(42 days)
This product is intended for use with cardiopulmonary bypass as an arterial return cannula.
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.
The provided text is a 510(k) summary for a medical device (EOPA Elongated One-Piece Arterial Cannula), but it does not contain the specific information requested in the prompt regarding acceptance criteria, a detailed study proving performance, sample sizes, expert involvement, or ground truth establishment for AI/ML device evaluation.
The 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices, which is a different regulatory pathway than providing detailed performance metrics against pre-defined acceptance criteria, especially in the context of AI/ML performance.
Therefore, I cannot populate the table or answer the specific questions about the study's methodology as the information is not present in the provided document.
Here's what I can extract based on the available text, noting the limitations:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Available | In vitro visual, dimensional, simulated use and functional testing was used to establish the performance characteristic of the modifications. For Carmeda® coated devices: coverage, bio-activity, leaching and functional testing was performed. |
| (No specific quantifiable criteria or pass/fail thresholds are mentioned) | (Results are summarized as demonstrating "substantial equivalence" to predicate devices, without detailed metrics) |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified (implied to be internal Medtronic testing, but country/retrospective/prospective not mentioned).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. This study refers to functional and physical testing of a medical device, not the interpretation of data/images by experts to establish ground truth for an AI/ML algorithm.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set:
- Not applicable. This was not a study involving human-in-the-loop data adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is a physical medical cannula, not an AI/ML-driven diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used:
- For the physical tests (visual, dimensional, functional, coverage, bio-activity, leaching), the "ground truth" would be established by engineering specifications, material standards, and validated laboratory methodologies. It is not "expert consensus, pathology, or outcomes data" in the typical AI/ML context.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML algorithm.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML algorithm.
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MAY 1 3 2003
(Optional Format 3-10-98)
510(k) Summary
| Date Prepared: | March 27, 2003 |
|---|---|
| Submitter: | Medtronic Perfusion Systems7611 Northland BoulevardBrooklyn Park, MN 55428 |
| Contact Person: | Ronald W. BennettPrincipal Regulatory Affairs Specialist |
| Phone: | (763)-391-9086 |
| Fax: | (763) 391-9603 |
Device Name and Classification:
| Trade Name: | EOPA Elongated One-Piece Arterial Cannula andEOPA Elongated One-Piece Arterial Cannula withGuidewire18, 20, 22, 24 Fr. with Carmeda® Coating |
|---|---|
| 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 withGuidewire20, 22 Fr.K991066 and K000274Extracorporeal Circuit with Bio-Active SurfaceK891687 |
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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.
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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.
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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
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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
§ 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).