(125 days)
The Multi-Med catheter is indicated for use in patients requiring administration of solutions, blood sampling, central venous pressure monitoring, and injection of contrast media.
Vantex central venous catheters are indicated for use in patients requiring administration of solutions, blood sampling, central venous pressure monitoring, and injection of contrast media. All catheters include a soft tip to reduce the risk of vessel perforation.
The Multi-Med CVCs are single use devices available in 7 or 8.5 French outside diameter, 2-4 lumens, 16 or 20 cm length. The catheters may be coated with AMC Thromboshield benzalkonium chloride heparin coating.
The provided document describes a 510(k) Pre-market Notification for Multi-Med Central Venous Catheters and Vantex CVCs. This type of submission is for demonstrating substantial equivalence to a previously cleared predicate device, rather than proving efficacy or a specific level of performance against predefined acceptance criteria for AI/ML devices. Therefore, much of the requested information (such as sample sizes for test/training sets, ground truth establishment, MRMC studies, and standalone performance) is not applicable or not detailed in this type of regulatory filing.
Here's an analysis of the available information based on the prompt's categories:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not Explicitly Stated as such in a traditional AI/ML sense) | Reported Device Performance |
|---|---|
| Safety and Effectiveness (implicitly): Must be as safe and effective as predicate devices. | "The Multi-Med CVCs have been demonstrated to be as safe and effective as the predicate devices for their intended use." |
| Functional Equivalence: Must perform comparably to predicate devices in functional tests. | "The Multi-Med CVCs have successfully undergone functional testing. These products have been shown to be equivalent to the predicate devices." |
| Material Equivalence: Consistent with accepted materials for such devices. | (Implied by substantial equivalence to predicate devices which use accepted materials, but not explicitly stated as a performance metric.) |
| Intended Use: Able to fulfill the same indications as predicate devices. | The Multi-Med CVCs are indicated for "access to the central venous system, infusion of solutions, blood sampling, and central venous pressure monitoring." This matches the intended use of similar CVCs. Vantex CVCs also have similar indications and include a soft tip to reduce risk. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Not Applicable. This is a medical device submission, not a study involving AI/ML models with distinct test and training datasets. The "testing" refers to functional and safety testing of the physical catheter, not algorithmic performance. The document does not specify sample sizes for these functional/safety tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This submission does not involve AI/ML performance evaluation requiring expert-established ground truth.
4. Adjudication Method for the Test Set
- Not Applicable. This submission does not involve AI/ML performance evaluation requiring an adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This type of study is not relevant for a physical medical device like a central venous catheter. MRMC studies are typically used to assess the impact of AI/ML tools on human reader performance, which is not the subject of this 510(k).
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No. This is a physical medical device, not an algorithm. Standalone performance studies are for AI/ML algorithms.
7. Type of Ground Truth Used
- Not Applicable. The concept of "ground truth" as it applies to AI/ML model performance is not relevant here. The device's "ground truth" is its physical characteristics, functional performance, and biological compatibility, which are assessed through standard engineering, material, and biocompatibility tests.
8. Sample Size for the Training Set
- Not Applicable. As this is not an AI/ML device, there's no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable.
Summary of the Study (510(k) Process for Medical Devices):
The "study" in this context is the 510(k) premarket notification process, which aims to demonstrate substantial equivalence to legally marketed predicate devices.
- Objective: To show that the Multi-Med CVCs and Vantex CVCs are as safe and effective as their predicate devices and have the same intended use.
- Methodology:
- Comparative Analysis: The submitter compared the Multi-Med CVCs to predicate devices (Multi-Med CVC cleared under K955839 and ArrowG+Ard, Arrow G+ Blue Plus Pressure Injectable CVC cleared under K071538) to demonstrate equivalence.
- Functional/Safety Testing: The device underwent functional testing to ensure it performs as intended and is safe. The specific details or results of these tests (e.g., burst pressure, flow rates, biocompatibility, etc.) are not provided in this summary but would be part of the full 510(k) submission.
- Conclusion: Based on the comparative analysis and functional/safety testing, Edwards Lifesciences concluded that the proposed Multi-Med CVCs are substantially equivalent to the predicate devices. The FDA concurred with this determination, allowing the device to be marketed.
Data Provenance: The document does not specify the country of origin for any testing data, nor does it classify the data as retrospective or prospective, as these terms are usually applied to clinical studies involving human patient data or AI/ML model development. The focus here is on the device's physical and functional properties.
{0}------------------------------------------------
Edwards Lifesciences
One I:dwards Way • Irvine. CA USA • 92614
Phone: 949-250-250-2500 • Fax: 949-250-2525 www.cdwards.com
1091709
ક 510(k) Summary
| Submitter: | Edwards Lifesciences LLCOne Edwards WayIrvine, CA 92614-5686 |
|---|---|
| OCT 1:3 2009 | |
| Contact Person: | Jason SmithRegulatory Affairs Manager |
| Date Prepared: | June 9, 2009 |
| Trade name: | Multi-Med Central Venous Catheters |
| Classification Name: | Catheter, Intravascular, Therapeutic, Short-Term, less than 30 days (21 CFR 880.5200) |
| Predicate Devices: | 1. Multi-Med CVC; cleared under K955839 (March 25, 1996)2. ArrowG+Ard, Arrow G+ Blue Plus Pressure Injectable CVC; cleared under K071538 (August 30, 2007) |
| Device Description: | The Multi-Med CVCs are single use devices available in 7 or 8.5 French outside diameter, 2-4 lumens, 16 or 20 cm length. The catheters may be coated with AMC Thromboshield benzalkonium chloride heparin coating. |
| Intended Use: | The Multi-Med CVCs are intended to provide access to the central venous system, infusion of solutions, blood sampling, and central venous pressure monitoring. |
| Comparative Analysis: | The Multi-Med CVCs have been demonstrated to be as safe and effective as the predicate devices for their intended use. |
| Functional/Safety Testing: | The Multi-Med CVCs have successfully undergone functional testing. These products have been shown to be equivalent to the predicate devices. |
| Conclusion: | The proposed Multi-Med CVCs are substantially equivalent to the predicate devices. |
June 9, 2009
510(k) Nolification for Multi-Med CVCs
Page 12
1: 1.6.6
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
DEC 16 2009
Mr. Jason Smith Manager of Regulatory Affairs Edwards Lifesciences, L.L.C. One Edwards Way Irvine, California 92614-5686
Re: K091709
Trade/Device Name: Multi-Med CVCs and Vantex CVCs Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: September 30, 2009 Received: October 2, 2009
Dear Mr. Smith:
This letter corrects our substantially equivalent letter of October 13, 2009.
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 (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 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.
{2}------------------------------------------------
Page 2 - Mr. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Centrum V,munte be
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
{3}------------------------------------------------
16091709 (જી)
Indications for Use Statement
510(k) Number (if known): K091709
Device Name: Multi-Med CVCs
Indications for Use:
The Multi-Med catheter is indicated for use in patients requiring administration of solutions, blood sampling, central venous pressure monitoring, and injection of contrast media.
Device Name: Vantex CVCs
Vantex central venous catheters are indicated for use in patients requiring administration of solutions, blood sampling, central venous pressure monitoring, and injection of contrast media. All catheters include a soft tip to reduce the risk of vessel perforation.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/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)
Cintron U. aming
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control. Dental Devices
Page 1 of _1
510(k) Number:
§ 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).