(246 days)
No
The description focuses on the physical components and function of a traditional oxygenator and heat exchanger. There is no mention of AI/ML terms, data analysis, or algorithmic decision-making.
Yes
Explanation: The device is intended for extracorporeal gas exchange support and blood temperature control to temporarily substitute the functions of the lung, which are therapeutic actions.
No
The device is described as an oxygenator with an integral heat exchanger used to perform cardiopulmonary bypass, which provides extracorporeal gas exchange support and blood temperature control, indicating a therapeutic rather than diagnostic function.
No
The device description clearly outlines a physical medical device (oxygenator with integral heat exchanger and blood reservoir) used for extracorporeal gas exchange. There is no mention of software as the primary or sole component.
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 (gas exchange and temperature regulation).
- Device Description: The description reinforces this by calling it a "microporous hollow-fiber oxygenator with an integral heat exchanger used to perform cardiopulmonary bypass." This is a life-support device that replaces the function of the lungs and heart during surgery.
- IVD Definition: In vitro diagnostics are devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit this definition as it is used to treat the patient by performing a physiological function, not to diagnose or monitor based on analyzing a specimen.
The device is a therapeutic device used in a surgical setting, not a diagnostic device used to analyze samples.
N/A
Intended Use / Indications for 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.
Product codes
DTZ
Device Description
The Advanced Membrane Gas Exchange and accessories PMP STERILE (A.M.G. PMP STERILE) is a microporous hollow-fiber oxygenator with an integral heat exchanger, used to perform cardiopulmonary bypass or surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours. It includes a detachable 4.5 liter blood reservoir.
The A.M.G. PMP STERILE is equipped with polymethyl pentene fibres, more hydrophobic than the polyethylene used for the predicate device and so considered a more reliable barrier between the blood pathway and gas pathway of the oxygenator.
The A.M.G. PMP STERILE is provided in different configurations:
- microporous hollow-fiber oxygenator with temperature probe and pre-connected venous cardiotomy reservoir (“A.M.G. PMP STERILE”),
- microporous hollow-fiber oxygenator with temperature probe and without pre-connected venous cardiotomy reservoir (“A.M.G. MODULE PMP STERILE”),
- microporous hollow-fiber oxygenator without temperature probe and without pre-connected venous cardiotomy reservoir (“A.M.G. MODULE PMP NO TP STERILE”),
- Venous Cardiotomy Reservoir 4500 PMP (“VCR 4500 PMP STERILE”).
The device is used to temporarily substitute the functions of the lung as it supplies oxygen and removes carbon dioxide from the blood. The device can be use with adult patients.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung
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)
In vitro bench testing was performed to support a determination of substantial equivalence (refer to performance testing below) between the new Advanced Membrane Gas Exchange PMP STERILE (A.M.G. PMP STERILE) and the predicate.
The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use and performs comparably to the existing predicate devices.
In vitro bench tests were carried out to demonstrate equivalence, according to the requirements of FDAs document "Guidance for Cardiopulmunary Bypass Oxygenators 510(k) Submission", issued on November 13, 2000, the ISO 7199:2009 and of the EN 12022:1998 "Blood-gas exchangers".
The following areas have been tested and/or evaluated:
- Gas Transfer and Pressure Drop,
- Fiber Hydrophilization,
- Cracking test external body,
- Coating Uniformity,
- Plasma hemoglobin concentration,
- Heat exchanger Efficiency and Filling Volume,
- Seal Connection,
- Structural and Mechanical Integrity,
- Bioburden tests,
- Sterility tests,
- LAL-test,
- Validation of the EtO Sterilization process,
- Sterility tests,
- Packaging evaluation,
- Labelling evaluation,
- EtO Residual, according to EN ISO 10993-7,
- Biocompatibility, according to ISO 10993 series requirements.
The results from these performance evaluations demonstrated that the AMG PMP STERILE met the acceptarfce criteria defined in the product specification and performed comparably to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(K) SUMMARY, AS REQUIRED BY 21 CFR 807.92
| Submitter's Name | Eurosets s.r.l. |
|---|---|
| Address | Strada Statale 12, nº143 |
| 41036 Medolla (MO) Italy | |
| Establishment | |
| Registration Number | 3003752502 |
| Summary | |
| Preparation Date | Feruary 05, 2015 |
| Contact Person | |
| Telephone Number | |
| Fax Number | Dr. Katia Vescovini, Regulatory Affairs Manager |
| 0039 0535660334 | |
| 0039 0535 51248 | |
| Name of the Device | Advanced Membrane Gas Exchange PMP STERILE (A.M.G. |
| PMP STERILE) | |
| Name of the | |
| Oxygenating module | A.M.G. MODULE PMP STERILE |
| A.M.G. MODULE PMP NO T.P. STERILE | |
| Name of the | |
| Cardiotomy | |
| reservoir | VCR 4500 PMP STERILE |
| Common name of | |
| the device | Advanced Membrane Gas Exchange and Accessories A.M.G. |
| PMP STERILE | |
| Common name of | |
| the Oxygenating | |
| module | A.M.G. MODULE PMP STERILE |
| A.M.G. MODULE PMP NO T.P. STERILE | |
| Common name of | |
| the Cardiotomy | |
| reservoir | Venous Cardiotomy Reservoir 4500 PMP STERILE |
| Classification Name | Cardiopulmunary device |
| Classification Name: Advanced membrane gas exchange | |
| Device Class: II | |
| Product Code: DTZ | |
| Regulation Number: 21 CFR §870.4350 | |
| Performance | |
| Standards | No performance standards applicable to Advanced Membrane |
| Gas Exchange PMP STERILE (A.M.G. PMP STERILE) have | |
| been established by the FDA |
4
510(k) SUMMARY, continued
| DESCRIPTION: | The Advanced Membrane Gas Exchange and accessories PMP
STERILE (A.M.G. PMP STERILE) is a microporous hollow-fiber
oxygenator with an integral heat exchanger, used to perform
cardiopulmonary bypass or surgical procedures requiring
extracorporeal gas exchange support and blood temperature
control for periods of up to 6 hours. It includes a detachable 4.5
liter blood reservoir.
The A.M.G. PMP STERILE is equipped with polymethyl pentene
fibres, more hydrophobic than the polyethylene used for the
predicate device and so considered a more reliable barrier
between the blood pathway and gas pathway of the oxygenator.
The A.M.G. PMP STERILE is provided in different configurations:
- microporous hollow-fiber oxygenator with temperature probe
and pre-connected venous cardiotomy reservoir (“A.M.G. PMP
STERILE”), - microporous hollow-fiber oxygenator with temperature probe
and without pre-connected venous cardiotomy reservoir
(“A.M.G. MODULE PMP STERILE”), - microporous hollow-fiber oxygenator without temperature
probe and without pre-connected venous cardiotomy reservoir
(“A.M.G. MODULE PMP NO TP STERILE”), - Venous Cardiotomy Reservoir 4500 PMP (“VCR 4500 PMP
STERILE”).
The device is used to temporarily substitute the functions of the |
|-----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | lung as it supplies oxygen and removes carbon dioxide from the
blood. The device can be use with adult patients. |
| Indications for 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. |
| Identification of
Predicate Device | Proprietary Name: AMG
Classification Name: 21 CFR 870.4350, Oxygenator,
Cardiopulmonary Bypass
Registered Establishment Name:
Eurosets srl
Strada Statale 12, n. 143
41036 Medolla (MO) Italy |
| Registered Establishment Number: | 3003752502
Owner/Operator: Eurosets srl
Establishment Operations: Manufacturer
510 (k): K102109
Device Name: A.M.G. advanced membrane gas exchange and
accessories
Applicant: Eurosets srl |
| | Please note that regarding the polymethyl pentene fibres used by
the A.M.G. PMP STERILE, Eurosets will refer to the following
predicate device: |
| | Proprietary Name: MEDOS HILITE 7000 & 7000 LT Hollow Fiber
Oxygenator |
| | Classification Name: 21 CFR 870.4350, Oxygenator,
Cardiopulmonary Bypass
Registered Establishment Name: GISH BIOMEDICAL, INC. |
| | Registered Establishment Number: 3002845651
Owner/Operator: GISH BIOMEDICAL, INC.
Owner/Operator Number: 3002845651
Establishment Operations: Manufacturer 510 (k): K082403 |
| | Device Name: 7000 LT Hollow Fiber Oxygenator (K082403) |
| | Applicant: GISH BIOMEDICAL, INC. |
| Common name of
the predicate device
for principles of
operatations | A.M.G. advanced membrane gas exchange and accessories |
| Classification Name
of the device | Oxygenator, Cardiopulmonary Bypass |
| Classification Name
of the Oxygenating
module | Device Class: II
Product Code: DTZ
Regulation Number: 21 CFR §870.4350
Oxygenator cardiopulmonary bypass Cardiovascular
Device Class: II
Product Code: DTZ |
| Classification Name
of the Cardiotomy
reservoir | Regulation Number: 21 CFR §870.4350
Hard shell Venous/cardiotomy reservoir Cardiovascular
Device Class: II
Product Code: DTZ
Regulation Number: 21 CFR §870.4350 |
| Applicant name and
address: | Eurosets s.r.l.
Strada Statale 12, n°143
41036 Medolla (MO) Italy |
| | MEDOS MEDIZINTECHNIK AG
Obere Steinfurt 8-10 |
| Comparison of
Technological
Characteristics | In vitro bench testing was performed to support a determination of
substantial equivalence (refer to performance testing below)
between the new Advanced Membrane Gas Exchange PMP
STERILE (A.M.G. PMP STERILE) and the predicate.
The results of these tests provide reasonable assurance that the
proposed device has been designed and tested to assure
conformance to the requirements for its intended use and
performs comparably to the existing predicate devices. |
| Performance
Testing (non-
clinical) | In vitro bench tests were carried out to demonstrate equivalence,
according to the requirements of FDAs document "Guidance for
Cardiopulmunary Bypass Oxygenators 510(k) Submission",
issued on November 13, 2000, the ISO 7199:2009 and of the EN
12022:1998 "Blood-gas exchangers".
The following areas have been tested and/or evaluated: - Gas Transfer and Pressure Drop,
- Fiber Hydrophilization,
- Cracking test external body,
- Coating Uniformity,
- Plasma hemoglobin concentration,
- Heat exchanger Efficiency and Filling Volume,
- Seal Connection,
- Structural and Mechanical Integrity,
- Bioburden tests,
- Sterility tests,
- LAL-test,
- Validation of the EtO Sterilization process,
- Sterility tests,
- Packaging evaluation,
- Labelling evaluation,
- EtO Residual, according to EN ISO 10993-7,
- Biocompatibility, according to ISO 10993 series
requirements.
The results from these performance evaluations demonstrated
that the AMG PMP STERILE met the acceptarfce criteria defined
in the product specification and performed comparably to the
predicate device. |
| SUBSTANTIAL
EQUIVALENCE: | The A.M.G PMP STERILE are identical to the predicate device in
terms of intended use, indications for use and surgical technique.
Based on the safety and performance testing, technological
characteristics and the indications for use for the device, the
proposed A.M.G PMP STERILE has been demonstrated to be
appropriate for its intended use and is considered substantially
equivalent to the previously cleared A.M.G. advanced membrane
gas exchange and accessories (K102109). |
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Stolberg, GERMANY 52222