(111 days)
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.
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.
The provided text describes a medical device, the VasoNova FlowPICC Catheter, and its 510(k) submission. However, it does not contain detailed information about acceptance criteria for device performance or a specific study proving it meets those criteria in a quantitative manner.
The "Performance Data" section merely states: "In vitro and in vivo testing demonstrates that the VasoNova FlowPICC Catheter meets all acceptance criteria." It does not provide the acceptance criteria themselves, nor does it present the results of those tests.
Therefore, I cannot fulfill your request for the specific table, sample sizes, expert qualifications, or details about standalone or MRMC studies as these are not present in the provided document.
To answer your request, here's what can be extracted from the text, and where gaps exist:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | "In vitro and in vivo testing demonstrates that the VasoNova FlowPICC Catheter meets all acceptance criteria." (Specific results not provided.) |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified.
- Data provenance: "In vitro and in vivo testing." No country of origin or whether the data was retrospective or prospective is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified. The document indicates performance data was generated through "in vitro and in vivo testing," but no mention of expert-established ground truth for a test set is made in the context of human evaluation.
4. Adjudication method for the test set
- Not applicable as no human-reviewed test set is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
- No, an MRMC comparative effectiveness study is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a catheter, not an algorithm.
7. The type of ground truth used
- The document refers to "in vitro and in vivo testing." For a physical medical device like a catheter, "ground truth" would likely refer to established engineering standards, physiological measurements, or clinical outcomes from the in vivo studies. Specifics are not provided.
8. The sample size for the training set
- Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
Summary of available information:
The document is a 510(k) summary and an FDA clearance letter for a medical device (a catheter). It states that performance data exists from "in vitro and in vivo testing" and that this data meets "all acceptance criteria." However, it does not disclose the specifics of these criteria, the test results, sample sizes for studies, or any details related to human evaluation, ground truth establishment by experts, or AI-related performance metrics. The focus is on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and principles of operation.
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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
§ 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.”