(148 days)
The Vygon Multicath Expert Catheter is intended for use in patients who require Short-term (less than 30 days) I.V. iherapy. It may be used to administer hyperalimentation, antibiotics, chemotherapy, drugs for pain management or intravenous fluids. The catheters are manufactured with a Pellethane-based AgION™ antimicrobial. The AglON™ uses silver as the antimicrobial agent.
The Multicath Expert catheters are a line of multilumen catheters which have an antimicrobial function. The polyurethane catheters are impregnated with the silver ion-based antimicrobial agent AgION™ and are available in 2-, 3-, 4-, or 5-lumen catheters. Silver has been shown to have exceptional broad antimicrobial spectrum against bacteria and fungi including antibiotic resistant strains. The expert technology is based on an antimicrobial substance which is both mineral and bio-inert. It is neither an antibiotic nor an organic antiseptic; and the silver ions are released in low, non-toxic concentrations. Expert catheters release silver ions from their internal and external surfaces, and silver ions are released very gradually over an extended period of time, ensuring long-term efficacy. Biocompatibility and performance testing demonstrates the safety and efficacy of these devices.
The Vygon Multicath Expert Catheter is cleared via the 510(k) pathway, which means it demonstrates substantial equivalence to predicate devices rather than fulfilling specific acceptance criteria in a clinical study. The provided document does not contain details about a study with acceptance criteria and a reported device performance as would be expected for a de novo device or a device with new indications requiring clinical efficacy data.
Instead, the submission focuses on demonstrating that the only change—the addition of the AgION™ silver ion-based antimicrobial agent—does not adversely affect the safety and efficacy of the device compared to its predicate.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy for an AI device) are mentioned because this is a 510(k) submission for a physical medical device (intravascular catheter) with an antimicrobial coating. The "acceptance criteria" are implied by the regulatory requirements for showing substantial equivalence.
| Acceptance Criteria (Implied by 510(k)) | Reported Device Performance |
|---|---|
| Biocompatibility: Non-irritant and non-toxic materials. | Biocompatibility testing of the material demonstrates it is non-irritant and non-toxic. |
| Performance: Changes do not affect safety or efficacy compared to predicate. | Performance testing demonstrates that the changes do not affect safety or efficacy. |
| Risk Assessment: Compliance with ISO 14971. | Risk Assessment was conducted in compliance with ISO 14971. |
| Antimicrobial Functionality (AgION™): Release of silver ions for broad antimicrobial spectrum. | "Silver has been shown to have exceptional broad antimicrobial spectrum against bacteria and fungi including antibiotic resistant strains." "Expert catheters release silver ions from their internal and external surfaces, and silver ions are released very gradually over an extended period of time, ensuring long-term efficacy." (This describes the technology characteristic, not necessarily a formal performance metric from a study within this submission). |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a "test set" in the context of an AI/algorithm-driven device. The evaluation of the Multicath Expert is based on:
- Biocompatibility testing: This typically involves in vitro and sometimes in vivo animal studies, but the sample sizes are not specified here.
- Performance testing: This refers to mechanical and functional testing (e.g., flow rates, tensile strength) to ensure the catheter's core functionality is maintained despite the coating. Sample sizes for these engineering tests are not provided.
- Risk assessment: An analytical process, not a data-driven test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. This is not an AI/algorithm device requiring expert-established ground truth.
4. Adjudication Method for the Test Set:
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
Not applicable. This is not an AI device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is a physical medical device.
7. The Type of Ground Truth Used:
Not applicable in the AI/algorithm sense. The "ground truth" for this device's safety and efficacy is derived from:
- Biocompatibility standards: established methods for evaluating biological harm.
- Performance specifications: engineering and functional requirements for catheters.
- Predicate device's known safety and efficacy: the established performance of the already-marketed Multicath (K870067).
8. The Sample Size for the Training Set:
Not applicable. There is no "training set" for this type of device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
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12
SEP 2 9 2006
510K Premarket Notification Submission Summary of Safety and Efficacy
Date of Preparation: September 12, 2006
| Applicant: | Vygon Corporation2495 General Amistead Ave.Norristown, PA 19403 |
|---|---|
| Contact Individual: | Courtney Smith, Regulatory Affairs Manager610-539-9300 Ext. 110 |
| Trade Name: | Multicath Expert |
| Common Name: | Intravascular Catheter |
| Regulation Number: | 880.5200 |
| Product Code: | FOZ |
| Classification Name: | Intravascular Catheter |
| Classification: | Class II |
| Predicate Device Name: | Multicath (K870067), Vantex (K992532 / K033250) |
Device Description: The Multicath Expert catheters are a line of multilumen catheters which have an antimicrobial function. The polyurethane catheters are impregnated with the silver ion-based antimicrobial agent AgION™ and are available in 2-, 3-, 4-, or 5-lumen catheters. Silver has been shown to have exceptional broad antimicrobial spectrum against bacteria and fungi including antibiotic resistant strains. The expert technology is based on an antimicrobial substance which is both mineral and bio-inert. It is neither an antibiotic nor an organic antise>tic; and the silver ions are released in low, non-toxic concentrations. Expert catheters release silver ions from their internal and external surfaces, and silver ions are released very gradually over an extended period of time, ensuring long-term efficacy. Biocompatibility and performance testing demonstrates the safety and efficacy of these devices.
The Multicath Expert catheters are as follows:
| Description | Reference |
|---|---|
| Multicath Expert Catheters | 8159.xxx, 8158.xxx, 8157.xxx, 8155.xxx |
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The Vygon Multicath Expert Catheter is intended for use in patients who Intended Use: require short-term (less than 30 days) I.V. therapy. It may be used to administer hyperalimentation, antibiotics, chemotherapy, drugs for pain management or intravenous fluids. The catheters incorporate a silver based antimicrobial agent.
Technology Characteristics: Silver has becn shown to have exceptional broad antimicrobial spectrum against bacteria and fungi including antibiotic resistant strains. The expert technology is based on an antimicrobial substance which is both mineral and bio-inert. It is neither an antibiotic nor an organic antiseptic; and the silver ions are released in low, non-toxic concentrations. Expert catheters release silver ions from their internal and external surfaces, and silver ions are released verv gradually over an extended period of time, ensuring longterm efficacy.
Summary of Design Control Activities:
Biocompatibility testing of the material demonstrate that it is non-irritant and non-toxic. ! erformance testing demonstrates that the changes do not affect safety or efficacy. Risk Assessment was conducted in compliance with ISO 14971.
Kdollast
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The only change between the predicate device (Multicath K870067) and the Conclusion: Multicath Expert is the addition of the Agion techniology. Biocompatibility testing, performance testing and risk assessment demonstrate that the Multicath Expert is safe and effective to use, when used in accordance with the supplied instructions for use.
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Image /page/2/Picture/1 description: The image shows a stylized logo of the U.S. Department of Health and Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three lines that form a wing-like shape, and it is enclosed within a circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
tilliUlt to the 2000
Ms. Courtney Smith Regulatory Affairs Manager Vygon Corporation 2495 General Armistead Avenue Norristown, Pennsylvania 19403
Re: K061250
Trade/Device Name: Vygon Multicath Expert Catheters Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: September 15, 2006 Received: September 18, 2006
Dear Ms. Smith:
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 - Ms. Smith
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 yours,
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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K06 1250
Indications for Use
510(k) Number (if known):
Device Name: Vygon Multicath Expert Catheters
Indications For Use:
The Vygon Multicath Expert Catheter is intended for use in patients who require Short-term (less than 30 days) I.V. iherapy. It may be used to administer hyperalimentation, antibiotics, chemotherapy, drugs for pain management or intravenous fluids. The catheters are manufactured with a Pellethane-based AgION™ antimicrobial. The AglON™ uses silver as the antimicrobial agent.
Prescription Use × (Per 21 CFR 801 Subpart D) OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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11-2.11 ri of Anesthesiology, General Hospital, on Control. Dental Devices
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§ 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).