(38 days)
The Vascular Pathways RIVS system is indicated for use to sample blood, monitor blood pressure, or administer fluids intravenously. This device may be used with consideration given to patient size, appropriateness of the solution being infused, and duration of therapy.
The RIVS 18, 20 and 22 Gauge devices are single use, sterile intravascular catheters designed to provide access to veins. The devices are provided with a safety mechanism which allows the needle to be shielded following placement of the catheter.
All devices have the basic structure of a protective cover, a catheter with a luer lock fitting, a needle connected to a flashback chamber, a safety container, a guide wire within the lumen of the needle which is connected to a slider and a spring and release button.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the "Rapid Intravascular Catheter Start System," based on the user's requested format.
It's important to note that the provided text is a 510(k) summary, which generally focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical study data with detailed acceptance criteria and performance metrics typically found in a full clinical trial report or a PMA submission. Therefore, some of the requested information may not be explicitly present or might be inferable only to a limited extent.
Acceptance Criteria and Study Details for the Rapid Intravascular Catheter Start System
The provided 510(k) summary for the Rapid Intravascular Catheter Start System (RIVS) focuses on demonstrating substantial equivalence to a predicate device (K073241 - Vascular Pathways, Inc., Rapid Intravascular Catheter Start System) for modified and new gauge devices. As such, the "acceptance criteria" discussed are primarily related to ensuring the modified devices maintain the same performance and safety characteristics as the predicate, rather than establishing de novo clinical performance thresholds. The "study" refers to verification and validation testing to confirm these aspects.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance results in the format requested. Instead, it makes a general statement about meeting design specifications and user needs. The core acceptance criterion for this 510(k) modification is demonstrating substantial equivalence to the predicate device in terms of design, performance, safety, and intended use.
| Acceptance Criteria Category (Inferred from 510(k) context) | Reported Device Performance (Summary Statements) |
|---|---|
| Intended Use (Maintain existing indications) | "The modified RIVS, two new gauge devices and the predicate device have the same intended use..." |
| Operating Principles (Comparable mechanism) | "The products share common features such as identical operating principles, basic design..." |
| Basic Design (Similar structure) | "The products share common features such as identical operating principles, basic design..." |
| Performance Characteristics (Maintain functional equivalence) | "Verification and validation testing provided proof the modifications met the design specifications and user needs..." |
| Safety (No new safety concerns) | "...biocompatibility testing provided evidence there were no changes to that safety aspect of the device." "There are no new issues raised regarding safety or effectiveness of the modified or additional gauge devices." |
| Physical Characteristics (Maintain physical attributes) | "...and physical characteristics." |
| Anatomical Site for Venous Access (Same application) | "...anatomical site for venous access..." |
| Sterility & Single Use (Maintain existing characteristics) | "The devices are packaged sterile and are for single patient use." |
| Biocompatibility (No adverse changes) | "...biocompatibility testing provided evidence there were no changes to that safety aspect of the device." |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Verification and validation testing" was conducted. However, it does not specify the sample sizes used for these tests. The provenance of the data (e.g., country of origin, retrospective or prospective) is also not mentioned. Given the nature of a 510(k) for an intravascular catheter, these tests would typically be benchtop (in-vitro) and potentially simulated use tests, rather than human clinical trials.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This submission is for a medical device (intravascular catheter) and focuses on the physical and functional performance of the device itself, not on diagnostic accuracy requiring expert interpretation or "ground truth" establishment in the context of imaging or diagnostic AI. The "ground truth" here would be defined by engineering specifications and objective measurements from the verification and validation (V&V) testing.
4. Adjudication Method for the Test Set
Not applicable. As the "ground truth" is defined by engineering specifications and objective measurements, there's no need for expert adjudication in the typical sense (e.g., 2+1, 3+1 consensus). The V&V testing would involve comparing device performance against predetermined specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices (e.g., imaging AI) to assess how human reader performance is impacted by AI assistance. The RIVS is an intravascular catheter, a therapeutic/access device, and thus an MRMC study is not relevant to its regulatory submission.
6. Standalone (Algorithm Only) Performance
Not applicable. The RIVS is a physical medical device, not an algorithm or AI system. Therefore, the concept of "standalone algorithm only performance" does not apply. The performance evaluated relates to the physical and functional attributes of the catheter itself.
7. Type of Ground Truth Used
The "ground truth" for the verification and validation testing would be the established design specifications and user needs (as stated in the document). This would involve engineering standards, material specifications, functional requirements (e.g., flow rates, material strength, ease of insertion, needle shielding mechanism effectiveness), and biocompatibility standards.
8. Sample Size for the Training Set
Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI development. The device design and manufacturing processes are developed through engineering and R&D, not through training on data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. Since there is no training set, the establishment of its ground truth is irrelevant.
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Special 510(k): Device Modification Rapid Intravascular Catheter Start System
SECTION 13. 510(K) SUMMARY
SEP 2 2 2011
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number: _ ___
Applicant Information:
| Date Prepared: | July 15, 2011 |
|---|---|
| Name: | Vascular Pathways, Inc. |
| Address: | 1847 Trade Center WayNaples, FL 34109 |
| Phone: | (239) 254-0391 |
| Fax: | (239) 513-1533 |
| Contact Person: | Michael A Daniel / Steven J Hoffman |
| Phone Number: | (415) 407-0223 |
| Office: | (925) 254-5228 |
| Facsimile Number: | (925) 254-5187 |
Device Information:
| Classification: | Class II |
|---|---|
| Trade Name: | Rapid Intravascular Catheter Start System |
| Common Name: | Intravascular Catheter |
| Classification Name: | Intravascular Catheter |
| Product Code/ Regulation: | FOZ / 21CFR 880.5200 |
Predicate Device:
The RIVS 18, 20 and 22 gauge devices are substantially equivalent in intended use and method of operation to the following predicate device:
K073241 - Vascular Pathways, Inc., Rapid Intravascular Catheter Start System
Device Description:
The RIVS 18, 20 and 22 Gauge devices are single use, sterile intravascular catheters designed to provide access to veins. The devices are provided with a safety mechanism which allows the needle to be shielded following placement of the catheter.
All devices have the basic structure of a protective cover, a catheter with a luer lock fitting, a needle connected to a flashback chamber, a safety container, a guide wire within the lumen of the needle which is connected to a slider and a spring and release button.
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Indications for Use:
The Vascular Pathways RIVS system is indicated for use to sample blood, monitor blood pressure, or administer fluids intravenously. This device may be used with consideration given to patient size, appropriateness of the solution being infused, and duration of therapy.
Comparison to Predicate Device:
The design of the three RIVS devices is essentially the same device as the predicate RIVS with moderate design modifications to reduce cost of goods and improve manufacturability. The products share common features such as identical operating principles, basic design, performance characteristics, anatomical site for venous access, safety, and physical characteristics.
The devices are packaged sterile and are for single patient use. Further, the modified RIVS, two new gauge devices and the predicate device have the same intended use, which is to provide access to veins. Verification and validation testing provided proof the modifications met the design specifications and user needs and biocompatibility testing provided evidence there were no changes to that safety aspect of the device.
Summary:
Based upon the intended use, product technical information, performance testing and biocompatibility information provided in this pre-market notification, the modified RIVS 22 gauge and the additional 18 and 20 gauge devices have been shown to be substantially equivalent to the currently cleared predicate RIVS device in terms of design, performance and intended use. There are no new issues raised regarding safety or effectiveness of the modified or additional gauge devices.
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Image /page/2/Picture/1 description: The image shows a logo with a stylized design. The logo features three curved lines that resemble a bird in flight or a wave pattern. The lines are arranged in a stacked formation, with each line slightly offset from the one above it. The logo is surrounded by a circular border containing text, although the text is too small to read.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002
Vascular Pathways, Incorporated C/O Michael A. Daniel President Daniel & Daniel Consulting 8 Snowberry Court Orinda, California 94563
SEP 22 2011
Re: K112347
Trade/Device Name: Vascular Pathways RIVS Rapid Intravascular Catheter Start System Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: September 8, 2011 Received: September 14. 2011
Dear Mr. Daniel:
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 vou. 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.
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Page 2 - Ms. Daniel
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 fisting (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/Safetv/ReportalProblem/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 L. Anutson
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
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INDICATIONS FOR USE 8.3
510(k) Number (if known): K112347
Device Name: Yascular Pathways RIVS Rapid Intravascular Catheter Start System
Indications For Use:
The Vascular Pathways RIVS system is indicated for use to sample blood, monitor blood pressure, or administer fluids intravenously. This device may be used with consideration given to patient size, appropriateness of the solution being infused, and duration of therapy.
Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rld C. Chagn
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K112347
§ 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).