(31 days)
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.
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 Since the needle is withdrawn through a septum that seals after the needle has been removed, blood is thus contained within the Introcan Safety® 3 device.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.
The document is a 510(k) summary for the Introcan Safety® 3 Closed IV Catheter, indicating that the device has been found substantially equivalent to a previously cleared predicate device (K182870). The primary difference for the new submission is an extension of the power injection capabilities to higher pressure rates for all gauge sizes.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly laid out in a table format with specific pass/fail thresholds for each test in the provided document. However, the document lists "Nonclinical Testing" that was performed and states that the "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."
Based on the information provided, we can infer the tested parameters and their implied "acceptance" through comparison to the predicate. The "Comparison" column in the Technological Characteristics table effectively serves as the reported device performance relative to the predicate, with the implied acceptance criteria being "Same" or that the difference does not raise additional safety and effectiveness questions.
| Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance (Proposed Device) |
|---|---|
| Indications for Use: Short term use to sample blood, monitor blood pressure, administer fluids/blood intravascularly. Power injectors at max pressure 300 psi for 18-24 gauge. | Indications for Use: Short term use to sample blood, monitor blood pressure, administer fluids/blood intravascularly. Power injectors at max pressure 325 psi for 14-24 gauge. |
| Configuration: Single Lumen, Tapered Tip | Single Lumen, Tapered Tip |
| Material Composition: (Catheter Tube, Hub, Needle, Safety Clip, Septum, Septum Opener, Septum Housing) | Identical to predicate (Polyurethane, Polypropylene, Stainless steel, MABS, Stainless steel, Silicone or Polyisoprene Rubber, Polyoximethylene, Polypropylene) |
| Catheter Gauge Sizes: 14ga-24ga | 14ga-24ga |
| Catheter Length: 3/4" (19mm) - 2" (50mm) | 3/4" (19mm) - 2" (50mm) |
| Gravity Flow Rate: (Specific values for each gauge x length) | Identical to predicate for all listed gauge x length combinations (e.g., 14ga x 32mm: 325 mL/min; 24ga x 19mm: 22 mL/min) |
| Sterilization: Ethylene Oxide | Ethylene Oxide |
| Shelf-Life: 5 year | 5 year |
| Power Injection (Performance at specified pressure/flow): Max 300 psi for 18-24g | Bench testing performed to demonstrate acceptable performance at 325 psi for 14-24ga, concluding that differences do not raise additional questions of safety and effectiveness. (Specifically, "Power Injection test for flowrate and device pressure per ISO 10555-1 Section 4.10 Annex G" and "Test for burst pressure under static conditions per ISO 10555-1 Section 4.10 Annex F" were conducted.) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of devices) used for each nonclinical test (Power Injection and Burst Pressure). It only states that "Bench testing performed on Introcan Safety® 3 Closed IV Catheters supports substantial equivalence of the proposed device."
- Sample Size: Not explicitly stated for each test.
- Data Provenance: The data is from "bench testing" performed by the manufacturer, B. Braun Medical Inc., located in Allentown, PA, USA. This is retrospective data collected for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not applicable as the study described is nonclinical bench testing of a physical medical device, not a diagnostic AI system requiring expert consensus for ground truth.
4. Adjudication Method for the Test Set
- This information is not applicable as it refers to clinical studies or studies using human interpretation, which is not the case here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
- No, an MRMC comparative effectiveness study was not done. The study was nonclinical bench testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This is not applicable as the device is a physical medical catheter, not an algorithm or AI system. The "standalone" performance here refers to the device's physical and mechanical properties. The bench tests conducted (Power Injection test, Burst Pressure test) represent the standalone performance of the device under simulated conditions.
7. Type of Ground Truth Used
The "ground truth" for the nonclinical tests is established by:
- Engineering specifications and recognized international standards: The tests were performed "per ISO 10555-1 Section 4.10 Annex G" (Power Injection) and "per ISO 10555-1 Section 4.10 Annex F" (Burst Pressure). These standards define the methodology and expected performance characteristics for intravascular catheters.
- Comparison to the predicate device: The new device's performance is gauged against the established and cleared performance of its predicate counterpart. The objective is to demonstrate that the proposed changes (higher pressure for power injection) do not compromise safety or effectiveness compared to the predicate, and meet the new specified performance.
8. Sample Size for the Training Set
- This is not applicable as there is no mention of a training set. This is a nonclinical bench test of a physical device, not an AI/ML algorithm that requires training.
9. How the Ground Truth for the Training Set Was Established
- This is not applicable as there is no training set.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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)
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 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 30day, 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 DeviceIntrocan Safety® 3 IV Catheter | Predicate Device(K182870)Introcan Safety® 3 IV Catheter | Comparison | ||
|---|---|---|---|---|
| Gravity FlowRate | 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 | |
| PowerInjection | 14ga-24ga may be used with powerinjectors at a maximum pressure of 325psi | 18-24g may be used with powerinjectors at a maximum pressure of300 psi | Bench testingperformedwhichdemonstratedthat thedifferences donot raiseadditionalquestions ofsafety andeffectiveness |
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.
§ 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).