(85 days)
Not found
Not Found
No
The device description and performance studies focus on the physical properties and function of a medical cannula, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a perfusion cannula used to return arterial blood to the patient during cardiopulmonary bypass, which is a supportive function rather than a direct therapeutic intervention to treat a disease or condition.
No
Explanation: The device is a perfusion cannula used to return arterial blood during cardiopulmonary bypass. Its function is to facilitate blood flow, not to diagnose medical conditions.
No
The device description clearly states the cannulae are made from polyvinyl chloride (PVC) and are physical devices used to return arterial blood, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The Jostra Pediatric Arterial Cannulae are used within the body to return arterial blood to the patient during cardiopulmonary bypass. They are a surgical/perfusion device, not a diagnostic one.
- Intended Use: The intended use clearly states the purpose is to "return arterial blood from the extracorporeal circuit to the patient," which is a therapeutic/supportive function, not a diagnostic one.
- Device Description: The description focuses on the physical characteristics and materials of the cannula for insertion into the body.
- Performance Studies: The performance studies mentioned are related to the physical properties and function of the cannula in a perfusion circuit (flow, kink resistance, bond strength, leakage), not diagnostic accuracy or analysis of biological samples.
The device is a medical device used in a surgical procedure, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Jostra Pediatric 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.
Product codes
DWF
Device Description
The Jostra Pediatric 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 aortic root or other large artery during extracorporeal circulation. The cannulaer are made from polyvinyl chloride (PVC) and range in size from 8fr. to 16fr. with a variety of tips, with or without attached connectors. The cannulas are specifically designed for pediatric use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
aortic root or other large artery
Indicated Patient Age Range
pediatric
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. Performance, and in-vitro testing demonstrate that the Jostra Peditorial vac Penomiance, and in viro cosing active the predicate devices in intended use, Ourinaliae are overation, materials, design, and performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Medtronic DLP Pediatric Arterial 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).
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510 (K) Summary
Submitter:
Jostra AG Hechinger Straße 38 72145 Hirrlingen Germany
- Contact Person: Kathleen Johnson Phone: (610) 932-7738 (610) 932-7366 Fax:
Date Prepared: June 21, 2001
Jostra Pediatric Arterial Cannulae Device Trade Name:
Common/Usual Name: Pediatric Arterial Cannulae
- Classification Names: Cardiopulmonary Bypass Vascular Cannula Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, or Fitting
Predicate Device: Medtronic DLP Pediatric Arterial Cannulae
Device Description:
The Jostra Pediatric 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 aortic root or other large artery during extracorporeal circulation. The cannulaer are made from polyvinyl chloride (PVC) and range in size from 8fr. to 16fr. with a variety of tips, with or without attached connectors. The cannulas are specifically designed for pediatric use.
Indications for use:
The Jostra Pediatric 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 Pediatric Cannulae have the same intended use as the Medtronic DLP Pediatric Cannulae. The wire-wound 8fr. to 16fr. Sizes from Medtronic are not available with a curved tip, and come with a "Flow-Guard" Style introducer. The Jostra Pediatric Cannulae provide the user with the option of a curved tip, and a vent plug for safe de-airing. 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 Peditorial vac Penomiance, and in viro cosing active the predicate devices in intended use, Ourinaliae are overation, materials, design, and performance.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 6 2001
Ms. Kathleen Johnson Regulatory Affairs, Submission Manager Jostra AG c/o Jostra-Bentley Corporation 478 Media Road Oxford, PA 19363
Re: K012617
Trade Name: Jostra Arterial Perfusion Cannulae Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing. Regulatory Class: Class II (two) Product Code: DWF Dated: June 29, 2001 Received: August 13, 2001
Dear Ms. Johnson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreours) is trgansjal the Medical Device Amendments, or to commerce proc to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, de noos mat ha re been 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 1 ou may, morelore, market of the Act include requirements for annual registration, listing of general controls pro vision 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 If your device is classinod (600 as controls. Existing major regulations affecting your device can may oe subject to basil acceral 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 r tease be actised alla i Drimination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I odolar statutes and equirements, 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 form in and quinn 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) I mis letter will and in you is ought tinding of substantial equivalence of your device to a legally prematication - No 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 additionally 21 (301) 594-4646. Additionally, for questions on the promotion and advertising of Compilance at (301) 594-461 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regaration on the responsibilities under the Act may be obtained from the Other general mistmation of Small 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,
Lh
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
NOV 0 6 2001
Page 1 of 1
510(k) Number:
Device Name: Arterial Cannulae (paediatric)
Indications for Use
indications for Soc The Jostia Fediatio Anonal Samulations are a circuit to the patient 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 Cardiovasc...
510(k) Number K0/2617