(71 days)
No
The device description focuses on a passive mechanical safety mechanism and does not mention any computational or data-driven components indicative of AI/ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No
The device is an IV catheter used for venous or arterial access, facilitating the placement of other vascular access devices, and infusing fluids, drugs, and blood components. While it delivers therapeutic substances, it is a tool for administration rather than a device with inherent therapeutic properties that directly treat disease. Its primary function from the description is as an access and delivery system, with a safety mechanism to prevent needlestick injuries, not a device that itself provides therapy.
No
This device is designed to provide venous or arterial access and facilitate the infusion of fluids, drugs, and/or blood components, or the placement of other vascular access devices. Its function is to deliver substances or enable other procedures, not to diagnose a condition or disease.
No
The device description clearly details a physical medical device (IV catheter) with a passive safety mechanism, not a software-only product.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for providing venous or arterial access for infusing fluids, drugs, blood components, or facilitating the placement of other vascular access devices. This is a direct medical intervention on the patient's body.
- Device Description: The description details a physical catheter and a needle-shielding mechanism used for accessing the vascular system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing. IVDs typically involve analyzing biological samples (blood, urine, tissue, etc.) outside of the body.
The device described is a medical device used for direct patient care, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Introcan Safety® IV Catheter is a passive anti-needle stick device to provide venous or arterial access for the infusion of fluids, drugs, and/or blood components, or to facilitate the placement of Vascular Access devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into the vascular system. The catheters may be used with power injectors at a maximum pressure of 325 psi with a luer lock connection only.
Product codes
FOZ
Device Description
The Introcan Safety® IV Catheter is a passive needle stick prevention device used for arterial and venous access for the infusion of fluids, drugs and/or blood components or to facilitate the placement of Vascular Access devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into the vascular system. The catheters may be used with power injectors for which the maximum pressure setting is 325 psi. The Introcan Safety IV Catheter is available in 14 - 24 gauge sizes, and both winged and non-winged versions and consists of an over-the-needle, peripheral intravascular catheter made of radiopaque polyurethane, and a passive safety needle-shielding mechanism.
The passive safety needle-shielding mechanism of the Introcan Safety® 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
venous or arterial access
Indicated Patient Age Range
any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.
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® 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 9 AnnexG
- Test for burst pressure under static conditions per ISO 10555-1 Section 4.10 Annex F
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 14, 2022
B.Braun Medical Inc. Tracy Larish Sr. Regulatory Affairs Specialist 901 Marcon Blvd. Allentown, Pennsylvania 18109
Re: K220626
Trade/Device Name: Introcan Safety IV Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular catheter Regulatory Class: Class II Product Code: FOZ Dated: April 13, 2022 Received: April 14, 2022
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,
Paval 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) K220626
Device Name Introcan Safety® IV Catheter
Indications for Use (Describe)
Introcan Salety® IV Catheter is a passive ani-needle stick device to provide venous or arterial access for the infusion of fluids, drugs, and/or blood components, or to facilitate the placement of Vascular Access devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into the vascular system. The catheters may be used with power injectors at a maximum pressure of 325 psi with a 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)
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3
510(k) SUMMARY - K220626
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: | (484) 375-9064 |
| Email: | tracy.larish@bbraunusa.com |
| Date Prepared: | March 2, 2022 |
DEVICE NAME:
| Device Trade Name: | Introcan Safety® IV Catheter |
|---|---|
| Common Name: | Catheter, Intravascular, Therapeutic, Short-Term Less |
| Than 30 Days | |
| Classification Name: | Intravascular Catheter, 21 CFR §880.5200: Class II, |
| Product code FOZ |
PREDICATE DEVICES:
- K020785 Introcan Safety® IV Catheter, B. Braun Medical, Inc. ●
DEVICE DESCRIPTION
The Introcan Safety® IV Catheter is a passive needle stick prevention device used for arterial and venous access for the infusion of fluids, drugs and/or blood components or to facilitate the placement of Vascular Access devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into the vascular system. The catheters may be used with power injectors for which the maximum pressure setting is 325 psi. The Introcan Safety IV Catheter is available in 14 - 24 gauge sizes, and both winged and non-winged versions and consists of an over-the-needle, peripheral intravascular catheter made of radiopaque polyurethane, and a passive safety needle-shielding mechanism.
The passive safety needle-shielding mechanism of the Introcan Safety® 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.
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 maximum pressure setting is 325 psi with a luer lock connection only.
4
INTENDED USE:
The Introcan Safety® IV Catheter is for short term use to sample blood, monitor blood pressure or administer fluids and blood intravascularly or to facilitate the placement of Vascular Access devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into the vascular system.
INDICATIONS FOR USE:
Introcan Safety® IV Catheter is a passive anti-needle stick device to provide venous or arterial access for the infusion of fluids, drugs, and/or blood components, or to facilitate the placement of Vascular Access devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into the vascular system. The catheters may be used with power injectors at a maximum pressure of 325 psi with a luer lock connection only.
TECHNOLOGICAL CHARACTERISTICS:
The proposed Introcan Safety® IV Catheter is substantially equivalent to the predicate Introcan Safety® 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® IV Catheter in formulation, processing, and sterilization, and no other chemicals have been added. The Introcan Safety device includes the identical design as the predicate and does not raise any new issues of safety and effectiveness.
The difference between the proposed and predicate Introcan Safety® IV Catheter device do not impact substantial equivalence and are listed below:
- Power injection capabilities were tested to higher pressure injections rates to meet . 325psi for all gauge sizes
- . Combined the indications for use of the same device to allow one 510k) to cover the full product offering.
- Instructions for Use revised to update the power injection capabilities, align with the . rest of the Introcan product family and utilize an e-IFU.
| | Proposed Device
Introcan Safety® IV Catheter | Reference Device(K021094)
Introcan Safety® IV Catheter | Predicate Device(K020785)
Introcan Safety® IV Catheter | Comparison |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Use: | Indications for Introcan Safety® IV Catheter is a passive anti-needle stick device to provide venous or arterial access for the infusion of fluids, drugs, and/or blood components, or to facilitate the placement of Vascular Access devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into the vascular system. The catheters may be used with power injectors at a maxirnum pressure of 325 psi with a luer lock connection only. | The Introcan Safety™ IV Catheter is a passive anti-needle stick device to provide venous or arterial access for the infusion of fluids, drugs, and/or blood components, or to facilitate the placement of Vascular Access devices such as guidewires, indwelling central venous catheters, peripherally inserted central catheters, and midline catheters into the vascular system. | Passive anti-needle stick devices for venous or arterial access for the infusion of fluids, drugs, and/or blood components. 14 - 22 gauge catheters may be used with power injectors for which the maximum pressure setting is 300 psi. | Difference:
All sizes to max pressure injection of 325psi. Combines indications for use and adds with a luer lock connection only to align the Introcan product family |
| | Proposed Device
Introcan Safety® IV Catheter | Reference Device(K021094)
Introcan Safety® IV Catheter | Predicate Device(K020785)
Introcan Safety® IV
Catheter | Comparison |
| | Configuration Single Lumen, Tapered Tip | Single Lumen, Tapered Tip | Single Lumen, Tapered Tip | Same |
| Material
Composition | Catheter Tube: Polyurethane/FEP
Catheter Hub: Polypropylene
[Needle: Stainless steel
[Needle Hub: MABS
Safety Clip: Stainless steel | Catheter Tube: Polyurethane or FEP
Catheter Hub: Polypropylene
[Needle: Stainless steel
[Needle Hub: MABS
Safety Clip: Stainless steel | Catheter Tube: Polyurethane
Catheter Hub: Polypropylene
[Needle: Stainless steel
[Needle Hub: MABS
Safety Clip: Stainless steel | Same |
| Catheter
Gauge Sizes | 14ga-24ga | 14ga-24ga | 14ga-24ga | Same |
| Catheter
length | 9/16" (14mm)-2 1/2" (64mm) | 9/16" (14mm)-2 1/2" (64mm) | 9/16" (14mm)-2 1/2" (64mm) | Same |
| Gravity Flow
Rate | 14ga x 32mm (1 1/4") 350 mL/min
14ga x 45mm (1 3/4") 345mL/min
14ga x 50mm (2") 345 mL/min
16ga x 32mm(1 1/4") 215 mL/min
16ga x 50mm (2") 210 mL/min
18ga x 32 mm (1 1/4") 105 mL/min
18ga x 45 mm (1 3/4") 100 mL/min
18ga x 50 mm (2") 95 mL/min
18ga x 64 mm (2½") 85 mL/min
20ga x 25 mm (1") 65 mL/min
20ga x 32 mm (1 1/4") 60 mL/min
20ga x 45mm (1 3/4") 57 mL/min
20ga x 50 mm (2") 55 mL/min
20ga x 64 mm (2½") 51 mL/min
22ga x 25 mm (1") 35 mL/min
22ga x 45mm (1 3/4") 26 mL/min
22ga x 64mm (2½") 24 mL/min
24ga x 14mm (9/16") 26 mL/min
24ga x 19 mm(3/4") 22 mL/min
24ga x 32 mm (1 1/4") 17 mL/min | 14ga x 32mm (1 1/4") 350 mL/min
14ga x 45mm (1 3/4") 345mL/min
14ga x 50mm (2") 345 mL/min
16ga x 32mm (1 1/4") 215 mL/min
16ga x 50mm (2") 210 mL/min
18ga x 32 mm (1 1/4") 105 mL/min
18ga x 45 mm (1 3/4") 100 mL/min
18ga x 50 mm (2") 95 mL/min
18ga x 64 mm (2½") 85 mL/min
20ga x 25 mm (1") 65 mL/min
20ga x 32 mm (1 1/4") 60 mL/min
20ga x 45mm (1 3/4") 57 mL/min
20ga x 50 mm (2") 55 mL/min
20ga x 64 mm (2½") 51 mL/min
22ga x 25 mm (1") 35 mL/min
22ga x 45mm (1 3/4") 26 mL/min
22ga x 64mm (2½") 24 mL/min
24ga x 14mm (9/16") 26 mL/min
24ga x 19 mm(3/4") 22 mL/min
24ga x 32 mm (1 1/4") 17 mL/min
Flow rate as indicated on labeling.
Flow rate was not included in
original submission | 14ga x 32mm (1 1/4") 350 mL/min | Same |
| | | | 14ga x 45mm (1 3/4") 345mL/min | |
| | | | 14ga x 50mm (2") 345 mL/min | |
| | | | 16ga x 32mm (1 1/4") 215 mL/min | |
| | | | 16ga x 50mm (2") 210 mL/min | |
| | | | 18ga x 32 mm (1 1/4") 105 mL/min | |
| | | | 18ga x 45 mm (1 3/4") 100 mL/min | |
| | | | 18ga x 50 mm (2") 95 mL/min | |
| | | | 18ga x 64 mm (2½") 85 mL/min | |
| | | | 20ga x 25 mm (1") 65 mL/min | |
| | | | 20ga x 32 mm (1 1/4") 60 mL/min | |
| | | | 20ga x 45mm (1 3/4") 57 mL/min | |
| | | | 20ga x 50 mm (2") 55 mL/min | |
| | | | 20ga x 64 mm (2½") 51 mL/min | |
| | | | 22ga x 25 mm (1") 35 mL/min | |
| | | | 22ga x 45mm (1 3/4") 26 mL/min | |
| | | | 22ga x 64mm (2½") 24 mL/min | |
| | | | 24ga x 14mm (9/16") 26 mL/min | |
| | | | 24ga x 19 mm(3/4") 22 mL/min | |
| | | | 24ga x 32 mm (1 1/4") 17 mL/min | |
| | | | Flow rate as indicated on
labeling. Flow rate was not
included in original
submission | |
| Sterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Same |
| Shelf-Life
Power
Injection | 5 year
14ga-24ga may be used with
power injectors at a maximum
pressure of 325 psi | 5 year
None claimed | 5 year
14-22g may be used with
power injectors at a maximum
pressure of 300 psi | Same
Bench testing
performed
which
demonstrated
that the
differences do
not raise
additional
questions of
safety and
effectiveness |
5
NONCLINICAL TESTING
Bench testing performed on Introcan Safety® 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 9 AnnexG
- Test for burst pressure under static conditions per ISO 10555-1 Section 4.10 Annex F .
6
CONCLUSION:
Results of the testing conducted on the proposed devices demonstrate that the Introcan Safety® IV Catheters are substantially equivalent to the predicate device and are as safe and effective as the predicate device.