-fiber oxygenator with an integral heat exchanger used to<br>perform cardiopulmonary bypass.<br>It includes a detachable 4.5 liter blood reservoir. |
| Identification of<br>Predicate Device | Proprietary Name: AMG<br>Classification Name: 21 CFR 870.4350, Oxygenator,<br>Cardiopulmonary Bypass<br>Registered Establishment Name:<br>Eurosets srl<br>Strada Statale 12, n. 143<br>41036 Medolla (MO) Italy |
| Registered Establishment Number: | 3003752502<br>Owner/Operator: Eurosets srl<br>Establishment Operations: Manufacturer<br>510 (k): K102109<br>Device Name: A.M.G. advanced membrane gas exchange and<br>accessories<br>Applicant: Eurosets srl |
| | Please note that regarding the polymethyl pentene fibres used by<br>the A.M.G. PMP STERILE, Eurosets will refer to the following<br>predicate device: |
| | Proprietary Name: MEDOS HILITE 7000 & 7000 LT Hollow Fiber<br>Oxygenator |
| | Classification Name: 21 CFR 870.4350, Oxygenator,<br>Cardiopulmonary Bypass<br>Registered Establishment Name: GISH BIOMEDICAL, INC. |
| | Registered Establishment Number: 3002845651<br>Owner/Operator: GISH BIOMEDICAL, INC.<br>Owner/Operator Number: 3002845651<br>Establishment Operations: Manufacturer 510 (k): K082403 |
| | Device Name: 7000 LT Hollow Fiber Oxygenator (K082403) |
| | Applicant: GISH BIOMEDICAL, INC. |
| Common name of<br>the predicate device<br>for principles of<br>operatations | A.M.G. advanced membrane gas exchange and accessories |
| Classification Name<br>of the device | Oxygenator, Cardiopulmonary Bypass |
| Classification Name<br>of the Oxygenating<br>module | Device Class: II<br>Product Code: DTZ<br>Regulation Number: 21 CFR §870.4350<br>Oxygenator cardiopulmonary bypass Cardiovascular<br>Device Class: II<br>Product Code: DTZ |
| Classification Name<br>of the Cardiotomy<br>reservoir | Regulation Number: 21 CFR §870.4350<br>Hard shell Venous/cardiotomy reservoir Cardiovascular<br>Device Class: II<br>Product Code: DTZ<br>Regulation Number: 21 CFR §870.4350 |
| Applicant name and<br>address: | Eurosets s.r.l.<br>Strada Statale 12, n°143<br>41036 Medolla (MO) Italy |
| | MEDOS MEDIZINTECHNIK AG<br>Obere Steinfurt 8-10 |
| Comparison of<br>Technological<br>Characteristics | In vitro bench testing was performed to support a determination of<br>substantial equivalence (refer to performance testing below)<br>between the new Advanced Membrane Gas Exchange PMP<br>STERILE (A.M.G. PMP STERILE) and the predicate.<br>The results of these tests provide reasonable assurance that the<br>proposed device has been designed and tested to assure<br>conformance to the requirements for its intended use and<br>performs comparably to the existing predicate devices. |
| Performance<br>Testing (non-<br>clinical) | In vitro bench tests were carried out to demonstrate equivalence,<br>according to the requirements of FDAs document "Guidance for<br>Cardiopulmunary Bypass Oxygenators 510(k) Submission",<br>issued on November 13, 2000, the ISO 7199:2009 and of the EN<br>12022:1998 "Blood-gas exchangers".<br>The following areas have been tested and/or evaluated:<br>- Gas Transfer and Pressure Drop,<br>- Fiber Hydrophilization,<br>- Cracking test external body,<br>- Coating Uniformity,<br>- Plasma hemoglobin concentration,<br>- Heat exchanger Efficiency and Filling Volume,<br>- Seal Connection,<br>- Structural and Mechanical Integrity,<br>- Bioburden tests,<br>- Sterility tests,<br>- LAL-test,<br>- Validation of the EtO Sterilization process,<br>- Sterility tests,<br>- Packaging evaluation,<br>- Labelling evaluation,<br>- EtO Residual, according to EN ISO 10993-7,<br>- Biocompatibility, according to ISO 10993 series<br>requirements.<br>The results from these performance evaluations demonstrated<br>that the AMG PMP STERILE met the acceptarfce criteria defined<br>in the product specification and performed comparably to the<br>predicate device. |
| SUBSTANTIAL<br>EQUIVALENCE: | The A.M.G PMP STERILE are identical to the predicate device in<br>terms of intended use, indications for use and surgical technique.<br>Based on the safety and performance testing, technological<br>characteristics and the indications for use for the device, the<br>proposed A.M.G PMP STERILE has been demonstrated to be<br>appropriate for its intended use and is considered substantially<br>equivalent to the previously cleared A.M.G. advanced membrane<br>gas exchange and accessories (K102109). |

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

-

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

Stolberg, GERMANY 52222