The Control Device (CCD) is intended for use in the IV delivery of contrast media during imaging procedures with a secondary intended use of conservation of contrast media.

Device Description

The CCD is made up of two parts: Part A, which is the reusable spike assembly (intended for use on only one container of contrast media/dye and considered an extension of the contrast container) and; Part B, which is the disposable valve and tubing set (intended for use on only one patient). The two in-line backcheck valves in Part B prevent inadvertent retrograde flow thereby protecting Part A from contamination.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Contrast Control Device" (CCD). However, it does not contain information about acceptance criteria, actual device performance (beyond intended use), specific studies conducted, sample sizes, ground truth establishment, or expert involvement.

The document primarily focuses on:

Administrative details: Submitter information, device names, predicate devices, and the date of submission.
Device description: How the two parts of the CCD work (reusable spike assembly and disposable valve/tubing set) and its multi-patient use protocol within a 6-hour timeframe.
Intended use: IV delivery of contrast media during imaging procedures and conservation of contrast media.
FDA's response: A letter confirming substantial equivalence to predicate devices and allowing marketing.
Indications for Use statement.

Therefore, I cannot provide the requested information in the format specified because the input text does not contain the necessary data regarding performance studies or acceptance criteria.

To answer your request, I would need a section of the 510(k) or accompanying documentation that details the verification and validation (V&V) activities performed for the device. This would typically include:

Test methods: Descriptions of how the device was tested.
Test results: Specific quantitative or qualitative outcomes of the tests.
Acceptance criteria: Predefined limits or conditions for the test results to demonstrate safety and effectiveness.
Study design details: Information on sample sizes, data collection, and ground truth.

Summary

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K982123

510 (k) Summary

This summary regarding 510(k) safety and effectiveness and being submitted in accordance with the requirements of SMDA 1990 and 21 CFR part 807.92.

807.92(a)(1) Submitter's (and Contact) Name, Address, Telephone No., Summary Date

Cathy Chenetski Director, Regulatory Affairs Medex 3637 Lacon Road Hilliard, OH 43026 (614) 529-3932

June 11, 1998

807.92(a)(2) Device Name (Including Trade Name), Common Name, Classification Name

Classification Name:	Intravascular Administration Set (80 FPA)
Common/Usual Name:	Intravascular Fluid Delivery Set
Trade/Propriety Name:	Not yet determined.
Part Number:	Not yet determined

807.92(a)(3) Legally Marketed Predicate Device to Which Equivalence is Claimed

The modified Contrast Control Device, for purposes as defined under Section 510(k) of the Federal Food, Drug and Cosmetic Act, are substantially equivalent to the Medex IV Administration Set, K883318 and pre-amendment (primary predicate). Additionally, the Contrast Control Device is substantially equivalent to the Namic Contrast Savings System. K903493 (secondary predicate).

807.92(a)(4) Description of the Premarket Notification Device and 807.92 (a) (5) Intended Use

The clinician spikes the bottle of contrast media with Part A and then dead-ends the spike assembly until the start of the case. The clinician then attaches Part B and proceeds with the first case. When that case is complete the clinician detaches Part B and caps Part A with a new sterile dead-ender. When the clinician is ready to start the next case he attaches a new sterile Part B and proceeds. This can be repeated up to two times (for a total of three patients) within a maximum six-hour time frame.

The Control Device (CCD) is intended for use in the IV delivery of contrast media during imaging procedures with a secondary intended use of conservation of contrast media.

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 21 1998

Ms. Cathy Chenetski Director, Regulatory Affairs Medex, Incorporated 3637 Lacon Road Hilliard, Ohio 43026

K982123 Re : Contrast Control Device Trade Name: Requlatory Class: II Product Code: FPA June 11, 1997 Dated: Received: June 16, 1997

Dear Ms. Chenetski:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Chenetski

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your sitem privalence of your device to a legally marketed predicate device results in a classification for your markets and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Ditrain gr

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K98212コ

Page 1 of 1

510(k) Number (if known) ____________________________________________________________________________________________________________________________________________________

Device Name: Contrast Control Device

Indications for Use:

The Control Device (CCD) is intended for use in the IV delivery of contrast media during The Ountrast Oontrol Donot (OOD) is intented use of conservation of contrast media.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ (Per 21 CFR 801.109) OR

Over-The-Counter Use_

Patricia Cucerdl
(Division Sign-Off)

(Optional Format 1-2-96)

Division of Dental, Infection Control, and General Hospital Devices

510(k) Number K982123

000013

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.