EMPOWER TRANSFER SET, (CAT. NO. 7725)

K041178 · E-Z-Em, Inc. · FPK · Jul 16, 2004 · General Hospital

Device Facts

• Record ID: K041178
• Device Name: EMPOWER TRANSFER SET, (CAT. NO. 7725)
• Applicant: E-Z-Em, Inc.
• Product Code: FPK · General Hospital
• Decision Date: Jul 16, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The Empower Transfer Set is intended to deliver fluid (contrast media or saline) from a container into a CT power Injector syringe.

Device Story

Empower Transfer Set is a disposable fluid delivery device used to transfer contrast media or saline from a container to a CT power injector syringe. The device consists of a vented spike, medical-grade PVC tubing, a pinch clamp, and a female luer connector. It is operated manually by clinical staff in a radiology or clinical setting. The device facilitates the filling of injector syringes, ensuring fluid delivery for CT imaging procedures. It is a passive mechanical device; no electronic or software components are involved.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1 and 10993-7.

Technological Characteristics

Disposable fluid transfer set. Components: Vented spike, 6" medical-grade PVC tubing, pinch clamp, ISO 594 female luer connector. Sterilization: Ethylene Oxide (EtO). Biocompatibility: ISO 10993-1 and 10993-7 compliant.

Indications for Use

Indicated for the transfer of contrast media or saline from a container into a CT power injector syringe.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Venusa Flu Ven Tr-1 (K791131)

Submission Summary (Full Text)

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JUL 1 6 2004

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Visualize a bealthier world

## Empower Transfer Set 510(k) Summary

| Submitter's Information: | E-Z-EM, Inc.<br>717 Main Street<br>Westbury, NY 11590 |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone Number: | [phone], ext. 2345 |
| Fax Number: | [phone] |
| Contact: | Steven Hartman, Senior Project Engineer, CT Injectors |
| Date Prepared: | June 28, 2004 |
| Trade Name: | Empower™ Transfer Set |
| Common Name: | Transfer Set |
| Classification Name: | Tubing, Fluid Delivery [21 CFR 880.5440]<br>Product Code: FPK<br>Regulatory Class: II |
| Predicate Device: | Venusa Flu Ven Tr-1 (K791131) |
| Indications for Use: | The Empower Transfer Set is intended to deliver fluid<br>(contrast media or saline) from a container into a CT<br>power Injector syringe. |
| Device Description: | The Empower Transfer Set is a disposable set used to<br>transfer contrast media or saline from a container that<br>can be spiked to a CT power Injector syringe. |

E-Z-EM Empower Transfer Set 510(k) Submission Summary Page 1 of 2

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## Comparative Summary Tables

| Parameter | Proposed E-Z-EM Empower<br>Transfer Set | Predicate Venusa Flu Ven Tr-1 (K791131) |
|--------------------|-----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Indication For Use | It is intended to be used in the delivery<br>of fluid (contrast media or saline) into a<br>syringe. | The device has been categorized for use of<br>I.V. fluid transfer. |
| Female Luer | Polycarbonate, Clear | Same |
| Clamp | Pinch clamp | Same |
| Spike | Vented Spike | Same |
| Tubing | 6" Length<br>PVC - Medical Grade | 7" Length<br>Same |
| Connection method | ISO 594 Luer | Same |
| Sterility | Ethylene Oxide (EtO) sterilized | Same |
| Biocompatibility | Tested to ISO 10993-1 and 10993-7 | Same |

A summary of the proposed device as compared to the predicate device is as follows:

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Public Health Service

JUL 1 6 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Steven Hartman Senior Project Engineer E-Z-EM, Incorporated 717 Main Street Westbury, New York 11590

Re: K041178

Trade/Device Name: Empower Transfer Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPK Dated: May 4, 2004 Received: May 5, 2004

Dear Mr. Hartman:

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 – Mr. Hartman

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html

Sincerely vours.

Ken Morley

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): _K041178

Device Name: Empower Transfer Set

Indications For Use:

The Empower Transfer Set is intended to deliver fluid (contrast media or saline) from a container into a CT power Injector syringe.

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)

Amore Nareem for Abdul

Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number:________________________________________________________________________________________________________________________________________________________________

Empower Transfer Set 510k Submission