(100 days)
Not Found
No
The device description focuses on mechanical and physical safety features and does not mention any computational or data-driven components indicative of AI/ML.
No
The device is used to insert a catheter for diagnostic or fluid administration purposes, not directly for therapy.
No
The device is used for sampling blood, monitoring blood pressure, or administering fluids and blood, which are interventional or monitoring actions, not diagnostic processes.
No
The device description clearly outlines a physical medical device (IV catheter) with hardware components (radiopaque polyurethane, septum, safety needleshielding mechanism). There is no mention of software as the primary or sole 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 insertion into a patient's vascular system for purposes like sampling blood, monitoring blood pressure, and administering fluids and blood intravascularly. This involves direct interaction with the patient's body.
- Device Description: The description details a catheter designed for insertion into a blood vessel, with features related to safety during insertion and withdrawal. This is consistent with an in-vivo device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside of the body to provide information about a physiological state, health, or disease. IVDs are typically used in laboratories or point-of-care settings to analyze samples like blood, urine, or tissue.
Therefore, the Introcan Safety® 2 IV Catheter is an in-vivo medical device, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
Introcan Salety® 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 325 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 septum, and a passive safety needleshielding mechanism. Introcan Safety® 2 is designed to protect clinicians and patients from blood exposure. During needle withdrawal 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 needle-shielding 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 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 (for short term use)
Indicated Patient Age Range
Any patient population
Intended User / Care Setting
Clinicians, Prescription Use
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 to demonstrate that the device performs as intended. No clinical testing was performed. Testing successfully completed included:
- ISO 10555-1 Intravascular catheters Sterile and single-use intravascular catheters - Part 1: General requirements (Air tightness, High pressure (Burst Test), Flow rate through capillary, Projecting length capillary tip, Catheter hub air aspiration, Power injection)
- ISO 10555-5 Intravascular Catheters-Sterile and single-use catheters- Part 5: Over-needle peripheral catheters (Dynamic tensile load)
- Performance and functional testing to internal specifications (Siliconization, Flow rate through metal cannula, Liquid tightness, Force Testing, Blood flashback, Septum opener retention force, Blood exposure, Flushing, Cannula withdrawal angle test).
Results demonstrated 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)
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and name on the right. The FDA acronym and name are in blue, with the acronym in a larger font size than the name. The name is written as "U.S. FOOD & DRUG ADMINISTRATION".
June 23, 2022
B.Braun Medical Inc. Tracy Larish Sr. Regulatory Affairs Specialist 901 Marcon Blvd. Allentown, Pennsylvania 18109
Re: K220756
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: May 24, 2022 Received: May 25, 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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.
David Wolloscheck, Ph.D. For 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) K220756
Device Name Introcan Safety® 2 IV Catheter
Indications for Use (Describe)
Introcan Salety® 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 325 psi with a luer lock connection only.
| 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)
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Page 1 of 1
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510(k) SUMMARY: K220756
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, Regulatory Affairs Project Manager |
| Telephone Number: | (484) 375-9064 |
| Email: | tracy.larish@bbraunusa.com |
| Date Prepared: | June 22nd, 2022 |
DEVICE NAME:
Introcan Safety® 2 IV Catheter Device Trade Name: Common Name: Short-Term Less than 30 Days Therapeutic Intravascular Catheter Classification Name: Intravascular catheter, 21 CFR §880.5200: Class II, Product code FOZ
PREDICATE DEVICE:
- K213664 Introcan Safety® 2 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 septum, and a passive safety needleshielding mechanism. Introcan Safety® 2 is designed to protect clinicians and patients from blood exposure. During needle withdrawal 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 needle-shielding 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 The catheters may be used solution being infused and duration of therapy. intravascularly with power injectors for which the maximum pressure setting is 325 psi with a luer lock connection only.
INTENDED USE:
The Introcan Safety® 2 Intravascular Catheter is for short term use to sample blood, monitor blood pressure or administer fluids and blood intravascularly.
4
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 maybe used intravascularly with power injectors at a maximum pressure of 325 psi with a luer lock connection only.
TECHNOLOGICAL CHARACTERISTICS:
The Introcan Safety 2 IV Catheters have the same intended use, the same principle of operation, the identical safety clip and the same fundamental scientific technology as the predicate device.
The differences between the proposed Introcan Safety® 2 IV Catheter and predicate Introcan Safety® 2 IV Catheter are:
- Maximum pressure has been increased to 325psi ●
- . Design changes to the septum and septum opener to maintain blood control during multiple connections
| | Proposed Device
Introcan Safety® 2 IV Catheter | | Predicate Device(K213664)
Introcan Safety® 2 IV Catheter | Comparison |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Indications | The Introcan Safety® 2 IV Catheter is
for short term use to sample blood,
monitor blood pressure, or administer
fluids and blood intravascularly and
administer fluids subcutaneously. The
catheters may be used intravascularly
with power injectors at a maximum
pressure of 325 psi with a luer lock
connection only. | | The Introcan Safety® 2 IV Catheter
is for short term use to sample blood,
monitor blood pressure, or administer
fluids and blood intravascularly and
administer fluids subcutaneously. The
catheters may be used intravascularly
with power injectors at a maximum
pressure of 300 psi with a luer lock
connection only. | Difference: Proposed has
maximum pressure
injection of 325psi
confirmed through bench
testing. See Nonclinical
Testing. |
| Configuration | Single Lumen, Tapered Tip, septum with
multi blood control | | Single Lumen, Tapered Tip, septum
with one-time blood control | Difference: Proposed has
multi access blood control
capabilities confirmed
through bench testing.
See Nonclinical Testing. |
| Material
Composition | Polyurethane, Polypropylene, Stainless
steel, MABS, Polyisoprene,
Polyoximethylene | | Polyurethane, Polypropylene,
Stainless steel, MABS, Polyisoprene,
Polyoximethylene | Same |
| Catheter Sizes | 18ga-24ga from 9/16" (14mm) –2"
(50mm) | | 18ga-24ga from 9/16" (14mm) –2"
(50mm) | Same |
| Gravity Flow
Rate | 18ga x 32 mm | 105 mL/min | 18ga x 32 mm | 105 mL/min |
| | 18ga x 45 mm | 90 mL/min | 18ga x 45 mm | 100 mL/min |
| | 20ga x 25 mm | 65 mL/min | 20ga x 25 mm | 65 mL/min |
| | 20ga x 32 mm | 60 mL/min | 20ga x 32 mm | 60 mL/min |
| | 20ga X 50 mm | 55ml/min | 20ga X 50 mm | 55ml/min |
| | 22ga x 25 mm | 35 mL/min | 22ga x 25 mm | 35 mL/min |
| | 24ga x 14 mm | 26 mL/min | 24ga x 14 mm | 26 mL/min |
| | 24ga x 19 mm | 22 mL/min | 24ga x 19 mm | 22 mL/min |
| | (all flow rates are for both winged and
wingless versions) | | (all flow rates are for both winged
and wingless versions) | Difference: Flow rate for
proposed 18ga x45mm
changed and was
confirmed through bench
testing. See Nonclinical
Testing. |
These differences does not raise new issues of safety and effectiveness.
5
| | Proposed Device
Introcan Safety® 2 IV Catheter | Predicate Device(K213664)
Introcan Safety® 2 IV Catheter | Comparison | |
|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------|
| Sterilization | Ethylene Oxide | Ethylene Oxide | Same | |
| Shelf life | 1 year | 1 year | Same | |
| Bench Testing | Testing according to:
ISO 10555-1:2013 Air tightness High pressure(Burst Test) Flow rate through capillary Projecting length capillary tip Catheter hub air aspiration Power injection ISO 10555-5 Dynamic tensile load Internal Requirement:
Siliconization Flow rate through metal cannula Liquid tightness Force Testing Blood flashback Septum opener retention force Blood exposure Flushing Cannula withdrawal angle test | Testing according to ISO 10555-
1:2013, Section 4.10, Annex E.
Flowrate through capillary, ISO
10555-1:2013 Annex F Burst
Pressure and Test for septum opener
retention force | Difference:
Bench testing
demonstrated that the
differences do not raise
additional questions of
safety and effectiveness | |
| | Biocompatibility
classification | Externally communicating blood path
indirect prolonged contact | Externally communicating blood path
indirect prolonged contact | Same |
| | MRI labeling | MRI Conditional | MRI Conditional | Same |
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:
- ISO 10555-1 Intravascular catheters Sterile and single-use intravascular ● catheters - Part 1: General requirements
- Air tightness o
- High pressure(Burst Test) o
- O Flow rate through capillary
- Projecting length capillary tip O
- O Catheter hub air aspiration
- o Power injection
- ISO 10555-5 Intravascular Catheters-Sterile and single-use catheters- Part 5: . Over-needle peripheral catheters
- o Dynamic tensile load
6
- Performance and functional testing to internal specifications: .
- o Siliconization
- Flow rate through metal cannula O
- Liquid tightness O
- Force Testing O
- Blood flashback O
- Septum opener retention force O
- Blood exposure O
- o Flushing
- o Cannula withdrawal angle test
CONCLUSION:
Results of the testing conducted on the proposed devices demonstrate that the Introcan Safety® 2 IV Catheters are substantially equivalent to the predicate device.