What is the regulatory pathway for DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES?

510(k) clearance (submission type: Abbreviated).

Who can help prepare an FDA 510(k) submission like DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES

Q: Who is the manufacturer of DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES?

Coeur, Inc. filed the 510(k) submission for DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES (K063114).

Q: What is the FDA product code for DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES?

FPK. It is classified under 21 CFR 880.5440 as a Class 2 device in the General Hospital panel.

Q: What are the predicate devices for DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES?

Fill Tube (K873597); Coeur SVTS - Swabable Valve Transfer Set (K031808); Medrad Transfer Set (K022431); Medrad Contrast Management System (K961794); Merit Empower Transfer Set (K041178).

K063114 · Coeur, Inc. · FPK · Feb 9, 2007 · General Hospital

Device Facts

Record ID	K063114
Device Name	DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES
Applicant	Coeur, Inc.
Product Code	FPK · General Hospital
Decision Date	Feb 9, 2007
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 880.5440
Device Class	Class 2

Intended Use

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.

Device Story

Disposable transfer sets consist of tubing, connectors, spikes, clamps, and optional swabbable or check valves. Device connects bulk fluid containers to injector syringes; allows aspiration of contrast, saline, or diagnostic fluids into syringe for subsequent injection. Used in clinical settings; operated by healthcare professionals. Facilitates fluid delivery by providing a sterile pathway between bulk supply and power injector syringe. Benefits include efficient, sterile fluid transfer.

Clinical Evidence

No clinical data. Bench testing only: verification of functional performance, including bond and leak testing, and sterilization cycle validation (SAL 10^-6).

Technological Characteristics

Materials: PVC tubing, various plastic components (spikes, luers, stopcocks, clamps). Connection: ISO 594 Luer. Sterilization: Ethylene Oxide (EtO). Form factor: Tubing assembly with connectors. No software or electronic components.

Indications for Use

Indicated for transferring contrast, saline, or other diagnostic fluids between bulk containers and a 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

Fill Tube (K873597)
Coeur SVTS - Swabable Valve Transfer Set (K031808)
Medrad Transfer Set (K022431)
Medrad Contrast Management System (K961794)
Merit Empower Transfer Set (K041178)

Related Devices

K022431 — MEDRAD TRANSFER SET · Medrad, Inc. · Sep 5, 2002
K102073 — MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS · Benlan, Inc. · Nov 8, 2010
K133147 — BRACCO INJEENERING TRANSFER SET · Bracco Injeneering S.A. · Jun 20, 2014
K041178 — EMPOWER TRANSFER SET, (CAT. NO. 7725) · E-Z-Em, Inc. · Jul 16, 2004
K161723 — ulrich Transfer Set · Ulrich GmbH & Co. KG · Dec 21, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ 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. 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. The materials and properties of the device are tabled in Item 6, below. {1}------------------------------------------------ #### ડ. Intended Use of Device: יווי . . . 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. | Technological Characteristics | Proposed Device | Coeur Device | Medrad Devices | Merit Device | E-Z-EM, INC. | Rationale for Applicable Differences | |----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | For use in transferring contrast, saline, or other diagnostic fluids from bulk containers into syringes. | For use in the delivery of contrast media to a syringe. | For use in the delivery of contrast media and saline to a syringe. | For use in the aspiration of contrast media from a container into a syringe and for subsequent injection into the catheter. | Intended to deliver fluid (contrast media or saline) from a container into a CT Power Injector Syringe. | NA - The proposed device is an extension of the existing Coeur device to enable use of contrast, saline, or other diagnostic fluids provided in bulk containers. | | Connector Tube | Flexible, clear or tinted, PVC | Polyethylene | PVC | Clear, flexible, PVC plastic | PVC | None | | Sterile | Yes | Yes | Yes | Yes | Yes | NA | | Sterilization Method | EtO | Same | Same | Same | Same | NA | | Components | Combinations of spikes, male and female luers, check valves (is used), stopcocks, clamps, various dust caps, and swabbable valves (Halkey- Roberts) | Tubing formed in the shape of a "J" | Vented spike, dust cap, stopcock, pinch clamp And Vented spike, female luer, swabbable threaded valve (Halkey- Roberts) | Spike assembly with stopcock, fixed male luer, burette chamber and check valves | Female luer, clamp, and spike | NA - No new components or materials or intended uses are being proposed with the proposed device | | Connection Method | ISO 594 Luer | Inner diameter of tubing is placed over syringe luer | ISO 594 Luer | ISO 594 Luer | ISO 594 Luer | NA - Device is connected to syringe via luer connection | | Multi-Fill Fill Sets | 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 no significant differences in the materials or components utilized | {2}------------------------------------------------ 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. {3}------------------------------------------------ ### 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. {4}------------------------------------------------ ## 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 {5}------------------------------------------------ # 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) יווי 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