(129 days)
Not Found
No
The device description and performance studies focus on the physical properties and pressure handling capabilities of tubing and connectors, with no mention of AI or ML.
No
The device is described as a connecting line for the injection of fluids during diagnostic procedures, not for treating a disease or condition. Its function is to facilitate the delivery of diagnostic substances, not to provide therapy.
No.
The device is described as a connecting line for the injection of fluids, including diagnostic fluids, during coronary angiography procedures. Its function is to facilitate the delivery of these fluids, not to perform a diagnostic assessment itself.
No
The device description explicitly states it is a "combination of connectors and tubing bonded together," which are physical hardware components. The performance studies also focus on pressure testing and sterilization of these physical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states the device is a "connecting line for the injection of radiopaque dye, saline or other diagnostic fluids" during a coronary angiography procedure. This means the device is used to deliver substances into the body for imaging purposes.
- Intended Use: The intended use is for "use during coronary angiography procedures as a connecting line for the injection of radiopaque dye, saline or other diagnostic fluids." This is an in vivo (within the body) application, not an in vitro one.
The device is a medical device used in a clinical procedure, but it does not perform diagnostic testing on specimens outside the body.
N/A
Intended Use / Indications for Use
for use during coronary angiography procedures as a connecting line for the injection of radiopaque dye, saline or other diagnostic fluids.
Product codes (comma separated list FDA assigned to the subject device)
DQO
Device Description
The Disposable High Pressure Injection Lines with and without Rotating Adapters are a combination of connectors and tubing bonded together for injection of radiopaque dye, saline, or other diagnostic fluids during a coronary angiography procedure. The device is designed, like other legally marketed devices, for one end to connect to the fluid source (such as an angiographic syringe) and the other end to connect to the catheter. The contrast, saline, or other diagnostic fluid is then injected from the syringe, through the high pressure line, into the catheter. 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Tests Submitted: Verification of functional performance has been performed. As 1200psi is the greatest pressure for which the device is developed. pressure testing was conducted at 1200psi to verify acceptable performance of the "worst case" challenge. The Coeur sterilization cycle is able to sterilize the proposed device with an SAL of 106, based on a comparison to products tested for inclusion into the Coeur cycle. (A product analysis, compliant with AAMI/ANS/ISO 11135/EN 550, will be performed and appropriate actions will be taken accordingly.)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K810924, K911884, K023591, K822100, K963749
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
Coeur, Inc.
K071196 page lof 3
SEP - 6 2007
Coeur Medical, a division of Coeur, Inc. Disposable High Pressure Injection Lines with and without Rotating Adapters
510(k) Summary
| 1. | Submitter: | Name: | Coeur Medical, a division of Coeur, Inc. | |
|---|---|---|---|---|
| Address: | 209 Creekside Drive | |||
| Washington, NC 27889 | ||||
| Phone: | (615) 547-7923 (Corporate Office) | |||
| Fax: | (615) 547-7937 (Corporate Fax) | |||
| Contact: | Debra F. Manning, VP, Q & RA | |||
| Date: | April 27, 2007 |
| 2. | Device: Trade/Proprietary Name: | Disposable High Pressure Injection Lines
with and without Rotating Adapters |
|----|---------------------------------|--------------------------------------------------------------------------------|
| | Common/Usual Name: | High Pressure Lines |
| | Classification Name: | Diagnostic Intravascular Catheter
(21 CFR 870.1200, Product Code DQO) |
3. Legally Marketed Devices to which Substantial Equivalence is claimed:
Medrad High Pressure Connecting Tube (K810924) - Medrad
Advance Pressure Monitor/High Pressure Lines (K911884) -Advance Medical Designs, Inc.
Ultra High Pressure Injector Lines (K023591) - DeRoyal Industries, Inc.
flexcil® Contrast Injection Lines (K822100) - NAMIC
High Pressure Lines (K963749) - Maxxim Medical, Inc.
4. Device Description:
The Disposable High Pressure Injection Lines with and without Rotating Adapters are a combination of connectors and tubing bonded together for injection of radiopaque dye, saline, or other diagnostic fluids during a coronary angiography procedure. The device is designed, like other legally marketed devices, for one end to connect to the fluid source (such as an angiographic syringe) and the other end to connect to the catheter. The contrast, saline, or other diagnostic fluid is then injected from the syringe, through the high pressure line, into the catheter. The materials and properties of the device are tabled in Item 6, below.
1
K071196 Page 2 of 3
-
- Intended Use of Device: The Disposable High Pressure Injection Line with and without Rotating Adapter is for use during coronary angiography procedures as a connecting line for the injection of radiopaque dye, saline, or other diagnostic fluids. As the table in Item 6 demonstrates, this is consistent with other legally marketed devices.
| Technological
Characteristics | Proposed Device | Other Legally
Marketed Devices | Rationale for
Applicable Differences |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For use during
coronary angiography
procedures as a
connecting line for the
injection of radiopaque
dye, saline, or other
diagnostic fluids. | Medrad: To connect
an angiographic
catheter for needle
to an automatic
power injector.
De Royal: For use
during coronary
angiography
procedures and
connecting line for
the injection of
radiopaque dye or
saline.
NAMIC: Intended to
be used in the
delivery of contrast
media. | NA: There are no
significant differences
in the intended uses. |
| Connector Tube | Multiple lengths of
braided or unbraided,
flexible, clear or tinted,
plastic polymers | Multiple lengths,
plastic polymers,
PVC, braided and
unbraided, varying
levels of flexibility | The same basic
materials will be used
in the proposed
devices as are used in
legally marketed
devices. Coeur intends
to offer a more flexible
device that meets the
needs of the high
pressure market. |
| Sterility | Sterile and Non-Sterile | Same | NA |
| Sterilization
Method (For
Sterile Product) | EtO | Same | NA |
| Components | Combinations of male
and female luers
(including rotating
male luers), with and
without dust caps | Same | NA |
| Packaging of
Sterile Product | Sealed Tyvek-lidded
package or included as
component in trays or
kits. Products may be
wrapped with a band
to facilitate packaging. | Same | NA |
| Pressure Rating | 500 to 1200psi | Same | NA |
Summary of Technological Characteristics As Compared to Predicate Devices: 6.
If Substantial Equivalence was based on an Assessment of Performance Data, the following information is also provided:
2
K671196 page 3 of 3
-
- Nonclinical Tests Submitted: Verification of functional performance has been performed. As 1200psi is the greatest pressure for which the device is developed. pressure testing was conducted at 1200psi to verify acceptable performance of the "worst case" challenge. The Coeur sterilization cycle is able to sterilize the proposed device with an SAL of 106, based on a comparison to products tested for inclusion into the Coeur cycle. (A product analysis, compliant with AAMI/ANS/ISO 11135/EN 550, will be performed and appropriate actions will be taken accordingly.)
- Clinical Tests Submitted: 2. NA
-
- Conclusions Drawn from Nonclinical and Clinical Tests Submitted: 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. Coeur intends to offer a variety of high pressure lines, including a more flexible device that meets the needs of the high pressure market. 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with flowing lines, representing the department's mission of health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The logo is presented in black and white.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 6 2007
Coeur, Inc. c/o Ms. Debra F. Manning V.P. of Quality and Regulatory Affairs 704 Cadet Court Lebanon, TN 370787
Re: K071196 Trade/Device Name: Disposable High Pressure Injection Lines with and without Rotating Adapters Regulation Number: 21 CFR 870.1200 Regulation Name: Catheter, Intravascular, Diagnostic Regulatory Class: Class II Product Code: DQO Dated: August 10, 2007 Received: August 13, 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.
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
4
Page 2 -- Ms. Debra F. Manning
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 yours,
Blymmermon for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K07119 (v
Coeur, Inc. Disposable High Pressure Injection Lines with and Device Name: without Rotating Adapters
Indications For Use:
for use during coronary angiography procedures as a connecting line for the injection of radiopaque dye, saline or other diagnostic fluids.
Prescription Use V (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)
B. Benveniste
(Division Sign-Off)
(Division/sign-On)
Division of Cardiovascular Devices
510(k) Number K071196
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