(305 days)
Not Found
No
The device description and intended use focus on a physical blood reservoir for cardiopulmonary bypass, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are based on in-vitro testing of physical properties.
No
The device is a reservoir for blood volume during cardiopulmonary bypass surgery and does not directly provide therapy.
No
The device is a reservoir used in extracorporeal circuits to hold blood during cardiopulmonary bypass procedures, not to diagnose a condition.
No
The device description clearly outlines a physical product made of plastic foils, tubes, and a polyester mesh, designed to hold blood during surgery. It is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "extracorporeal circuits during cardiopulmonary bypass procedures in the field of open-heart-surgery." This describes a device used during a surgical procedure to manage blood flow outside the body.
- Device Description: The description details a "container for a certain blood volume" used in these extracorporeal circuits. It's a physical component of a system that handles blood during surgery.
- Lack of Diagnostic Purpose: There is no mention of this device being used to analyze blood or other biological samples to provide diagnostic information about a patient's condition. IVDs are specifically designed for in vitro (outside the body) examination of specimens to diagnose, monitor, or screen for diseases or conditions.
The Jostra Venous Softbag Reservoir is a medical device used in a surgical procedure, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Jostra Venous Softbag Reservoirs are indicated for use in extracorporeal circuits during cardiopulmonary bypass procedures in the field of open-heart-surgery. The utilization period of this device is restricted to six hours. Blood contact longer than 6 hours is not recommended. Application and use of the softbag reservoir is in the sole responsibility of the respective physician.
Product codes (comma separated list FDA assigned to the subject device)
DTN
Device Description
The Venous Softbag Reservoir is used in extracorporeal circuits during cardiopulmonary bypass surgery and serves as container for a certain blood volume. It consists of plastic foils which are welded together and between which tubes of different diameters and a polyester mesh are sandwiched. The polyester mesh serves for an improved air removal. Application duration: The utilization period of this device is restricted to six hours. The softbag reservoir is delivered sterile and is determined for single use only.
The group of Venous Softbag Reservoirs consists of a variety of models which differ in size (filling volume) and in the port sizes. The filling volumes of the reservoirs range from 650 ml to 1900 ml depending on the model and the ports are either 3/8" or ½" in size.
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
Not Found
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 testing on safety and effectiveness was executed to demonstrate that the Jostra Venous Softbag Reservoirs with and without Safeline Coating described in this submission are substantially equivalent to the named predicate devices.
The following areas have been tested:
- Integrity .
- Performance -
- Stability of the coating -
- Biocompatibility ・
- -Sterility
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.
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
§ 870.4400 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
JAN - 4 2008
K070605 MAQUET
510 (K) Summary Jas required by 21 CFR 807.92(c) 1
| Submitter: | Maquet Cardiopulmonary AG
Hechinger Strasse 38
72145 Hirrlingen
Germany |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Katrin Schwenkglenks
Phone: +49 7478 921-151
Fax: +49 7478 921-400
E-mail: katrin.schwenkglenks@maquet-cp.com |
| Date Prepared:
Device Trade Name: | February 28, 2007
Jostra Venous Softbag Reservoirs with and without
Safeline Coating |
| Common/Usual Name: | Venous Reservoir Bag |
| Classification Names: | Reservoir, Blood, Cardiopulmonary Bypass
(21 CFR 870.4400, product code: DTN) |
| Predicate Devices: | BMR 1900 Soft-Shell Venous Reservoir, Cobe
Cardiovascular Inc. (K050111),
MVR 800 Collapsible Venous Reservoir Bag,
Medtronic Inc. (K920774)
RotaFlow Centrifugal Pump with Safeline Coating
(K061072) |
Device Description
The Venous Softbag Reservoir is used in extracorporeal circuits during cardiopulmonary bypass surgery and serves as container for a certain blood volume. It consists of plastic foils which are welded together and between which tubes of different diameters and a polyester mesh are sandwiched. The polyester mesh serves for an improved air removal. Application duration: The utilization period of this device is restricted to six hours. The softbag reservoir is delivered sterile and is determined for single use only.
The group of Venous Softbag Reservoirs consists of a variety of models which differ in size (filling volume) and in the port sizes. The filling volumes of the reservoirs range from 650 ml to 1900 ml depending on the model and the ports are either 3/8" or ½" in size.
Statement of Indications for Use
The Jostra Venous Softbag Reservoirs are indicated for use in extracorporeal circuits during cardiopulmonary bypass procedures in the field of open-heart-surgery. The utilization period of this device is restricted to six hours. Blood contact longer than 6 hours is not recommended. Application and use of the softbag reservoir is in the sole responsibility of the respective physician.
1
MAQUET
Statement of Technical Characteristics Comparison
Maquet Cardiopulmonary AG has compared indications for use, design, specifications, performance characteristics and safety of the Jostra Venous Softbag Reservoirs with and without Safeline Coating and of the predicate devices.
In-vitro testing on safety and effectiveness was executed to demonstrate that the Jostra Venous Softbag Reservoirs with and without Safeline Coating described in this submission are substantially equivalent to the named predicate devices.
The following areas have been tested:
- Integrity .
- Performance -
- Stability of the coating -
- Biocompatibility ・
- -Sterility
Conclusion
The Jostra Venous Softbag Reservoirs with and without Safeline Coating are substantially equivalent to the named predicate devices that currently hold market clearance.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized emblem featuring three abstract human profiles or faces, stacked vertically and connected by flowing lines, creating a sense of unity and movement.
JAN - 4 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Maquet Cardiopulmonary AG c/o Ms. Katrin Schwenkglenks Regulatory Affairs Manager Hechinger Strasse 38 72145 Hirrlingen, Germany
Re: K070605
Jostra Venous Softbag Reservoirs with and without Safeline Regulation Number: 21 CFR 870.4400 Regulation Name: Cardiopulmonary bypass blood reservoir Regulatory Class: Class II (two) Product Code: DTN Dated: December 20, 2007 Received: December 26, 2007
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Bfommamourh
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): Ko 70605
Device Name: Jostra Venous Softbag Reservoir with and without Safeline Coating
Indications for Use:
The Jostra Venous Softbag Reservoirs are indicated for use in extracorporeal circuits during cardiopulmonary bypass procedures in the field of open-heart-surgery. The utilization period of this device is restricted to six hours. Blood contact longer than 6 hours is not recommended. Application and use of the softbag reservoir is in the sole responsibility of the respective physician.
Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (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)
Bhammana
San-Off second Cardiovascular De
Page ___ of __________________________________________________________________________________________________________________________________________________________________
(Posted November 13, 2003)