K Number
K102109
Device Name
ADVANCED MEMBRANE GAS EXCHANGE (AMG), AMG OXYGENALING MODULE, AMG VENOUS CARDIOTOMY RESEVOIR 4500 MODEL EU5011, EU5012
Manufacturer
Date Cleared
2011-02-15

(202 days)

Product Code
Regulation Number
870.4350
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 Description
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.
More Information

Not Found

No
The description focuses on the physical components and function of a hollow fiber oxygenator and heat exchanger, with no mention of AI or ML capabilities.

Yes
The device is used to temporarily substitute the functions of the lung by supplying oxygen and removing carbon dioxide from the blood, directly treating a physiological function.

No

Explanation: The device is an oxygenator used for extracorporeal gas exchange and temperature control during surgical procedures, temporarily substituting lung function. It does not perform diagnostic functions.

No

The device description clearly outlines a physical medical device, including components like a microporous hollow-fiber oxygenator, integral heat exchanger, and a detachable blood reservoir. The performance studies also focus on physical characteristics and biological interactions, not software validation.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the device is for "extracorporeal gas exchange support and blood temperature control" during surgical procedures. This involves directly interacting with the patient's blood outside the body to perform a physiological function (oxygenation and CO2 removal).
  • Device Description: The description reinforces this by calling it an "oxygenating device for extracorporeal circulation" that "temporarily substitute the functions of the lung."
  • Lack of Diagnostic Purpose: An IVD is a device used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any diagnostic testing on the blood; it modifies the blood's composition (gas exchange) and temperature.

Therefore, the AMG Adult Hollow Fiber Oxygenator is a therapeutic device used for cardiopulmonary bypass, not an in vitro diagnostic device.

N/A

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

DTZ

Device Description

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.
Hardshell Venous and Cardiotomy Reservoir

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

adult

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Applicable tests were carried out in accordance with the requirements of ISO 10993-1:2003 and the FDA May 1, 1995 Memorandum on the use of the ISO 10993 standard for biocompatibility testing of raw materials. Tests were performed on devices accelerated aged to an equivalent of 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 - 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K050447, K073380

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 870.4350 Cardiopulmonary bypass oxygenator.

(a)
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.(b)
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.”

0

FEB 1 5 2011

:

  1. 510 (k) Summary `

. .

Submission dateJanuary 4th 2011
Submitter's Name
AddressEurosets srl
Strada Statale 12, n°143
41036 Medolla (MO) Italy
Establishment
Registration NumberK102109
Date of SummaryJanuary 4th, 2011
Telephone Number
Fax Number0039 0535660334
0039 0535 51248
Contact PersonDr. Katia Vescovini,
Regulatory Affairs Manager
Strada Statale 12, n°143
41036 Medolla (MO) Italy
Official ContactDr. Mario Gennari
Via G. Puccini, 1
I-41036 Medolla (Mo) ITALY
+39 (0)535 52161/731216/730576
+39 (0)535 731216
Trade name of the
Complete DeviceAdvance membrane gas exchange (A.M.G.)
Trade name of the
Oxygenating moduleA.L.ONE A.M.G.
Trade name of the
Cardiotomy reservoirVCR 4500
Common or Usual
Name of the
CompleteDeviceA.M.G. advanced membrane gas exchange and accessories
Common or Usual
Name of the
Oxygenating moduleA.M.G. Oxygenating module
Common or Usual
Name of Cardiotomy
reservoirVenous cardiotomy reservoir 4500

:

1

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

2

| reservoir | the manufacturer SORIN GROUP ITALIA S.R.L.;
Please also note that with regard to the membrane surface
area of the AMG oxygenator, reference will be made to the
following devices:

  • Synthesis manufactured by SORIN GROUP ITALIA
    S.R.L., (K073380). |
    |-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
    | Device Description
    of the Complete
    Device | 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. |
    | Device Description
    of the
    Oxygenating module | 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. |
    | Device Description
    of the Cardiotomy
    reservoir | Hardshell Venous and Cardiotomy Reservoir |
    | Technology
    comparison of the
    Complete Device | The A.M.G. has the same in design, intended use, method of
    operation, components, packaging, and fundamental scientific
    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. |
    | Technology
    comparison of the
    Oxygenating module | The A.L.ONE A.M.G. has the same in design, intended use,
    method of operation, components, packaging, and
    fundamental scientific 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. |

3

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 -

4

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.

5

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

6

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 (800) 638-2041 or (301) 796-7100 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

7

  1. 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)

Page 1 of 1

uma R.V.l.l.l

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

510(k) Number_KIO 2109