(19 days)
Not Found
No
The summary describes a mechanical device (cannula) and its physical properties and testing. There is no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is used to facilitate cardiopulmonary bypass surgery, which is a therapeutic intervention.
No
Explanation: The device is a venous cannula used for drainage during cardiopulmonary bypass surgery, not for diagnosing a condition or disease.
No
The device description clearly describes a physical cannula with an occluder and stylet, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the cannulae are for "venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery." This is a surgical procedure performed directly on a patient's body.
- Device Description: The description details a physical device (cannula, occluder, stylet) used for direct intervention in the circulatory system.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. This device does not involve the analysis of specimens.
The information provided describes a surgical instrument used in vivo (within the living body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This product is intended for use with cardiopulmonary bypass as a venous drainage cannula.
These cannulae are intended for use in venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery.
Product codes
74 DWF
Device Description
The ULTRAFLEX™ Venous Cannula is designed for use with cardiopulmonary bypass as a venous drainage cannula. The occluder with a malleable stylet aids in positioning and placement of the cannula. The device is available in 23 and 29 Fr. diameters. The device may also include Carmeda® coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
right atrium and inferior vena cava
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)
In vitro visual, dimensional, simulated use and functional testing was used to establish the performance characteristic of the modifications of this device from previously marketed devices. In addition coverage, bio-activity and functional testing was performed on Carmeda® coated devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
j( 03) 827
JUL 2 2003
510(k) Summary
June 12, 2003 Date Prepared:
Submitter:
Medtronic Perfusion Systems 7611 Northland Boulevard
Brooklyn Park, MN 55428
Preeti Jain Contact Person: Senior Manager, Regulatory Affairs
Phone: (763) 391-9533 (763) 391-9100 Fax:
Device Name and Classification:
| Trade Name: | ULTRAFLEX™ Venous Cannula
23, 29 Fr. |
|--------------------|----------------------------------------------------------------|
| Common Name: | Cardiopulmonary bypass vascular catheter, cannula or
tubing |
| Classification: | Class II |
| Predicate Devices: | VC2® Venous Cannula
K845045 |
| | Bio-Medicus® Femoral Cannula and Introducer
K924642 |
| | Extracorporeal Circuit with Bio-Active Surface
K8918687 |
1
Device Description:
The ULTRAFLEX™ Venous Cannula is designed for use with cardiopulmonary bypass as a venous drainage cannula. The occluder with a malleable stylet aids in positioning and placement of the cannula. The device is available in 23 and 29 Fr. diameters. The device may also include Carmeda® coating.
Indication for Use
This product is intended for use with cardiopulmonary bypass as a venous drainage cannula.
Comparison to Predicate Devices
The predicate devices are cannulae with the same or similar design characteristics. The predicate cannulae VC2® Two Stage Venous Cannula has the same indications for use. The other predicate cannulae Bio-Medicus® Femoral Cannula and Introducer features the same material and similar introducer configuration and tip design to the ULTRAFLEX™.
Summary of Performance Data
In vitro visual, dimensional, simulated use and functional testing was used to establish the performance characteristic of the modifications of this device from previously marketed devices. In addition coverage, bio-activity and functional testing was performed on Carmeda® coated devices.
Conclusion
Medtronic Perfusion Systems has demonstrated that the ULTRAFLEX™ Venous Cannulae are substantially equivalent to the predicate devices based upon design, test results, and indications for use.
2
Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol that resembles an abstract caduceus, with three parallel lines that curve and flow into a serpentine shape at the bottom.
JUL 2 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtronic Perfusion Systems c/o Mr. Preeti Jain 7611 Northland Drive N Minneapolis, MN 55428-1088
Re: K031827
ULTRAFLEXTM Venous Cannula Regulation Number: 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, ad Tubing Regulatory Class: Class II (two) Product Code: 74 DWF Dated: June 12, 2003 Received: June 13, 2003
Dear Mr Jain:
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. Preeti Jain
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 (301) 594-4646. 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/dsma/dsmamain.html
Sincerely yours,
Quesada Vaz Sr
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1_
510(k) Number (if known): _______________
Device Name:
ULTRAFLEXTM Venous Cannula
Indications for Use:
These cannulae are intended for use in venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Only
(Optional Format 3-10-98)
Alina D. Ag fr BPZ 7/1/03
510(k) Numbe