(119 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the Angiotech CVC, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text details various tests performed, but it mostly lists the types of tests without specific numerical acceptance criteria. For the clinical performance, the acceptance criterion seems to be non-inferiority to the predicate device regarding bacterial colonization prevention.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with ISO 10555-1 and ISO 10555-3 | Product meets all requirements. |
| Catheter stiffness performance | Performed. Results presumably met internal standards (no specific values given). |
| Catheter elongation performance | Performed. Results presumably met internal standards. |
| Catheter flexural fatigue tolerance performance | Performed. Results presumably met internal standards. |
| Priming volume (distal, medial, proximal lumen) performance | Performed. Results presumably met internal standards. |
| Flow rate (distal, medial, proximal lumen) performance | Performed. Results presumably met internal standards. |
| Biocompatibility | Undergone in vitro and in vivo testing; provides assurance for safety and effectiveness. |
| Zone of inhibition, minimal inhibitory concentration, minimal bactericidal concentration | Undergone in vitro testing; provides assurance for safety and effectiveness. |
| Mechanical and physical testing | Undergone testing; provides assurance for safety and effectiveness. |
| Drug release testing | Undergone testing; provides assurance for safety and effectiveness. |
| Non-inferiority for prevention of bacterial colonization | Proved effective and non-inferior compared to the predicate device in a prospective, randomized clinical trial. |
| Low rate of catheter-related bloodstream infection (CRBSI) | None in the Angiotech CVC group, two in the predicate device group. Comparison supported by "low rate." |
| Low and comparable rates of catheter insertion site infections | Rates were low and comparable in both groups. No adverse effects associated with clinical use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The sample size for the clinical trial is not explicitly stated. It mentions "adult patients in an ICU setting."
- Data Provenance: The data is from a prospective, randomized clinical trial. The country of origin is not specified but is implicitly assumed to be the USA, given the FDA 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given text. Clinical trials often involve medical professionals for assessment, but the text does not detail the number or qualifications of experts specifically for establishing ground truth related to the outcomes (e.g., bacterial colonization, infections).
4. Adjudication Method for the Test Set
This information is not provided in the given text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done as this an medical device, not an AI/Software device subject to such studies.
- Effect Size: Not applicable.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
- No, this is a physical medical device (Central Venous Catheter) with an antimicrobial coating, not an AI algorithm. Therefore, "standalone performance" in the context of an algorithm is not applicable. The device's performance is inherently "standalone" from human intervention in its antimicrobial action.
7. Type of Ground Truth Used
For the clinical trial, the "ground truth" was established by clinical outcomes data from patients. This includes:
- Prevention of bacterial colonization on catheters.
- Rate of catheter-related bloodstream infection.
- Rates of catheter insertion site infections.
These outcomes would be determined through standard microbiological and clinical diagnostic procedures.
8. Sample Size for the Training Set
This information is not applicable as this is a physical medical device, not an AI/software device that undergoes "training." The device's efficacy relies on its physical and chemical properties and its antimicrobial coating, which are developed through engineering and laboratory testing rather than machine learning training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated above (not an AI/software device). The development and testing of the antimicrobial coating (5-FU) and the catheter itself would involve various laboratory and pre-clinical studies, with "ground truth" derived from established scientific methods for assessing antimicrobial efficacy, material properties, and biocompatibility.
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KO 73520 page 2 of 2
Section 5 - 510(k) Summary
| Technologicalcharacteristics: | The proposed device has the same technological characteristics as thepredicate device(s) with difference being the use of 5-FU to preventbacterial 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 substantialequivalence 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 performancedata: | The Angiotech CVC has undergone testing to that providesassurance of safety and effectiveness for its intended use. Testingincluded both in vitro and in vivo biocompatibility, in vitro zoneof inhibition, in vitro minimal inhibitory concentration, in vitrominimal bactericidal concentration, mechanical and physicaltesting, and drug release testing. |
| Assessment of clinicalperformance 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 settingproved that the Angiotech CVC was effective and non-inferiorwhen compared to the predicate device for prevention of bacterialcolonization on catheters. The comparability of the two deviceswas further supported by the low rate of catheter-relatedbloodstream infection, which occurred in none of the AngiotechCVC group and two in the predicate device group. The rates ofcatheter insertion site infections were low and comparable in thetwo groups. No adverse effects have been associated with theclinical use of Angiotech CVC. The results of the clinical trialsupport the intended use of the Angiotech CVC. |
| Conclusion: | The results of non-clinical and clinical testing demonstrate thatthe device is as safe and effective as the legally marketedpredicate device(s). |
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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 Corp336 Summit Point DriveHenrietta, NY 14467 USA |
|---|---|
| Applicant Contact: | Trudy D. Estridge, Ph.D.Director of Regulatory AffairsAngiotechDulles Gateway Center13921 Park Center Road, Suite 100Herndon, VA 20171 USAVoice: 703-796-8927Fax: 703-673-0061Email: testridge@angio.com |
| Date summaryprepared: | December 13, 2007 |
| Device trade name: | Angiotech® CVC |
| Device CommonName: | 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 marketeddevices to which thedevice is substantiallyequivalent: | ARROWg+ard Blue® Central Venous CatheterK993691 and K900263 |
| Description of thedevice: | The Angiotech® CVC Multi-lumen Central Venous Catheter withMEDI-COATTM Antimicrobial Surface is a 7-French, polyurethanetriple lumen, 15 or 20-cm catheter with a MEDI-COAT containing 48.8µg/cm of 5-fluorouracil. |
| Intended use of thedevice: | The multiple-lumen catheter permits venous access to the centralcirculation. The Angiotech antimicrobial surface is intended to helpprovide protection against bacterial colonization on the catheter surfaceand it may help reduce catheter-related infections. The catheter is notintended to be used as a treatment for existing infections, nor is itindicated for longer than 30 days use. |
Angiotech CVC 510(k) Summary
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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.
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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
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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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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
§ 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).