(118 days)
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No
The document describes a physical medical device (cannula) and its performance testing, with no mention of software, algorithms, or AI/ML capabilities.
No
This device is a cannula used for venous drainage during surgery, which is a supporting device rather than a device that directly treats a condition.
No
This device is a cannula intended for venous drainage during cardiopulmonary bypass surgery. Its description focuses on its physical characteristics, materials, and mechanical performance rather than its ability to detect, monitor, or diagnose a medical condition.
No
The device description clearly describes a physical, hardware-based medical device (cannula) made of PVC with specific dimensions and features. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for venous drainage during cardiopulmonary bypass surgery. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a physical cannula designed for insertion into veins.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) for a surgical purpose.
N/A
Intended Use / Indications for Use
"This cannula is intended for use in venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery up to six hours or less."
Product codes
DWF
Device Description
"The Multi-Stage Venous Cannula product family includes the MC2" Two-Stage Venous Cannula, OVAL MC2™ Two-Stage Venous Cannula, Thin Wall Two-Stage Venous Cannula, and MC2X " Three-Stage Venous Cannula configurations. All Multi-Stage Venous Cannula configurations feature a wire wound polyvinyl chloride (PVC) body with side ports in the distal tip, a ported atrial basket, and a % inch (0.95cm) - ½ inch (1.27cm) connection site. The overall length of each cannula is approximately 15% inch (38.7cm). Insertion depth marks are provided to aid in positioning of the cannula during the surgical procedure. These cannulae are sterile, non-pyrogenic, disposable medical devices."
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
right atrium and inferior vena cava
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Medtronic conducted the following performance testing for the modified Multi-Stage Venous Cannula product:
. Kink / Bend
. Collapse under negative pressure
· Tensile strength / Pull
Additionally, biocompatibility testing was performed in accordance with EN ISO 10993-1 Biological evaluation of medical devices –Part 1: Evaluation and testing within a risk management process. Performance and biological tests confirm that the modified Multi-Stage Venous Cannula product met pre-determined acceptance criteria and is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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).
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Image /page/0/Picture/0 description: The image shows the Medtronic logo. The logo consists of a stylized human figure inside a circle to the left of the word "Medtronic". The text is in a bold, sans-serif font.
510(k) Summary
MAY 2 0 2014
Date Prepared:
Submitter:
Medtronic, Inc. Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428
January 17, 2014
Establishment Registration Number: 2184009
Contact Person:
Jacqueline A. Hauge Senior Regulatory Affairs Specialist Medtronic Perfusion Systems Phone: 763.514.9967 763.367.8360 Fax: Email: jacqueline.a.hauge@medtronic.com
Alternate Contact: Susan C. Fidler Senior Regulatory Affairs Manager Medtronic Perfusion Systems Phone: 763.514.9839 Fax: 763.367.8360 Email: susan.c.fidler@medtronic.com
Device Name and Classification
| Trade Name: | MC2™ Two-Stage Venous Cannula
OVAL MC2™ Two-Stage Venous Cannula
Thin Wall Two-Stage Venous Cannula
MC2X™ Three-Stage Venous Cannula |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Cardiopulmonary bypass vascular catheter, cannula, or tubing |
| Regulation Number: | 870.4210 |
| Product Code: | DWF |
| Product Classification: | Class II |
1
Image /page/1/Picture/0 description: The image shows the Medtronic logo. The logo consists of a symbol on the left and the word "Medtronic" on the right. The symbol appears to be a stylized representation of a person or figure within a circular shape. The word "Medtronic" is written in a bold, sans-serif font.
Predicate Devices
1
MC2XTM Multi-Stage Venous Cannula K052372 DLPTM Single Stage Venous Cannula K120988
Device Description
The Multi-Stage Venous Cannula product family includes the MC2" Two-Stage Venous Cannula, OVAL MC2™ Two-Stage Venous Cannula, Thin Wall Two-Stage Venous Cannula, and MC2X " Three-Stage Venous Cannula configurations. All Multi-Stage Venous Cannula configurations feature a wire wound polyvinyl chloride (PVC) body with side ports in the distal tip, a ported atrial basket, and a % inch (0.95cm) - ½ inch (1.27cm) connection site. The overall length of each cannula is approximately 15% inch (38.7cm). Insertion depth marks are provided to aid in positioning of the cannula during the surgical procedure. These cannulae are sterile, non-pyrogenic, disposable medical devices.
Indications for Use
This cannula is intended for use in venous drainage via the right atrium and inferior vena cava simultaneously during cardiopulmonary bypass surgery up to six hours or less.
Comparison to Predicate Devices
A comparison of the modified Multi-Stage Venous Cannula product to the currently marketed predicate products (K052372 and K120988) indicates the following similarities:
- Same intended use .
- . Same technological characteristics
- 에 Same operating principle
- l Same design features
- . Same base materials (Polyvinyl Chloride (PVC), Stainless Steel)
- I Same shelf life
Summary of Performance and Biological Testing
Medtronic conducted the following performance testing for the modified Multi-Stage Venous Cannula product:
. Kink / Bend . Collapse under negative pressure · Tensile strength / Pull Additionally, biocompatibility testing was performed in accordance with EN ISO 10993-1 Biological evaluation of medical devices –Part 1: Evaluation and testing within a risk management process. Performance and biological tests confirm that the modified Multi-Stage Venous Cannula product met pre-determined acceptance criteria and is substantially equivalent to the predicate device.
Conclusion
Medtronic has demonstrated that the modifications made to the Multi-Stage Venous Cannula product family described in this submission result in a substantially equivalent device because the fundamental scientific principle, operating principle, design features and intended use are unchanged from the predicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure with three swooping lines representing its wings or body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 20, 2014
Medtronic, Inc. Medtronic Perfusion Systems Jacqueline A. Hauge Senior Regulatory Affairs Specialist 7611 Northland Drive Minneapolis, MN 55428
Re: K140165
Trade/Device Name: MC2TM Two-Stage Venous Cannula OVAL MC2™ Two-Stage Venous Cannula Thin Wall Two-Stage Venous Cannula MC2XTM Three-Stage Venous Cannula
Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing Regulatory Class: Class II Product Code: DWF Dated: February 17, 2014 Received: February 19, 2014
Dear Ms. Hauge:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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
.. . .
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Page 2 - Jacqueline A. Hauge
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
.ポイ
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
M
for 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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration | |
| Indications for Use | Form Appro |
| Expiration C | |
| See PRA S |
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510(k) Number (if known).
K140165
Device Name MC27M Two-Stage Venous Cannula
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Indications for Use (Describe)
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2008 11:20 11 12 12 12 12 11 11 This cannula is intended for use in venous drains and inferior vena cava similaneously during cardlopulnonary bypass surgery up to six hours or less.
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2017 11:12:12
Type of Use (Select one or both, as applicable) 1 80 - 60 [2] Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
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FORM FDA 3881 (1/14)
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