(121 days)
No
The device description and performance studies focus on mechanical fluid transfer and sterilization, with no mention of AI/ML terms or functionalities.
No
The device is described as being "for use in transferring contrast, saline, or other diagnostic fluids between bulk containers and a syringe," which falls under fluid delivery and transfer, not direct therapeutic action on a patient.
No
The device is described as a transfer set for moving fluids between containers and syringes, not for the purpose of diagnosis.
No
The device description clearly outlines physical components such as connectors, clamps, tubing, and spikes, and the performance studies describe physical testing like bond and leak testing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for transferring fluids (contrast, saline, diagnostic fluids) between containers and a syringe. This is a fluid handling function, not a diagnostic test performed in vitro (outside the body) on a specimen.
- Device Description: The description focuses on the physical components and how they are used to facilitate fluid transfer. It does not mention any components or processes related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: The document does not contain any of the typical indicators of an IVD, such as:
- Mention of analyzing biological specimens (blood, urine, tissue, etc.).
- Reference to diagnostic assays or tests.
- Discussion of analytical or clinical performance related to a diagnostic outcome.
The device is a tool for preparing and administering fluids, which is a supportive function in a medical procedure, but not a diagnostic test itself.
N/A
Intended Use / Indications for 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.
Indications For Use: for use in transferring contrast, saline, or other diagnostic fluids between bulk containers and a syringe.
Product codes
FPK, FPA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 a 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.
Key Metrics
Not Found
Predicate Device(s)
K873597, K031808, K022431, K961794, K041178
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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.
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