(22 days)
K022272, K8918687
Not Found
No
The summary describes a physical medical device (cannula) with a malleable feature and a heparin coating. There is no mention of software, algorithms, image processing, AI, ML, or any data processing that would indicate the use of AI/ML technology.
No.
The device is a cannula used for blood collection during cardiopulmonary bypass surgery, which is a supportive function during a medical procedure, not a therapeutic treatment itself.
No
Explanation: The device is a venous cannula used for blood collection during cardiopulmonary bypass surgery, which is a therapeutic procedure, not a diagnostic one. It's designed to facilitate blood flow, not to diagnose a condition.
No
The device description clearly describes a physical cannula, which is a hardware component, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the collection of venous blood from the right side of the heart during cardiopulmonary bypass surgery. This is a procedure performed on the patient's body, not a test performed on a sample of the patient's body outside of the body.
- Device Description: The description details a cannula designed for venous drainage during surgery. This is a surgical instrument, not a diagnostic test kit or instrument used to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances in samples
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis
- Reagents, calibrators, or controls used in laboratory testing
This device is a surgical instrument used in a medical procedure.
N/A
Intended Use / Indications for Use
These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less.
Product codes (comma separated list FDA assigned to the subject device)
74 DWF
Device Description
The Malleable Single Stage Venous Cannula with Carmeda® BioActive Surface, is designed for use with cardiopulmonary bypass as a venous drainage cannula. The malleability feature allows the cannulae to be shaped and positioned to meet each customer's specific needs. The Carmeda® BioActive Surface adds a heparin based coating to the cannulae surface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
right side of the heart via the superior 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, coverage, bioactivity, leaching, functional and biocompatibility testing on Carmeda® coated devices was used to establish the performance characteristics of the modifications of this device from previously marketed devices.
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.
K022272, K8918687
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
:
.
510(k) Summary
| Date Prepared: | September 26, 2003 |
|---|---|
| Submitter: | Medtronic Perfusion Systems |
| 7611 Northland Boulevard | |
| Brooklyn Park, MN 55428 | |
| Contact Person: | Preeti Jain |
| Director, Regulatory/Clinical Affairs | |
| Phone: (763) 391-9533 | |
| Fax: (763) 391-9603 |
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
:
Device Name and Classification:
.
| Trade Name: | Malleable Single Stage Venous Cannula with Carmeda®
BioActive Surface
12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40 Fr. |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Cardiopulmonary bypass vascular catheter, cannula or
tubing |
| Classification: | Class II |
| Predicate Devices: | Malleable Single Stage Venous Cannula
K022272 |
| | Extracorporeal Circuit with Bio-Active Surface
K8918687 |
1
Device Description:
The Malleable Single Stage Venous Cannula with Carmeda® BioActive Surface, is designed for use with cardiopulmonary bypass as a venous drainage cannula. The malleability feature allows the cannulae to be shaped and positioned to meet each customer's specific needs. The Carmeda® BioActive Surface adds a heparin based coating to the cannulae surface.
Indication for Use
These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less.
Comparison to Predicate Devices
The predicate devices are cannulae with the same design characteristics. The predicate Malleable Single Stage Venous Cannula has the same indications for use.
Summary of Performance Data
In vitro visual, coverage, bioactivity, leaching, functional and biocompatibility testing on Carmeda® coated devices was used to establish the performance characteristics of the modifications of this device from previously marketed devices.
Conclusion
Medtronic Perfusion Systems has demonstrated that the Malleable Venous Cannulae with Carmeda® BioActive Surface are substantially equivalent to the predicate devices based upon design, test results, and indications for use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 31 2003
Medtronic Perfusion Systems c/o Ms. Preeti Jain Director, Regulatory/Clinical Affairs 7611 Northland Drive N Brooklyn Park, MN 55428-1088
Re: K033264
Malleable Single Stage Venous Cannula with Carmeda® BioActive Suface Regulation Number: 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, and Tubing Regulatory Class: Class II (two) Product Code: 74 DWF Dated: October 2, 2003 Received: October 9, 2003
Dear Ms. 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.
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Page 2 - Ms. 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 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
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Page _ 1 _ of _ 1 _
510(k) Number (if known):
Device Name:
Malleable Single Stage Venous Cannula with Carmeda® BioActive Surface
Indications for Use:
These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K033264