(161 days)
No
The device description and performance studies focus on the physical characteristics and biological compatibility of a blood reservoir for cardiopulmonary bypass, with no mention of AI or ML capabilities.
No
The device is used to collect, store, and filter blood in extracorporeal circulation during cardiopulmonary bypass operations, and also as a drainage and autotransfusion reservoir. It does not directly provide therapy, but rather manages blood during and after a surgical procedure.
No
This device is used to collect, store, and filter blood during cardiopulmonary bypass operations or for postoperative drainage and autotransfusion. It does not analyze patient data or provide diagnostic information about the patient's condition.
No
The device is a physical, hardware-based reservoir used in cardiopulmonary bypass operations and postoperative drainage. The description details its physical components, materials, and intended use in handling blood, which are characteristics of a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is a reservoir used in extracorporeal circulation during cardiopulmonary bypass. Its primary functions are to collect, store, filter, and return blood to the patient. It handles blood within the extracorporeal circuit, which is a temporary external system connected to the patient.
- Lack of Diagnostic Purpose: The device does not perform any analysis or testing of the blood to provide diagnostic information. It is a component of a life support system used during surgery and post-operatively for blood management.
Therefore, while it handles blood, its purpose is not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The venous hardshell cardiotomy reservoir is used to collect, store and filter blood in extracorporeal circulation in cardiopulmonary bypass operations on pediatric patients for up to 6 hours:
The reservoir can also be employed postoperatively as drainage and autotransfusion reservoir (e.g., for thorax drainage) to return the autologous blood to the patient which was removed from the thorax for the volume exchange.
Product codes
DTN, DTP, JOD
Device Description
The Neonatal and Pediatric Venous Hardshell Cardiotomy Reservoirs are developed for the use in the field of cardiopulmonary bypass operation. They are used as blood buffer in the extracorporeal circuit and as collecting and defoaming device for sucked blood.
The Neonatal and Pediatric Reservoirs may be applied during the surgery in the extracorporeal circulation for collecting venous blood by gravitation or vacuum assist venous drainage (VAVD), air removal in venous blood, as a volume depot of blood, for collecting, defoaming and filtering cardiotomy blood.
The Reservoirs may also be applied after the surgery on the intensive care unit for vacuum operated thoracic drainage and for the autotransfusion of autologous blood. If the application occurs in the intensive care unit the reservoir which was employed in the operation is usually used.
The blood contacting surfaces are coated optionally with SOFTLINE Coating.
The Neonatal and Pediatric Reservoirs are sterile and non-pyrogenic devices, for single use only and are not to be re-sterilized by the user.
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
pediatric patients / neonate and pediatric patients
Intended User / Care Setting
cardiopulmonary bypass operation / surgery in the extracorporeal circulation / intensive care unit
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)
Non-clinical Testing:
The Neonatal Venous Hardshell Cardiotomy Reservoir and Pediatric Venous Hardshell Cardiotomy Reservoir, with and without SOFTLINE Coating have been tested or evaluated for compliance to ISO 10993-1 Biologic Evaluation of Medical Devices and ISO 15674 "Cardiovascular implants and artificial orqans - Hard-shell cardiotomy / venous reservoir systems (with/without filter) and softbag venous reservoir bags" The products met these requirements.
Determination of Substantial Equivalence
Testing and evaluation on safety and effectiveness was conducted to demonstrate that the Neonatal Venous Hardshell Cardiotomy Reservoir and Pediatric Venous Hardshell Cardiotomy Reservoir, with and without SOFTLINE Coating is substantially equivalent to the Capiox Reservoir RX 05 Baby from Terumo (K022115) as well as to the Resevoir D101 Dideco Kids Infant with Ph.1.S.I.O. Coating from Sorin (K072091).
The following areas have been tested or evaluated:
- Indications for Use
- Integrity
- Performance
- Biocompatibility
- Sterility
Conclusion
The data given demonstrate that the Neonatal Venous Hardshell Cardiotomy Reservoir and Pediatric Venous Hardshell Cardiotomy Reservoir, with and without SOFTLINE Coating is substantially equivalent to the named predicate devices which currently hold market clearance.
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
§ 870.4400 Cardiopulmonary bypass blood reservoir.
(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
MAR 1 1 2011
510 (K) Summary [as required by 21 CFR 807.92(c) ]
Submitter: Maquet Cardiopulmonary AG Hechinger Strasse 38 72145 Hirrlingen Germany
Katrin Schwenkglenks Contact Person: Phone: +49 7478 921-151 +49 7478 921-400 Fax: E-mail: katrin.schwenkglenks@maquet-cp.com
September 28, 2010 Date Prepared:
Neonatal Venous Hardshell Cardiotomy Reservoir Device Trade Name: and Pediatric Venous Hardshell Cardiotomy Reservoir, with and without SOFTLINE Coating
Venous Hardshell Cardiotomy Reservoir Common/Usual name:
Cardiopulmonary bypass blood reservoir, Classification names: Cardiopulmonary bypass defoamer, Cardiopulmonary bypass cardiotomy suction line
Predicate Devices:
Capiox Resevoir RX 05R Baby, Terumo Cardiovascular Systems Corp (K022115),
Resevoir D101 Dideco Kids Infant with Ph.J.S.I.O. Coating, Sorin (K072091), Venous Hardshell Cardiotomy Reservoir with SOFTLINE Coating (K090534), MAQUET Cardiopulmonary AG.
1
Device Description:
The Neonatal and Pediatric Venous Hardshell Cardiotomy Reservoirs are developed for the use in the field of cardiopulmonary bypass operation. They are used as blood buffer in the extracorporeal circuit and as collecting and defoaming device for sucked blood.
The Neonatal and Pediatric Reservoirs may be applied during the surgery in the extracorporeal circulation for collecting venous blood by gravitation or vacuum assist venous drainage (VAVD), air removal in venous blood, as a volume depot of blood, for collecting, defoaming and filtering cardiotomy blood.
The Reservoirs may also be applied after the surgery on the intensive care unit for vacuum operated thoracic drainage and for the autotransfusion of autologous blood. If the application occurs in the intensive care unit the reservoir which was employed in the operation is usually used.
The blood contacting surfaces are coated optionally with SOFTLINE Coating.
The Neonatal and Pediatric Reservoirs are sterile and non-pyrogenic devices, for single use only and are not to be re-sterilized by the user.
Indications for Use:
The venous hardshell cardiotomy reservoir is used to collect, store and filter blood in extracorporeal circulation in cardiopulmonary bypass operations on pediatric patients for up to 6 hours.
The reservoir can also be employed postoperatively as drainage and autotransfusion reservoir (e.g., for thorax drainage) to return the autologous blood to the patient which was removed from the thorax for the volume exchange.
Statement of Technical Comparison:
The Neonatal Venous Hardshell Cardiotomy Reservoir and Pediatric Venous Hardshell Cardiotomy Reservoir, with and without SOFTLINE Coating is comparable to the above named predicate devices which are also designed and intended to be used with neonate and pediatric patients. The Softline Coating is the same coating contained in the Venous Hardshell Cardiotomy Reservoir with SOFTLINE Coating.
2
GETINGE GROUP
Non-clinical Testing:
The Neonatal Venous Hardshell Cardiotomy Reservoir and Pediatric Venous Hardshell Cardiotomy Reservoir, with and without SOFTLINE Coating have been tested or evaluated for compliance to ISO 10993-1 Biologic Evaluation of Medical Devices and ISO 15674 "Cardiovascular implants and artificial orqans - Hard-shell cardiotomy / venous reservoir systems (with/without filter) and softbag venous reservoir bags" The products met these requirements.
Determination of Substantial Equivalence
Testing and evaluation on safety and effectiveness was conducted to demonstrate that the Neonatal Venous Hardshell Cardiotomy Reservoir and Pediatric Venous Hardshell Cardiotomy Reservoir, with and without SOFTLINE Coating is substantially equivalent to the Capiox Reservoir RX 05 Baby from Terumo (K022115) as well as to the Resevoir D101 Dideco Kids Infant with Ph.1.S.I.O. Coating from Sorin (K072091).
The following areas have been tested or evaluated:
- Indications for Use
- Integrity
- Performance
- Biocompatibility
- Sterility
Conclusion
The data given demonstrate that the Neonatal Venous Hardshell Cardiotomy Reservoir and Pediatric Venous Hardshell Cardiotomy Reservoir, with and without SOFTLINE Coating is substantially equivalent to the named predicate devices which currently hold market clearance.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Maquet Cardiopulmonary AG c/o Ms. Katrin Schwenkglenks Hechinger Strasse 38 D-72145 Hirrlingen, Germany
MAR 1 1 2511
Re: K102919
Trade/Device Name: Neonatal Venous Hardshell Cardiotomy Reservoir (VHK11000), Neonatal Venous Hardshell Cardiotomy Reservoir with SOFTLINE Coating (BO-VHK 11000), Pediatric Venous Hardshell Cardiotomy Reservoir (VHK31000), and Pediatric Venous Hardshell Cardiotomy Reservoir with SOFTLINE (THRS1000), and Fedaring Regulation Number: 21 CFR 870.4400 Regulation Name: Cardiopulmonary bypass blood reservoir Regulatory Class: II Product Code: DTN, DTP, JOD Dated: March 1, 2011 Received: March 4, 2011
Dear Ms. Schwenkglenks:
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 (fav the ucications 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, Dr w 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 misbanding 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 af the Act
4
Page 2 – Ms. Katrin Schwenkglenks
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements 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.html fart 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.
R. Vahner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K102912
Device Name: Neonatal Venous Hardshell Cardiotomy Reservoir and Pediatric Venous Hardshell Cardiotomy Reservoir, with and without SOFTLINE Coating
Indications for Use:
The venous hardshell cardiotomy reservoir is used to collect, store and filter blood in extracorporeal circulation in cardiopulmonary bypass operations on pediatric patients for up to 6 hours:
The reservoir can also be employed postoperatively as drainage and autotransfusion reservoir (e.g., for thorax drainage) to return the autologous blood to the patient which was removed from the thorax for the volume exchange.
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Summa R. Varner
(Division Sian-Off) Division of Cardiovascular Devices
510(k) Number K102919