(69 days)
Not Found
No
The description focuses on the physical characteristics and intended use of a percutaneous cannula and introducer set for cardiopulmonary bypass, with no mention of AI or ML capabilities.
No
The device is a cannula intended for use in cardiopulmonary bypass circulation, facilitating the perfusion of vessels or organs. It is a tool used during a medical procedure, not a therapeutic device that directly treats a condition or disease.
No
The device description clearly states its purpose is to "cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal equipment" for cardiopulmonary bypass, which describes a therapeutic or interventional function, not a diagnostic one.
No
The device description clearly details a physical medical device (cannula and introducer set) made of materials like wire and with specific physical dimensions and features. There is no mention of software as a component or the primary function of the device.
Based on the provided text, 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 outside the body (in vitro) to analyze these samples.
- Device Function: The description clearly states the device is a percutaneous cannula used to "cannulate vessels, perfuse vessels or organs in a patient for cardiopulmonary bypass circulation." This involves inserting the device into the patient's body to facilitate blood flow during surgery.
- No Mention of Sample Analysis: There is no mention of the device being used to collect or analyze samples from the body. Its purpose is to directly interact with the patient's circulatory system.
Therefore, this device falls under the category of a surgical or interventional device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The percutaneous cannula is for use by trained physicians only, to cannulate vessels, perfuse vessels or organs in a patient for cardiopulmonary bypass circulation. Standard surgical or percutaneous insertion techniques can be employed.
This product is intended for use up to six hours or less.
Product codes (comma separated list FDA assigned to the subject device)
DWF
Device Description
The Biomedicus Femoral Cannula and Introducer Set include the new Bio-Medicus Femoral Venous Cannula and Introducer. The Cannula are one piece, wire wound bodies with basket type holes. Insertion depth marks aid in positioning the Cannula. All are supplied sterile, and non-pyrogenic and are single use.
This new Biomedicus Femoral Venous Cannula and Introducer Set consists of a longer flexible cannula with multiple side holes, a longer introducer, an improved introducer to cannula tip transition and 3/8" barbed connector.
The cannulae are available in 19 Fr, 21 Fr and 25 Fr sizes.
The Cannula are intended to be used to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal equipment. The Cannula Introducer is intended to facilitate proper insertion and placement of the appropriate sized Cannula within the vessel for cardiopulmonary bypass.
The overall product length is approximately 30.125 inches. The device is sterile, non-pyrogenic and disposable, and is intended for short-term single use.
The product will be available in both Carmeda coated and uncoated versions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physicians
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)
Validation testing was used to establish the performance characteristic of the modifications of this device from the previously marketed device.
Medtronic Perfusion Systems has demonstrated that the Bio-Medicus Femoral Venous Cannula and Introducer is substantially equivalent to the predicate devices based upon design, test results, and indications for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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 2 2 2005
510(k) Summary
| Date Prepared: | September 7, 2005 |
|---|---|
| ---------------- | ------------------- |
Submitter:
Medtronic Perfusion Systems 7611 Northland Boulevard Brooklyn Park, MN 55428
Contact Person:
Bruce Backlund Senior Regulatory Affairs Specialist
Phone: (763)-391-9183 (763) 391-9603 Fax:
.
Device Name and Classification:
| Trade Name: | Bio-Medicus Multi-Stage Venous Femoral Percutaneous
Kit |
|--------------------|------------------------------------------------------------|
| Common Name: | Percutaneous Cannula and Introducer Set |
| Classification: | Class II |
| Predicate Devices: | Bio-Medicus Femoral Cannula and Introducer
K884129 |
And Children Children Children
1
Device Description
The Biomedicus Femoral Cannula and Introducer Set include the new Bio-Medicus Femoral Venous Cannula and Introducer. The Cannula are one piece, wire wound bodies with basket type holes. Insertion depth marks aid in positioning the Cannula. All are supplied sterile, and non-pyrogenic and are single use.
This new Biomedicus Femoral Venous Cannula and Introducer Set consists of a longer flexible cannula with multiple side holes, a longer introducer, an improved introducer to cannula tip transition and 3/8" barbed connector.
The cannulae are available in 19 Fr, 21 Fr and 25 Fr sizes.
The Cannula are intended to be used to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal equipment. The Cannula Introducer is intended to facilitate proper insertion and placement of the appropriate sized Cannula within the vessel for cardiopulmonary bypass.
The overall product length is approximately 30.125 inches. The device is sterile, nonpvrogenic and disposable, and is intended for short-term single use.
The product will be available in both Carmeda coated and uncoated versions.
Indications for Use
The percutaneous cannula is for use by trained physicians only, to cannulate vessels, perfuse vessels or organs in a patient for cardiopulmonary bypass circulation. Standard surgical or percutaneous insertion techniques can be employed.
This product is intended for use up to six hours or less.
Comparison to Predicate Device
The predicate device 510(k) K884129 was cleared on December 21, 1988. This 510(k) was for various sizes and shapes of Cannula.
This Cannula was indicated as intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory Extracorporeal equipment.
The Cannula Introducer is intended to facilitate proper insertion and placement of the appropriate sized Cannula within the vessel for cardiopulmonary bypass.
A copy of the original IFU as provided in the 510(k) is included in Appendix A.
2
Summary of Performance Data
Validation testing was used to establish the performance characteristic of the modifications of this device from the previously marketed device.
Conclusion
Medtronic Perfusion Systems has demonstrated that the Bio-Medicus Femoral Venous Cannula and Introducer is substantially equivalent to the predicate devices based upon design, test results, and indications for use.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" written around it. Inside the circle is a symbol consisting of three stylized human profiles facing to the right, with flowing lines above them.
Public Health Service
NOV 2 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtronic Perfusion Systems c/o Mr. Bruce Backlund Senior Regulatory Affairs Specialist 7611 Northland Drive N Brooklyn Park, MN 55428
Re: K052524
Bio-Medicus Multi-Stage Venous Femoral Percutaneous Kit Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, and Tubing Regulatory Class: Class II (Two) Product Code: DWF Dated: October 28, 2005 Received: October 31, 2005
Dear Mr. Backlund:
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.
4
Page 2 - Mr. Bruce Backlund
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), please contact the Office of Compliance at (240) 276-0120. 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 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/industry/support/index.html.
Sincerely yours.
Dmne R. Wagner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): Koss252A
Device Name: Bio-Medicus Multistage Venous Femoral Percutaneous Kit
Indications for Use:
The percutaneous cannula is for use by trained physicians only, to cannulate vessels, perfuse vessels or organs in a patient for cardiopulmonary bypass circulation. Standard surgical or percutaneous insertion techniques can be employed.
This product is intended for use up to six hours or less
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R. Vorhuer
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K c52524
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(Posted November 13, 2003)