(284 days)
Not Found
No
The description focuses on the mechanical function of a valve and material properties, with no mention of AI or ML.
No.
The device is described as providing "peripheral access to the central venous system for intravenous therapy or blood sampling," which indicates a functional role in delivering or obtaining substances, rather than directly treating a condition or disease.
No
This device is a peripherally inserted central catheter (PICC) used for providing intravenous therapy and blood sampling, not for diagnosing medical conditions.
No
The device description clearly describes a physical catheter made from medical grade materials with a mechanical valve, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for providing peripheral access to the central venous system for intravenous therapy or blood sampling. This is a direct medical intervention on a patient, not a test performed on a sample taken from a patient.
- Device Description: The description details a catheter and its valve mechanism for fluid infusion and blood aspiration within the body. This is consistent with a medical device used for treatment or diagnosis in vivo.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) to provide information about a patient's health status. The device facilitates the collection of blood, but it doesn't analyze it.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used to access the vascular system for therapeutic or sampling purposes, which falls under the category of a medical device, but not specifically an IVD.
N/A
Intended Use / Indications for Use
The Groshong® NXT PICC provides short (less than 30 days) or long (greater than 30 days) term peripheral access to the central venous system for intravenous therapy or blood sampling.
Product codes
LJS
Device Description
Groshong™ NXT Peripherally Inserted Central Catheters are made from specially formulated and processed medical grade materials in a tray with accessories for reliable long- (greater than 30 days) or short- (less than 30 days) term vascular access.
Groshong™ Valve Function
The Groshong™ catheter incorporates the patented, 3-position, pressure-sensitive Groshong™ valve. The valve is located near the rounded, closed, radiopaque catheter tip and allows fluid infusion and blood aspiration. When not in use, the valve restricts blood backflow and air embolism by remaining closed.
The Groshong™ valve is designed to remain closed between -7- and 80-mm Hg. Since the normal central venous pressure range in the superior vena cava is 0 to 5 mm Hg, the valve remains closed at normal central venous pressure. Pressure in the superior vena cava must exceed 80 mm Hg to open the valve inward. Also, negative pressure (vacuum) will cause the valve to open inward, allowing blood aspiration.
Positive pressure into the catheter (gravity, pump, syringe) will open the valve outward, allowing fluid infusion. The need for the anticoagulant effect of heparin is eliminated because the closed valve prevents blood from entering the catheter and clotting. If the catheter is aspirated, pulling the valve inward, it must be flushed with normal saline to clear blood from the lumen and allow the valve to return to its normal, closed position.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central venous system
Indicated Patient Age Range
General 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)
Verification and validation tests were performed in accordance with Design Controls per 21 CFR 820.30. The performance tests completed on the subject device were limited to those tests required to support a determination of substantial equivalence to the predicate device. In addition, where technological characteristics between the subject and predicate device were found to be identical, results of performance testing conducted on the predicate device were adopted and applied to the subject device. The following performance tests were conducted per guidance documents, industry standards, and in-house protocols to establish the performance of the device, thereby leading to a conclusion of substantial equivalence of the subject Groshong™ NXT PICC Catheter to the predicate device, the Groshong™ NXT PICC Catheter.
Performance:
ISO 10555-1:2013/Amd 1:2017 Intravascular Catheters - Sterile and Single-Use Intravascular Catheters - Part 1: General Requirements
ISO 10555-3:2013- Intravascular catheters - Sterile and single-use catheters - Part 3: Central venous catheters
ASMT F640-12 Standard Test Methods for Determining Radiopacity for Medical Use
ASTM F2119-07 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
ASTM F2182 Standard Test Method for Measurement of Radio Frequency Induced Heating on or Near Passive Implants During Magnetic Resonance Imaging
ASTM F2052-15 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
ASTM F2213-17 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
Biocompatibility Evaluations:
ISO 10993-1:2018 – Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process
USP Particulate Matters in Injections (method 1 Light Obscuration Particle Count Test)
Sterilization:
ANSI AAMI ISO 11135:2014C Sterilization of Health Care Products - Ethylene Oxide - Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices.
Key Results:
Based on the risk management activities and testing, the subject Groshong™ NXT PICC Catheter has demonstrated to be substantially equivalent to the cited 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
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The logo is simple and professional, and it is easily recognizable.
March 12, 2021
C.R. Bard, Inc. Matthew Lyman Manager, Regulatory Affairs 605 North 5600 West Salt Lake City, Utah 84116
Re: K201452
Trade/Device Name: Groshong NXT PICC Catheter Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, implanted, long-term intravascular catheter Regulatory Class: Class II Product Code: LJS Dated: February 8, 2021 Received: February 12, 2021
Dear Matthew Lyman:
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,
for Payal Patel Acting 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) K201452
Device Name Groshong® NXT PICC Catheter
Indications for Use (Describe)
The Groshong® NXT PICC provides short (less than 30 days) or long (greater than 30 days) term peripheral access to the central venous system for intravenous therapy or blood sampling.
| 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
Bard Access Systems, Inc. 605 North 5600 West
Salt Lake City, UT 84116 USA Phone: +1-801-522-5000 Fax: +1-801-522-4948
has joined BD
510(k) Summary- K201452
| General
Provisions | Submitter Name: | Bard Access Systems, Inc.
(wholly owned subsidiary of BD) | |
|-----------------------|-------------------------|-------------------------------------------------------------------------|--|
| | Submitter Address: | 605 North 5600 West
Salt Lake City, UT 84116 | |
| | Contact Person: | Matthew Lyman
Sr. Manager, Regulatory Affairs | |
| | Telephone Number: | 801.522.5416 | |
| | Fax Number: | 801.522.4907 | |
| | Date of Preparation: | 3/12/2021 | |
| | Trade Name: | Groshong™ NXT PICC Catheter | |
| | Common Name: | Catheter, Intravascular, Therapeutic, Long-Term
Greater than 30 Days | |
| Subject
Device | Classification Name: | Percutaneous, Implanted, Long-Term
Intravascular Catheter | |
| | Device Class: | II | |
| | Regulation Number: | 21 CFR 880.5970 | |
| | Product Code: | LJS | |
| | Review Panel | General Hospital | |
| | Trade Name: | Groshong™ NXT PICC Catheter | |
| | Manufacturer: | Bard Access Systems, Inc.
(wholly owned subsidiary of BD) | |
| | Premarket Notification: | K034020 | |
| | Common Name: | Catheter, Intravascular, Therapeutic, Long-Term
Greater than 30 Days | |
| Predicate
Device | Classification Name: | Percutaneous, Implanted, Long-Term
Intravascular Catheter | |
| | Device Class: | II | |
| | Regulation Number: | 21 CFR 880.5970 | |
| | Product Code: | LJS | |
| | Review Panel | General Hospital | |
4
Image /page/4/Picture/1 description: The image shows the logos of two companies, BD and BARD. The BD logo is on the left and consists of an orange sun-like symbol and the letters "BD" in blue. The BARD logo is on the right and consists of the word "BARD" in green, with the words "has joined BD" in smaller font below it. The image suggests that BARD has been acquired by or merged with BD.
| Device Description | Groshong™ NXT Peripherally Inserted Central Catheters are made from
specially formulated and processed medical grade materials in a tray with
accessories for reliable long- (greater than 30 days) or short- (less than 30
days) term vascular access.
Groshong™ Valve Function
The Groshong™ catheter incorporates the patented, 3-position, pressure-
sensitive Groshong™ valve. The valve is located near the rounded, closed,
radiopaque catheter tip and allows fluid infusion and blood aspiration. When
not in use, the valve restricts blood backflow and air embolism by remaining
closed.
The Groshong™ valve is designed to remain closed between -7- and 80-mm
Hg. Since the normal central venous pressure range in the superior vena
cava is 0 to 5 mm Hg, the valve remains closed at normal central venous
pressure. Pressure in the superior vena cava must exceed 80 mm Hg to
open the valve inward. Also, negative pressure (vacuum) will cause the
valve to open inward, allowing blood aspiration.
Positive pressure into the catheter (gravity, pump, syringe) will open the
valve outward, allowing fluid infusion. The need for the anticoagulant effect
of heparin is eliminated because the closed valve prevents blood from
entering the catheter and clotting. If the catheter is aspirated, pulling the
valve inward, it must be flushed with normal saline to clear blood from the
lumen and allow the valve to return to its normal, closed position. |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Groshong™ NXT PICC provides short (less than 30 days) or long
(greater than 30 days) term peripheral access to the central venous system
for intravenous therapy or blood sampling. |
5
Image /page/5/Picture/1 description: The image shows the logos of BD and Bard. The BD logo is on the left, and it consists of an orange circle with a stylized sun inside, followed by the letters "BD" in blue. The Bard logo is on the right, and it consists of the word "BARD" in green, with the words "has joined BD" in smaller font below it. The image suggests that Bard has been acquired by BD.
The technological characteristics of the subject Groshong™ NXT PICC Catheter are substantially equivalent to those of the cited predicate device with respect to basic design, function, and fundamental scientific technology. Modifications to the subject device, when compared to the predicate device, include:
- · A change to the inner lumen geometry.
- · A material and formulation change to the catheter silicone and catheter silicone colorant.
The technological differences were evaluated per the device risk assessment using the same test requirements and industry consensus standards, where applicable, as the predicate device. The conclusion of these evaluations is that the changes to the subject device compared to the predicate device do not raise new or different questions of safety or effectiveness, and the devices are substantially equivalent.
The following table provides a comparison between the subject and predicate devices.
| | Attribute | Subject Device –
Groshong™ NXT PICC Catheter | Predicate Device –
Groshong™ NXT PICC Catheter | Discussion of Characteristics |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics | Owner | Same as predicate | Bard Access Systems, Inc.
(wholly owned subsidiary of BD) | Same as predicate. |
| | Classification | Same as predicate | LJS – 21 CFR 880.5970
Percutaneous, implanted, long-term
intravascular catheter | The classification of the subject
device is the same as the
predicate device. |
| | 510(k) Status | Subject of this Premarket Notification | K034020 –
Concurrence date: January 21, 2004 | N/A. |
| | Trade Name | Groshong™ NXT PICC Catheter | Groshong™ NXT PICC Catheter | Same as predicate. |
| | Indications for
Use | Same as predicate | The Groshong™ NXT PICC provides
short (less than 30 days) or long
(greater than 30 days) term peripheral
access to the central venous system
for intravenous therapy or blood
sampling. | The indications for use of the
subject device are the same as
the predicate device. |
| | Catheter
Dimensions | Same as predicate | 4 Fr single lumen, 60 cm trimmable
length | The dimensions of the subject
device are the same as the
predicate device. |
| | Catheter
Configuration | 18-gauge, striped blue colored shaft | 18-gauge, solid blue colored shaft | The catheter configuration of the
subject device is substantially
equivalent to the predicate
device, and a risk assessment |
| Inner Lumen | Round | Rectangular | did not identify any new or
significantly modified risks.
These differences do not raise
new or different questions of
safety or effectiveness.
The inner lumen of the subject
device is substantially equivalent
to the predicate device, and a
risk assessment did not identify
any new or significantly modified
risks. These differences do not
raise new or different questions | |
| Duration of
Use | Same as predicate | Short (less than 30 days) or long
(greater than 30 days) term | of safety or effectiveness.
The duration of use of the
subject device is the same as
the predicate device. | |
| Means of
insertion | Same as predicate | Percutaneous introducer,
microintroducer | The means of insertion of the
subject device is the same as
the predicate device. | |
| Insertion Site | Same as predicate | Peripheral | The insertion site of the subject
device is the same as the
predicate device. | |
| Intended
Patient
Population | Same as predicate | General population | The intended patient population
of the subject device is the same
as the predicate device. | |
| Catheter
Materials (by
Device
Component) | Base Materials
Shaft Tubing:
65-durometer radiopaque silicone
(33% barium sulfate [BaSO4] in
colored stripe), blue silicone colorant,
40-durometer silicone tip
Luer Connector:
Same
Extension Leg:
Same
Proximal Connector:
Same | Base Materials
Shaft Tubing:
80-durometer radiopaque silicone
(17% BaSO4 evenly distributed), blue
silicone colorant, 40-duromter silicone
tip
Luer Connector:
Polybutylene terephthalate (PBT),
stainless steel
Extension Leg:
Silicone
Proximal Connector:
Stainless steel, PBT, radiopaque
silicone, silicone | The base materials of the
catheter for the subject device
are the same as the predicate
device. All material formulation
differences of the subject device
were evaluated and are
substantially equivalent to the
predicate device, and a risk
assessment did not identify any
new or significantly modified
risks. These differences do not
raise new or different questions
of safety or effectiveness. | |
| | Distal Connector:
Same | Distal Connector:
PBT, silicone | | |
| Catheter Distal
Configuration | Same as predicate | Closed-ended with 3-position,
pressure-sensitive Groshong™ valve | The distal configuration of the
subject device is the same as
the predicate device. | |
| Catheter
Connector | Same as predicate | 2-piece connection with extension leg
and luer lock connector | The catheter connector of the
subject device is the same as
the predicate device. | |
| Priming
Volume | 0.24mL | 0.51mL | Differences in priming volume do
not raise new or different
questions of safety or
effectiveness. | |
| Sterility | Same as predicate | Provided sterile (ethylene oxide) | The subject and predicate
device are both provided sterile. | |
6
Image /page/6/Picture/1 description: The image shows the logos of BD and Bard. The BD logo is an orange sun-like symbol followed by the letters BD in blue. The Bard logo is the word BARD in green, with the text "has joined BD" in smaller font below it. The image suggests that Bard has been acquired or merged with BD.
7
Image /page/7/Picture/1 description: The image shows the logos of BD and Bard. The BD logo is in blue and consists of a stylized sunburst and the letters "BD". The Bard logo is in green and consists of the word "BARD" in a stylized font. Below the Bard logo, the text "has joined BD" is written in a smaller font.
Verification and validation tests were performed in accordance with Design Controls per 21 CFR 820.30. The performance tests completed on the subject device were limited to those tests required to support a determination of substantial equivalence to the predicate device. In addition, where technological characteristics between the subject and predicate device were found to be identical, results of performance testing conducted on the predicate device were adopted and applied to the subject device. The following performance tests were conducted per guidance documents, industry standards, and in-house protocols to establish the performance of the device, thereby leading to a conclusion of substantial equivalence of the subject Groshong™ NXT PICC Catheter to the predicate device, the Groshong™ NXT PICC Catheter.
| Performance
| Tests | Performance Tests for Subject Device | |
|---|---|---|
| Verification / Validation | ||
| Method | Reference Standard | |
| Performance | ISO 10555-1:2013/Amd 1:2017 Intravascular Catheters - Sterile and Single-Use Intravascular | |
| Catheters - Part 1: General Requirements ISO 10555-3:2013- Intravascular catheters - Sterile and single-use catheters - Part 3: Central | ||
| venous catheters ASMT F640-12 Standard Test Methods for Determining Radiopacity for Medical Use ASTM F2119-07 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants ASTM F2182 Standard Test Method for Measurement of Radio Frequency Induced Heating on or | ||
| Near Passive Implants During Magnetic Resonance Imaging ASTM F2052-15 Standard Test Method for Measurement of Magnetically Induced Displacement | ||
| Force on Medical Devices in the Magnetic Resonance Environment |
8
Bard Access Systems, Inc.
Image /page/8/Picture/1 description: The image shows the logos of two companies, BD and BARD. The BD logo is on the left and consists of an orange sun-like symbol and the letters "BD" in blue. The BARD logo is on the right and consists of the word "BARD" in green, with the text "has joined BD" below it.
| | | ASTM F2213-17 Standard Test Method for Measurement of Magnetically Induced Torque on
Medical Devices in the Magnetic Resonance Environment |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Biocompatibility
Evaluations | ISO 10993-1:2018 – Biological Evaluation of Medical Devices – Part 1: Evaluation and testing
within a risk management process USP Particulate Matters in Injections (method 1 Light Obscuration Particle Count Test) |
| | Sterilization | ANSI AAMI ISO 11135:2014C Sterilization of Health Care Products - Ethylene Oxide -
Requirements for Development, Validation and Routine Control of a Sterilization Process for
Medical Devices. |
| Summary of
Substantial
Equivalence | Based on the risk management activities and testing, the subject Groshong™ NXT PICC Catheter has
demonstrated to be substantially equivalent to the cited predicate device. | |