(74 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and fluid dynamics of a venous cannula, with no mention of AI or ML technology.
No
This device diverts blood during extracorporeal circulation and does not directly treat a disease or condition for therapeutic purposes.
No
The device is described as a perfusion cannula used to divert venous blood during surgery requiring extracorporeal circulation. Its purpose is to facilitate blood flow, not to diagnose a condition or disease.
No
The device description clearly states the device is made from polyvinyl chloride (PVC) and describes physical characteristics like size and tips, indicating it is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "divert venous blood from the patient during surgery requiring extracorporeal circulation." This is a direct intervention on the patient's circulatory system for therapeutic purposes (supporting circulation during surgery).
- Device Description: The device is a cannula designed to be inserted into the patient's veins (Right atrium and Inferior vena cava) to drain blood. This is a surgical instrument used in vivo.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
This device is clearly used within the patient's body during a surgical procedure, not for testing specimens outside the body.
N/A
Intended Use / Indications for Use
The Jostra Two-Stage Venous Cannulae are designed to be used as perfusion cannulae to divert venous blood from the patient during surgery requiring extracorporeal circulation for up to 6 hours.
Product codes
DWF, DTL
Device Description
The Jostra Two-Stage Venous Cannulas are single, sterile devices for single use only and not to be resterilized by the user. The cannulas are to be used to divert blood from the patient to the extracorporeal circuit by draining blood simultaneously from the Right atrium and the Inferior vena cava. The cannulae are made from polyvinyl chloride (PVC) and range in size from 32Fr./40Fr. to 36Fr./51Fr. with a variety of tips and with or without attached connectors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Right atrium and the Inferior vena cava
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)
Performance testing included: Flow-Pressure curves Kink Resistance Bond Strength Leakage Test. Additionally, in-vitro testing was performed to determine the effects on cellular components.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Medtronic DLP Two-Stage Venous Cannulae
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).
0
K013944
p½
007
510 (K) Summary
Submitter:
Jostra AG Hechinger Straße 38 72145 Hirrlingen Germany
Contact Person:
Kathleen Johnson P. O. Box 218 Oxford, PA 19363 Phone: (610) 932-7738 (610) 932-7366 Fax:
Date Prepared:
Device Trade Name: Jostra Dual-stage Venous Cannulae
November 21, 2001
Common/Usual Name: Two-Stage Venous Cannulae
Cardiopulmonary Bypass Vascular Cannula Classification Names: Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, or Fitting
Medtronic DLP Two-Stage Venous Cannulae Predicate Device:
Device Description:
The Jostra Two-Stage Venous Cannulas are single, sterile devices for single use only and not to be resterilized by the user. The cannulas are to be used to divert blood from the patient to the extracorporeal circuit by draining blood simultaneously from the Right atrium and the Inferior vena cava. The cannulae are made from polyvinyl chloride (PVC) and range in size from 32Fr./40Fr. to 36Fr./51Fr. with a variety of tips and with or without attached connectors.
Indications for use:
The Jostra Two-Stage Venous Cannulae are designed to be used as perfusion cannulae to divert venous blood from the patient during surgery requiring extracorporeal circulation for up to 6 hours.
Statement of Technical Characteristics Comparison:
The Jostra Two-Stage Venous Cannula have the same intended use and design as the Medtronic DLP Two-Stage Venous Cannula. The Jostra Two-Stage Venous Cannula are available in sizes 32/40Fr to 36/51Fr. The Medtronic DLP Two-stage Venous cannula range in sizes from 28/36Fr. to 36/51Fr. Comparative testing has demonstrated that these differences do not affect safety and effectiveness.
1
Biocompatibility and performance testing was performed to demonstrate substantial equivalency to the predicate device.
Performance testing included:
Flow-Pressure curves Kink Resistance Bond Strength Leakage Test
Additionally, in-vitro testing was performed to determine the effects on cellular components.
Conclusion:
Performance, and in-vitro testing demonstrate that the Jostra Two-Stage Venous Cannulae are "substantially equivalent" to the predicate devices in intended use, principles of operation, materials, design, and performance.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1 2002
Ms. Kathleen Johnson Regulatory Affairs, Submissions Manager c/o Jostra-Bentley Corp. Jostra AG 478 Media Road Oxford, PA 19363
Re: K013944
Trade Name: Jostra Dual Stage Venous Return Cannulae Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing. Regulatory Class: Class II (two) Product Code: DWF, DTL Dated: November 21, 2001 Received: November 29, 2001
Dear Ms. Johnson:
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.
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
3
Page 2 - Ms. Kathleen Johnson
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Danle Teth
la Bram D. Zuckerman, M.D.
Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K01394L
Page 1 of 1
510(k) Number:
Device Name: Jostra Two-Stage Venous Cannulas
Indications for Use
The Jostra Two-Stage Venous Cannulas are designed to be used as perfusion cannulae to divert venous blood from the patient during surgery requiring extracorporeal circulation for up to 6 hours.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
(Optional Format 3-10-98)
Division of Cardiovascular & Respiratory Devices
510(k) Number K013944