(121 days)
VasoNova VPS Catheter, Bard PerQCath
Not Found
No
The summary describes a catheter and stylet system that uses Doppler and ivECG signals for physiological information transmission to a console, but there is no mention of AI or ML being used to process or interpret this data.
No
The device is a catheter used for vascular access for intravenous therapy and contrast media injection, not for treating a disease or condition itself.
No
The device description indicates that the VPS Stylet, when connected to the VPS Console, detects and transmits physiological information (Doppler sensor and ivECG signal). However, the "Intended Use / Indications for Use" section focuses on the catheter's role in providing peripheral access for intravenous therapy, injection of contrast media, and blood sampling. The document does not describe the use of the physiological information for diagnosing a condition or disease.
No
The device description clearly details physical components like catheters and stylets made of polyurethane and polymeric tubes, containing sensors and wires. It also mentions accessories for percutaneous placement. This indicates a hardware-based medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "short or long-term peripheral access to the central venous system for intravenous therapy and injection of contrast media. For blood sampling, infusions, or therapies." This describes a device used in vivo (within the body) for delivering substances and accessing the circulatory system.
- Device Description: The description details a catheter and stylet designed for insertion into the central venous system. It mentions a Doppler sensor and ivECG signal sensing wire to detect and transmit physiological information from within the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnostic purposes. This device does not perform any analysis of bodily specimens outside the body.
The device is a medical device used for accessing the central venous system, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VPS Catheters are indicated for short or long-term peripheral access to the central venous system for intravenous therapy and injection of contrast media. For blood sampling, infusions, or therapies, use a 4F or larger catheter. The maximum recommended injection rate is 2cc/sec for the 3F catheter and 5cc/sec for the 4F and 5F catheters. The VPS Catheter is indicated for use by itself or with the VPS System (Stylet and Console) sold separately.
Product codes
LJS
Device Description
The VPS Catheter and VPS Stylet are designed for use together and with the VPS Console. The VPS Catheter is preloaded with the Stylet and supplied in a tray. The VPS Catheter/Stylet is sterile, single use, non-pyrogenic and non-toxic.
The VPS Catheters are single lumen (3 and 4 Fr) or dual lumen (5 Fr) central venous access catheters made from soft, radiopaque medical grade polyurethane and packaged with the VPS Stylet in a tray with the accessories necessary for a percutaneous microintroducer placement (Modified Seldinger or Seldinger technique). The VPS Catheters feature a reverse-taper open ended design with a working length of 50 or 55 cm. VPS Catheters are marked at 1 cm intervals and labeled every 5 cm for the entire length.
The VPS Stylet is a 6 foot long polymeric tube which contains a Doppler sensor at the distal tip and an intravascular electrocardiogram (ivECG) signal sensing wire. The Doppler sensor and the ivECG signal sensing wire, when connected to the VPS Stylet are used to detect and transmit physiological information to the VPS Console (available separately). The VPS Stylet has an outer diameter of 0.019 inches and is designed to be used with the compatible VPS Catheter with an inner lumen of 0.021 inches.
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)
In vitro testing demonstrates that the subject device meets all acceptance criteria. Completed testing included:
- Static, burst and dynamic pressure.
- Physical characteristics
- Flexural fatigue and flexibility.
- Flow rate
- Flexural fatigue, flexibility, collapsibility and elongation.
- Tensile and torque strength.
- Freedom from air leakage.
- Priming volume.
- Mechanical hemolysis
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
VasoNova VPS Catheter, Bard PerQCath
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”
0
ร์. 510(k) Summary K083920, page 1 of 2
| MAY - 1 200 | |
|---|---|
| Sponsor: | VasoNova Inc. |
| 1368 Bordeaux Drive | |
| Sunnyvale, CA 94089 | |
| Contact Person: | Kim Tompkins |
| Phone Number: | 408.738.7006 |
| Fax Number: | 650.644.2456 |
| Prepared: | March 27, 2009 |
| Trade Name: | VPSTM Catheter, sizes 3F and 4F name subject to change |
| Common Name: | Central venous catheter |
| Classification Name: | Percutaneous, implanted, long-term intravascular catheter |
| Classification: | II |
| Product Code: | LJS 21 CFR 880.5970 |
| Advisory Panel: | General Hospital |
| Predicate Device: | VasoNova VPS Catheter |
| Bard PerQCath |
Device Description
The VPS Catheter and VPS Stylet are designed for use together and with the VPS Console. The VPS Catheter is preloaded with the Stylet and supplied in a tray. The VPS Catheter/Stylet is sterile, single use, non-pyrogenic and non-toxic.
The VPS Catheters are single lumen (3 and 4 Fr) or dual lumen (5 Fr) central venous access catheters made from soft, radiopaque medical grade polyurethane and packaged with the VPS Stylet in a tray with the accessories necessary for a percutaneous microintroducer placement (Modified Seldinger or Seldinger technique). The VPS Catheters feature a reverse-taper open ended design with a working length of 50 or 55 cm. VPS Catheters are marked at 1 cm intervals and labeled every 5 cm for the entire length.
The VPS Stylet is a 6 foot long polymeric tube which contains a Doppler sensor at the distal tip and an intravascular electrocardiogram (ivECG) signal sensing wire. The Doppler sensor and the ivECG signal sensing wire, when connected to the VPS Stylet are used to detect and transmit physiological information to the VPS Console (available separately). The VPS Stylet has an outer diameter of 0.019 inches and is designed to be used with the compatible VPS Catheter with an inner lumen of 0.021 inches.
Intended Use
VPS catheters are indicated for short or long-term central or peripheral access to the central venous system for intravenous therapy, power injection of contrast media, central venous monitoring and blood sampling.
1
Performance Data
In vitro testing demonstrates that the subject device meets all acceptance criteria. Competed testing included:
- Static, burst and dynamic pressure .
- � Physical characteristics
- Flexural fatigue and flexibility .
- . Flow rate
·
- Flexural fatigue, flexibility, collapsibility and elongation .
- Tensile and torque strength .
- Freedom from air leakage .
- Priming volume .
- . Mechanical hemolysis
Substantial Equivalence
VasoNova VPS Catheters have the same intended use, technological characteristics and principles of operation as its predicate devices. The subject and predicate catheters are similar in that they are fabricated from polyurethane, are 50-55cm in length, have markings every 1-5 cm, have one or two lumens, may have labeled power injectability, and similar flow rates and maximum pressures. Performance data demonstrate that the subject device is as safe and effective as the predicate devices.
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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 the department's name arranged in a circular fashion around a symbol. The symbol consists of three stylized human figures intertwined, representing the department's focus on health and well-being. The logo is presented in black and white.
Public Health Service
MAY - 1 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kim Tompkins, RN, MBA VP, Regulatory/Quality/Clinical VasoNova Incorporated 1368 Bordeaux Drive, Suite 100 Sunnyvale, California 94089
Re: K083920
Trade/Device Name: VasoNova VSP Catheter Regulation Number: 21 CFR 880.5970 Regulation Name: Percutancous, Implanted, Long-term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: April 27, 2009 Received: April 29, 2009
Dear Ms. Tompkins:
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 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.
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
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Page 2- Ms. Tompkins
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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biomctrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
Susan Turner
Susan Runner, D.D.S., MA Acting 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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4. 510(k) Indications for Use
K083920 510(k) Number (if known):
Device Name:
VasoNova VPS Catheter
Indications for use:
VPS Catheters are indicated for short or long-term peripheral access to the central venous system for intravenous therapy and injection of contrast media. For blood sampling, infusions, or therapies, use a 4F or larger catheter. The maximum recommended injection rate is 2cc/sec for the 3F catheter and 5cc/sec for the 4F and 5F catheters. The VPS Catheter is indicated for use by itself or with the VPS System (Stylet and Console) sold separately.
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)
s al for
on Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K083920
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