The Bio-Probe blood flow monitoring system is to be used with an appropriate model Bio-Console extracorporeal blood pumping console to measure directly the blood flow in the extracorporeal perfusion circuit.

Device Description

The Bio-Probe 10 Blood Flow Monitoring System consists of a flow transducer and a sterile, single-use insert. The flow transducer consists of a flow-meter, cable and connector. The TX50 (adult) and TX50P (pediatric) transducer models are reusable. The Bio-Probe blood flow monitoring system can be used to measure the patient blood flow during the extracorporeal procedure.

AI/ML Overview

The provided document is a 510(k) summary for the Bio-Probe Blood Flow Transducer. This particular submission concerns the addition of a contraindication statement to the device.

Therefore, the document explicitly states that "Testing was not required for addition of a contraindication statement. Addition of the contraindication statement does not change the indications for use, technology and performance specifications of this device." This means there is no study described in this document proving the device meets acceptance criteria, as the submission is not about performance.

Here's the breakdown based on your request, highlighting the lack of relevant information for a performance study in this specific submission:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not applicable/Provided.
Reported Device Performance: Not applicable/Provided.

Explanation: This 510(k) is solely for adding a contraindication statement, not for demonstrating new performance or design changes.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size (Test Set): Not applicable.
Data Provenance: Not applicable.

Explanation: No testing was performed for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: Not applicable.
Qualifications of Experts: Not applicable.

Explanation: No ground truth establishment was needed as no performance testing was conducted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable.

Explanation: No adjudication was needed as no performance testing was conducted.

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

MRMC Study: No.
Effect Size: Not applicable.

Explanation: This device is a blood flow transducer, not an AI-assisted diagnostic or interpretation device that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable.

Explanation: This device is a physical transducer for measuring blood flow, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: Not applicable.

Explanation: No ground truth was established as no performance testing was conducted.

8. The sample size for the training set

Training Set Sample Size: Not applicable.

Explanation: This submission does not involve an algorithm or machine learning that would require a training set.

9. How the ground truth for the training set was established

Ground Truth Establishment (Training Set): Not applicable.

Explanation: No training set or ground truth for it was established.

In summary, this 510(k) submission is a regulatory update for an existing device (Bio-Probe Blood Flow Transducer, predicate device K070286) to add a contraindication statement. It explicitly states that no testing was required or performed because the change does not impact the device's indications for use, technology, or performance specifications. Therefore, information regarding acceptance criteria and performance study details is not present in this document.

Summary

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APR 1 0 2014

510(k) Summary of Safety and Effectiveness

Date Prepared:

Applicant:

Contact Person:

Trade Name:

Common Name:

Classification:

Product Code:

Classification Name:

December 18, 2013

Medtronic, Inc. Medtronic Perfusion Systems 7611 Northland Drive Brooklyn Park, MN 55428 Establishment Registration No. 2184009

Rahul Shah Regulatory Operations Specialist Medtronic, Inc. Cardiac and Vascular Group - Structural Heart 8200 Coral Sea Street NE, MVS 83 Mounds View. MN 55112 Phone: (763) 514-9846 (763) 367-8147 Fax: Email: rahul.m.shah@medtronic.com

Bio-Probe® Blood Flow Transducer

Probe, Blood Flow, Extravascular

Probe. Blood-Flow, Extravascular

Class II, 21 CFR 870.2120

DPT

Name of Predicate Device:

Bio-Probe Blood Flow Transducer (K070286)

Device Description

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Image /page/1/Figure/2 description: The image shows a flow-meter, cable, disposable insert, and connector. The flow-meter is a device used to measure the flow rate of a fluid. The cable is used to connect the flow-meter to a power source or other device. The disposable insert is a part of the flow-meter that is designed to be replaced after each use. The connector is used to connect the cable to the flow-meter.

This submission covers the addition of a contraindication for the Bio-Probe Flow Transducer.

"This device used for any other purpose other than for the indicated intended use is the responsibility of the user. "

Intended Use

The Bio-Probe Blood Flow Monitoring System is to be used with an appropriate model Bio-Console "1 Extracorporeal Blood Pumping Console to measure directly the blood flow in the extracorporeal perfusion circuit.

Comparison to the Predicate Device

The Bio-Probe Blood Flow Transducer has the same indications for use, technology and performance specifications as the previously cleared Bio-Probe Blood Flow Transducer. The only change to the device is the incorporation of the contraindication statement to be consistent with contraindications in other Medtronic devices in the extracorporeal perfusion circuit.

Summary of Performance Data

Testing was not required for addition of a contraindication statement. Addition of the contraindication statement does not change the indications for use, technology and performance specifications of this device.

Conclusion

Addition of the contraindication statement does not change the indications for use, technology and performance specifications of this device. Therefore the Bio-Probe Blood Flow Transducer is substantially equivalent to the currently marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -WO66-G609 Silver Spring, MD 20993-0002

April 10, 2014

Medtronic Inc. Mr. Rahul Shah Regulatory Operations Specialist 8200 Coral Sea Street Ne Mounds View, MN 55112 US

Re: K133903

Trade/Device Name: Bio-probe Blood-Flow Transducer, models TX50 (adult) and TX50P (pediatric)

Regulation Number: 21 CFR 870.2120 Regulation Name: Extravascular blood-flow probe Regulatory Class: Class II Product Code: DPT Dated: February 26, 2014 Received: February 27, 2014

Dear Mr. Shah:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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Page 2 - Mr. Rahul Shah

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Kenneth J. Cavanaugh -S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known)

K133903

Device Name

Bio-Probe Flow Transducer (Adult and Pediatric)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

🇿 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Kenneth J. Cavanaugh -S

Region Asy(k)_KXXXXXXX FORM FD onfidential edtron

Regulation Number and Section

§ 870.2120 Extravascular blood flow probe.

(a)
Identification. An extravascular blood flow probe is an extravascular ultrasonic or electromagnetic probe used in conjunction with a blood flowmeter to measure blood flow in a chamber or vessel.(b)
Classification. Class II (performance standards).