(83 days)
Not Found
Not Found
No
The description focuses on the physical characteristics and intended use of a medical catheter, with no mention of AI or ML capabilities.
No
Therapeutic devices are used to treat or alleviate a medical condition. This device is used to drain blood or fluid during cardiopulmonary bypass surgery, which is a supportive function during a surgical procedure rather than a direct treatment of a disease or condition itself.
No
The device is described as a surgical tool used to drain fluid from the left ventricle during cardiopulmonary bypass surgery. Its purpose is therapeutic/procedural, not diagnostic.
No
The device description clearly indicates it is a physical catheter made of polyvinyl chloride, available in various sizes and configurations, and intended for insertion into the left ventricle. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Jostra Vent Catheters are used to drain blood or fluid directly from the left ventricle during surgery. This is a surgical intervention and not a diagnostic test performed on a sample outside the body.
- Intended Use: The intended use clearly states draining blood or fluid, not analyzing a sample for diagnostic purposes.
The device description and intended use clearly indicate that this is a surgical tool used for a therapeutic purpose (draining fluid) during a medical procedure, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Jostra Vent Catheters are used to drain blood or fluid from the left ventricle during cardiopulmonary bypass surgery up to 6 hours or less.
Product codes
DWF, DRA
Device Description
The Jostra Vent Catheters are sterile devices for single use only and are not to be resterilized by the user. They are designed for use in venting the left ventricle during cardiopulmonary bypass surgery. The catheter is inserted into the left ventricle via the pulmonary vein, cardiac auricle or cardiac apex. The catheters are made of polyvinyl chloride and are available in a variety of sizes. They are also available in a variety of configurations (straight or bent tip, with or without wire reinforcement, with or without an integrated stylet, with or without a vacuum valve, malleable and non malleable). The catheters range from 8 to 18 French and are offered in lengths from 23 to 40 cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
left ventricle, pulmonary vein, cardiac auricle, cardiac apex
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)
Non-Clinical Testing:
Biocompatibility and performance testing was performed to demonstrate substantial equivalency to the predicate device.
Performance testing of the smallest and largest models included:
Kink stability Leak testing Tensile strength testing
Additionally, in-vitro testing was performed to determine the effects on cellular components.
Conclusion:
Performance and in-vitro testing demonstrate that the Jostra Vent Catheters 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 Left Heart Vent Catheters, Edwards Lifesciences Research Medical Vent Catheters
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
KO22022
510 (K) Summary
| Submitter: | Jostra AG
Hechinger Straße 38
72145 Hirrlingen
Germany | SEP 11 2002 |
|-----------------------|-------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Kathleen Johnson
P. O. Box 218
Oxford, PA 19363
Phone: (610) 932-7738
Fax: (610) 932-7366 | |
| Date Prepared: | May 29, 2002 | |
| Device Trade Name: | Jostra Vent Catheter | |
| Common/Usual Name: | Cardiac Vent Catheter | |
| Classification Names: | Cardiopulmonary Bypass Vascular Catheter, Cannula and
Tubing | |
| Predicate Device: | Medtronic DLP Left Heart Vent Catheters
Edwards Lifesciences Research Medical Vent Catheters | |
Device Description:
The Jostra Vent Catheters are sterile devices for single use only and are not to be resterilized by the user. They are designed for use in venting the left ventricle during cardiopulmonary bypass surgery. The catheter is inserted into the left ventricle via the pulmonary vein, cardiac auricle or cardiac apex. The catheters are made of polyvinyl chloride and are available in a variety of sizes. They are also available in a variety of configurations (straight or bent tip, with or without wire reinforcement, with or without an integrated stylet, with or without a vacuum valve, malleable and non malleable). The catheters range from 8 to 18 French and are offered in lengths from 23 to 40 cm.
Indications for use:
The Jostra Vent Catheters are used to drain blood or fluid from the left ventricle during cardiopulmonary bypass surgery up to 6 hours or less.
1
Statement of Technical Characteristics Comparison:
The Jostra Vent Catheters have the same intended use and similar design as the Medtronic DLP and Edwards Lifesciences Research Medical Vent Catheters. The Jostra Vent Catheters range from 8 to 18 French and are 23 to 40 cm in length. The Medtronic DLP Vent Catheters range from 10 to 20 French and are 33 and 41 cm in length. The Edwards Lifesciences Research Medical device is a 20Fr. O.D. and 36.8 cm long. Comparative testing has demonstrated that the 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 of the smallest and largest models included:
Kink stability Leak testing Tensile strength testing
Additionally, in-vitro testing was performed to determine the effects on cellular components.
Conclusion:
Performance and in-vitro testing demonstrate that the Jostra Vent Catheters are "substantially equivalent" to the predicate devices in intended use, principles of operation, materials, design, and performance.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three wavy lines, resembling an abstract bird or a symbol representing health and human services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SFP 1 1 2002
Jostra AG c/o Ms. Kathleen Johnson Regulatory Affairs, Submissions Manager Jostra-Bentley Corporation 478 Media Road Oxford, PA 19363
Re: K022022
Trade Name: Vent Catheters Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, or Tubing Regulatory Class: Class II (two) Product Code: DWF and DRA Dated: May 29, 2002 Received: June 20, 2002
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.
3
Page 2 – Ms. Kathleen Johnson
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 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,
Dria Plenhu for
Bram D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number:
Device Name: Vent Catheters
Indications for Use
The Jostra Vent Catheters are used to drain blood or fluid from the left ventricle during cardiopulmonary bypass surgery 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)
| FDA/CDRH/ODE/DMC |
|---|
| JUN 205 3 25 PM 02 |
| RECEIVED |
(Optional Format 3-10-98)
Division of Cardiovascular & Respiratory Devices
510(k) Number K022022
Prescription Use _____________________________________________________________________________________________________________________________________________________________ × (Per 21 CFR 801.109)