(81 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML technologies.
No
The device is an IV catheter used for sampling blood, monitoring blood pressure, and administering fluids and blood, which are diagnostic and supportive functions, not directly therapeutic interventions.
No
The device is an IV catheter used for administering fluids, monitoring blood pressure, and sampling blood, not for diagnosing a condition.
No
The device description clearly outlines physical components like a catheter, needle, septum, and safety shield, indicating it is a hardware medical device.
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 the patient's vascular system for purposes like sampling blood, monitoring blood pressure, and administering fluids and blood. These are all direct interactions with the patient's body for therapeutic or monitoring purposes.
- Device Description: The description details a physical catheter and needle system designed for insertion into a blood vessel. It focuses on features related to insertion, safety mechanisms, and fluid delivery.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples outside of the body to diagnose a condition, which is the core function of an IVD. While it can be used to sample blood, the device itself doesn't perform any diagnostic testing on that sample.
IVD devices are typically used to examine specimens (like blood, urine, tissue) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening. This device is used in vivo (within the living body).
N/A
Intended Use / Indications for Use
The Introcan Safety® 2 IV Catheter is inserted into the patient's vascular system for short term use to sample blood, monitor blood pressure, administer fluids and blood intravascularly. The catheters maybe 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, 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 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 300 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
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 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:
- Flowrate through capillary per ISO 10555-1 Intravascular catheters Sterile and single-use intravascular catheters - Part 1: General requirements, Annex E
- Burst Pressure per ISO 10555-1:2013 Annex F
- Septum opener retention force to internal specifications
- Biocompatibility per ISO 10993-1
Results of the 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
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February 11, 2022
B. Braun Medical Inc. Tracy Larish Sr. Regulatory Affairs Specialist 901 Marcon Blvd. Allentown, Pennsylvania 18109
Re: K213664
Trade/Device Name: B. Braun Introcan Safety 2 IV Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: January 12, 2022 Received: January 13, 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 medical devices and radiation-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.
Gang Peng for 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) K213664
Device Name Introcan Safety® 2 IV Catheter
Indications for Use (Describe)
The Introcan Safety® 2 IV Catheter is inserted into the patient's vascular system for short term use to sample blood, monitor blood pressure, administer fluids and blood intravascularly. The catheters maybe 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) |
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3
K213664. 510(k) SUMMARY
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: | February 12th, 2022 |
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:
- K192676 Introcan Safety® 2 IV Catheter, B. Braun Medical, Inc. ●
- Product code FOZ o
- 0 21 CFR §880.5200 Catheter, intravascular, therapeutic, short-term less than 30 day
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, 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 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 300 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 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, the identical safety clip and the same fundamental scientific technology as the predicate device.
The difference between the proposed Introcan Safety® 2 IV Catheter and predicate Introcan Safety® 2 IV Catheter is the septum holder material. This difference does not raise new issues of safety and effectiveness.
| | Proposed Device
Introcan Safety® 2 IV Catheter | Predicate Device (K192676)
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 300 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. | Same |
| Configuration | Single Lumen, Tapered Tip, septum with
one-time blood control | Single Lumen, Tapered Tip, septum with
one-time blood control | Same |
| Material
Composition | Polyurethane, Polypropylene, Stainless
steel, MABS, Polyisoprene,
Polyoximethylene | Polyurethane, Polypropylene, Stainless
steel, MABS, Polyisoprene | Different:
Performance and
biocompatibility
evaluation
demonstrates that
the addition of
Polyoximethylene
does not raise
additional
questions of safety
and effectiveness. |
| 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 45 mm
100 mL/min
20ga x 25 mm
65 mL/min
20ga x 32 mm
60 mL/min
20ga X 50 mm
55ml/min
22ga x 25 mm
35 mL/min
24ga x 14 mm
26 mL/min
24ga x 19 mm
22 mL/min
(all flow rates are for both winged and
wingless versions) | 18ga x 32 mm
105 mL/min
18ga x 45 mm
100 mL/min
20ga x 25 mm
65 mL/min
20ga x 32 mm
60 mL/min
20ga X 50 mm
55ml/min
22ga x 25 mm
35 mL/min
24ga x 14 mm
26 mL/min
24ga x 19 mm
22 mL/min
(all flow rates are for both winged and
wingless versions) | Same |
| Sterilization | Ethylene Oxide | Ethylene Oxide | Same |
5
| | Proposed Device
Introcan Safety® 2 IV Catheter | Predicate Device (K192676)
Introcan Safety® 2 IV Catheter | Comparison |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Shelf life | 1 year | 1 year | Same |
| Bench Testing | 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 | Testing according to ISO 10555-1:2013,
Section 4.10, Annex E. Flowrate through
capillary and Test for septum opener
retention force | Different:
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:
- Flowrate through capillary per ISO 10555-1 Intravascular catheters Sterile and ● single-use intravascular catheters - Part 1: General requirements, Annex E
- Burst Pressure per ISO 10555-1:2013 Annex F ●
- Septum opener retention force to internal specifications .
- Biocompatibility per ISO 10993-1 ●
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.