(31 days)
Not Found
No
The description focuses on mechanical and physical features for safety and blood containment, with no mention of AI or ML algorithms for analysis, prediction, or decision-making.
No.
The device is used for administering fluids, blood, or for blood sampling and monitoring, which are diagnostic and procedural functions, not therapeutic treatments themselves.
No
The device is described as an intravascular catheter used for administering fluids, blood, or for monitoring blood pressure and sampling blood. These are interventional and observational actions, not primarily diagnostic. While blood sampling can be for diagnostic purposes, the device itself is not performing the diagnosis.
No
The device description clearly details a physical medical device (catheter, needle, septum, etc.) and does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states 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, managing blood flow, and ensuring safety during insertion and removal. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Function: The device's function is to access the vascular system for various therapeutic and monitoring purposes. It does not perform any tests or analyses on blood or other biological samples to diagnose a condition.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
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. The catheters may be used with power injectors at a maximum pressure of 325 psi with luer lock connection only.
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 design is 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 catheter has an integrated stabilization is designed to improve catheter stability while minimizing catheter movement within the vessel. The device controls the flow of blood, aiding in the prevention of blood exposure.
The passive safety needle-shielding mechanism of the Introcan Safety® 3 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.
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. The catheters may be used with power injectors with a rate of injection based on gauge size and for which the maximum pressure setting is 325 psi with a luer lock connection only.
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
any patient population
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)
Bench testing performed on Introcan Safety® 3 Closed IV Catheters supports substantial equivalence of the proposed device. No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device. The following testing has been completed for the proposed devices:
- Power Injection test for flowrate and device pressure per ISO 10555-1 Section 4.10 Annex G
- Test for burst pressure under static conditions per ISO 10555-1 Section 4.10 Annex F
Results of the testing conducted on the proposed devices demonstrate that the Introcan Safety® 3 Closed IV Catheters are substantially equivalent to the predicate device and are as safe and effective as the predicate devices.
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
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October 25, 2021
B.Braun Medical Inc. Tracy Larish Sr. Regulatory Affairs Specialist 901 Marcon Blvd Allentown, Pennsylvania 18109
Re: K213085
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: September 17, 2021 Received: September 24, 2021
Dear Tracy Larish:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Payal Patel Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213085
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. The catheters may be used with power injectors at a maximum pressure of 325 psi with luer lock connection only.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY K213085
SUBMITTER INFORMATION:
| Name: | B. Braun Medical Inc. |
|---|---|
| Address: | 901 Marcon Boulevard |
| Allentown, PA 18109-9341 | |
| Telephone Number: | 610-266-0500, ext. 2966 |
| Contact Person: | Tracy Larish, Sr. Regulatory Affairs Specialist |
| Telephone Number: | (610) 596-2941 |
| Fax Number: | (610) 849-9286 |
| Email: | tracy.larish@bbraunusa.com |
| Date Prepared: | October 13, 2021 |
DEVICE NAME:
| Device Trade Name: | Introcan Safety® 3 Closed IV Catheter |
|---|---|
| Common Name: | Safety Intravascular Catheter |
| Classification Name: | Catheter, intravascular, therapeutic, short-term less than 30 |
| day, 21 CFR §880.5200: Class II, Product code FOZ |
PREDICATE DEVICES:
- K182870 Introcan Safety® 3 Closed IV Catheter, B. Braun Medical, Inc. .
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 design is 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 catheter has an integrated stabilization is designed to improve catheter stability while minimizing catheter movement within the vessel. The device controls the flow of blood, aiding in the prevention of blood exposure.
The passive safety needle-shielding mechanism of the Introcan Safety® 3 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.
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. The catheters may be used with power injectors with a rate of injection based on gauge size and for which the maximum pressure setting is 325 psi with a luer lock connection only.
4
INTENDED USE:
The Introcan Safety® 3 Closed Intravascular Catheter is 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. The catheters may be used with power injectors at a maximum pressure of 325 psi with luer lock connection only.
TECHNOLOGICAL CHARACTERISTICS:
The proposed Introcan Safety® 3 Closed IV Catheter is substantially equivalent to the predicate Introcan Safety® 3 Closed IV Catheters in terms of indications for use, intended use, general design, functional performance and materials of construction. The materials of the final sterilized device are identical to the currently marketed Introcan Safety® 3 Closed IV Catheter in formulation, processing, and sterilization, and no other chemicals have been added. The Introcan Safety® 3 device includes the identical septum and clip design as the predicate and does not raise any new issues of safety and effectiveness.
The difference between the proposed and predicate Introcan Safety® 3 Closed IV Catheter device is the power injection capabilities were tested to higher pressure injections rates to meet 325psi for all gauge sizes. Changes were also made to the Instructions for Use to update the power injection capabilities, align with the rest of the Introcan product family and utilize an E-IFU. These differences do not impact the statement of substantial equivalence.
| Proposed Device | Predicate Device(K182870) | Comparison | |
|---|---|---|---|
| Introcan Safety® 3 IV Catheter | Introcan Safety® 3 IV Catheter | ||
| Indications | Introcan Safety® 3 Closed Intravascular | Introcan Safety® 3 Closed Intravascular | Proposed |
| for Use: | Catheter is inserted into a patient's | Catheter is inserted into a patient's | Includes all |
| vascular system for short term use to | vascular system for short term use to | sizes to | |
| sample blood, monitor blood pressure or | sample blood, monitor blood pressure or | maximum | |
| administer fluids and blood | administer fluids and blood | pressure | |
| intravascularly. | intravascularly. | injection of | |
| The catheters may be used with power | The 18-24 gauge catheters may be used | 325psi. | |
| injectors at a maximum pressure of 325 | with power injectors at a maximum | ||
| psi with a luer lock connection only. | pressure of 300 psi with a luer lock | ||
| connection only. | |||
| Configuration | Single Lumen, Tapered Tip | Single Lumen, Tapered Tip | Same |
| Material | Catheter Tube: Polyurethane | Catheter Tube: Polyurethane | Same |
| Composition | Catheter Hub: Polypropylene | Catheter Hub: Polypropylene | |
| Needle: Stainless steel | Needle: Stainless steel | ||
| Needle Hub: MABS | Needle Hub: MABS | ||
| Safety Clip: Stainless steel | Safety Clip: Stainless steel | ||
| Septum: Silicone or Polyisoprene Rubber | Septum: Silicone or Polyisoprene Rubber | ||
| Septum Opener: Polyoximethylene | Septum Opener: Polyoximethylene | ||
| Septum Housing: Polypropylene | Septum Housing: Polypropylene | ||
| Catheter | 14ga-24ga | 14ga-24ga | Same |
| Gauge Sizes | |||
| Catheter | 3/4" (19mm) -2" (50mm) | 3/4" (19mm) -2" (50mm) | Same |
| Length |
5
| | Proposed Device
Introcan Safety® 3 IV Catheter | | Predicate Device(K182870)
Introcan Safety® 3 IV Catheter | Comparison |
|----------------------|-----------------------------------------------------------------------------------|------------|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Gravity Flow
Rate | 14ga x 32mm (11/4") | 325 mL/min | 14ga x 32mm (11/4")
325 mL/min | Same |
| | 14ga x 50mm (2") | 310 mL/min | 14ga x 50mm (2")
310 mL/min | |
| | 16ga x 32mm (11/4") | 195 mL/min | 16ga x 32mm (11/4")
195 mL/min | |
| | 16ga x 50mm (2") | 185 mL/min | 16ga x 50mm (2")
185 mL/min | |
| | 18ga x 32 mm (11/4") | 105 mL/min | 18ga x 32 mm (11/4")
105 mL/min | |
| | 18ga x 45 mm (13/4") | 100 mL/min | 18ga x 45 mm (13/4")
100 mL/min | |
| | 20ga x 25 mm (1") | 65 mL/min | 20ga x 25 mm (1")
65 mL/min | |
| | 20ga x 32 mm (11/4") | 60 mL/min | 20ga x 32 mm (11/4")
60 mL/min | |
| | 20ga x 50mm (2") | 55 mL/min | 20ga x 50mm (2")
55 mL/min | |
| | 22ga x 25 mm (1") | 35 mL/min | 22ga x 25 mm (1")
35 mL/min | |
| | 24ga x 19 mm (3/4") | 22 mL/min | 24ga x 19 mm (3/4")
22 mL/min | |
| Sterilization | Ethylene Oxide | | Ethylene Oxide | Same |
| Shelf-Life | 5 year | | 5 year | Same |
| Power
Injection | 14ga-24ga may be used with power
injectors at a maximum pressure of 325
psi | | 18-24g may be used with power
injectors at a maximum pressure of
300 psi | Bench testing
performed
which
demonstrated
that the
differences do
not raise
additional
questions of
safety and
effectiveness |
NONCLINICAL TESTING
Bench testing performed on Introcan Safety® 3 Closed IV Catheters supports substantial equivalence of the proposed device. No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device. The following testing has been completed for the proposed devices:
- . Power Injection test for flowrate and device pressure per ISO 10555-1 Section 4.10 Annex G
- . Test for burst pressure under static conditions per ISO 10555-1 Section 4.10 Annex F
CONCLUSION:
Results of the testing conducted on the proposed devices demonstrate that the Introcan Safety® 3 Closed IV Catheters are substantially equivalent to the predicate device and are as safe and effective as the predicate devices.