The Disposable Transfer Sets with and without Swabbable Valves and/or Check Valves are a combination of connectors and accessories, such as clamps, tubing, and spikes, and are used for fluid delivery. The device is designed, like other legally marketed devices, for one end to connect to the syringe to be filled (which is installed on an injector with the plunger forward) and the other end is connected to the bulk container. The plunger is then retracted and contrast, saline, or other diagnostic fluid is drawn into the syringe.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Coeur, Inc. Disposable Transfer Sets:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Functional Performance)	Reported Device Performance
Bond testing (to verify acceptable performance)	Performed acceptably
Leak testing (to verify acceptable performance)	Performed acceptably
Sterilization (Surgical Aseptic Level (SAL) of 10⁻⁶)	Achieved (product adoption study verified)

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

The document does not explicitly state the sample sizes for the bond testing, leak testing, or sterilization product adoption study.
The studies appear to be retrospective in nature, done by Coeur, Inc. to verify the performance of their device prior to seeking regulatory approval.
The data provenance is Coeur, Inc., within the USA (Washington, NC, and Lebanon, TN are listed company addresses).

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

The document does not mention the use of experts or a ground truth established by experts for these non-clinical tests. The tests appear to be objective measurements of physical performance.

4. Adjudication Method for the Test Set

Not applicable as there is no mention of expert-led adjudication for these non-clinical performance tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This device is a medical accessory (transfer set), and the evaluation focuses on its physical and functional performance, not on clinical diagnostic or treatment efficacy that would involve human readers or AI.

6. If a Standalone Study (i.e. algorithm only without human-in-the-loop performance) was Done

This is not applicable. The device is a physical medical accessory, not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests appears to be:

Engineering specifications/standards for bond and leak testing (implied by "performs acceptably").
Microbiological standards (Surgical Aseptic Level (SAL) of 10⁻⁶) for sterilization.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm requiring a training set. The "product adoption study" may refer to testing on a set of actual production units, but it's not a "training set" in the context of AI.

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

Not applicable as there is no training set for an AI algorithm.

Summary

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Image /page/0/Picture/0 description: The image shows the word "COEUR" in a bold, serif font, with a stylized heart symbol to the left. The heart symbol is composed of two overlapping hearts and a circle above them. The "R" in "COEUR" has a registered trademark symbol next to it. The text and symbol are all in black and are set against a white background.

K063114

COEUR, INCORPORATED 209 CREEKSIDE DRIVE PO BOX 2125 WASHINGTON, NC 27889 252-946-1963 · FAX: 252-946-2317 E-MAIL: www.coeurinc.com

Coeur, Inc.

9 2007 FEB

Coeur Medical, a division of Coeur, Inc. Disposable Transfer Sets with and without Swabbable Valves and/or Check Valves

510(k) Summary

Coeur Medical, a division of Coeur, Inc. Name: Submitter: 1. 209 Creekside Drive Address: Washington, NC 27889 (615) 547-7923 (Corporate Office) Phone: (615) 547-7937 Fax: Debra F. Manning, VP, Q & RA Contact: October 5, 2006 Date:

Trade/Proprietary Name: Disposable Transfer Sets with and without 2. Device: Swabbable Valves and/or Check Valves Transfer Sets Common/Usual Name: Fluid Delivery Tubing (a product included Classification Name: in the definition of Intravascular administration set, 21 CFR 880.5440, Product Code FPK or FPA)

Legally Marketed Devices to which Substantial Equivalence is claimed: 3.

Fill Tube (K873597) - Coeur SVTS - Swabable Valve Transfer Set (K031808) - Medrad Transfer Set (K022431) - Medrad Contrast Management System (K961794) – Merit Empower Transfer Set (K041178) - E-Z-EM, INC.

Device Description: 4.

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ડ. Intended Use of Device:

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. . .

The Disposable Transfer Sets with and without Swabbable Valves and/or Check Valves are for use in transferring contrast, saline, or other diagnostic fluids from bulk containers into syringes. As the table in Item 6 demonstrates, this is consistent with other legally marketed devices.

Summary of Technological Characteristics As Compared to Predicate Devices: 6.

TechnologicalCharacteristics	ProposedDevice	Coeur Device	MedradDevices	Merit Device	E-Z-EM,INC.	Rationale forApplicableDifferences
Intended Use	For use intransferringcontrast, saline,or otherdiagnostic fluidsfrom bulkcontainers intosyringes.	For use in thedelivery ofcontrast media to asyringe.	For use in thedelivery ofcontrast mediaand saline to asyringe.	For use in theaspiration ofcontrast mediafrom acontainer intoa syringe andfor subsequentinjection intothe catheter.	Intended todeliver fluid(contrastmedia orsaline) from acontainer intoa CT PowerInjectorSyringe.	NA - Theproposed device isan extension of theexisting Coeurdevice to enableuse of contrast,saline, or otherdiagnostic fluidsprovided in bulkcontainers.
Connector Tube	Flexible, clearor tinted, PVC	Polyethylene	PVC	Clear, flexible, PVCplastic	PVC	None
Sterile	Yes	Yes	Yes	Yes	Yes	NA
SterilizationMethod	EtO	Same	Same	Same	Same	NA
Components	Combinations ofspikes, male andfemale luers,check valves (isused),stopcocks,clamps, variousdust caps, andswabbablevalves (Halkey-Roberts)	Tubing formed inthe shape of a "J"	Vented spike,dust cap,stopcock, pinchclampAndVented spike,female luer,swabbablethreaded valve(Halkey-Roberts)	Spikeassembly withstopcock, fixedmale luer,burettechamber andcheck valves	Female luer,clamp, andspike	NA - No newcomponents ormaterials orintended uses arebeing proposedwith the proposeddevice
ConnectionMethod	ISO 594 Luer	Inner diameter oftubing is placedover syringe luer	ISO 594 Luer	ISO 594 Luer	ISO 594 Luer	NA - Device isconnected tosyringe via luerconnection
Multi-Fill FillSets	Yes	If required.	Yes	Yes	Yes	NA
Packaging	Sealed Pouch	Same	Same	Same	Same	NA
Shelf Life	3 years	Same	5 years	5 years	3 years	There are nosignificantdifferences in thematerials orcomponentsutilized

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If Substantial Equivalence was based on an Assessment of Performance Data, the following information is also provided:

Nonclinical Tests Submitted: 1. Verification of functional performance has been performed. Bond testing and leak testing were conducted to verify the device performs acceptably. Coeur conducted a product adoption study to verify that the Coeur sterilization cycle is able to sterilize the proposed device with and SAL of 10°.

Clinical Tests Submitted: 2. NA

Conclusions Drawn from Nonclinical and Clinical Tests Submitted: 3. The primary difference between the proposed Coeur devices and other legally marketed predicate devices is that Coeur, who has experience in the production of tubing extension products and has the facilities and equipment for assembly of the proposed devices, will assemble the components to make the proposed devices which will be sterilized in Coeur's sterilization cycle. The results of the testing verify the proposed devices are suitable for their intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white and appears to be a scanned image.

Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Ms. Debra F. Manning Vice President, Quality & Regulatory Affairs Coeur, Incorporated 704 Cadet Court Lebanon, Tennessee 37087

FEB 9 2027

Re: K063114

Trade/Device Name: Coeur, Inc. Disposable Transfer Sets with and without Swabbable Valves and/or Check Valves Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPK, FPA Dated: January 24, 2007 Received: January 25, 2007

Dear Ms. Manning:

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 - Ms. Manning

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) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Susan Runnos
Chiu Lin, Ph.D,

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Coeur, Inc. Disposable Transfer Sets with and without Swabbable Device Name: Valves and/or Check Valves

Indications For Use:

for use in transferring contrast, saline, or other diagnostic fluids between bulk containers and a syringe

Prescription Use (Part 21 CFR 801 Subpart D)

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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)

Chas Evans

General Manager,
Local Engines

4-1

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.