(42 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and functional performance of a cannula, with no mention of AI or ML technologies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes.
The device is described as an "arterial return cannula" intended "for use with cardiopulmonary bypass," which is a therapeutic intervention.
No
The device is described as an arterial return cannula for cardiopulmonary bypass. Its function is to facilitate blood flow during bypass, not to diagnose a condition.
No
The device description clearly details physical components such as a flexible wirewound body, tapered tip, depth markings, suture ring, connector, and introducer, indicating it is a hardware device.
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 in vivo (within the body) during a surgical procedure to manage blood flow.
- Device Description: The description details a physical cannula designed for insertion into an artery. This is a surgical/medical device, not a device used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is entirely focused on facilitating blood flow during cardiopulmonary bypass, which is a direct medical intervention, not a diagnostic test.
N/A
Intended Use / Indications for Use
This product is intended for use with cardiopulmonary bypass as an arterial return cannula.
Product codes (comma separated list FDA assigned to the subject device)
DWF
Device Description
The EOPA Elongated One-Piece Arterial Cannulae have a flexible, thin wall wirewound body with a tapered distal tip. The tip features depth markings and an adjustable radiopaque suture ring to indicate insertion depth. The proximal end of the cannula terminates in a vented or non-vented 3/8" (0.95 cm) connector. A plastic tapered tip introducer with porous plug is provided to facilitate cannula insertion and priming. The introducer features a guidewire port for use with a 0.038" (0.1 cm) guidewire. Some models include a guidewire while some do not. The devices are marketed in 18, 20, 22, and 24 Fr. diameters. The devices may include a 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, leaching and functional testing was performed on Carmeda® coated 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.
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
MAY 1 3 2003
(Optional Format 3-10-98)
510(k) Summary
| Date Prepared: | March 27, 2003 |
|---|---|
| Submitter: | Medtronic Perfusion Systems |
| 7611 Northland Boulevard | |
| Brooklyn Park, MN 55428 | |
| Contact Person: | Ronald W. Bennett |
| Principal Regulatory Affairs Specialist | |
| Phone: | (763)-391-9086 |
| Fax: | (763) 391-9603 |
Device Name and Classification:
| Trade Name: | EOPA Elongated One-Piece Arterial Cannula and
EOPA Elongated One-Piece Arterial Cannula with
Guidewire
18, 20, 22, 24 Fr. with Carmeda® Coating |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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
20, 22 Fr.
K991066 and K000274
Extracorporeal Circuit with Bio-Active Surface
K891687 |
1
Device Description:
The EOPA Elongated One-Piece Arterial Cannulae have a flexible, thin wall wirewound body with a tapered distal tip. The tip features depth markings and an adjustable radiopaque suture ring to indicate insertion depth. The proximal end of the cannula terminates in a vented or non-vented 3/8" (0.95 cm) connector. A plastic tapered tip introducer with porous plug is provided to facilitate cannula insertion and priming. The introducer features a guidewire port for use with a 0.038" (0.1 cm) guidewire. Some models include a guidewire while some do not. The devices are marketed in 18, 20, 22, and 24 Fr. diameters. The devices may include a 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 are also Elongated One-Piece Arterial Cannulae with the same design characteristics. Predicate 510(k)s described the 20 and 22 Fr. device. The predicate devices were uncoated. The predicate cannulae have the same indications for use.
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, leaching and functional testing was performed on Carmeda® coated devices.
Conclusion
Medtronic Perfusion Systems has demonstrated that the modified Elongated One-Piece Arterial Cannulae are substantially equivalent to the predicate devices based upon design, test results, and indications for use.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 3 2003
Medtronic Perfusion Systems c/o Mr. Ronald W. Bennett Principal Regulatotry Affairs Specialist 7611 Northland Drive Minneapolis, MN 55428
Re: K031037
EOPA Elongated One-Piece Arterial Cannula w/o Guidewire Regulation Number: 21 CFR 870.4210 Regulation Name: Catheter, Cannula and Tubing, Vascular Regulatory Class: Class II (two) Product Code: DWF Dated: April 1, 2003 Received: May 6, 2003
Dear Mr. Bennett:
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 - Mr.Ronald Bennett
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,
Prem 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
4
Page _ 1_ of _________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): __KO31037
Device Name:
EOPA Elongated One-Piece Arterial Cannula and EOPA Elongated One-Piece Arterial Cannula with Guidewire
Indications for Use:
This product is 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
Valester
(Division Sign-Off)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K031037