(674 days)
Not Found
No
The description focuses on mechanical aspiration and fluid return, with no mention of AI/ML terms or functionalities.
No
The device is described as a suction device used to aspirate fluids during surgery, which is a supportive function during a medical procedure, not a therapeutic treatment itself.
No
The device is described as aspirating fluids during surgery and returning them to an extracorporeal circuit. This is a therapeutic or operational function, not a diagnostic one. There is no mention of analysis, measurement, or identification of a disease or condition.
No
The device description explicitly states that the Jostra Suction Devices are "single, sterile devices for single use only" and include "rigid, flexible and pericardial suckers," which are physical hardware components used for aspiration. There is no mention of software as the primary or sole component.
Based on the provided information, the Jostra Suction Devices are not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "aspirate blood and other fluids from the operative field and return it to the extracorporeal circuit during open heart surgery." This describes a device used during a surgical procedure to manage fluids within the body, not a device used to examine specimens outside the body to provide diagnostic information.
- Device Description: The description reinforces the surgical use by mentioning "aspirate blood and other fluids from the operative field" and "return it to the extracorporeal circuit."
- Lack of IVD Characteristics: There is no mention of analyzing samples, providing diagnostic results, or any of the typical functions associated with IVD devices (e.g., testing for biomarkers, identifying pathogens, etc.).
- Performance Studies: The performance studies focus on physical characteristics like "Bond Strength Leakage Test" and the effects on "cellular components" within the context of the surgical circuit, not on diagnostic accuracy or analytical performance.
In summary, the Jostra Suction Devices are surgical devices used for fluid management during open-heart surgery, not devices used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Jostra Suction Devices are designed to aspirate blood and other fluids from the operative field and return it to the extracorporeal circuit during open-heart surgery lasting 6 hours or less.
Product codes
DWF
Device Description
The Jostra Suction Devices are single, sterile devices for single use only and not to be resterilized by the user. The Jostra Suction Devices are designed to aspirate blood and other fluids from the operative field and return it to the extracorporeal circuit during open-heart surgery. The suction devices include rigid, flexible and pericardial suckers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 were performed to demonstrate substantial equivalency to the predicate device. Performance testing included: 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 Suction Devices 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 Suction Devices
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
JAN : 0 2004
00:00:00
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| 510 (K) Summary | |
|---|---|
| Submitter: | Jostra AG |
| Hechinger Straße 38 | |
| 72145 Hirrlingen | |
| Germany | |
| Contact Person: | Kathleen Johnson |
| Phone: (610) 932-7738 | |
| Fax: (610) 932-7366 | |
| Date Prepared: | March 11, 2002 |
| Device Trade Name: | Jostra Suction Devices |
| Common/Usual Name: | Suction Devices |
| Classification Names: | Cardiopulmonary Bypass Vascular Cannula |
| Cardiopulmonary-Bypass Cardiotomy Return Sucker | |
| Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, or | |
| Fitting | |
| Predicate Device: | Medtronic DLP Suction Devices |
Device Description:
The Jostra Suction Devices are single, sterile devices for single use only and not to be resterilized by the user. The Jostra Suction Devices are designed to aspirate blood and other fluids from the operative field and return it to the extracorporeal circuit during open-heart surgery. The suction devices include rigid, flexible and pericardial suckers.
Indications for use:
The Jostra Suction Devices are designed to aspirate blood and other fluids from the operative field and return it to the extracorporeal circuit during open-heart surgery lasting 6 hours or less.
Statement of Technical Characteristics Comparison;
The Jostra Suction Devices have the same intended use as the Medtronic DLP Suction Devices. Comparative testing has demonstrated that these differences do not affect safety and effectiveness.
1
Non-Clinical Testing:
Biocompatibility and performance testing were performed to demonstrate substantial equivalency to the predicate device.
.'
Performance testing included:
Bond Strength Leakage Test
Additionally, in-vitro testing was performed to determine the effects on cellular components.
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Conclusion:
Section of the couple
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.
Performance, and in-vitro testing demonstrate that the Jostra Suction Devices are "substantially equivalent" to the predicate devices in intended use, principles of operation, materials, design, and performance.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 0 2004
Jostra AG c/o Ms. Katrin Schwenkglenks Regulatory Affairs Hechinger Strasse 38 72145 Hirrlingen Germany
Re: K020983
Suction Devices Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Catheter, Cannula and Tubing Regulatory Class: Class II (two) Product Code: DWF Dated: November 11, 2003 Received: November 14, 2003
Dear Ms. Schwenkglenks:
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. Katrin Schwenkglenks
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 or any I 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 Of It 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 prarketed 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), 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) you may obtain. 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,
Duna R. Willines
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
020983
Page 1 of 1
510(k) Number:
1988 - 1999
. . .
Device Name: Suction Devices
Indications for Use
The Jostra Suction Devices are designed to aspirate blood and other fluids from the operative field and return it to the extracorporeal circuit during open heart surgery lasting 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)
Prescription use X
Dolma, R. builting Division of Cardiovascular & Respiratory Devices 510(k) Number K620983