(85 days)
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Not Found
No
The device description and performance studies focus on the physical characteristics and functional performance of a medical cannula, with no mention of software, algorithms, or AI/ML technologies.
Yes
The device is designed to infuse blood or cardioplegia arrest solution to myocardial tissue, which is a therapeutic intervention aimed at treating or preventing damage to the heart during cardiopulmonary bypass.
No
This device is designed to infuse solutions to myocardial tissue, not to diagnose medical conditions.
No
The device description clearly states it is a physical cannula made from PVC with various components like balloons and stylets, indicating 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 to infuse solutions directly into the coronary sinus during cardiopulmonary bypass. This is a therapeutic procedure performed on a living patient, not a diagnostic test performed on a sample taken from a patient.
- Device Description: The device is a cannula designed for direct insertion into the body. IVD devices are typically used to analyze samples (like blood, urine, tissue) outside of the body.
- Lack of Diagnostic Function: There is no mention of this device being used to analyze a sample or provide diagnostic information about a patient's condition.
Therefore, the Jostra Retrograde Cardioplegia Cannulas are a medical device used for a therapeutic purpose, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Jostra Retrograde Cardioplegia Cannulas are designed to infuse blood or cardioplegia arrest solution to the myocardial tissue retrograde via the coronary sinus during cardiopulmonary bypass up to 6 hours or less.
Product codes (comma separated list FDA assigned to the subject device)
DWF
Device Description
The Jostra Retrograde Cardioplegia Cannulas are single, sterile devices for single use only and not to be resterilized by the user. The cannulas are to be used to infuse blood or cardioplegia arrest solution retrograde via the coronary sinus during extracorporeal circulation. The cannulas are made from polyvinyl chloride (PVC) in size 14 Fr. with a variety of balloons, with or without pressure monitoring lines and a choice of stiff or flexible stylets.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
coronary sinus, myocardial tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing: 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 Retrograde Cardioplegia Cannulae are "substantially equivalent" to the predicate devices in intended use, principles of operation, materials, design, and performance.
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.
Medtronic DLP Retrograde Cardioplegia Cannula
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.
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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).
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§ 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).
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MAR 2 6 2002
510 (K) Summary
Submitter:
Jostra AG Hechinger Straße 38 72145 Hirrlingen Germany
Contact Person:
Kathleen Johnson Phone: (610) 932-7738 (610) 932-7366 Fax:
December 21, 2001 Date Prepared:
Device Trade Name:
Common/Usual Name: Retrograde Cardioplegia Cannula
Classification Names:
Cardiopulmonary Bypass Vascular Cannula Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, or Fitting Catheter Stylet Piston Svringe
Jostra Retrograde Cardioplegia Cannula
Predicate Device: Medtronic DLP Retrograde Cardioplegia Cannula
Device Description:
The Jostra Retrograde Cardioplegia Cannulas are single, sterile devices for single use only and not to be resterilized by the user. The cannulas are to be used to infuse blood or cardioplegia arrest solution retrograde via the coronary sinus during extracorporeal circulation. The cannulas are made from polyvinyl chloride (PVC) in size 14 Fr. with a variety of balloons, with or without pressure monitoring lines and a choice of stiff or flexible stylets.
Indications for use:
The Jostra Retrograde Cardioplegia Cannulas are designed to infuse blood or cardioplegia arrest solution to the myocardial tissue retrograde via the coronary sinus during cardiopulmonary bypass up to 6 hours or less.
Statement of Technical Characteristics Comparison:
The Jostra Retrograde Cardioplegia Cannulas have the same intended use as the Medtronic DLP Retrograde Cardioplegia Cannulas. Comparative testing has demonstrated that these differences do not affect safety and effectiveness.
1
Non-Clinical Testing:
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 Retrograde Cardioplegia 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 the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure embracing a globe. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 6 2002
Ms. Kathy Johnson Regulatory Affairs, Submission Manager JOSTRA® AG c/o JOSTRA-Bentley Corporation 478 Media Road Oxford, PA 19363
Re: K014303
Trade Name: Jostra Retrograde Cardioplegia Cannula Regulation Number: 21 CFR 4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing. Regulatory Class: Class II (two) Product Code: DWF Dated: December 21, 2001 Received: December 31, 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. Kathy 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. Control provided in the marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premaince notification " 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). Toganalers 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,
Dak Telle
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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Page 1 of 1
510(k) Number:
.
Device Name: Jostra Retrograde Cardioplegia Cannulas
Indications for Use
indications for USE
The Jostra Retrograde Cardioplegia Cannulas are designed for the coronary The Jostra Rerograde Cardioplegia Cannarao al Sissue retrograde via the coronary
or cardioplegia arrest solution to the myocardial tissue retograde via the coronary of Cardloplegia an ook default to are bypass up to 6 hours or less.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number R014305
(Optional Format 3-10-98)
Prescription Use
(Per 21 CFR 801.109)