(85 days)
Not Found
No
The summary describes a physical, disposable medical device (cannula) with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is used to perfuse a vein graft or check for leaks in a harvested vein, which are surgical tools or accessories, not typically considered therapeutic devices that treat a disease or condition directly.
No
The device is described as a surgical tool used to perfuse a vein graft or to check for leaks in a harvested vein during surgery, which are interventional or procedural uses, not diagnostic.
No
The device description clearly states it is a physical, disposable device made of a flexible body with a valve, luer, and tip, indicating it is hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use in conjunction with cardiopulmonary bypass surgery or in vascular surgery to perfuse a vein graft or check for leaks. This is a surgical procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a physical device (cannula) used for fluid delivery and manipulation during surgery. It doesn't describe reagents, test kits, or equipment 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.)
- Providing diagnostic information about a patient's condition
- Using reagents or assays
- Measuring analytes
In summary, the Medline Vessel Cannula is a surgical instrument used during a medical procedure, not a device used to perform diagnostic tests on samples.
N/A
Intended Use / Indications for Use
Medline Vessel Cannulae are intended for use in conjunction with cardiopulmonary bypass surgery or in vascular surgery to perfuse a vein graft or to help check for leaks in a harvested vein which will be used for a graft.
Product codes
DWF
Device Description
Medline's Vessel Cannula are to be supplied as sterile, non-pyrogenic, single use, disposable devices. They are visually transparent and consist of a flexible, kink resistant body with a one way valve. This vessel cannula is 2 inches in length and terminates with a female luer and a soft blunt tip.
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)
Biocompatibility testing of the Medline Vessel Cannula demonstrated that it meets the requirements of guidelines presented in the ISO 10993 Testing Standard. Functional performance testing of the Medline Vessel Cannula demonstrated device effectiveness in accordance with relevant ISO/ASTM test methods.
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
510(k) Summary
K 11147 JUL 1 9 2011
Summary Preparation Date
July 1, 2011
Submitter / 510(k) Sponsor
Medline Industries, Inc. One Medline Place Mundelein, IL 60060
Contact Person
Matt Clausen Regulatory Affairs Specialist Phone: 847-643-4785 Fax: 847-643-4466
Device Name / Classification
Device Name: Vessel Cannula Proprietary Name: Medline Vessel Cannula Common Name: Vessel Cannulae Classification Name: Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass under 21 CFR 870.4210
Predicate Device
DLP Vessel Cannulae (Medtronic), K810820
Device Description
Medline's Vessel Cannula are to be supplied as sterile, non-pyrogenic, single use, disposable devices. They are visually transparent and consist of a flexible, kink resistant body with a one way valve. This vessel cannula is 2 inches in length and terminates with a female luer and a soft blunt tip.
Indications for Use
Medline Vessel Cannulae are intended for use in conjunction with cardiopulmonary bypass surgery or in vascular surgery to perfuse a vein graft or to help check for leaks in a harvested vein which will be used for a graft.
1
Summary of Technological Characteristics
Information included in this submission demonstrates that there are no significant differences in technological characteristics between Medline's Vessel Cannula and the cited predicate device.
Summary of Non-Clinical Testing
Biocompatibility testing of the Medline Vessel Cannula demonstrated that it meets the requirements of guidelines presented in the ISO 10993 Testing Standard. Below is a listing of the specific testing performed.
-
- Sensitization
-
- Irritation
-
- Cytotoxicity
-
- Intramuscular Implant
- న్. Acute Systemic Toxicity
-
- Subchronic Systemic Toxicity
-
- Pyrogen
-
- Hemolysis (direct contact method)
-
- Hemolysis (extract method)
-
- Complement Activation
Functional performance testing of the Medline Vessel Cannula demonstrated device effectiveness in accordance with relevant ISO/ASTM test methods. Below is a listing of the specific testing performed.
- Appearance 1.
-
- Dimensions
-
- Direction of Flow
- Tensile Strength 4.
-
- Leakage
Conclusion
In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, Medline Industries, Inc. concludes that the Medline Vessel Cannula is safe, effective and substantially equivalent as described herein.
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2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medline Industries, Inc. c/o Mr. Matt Clausen Regulatory Affairs Specialist One Medline Place Mundelein, IL 60060
JUL 19 2011
Re: K11147 Medline Vessel Cannula Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheters, cannula, or tubing Regulatory Class: Class II (two) Product Code: DWF Dated: April 21, 2011 Received: April 25, 2011
Dear Mr. Clausen:
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
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours
R. D. Zuckerman, M.D.
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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Indications for Use
510(k) Number (if known): K11147
Device Name:
Medline Vessel Cannula
Indications For Use:
Medline Vessel Cannulae are intended for use in conjunction with cardiopulmonary bypass surgery or in vascular surgery to perfuse a vein graft or to help check for leaks in a harvested vein which will be used for a graft.
Prescription Use X (Part 21 CFR 801 Subpart D) OR
Over-the-Counter Use (21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Division of Cardiovascular Devices
510(k) Number K111147