(84 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a cannula, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
A therapeutic device is one that treats or cures a disease or condition. This device is a cannula used to facilitate blood flow during cardiopulmonary bypass surgery, which is a supportive role, not a therapeutic one.
No.
The Stöckert V172-28 Venous Femoral Cannula is a device used for venous drainage during cardiopulmonary bypass surgery. It facilitates the movement of blood into an extracorporeal circuit, rather than providing information for diagnosis.
No
The device description clearly describes a physical, sterile, single-use cannula made of PVC with a wire reinforcement and an obturator. It is a hardware device intended for surgical insertion.
Based on the provided information, the Stöckert V172-28 Venous Femoral Cannula is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Stöckert V172-28 Venous Femoral Cannula is a surgical device used to directly access and drain blood from the body during cardiopulmonary bypass surgery. It is inserted into the body (in vivo) and is part of the extracorporeal circuit, not a device used for analyzing samples.
- Intended Use: The intended use clearly states it's for cannulating vessels during surgery for cardiopulmonary bypass.
- Device Description: The description details its physical characteristics and how it's used to facilitate blood flow from the body to the bypass circuit.
- Performance Studies: The performance studies focus on the physical and functional properties of the cannula itself (pressure drop, blood trauma, leak, kink resistance), not on the accuracy or reliability of diagnostic test results.
Therefore, the Stöckert V172-28 Venous Femoral Cannula is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Stöckert V172-28 Venous Femoral Cannula is intended to be used to cannulate the inferior vena cava and the right atrium via femoral access during cardiopulmonary bypass surgery for periods up to six hours.
Product codes
DWF
Device Description
The Stöckert V172-28 Venous Femoral Cannula is a sterile, non-pyrogenic device, for single use only, and is not to be resterilized by the user. The device is a polyvinyl chloride (PVC) wire reinforced Cannula with a non-wire reinforced proximal end for connecting the device to a cardiopulmonary bypass circuit. The Stöckert V172-28 Cannula is intended to be used to cannulate the femoral vessels during cardiopulmonary bypass surgery. During use, the cannula is inserted into the vena femoralis and advanced into the right atrium, allowing blood from the systemic circulation to enter the extracorporeal circuit. Insertion of the cannula into the vena femoralis during cardiopulmonary bypass surgery is an alternative method for insertion of a cannula into the superior or inferior vena cava.
The Stöckert V172-28 Cannula is 28 Fr and 90 cm in length, with a flexible proximal end that can accommodate a 1/2" connector. The cannula tube contains two sets of side holes, one set for drainage from the right atrium and one set for drainage from the inferior vena cava and hepatic veins. An obturator is provided with each cannula, which seals the inside of the cannula tube in the areas of the side holes to prevent blood leakage from the cannula during insertion. After insertion, the obturator is removed and discarded by the user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
inferior vena cava and the right atrium via femoral access
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
The following tests were performed to demonstrate substantial equivalency of the devices:
-
- Pressure Drop
-
- Blood Trauma
-
- Leak
-
- Kink Resistance
Key Metrics
Not Found
Predicate Device(s)
Medtronic DLP Venous Femoral Cannula
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).
0
510(k) Pre-Market Notification: Stöckert V172-28 Venous Femoral Cannula
KO22321 PG1 of 2
510(K) SUMMARY
OCT 0 9 2002
| SUBMITTER: | Stöckert Instrumente GmbH
Lindberghstr.25
D-80939 Munich Germany |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| APPLICANT: | COBE Cardiovascular, Inc.
14401 W. 65th Way
Arvada, Colorado 80004-3599 USA |
| CONTACT PERSON: | Shawn Riedel
Regulatory and Quality Assurance Manager
COBE Cardiovascular, Inc.
Arvada, Colorado USA
Phone: (303) 467-6521
Fax: (303) 467-6525
Email: shawn.riedel@cobecv.com |
| DATE PREPARED: | 11 July 2002 |
| DEVICE TRADE NAME: | Stöckert V172-28 Venous Femoral Cannula |
| COMMON/USUAL NAME: | Cardiovascular Femoral Cannula |
| CLASSIFICATION NAME: | Cardiopulmonary Bypass Vascular Catheter, Cannula or
Tubing |
| PREDICATE DEVICE: | Medtronic DLP Venous Femoral Cannula |
DEVICE DESCRIPTION:
The Stöckert V172-28 Venous Femoral Cannula is a sterile, non-pyrogenic device, for single use only, and is not to be resterilized by the user. The device is a polyvinyl chloride (PVC) wire reinforced Cannula with a non-wire reinforced proximal end for connecting the device to a cardiopulmonary bypass circuit. The Stöckert V172-28 Cannula is intended to be used to cannulate the femoral vessels during cardiopulmonary bypass surgery. During use, the cannula is inserted into the vena femoralis and advanced into the right atrium, allowing blood from the systemic circulation to enter the extracorporeal circuit. Insertion of the cannula into the vena femoralis during cardiopulmonary bypass surgery is an alternative method for insertion of a cannula into the superior or inferior vena cava.
The Stöckert V172-28 Cannula is 28 Fr and 90 cm in length, with a flexible proximal end that can accommodate a 1/2" connector. The cannula tube contains two sets of side holes, one set for drainage from the right atrium and one set for drainage from the inferior vena cava and hepatic veins. An obturator is provided with each cannula, which seals the inside of the cannula tube in the areas of the side holes to prevent blood leakage from the cannula during insertion. After insertion, the obturator is removed and discarded by the user.
1
INDICATIONS FOR USE
The Stöckert V172-28 Venous Femoral Cannula is intended to cannulate the inferior vena cava and the right atrium via femoral access during cardiopulmonary bypass surgery for periods up to six hours.
STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON
The Stöckert V172-28 Venous Femoral Cannula are substantially equivalent to the Medtronic DLP Venous Femoral Cannula. The following tests were performed to demonstrate substantial equivalency of the devices:
-
- Pressure Drop
-
- Blood Trauma
-
- Leak
-
- Kink Resistance
TRUTHFUL AND ACCURATE STATEMENT
A statement attesting to the truthfulness and accuracy of the information contained in this submission is attached as Appendix 11.
FURTHER INFORMATION
In the event that additional information is required, please contact the following individual at COBE Cardiovascular, Inc. the applicant of this 510(k) notification, submitting on behalf of the manufacturer and specification holder of the product, Stöckert Instrumente GmbH. Munich, Germany:
Shawn Riedel Manager, Regulatory and Quality Assurance COBE Cardiovascular, Inc. 14401 West 65" Way Arvada, Colorado 80004-3599 USA Phone: (303) 467-6521 Fax: (303) 467-6525 Email: shawn.riedel(@cobecv.com
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 0 9 2002
Stöckert Instrumente GmbH c/o Mr. Shawn Riedel COBE Cardiovascular, Inc. 14401 W. 65th Way Arvada, CO 80004-3599
Re: K022321
Stöckert V172-28 Venous Femoral Cannula Regulation Number: 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, and Tubing Regulatory Class: II (two) . Product Code: DWF Dated: July 12, 2002 Received: July 17, 2002
Dear Mr. Riedel:
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 - Mr. Shawn Riedel
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,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KØ22321
4
Indications For Use
510(k) Number (If known): K020321
Device Name:
Stöckert V172-28 Venous Femoral Cannula
Indications For Use:
The Stöckert V172-28 Venous Femoral Cannula is intended to be used to cannulate the inferior vena cava and the right atrium via femoral access during cardiopulmonary bypass surgery for periods up to six hours.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
Division of Cardiovascular & Respiratory Devices
510(k) Number K022332
0005