(188 days)
Not Found
No
The summary describes a mechanical IV catheter with passive safety features and does not mention any AI or ML components or capabilities.
No.
The device description indicates its purpose is for "sampling blood, monitoring blood pressure, or administering fluids and blood intravascularly," rather than directly treating a condition or disease.
No
The device is an IV catheter used for administering fluids, blood, and sampling blood, not for diagnosing a condition.
No
The device description clearly outlines physical components like a catheter, septum, and safety needle-shielding mechanism, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for insertion into a patient's vascular system for purposes like sampling blood, monitoring blood pressure, or administering fluids and blood intravascularly. This is a direct interaction with the patient's body for therapeutic or monitoring purposes.
- Device Description: The description details a catheter designed for insertion into a blood vessel, with features related to blood flow control during insertion and a safety mechanism for the needle. This aligns with a device used for accessing the vascular system.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to monitor therapeutic measures.
This device is used in vivo (within the living body) to access the vascular system, not in vitro (outside the living body) to examine specimens. While it can be used to sample blood, the primary function is accessing the vascular system for various purposes, not the diagnostic examination of the blood sample itself.
N/A
Intended Use / Indications for Use
The Introcan Safety® 2 IV 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 intravascularly with power injectors at a maximum pressure of 300 psi with a luer lock connection only.
Product codes
FOZ
Device Description
The Introcan Safety® 2 IV Catheter consists of an over-the-needle, peripheral catheter made of radiopaque polyurethane, an integrated one directional septum that controls the flow of blood during and after cannulation, and a passive safety needle-shielding mechanism. Introcan Safety® 2 is designed to reduce blood exposure at insertion until first connection of an infusion line or luer device to protect clinicians and patients from blood exposure. During needle withdrawal, the needle is withdrawn through a septum that seals after the needle has been removed, blood is thus contained within the Introcan Safety® 2 device. The pressure exerted on the needle as it passes through the septum wipes blood from the needle further reducing potential blood exposure. The passive safety needleshielding mechanism of the Introcan Safety® 2 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 intravascularly with power injectors for which the maximum pressure setting is 300 psi with a luer lock connection only. The devices will be available in 18, 20, 22, and 24-gauge versions with and without a stabilization platform.
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 was performed on Introcan Safety® 2 IV Catheters. No clinical testing was performed as these devices do not require clinical studies to demonstrate substantial equivalence with the predicate device. The following testing has been successfully completed for the proposed devices:
- Biocompatibility in accordance with ISO 10993-1 (leveraged from K182870)
- Sterilization Residual testing in accordance with ISO 10993-7
- Sterilization Validation in accordance with ISO 11135
- Testing in accordance with ISO 10555-1, ISO 10555-5, ISO 80369-7, ISO 80369-20, and ISO 9626
- MRI Testing in accordance with ASTM F2052-15, ASTM F2213-17, ASTM F2182-11A, and ASTM F2119-07.
- Performance and functional testing to internal specifications that include:
- Safety Clip function
- Liquid Tightness for blood control
- During cannula Withdrawal
- After Cannula Withdrawal
- Flashback
- Force Testing
- Shelf life Testing
Results of the functional and performance testing conducted on the proposed devices demonstrate that the Introcan Safety® 2 IV Catheters are substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 1, 2020
B. Braun Medical Inc. Tracy Larish Sr. Regulatory Affairs Specialist 901 Marcon Blvd. Allentown, Pennsylvania 18109
Re: K192676
Trade/Device Name: Introcan Safety® 2 IV Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: February 28, 2020 Received: March 2, 2020
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,
for Tina Kiang, Ph.D. 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) K192676
Device Name Introcan Safety® 2 IV Catheter
Indications for Use (Describe)
The Introcan Safety® 2 IV 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 intravascularly with power injectors at a maximum pressure of 300 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) |
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 - K192676
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: | March 30, 2020 |
DEVICE NAME:
| Device Trade Name: | Introcan Safety® 2 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 DEVICE:
- K182870 Introcan Safety® 3 Closed IV Catheter, B. Braun Medical, Inc. ●
DEVICE DESCRIPTION
The Introcan Safety® 2 IV Catheter consists of an over-the-needle, peripheral catheter made of radiopaque polyurethane, an integrated one directional septum that controls the flow of blood during and after cannulation, and a passive safety needle-shielding mechanism. Introcan Safety® 2 is designed to reduce blood exposure at insertion until first connection of an infusion line or luer device to protect clinicians and patients from blood exposure. During needle withdrawal, the needle is withdrawn through a septum that seals after the needle has been removed, blood is thus contained within the Introcan Safety® 2 device. The pressure exerted on the needle as it passes through the septum wipes blood from the needle further reducing potential blood exposure. The passive safety needleshielding mechanism of the Introcan Safety® 2 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 intravascularly with power injectors for which the maximum pressure setting is 300 psi with a luer lock connection only. The devices will be available in 18, 20, 22, and 24-gauge versions with and without a stabilization platform.
INDICATIONS FOR USE:
The Introcan Safety® 2 IV Catheter is inserted into a patient's vascular system for short term use to sample blood, monitor blood pressure, or administer fluids and blood
4
intravascularly. The catheters may be used intravascularly with power injectors at a maximum pressure of 300 psi with a luer lock connection only.
TECHNOLOGICAL CHARACTERISTICS:
The Introcan Safety 2 IV Catheters have the same indications for use, the same intended use, the same principle of operation and the same fundamental scientific technology as the predicate device. They are comprised of the same materials of composition and contain the identical safety clip design as the predicate device
The differences between the proposed Introcan Safety® 2 IV Catheter and predicate Introcan Safety® 3 Closed IV Catheter devices are listed below. These differences do not raise new issues of safety and effectiveness.
- The size offerings are 18-24ga with lengths from 14mm-50mm. Performance of the ● 14mm Introcan Safety® 2 IV Catheters was confirmed through verification testing to meet the performance requirements of the predicate and proposed device and does not raise concerns of safety and effectiveness when compared to the predicate device.
- The septum provides closed catheter capabilities until the first connection, one-time ● blood control. The blood control septum of the predicate Introcan Safety® 3 Closed IV Catheter maintains closed catheter capabilities, before and after cannulization and through multiple connections of an infusion device or luer access device. The blood control septum was successfully verified to maintain closed catheter capabilities until first connection using the same verification testing as applied to the predicate device and does not raise new issues of safety and effectiveness when compared to the predicate device.
- A slimmer hub profile which is available with and without securement wings. ● Performance of the proposed device was confirmed through verification testing to meet the requirements of the predicate and proposed device and does not raise concerns of safety and effectiveness when compared to the predicate device
| | Proposed Device | Predicate Introcan Safety® 3
Closed IV Catheter(K182870) | Comments |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Indications | The Introcan Safety® 2 IV 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 intravascularly with power
injectors at a maximum pressure of
300 psi with a luer lock connection
only. | 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
18-24 gauge catheters may be used
with power injectors at a maximum
pressure of 300 psi with a luer lock
connection only. | Same |
| Configuration | Single Lumen, Tapered Tip, with
one-time blood control septum | Single Lumen, Tapered Tip, with
repeat blood control septum | Similar, blood control at
insertion providing for
closed catheter capabilities
until the first connection.
See discussion above. |
| Material Composition | Polyurethane, Polypropylene,
Stainless steel, MABS, Polyisoprene | Polyurethane, Polypropylene,
Stainless steel, MABS | Similar, Polyoximethylene
and silicone not required |
5
| | Proposed Device
Introcan Safety® 2 IV Catheter | Predicate Introcan Safety® 3
Closed IV Catheter(K182870) | Comments |
|--------------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Catheter Sizes | 18ga-24ga from 9/16 " (14mm) –2"
(50mm) | Polyisoprene, Polyoximethylene,
silicone
14ga-24ga from 3/4" (19mm) -2"
(50mm) | for the slimmer hub profile
see discussion above.
Similar, see discussion
above. |
| Safety Clip Conforms
to ISO 23908 | Yes | Yes | Same |
| Gravity Flow Rate | 18ga x 32 mm 105 mL/min | 14ga x 32 mm 325 ml/min | Same per size |
| | 18ga x 45 mm 100 mL/min | 14ga x 50 mm 310 ml/min | |
| | 20ga x 25 mm 65 mL/min | 16ga x 32 mm 195 mL/min | |
| | 20ga x 32 mm 60 mL/min | 16ga x 50 mm 185 mL/min | |
| | 20ga X 50 mm 55ml/min | 18ga x 32 mm 105 mL/min | |
| | 22ga x 25 mm 35 mL/min | 18ga x 45 mm 100 mL/min | |
| | 24ga x 14 mm 26 mL/min | 20ga x 25 mm 65 mL/min | |
| | 24ga x 19 mm 22 mL/min
(all flow rates are for both winged
and wingless versions) | 20ga x 32 mm 60 mL/min
20ga X 50 mm 55ml/min
22ga x 25 mm 35 mL/min
24ga x 19 mm 22 mL/min | |
| Sterilization | Ethylene Oxide | Ethylene Oxide | Same |
| Biocompatibility
classification | Externally communicating blood path
indirect prolonged contact | Externally communicating blood
path indirect prolonged contact | Same |
| Shelf Life | 1 year | 5 year | Testing on subject device
supports 1 year shelf life |
| MRI Testing | Yes | No | Testing performed in
accordance to standards |
| MRI Test results | MRI Conditional | Labeling does not contain MRI
Safety Information | MRI Testing performed on
subject device |
NONCLINICAL TESTING
Bench testing performed on Introcan Safety® 2 IV Catheters demonstrates that the device performs as intended. No clinical testing was performed as these devices does not require clinical studies to demonstrate substantial equivalence with the predicate device. The following testing has been successfully completed for the proposed devices:
- Biocompatibility in accordance with ISO 10993-1 (leveraged from K182870)
- Sterilization Residual testing in accordance with ISO 10993-7
- Sterilization Validation in accordance with ISO 11135 ●
- Testing in accordance with ISO 10555-1, ISO 10555-5, ISO 80369-7, ISO 80369-. 20, and ISO 9626
- MRI Testing in accordance with ASTM F2052-15, ASTM F2213-17, ASTM F2182-11A, and ASTM F2119-07.
- Performance and functional testing to internal specifications that include:
- o Safety Clip function
- o Liquid Tightness for blood control
- During cannula Withdrawal .
- . After Cannula Withdrawal
- o Flashback
- o Force Testing
- o Shelf life Testing
6
CONCLUSION:
Results of the functional and performance testing conducted on the proposed devices demonstrate that the Introcan Safety® 2 IV Catheters are substantially equivalent to the predicate device.