(202 days)
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.
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 provided 510(k) summary for the Eurosets Advanced Membrane Gas Exchange (AMG) device details the device's substantial equivalence to predicate devices, but does not contain the specific acceptance criteria or a study proving the device meets those criteria in the way a typical AI/ML medical device submission would.
This document is a premarket notification for a traditional medical device (an oxygenator), which follows a different regulatory pathway and relies on different types of performance testing than an AI/ML device. Therefore, many of the requested categories for AI/ML device studies (like sample size for test/training sets, ground truth by experts, MRMC studies, standalone performance with metrics like AUC or sensitivity/specificity) are not applicable to this submission.
Instead, this submission focuses on demonstrating substantial equivalence through:
- Comparison to predicate devices: Highlighting similarities in design, intended use, method of operation, components, packaging, and fundamental scientific technology.
- In vitro performance testing: To show that the device meets established specifications, primarily related to its physical and functional properties, as guided by relevant ISO standards and FDA guidance for oxygenators.
Here's a breakdown of the available information based on your request, with explanations for why some categories are not present:
Acceptance Criteria and Device Performance (Not Applicable for AI/ML metrics)
The document states that "The results of these tests met established specifications," but the specific numerical acceptance criteria for each test are not explicitly detailed in this summary. Instead, the focus is on the device demonstrating equivalence to its predicates and meeting general safety and effectiveness requirements through standard in vitro tests for oxygenators.
Table of Acceptance Criteria and Reported Device Performance
| Performance Metric (Type of Test) | Acceptance Criteria (Not explicitly stated numerically in summary) | Reported Device Performance |
|---|---|---|
| Biocompatibility (ISO 10993-1:2003) | Met established specifications | Met established specifications |
| Sterility | Met established specifications | Met established specifications |
| Pyrogenicity | Met established specifications | Met established specifications |
| EO residuals | Met established specifications | Met established specifications |
| Package integrity | Met established specifications | Met established specifications |
| Gas transfer characteristics (ISO 7199) | Met established specifications | Met established specifications |
| Pressure drop (ISO 7199) | Met established specifications | Met established specifications |
| Plasma leakage (ISO 7199) | Met established specifications | Met established specifications |
| Heat exchanger performance (ISO 7199) | Met established specifications | Met established specifications |
| Hemolysis tests (blood damage) (ISO 7199) | Met established specifications | Met established specifications |
| Operating blood volume (ISO 7199) | Met established specifications | Met established specifications |
| Mechanical integrity (ISO 7199) | Met established specifications | Met established specifications |
Detailed Breakdown of Study Information (Acknowledging N/A for AI/ML Specifics):
-
Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified in terms of "cases" or "patients" as this is an in-vitro performance study of a physical device, not an AI/ML diagnostic system. The "sample" would likely refer to the number of devices tested, but this detail is not provided.
- Data Provenance: Not applicable in the context of clinical data. The tests were "in vitro," meaning they were conducted in a controlled laboratory environment using test fluids/blood, not on human subjects. The testing was carried out by Eurosets srl (Italy).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable: This type of "ground truth" (e.g., expert consensus on medical images) is not relevant for the performance testing of an oxygenator. The "ground truth" here is determined by physical and chemical measurements against engineering specifications and industry standards (ISO 7199).
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable: Adjudication is not part of this type of engineering and laboratory performance testing. Results are typically quantitative measurements compared to predefined thresholds.
-
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:
- Not Applicable: This is a physical medical device, not an AI/ML algorithm that assists human readers. No MRMC study was conducted.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable: There is no AI/ML algorithm involved. The performance described is that of the physical device. The "standalone" performance is the intrinsic functional performance of the oxygenator itself in various in-vitro tests (e.g., gas transfer, pressure drop).
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Standard Specifications/Engineering Measurables: The "ground truth" for this device's performance is objective measurements (e.g., gas concentrations, flow rates, temperature, and material integrity) against established engineering specifications and international standards (ISO 7199) for cardiopulmonary bypass oxygenators.
-
The sample size for the training set:
- Not Applicable: There is no AI/ML algorithm requiring a "training set."
-
How the ground truth for the training set was established:
- Not Applicable: There is no AI/ML algorithm requiring a "training set" or its associated ground truth.
Summary:
This 510(k) pertains to a traditional medical device (oxygenator) and demonstrates substantial equivalence through comparative analysis with predicate devices and in-vitro performance testing against established industry standards and specifications. It does not involve AI/ML technology, and therefore, many of the detailed questions related to AI/ML device study design (like ground truth establishment by experts, training/test set sizes for algorithms, or MRMC studies) are not pertinent to this submission. The device successfully met all "established specifications" for the performed biocompatibility and in-vitro functional tests.
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FEB 1 5 2011
:
- 510 (k) Summary `
. .
| Submission date | January 4th 2011 |
|---|---|
| Submitter's NameAddress | Eurosets srlStrada Statale 12, n°14341036 Medolla (MO) Italy |
| EstablishmentRegistration Number | K102109 |
| Date of Summary | January 4th, 2011 |
| Telephone NumberFax Number | 0039 05356603340039 0535 51248 |
| Contact Person | Dr. Katia Vescovini,Regulatory Affairs ManagerStrada Statale 12, n°14341036 Medolla (MO) Italy |
| Official Contact | Dr. Mario GennariVia G. Puccini, 1I-41036 Medolla (Mo) ITALY+39 (0)535 52161/731216/730576+39 (0)535 731216 |
| Trade name of theComplete Device | Advance membrane gas exchange (A.M.G.) |
| Trade name of theOxygenating module | A.L.ONE A.M.G. |
| Trade name of theCardiotomy reservoir | VCR 4500 |
| Common or UsualName of theCompleteDevice | A.M.G. advanced membrane gas exchange and accessories |
| Common or UsualName of theOxygenating module | A.M.G. Oxygenating module |
| Common or UsualName of Cardiotomyreservoir | 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.;Please also note that with regard to the membrane surfacearea of the AMG oxygenator, reference will be made to thefollowing devices:- Synthesis manufactured by SORIN GROUP ITALIAS.R.L., (K073380). |
|---|---|
| Device Descriptionof the CompleteDevice | The AMG Adult Hollow Fiber Oxygenator is intended for use inadult Surgical procedures requiring extracorporeal gasexchange support and blood temperature control for periodsof up to 6 hours. |
| The AMG oxygenating device for extracorporeal circulation isa microporous hollow-fiber oxygenator with an integral heatexchanger used to perform cardiopulmonary bypass.It includes a detachable 4.5 liter blood reservoir. | |
| Device Descriptionof theOxygenating module | The AMG Adult Hollow Fiber Oxygenator is intended for use inadult Surgical procedures requiring extracorporeal gasexchange support and blood temperature control for periodsof up to 6 hours. |
| The AMG oxygenating device for extracorporeal circulation isa microporous hollow-fiber oxygenator with an integral heatexchanger used to perform cardiopulmonary bypass. | |
| Device Descriptionof the Cardiotomyreservoir | Hardshell Venous and Cardiotomy Reservoir |
| Technologycomparison of theComplete Device | The A.M.G. has the same in design, intended use, method ofoperation, components, packaging, and fundamental scientifictechnology as compared to the predicate device. |
| On the base of these comparative data the AMG Oxygenatordoes not introduce new or substantially modified materials ordesign when compared with the predicate device. | |
| Technologycomparison of theOxygenating module | The A.L.ONE A.M.G. has the same in design, intended use,method of operation, components, packaging, andfundamental scientific technology as compared to thepredicate device. |
| On the base of these comparative data the AMG Oxygenatordoes not introduce new or substantially modified materials ordesign 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 (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
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- 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
§ 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.”