(7 days)
Not Found
No
The summary describes a physical medical device (cannula) with a pressure monitoring line and coating options. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as an arterial return cannula used in cardiopulmonary bypass, which is a supportive device during surgery, not a device that directly treats a medical condition or disease.
No
The device is described as an arterial return cannula for cardiopulmonary bypass, and while it has a pressure monitoring line, its primary stated purpose is for blood flow, not diagnosis. The "Intended Use" explicitly states "as an arterial return cannula," and no diagnostic claim is made.
No
The device description clearly describes a physical medical device (cannula) with different sizes and features, not a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use with cardiopulmonary bypass as an arterial return cannula." This describes a device used during a medical procedure to manage blood flow, not a device used to test samples (like blood, urine, or tissue) outside the body to diagnose or monitor a condition.
- Device Description: The description focuses on the physical characteristics and function of a cannula used for blood return during bypass surgery. It mentions a pressure monitoring line, which is a functional component of the device during the procedure, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
This product is intended for use with cardiopulmonary bypass as an arterial return cannula.
These cannulae are intended for use with cardiopulmonary bypass as an arterial return cannula.
Product codes
DWF
Device Description
The EOPA CAP™ Elongated One-Piece Arterial Cannula with Pressure Monitoring Line is designed for use with cardiopulmonary bypass as an arterial return cannula. The pressure monitoring line allows measurement of central arterial pressure. The device is available in 18, 20, 22, and 24 Fr. diameters, with vented or non-vented caps. 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
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)
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
331518
510(k) Summary
Date Prepared: May 14, 2003
Submitter:
(1.1a) 1.7, 3.86
Medtronic Perfusion Systems 7611 Northland Boulevard Brooklyn Park, MN 55428
Contact Person: Dawn M. Stenstrom Senior Regulatory Affairs Specialist
MAY 22 2003
Phone: (763) 391-9604 (763) 391-9603 Fax:
Device Name and Classification:
| Trade Name: | EOPA CAP™ Elongated One-Piece Arterial Cannula with
Pressure Monitoring Line
18, 20, 22, 24 Fr. |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Cardiopulmonary bypass vascular catheter, cannula or
tubing |
| Classification: | Class II |
| Predicate Devices: | EOPA Elongated One-Piece Arterial Cannula and
EOPA Elongated One-Piece Arterial Cannula with
Guidewire
18, 20, 22, 24 Fr.
K031037
SELECT CAP™ Arterial Cannula with Pressure
Monitoring Line
K010737 |
1
Device Description:
The EOPA CAP™ Elongated One-Piece Arterial Cannula with Pressure Monitoring Line is designed for use with cardiopulmonary bypass as an arterial return cannula. The pressure monitoring line allows measurement of central arterial pressure. The device is available in 18, 20, 22, and 24 Fr. diameters, with vented or non-vented caps. The device may also include Carmeda® coating.
Indication for Use
This product is intended for use with cardiopulmonary bypass as an arterial return cannula.
Comparison to Predicate Device
The predicate devices are cannulae with the same design characteristics. The predicate cannulae EOPA Elongated One-Piece Arterial Cannula has the same indications for use. The other predicate cannulae SELECT CAP Arterial Cannula features the same pressure monitoring line as the EOPA CAP.
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 EOPA CAP Elongated One-Piece Arterial Cannulae with pressure monitoring line 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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, depicted in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 22 2003
Medtronic Perfusion Systems c/o Ms. Dawn Stenstrom Principal Regulatotry Affairs Specialist 7611 Northland Drive Minneapolis, MN 55428
Re: K031518
EOPA Elongated One-Piece Arterial Cannula with Pressure Monitoring Regulation Number: 21 CFR 870.4210 Regulation Name: Catheter, Cannula and Tubing, Vascular Regulatory Class: Class II (two) Product Code: DWF Dated: May 14, 2003 Received: May 15, 2003
Dear Ms. Stenstrom:
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 - Ms. Dawn Stenstrom
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,
V. D. Sriram, 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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ﻣﺪﻧﺪ ﺯﻣ
510(k) Number (if known): K031518
Device Name:
EOPA CAP™ Elongated One-Piece Arterial Cannula with Pressure Monitoring Line
Indications for Use:
These cannulae are intended for use with cardiopulmonary bypass as an arterial return cannula.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Only
V. Deaton
510(k) Numb
(Optional Format 3-10-98)