(84 days)
Not Found
Not Found
No
The summary describes a physical catheter for fluid administration, blood sampling, and monitoring, with no mention of AI/ML terms, image processing, or data analysis beyond basic physiological measurements.
No
The device is primarily used for monitoring, sampling, and administration of solutions, which are diagnostic and supportive functions rather than direct therapeutic intervention.
Yes
The device is indicated for "temperature monitoring" and "central venous pressure monitoring," which are diagnostic functions.
No
The device description clearly states it is a central venous catheter, which is a physical medical device, not software.
Based on the provided information, the Edwards Lifesciences Vantex Central Venous Catheters with Thermistor is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) for administering solutions, blood sampling, temperature monitoring, and central venous pressure monitoring. These are all procedures performed directly on a patient.
- Device Description: The description reinforces the in vivo use by stating it's used to access the central vein, infuse solutions, take blood samples, measure temperature, and monitor pressure.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a patient's health. The provided information does not mention any such use or analysis of specimens.
Therefore, this device is a medical device used for direct patient care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The VCVC-T are indicated for use in patients requiring administration of solutions, blood sampling, temperature monitoring, and central venous pressure monitoring.
Product codes
FOZ
Device Description
The VCVC-T are used to access the central vein, infuse solutions, take blood samples, measure central venous temperature, and monitor central venous pressures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central vein
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 VCVC-T have successfully undergone functional and Functional/Safety biocompatibility testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Edwards Lifesciences Vantex Central Venous Catheters with Oligon material, Edwards Lifesciences Swan-Ganz True-Size Thermodilution Catheters.
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
510(k) Summary
| Submitter: | Edwards Lifesciences LLC
One Edwards Way
Irvine, California 92614 USA |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jason Smith, Senior Regulatory Affairs Specialist
Phone: 949-250-2662
Fax: 949-250-3579
E-mail: jason smith@edwards.com |
| Date Prepared: | October 3, 2003 |
| Trade Name: | Edwards Lifesciences Vantex Central Venous Catheters
with Thermistor (abbreviated to VCVC-T) |
| Common Name: | Intravascular Therapeutic Short-Term Catheter (21 CFR
880.5200) |
| Predicate
Devices: | Edwards Lifesciences Vantex Central Venous Catheters
with Oligon material |
| | Edwards Lifesciences Swan-Ganz True-Size
Thermodilution Catheters. |
| Device
Description: | The VCVC-T are used to access the central vein, infuse
solutions, take blood samples, measure central venous
temperature, and monitor central venous pressures. |
| Indications for
Use: | The VCVC-T are indicated for use in patients requiring
administration of solutions, blood sampling, temperature
monitoring, and central venous pressure monitoring. |
| Comparative
Analysis: | The VCVC-T add a new intended use (temperature
monitoring) compared to the Vantex Central Venous
Catheters. It accomplishes this new use by a different
lumen configuration (3 infusion lumens, 1 thermistor
lumen, and 1 isolation lumen), the addition of a
thermistor, and a larger diameter than the Vantex Central
Venous Catheters. The VCVC-T also has a new material,
a potting material used to secure the thermistor at its distal
end. |
1
The VCVC-T have successfully undergone functional and Functional/Safety biocompatibility testing. Testing:
The VCVC-T are substantially equivalent to the predicate Conclusion: devices.
Tham Smith
10/3/03 Date
Jason Smith Senior Regulatory Affairs Specialist Edwards Lifesciences LLC
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread. The eagle is facing to the left.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 3 0 2003
Mr. Jason Smith Senior Regulatory Affairs Edwards Lifesciences LLC One Edward Way Irvine, California 92614
Re: K033250
Trade/Device Name: Edwards Lifesciences Vantex Central Venous Catheters with Thermistor Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: October 6, 2003 Received: October 7, 2003
Dear Mr. Smith:
We have reviewed your Scction 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 markcted 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 cither 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.
3
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); 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 (301) 594-4618. 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/dsma/dsmamain.html
Sincerely vours.
Viola Hibbard for
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
4
1033250 510(k) Number (if known):
Device Name: Edwards Lifesciences Vantex Central Venous Catheters with Thermistor
Indications For Use:
The Edwards Lifesciences Vantex Central Venous Catheters with Thermistor are indicated for use in patients requiring administration of solutions, blood sampling, tempcrature monitoring, and central venous pressure monitoring.
Astuce Cuscenite
Division of Anesthesiology, General Hospital, Infection Control, Dental Devic
510(k) Number ..
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
2 Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)