(74 days)
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.
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.
This document describes the 510(k) submission for the Jostra Dual-stage Venous Cannulae (K013944), a medical device used in cardiopulmonary bypass surgery. The submission focuses on demonstrating substantial equivalence to a predicate device, the Medtronic DLP Two-Stage Venous Cannulae.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the nature of the tests performed to demonstrate "substantial equivalence" to the predicate device. The goal is to show comparable performance. The document does not explicitly state numerical acceptance criteria for each test but rather describes the types of tests conducted and their stated outcome.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Performed, demonstrating substantial equivalency to predicate device. |
| Flow-Pressure curves | Performed, demonstrating substantial equivalency to predicate device. |
| Kink Resistance | Performed, demonstrating substantial equivalency to predicate device. |
| Bond Strength | Performed, demonstrating substantial equivalency to predicate device. |
| Leakage Test | Performed, demonstrating substantial equivalency to predicate device. |
| Effects on cellular components (in-vitro) | Performed, demonstrating substantial equivalency to predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each of the performance tests (Flow-Pressure curves, Kink Resistance, Bond Strength, Leakage Test, and in-vitro cellular effects). The data provenance is likely from laboratory testing conducted by the manufacturer, Jostra AG, in Germany. The tests are described as in-vitro and performance testing, implying a controlled laboratory setting rather than human or animal studies. The data is retrospective in the sense that it was collected as part of the device development and verification process to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since this is a submission for a physical medical device (venous cannulae) and the tests are in-vitro performance and biocompatibility studies, there is no "ground truth" in the traditional sense established by human experts in the way it would be for an AI/algorithm-based diagnostic device. The "ground truth" for compliance with acceptance criteria is based on objective measurements and established industry standards for device performance and safety, as evaluated by engineers and technical specialists.
4. Adjudication Method for the Test Set
Not applicable. This is not an imaging or diagnostic device that requires expert adjudication of results. The performance of the device is assessed through objective physical and biological tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices or AI algorithms where human interpretation is involved. The Jostra Dual-stage Venous Cannulae is a physical medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is not an algorithm or AI system. Its performance is inherent in its physical and material properties.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on objective, measurable physical and biological parameters established through engineering and laboratory testing. This includes:
- Physical measurements (e.g., flow rates, pressure resistance, bond strength).
- Mechanical properties (e.g., kink resistance).
- Biocompatibility assessments (e.g., in-vitro effects on cellular components).
- Comparison to the established performance characteristics of the predicate device.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set. The device is a physical product.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for a physical medical device of this nature.
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K013944
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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.
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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.
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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
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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
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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
§ 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).