The Medrad Transfer Set is medical disposable device used to transfer intravascular contrast media and saline from a spikeable container to a power injector syringe. The device components consist of a vented spike, connector tube, a means of manually stopping flow, female luer, and individually packaged sterile caps.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Medrad Transfer Set." This document focuses on demonstrating substantial equivalence to an already legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a standalone study with performance metrics in the way one might expect for a diagnostic AI device.

Therefore, many of the requested elements (like sample size for test sets, number of experts, adjudication methods, MRMC studies, ground truth types, training set details) are not applicable or not present in this type of regulatory submission for a simple medical device.

The study described here is essentially a comparison of features and principles of operation between the proposed device and a predicate device (Merit Contrast Management System K961794) to demonstrate substantial equivalence.

Here's a breakdown based on the information provided:

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

Since this is a substantial equivalence submission for a simple transfer set, the "acceptance criteria" are not reported as quantitative performance metrics. Instead, the acceptance criteria are met by demonstrating that the proposed device is substantially equivalent to a predicate device in terms of intended use, principle of operation, materials, and other characteristics. The "reported device performance" is essentially the comparison of features.

Feature	Acceptance Criteria (Implied by Predicate Device)	Reported Device Performance (Medrad Transfer Set)
Intended Use	Contrast media delivery system	Same (Delivery of contrast media and saline into a syringe)
System Configuration	2-part system	1-part system
Multi-fill	Yes, until reservoir empty or time limit exceeded	Same
Time limit	6 hours maximum	Same
Materials	Clear flexible plastic tubing, rigid plastic spike and stopcock	Polyvinyl chloride tubing, Acylontrile-butadiene-styrene
Packaging	Pouch, sealed	Same
Sterility	Ethylene Oxide (EtO) Sterilized	Same
Shelf Life	5 Years	1 Year (to be extended to 5 years upon testing)
Connection method	ISO 594 Luer	Same
Sterile caps provided	Yes	Yes

Key Difference/Consideration for Equivalence:
The primary difference highlighted is that the predicate device included a separate disposable single-patient use tubing component for direct patient connection, whereas the Medrad Transfer Set does not. The Medrad set must be removed from the syringe before the syringe can be connected to the patient, thus preventing contact with patient fluid. This difference is addressed in the submission to ensure it does not raise new questions of safety or effectiveness.

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

Not Applicable. This submission does not involve a "test set" in the sense of a dataset for performance evaluation of an AI algorithm. It's a review of device characteristics and intended use against a predicate.

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)

Not Applicable. There is no "ground truth" establishment in this type of submission. The comparison is based on the technical specifications and intended use of the devices.

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

Not Applicable. No test set or expert adjudication is described.

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 mechanical transfer set, not an AI or diagnostic imaging device. No MRMC study was conducted.

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

Not Applicable. This is a hardware device, not an algorithm.

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

Not Applicable. No ground truth for performance evaluation is established or used for this type of device. The "ground truth" for substantial equivalence is the established performance and safety profile of the predicate device.

8. The sample size for the training set

Not Applicable. No training set is involved as this is not an AI algorithm.

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

Not Applicable. No training set and no ground truth for a training set are involved.

Summary

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KO22 431

SEP 5 2002

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Submitter's Name: Submitter's Address: Telephone Number: Fax Number: Contact Person: Date:

Proprietary Name: Common Name: Classification Name: Classification:

Medrad Inc. One Medrad Drive, Indianola, PA 15051 USA (412) 767-2400, ext. 3536 (412) 767-2499 Frank Pelc July 24, 2002

Medrad Transfer Set Intravascular Administration Set Intravascular Administration Set 80 FPK, Class II

Predicate Device:

Merit Contrast Management System (K961794)

Device Description - The Medrad Transfer Set is medical disposable device used to transfer intravascular contrast media and saline from a spikeable container to a power injector syringe. The device components consist of a vented spike, connector tube, a means of manually stopping flow, female luer, and individually packaged sterile caps.

Substantial Equivalence - The information provided in this premarket notification demonstrates that the proposed device is substantially equivalent to legally marketed devices. The proposed Medrad Transfer Set is substantially equivalent to the Merit Contrast Management System (K961794). Both devices have the same intended use to deliver contrast media (and saline solutions) for diagnostic imaging procedures, and both allow multiple filling from one reservoir up to a 6 hour time limit.

A comparison of features and principles of operation between the proposed device and predicate device is provided in the table below.

Feature	Predicate Device (MeritContrast ManagementSystem) K961794	Proposed Device: MedradTransfer Set
Intended Use	Contrast media delivery system	Same
SystemConfiguration	2 Part System- multi-fill spike system- per patient administration set	1 Part System- multi-fill spike system
Multi-fill	Yes, until reservoir is empty ortime limit exceeded.	Same
Time limit	6 hours maximum	Same
Materials	Clear flexible plastic tubing, rigidplastic spike and stopcock	Polyvinyl chloride tubing,Acylontrile-butadiene-styrene
Packaging	Pouch, sealed	Same
Sterility	Ethylene Oxide (EtO) Sterilized	Same
Shelf Life	5 Years	1 Year (The shelf life will beextended to 5 years whensatisfactory test results arecompleted.)
Connection method	ISO 594 Luer	ISO 594 Luer
Sterile caps providedto cap connectionport between fillings	Yes	Yes

COMPARISON DATA

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Summary of differences between predicate and proposed devices -

The predicate device includes a separate disposable single-patient use tubing component. This component is attached to the open port on the administration set and leads to the patient, allowing fluid to be delivered to the patient without removing the filling component.

Medrad's transfer set will not include a separate tubing section. Medrad's transfer set must be removed from the syringe before the syringe can be connected to the patient; therefore it cannot come in contact with patient fluid through the syringe or administration set tubing. Additionally, the product labeling will state that the product is for single patient use only.

Intended Use – The Medrad Transfer Set is intended to be used in the delivery of contrast media and saline into a syringe.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

5 2002 SEP

Mr. Frank W. Pelc III Regulatory Affairs Coordinator Medrad, Incorporated One Medrad Drive Indianola, Pennsylvania 15051

Re: K022431

Trade/Device Name: Medrad Transfer Set Regulation Number: 880.5440 Regulation Name: Intravascular Administrative Set Regulatory Class: II Product Code: LHI and FPK Dated: July 24, 2002 Received: July 25, 2002

Dear Mr. Pelc:

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.

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.

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Page 2 -- Mr. Pelc

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski 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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K022431

INDICATION FOR USE

. . .

510(k) Number: K022 431

Device Name: Medrad Transfer Set

Indications for Use/Intended Use:

The Medrad Transfer Set is intended to be used in the delivery of contrast media and saline into a syringe.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Viola Hubbard for Pat Ciuente

(Division Sigr Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number. K022431

Prescription Use (Per 21 CFR 801.109) OR

. .

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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.