(100 days)
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.
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.
This document is a 510(k) Pre-market Notification for the Introcan Safety® 2 IV Catheter. As such, it focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets novel acceptance criteria through a standalone study structured like a diagnostic AI performance evaluation. Therefore, many of the requested elements (like MRMC studies, number of experts, training set details) are not applicable or provided in the context of this regulatory submission for a physical medical device.
However, based on the provided text, I can extract information related to the device's performance and the non-clinical testing conducted to support its substantial equivalence.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally established based on international standards (e.g., ISO 10555-1, ISO 10555-5) and internal specifications. The reported performance is presented as the device successfully passing or meeting these criteria, particularly highlighting the changes from the predicate device.
| Performance Metric (Acceptance Criteria Implicit in Standards/Internal Specs) | Reported Device Performance (Proposed Introcan Safety® 2 IV Catheter) | Comparison/Notes |
|---|---|---|
| Maximum Pressure for Power Injection | 325 psi | Meets the new proposed maximum pressure. (Predicate was 300 psi). Confirmed through bench testing. |
| Blood Control Capabilities | Multi blood control (design changes to septum and septum opener) | Meets the enhanced multi-access blood control capabilities. (Predicate had one-time blood control). Confirmed through bench testing. |
| Gravity Flow Rate | ||
| 18ga x 32 mm | 105 mL/min | Same as Predicate (105 mL/min) |
| 18ga x 45 mm | 90 mL/min | Meets this flow rate. (Predicate was 100 mL/min). This specific flow rate for 18ga x 45mm changed and was confirmed through bench testing. |
| 20ga x 25 mm | 65 mL/min | Same as Predicate (65 mL/min) |
| 20ga x 32 mm | 60 mL/min | Same as Predicate (60 mL/min) |
| 20ga X 50 mm | 55 ml/min | Same as Predicate (55 ml/min) |
| 22ga x 25 mm | 35 mL/min | Same as Predicate (35 mL/min) |
| 24ga x 14 mm | 26 mL/min | Same as Predicate (26 mL/min) |
| 24ga x 19 mm | 22 mL/min | Same as Predicate (22 mL/min) |
| Air tightness (ISO 10555-1) | Testing successfully completed. | Meets standard as demonstrated by successful completion of testing. |
| High pressure (Burst Test) (ISO 10555-1) | Testing successfully completed. | Meets standard as demonstrated by successful completion of testing. |
| Flow rate through capillary (ISO 10555-1) | Testing successfully completed. | Meets standard as demonstrated by successful completion of testing. |
| Projecting length capillary tip (ISO 10555-1) | Testing successfully completed. | Meets standard as demonstrated by successful completion of testing. |
| Catheter hub air aspiration (ISO 10555-1) | Testing successfully completed. | Meets standard as demonstrated by successful completion of testing. |
| Power injection (ISO 10555-1) | Testing successfully completed. | Meets standard as demonstrated by successful completion of testing, confirming 325psi capability. |
| Dynamic tensile load (ISO 10555-5) | Testing successfully completed. | Meets standard as demonstrated by successful completion of testing. |
| Siliconization (Internal Requirement) | Testing successfully completed. | Meets internal specification. |
| Flow rate through metal cannula (Internal Requirement) | Testing successfully completed. | Meets internal specification. |
| Liquid tightness (Internal Requirement) | Testing successfully completed. | Meets internal specification. |
| Force Testing (Internal Requirement) | Testing successfully completed. | Meets internal specification. |
| Blood flashback (Internal Requirement) | Testing successfully completed. | Meets internal specification. |
| Septum opener retention force (Internal Requirement) | Testing successfully completed. | Meets internal specification. |
| Blood exposure (Internal Requirement) | Testing successfully completed. | Meets internal specification, demonstrating effective blood control. |
| Flushing (Internal Requirement) | Testing successfully completed. | Meets internal specification. |
| Cannula withdrawal angle test (Internal Requirement) | Testing successfully completed. | Meets internal specification. |
| Biocompatibility Classification | Externally communicating blood path, indirect prolonged contact (Same as predicate) | Same as predicate, implying continued compliance with biocompatibility requirements. |
| MRI labeling | MRI Conditional (Same as predicate) | Same as predicate, implying continued compliance with MRI safety requirements. |
| Sterilization | Ethylene Oxide (Same as predicate) | Same as predicate, implying continued compliance with sterilization requirements. |
| Shelf life | 1 year (Same as predicate) | Same as predicate, implying continued compliance with shelf-life requirements. |
2. Sample size used for the test set and the data provenance
The document describes non-clinical bench testing rather than clinical studies with human data. Therefore, the concept of "test set" in the context of diagnostic AI is not directly applicable.
- Sample Size: Not explicitly stated as a single number across all tests. The testing section lists various tests performed (e.g., ISO standards, internal specifications). For each test, an appropriate number of device samples would have been used to demonstrate compliance, but specific counts are not provided in this summary.
- Data Provenance: N/A, as this is bench testing of physical devices, not clinical data provenance (country of origin, retrospective/prospective). The tests were conducted internally by B. Braun Medical Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. This is a physical device, and the "ground truth" for its performance is established through adherence to engineering standards and protocols, not through expert human interpretation of clinical data as would be done for a diagnostic AI.
4. Adjudication method for the test set
N/A. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in expert interpretations of data, typically in diagnostic studies. This is not relevant for bench testing of a physical device.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
N/A. This is a physical medical device, not an AI diagnostic tool. No MRMC study was performed, nor would it be relevant for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is a physical medical device. It does not involve an algorithm, so "standalone performance" in the AI sense is not applicable.
7. The type of ground truth used
The "ground truth" for this device's performance is compliance with established international consensus standards (ISO 10555-1, ISO 10555-5) and internal engineering specifications and test protocols. These standards define measurable performance characteristics (e.g., flow rate, burst pressure, air tightness) that the device must meet.
8. The sample size for the training set
N/A. This device is not an AI algorithm and therefore does not have a "training set."
9. How the ground truth for the training set was established
N/A. Not applicable, as there is no training set for a physical medical device.
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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
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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
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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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510(k) SUMMARY: K220756
SUBMITTER INFORMATION:
| Name: | B. Braun Medical Inc. |
|---|---|
| Address: | 901 Marcon BoulevardAllentown, 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.
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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 DeviceIntrocan Safety® 2 IV Catheter | Predicate Device(K213664)Introcan Safety® 2 IV Catheter | Comparison | ||
|---|---|---|---|---|
| Indications | The Introcan Safety® 2 IV Catheter isfor short term use to sample blood,monitor blood pressure, or administerfluids and blood intravascularly andadminister fluids subcutaneously. Thecatheters may be used intravascularlywith power injectors at a maximumpressure of 325 psi with a luer lockconnection only. | The Introcan Safety® 2 IV Catheteris for short term use to sample blood,monitor blood pressure, or administerfluids and blood intravascularly andadminister fluids subcutaneously. Thecatheters may be used intravascularlywith power injectors at a maximumpressure of 300 psi with a luer lockconnection only. | Difference: Proposed hasmaximum pressureinjection of 325psiconfirmed through benchtesting. See NonclinicalTesting. | |
| Configuration | Single Lumen, Tapered Tip, septum withmulti blood control | Single Lumen, Tapered Tip, septumwith one-time blood control | Difference: Proposed hasmulti access blood controlcapabilities confirmedthrough bench testing.See Nonclinical Testing. | |
| MaterialComposition | Polyurethane, Polypropylene, Stainlesssteel, 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 FlowRate | 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 andwingless versions) | (all flow rates are for both wingedand wingless versions) | Difference: Flow rate forproposed 18ga x45mmchanged and wasconfirmed through benchtesting. See NonclinicalTesting. |
These differences does not raise new issues of safety and effectiveness.
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| Proposed DeviceIntrocan 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, ISO10555-1:2013 Annex F BurstPressure and Test for septum openerretention force | Difference:Bench testingdemonstrated that thedifferences do not raiseadditional questions ofsafety and effectiveness | |
| Biocompatibilityclassification | Externally communicating blood pathindirect prolonged contact | Externally communicating blood pathindirect 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
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- 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.
§ 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).