(168 days)
Not Found
No
The summary describes a physical medical device (catheters and guidewires) and its intended use for fluid administration, blood sampling, and monitoring. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on bench and pre-clinical testing comparing the physical device to predicates.
No.
A therapeutic device is one that treats a disease or condition. These devices are used for monitoring, sampling, and administering solutions, which are diagnostic or supportive functions, not therapeutic.
No
Explanation: The device is a central venous catheter used for administering solutions, blood sampling, central venous pressure monitoring, and injecting contrast media. While "central venous pressure monitoring" involves measurement and could be considered diagnostic in a broad sense, the device itself is primarily a conduit for these functions, not an instrument that directly provides a diagnosis or diagnostic information.
No
The device description explicitly states that the device is a central venous catheter, which is a physical medical device, and mentions components like guidewires.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses listed are for administering solutions, blood sampling, central venous pressure monitoring, and injecting contrast media. These are all procedures performed on the patient, not tests performed on samples taken from the patient to diagnose or monitor a condition.
- Device Description: The description focuses on the physical components of the catheters and their use in direct patient procedures.
- Lack of IVD Language: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples (like blood, urine, tissue) outside of the body to provide information about a patient's health status. This device is a medical device used for direct patient care procedures.
N/A
Intended Use / Indications for Use
The Multi-Med catheters are indicated for use in patients requiring administration of solutions, blood sampling, central venous pressure monitoring and injection of contrast media.
The 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 (comma separated list FDA assigned to the subject device)
FOZ
Device Description
The Multi-Med Central Venous Catheters (Multi-Med CVCs) and Vantex Central Venous Catheters (Vantex CVCs) and their respective convenience kits are used with Edwards monitoring instruments. They are used in patients who require the administration of solutions, blood sampling, central venous monitoring and injection of contrast media. The Multi-Med CVCs and Vantex CVCs can be used with an uncoated stainless steel guidewire (SS guidewire) or a PTFE-coated Nitinol core guidewire (Nitinol guidewire). The guidewire is included with the Multi-Med CVCs and Vantex CVCs in convenience kits or the guidewire can be packaged as a separate component.
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
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)
Comparative Verification and validation testing was conducted to compare the performance and functionality of the Multi-Med CVCs and Vantex CVCs to the predicate devices. This testing regimen included side-byside comparative bench and pre-clinical performance testing of the pending and predicate devices. The results show that the performance functionality of the Multi-Med CVCs and Vantex CVCs and the pending guidewire is substantially equivalent to the predicate devices, and provides a marked improvement in the ease of use of the pending devices in comparison to the predicate devices. Thus, the Multi-Med CVCs and Vantex CVCs have been demonstrated to be safe and effective and substantially equivalent to the predicate devices for their intended use.
The Multi-Med CVCs and Vantex CVCs have successfully undergone functional and performance testing, including bench studies, pre-clinical animal studies and biocompatibility testing. Multi-Med CVCs and Vantex CVCs have been shown to be safe and effective and substantially equivalent to the cited predicate devices for their intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K955839, K992532, K091709, K100739, K110167
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
510(k) Summary
:
.
MAY 1 8 2012
.
| 510(k) Summary | MAY 1 | ||
|---|---|---|---|
| Submitter: | Edwards Lifesciences LLC | ||
| One Edwards Way | |||
| Irvine, CA 92614-5686 | |||
| Contact Person: | Marguerite Thomlinson, JD, BSME | ||
| Director of Regulatory Affairs | |||
| Phone: (949) 756-4386 | |||
| Fax: (949) 809-5676 | |||
| Date Prepared: | November 30, 2011 | ||
| Trade Name: | Multi-Med Central Venous Catheters . | ||
| Vantex Central Venous Catheters | |||
| Classification Name: | Intravascular Catheter (21 CFR Part 880.5200) | ||
| Product Class/ | |||
| Product Code: | Class II/FOZ | ||
| Predicate Devices: | K955839: Multi-Med Multi-Lumen CVCs | ||
| K992532: Vantex CVCs with Oligon Material | |||
| K091709: Multi-Med CVCs and Vantex CVCs | |||
| K100739: VolumeView System | |||
| K110167: PreSep Oligon Oximetry Catheters | |||
| Device Description: | The Multi-Med Central Venous Catheters (Multi-Med CVCs) and | ||
| Vantex Central Venous Catheters (Vantex CVCs) and their respective | |||
| convenience kits are used with Edwards monitoring instruments. They | |||
| are used in patients who require the administration of solutions, blood | |||
| sampling, central venous monitoring and injection of contrast media. | |||
| The Multi-Med CVCs and Vantex CVCs can be used with an uncoated | |||
| stainless steel guidewire (SS guidewire) or a PTFE-coated Nitinol core | |||
| guidewire (Nitinol guidewire). The guidewire is included with the | |||
| Multi-Med CVCs and Vantex CVCs in convenience kits or the | |||
| guidewire can be packaged as a separate component. |
· .
1
Indications for Use:
The Multi-Med catheters are indicated for use in patients requiring administration of solutions, blood sampling, central venous pressure monitoring and injection of contrast media.
The 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.
Comparative Verification and validation testing was conducted to compare the Analysis: performance and functionality of the Multi-Med CVCs and Vantex CVCs to the predicate devices. This testing regimen included side-byside comparative bench and pre-clinical performance testing of the pending and predicate devices. The results show that the performance functionality of the Multi-Med CVCs and Vantex CVCs and the pending guidewire is substantially equivalent to the predicate devices, and provides a marked improvement in the ease of use of the pending devices in comparison to the predicate devices. Thus, the Multi-Med CVCs and Vantex CVCs have been demonstrated to be safe and effective and substantially equivalent to the predicate devices for their intended use.
Functional/ Safety Testing:
The Multi-Med CVCs and Vantex CVCs have successfully undergone functional and performance testing, including bench studies, pre-clinical animal studies and biocompatibility testing. Multi-Med CVCs and Vantex CVCs have been shown to be safe and effective and substantially equivalent to the cited predicate devices for their intended use.
Conclusion:
The Multi-Med CVCs and Vantex CVCs are safe and effective and are substantially equivalent to the cited predicate devices.
Page 27 of 520 Nov. 30. 2011
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and three horizontal bars running through the body of the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 1 8 2012
Ms. Marguerite Thomlinson, JD, BSME Director of Regulatory Affairs Edwards Lifesciences, LLC One Edwards Way Irvine, California 92614-5686
Re: K113565
Trade/Device Name: Multi-Med Central Venous Catheters, Vantex Central Venous Catheters Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: April 16, 2012 Received: April 18, 2012
Dear Ms. Thomlinson:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
3
Page 2- Ms. Thomlinson
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony D. Avant
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K 113565
Device Name:
Multi-Med Central Venous Catheters Vantex Central Venous Catheters
Indications for Use:
The Multi-Med catheters are indicated for use in patients requiring administration of solutions, blood sampling, central venous pressure monitoring and injection of contrast media.
The 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 AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L.L. for RZC May 16, 2012
Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices
510(k) Number:
Special 510k: Edwards Multi-Med/Vantex
Page 29 of 520 Nov. 30, 2011