Bio-Medicus Life Support catheters are peripheral-access catheters used to perfuse vessels or organs in conjunction with extracorporeal cardiopulmonary bypass (CPB) procedures. The catheter introducer is intended to facilitate proper insertion and placement of the appropriately-sized catheter within the vessel. Catheter models with tip lengths of 18 cm (7.09 in), 50 cm (19.7 in), or 55 cm (21.7 in) and without additional side holes may be used as either drainage or reinfusion catheters. This product is intended for use in adult and pediatric patients for up to 6 hours.

Device Description

The Bio-Medicus Life Support catheter is a single-lumen catheter used to drain or reinfuse blood. These devices are sterile, nonpyrogenic, disposable, and intended for single use only. Do not store the product above 25°C (77°F).

AI/ML Overview

This document is a 510(k) summary for the Bio-Medicus Life Support Catheter and Introducer. It is a premarket notification for a medical device seeking clearance from the U.S. FDA, not a study report that details acceptance criteria and device performance in the way a clinical trial or a deep learning algorithm validation would.

Therefore, the requested information elements related to AI models, ground truth establishment, expert adjudication, sample sizes for training/test sets, MRMC studies, or standalone algorithm performance are not applicable (N/A) to this device or document. This document pertains to a physical medical device (catheter and introducer) and its pre-clinical testing, not an AI/ML algorithm.

However, I can extract the information that is available about the "device performance" in the context of this 510(k) submission, interpreted as the pre-clinical bench and in-vivo animal testing conducted.

1. Table of Acceptance Criteria and the Reported Device Performance:

The document summarises that "Pre-clinical bench testing was used to verify the performance characteristics of this device. In vivo animal testing was also completed to establish substantial equivalence with the predicate device." It also lists the types of performance tests conducted.

However, the document does not provide specific acceptance criteria values or detailed quantitative results for each test. It only states that the data is "sufficient to demonstrate that the Medtronic Bio-Medicus Life Support Catheter and Introducer is substantially equivalent to the legally marketed predicate devices."

Test Category	Acceptance Criteria (Not explicitly stated in detail)	Reported Device Performance (Summary)
Catheter testing	To demonstrate performance and safety profile	Data considered sufficient for substantial equivalence
Catheter and Introducer Testing	To demonstrate performance and safety profile	Data considered sufficient for substantial equivalence
Introducer Testing	To demonstrate performance and safety profile	Data considered sufficient for substantial equivalence
Blood trauma testing	To ensure minimal blood damage during use	Data considered sufficient for substantial equivalence
Packaging Testing	To ensure sterility and product integrity	Data considered sufficient for substantial equivalence
Sterilization Testing	To confirm effective sterilization	Data considered sufficient for substantial equivalence
Catheter and Introducer Life Testing	To confirm durability and functional life	Data considered sufficient for substantial equivalence
Biocompatibility Testing	To ensure material compatibility with biological systems	Data considered sufficient for substantial equivalence
Pressure Drop Testing	To evaluate flow characteristics through the device	Data considered sufficient for substantial equivalence
In-vivo animal testing	To establish substantial equivalence with predicates	Demonstrated substantial equivalence with predicate devices

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

Sample Size for Test Set: Not specified in this summary. The tests listed are "pre-clinical bench testing" and "in vivo animal testing," which implies physical testing samples rather than human clinical data sets. The exact number of catheters/introducers tested or animals used is not detailed.
Data Provenance: Not specified in this summary. These are pre-clinical tests, so "country of origin of data" is not typically a relevant factor like it would be for a clinical trial with human subjects. The tests would have been conducted in a lab environment.
Retrospective or Prospective: These would be considered prospective tests, as they are specifically conducted to evaluate the performance of the new device for regulatory 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):

N/A. This information is not relevant for a physical device's pre-clinical performance testing. There is no "ground truth" to be established by human experts in the context of catheter performance testing, such as flow rates, tensile strength, or blood trauma. These are typically measured by laboratory equipment and standardised protocols.

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

N/A. Not applicable for pre-clinical bench or animal testing of a physical medical device. Adjudication methods are typically used in clinical trials or for subjective assessments by human readers/experts, which is not the case here.

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:

N/A. This is a clearance for a physical medical device (catheter and introducer), not an AI/ML diagnostic or assistive tool. Therefore, no MRMC study, human readers, or AI assistance is involved.

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

N/A. Not applicable for a physical medical device. This is relevant for AI/ML algorithms.

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

N/A. For pre-clinical bench testing, the "ground truth" would be objective measurements obtained through calibrated equipment and validated test methods (e.g., specific flow rates under defined pressures, measured tensile strength, observed material characteristics under stress, analysis of blood components for trauma). For animal testing, it would involve direct physiological measurements or observation of biological responses, with controls. It's not "ground truth" in the sense of expert diagnosis or pathology.

8. The sample size for the training set:

N/A. There is no "training set" in the context of a physical medical device. This term applies to machine learning algorithms.

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

N/A. As there is no training set for a physical device, this question is not applicable.

Summary

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July 15, 2021

Medtronic Inc. Juli Rubin Sr. Principal Regulatory Affairs Specialist 8200 Coral Sea St. NE Mounds Views, Minnesota 55112

Re: K201100

Trade/Device Name: Bio-Medicus Life Support Catheter and Introducer Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing Regulatory Class: Class II Product Code: DWF Dated: June 11, 2021 Received: June 14, 2021

Dear Juli Rubin:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Nicole Gillette Assistant Director (Acting) DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name

Bio-Medicus Life Support™ Catheter and Introducer

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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5.0 510(k) Summary of Safety and Effectiveness

Date Prepared:	April 23, 2020
Applicant:	Medtronic, Inc.Medtronic Perfusion Systems7611 Northland DriveMinneapolis, MN 55428Establish Registration Number: 2184009
Contact Person:	Juli Rubin, MBA, RACSr. Principal Regulatory Affairs SpecialistPhone: (763) 526-2357Fax: (763) 367-8361E-mail:juli.c.rubin@medtronic.comMike Green, MBA (Alternate)Sr. Regulatory Affairs ManagerPhone: (763) 514-9774Email: mike.green@medtronic.com
Trade Name:	Bio-Medicus Life Support™ Catheter and Introducer
Common Name:	Cardiopulmonary bypass vascular catheter, cannula, or tubing
Classification Name:	Catheter, Cannula and Tubing, Vascular, CardiopulmonaryBypass
Classification:	Class II
Regulation Number:	CFR 870.4210
Product Code:	DWF
Name of Predicate Device:	Bio-Medicus Adult Cannulae and Introducer (K142673)Bio-Medicus Pediatric Arterial and Femoral Cannula (K143083)Bio-Medicus Adult Cannulae and Introducer (K180453)

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Device Description:

Indication for Use:

Bio-Medicus Life Support catheters are peripheral-access catheters used to perfuse vessels or organs in conjunction with extracorporeal cardiopulmonary bypass (CPB) procedures. The catheter introducer is intended to facilitate proper insertion and placement of the appropriatelysized catheter within the vessel. Catheter models with tip lengths of 18 cm (7.09 in), 50 cm (19.7 in), or 55 cm (21.7 in) and without additional side holes may be used as either drainage or reinfusion catheters. This product is intended for use in adult and pediatric patients for up to 6 hours.

Contraindications:

Alone, the catheter and introducer are not medical treatment devices. The introducer is to be used only with the appropriately sized Bio-Medicus Life Support catheter. These devices are intended for use only as indicated in these instructions for use. Do not insert the catheter in a vessel that has arterial dissection or severe peripheral atherosclerosis.

Comparison to Predicate:

A comparison of the Medtronic Bio-Medicus Life Support Catheters and Introducers to the predicate devices indicates the following similarities:

. Same intended use
Same technological characteristics
Same operating principle ●
Same design features; the only exception is a slight increase in outer diameter (OD) ● of small sized devices to ensure durability throughout the duration of intended use. The inner diameter (ID) is identical to the predicate device.
. Similar materials: the only exception is the catheter body blood-contacting material which has changed from polyurethane to a siloxane-urethane co-polymer.
Similar shelf life; the subject device has a 3-year shelf life, which is one year shorter than the predicate device (4-year shelf life).

Summary of Performance Data

Pre-clinical bench testing was used to verify the performance characteristics of this device. In vivo animal testing was also completed to establish substantial equivalence with the predicate device.

The following performance tests were conducted:

Catheter testing
Catheter and Introducer Testing ●

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Introducer Testing ●
Blood trauma testing ●
Packaging Testing .
Sterilization Testing ●
Catheter and Introducer Life Testing ●
Biocompatibility Testing ●
Pressure Drop Testing ●

Conclusion:

The data included in this submission are sufficient to demonstrate that the Medtronic Bio-Medicus Life Support Catheter and Introducer is substantially equivalent to the legally marketed predicate devices, Bio-Medicus Adult Cannulae and Introducer (K142673), Bio-Medicus Pediatric Arterial and Femoral Cannula (K143083), and Bio-Medicus Adult Cannulae and Introducer (K1804530) for the perfusion of vessels or organs in conjunction with extracorporeal cardiopulmonary bypass (CPB) procedures for up to 6 hours.

Regulation Number and Section

§ 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).