ADVANCED MEMBRANE GAS EXCHANGE (AMG), AMG OXYGENALING MODULE, AMG VENOUS CARDIOTOMY RESEVOIR 4500 MODEL EU5011, EU5012

K102109 · Eurosets S.R.L · DTZ · Feb 15, 2011 · Cardiovascular

Device Facts

• Record ID: K102109
• Device Name: ADVANCED MEMBRANE GAS EXCHANGE (AMG), AMG OXYGENALING MODULE, AMG VENOUS CARDIOTOMY RESEVOIR 4500 MODEL EU5011, EU5012
• Applicant: Eurosets S.R.L
• Product Code: DTZ · Cardiovascular
• Decision Date: Feb 15, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AMG Adult Hollow Fiber Oxygenator 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 AMG oxygenating device 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. The device is used to temporarily substitute the functions of the lung as it supplies oxygen and removes carbon dioxide from the blood. AMG is a single use device.

Device Story

Device is a microporous hollow-fiber oxygenator with an integral heat exchanger and a detachable 4.5-liter hardshell venous/cardiotomy reservoir. Used during adult cardiopulmonary bypass to temporarily substitute lung function by supplying oxygen and removing carbon dioxide from blood; provides blood temperature control. Operated by perfusionists or surgical staff in an OR setting. Device receives venous blood from patient and surgical field; processes blood through hollow-fiber membrane for gas exchange and heat exchanger for thermal regulation; returns oxygenated blood to patient. Single-use device. Benefits include temporary life support during cardiac surgery.

Clinical Evidence

Bench testing only. Testing performed on devices accelerated-aged to 3 years. Evaluations included gas transfer characteristics, pressure drop, plasma leakage, heat exchanger performance, hemolysis (blood damage), operating blood volume, and mechanical integrity per ISO 7199 and FDA guidance. Biocompatibility testing conducted per ISO 10993-1:2003. All results met established specifications.

Technological Characteristics

Microporous hollow-fiber oxygenator with integral heat exchanger and 4.5L hardshell venous/cardiotomy reservoir. Materials tested for biocompatibility per ISO 10993-1. Single-use, non-electronic, mechanical device. No software or algorithm components.

Indications for Use

Indicated for adult patients undergoing surgical procedures requiring extracorporeal gas exchange support and blood temperature control for up to 6 hours during 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

• PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR (K050447)
• SYNTHESIS Cardiotomy reservoir (K073380)

Submission Summary (Full Text)

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## FEB 1 5 2011

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5. 510 (k) Summary `

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| Submission date | January 4th 2011 |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Submitter's Name<br>Address | Eurosets srl<br>Strada Statale 12, n°143<br>41036 Medolla (MO) Italy |
| Establishment<br>Registration Number | K102109 |
| Date of Summary | January 4th, 2011 |
| Telephone Number<br>Fax Number | 0039 0535660334<br>0039 0535 51248 |
| Contact Person | Dr. Katia Vescovini,<br>Regulatory Affairs Manager<br>Strada Statale 12, n°143<br>41036 Medolla (MO) Italy |
| Official Contact | Dr. Mario Gennari<br>Via G. Puccini, 1<br>I-41036 Medolla (Mo) ITALY<br>[phone]/731216/730576<br>[phone] |
| Trade name of the<br>Complete Device | Advance membrane gas exchange (A.M.G.) |
| Trade name of the<br>Oxygenating module | A.L.ONE A.M.G. |
| Trade name of the<br>Cardiotomy reservoir | VCR 4500 |
| Common or Usual<br>Name of the<br>CompleteDevice | A.M.G. advanced membrane gas exchange and accessories |
| Common or Usual<br>Name of the<br>Oxygenating module | A.M.G. Oxygenating module |
| Common or Usual<br>Name of Cardiotomy<br>reservoir | Venous cardiotomy reservoir 4500 |

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Classification Name of Cardiopulmunary device Classification Name: Advanced the Complete Device membrane gas exchange Device Class: II Product Code: DTZ Regulation Number: 21 CFR §870.4350 Oxygenator cardiopulmonary bypass Classification Name of the Oxygenating Cardiovascular module Device Class: II Product Code: DTZ Regulation Number: 21 CFR §870.4350 Classification Name of Hard shell Venous/cardiotomy reservoir Cardiovascular Cardiotomy reservoir Device Class: II Product Code: DTZ Regulation Number: 21 CFR §870.4350 Proprietary Name: PRIMO2X Classification Name: OXYGENATOR, CARDIOPULMONARY ldentification of the BYPASS Registered Establishment Name: SORIN GROUP ITALIA Predicate Device for the Complete Device S.R.L Registered Establishment Number: 9680841 Owner/Operator: SORIN GROUP ITALIA S.R.L Owner/Operator Number: 9011842 Establishment Operations: Manufacturer 510 (k): K050447 Device Name: PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR Applicant DIDECO S.R.L. 195 West St., Waltham, MA 02451 Proprietary Name: PRIMO2X ldentification of the Classification Name: OXYGENATOR, CARDIOPULMONARY Predicate Oxygenating BYPASS module Registered Establishment Name: SORIN GROUP ITALIA S.R.L Registered Establishment Number: 9680841 Owner/Operator: SORIN GROUP ITALIA S.R.L Owner/Operator Number: 9011842 Establishment Operations: Manufacturer 510 (k): K050447 Device Name: PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR Applicant DIDECO S.R.L. 195 West St., Waltham, MA 02451 Please note that regarding the card pore size employed by the ldentification of the AMG. Eurosets will refer to the following predicate device: Predicate Device for - SYNTHESIS Cardiotomy resevoir, (K073380), produced by the Cardiotomy

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| reservoir | the manufacturer SORIN GROUP ITALIA S.R.L.;<br>Please also note that with regard to the membrane surface<br>area of the AMG oxygenator, reference will be made to the<br>following devices:<br>- Synthesis manufactured by SORIN GROUP ITALIA<br>S.R.L., (K073380). |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description<br>of the Complete<br>Device | The AMG Adult Hollow Fiber Oxygenator is intended for use in<br>adult Surgical procedures requiring extracorporeal gas<br>exchange support and blood temperature control for periods<br>of up to 6 hours. |
| | The AMG oxygenating device for extracorporeal circulation is<br>a microporous hollow-fiber oxygenator with an integral heat<br>exchanger used to perform cardiopulmonary bypass.<br>It includes a detachable 4.5 liter blood reservoir. |
| Device Description<br>of the<br>Oxygenating module | The AMG Adult Hollow Fiber Oxygenator is intended for use in<br>adult Surgical procedures requiring extracorporeal gas<br>exchange support and blood temperature control for periods<br>of up to 6 hours. |
| | The AMG oxygenating device for extracorporeal circulation is<br>a microporous hollow-fiber oxygenator with an integral heat<br>exchanger used to perform cardiopulmonary bypass. |
| Device Description<br>of the Cardiotomy<br>reservoir | Hardshell Venous and Cardiotomy Reservoir |
| Technology<br>comparison of the<br>Complete Device | The A.M.G. has the same in design, intended use, method of<br>operation, components, packaging, and fundamental scientific<br>technology as compared to the predicate device. |
| | On the base of these comparative data the AMG Oxygenator<br>does not introduce new or substantially modified materials or<br>design when compared with the predicate device. |
| Technology<br>comparison of the<br>Oxygenating module | The A.L.ONE A.M.G. has the same in design, intended use,<br>method of operation, components, packaging, and<br>fundamental scientific technology as compared to the<br>predicate device. |
| | On the base of these comparative data the AMG Oxygenator<br>does not introduce new or substantially modified materials or<br>design when compared with the predicate device. |

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Technology The Hardshell Venous and Cardiotomy Reservoir has the same in design, intended use, method of operation, comparison of the components, packaging, and fundamental scientific Cardiotomy reservoir technology as compared to the predicate device. On the base of these comparative data the AMG Oxygenator does not introduce new or substantially modified materials or design when compared with the predicate device. Intended Use of the The AMG Adult Hollow Fiber Oxygenator is intended for use in adult Surgical procedures requiring extracorporeal gas CompleteDevice exchange support and blood temperature control for periods of up to 6 hours. The AMG oxygenating device 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. The device is used to temporarily substitute the functions of the lung as it supplies oxygen and removes carbon dioxide from the blood. A.M.G. is a single use device. A.L.ONE A.M.G. is intended for use in adult surgical Intended Use of the procedures requiring extracorporeal gas exchange support Oxygenating module and blood temperature control for periods of up to 6 hours. VCR 4500 is intended to collect the blood from the suckers Intended Use of the placed in the operative field during surgical treatments , and Cardiotomy reservoir the blood coming from the patient's cave venous. VCR 4500 is an ADULT Cardiotomy reservoir. VCR 4500 should not be used for more than 6 hours. Applicable tests were carried out in accordance with the Performance testing of requirements of ISO 10993-1:2003 and the FDA May 1, 1995 the CompleteDevice, Memorandum on the use of the ISO 10993 standard for Oxygenating module biocompatibility testing of raw materials. Tests were and Cardiotomy performed on devices accelerated aged to an equivalent of reservoir three years real time aging. Sterility, pyrogenicity. EO residuals and package integrity testing were also conducted. The results of this testing met established specifications. In vitro testing was carried out in accordance with the requirements of ISO 7199 and the Guidance for Cardiopulmonary Bypass Oxygenators 510(k) submissions -

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Final Guidance for Industry and FDA Staff November 13, 2000 to provide the data necessary to demonstrate compliance of the predicate device with safety and effectiveness requirements. The A.M.G. Oxygenator, A.L.ONE A.M.G. Oxygenator and Hardshell Cardiotomy Reservoir aged to 3 years was tested for gas transfer characteristics, pressure drop and plasma leakage, heat exchanger performance, hemolysis tests (blood damage), operating blood volume and mechanical integrity. The results of these tests met established specifications.

Based upon a comparison of devices and performance testing results, the A.M.G. Oxygenator, A.L.ONE A.M.G. and the Hardshell Venous Cardiotomy Reservoir are substantially equivalent to the predicate devices.

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Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three stripes forming its wing, and three wavy lines below representing water. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

Eurosets, s.r.l. c/o Eric J. Nemeth 55 Madison Ave., Suite 400 Morristown, New Jersey 07960

FEB 1 5 201

Re: K102109

Trade Name: Eurosets Advanced Membrane Gas Exchange ("AMG") Regulation Number: 21 CFR 870.4350 Regulation Name: Oxygenator, cardiopulmonary bypass Regulatory Class: II Product Code: DTZ Dated: January 4, 2011 Received: January 7, 2011

Dear Mr. Nemeth:

We have reviewed vour 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.

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 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 (reporting of medical

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Page 2 -- Mr. Eric J. Nemeth

device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Dumas R. V. Lumer

~ 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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5. 510 (k) Summary

## Indications for Use

510(k) Number (if known); K102109

Device Name: Advanced Membrane Gas Exchange (AMG)

Indications for Use:

The AMG Adult Hollow Fiber Oxygenator 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 AMG oxygenating device 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.

The device is used to temporarily substitute the functions of the lung as it supplies oxygen and removes carbon dioxide from the blood.

AMG is a single use device.

Prescription Use × (Part 21 CFR 801 109)

AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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uma R.V.l.l.l

(Division Sign-Off) (Division Sign-Om)
Division of Cardiovascular Devices

510(k) Number_KIO 2109