(149 days)
Not Found
No
The device description and performance studies focus on mechanical and fluid dynamics, with no mention of AI/ML terms or functionalities.
No.
This device is an intravascular catheter used for accessing the vascular system to sample blood, monitor blood pressure, or administer fluids and blood. While it facilitates medical procedures, it does not inherently treat or cure a disease or condition itself. Its primary function is to provide access to the bloodstream, which is a diagnostic or administrative function rather than a therapeutic one.
No
The device is used to "sample blood, monitor blood pressure or administer fluids and blood intravascularly," which are functions related to treatment or monitoring but not diagnosis. While blood sampling can be part of a diagnostic process, the device itself simply collects the sample and does not perform the diagnostic analysis.
No
The device description clearly details physical components made of materials like polyurethane and includes mechanical safety features, indicating it is a hardware device, not software-only.
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 device is for "sampling blood, monitor blood pressure or administer fluids and blood intravascularly." These are all procedures performed on the patient's vascular system, not on samples outside the body for diagnostic purposes.
- Device Description: The description focuses on the physical components and mechanisms for inserting the catheter into a blood vessel and managing blood flow and safety during this process. It does not describe any components or functions related to analyzing biological samples for diagnostic information.
- No Mention of Diagnostic Testing: There is no mention of analyzing blood or other samples for diagnostic markers, conditions, or diseases.
- Performance Studies: The performance studies described focus on the physical and functional aspects of the catheter itself (tensile strength, flow rate, leakage, etc.), not on the accuracy or reliability of any diagnostic results obtained from samples collected with the device.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device is a tool for accessing the vascular system for various medical procedures, not for performing diagnostic tests on samples.
N/A
Intended Use / Indications for Use
Introcan Safety® 3 Closed Intravascular Catheter is inserted into a patient's vascular system for short term use to sample blood, monitor blood pressure or administer fluids and blood intravascularly.
Product codes
FOZ
Device Description
The Introcan Safety® 3 Closed IV Catheter consists of an over-the-needle, peripheral intravascular catheter made of radiopaque polyurethane, an integrated bidirectional septum, a stabilization platform, and a passive safety needle shielding mechanism.
Introcan Safety® 3 Closed IV Catheter design is described as a closed IV catheter since it protects clinicians and patients from blood exposure. Since the needle is withdrawn through a septum that seals after the needle has been removed, blood is thus contained within the Introcan Safety 3 device. The pressure exerted on the needle as it passes through the septum wipes blood from the needle further reducing potential blood exposure.
The Introcan Safety® 3 Closed IV Catheter has an integrated stabilization platform is designed to improve catheter stability while minimizing catheter movement within the vessel.
The passive safety needle-shielding mechanism of the Introcan Safety® 3 Closed IV Catheter is located inside the catheter hub. Upon withdrawal of the needle, the safety shield engages as the needle passes through the catheter hub and deploys automatically to shield the needle tip. The safety shield protects during disposal, aiding in the prevention of needlestick injuries. Once the safety shield engages and shields the needle tip, the user is unable to re-insert the needle, which aids in the prevention of catheter shearing.
The 16ga includes the incremental changes to the predicate since clearance that were implemented in accordance with 21 CFR 820.30. The changes included an alternative septum material, establishment of a 5 year shelf life, instructions for use update to include precise flow rates, and product enhancements.
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)
The Introcan Safety® 3 Closed IV Catheter 16ga x 1-1/4 in. (32mm) and 16ga x 2 in. (50mm) sizes were subjected to functional and performance testing to demonstrate that the devices perform as intended. The following testing was performed:
- Dynamic Tensile
- Air Tightness
- Flow Rate
- Projecting/Trim Length Capillary Tip
- Liquid Tightness
- Withdrawal Force
- Clip Drag Force
- Pull Strength
- Blood Flashback
- Clip Function
Results of the performance testing demonstrate that the proposed devices perform similarly to the predicate device. No clinical testing was performed, as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized representation of three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 28, 2017
B. Braun Melsungen Ag % Kimberly Smith Senior Regulatory Affairs Specialist B. Braun Medical Inc. 901 Marcon Blvd. Allentown, Pennsylvania 18109
Re: K163358
Trade/Device Name: Introcan Safety® 3 Closed IV Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: March 29, 2017 Received: March 30, 2017
Dear Kimberly Smith:
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.
1
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 and Part 809: 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 and Part 809, please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.
Tina
Kiang -S
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K163356
Device Name Introcan Safety® 3 Closed IV Catheter
Indications for Use (Describe)
Introcan Safety® 3 Closed Intravascular Catheter is inserted into a patient's vascular system for short term use to sample blood, monitor blood pressure or administer fluids and blood intravascularly.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
| 510(k) Summary | K163358 |
|---|---|
| SUBMITTER: | B. Braun Medical Inc. |
| 901 Marcon Boulevard | |
| Allentown, PA 18109-9341 | |
| 610-266-0500 | |
| Contact: Kimberly Smith, Sr. Regulatory Affairs Specialist | |
| DATE: | April 28, 2017 |
| DEVICE NAME: | Introcan Safety® 3 Closed IV Catheter |
| COMMON OR | |
| USUAL NAME: | Safety Intravascular Catheter |
| DEVICE | |
| CLASSIFICATION: | Class II per 21 CFR §880.5200 |
| Intravascular Catheter | |
| Product Code FOZ | |
| PREDICATE | |
| DEVICE: | Introcan Safety® 3 Closed IV Catheter |
| B. Braun Medical Inc., K111236 | |
| General Hospital, Class II, per 21 CFR §880.5200 | |
| Intravascular Catheter |
SUBJECT OF 510(K): Addition of 16G Catheter Size to Product PortfolioSUBJECT OF 510(K): Addition of 16G Catheter Size to Product Portfolio
DESCRIPTION:
The Introcan Safety® 3 Closed IV Catheter consists of an over-the-needle, peripheral intravascular catheter made of radiopaque polyurethane, an integrated bidirectional septum, a stabilization platform, and a passive safety needle shielding mechanism
Introcan Safety® 3 Closed IV Catheter design is described as a closed IV catheter since it protects clinicians and patients from blood exposure. Since the needle is withdrawn through a septum that seals after the needle has been removed, blood is thus contained within the Introcan Safety 3 device. The pressure exerted on the needle as it passes through the septum wipes blood from the needle further reducing potential blood exposure.
The Introcan Safety® 3 Closed IV Catheter has an integrated stabilization platform is designed to improve catheter stability while minimizing catheter movement within the vessel.
The passive safety needle-shielding mechanism of the Introcan Safety® 3 Closed IV Catheter is located inside the catheter hub. Upon withdrawal of the needle, the safety shield engages as the
4
needle passes through the catheter hub and deploys automatically to shield the needle tip. The safety shield protects during disposal, aiding in the prevention of needlestick injuries. Once the safety shield engages and shields the needle tip, the user is unable to re-insert the needle, which aids in the prevention of catheter shearing.
The 16ga includes the incremental changes to the predicate since clearance that were implemented in accordance with 21 CFR 820.30. The changes included an alternative septum material, establishment of a 5 year shelf life, instructions for use update to include precise flow rates, and product enhancements.
This device may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.
INTENDED USE:
The Introcan Safety® 3 Closed Intravascular Catheter is inserted into a patient's vascular system for short term use to sample blood, monitor blood pressure or administer fluids and blood intravascularly.
INDICATIONS FOR USE:
Introcan Safety® 3 Closed Intravascular Catheter is inserted into a patient's vascular system for short term use to sample blood, monitor blood pressure or administer fluids and blood intravascularly.
SUBSTANTIAL EQUIVALENCE:
Technological Characteristics
The Introcan Safety® 3 Closed IV Catheter 16ga x 1-1/4 in. (32mm) and 16ga x 2 in. (50mm) sizes has a slightly modified indications to remove the regulatory language (