(88 days)
Medtronic DLP Adult Arterial Cannulae
Not Found
No
The device description and performance studies focus on the physical characteristics and performance of a medical device (cannulae) and do not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is a cannula used to return arterial blood during extracorporeal circulation, which is a supportive device rather than a therapeutic one itself. It facilitates a medical procedure but does not directly cure or treat a disease or condition.
No
The device is a perfusion cannula used to return arterial blood during extracorporeal circulation, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states the cannulae are made from polyvinyl chloride (PVC) and are physical devices used for returning arterial blood. The performance studies also focus on physical characteristics like flow-pressure curves, kink resistance, and bond strength, which are relevant to hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for perfusion during extracorporeal circulation and returning arterial blood to the patient. This is a direct medical intervention on the patient's circulatory system.
- Device Description: The device is a cannula, designed to be inserted into an artery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The device is a medical device used for a therapeutic procedure (cardiopulmonary bypass), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Jostra Adult Arterial Cannulae are designed to be used as perfusion cannulae to return arterial blood from the extracorporeal circuit to the patient during cardiopulmonary bypass up to 6 hours or less.
Product codes
DWF
Device Description
The Jostra Adult Arterial Cannulae are single, sterile devices for single use only and not to be resterilized by the user. The cannulas are to be used to return arterial blood to the patient via the antic root or other large artery during extracorporeal circulation. to the cannulae are made from polyvinyl chloride (PVC) and range in size from 20fr. to 24fr. with a variety of tips, with or without attached connectors. The cannulas are specifically designed for use on patients requiring more than 3L/Min. of blood flow.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
antic root or other large artery
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)
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 Adult Arterial 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)
Medtronic DLP Adult Arterial Cannulae
Reference Device(s)
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
§ 870.4210 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
NOV 1 6 2001
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
Fax: (610) 932-7366 |
| Date Prepared: | July, 27 2001 |
| Device Trade Name: | Jostra Adult Arterial Cannulae |
| Common/Usual Name: | Adult Arterial Cannulae |
| Classification Names: | Cardiopulmonary Bypass Vascular Cannula
Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, or
Fitting |
| Predicate Device: | Medtronic DLP Adult Arterial Cannulae |
Device Description:
The Jostra Adult Arterial Cannulae are single, sterile devices for single use only and not to be resterilized by the user. The cannulas are to be used to return arterial blood to the patient via the antic root or other large artery during extracorporeal circulation. to the cannulae are made from polyvinyl chloride (PVC) and range in size from 20fr. to 24fr. with a variety of tips, with or without attached connectors. The cannulas are specifically designed for use on patients requiring more than 3L/Min. of blood flow.
Indications for use:
The Jostra Adult Arterial Cannulae are designed to be used as perfusion cannulae to return arterial blood from the extracoproeal circuit to the patient during cardiopulmonary bypass up to 6 hours or less.
Statement of Technical Characteristics Comparison:
The Jostra Arterial Cannulae have the same intended use as the Medtronic DLP Cannulae Both the Jostra Arterial Cannulae and the Medtronic-DLP lines provide the user with the option of a curved or straight tip. The Jostra Arterial Cannulae come with a vent plug for safe de-airing and are available in 23cm length only. The Medtronic-DLP Arterial Cannula have an optional vent plug on models without a
1
connector and range in length from 18cm to 33cm. Comparative testing has demonstrated that these differences do not affect safety and effectiveness.
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 Adult Arterial Cannulae are "substantially equivalent" to the predicate devices in intended use, principles of operation, materials, design, and performance.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 2001
Ms. Kathleen Johnson Jostra AG C/O Jostra-Bentlye Corporation 478 Media road Oxford, PA 19363
Re: K012774
Device Name: Jostra Arterial Perfusion Cannulae Regulation Number: 21 CFR 870.4210 Regulatory Class: Class II (two) Product Code: DWF Dated: July 25, 2001 Received: August 20, 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
3
Page 2 - Ms. Kathleen Johnson
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 O insion 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,
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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NOV 1 6 2001
Page 1 of 1
510(k) Number: K012774
Device Name: Arterial Cannulae (adults)
Indications for Use
The Jostra Arterial Cannulae (adults) are designed to be used as perfusion cannulae during extracorporeal circulation during cardiopulmonary 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)
(Optional Format 3-10-98)
Division of Cardiovascular & Respiratory Devices
510(k) Number K012774
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