(22 days)
The Medtronic centrifugal blood pumping system is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass procedures (up to 6 hours).
The Bio-Console® 560 is a cardiopulmonary bypass pump speed controller. It is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass procedures (up to 6 hours).
The provided text does not contain specific acceptance criteria or an in-depth study description with performance metrics for the Bio-Console® 560. Instead, it describes a 510(k) premarket notification for a Class II medical device, the Bio-Console® 560, a cardiopulmonary bypass pump speed controller. The submission aims to demonstrate substantial equivalence to previously marketed predicate devices (Bio-Console® 550 and Bio-Console® 550M).
The key takeaway is that the manufacturer performed functional, hardware, and software testing to establish the device's performance characteristics. However, the details of these tests and the specific quantitative acceptance criteria and results are not provided in this summary.
Therefore, I cannot complete the table or answer most of the specific questions as the information is not present in the provided text.
Here's an assessment based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (e.g., Accuracy, Precision) | Reported Device Performance |
|---|---|
| Not Specified in the document. | Not Specified in the document. Functional, hardware, and software testing was performed, but no quantitative results or specific performance metrics are provided. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: Not specified, but implied to be from internal testing by the manufacturer (Medtronic Perfusion Systems). It is not stated whether it was retrospective or prospective, or the country of origin of the data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as the device is a pump speed controller, and the "ground truth" would likely be based on engineering specifications and measurement standards, not expert clinical interpretation.
4. Adjudication method for the test set
- Not applicable for this type of device testing.
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
- Not applicable. This device is a hardware speed controller, not an AI-assisted diagnostic or interpretative system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The performance assessment likely focused on the device's standalone functional performance, as it's a pump speed controller. However, specific details of "standalone" testing are not provided beyond "functional, hardware and software testing."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for a device like this would typically involve engineering specifications, calibration standards, and established metrics for pump performance (e.g., flow rate, pressure, RPM accuracy). The document does not specify these details.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that would require a "training set" in the conventional sense. The "training" here refers to the engineering design and development process.
9. How the ground truth for the training set was established
- Not applicable. As above, this is not an AI/machine learning device.
Summary of available information:
The 510(k) summary states that "Functional, hardware and software testing was used to establish the performance characteristic of the modifications of this device from previously marketed devices." The conclusion drawn is that the Bio-Console® 560 is "substantially equivalent to the predicate devices based upon design, test results, and indications for use." This implies that the testing performed demonstrated performance comparable to the predicate devices, meeting the requirements for substantial equivalence, but the specific details of these tests and their numerical outputs are not included in this document.
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JUN 1 0 2005
510(k) Summary
| Date Prepared: | May 18, 2005 |
|---|---|
| Submitter: | Medtronic Perfusion Systems7611 Northland BoulevardBrooklyn Park, MN 55428 |
| Contact Person: | Dawn M. StenstromPrinciple Regulatory Affairs SpecialistPhone: (763) 391-9604Fax: (763) 391-9603 |
Device Name and Classification:
| Trade Name: | Bio-Console® 560 |
|---|---|
| Common Name: | Cardiopulmonary bypass pump speed control |
| Classification: | Class II |
| Predicate Devices: | Bio-Console® 550K924205 |
| Bio-Console® 550MK936091 |
Device Description:
The Bio-Console® 560 is a cardiopulmonary bypass pump speed controller. It is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass procedures (up to 6 hours).
Indication for Use
The Medtronic centrifugal blood pumping system is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass procedures (up to 6 hours).
Comparison to Predicate Devices
The Bio-Console® 550 and Bio-Console® 550M are cardiopulmonary bypass pump speed controllers with the same design characteristics. The modification to the current Bio-Console® 550 adds an additional pressure monitor and a remote touch screen user interface. Currently a remote user interface is used in the Bio-Console® 550M.
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Summary of Performance Data
Functional, hardware and software testing was used to establish the performance characteristic of the modifications of this device from previously marketed devices.
Conclusion
Medtronic Perfusion Systems has demonstrated that the Bio-Console® 560 is substantially equivalent to the predicate devices based upon design, test results, and indications for use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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JUN 1 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtronic Perfusion Systems c/o Ms. Dawn M. Stenstrom Principle Regulatory Affairs Specialist 7611 Northland Boulevard Brooklyn Park, MN 55428
Re: K051303
Bio-Console® 560 Regulation Number: 21 CFR 870.4380 Regulation Name: Cardiopulmonary bypass pump speed control Regulatory Class: Class II Product Code: DWA Dated: May 18, 2005 Received: May 19, 2005
Dear Ms. Stenstrom:
We have reviewed your Section 510(k) premarket notification of intent to market the device wfo nave rowed your your 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 for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conniner of the 114) 2011-11-11 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). and Cosmetter For (10) that to device, subject to the general controls provisions of the Act. The I ou may, iteres, maxs 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 M. 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 (240) 276-0120. 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/industry/support/index.html.
Sincerely yours,
Dona R. Lochner
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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Indications for Use
510(k) Number (if known): ¥ 05130 3
Device Name:
Bio-Console® 560
Indications for Use:
The Medtronic centrifugal blood pumping system is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass procedures (up to 6 hours).
Prescription Use x________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R. Lochner
(Division Sign-Off) Division of Cardiovascular Devices
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510(k) Number_Koc
§ 870.4380 Cardiopulmonary bypass pump speed control.
(a)
Identification. A cardiopulmonary bypass pump speed control is a device used that incorporates an electrical system or a mechanical system, or both, and is used to control the speed of blood pumps used in cardiopulmonary bypass surgery.(b)
Classification. Class II (performance standards).