(125 days)
Not Found
No
The document describes a standard central venous catheter and does not mention any AI or ML capabilities, image processing, or data sets typically associated with AI/ML devices.
No
The device is described as a central venous catheter for administering solutions, blood sampling, monitoring pressure, and injecting contrast, not for directly treating a disease or condition.
No
The device is described as a catheter for administering solutions, blood sampling, pressure monitoring, and contrast media injection, which are therapeutic or monitoring functions, not diagnostic ones.
No
The device description explicitly states it is a physical catheter (single use devices available in 7 or 8.5 French outside diameter, 2-4 lumens, 16 or 20 cm length), which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for administering solutions, blood sampling, monitoring central venous pressure, and injecting contrast media directly into the patient's central venous system. These are all procedures performed in vivo (within the living body).
- Device Description: The description details a catheter designed for insertion into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a physiological state, health, or disease.
IVDs are devices used to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a therapeutic and diagnostic tool used directly on the patient.
N/A
Intended Use / Indications for 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.
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.
Product codes
FOZ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central venous system
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)
The Multi-Med CVCs have successfully undergone functional testing. These products have been shown to be equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 LLC
One Edwards Way
Irvine, CA 92614-5686 |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | OCT 1:3 2009 |
| Contact Person: | Jason Smith
Regulatory 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
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