(111 days)
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No
The summary describes a standard PICC catheter and its accessories, with no mention of AI or ML technology in the intended use, device description, or other sections.
No
A therapeutic device is used to treat or cure a disease or condition. This device, a PICC catheter, is used to facilitate intravenous therapy and injection of contrast media, which are forms of treatment, but the device itself is a delivery mechanism and not the therapy.
No
Explanation: The device, FlowPICC Catheter, is described as a medical device for providing peripheral access to the central venous system for intravenous therapy, injection of contrast media, blood sampling, infusions, or therapies. Its function is to facilitate the delivery or withdrawal of substances, which are therapeutic or preparatory for diagnostic imaging (contrast media injection), rather than to diagnose medical conditions itself.
No
The device description clearly describes a physical catheter made of polyurethane and packaged with accessories for implantation, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the FlowPICC Catheter is for "peripheral access to the central venous system for intravenous therapy and injection of contrast media," "blood sampling, infusions, or therapies," and "power injection." These are all procedures performed on the patient's body, not on samples taken from the patient's body for diagnostic purposes.
- Device Description: The description details a catheter designed for insertion into the vascular system. This is consistent with an in-vivo device, not an in-vitro diagnostic device which would typically involve reagents, analyzers, or test kits for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
In-vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The FlowPICC Catheter is a medical device used for delivering substances into or withdrawing substances from the body, which is an in-vivo application.
N/A
Intended Use / Indications for Use
The FlowPICC catheter is indicated for short or long-term access to the central venous system for intravenous therapy, power injection of contrast media and blood sampling.
The FlowPICC Catheter is 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 5F or larger catheter. The maximum recommended infusion rate is 5cc/sec.
The FlowPICC Catheter is indicated for use by itself or with the FlowPICC System (Stylet and Console) sold separately.
Product codes
LJS
Device Description
The FlowPICC Catheter is a double lumen open-ended PICC designed for power injection through one designated lumen. The FlowPICC Catheter is fabricated from a soft, radiopaque, biocompatible polyurethane material with a working length of 50 cm with markings in 5 cm increments. The catheter is packaged with accessories necessary for implantation of a PICC catheter using a Seldinger or modified Seldinger technique. A stylet and adaptor sidenort are provided to assist in catheter insertion.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central venous system, peripheral access to the central venous system
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In vitro and in vivo testing demonstrates that the VasoNova FlowPICC Catheter meets all acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Bard PowerPICC Catheter, Cook Turbo-Ject Catheter
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
1082481
5. 510(k) Summary
Sponsor:
VasoNova Inc. 1368 Bordeaux Drive Sunnyvale, CA 94089
Tina Cheng
510.589.6084 650 644.2456
August 27, 2008
DEC 1 7 2008
Contact Person: Phone Number: Fax Number: Prepared:
Trade Name: Common Name: Classification: Product Code: Advisory Panel:
VasoNova FlowPICC Catheter, name subject to change Percutaneous, implanted, long-term intravascular catheter II LJS 21 CFR 880.5970 General and Plastic Surgery
Predicate Device:
Bard PowerPICC Catheter Cook Turbo-Ject Catheter
Device Description
The FlowPICC Catheter is a double lumen open-ended PICC designed for power injection through one designated lumen. The FlowPICC Catheter is fabricated from a soft, radiopaque, biocompatible polyurethane material with a working length of 50 cm with markings in 5 cm increments. The catheter is packaged with accessories necessary for implantation of a PICC catheter using a Seldinger or modified Seldinger technique. A stylet and adaptor sidenort are provided to assist in catheter insertion.
Intended Use
The FlowPICC catheter is indicated for short or long-term access to the central venous system for intravenous therapy, power injection of contrast media and blood sampling.
Performance Data
In vitro and in vivo testing demonstrates that the VasoNova FlowPICC Catheter meets all acceptance criteria.
Substantial Equivalence
The VasoNova FlowPICC catheter has the same intended use, technological characteristics and principles of operation as its predicate devices. Performance data demonstrate that the VasoNova FlowPICC is as safe and effective as the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal features the department's name in a circular arrangement around the perimeter. In the center is a stylized symbol, possibly representing a human figure or abstract design, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 7 2008
Ms. Tina Cheng Director, Product Development Vasonova, Incorporated 1368 Bordeaux Drive, Suite 100 Sunnyvale, California 94089
Re: K082481
Trade/Device Name: VasoNova FlowPICC Catheter Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: December 5, 2008 Received: December 8, 2008
Dear Ms. Cheng:
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 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.
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Page 2 - Ms. Cheng
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 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 regardingpostmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Clive
Shih, S., Liu, Ph.D.
Chiu S. Lin. Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Indications for Use
K082481 510(k) Number (if known):
Device Name:
VasoNova FlowPICC Catheter
Indications for use:
The FlowPICC Catheter is 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 5F or larger catheter. The maximum recommended infusion rate is 5cc/sec.
The FlowPICC Catheter is indicated for use by itself or with the FlowPICC System (Stylet and Console) sold separately.
signature
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K082481