(7 days)
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.
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.
The provided text does not contain detailed acceptance criteria or a specific study that proves the device meets those criteria in the way typically expected for performance-based medical device submissions. This 510(k) summary is for a Class II vascular catheter and focuses on demonstrating substantial equivalence to predicate devices based on design, general functional testing, and indications for use, rather than a clinical performance study with defined quantitative acceptance metrics.
However, based on the information provided, here's a breakdown of what can be gleaned:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly present a table of quantitative acceptance criteria with corresponding performance data. The "Summary of Performance Data" describes the types of testing performed, implying that the device successfully met the requirements for those tests to demonstrate substantial equivalence.
| Acceptance Criteria Category (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Design Characteristics | Maintained same design characteristics as predicate devices. |
| Visual Inspection | Passed visual inspection. |
| Dimensional Specifications | Met dimensional specifications. |
| Simulated Use Testing | Performed adequately in simulated use. |
| Functional Testing | Performed adequately in functional tests, including pressure monitoring line functionality. |
| Bio-activity (for Carmeda® coated devices) | Passed bio-activity testing. |
| Coverage (for Carmeda® coated devices) | Passed coverage testing (of the coating). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The testing mentioned (visual, dimensional, simulated use, functional) implies a sample of devices were tested, but the exact number is not provided.
- Data Provenance: The type of testing (in vitro) suggests laboratory-based testing. The country of origin of the data is not explicitly stated but would presumably be where Medtronic Perfusion Systems conducted its internal testing. The data is retrospective in the sense that it was generated prior to the 510(k) submission for the purpose of demonstrating equivalence, not collected in an ongoing prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This was an in vitro device performance evaluation, not a study requiring expert clinical assessment to establish ground truth. The "ground truth" would be established by validated test methods and measurement equipment.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical ground truth established by experts requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC comparative effectiveness study is not mentioned. This type of study is typically performed in areas like diagnostic imaging where different readers (e.g., radiologists) interpret cases with or without AI assistance, and their performance is compared. This device is an arterial cannula, which does not involve this type of interpretive task.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not directly applicable to a physical medical device like an arterial cannula. The "device" itself is a standalone product in the sense that it performs its intended function without requiring a human-in-the-loop interpretive component. The performance mentioned ("in vitro visual, dimensional, simulated use and functional testing") can be considered "standalone" device performance.
7. The Type of Ground Truth Used
The "ground truth" for this types of in vitro performance testing is typically defined by:
- Design Specifications: Meeting predefined dimensional, material, and functional specifications.
- Engineering Standards: Compliance with relevant engineering standards for performance (e.g., strength, flow rates).
- Predicate Device Performance Benchmarks: The device is expected to perform comparably to its legally marketed predicate devices, which serve as a benchmark for acceptable performance.
8. The Sample Size for the Training Set
Not applicable. The device is a physical medical device (an arterial cannula), not an algorithm or AI system that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
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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 withPressure Monitoring Line18, 20, 22, 24 Fr. |
|---|---|
| Common Name: | Cardiopulmonary bypass vascular catheter, cannula ortubing |
| Classification: | Class II |
| Predicate Devices: | EOPA Elongated One-Piece Arterial Cannula andEOPA Elongated One-Piece Arterial Cannula withGuidewire18, 20, 22, 24 Fr.K031037SELECT CAP™ Arterial Cannula with PressureMonitoring LineK010737 |
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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.
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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.
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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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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)
§ 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).