(72 days)
The Empower Transfer Set is intended to deliver fluid (contrast media or saline) from a container into a CT power Injector syringe.
The Empower Transfer Set is a disposable set used to transfer contrast media or saline from a container that can be spiked to a CT power Injector syringe.
This document is a 510(k) summary for the E-Z-EM Empower Transfer Set, seeking clearance for a medical device. It does not contain information about studies or acceptance criteria for device performance in the way a clinical or AI performance study would.
Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on regulatory compliance, device description, and comparison to a predicate device, not on analytical or clinical performance studies with specific acceptance criteria and detailed study designs.
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JUL 1 6 2004
Image /page/0/Picture/1 description: The image shows a handwritten alphanumeric string. The string appears to be "K041178" and is written in black ink on a white background. The numbers are slightly slanted to the right, and the overall impression is that of a quick, informal note.
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Empower Transfer Set 510(k) Summary
| Submitter's Information: | E-Z-EM, Inc.717 Main StreetWestbury, NY 11590 |
|---|---|
| Telephone Number: | (516) 333-8230, ext. 2345 |
| Fax Number: | (516) 333-8278 |
| 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]Product Code: FPKRegulatory Class: II |
| Predicate Device: | Venusa Flu Ven Tr-1 (K791131) |
| Indications for Use: | The Empower Transfer Set is intended to deliver fluid(contrast media or saline) from a container into a CTpower Injector syringe. |
| Device Description: | The Empower Transfer Set is a disposable set used totransfer contrast media or saline from a container thatcan 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 EmpowerTransfer Set | Predicate Venusa Flu Ven Tr-1 (K791131) |
|---|---|---|
| Indication For Use | It is intended to be used in the deliveryof fluid (contrast media or saline) into asyringe. | The device has been categorized for use ofI.V. fluid transfer. |
| Female Luer | Polycarbonate, Clear | Same |
| Clamp | Pinch clamp | Same |
| Spike | Vented Spike | Same |
| Tubing | 6" LengthPVC - Medical Grade | 7" LengthSame |
| 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 (301) 594-4618. 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 (301) 443-6597 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
§ 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.