(119 days)
Not Found
No
The summary describes a physical catheter with an antimicrobial coating and a clinical trial evaluating its effectiveness against a predicate device. There is no mention of AI or ML technology in the device description, intended use, or performance studies.
No.
The device is described as a catheter for venous access and infection prevention, not as a treatment for existing conditions.
No
The device description and intended use state that it is a catheter for venous access and protection against bacterial colonization, not for diagnosing conditions.
No
The device description clearly states it is a physical catheter made of polyurethane with an antimicrobial surface, 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 to provide venous access to the central circulation and help protect against bacterial colonization on the catheter surface. This is a direct intervention on the patient's body.
- Device Description: The device is a physical catheter designed to be inserted into a vein.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
IVD devices are typically used to test samples like blood, urine, or tissue outside of the body to gain diagnostic information. This device is a therapeutic/interventional device.
N/A
Intended Use / Indications for Use
The multiple-lumen catheter permits venous access to the central circulation. The Angiotech antimicrobial surface is intended to help provide protection against bacterial colonization on the catheter surface and it may help reduce catheterrelated infections. The catheter is not intended to be used as a treatment for existing infections, nor is it indicated for longer than 30 days use.
Product codes (comma separated list FDA assigned to the subject device)
FOZ
Device Description
The Angiotech® CVC Multi-lumen Central Venous Catheter with MEDI-COATTM Antimicrobial Surface is a 7-French, polyurethane triple lumen, 15 or 20-cm catheter with a MEDI-COAT containing 48.8 µg/cm of 5-fluorouracil.
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
Adult patients in an ICU setting
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
The Angiotech® CVC was evaluated in a prospective, randomized clinical trial as compared to the predicate device. Angiotech Catheter insertions in adult patients in an ICU setting proved that the Angiotech CVC was effective and non-inferior when compared to the predicate device for prevention of bacterial colonization on catheters.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Prospective, randomized clinical trial.
Sample Size: Not explicitly stated for each group, but refers to "two groups" for comparison.
Key Results: The Angiotech CVC was effective and non-inferior when compared to the predicate device for prevention of bacterial colonization on catheters. The comparability of the two devices was further supported by the low rate of catheter-related bloodstream infection, which occurred in none of the Angiotech CVC group and two in the predicate device group. The rates of catheter insertion site infections were low and comparable in the two groups. No adverse effects have been associated with the clinical use of Angiotech CVC.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Catheter-related bloodstream infection: none in Angiotech CVC group, two in predicate device group. Catheter insertion site infections: low and comparable in both groups.
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.
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
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).
0
KO 73520 page 2 of 2
Section 5 - 510(k) Summary
| Technological
characteristics: | The proposed device has the same technological characteristics as the
predicate device(s) with difference being the use of 5-FU to prevent
bacterial colonization. |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance tests: | The product meets all the requirements of ISO 10555-1 (Sterile,
single use intravascular catheters) and ISO10555-3 (Sterile,
central venous catheters)
The following were performed to demonstrate substantial
equivalence catheter stiffness catheter elongation catheter flexural fatigue tolerance priming volume: distal lumen priming volume: medial lumen priming volume: proximal lumen distal lumen flow rate medial lumen flow rate proximal lumen flow rate clinical evaluation |
| Assessment of non-
clinical performance
data: | The Angiotech CVC has undergone testing to that provides
assurance of safety and effectiveness for its intended use. Testing
included both in vitro and in vivo biocompatibility, in vitro zone
of inhibition, in vitro minimal inhibitory concentration, in vitro
minimal bactericidal concentration, mechanical and physical
testing, and drug release testing. |
| Assessment of clinical
performance data: | The Angiotech® CVC was evaluated in a prospective,
randomized clinical trial as compared to the predicate device.
Angiotech Catheter insertions in adult patients in an ICU setting
proved that the Angiotech CVC was effective and non-inferior
when compared to the predicate device for prevention of bacterial
colonization on catheters. The comparability of the two devices
was further supported by the low rate of catheter-related
bloodstream infection, which occurred in none of the Angiotech
CVC group and two in the predicate device group. The rates of
catheter insertion site infections were low and comparable in the
two groups. No adverse effects have been associated with the
clinical use of Angiotech CVC. The results of the clinical trial
support the intended use of the Angiotech CVC. |
| Conclusion: | The results of non-clinical and clinical testing demonstrate that
the device is as safe and effective as the legally marketed
predicate device(s). |
1
K073520 page 1 of 2
Section 5 - 510(k) Summary
In accordance with 212 CFR 807.87, the following 510(k) summary has been prepared per 21 CFR 8107.92
| Submitter | Angiotech BioCoatings Corp
336 Summit Point Drive
Henrietta, NY 14467 USA |
|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant Contact: | Trudy D. Estridge, Ph.D.
Director of Regulatory Affairs
Angiotech
Dulles Gateway Center
13921 Park Center Road, Suite 100
Herndon, VA 20171 USA
Voice: 703-796-8927
Fax: 703-673-0061
Email: testridge@angio.com |
| Date summary
prepared: | December 13, 2007 |
| Device trade name: | Angiotech® CVC |
| Device Common
Name: | Central Venous Catheter (CVC) |
| Device classification: | Catheter, intravascular, therapeutic, short-term less than 30 days.
Product Code FOZ, 21 CFR 880.5200, Class II |
| Legally marketed
devices to which the
device is substantially
equivalent: | ARROWg+ard Blue® Central Venous Catheter
K993691 and K900263 |
| Description of the
device: | The Angiotech® CVC Multi-lumen Central Venous Catheter with
MEDI-COATTM Antimicrobial Surface is a 7-French, polyurethane
triple lumen, 15 or 20-cm catheter with a MEDI-COAT containing 48.8
µg/cm of 5-fluorouracil. |
| Intended use of the
device: | The multiple-lumen catheter permits venous access to the central
circulation. The Angiotech antimicrobial surface is intended to help
provide protection against bacterial colonization on the catheter surface
and it may help reduce catheter-related infections. The catheter is not
intended to be used as a treatment for existing infections, nor is it
indicated for longer than 30 days use. |
Angiotech CVC 510(k) Summary
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Public Health Service
APR 1 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Trudy D. Estridge, Ph.D. Director of Regulatory Affairs Angiotech Pharmaceuticals, Incorporated Dulles Gateway Center 13921 Park Center Road, Suite 100 Herndon, Virginia 20171
Re: K073520
Trade/Device Name: Angiotech CVC Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: March 28, 2008 Received: March 28, 2008
Dear Dr. Estridge:
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.
3
Page 2 - Dr. Estridge
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu-Lin, Ph.D.
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
4
Section 4 - Indications for Use Statement
510k number if known:
Device Name:
Angiotech CVC
Indications for Use:
The multiple-lumen catheter permits venous access to the central circulation. The Angiotech antimicrobial surface is intended to help provide protection against bacterial colonization on the catheter surface and it may help reduce catheterrelated infections. The catheter is not intended to be used as a treatment for existing infections, nor is it indicated for longer than 30 days use.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Charles Brown Jr for ADW
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K073520
Section 4 Page 1 of 1