Flexible Luer Lock Adapters are indicated for use in connecting tubing and/or devices during cardiopulmonary bypass procedures up to 6 hours in duration.

Device Description

The flexible luer lock adapters are single use only devices that consist of a flexible tubing segment with an inner diameter of 0.32 cm (0.125 in) with a male luer adapter on one end and a female luer adapter on the other end. This device is currently packaged with the Affinity Pixie Cardiotomy/Venous Reservoir device. It is also available as a standalone device (subject of this submission).

AI/ML Overview

The provided text describes a 510(k) submission for the Medtronic Affinity® Flexible Luer Lock Adapters. This submission focuses on demonstrating substantial equivalence to a predicate device, primarily through performance testing of the updated packaging for a device that was previously an accessory.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Study Details/Context
Packaging Integrity	Compliance with ISO 11607-1 and 11607-2, 2006	Packaging was visually inspected, subjected to dye penetration test, and peel test.	Packaged samples were sterilized twice and subjected to climactic conditioning prior to distribution simulation (ASTM D4169-08) and testing. The tests ensure integrity of seals and proper adherence between Tyvek lid and blister tray. The conclusion states compliance was demonstrated.
Sterility Maintenance	Maintenance of sterility after processing and distribution	Packaged samples were sterilized twice and subjected to climactic conditioning. (Implies sterility was maintained after these processes as part of overall packaging integrity.)	Sterilization was a pre-step for packaging integrity testing, demonstrating packaging's ability to maintain sterility after multiple cycles and environmental stresses.

Note: The core product (the luer lock adapter itself) is stated to be identical to the predicate device in terms of design, materials, intended use, and principles of operation. Therefore, there are no specific performance criteria for the adapter's function (e.g., fluid flow, connection strength) in this submission, as those were already established for the predicate device. The focus is solely on the new packaging configuration.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document does not specify the exact number of samples used for the packaging tests (e.g., how many blister trays were tested for dye penetration or peel strength). It refers to "packaged samples."
Data Provenance: Not explicitly stated regarding country of origin. The study appears to be retrospective in the sense that the device itself largely pre-exists as part of another product, and the study is for demonstrating the adequacy of the new packaging for standalone distribution. It's a lab-based performance study, not a clinical trial involving human patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable (N/A). This study is a physical and mechanical performance test of packaging, not a diagnostic or AI-driven device requiring expert-established ground truth. The "ground truth" for packaging integrity is defined by compliance with ISO and ASTM standards and visual/mechanical tests (dye penetration, peel strength).

4. Adjudication Method for the Test Set

Not applicable (N/A). As this is a physical performance study, there is no need for expert adjudication in the traditional sense. The results are objectively measured against established criteria (e.g., successful dye penetration vs. no penetration, peel strength within a range).

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. This is not an AI/imaging device. It's a medical device accessory whose performance evaluation focuses on packaging integrity.

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

Not applicable (N/A). This is not an AI/algorithm-based device. The device itself (the luer lock adapter) is a standalone accessory, but its performance in this submission relates to its packaging.

7. The type of ground truth used

Defined by International Standards and Objective Physical Measurements: The "ground truth" for the packaging performance is compliance with ISO 11607-1 and 11607-2, 2006, and ASTM D4169-08. Performance is assessed through objective measurements like visual inspection, dye penetration, and peel tests.

8. The Sample Size for the Training Set

Not applicable (N/A). There is no "training set" as this is not an AI or machine learning product.

9. How the Ground Truth for the Training Set was Established

Not applicable (N/A). There is no training set or associated ground truth for this type of device submission.

Summary

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K123448

510(k) Summary

Date Prepared:	September 28, 2012
Applicant:	Medtronic, Inc.Medtronic Perfusion Systems7611 Northland DriveMinneapolis, MN 55428
Contact Person:	Julia A. NelsonPrincipal Regulatory Affairs SpecialistMedtronic Perfusion SystemsPhone: 763-514-9844Fax: 763-367-8360E-Mail: julia.a.nelson@medtronic.com
	Alternate contact:Sue FidlerSenior Regulatory Affairs ManagerMedtronic Perfusion SystemsPhone: 763-514-9839Fax: 763-367-8360E-Mail: susan.c.fidler@medtronic.com

Device Name and Classification:

Affinity® Flexible Luer Lock Adapters with Carmeda BioActive Trade Name: Surface (Model CBPT1830) or Balance Biosurface (Model BBPT1830) Common Name: Adapter, stopcock, manifold or fitting; cardiopulmonary bypass Regulation Number: 21 CFR 870.4290 Product Code: DTL Classification: Class II Classification Panel: Cardiovascular

Predicate Device

The predicate device is the Affinity Flexible Luer Lock Adapters, accessory packaged with the Affinity Pixie Cardiotomy/Venous Reservoir (CVR) (K100645).

Device Description

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with the Affinity Pixie Cardiotomy/Venous Reservoir device. It is also available as a standalone device (subject of this submission).

Product Family	Model	Description
Adapters	CBPT1830	Flexible Luer Lock Adapter with Carmeda BioActiveSurface
	BBPT1830	Flexible Luer Lock Adapter with Balance Biosurface

Intended Use

Affinity Flexible Luer Lock Adapters are indicated for use in connecting tubing and/or devices during cardiopulmonary bypass procedures up to 6 hours in duration.

Comparison to Predicate Devices

The Affinity Flexible Luer Lock Adapters has the same intended use, design and materials, and principles of operation and technology when compared to the predicate devices.

. Intended Use: Flexible Luer Lock Adapters are indicated for use in connecting tubing and/or devices during cardiopulmonary bypass procedures up to 6 hours in duration.
Design: There is no change in the device design of the Affinity Luer Lock Adapters ● as compared to the predicate, only the packaging has changed.
Materials: There are no changes to the device design, additional materials are ● included in the Affinity Luer Lock Adapters in comparison to the predicate devices as it is packaged in a different configuration.
Principles of Operation and Technology: The flexible luer lock adapters are for . connecting tubing and or components together in an extracorporeal circuit which is used in the same manner of operation as the predicate connectors.
Performance: The performance of the adapters did not change from the predicate . device.

The Affinity Flexible Luer Lock Adapters are identical to the predicate device, with the exception of packaging. The predicate device is currently an accessory which is packaged . and sterilized with the Affinity Pixie Cardiotomy/Venous Reservoir.

The stand-alone flexible luer lock adapters will be sold as a ten (10) pack of Tyvek lidded sealed blister trays in a paperboard carton with 1 Instruction For Use (IFU). These trays are overpacked in a corrugated shipper box.

Summary of Performance Data

The packaging for these products was tested to demonstrate compliance to ISO 11607-1 and 11607-2, 2006.

The packaged samples were sterilized twice and subjected to climactic conditioning prior to testing. After being subjected to the distribution simulation and testing (ASTM D4169-08), the packaging was visually inspected. The seals are then subjected to the dye penetration test to ensure integrity of the seals. In addition, seals then undergo a peel test to ensure the proper level of adherence between the Tyvek lid and the blister tray.

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Conclusion

Medtronic has demonstrated that the Affinity Flexible Luer Lock Adapters are substantially equivalent to the predicate devices based upon design, test results, and indications for use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract shapes that resemble ribbons or waves, stacked on top of each other.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

DEC 1 3 2012

Medtronic, Inc. c/o Ms. Julia A. Nelson, MS. RAC Principal Regulatory Affairs Specialist 8200 Coral Street NE Mailstop MVS83 Mounds View, MN 55112

Re: K123448

Trade/Device Name: Affinity Flexible Luer Lock Adapters Regulation Number: 21 CFR 870.4290 Regulation Name: Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting Regulatory Class: Class II Product Code: DTL Dated: November 7, 2012 Received: November 8, 2012

Dear Ms. Nelson:

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.

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.

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Page 2 – Ms. Julia A. Nelson

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 device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 vours,

Matthew G. Hjllebrenner

for 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 Statement

510(k) Number (if known): _ K123448

Device Name:

Affinity® Flexible Luer Lock Adapters with Balance™ Biosurface Affinity® Flexible Luer Lock Adapters with Carmeda® BioActive Surface

Indications for Use:

Flexible Luer Lock Adapters are indicated for use in connecting tubing and/or devices during cardiopulmonary bypass procedures up to 6 hours in duration.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cus Hillebeure

Cardiovascular Devices

510(k) Number

Regulation Number and Section

§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.