(140 days)
Not Found
No
The device description focuses on mechanical features and blood control mechanisms, with no mention of AI or ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
The device is used for diagnostic purposes (sampling blood, monitoring blood pressure) and for administering fluids, but it does not directly treat a disease or condition.
No
The device is designed for administering fluids, monitoring blood pressure, and sampling blood, which are interventional or measurement activities, not primarily diagnostic interpretation. While blood sampling provides data for diagnostic tests, the device itself is not performing the diagnosis.
No
The device description clearly outlines a physical intravascular catheter system with various hardware components (catheter, needle, hub, septum, safety mechanism, etc.). There is no mention of software as a component of this device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be inserted into a patient's vascular system for sampling blood, monitoring blood pressure, or administering fluids intravenously. These are direct interactions with the patient's body for therapeutic or monitoring purposes.
- Device Description: The description details a physical catheter system designed for insertion into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body in vitro (outside the body) to provide information for diagnostic purposes. IVDs typically involve reagents, analyzers, or test kits used on samples like blood, urine, or tissue.
The device is an intravascular catheter, which is a medical device used for accessing the vascular system in vivo.
N/A
Intended Use / Indications for Use
The AccuCath BC Intravascular Catheter System is inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. This device may be used with consideration given to adequacy of vascular anatomy, appropriateness of the solution being infused, and duration of therapy. The AccuCath BC is suitable for use with low pressure power injectors having a maximum pressure setting of 300 psi and maximum flow rate of 6mL/second.
Product codes
FOZ
Device Description
The AccuCath BC Intravascular Catheter System has a usable length catheter of 2.25 inches in 18, 20 and 22 Gauge sizes. The devices are single use, sterile intravascular catheters designed to be inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. This longer AccuCath BC catheter is identical to the AccuCath with the addition of needle echogenicity and a septum with plunger integrated into the catheter hub. The AccuCath BC catheter's hub has a built in blood control septum. The blood control feature is a single-use septum that automatically activates to stop the blood flow in the catheter hub when the needle is removed from the catheter during initial insertion by the clinician. Blood flow from the catheter hub will be restricted immediately after the needle retraction until a secure luer connection is made. The flow path is permanently opened once a secure luer connection has been made. Similar to the original AccuCath system, the device is 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 bier lock fitting, an echogenic 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's vascular 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)
Biocompatibility and functional bench testing performed by Vascular Pathways, Inc. demonstrate the substantial equivalence, in terms of the safety and effectiveness, of the AccuCath BC Intravascular Catheter System to the predicate devices cited. In vitro bench testing included an assessment of all design input requirements and confirmation that the output of the design process met all design input requirements as follows:
- ISO 10993-1:2009, Biological Evaluation of Medical Devices- Part I: Evaluation and Testing
- ISO 10555-1: 1995 - Sterile, Single Use intravascular Catheters - Part 1: General Requirements
- ISO 10555-5: 2012 - Sterile, Single Use Intravascular Catheters - Part 5: Over-Needle Peripheral Catheters
- ISO 594-1:1986 Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain Other Equipment - Part 1: General Requirements
- ISO 594-2:1998 Conical Fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock Fittings
- ASTM F640:2012 - Std Test Methods for Determining Radiopacity for Medical Use
- ISO 11607-1:2006 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials...
- ISO 11607-2:2006 - Packaging for terminally sterilized medical devices - Part 2: Validation requirements..
- ASTM D4169-09, Std Practice for Performance Testing of Shipping Containers and Systems.
- ASTM F2096-11, Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test).
- ASTM F88/F88M-09, Standard Test Method for Seal Strength of Flexible Barrier Materials.
- ASTM F1980-07 (2011) Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
- Guidance Document No. 934 - Medical Devices with sharps injury prevention features (August 9, 2005)
- AAMI TIR16:2000 - Process Development and Performance Qualification for Ethylene Oxide Sterilization - Microbiological aspects
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
8. 510(k) Summary
In accordance with 21 CFR 807.87(h), a 510(k) Summary (21 CFR 807.92) follows:
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: | February 22, 2014 |
|---|---|
| Name: | Vascular Pathways, Inc. |
| Address: | 1847 Trade Center Way |
| Naples, FL 34109 | |
| Phone: | 239-254-0391 |
Contact Person: Scott Pease, VP of RA and QA
1847 Trade Center Way Naples, Fl 34109 Cell - 678-689-8010 e-mail: spease@vascularpathways.com
Device Information:
| Device Trade Name: | AccuCath BC Intravascular Catheter System |
|---|---|
| Common Name: | Intravascular Catheter |
| Classification Name(s): | Intravascular Catheter. |
| Product Code/ Regulation: | FOZ / 21 CFR 880.5200 |
| Classification: | Class II |
Predicate Devices:
Becton Dickinson BD INSYTE AUTOGUARD BC device (K110443), Ethicon Endo-Surgery PROTECTIV* ACUVANCE IV Catheter System (K012128) Vascular Pathways, Inc., Rapid Intravascular Catheter Start System (K112347)
Device Description:
The AccuCath BC Intravascular Catheter System has a usable length catheter of 2.25 inches in 18, 20 and 22 Gauge sizes. The devices are single use, sterile intravascular catheters designed to be inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. This longer AccuCath BC catheter is identical to the AccuCath with the addition of needle echogenicity and a septum with plunger integrated into the catheter hub. The AccuCath BC catheter's hub has a built in blood control septum. The blood control feature is a single-use septum that automatically activates to stop the blood flow in the catheter hub when the needle is removed from the catheter during initial insertion by the clinician. Blood flow from the catheter hub will be restricted immediately after the needle retraction until a secure luer connection is made. The flow path is permanently opened once a secure luer connection has been made. Similar to the original AccuCath system, the device is 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 bier lock fitting, an echogenic 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.
1
Premarket Notification 510(k) Summary - Continued
Indications for Use:
The AccuCath BC Intravascular Catheter System is inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. This device may be used with consideration given to adequacy of vascular anatomy, appropriateness of the solution being infused, and duration of therapy. The AccuCath BC is suitable for use with low pressure power injectors having a maximum pressure setting of 300 psi and maximum flow rate of 6mL/second.
Comparison to Predicate Devices:
The AccuCath BC Intravascular Catheter System has the same intended use, mechanism of action, and basic design attributes as the BD INSYTE AUTOGUARD BC device (K110443), the Ethicon PROTECTIV* ACUVANCE IV Catheter System (K012128) and the Vascular Pathways, Inc., Rapid Intravascular Catheter Start System (K112347) (the predicate devices). It has the same indications for use as the BD INSYTE AUTOGUARD BC device – adding power injection to the previously cleared Rapid Intravascular Catheter Start System indication consistent with the Ethicon PROTECTIV* ACUV ANCE IV Catheter System (K012128). Performance data demonstrates substantially equivalence in terms of safety and effectiveness to the predicate devices.
Performance Testing:
Biocompatibility and functional bench testing performed by Vascular Pathways, Inc. demonstrate the substantial equivalence, in terms of the safety and effectiveness, of the AccuCath BC Intravascular Catheter System to the predicate devices cited. In vitro bench testing included an assessment of all design input requirements and confirmation that the output of the design process met all design input requirements as follows:
| 1. | ISO 10993-1:2009, Biological Evaluation of Medical Devices- Part I: Evaluation and Testing |
|---|---|
| 2. | ISO 10555-1: 1995 - Sterile, Single Use intravascular Catheters - Part 1: General Requirements |
| 3. | ISO 10555-5: 2012 - Sterile, Single Use Intravascular Catheters - Part 5: Over-Needle Peripheral Catheters |
| 4. | ISO 594-1:1986 Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain Other Equipment - Part 1: General Requirements |
| 5. | ISO 594-2:1998 Conical Fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock Fittings |
| 6. | ASTM F640:2012 - Std Test Methods for Determining Radiopacity for Medical Use |
| 7. | ISO 11607-1:2006 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials... |
| 8. | ISO 11607-2:2006 - Packaging for terminally sterilized medical devices - Part 2: Validation requirements.. |
| 9. | ASTM D4169-09, Std Practice for Performance Testing of Shipping Containers and Systems. |
| 10. | ASTM F2096-11, Standard Test Method for Detecting Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test). |
| 11. | ASTM F88/F88M-09, Standard Test Method for Seal Strength of Flexible Barrier Materials. |
| 12. | ASTM F1980-07 (2011) Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. |
| 13. | Guidance Document No. 934 - Medical Devices with sharps injury prevention features (August 9, 2005) |
| 14. | AAMI TIR16:2000 - Process Development and Performance Qualification for Ethylene Oxide Sterilization - |
| Microbiological aspects |
2
Summary:
Based upon the device description and test data provided in this submission the AccuCath BC Intravascular Catheter System is substantially equivalent to the predicate devices cited.
.
ﻴ
.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MID 20993-0002
July 17, 2014
Vascular Pathways, Inc. Mr. Scott Pease Vice President of Regulatory Affairs and Quality Assurance 1847 Trade Center Way Naples, FL 34109
Re: K140504
Trade/Device Name: AccuCath BC Intravascular Catheter System Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: June 10, 2014, 2014 Received: June 16, 2014, 2014
Dear Mr. Pease:
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 you, 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.
4
Page 2 - Mr. Pease
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); medical device 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 Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/Safety/ReportaProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
. ആപ്പ Sheth, M. Tojashri Purohit-Sheth, M.D.
Tolashri Sheth, M.D. Cluical Deputy Director Tejashri Purofitit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K140504
Device Name
AccuCath BC Intravascular Catheter System
Indications for Use (Describe)
The AccuCath BC Intravascular Catheter System is inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. This device may be used with consideration given to adequacy of vascular anatomy, appropriateness of the solution being infused, and duration of therapy. The AccuCath for use with low pressure power injectors having a maximum pressure setting of 300 psi and maximum flow rate of 6mL second.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Digitally signed by Richard C. Chapman -S Date: 2014.07.16 16:29:43 -04'00'
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