(226 days)
Not Found
No
The 510(k) summary describes a physical medical device (catheter) and its performance characteristics, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is a catheter used for vascular access, blood sampling, and contrast media injection, but it does not treat or cure a disease or condition; it facilitates diagnostic or supportive care.
No
The device is a midline catheter used for access to the peripheral venous system for therapies, blood sampling, and contrast media injection. Its purpose is to provide vascular access, not to diagnose a condition. While it can be used for blood sampling, the device itself doesn't perform diagnostic analysis of the blood.
No
The device description clearly states it is a physical catheter made from polyurethane materials, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media." This describes a device used in vivo (within the body) for accessing the circulatory system and delivering or withdrawing substances.
- Device Description: The description details a "peripherally placed catheter" made from materials suitable for insertion into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs typically involve reagents, test strips, analyzers, or other components used to perform tests on samples like blood, urine, or tissue.
Therefore, the Provena™ Midline Catheter is a medical device used for vascular access, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Provena™ Midline Catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The Provena™ Midline Catheters are suitable for use with power injectors.
Product codes
PND
Device Description
Provena™ Midline Catheters are a family of peripherally placed catheters made from radiopaque body-softening polyurethane materials. Each Provena™ Midline Catheter is designed with kink-resistant, reverse taper design. Catheters are packaged in a tray with accessories for reliable short term (less than 30 days) vascular access. The Provena™ Midline Catheters are suitable for use with power-injectors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral venous 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)
The performance tests completed on the subject devices were limited to those tests required to support a determination of substantial equivalence to the predicate devices. In addition, when technological characteristics between the subject and predicate devices were found to be identical, results of the performance testing conducted on the predicate devices were applied to the subject devices.
Performance Tests:
- Priming Volume
- Particulate Matter Testing
- Assembly Burst (Burst Pressure with Power Injection)
- Catheter Assembly Leak
- Catheter Assembly Tensile
- Gravity Flow
- Device Dimensional Characterization
- Power Injection Testing
- Biocompatibility evaluation (Per ISO 10993-1:2009)
- Risk management, including a failure modes and effects analysis (FMEA) (in accordance with BS EN ISO 14971:2012)
Key Results: As required by the risk analysis, the subject devices met all predetermined acceptance criteria derived from the above listed tests and demonstrated substantial equivalence as compared to the cited predicate devices.
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).
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May 13, 2022
C. R. Bard, Inc. Jeremy Kuyakana Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, Utah 84116
Re: K213203
Trade/Device Name: Provena Midline Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: PND Dated: April 13, 2022 Received: April 14, 2022
Dear Jeremy Kuyakana:
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.
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
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Indications for Use
510(k) Number (if known) K213203
Device Name Provena™ Midline Catheter
Indications for Use (Describe)
The Provena™ Midline Catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The Provena™ Midline Catheters are suitable for use with power injectors.
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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K213203 - 510(k) Summary
21 CFR 807.92(a)
| General
Provisions | Submitter Name:
Submitter Address:
Contact Person:
Telephone Number:
Fax Number:
Date of Preparation: | Bard Access Systems, Inc.
605 North 5600 West
Salt Lake City, UT 84116
Jeremy Kuyakana
Sr. Regulatory Affairs Specialist
(801) 800-6474
(801) 565-2390
April 13, 2022 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject
Device | Trade Name:
Common Name:
Classification Name:
Product Code:
Regulation:
Requlatory Class:
Classification Panel: | Provena™ Midline Catheter (SL, DL)
Intravascular Catheter
Intravascular Catheter
PND
21 CFR § 880.5200
Class II
General Hospital |
| Predicate
Device | Predicate Trade Name:
Common Name:
Classification Name:
Premarket Notification:
Manufacturer:
Product Code:
Regulation:
Regulatory Class:
Classification Panel: | PowerMidline™ Catheter (SL, DL)
Intravascular Catheter
Intravascular Catheter
K162900 (Cleared 12/14/2016)
Bard Access Systems, Inc.
PND
21 CFR § 880.5200
Class II
General Hospital |
| Device
Description | Provena™ Midline Catheters are a family of peripherally placed catheters made from
radiopaque body-softening polyurethane materials. Each Provena™ Midline Catheter is
designed with kink-resistant, reverse taper design. Catheters are packaged in a tray with
accessories for reliable short term (less than 30 days) vascular access. The Provena™
Midline Catheters are suitable for use with power-injectors. | |
| Intended Use | The Provena™ Midline Catheters are intended for short term peripheral access for
selected intravenous therapies, blood sampling, and power injection of contrast media. | |
| Indications for
Use | The Provena™ Midline Catheters are indicated for short term access to the
peripheral venous system for selected intravenous therapies, blood sampling,
and power injection of contrast media. These catheters may be used for any
patient population with consideration given to adequacy of vascular anatomy and
appropriateness of the procedure. The Provena™ Midline Catheters are suitable for use
with power injectors. | |
4
The technological characteristics of the subject Provena™ Midline Catheters are substantially equivalent with respect to basic design, materials and function to those of the cited predicate device. The differences are not critical and do not raise any new or different questions of safety and effectiveness.
Key modifications made to the subject device when compared to the predicate device are as follows:
-
- Labelling
- Modification made to the product name to introduce the Provena™ Midline . Catheters. The new name is reflected in the indications for use as well as throughout the device labeling.
-
- Materials
- Depending on subject catheter models:
- Modifications made to the base materials, colorants, and inks .
3. Technology
- Depending on subject catheter models:
- . Dimensional modifications
-
- Performance
- Modification to the power injection flow rate. .
Technological Characteristics
The following table provides a comparison between the technological characteristics of the subject and predicate devices.
| Subject and Predicate Devices Comparison Table | |||
|---|---|---|---|
| Attribute | Subject Devices: | ||
| ProvenaTM Midline Catheters | Predicate Devices: | ||
| Dual Lumen PowerMidlineTM | |||
| Catheters | |||
| Owner | Same as predicate | Bard Access Systems, Inc. | |
| Classification | Same as predicate | PND - 21 CFR 880.5200 - Short-term - | |
| Intravascular Catheter | |||
| 510(k) Status | Subject of this Premarket | ||
| Notification | K162900 – Dual Lumen | ||
| PowerMidlineTM Catheters (Clearance | |||
| date December 14, 2016) | |||
| Commercial | |||
| Name | ProvenaTM Midline Catheter | PowerMidlineTM Catheter | |
| Indications for | |||
| Use | Same as predicate | The PowerMidline™ Catheters are | |
| indicated for short term access to the | |||
| peripheral venous system for selected | |||
| intravenous therapies, blood sampling, | |||
| and power injection of contrast media. | |||
| These catheters may be used for any | |||
| patient population with consideration | |||
| given to adequacy of vascular | |||
| anatomy and appropriateness of the | |||
| procedure. The PowerMidline™ | |||
| Catheters are suitable for use with | |||
| power injectors. | |||
| Duration of Use | Same as predicate | Short term ( |