(30 days)
No
The description focuses on the physical components and function of a blood reservoir and filter, with no mention of AI or ML capabilities.
No
The device collects, stores, and filters blood, and can be used for autotransfusion, which are supportive functions for procedures but are not directly therapeutic in themselves.
No
Explanation: The device is designed to collect, store, and filter blood during cardiopulmonary bypass procedures and for autotransfusion, which are therapeutic and supportive functions, not diagnostic.
No
The device description clearly indicates it is a physical reservoir designed to collect, store, and filter blood, which is a hardware component. 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:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Jostra Venous Hardshell Cardiotomy Reservoir is designed to collect, store, and filter blood during cardiopulmonary bypass procedures and potentially for autotransfusion postoperatively. It is part of an extracorporeal circuit, meaning it handles blood outside the body for therapeutic purposes, not for diagnostic testing.
- Intended Use: The intended use clearly describes its role in managing blood flow and volume during and after surgery, not for analyzing blood components to diagnose or monitor a condition.
The device is a component of a system used to support a patient's circulatory function during and after surgery, which falls under the category of medical devices used for treatment and support, not in vitro diagnosis.
N/A
Intended Use / Indications for Use
The Jostra Venous Hardshell Cardiotomy Reservoir (non-vacuum-tight model) is designed to collect, store and filter the blood in an extracorporeal circuit during cardiopulmonary bypass procedures up to six hours in adult surgery. It can be integrated into almost all perfusion systems. The Jostra Venous Hardshell Cardiotomy Reservoir is designed and sold for use only as indicated.
The Jostra Venous Hardshell Cardiotomy Reservoir (vacuum-tight model) is designed to collect, store and filter the blood in an extracorporeal circuit during cardiopulmonary bypass procedures with or without vacuum assisted venous return up to six hours in adult surgery. It can be integrated into almost all perfusion systems. The Jostra Venous Hardshell Cardiotomy Reservoir is designed and sold for use only as indicated. This reservoir is also designed to be used postoperatively as a drainage and autotransfusion reservoir (e.g. for chest drainage) to return autologous blood shed from the chest to the patient for volume replacement.
Product codes (comma separated list FDA assigned to the subject device)
DTN
Device Description
The Jostra Venous Hardshell Cardiotomy Reservoir (non-vacuum-tight model) is designed to collect, store and filter the blood in an extracorporeal circuit during cardiopulmonary bypass procedures up to six hours in adult surgery. It can be integrated into almost all perfusion systems. The Jostra Venous Hardshell Cardiotomy Reservoir is designed and sold for use only as indicated.
The Jostra Venous Hardshell Cardiotomy Reservoir (vacuum-tight model) is designed to collect, store and filter the blood in an extracorporeal circuit during cardiopulmonary bypass procedures with or without vacuum assisted venous return up to six hours in adult surgery. It can be integrated into almost all perfusion systems. The Jostra Venous Hardshell Cardiotomy Reservoir is designed and sold for use only as indicated. This reservoir is also designed to be used postoperatively as a drainage and autotransfusion reservoir (e.g. for chest drainage) to return autologous blood shed from the chest to the patient for volume replacement.
The Jostra Venous Hardshell Cardiotomy Reservoirs (vacuum-tight and non-vacuum-tight model) with Safeline Coating are identical to the Jostra Venous Hardshell Cardin tygn Reservoirs with the only exception that the Venous Hardshell Cardiotomy Reservoirs with Safeline Coating have been coated with Safeline. The Safeline Coating is the same as with the Jostra RotaFlow Centrifugal Pump with Safeline Coating. Besides this difference the Venous Hardshell Cardiotomy Reservoirs with Safeline Coating are the same in design. intended use, method of operation, components, packaging, and fundamental scientific technology as compared to the uncoated Venous Hardshell Cardiotomy Reservoirs.
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)
Evaluation and testing on safety and effectiveness was executed to demonstrate that the Jostra Venous Hardshell Cardiotomy Reservoirs with Safeline Coating described in this submission are substantially equivalent to the Jostra Venous Hardshell Cardiotomy Reservoirs as reservoirs and to the RotaFlow Centrifugal Pump with Safeline Coating regarding the Safeline coating.
The following areas have been tested and / or evaluated:
- Integrity
- Performance
- Biocompatibility
- Sterility
The data given demonstrate that the Jostra Venous Hardshell Cardiotomy Reservoirs (sealed and non-sealed model) with Safeline Coating are substantially equivalent to the named predicate devices which hold currently market clearance.
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.
Jostra Venous Hardshell Cardiotomy Reservoirs (K982136, K003551)
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.
Jostra RotaFlow Centrifugal Pump with Safeline Coating (K061072)
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
§ 870.4400 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
K061743
MAQUET
JUL 21 2006
Special 510(k): Device Modification: Venous Hardshell Cardiotomy Reservoirs with Safeline Coating
510(k) SUMMARY
SUBMITTER:
Maquet Cardiopulmonary AG Hechinger Strasse 38 72145 Hirrlingen, Germany
Phone: (011) 49 7478 921- 151
011 49 7478 921- 400
Katrin Schwenkglenks
CONTACT PERSON:
DATE PREPARED:
DEVICE TRADE NAME:
COMMON/USUAL NAME
CLASSIFICATION NAME
June 16, 2006
Fax:
Jostra Venous Hardshell Cardiotomy Reservoirs with Safeline Coating
Venous Reservoirs
Cardiopulmonary bypass blood reservoir Cardiopulmonary bypass defoamer Cardiopulmonary bypass cardiotomy suction line blood filter
PREDICATE DEVICES OR LEGALLY MARKETED DEVICES
Jostra Venous Hardshell Cardiotomy Reservoirs (K982136, K003551) Jostra RotaFlow Centrifugal Pump with Safeline Coating (K061072)
DEVICE DESCRIPTION/INDICATONS FOR USE STATEMENT
The Jostra Venous Hardshell Cardiotomy Reservoir (non-vacuum-tight model) is designed to collect, store and filter the blood in an extracorporeal circuit during cardiopulmonary bypass procedures up to six hours in adult surgery . It can be integrated into almost all perfusion systems. The Jostra Venous Hardshell Cardiotomy Reservoir is designed and sold for use only as indicated.
The Jostra Venous Hardshell Cardiotomy Reservoir (vacuum-tight model) is designed to collect, store and filter the blood in an extracorporeal circuit during cardiopulmonary bypass procedures with or without vacuum assisted venous return up to six hours in adult surgery . It can be integrated into almost all perfusion systems. The Jostra Venous Hardshell Cardiotomy Reservoir is designed and sold for use only as indicated. This reservoir is also designed to be used postoperatively as a drainage and autotransfusion reservoir (e.g. for chest drainage) to return autologous blood shed from the chest to the patient for volume replacement.
1
MAQUET
STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON
The Jostra Venous Hardshell Cardiotomy Reservoirs (vacuum-tight and non-vacuum-tight model) with Safeline Coating are identical to the Jostra Venous Hardshell Cardin tygn Reservoirs with the only exception that the Venous Hardshell Cardiotomy Reservoirs with Safeline Coating have been coated with Safeline. The Safeline Coating is the same as with the Jostra RotaFlow Centrifugal Pump with Safeline Coating. Besides this difference the Venous Hardshell Cardiotomy Reservoirs with Safeline Coating are the same in design. intended use, method of operation, components, packaging, and fundamental scientific technology as compared to the uncoated Venous Hardshell Cardiotomy Reservoirs.
DETERMINATION OF SUBSTANTIAL EQUIVALENCE
Evaluation and testing on safety and effectiveness was executed to demonstrate that the Jostra Venous Hardshell Cardiotomy Reservoirs with Safeline Coating described in this submission are substantially equivalent to the Jostra Venous Hardshell Cardiotomy Reservoirs as reservoirs and to the RotaFlow Centrifugal Pump with Safeline Coating regarding the Safeline coating.
The following areas have been tested and / or evaluated:
- Integrity -
- Performance 1
- -Biocompatibility
- -Sterility
Conclusion
The data given demonstrate that the Jostra Venous Hardshell Cardiotomy Reservoirs (sealed and non-sealed model) with Safeline Coating are substantially equivalent to the named predicate devices which hold currently market clearance.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 21 2006
Maquet Cardiopulmonary AG c/o Ms. Katrin Schwenkglenks Regulatory Affairs Manager Hechinger Strasse 38 Hirrling Germany 72145
Re: K061743
Trade Name: Venous Hardshell Cardiotomy Reservoir with Safeline Coating Regulation Number: 21 CFR 870.4400 Regulation Name: Cardiotomy Reservoir Regulatory Class: Class II (two) Product Code: DTN Dated: June 16, 2006 Received: June 21, 2006
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 (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 such 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.
3
Page 2 - Ms. Katrin Schwenkglenks
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Duna R. Holmes
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K061743
Device Name: Venous Hardshell Cardiotomy Reservoirs with Safeline Coating _____
The Jostra Venous Hardshell Cardiotomy Reservoir (non-vacuum-tight model) is designed to collect, store and filter the blood in an extracorporeal circuit during cardiopulmonary bypass procedures up to six hours in adult surgery . It can be integrated into almost all perfusion systems. The Jostra Venous Hardshell Cardiotomy Reservoir is designed and sold for use only as indicated.
The Jostra Venous Hardshell Cardiotomy Reservoir (vacuum-tight model) is designed to collect, store and filter the blood in an extracorporeal circuit during cardiopulmonary bypass procedures with or without vacuum assisted venous return up to six hours in adult surgery . It can be integrated into almost all perfusion systems. The Jostra Venous Hardshell Cardiotomy Reservoir is designed and sold for use only as indicated. This reservoir is also designed to be used postoperatively as a drainage and autotransfusion reservoir (e.g. for chest drainage) to return autologous blood shed from the chest to the patient for volume replacement.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
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 Lof I
(Posted November 13, 2003)
uma P. Vorland
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K061743
062