(284 days)
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.
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.
The provided text is a 510(k) summary for the Groshong™ NXT PICC Catheter. It outlines the device's characteristics, its similarities to a predicate device, and the testing performed to demonstrate substantial equivalence. However, it does not contain detailed acceptance criteria, specific reported device performance values, or information about a study proving the device meets these criteria in the format requested.
The document focuses on demonstrating substantial equivalence to a predicate device (also named Groshong™ NXT PICC Catheter, K034020), rather than establishing and meeting novel acceptance criteria for the new device and then detailing a study specifically proving the new device's performance against them. The premise is that because the new device is largely similar to the predicate and differences have been evaluated not to raise new safety/effectiveness concerns, its performance is considered substantially equivalent.
Therefore, many of the requested items cannot be extracted from this document, as it's designed for a different purpose (510(k) clearance based on substantial equivalence) than a detailed clinical or performance study report.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided directly from the text. The document lists performance tests and reference standards (e.g., ISO 10555-1, ASTM F640), but it does not specify quantitative acceptance criteria or the reported performance values for the "subject device" against these criteria. It only states that the 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."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document mentions "Verification and validation tests" and "Performance tests for Subject Device," but does not specify sample sizes for these tests, the country of origin of the data, or whether the data was retrospective or prospective. These would typically be detailed in a separate test report, not the 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Cannot be provided. This type of information is relevant for studies involving expert review, such as image analysis for AI devices. The Groshong™ NXT PICC Catheter is an intravascular catheter, and the performance tests mentioned (e.g., biocompatibility, sterility, radiopacity) do not typically involve human expert interpretation in the way an AI diagnostic device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Cannot be provided. Similar to point 3, adjudication methods are typically used in studies involving human interpretation or outcome assessment, not for the technical performance testing of a catheter.
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
- Not applicable. This device is a medical catheter, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a medical catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Limited information. For the physical and material tests, the "ground truth" would be the established scientific principles and specifications defined by the referenced ISO and ASTM standards. For example, for biocompatibility, the ground truth is adherence to ISO 10993-1. For radiopacity, it's meeting the criteria of ASTM F640. There isn't "expert consensus" or "pathology" in the sense of a diagnostic outcome for this type of device performance testing.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set is involved.
Summary of what is available from the text:
The document describes the Groshong™ NXT PICC Catheter and states that its technological characteristics are substantially equivalent to a predicate device (K034020) with the same name. The key differences evaluated were:
- A change to the inner lumen geometry (from round to rectangular).
- A material and formulation change to the catheter silicone and catheter silicone colorant.
These differences were evaluated through risk assessment and performance tests. The document asserts these changes "do not raise new or different questions of safety or effectiveness."
Performance Tests Conducted (Verification / Validation Method and Reference Standards):
- 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<788>: 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.
In conclusion, while the document confirms tests were done according to established standards to support substantial equivalence, it does not provide the detailed study information or quantitative acceptance criteria and results as typically found in a clinical study report for an AI 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). 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
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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
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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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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
| GeneralProvisions | Submitter Name: | Bard Access Systems, Inc.(wholly owned subsidiary of BD) | |
|---|---|---|---|
| Submitter Address: | 605 North 5600 WestSalt Lake City, UT 84116 | ||
| Contact Person: | Matthew LymanSr. 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-TermGreater than 30 Days | ||
| SubjectDevice | Classification Name: | Percutaneous, Implanted, Long-TermIntravascular 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-TermGreater than 30 Days | ||
| PredicateDevice | Classification Name: | Percutaneous, Implanted, Long-TermIntravascular Catheter | |
| Device Class: | II | ||
| Regulation Number: | 21 CFR 880.5970 | ||
| Product Code: | LJS | ||
| Review Panel | General Hospital |
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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 fromspecially formulated and processed medical grade materials in a tray withaccessories for reliable long- (greater than 30 days) or short- (less than 30days) term vascular access.Groshong™ Valve FunctionThe 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. Whennot in use, the valve restricts blood backflow and air embolism by remainingclosed.The Groshong™ valve is designed to remain closed between -7- and 80-mmHg. Since the normal central venous pressure range in the superior venacava is 0 to 5 mm Hg, the valve remains closed at normal central venouspressure. Pressure in the superior vena cava must exceed 80 mm Hg toopen the valve inward. Also, negative pressure (vacuum) will cause thevalve to open inward, allowing blood aspiration.Positive pressure into the catheter (gravity, pump, syringe) will open thevalve outward, allowing fluid infusion. The need for the anticoagulant effectof heparin is eliminated because the closed valve prevents blood fromentering the catheter and clotting. If the catheter is aspirated, pulling thevalve inward, it must be flushed with normal saline to clear blood from thelumen 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 systemfor intravenous therapy or blood sampling. |
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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 | |
|---|---|---|---|---|
| TechnologicalCharacteristics | Owner | Same as predicate | Bard Access Systems, Inc.(wholly owned subsidiary of BD) | Same as predicate. |
| Classification | Same as predicate | LJS – 21 CFR 880.5970Percutaneous, implanted, long-termintravascular catheter | The classification of the subjectdevice is the same as thepredicate 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 forUse | Same as predicate | The Groshong™ NXT PICC providesshort (less than 30 days) or long(greater than 30 days) term peripheralaccess to the central venous systemfor intravenous therapy or bloodsampling. | The indications for use of thesubject device are the same asthe predicate device. | |
| CatheterDimensions | Same as predicate | 4 Fr single lumen, 60 cm trimmablelength | The dimensions of the subjectdevice are the same as thepredicate device. | |
| CatheterConfiguration | 18-gauge, striped blue colored shaft | 18-gauge, solid blue colored shaft | The catheter configuration of thesubject device is substantiallyequivalent to the predicatedevice, and a risk assessment | |
| Inner Lumen | Round | Rectangular | did not identify any new orsignificantly modified risks.These differences do not raisenew or different questions ofsafety or effectiveness.The inner lumen of the subjectdevice is substantially equivalentto the predicate device, and arisk assessment did not identifyany new or significantly modifiedrisks. These differences do notraise new or different questions | |
| Duration ofUse | Same as predicate | Short (less than 30 days) or long(greater than 30 days) term | of safety or effectiveness.The duration of use of thesubject device is the same asthe predicate device. | |
| Means ofinsertion | Same as predicate | Percutaneous introducer,microintroducer | The means of insertion of thesubject device is the same asthe predicate device. | |
| Insertion Site | Same as predicate | Peripheral | The insertion site of the subjectdevice is the same as thepredicate device. | |
| IntendedPatientPopulation | Same as predicate | General population | The intended patient populationof the subject device is the sameas the predicate device. | |
| CatheterMaterials (byDeviceComponent) | Base MaterialsShaft Tubing:65-durometer radiopaque silicone(33% barium sulfate [BaSO4] incolored stripe), blue silicone colorant,40-durometer silicone tipLuer Connector:SameExtension Leg:SameProximal Connector:Same | Base MaterialsShaft Tubing:80-durometer radiopaque silicone(17% BaSO4 evenly distributed), bluesilicone colorant, 40-duromter siliconetipLuer Connector:Polybutylene terephthalate (PBT),stainless steelExtension Leg:SiliconeProximal Connector:Stainless steel, PBT, radiopaquesilicone, silicone | The base materials of thecatheter for the subject deviceare the same as the predicatedevice. All material formulationdifferences of the subject devicewere evaluated and aresubstantially equivalent to thepredicate device, and a riskassessment did not identify anynew or significantly modifiedrisks. These differences do notraise new or different questionsof safety or effectiveness. | |
| Distal Connector:Same | Distal Connector:PBT, silicone | |||
| Catheter DistalConfiguration | Same as predicate | Closed-ended with 3-position,pressure-sensitive Groshong™ valve | The distal configuration of thesubject device is the same asthe predicate device. | |
| CatheterConnector | Same as predicate | 2-piece connection with extension legand luer lock connector | The catheter connector of thesubject device is the same asthe predicate device. | |
| PrimingVolume | 0.24mL | 0.51mL | Differences in priming volume donot raise new or differentquestions of safety oreffectiveness. | |
| Sterility | Same as predicate | Provided sterile (ethylene oxide) | The subject and predicatedevice are both provided sterile. |
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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.
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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.
| PerformanceTests | Performance Tests for Subject Device | |
|---|---|---|
| Verification / ValidationMethod | Reference Standard | |
| Performance | ISO 10555-1:2013/Amd 1:2017 Intravascular Catheters - Sterile and Single-Use IntravascularCatheters - Part 1: General Requirements ISO 10555-3:2013- Intravascular catheters - Sterile and single-use catheters - Part 3: Centralvenous 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 orNear Passive Implants During Magnetic Resonance Imaging ASTM F2052-15 Standard Test Method for Measurement of Magnetically Induced DisplacementForce on Medical Devices in the Magnetic Resonance Environment |
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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 onMedical Devices in the Magnetic Resonance Environment | ||
|---|---|---|
| BiocompatibilityEvaluations | ISO 10993-1:2018 – Biological Evaluation of Medical Devices – Part 1: Evaluation and testingwithin a risk management process USP<788> 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 forMedical Devices. | |
| Summary ofSubstantialEquivalence | Based on the risk management activities and testing, the subject Groshong™ NXT PICC Catheter hasdemonstrated to be substantially equivalent to the cited predicate device. |
§ 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.”