(71 days)
Not Found
No
The summary describes a standard medical device (PICC catheter) and its physical characteristics and performance testing, with no mention of AI or ML.
Yes
The device is a catheter designed for the administration of various therapies (e.g., hyperalimentation, chemotherapy) and intravenous fluids, which directly relates to the treatment or management of a disease or condition.
No
The device is a PICC catheter used for intravenous therapy and blood sampling, not for diagnosing medical conditions.
No
The device description clearly details a physical catheter with lumens, valves, connectors, and a stylet, 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 "short term or long term intravenous therapy and any other therapies requiring long term central venous access (e.g. blood sampling)." This describes a device used for administering substances into the body and collecting blood from the body, not for performing tests on samples of blood or other bodily fluids outside the body.
- Device Description: The description details a catheter designed for insertion into the central venous system. This is consistent with a device used for direct patient care and access, not for laboratory testing.
- Lack of IVD Characteristics: There is no mention of reagents, assays, analysis of samples, or any other components or processes typically associated with in vitro diagnostics.
In summary, the Groshong® NXT PICC Catheter is a medical device used for accessing the central venous system for therapeutic and blood sampling purposes, which falls under the category of devices used in vivo (within the living body), not in vitro (in glass, or outside the living body).
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
The 5 Fr Dual Lumen silicone Groshong® NXT PICC Catheters feature a reverse-taper catheter design. They are 45 or 55 cm in length. The catheters have two equal-sized lumens and a closed, rounded, atraumatic, radiopaque, distal tip with the 3-position, pressure-sensitive Groshong® valve in each lumen. Valves are staggered for simultaneous infusion of incompatible solutions and/or aspiration of blood samples.
The proximal end of the catheter has a bifurcation with integral Statlock compatible suture wings. There are red and white plastic luer lock connectors on the extension legs. Extension legs are insert molded into the proximal end of the bifurcation. Catheters are provided sterile with a preloaded hydrophilic stiffening stylet.
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
Not Found
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)
Testing was performed using the Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/95 included assessments of:
Dimensions
Priming Volume
Flow Rate
Tensile, Elongation and Stiffness (Modulus) of Catheter Shaft
Tensile, Elongation and Stiffness (Modulus) of Extension Leg Tubing
Tensile: Extension Leg to Connector
Tensile Extension Leg to Bifurcation
Tensile Catheter Shaft to Bifurcation
Tensile Catheter Tip
Tensile Assembly Leak (Leak at Hub)
Catheter Burst: Assembly
Extension Leg tubing
Catheter Collapse
Catheter Flexural Fatigue Tolerance (Cyclic Flexure)
Additional non-guidance testing performed:
Creep (Static)
Radiopacity
Valve Function
Stylet Drag
Guidance testing not performed:
Biocompatibility. No new materials were used
Performance data gathered in design verification testing demonstrated that the Groshong® NXT PICC is substantially equivalent to the predicate 5 Fr DL Groshong® PICC (design).
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
6.2
5 Fr DL Groshong® NXT 510(k)
Section 6
510(k) Summary of Safety and Effectiveness Information
5 Fr Dual Lumen Groshong®NXT PICC Catheter
6.1 Submitter Information
| Submitter Name: | Bard Access Systems, Inc. (BAS)
[Subsidiary of C. R. Bard, Inc.] |
|----------------------|---------------------------------------------------------------------|
| Address: | 5425 W. Amelia Earhart Drive
Salt Lake City, UT 84116 |
| Telephone Number: | (801) 595-0700, Ext. 5439 |
| Fax Number: | (801) 595-4903 |
| Contact Person: | Peggy Keiffer |
| Date of Preparation: | September 26, 2002 |
| Device Name | |
| Device Name: | 5 Fr Dual Lumen Groshong®NXT PICC Catheter |
|---|---|
| Trade Name: | 5 Fr Dual Lumen Groshong®NXT PICC Catheter |
| Common/Usual Name: | Peripherally Inserted Central Catheter (PICC) |
| Classification Name: | Class II, 80 LJS - Long Term Intravascular Catheter |
| Classification Panel: | General Hospital |
6.3 Predicate Device(s):
Device Name:
| Trade Name: |
|---|
| Common/Usual Name: |
| Classification Name: |
| Classification Panel: |
| Premarket Notification: |
5 Fr Dual Lumen Groshong® PICC Catheter 3.0 Fr Groshong® PICC Procedure Tray Groshong®PICC Catheter Peripherally Inserted Central Catheter (PICC) Class II, 80 LJS - Long Term Intravascular Catheter General Hospital K904558, concurrence date February 11, 1991 K926331, concurrence date March 11, 1994
6.4 Device Description
The 5 Fr Dual Lumen silicone Groshong® NXT PICC Catheters feature a reverse-taper catheter design. They are 45 or 55 cm in length. The catheters have two equal-sized lumens and a closed, rounded, atraumatic, radiopaque, distal tip with the 3-position, pressure-sensitive Groshong® valve in each lumen. Valves are staggered for simultaneous infusion of incompatible solutions and/or aspiration of blood samples.
The proximal end of the catheter has a bifurcation with integral Statlock compatible suture wings. There are red and white plastic luer lock connectors on the extension legs. Extension legs are insert molded into the proximal end of the bifurcation. Catheters are provided sterile with a preloaded hydrophilic stiffening stylet.
49
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6.5 Intended Use
The 5 Fr Dual Lumen Groshong® NXT PICC Catheter is designed for use in short term or long term intravenous therapy and any other therapies requiring long term central venous access (e.g. blood sampling). It is used for administration of hyperalimentation, chemotherapy and other I.V. fluids. The dual lumen feature permits simultaneous infusion of incompatible solutions and/or aspiration of blood samples. Refer to the appropriate drug labeling for indications, contraindications, warnings, precautions, dosage and administration information.
This is the same basic intended use as previously cleared for the 5 Fr Groshong® PICC Catheter, K904558, and the 3.0 Fr Groshong® PICC Procedure Tray.
ર્ રીક Technological Characteristics Summary
New device is compared to Marketed Device
Yes.
Does the new device have the same indication statement?
Yes. However, there are minor modifications to the indication verbiage.
Does the new device have the same technological characteristics, e.g. design, material, etc. ?
Not in all regards. The basic fundamental scientific technology of the catheter has not changed. However, the Groshong® NXT PICC has some mlnor differences from the predicate 5 Fr DL Groshong® PICC.
Could the new characteristics affect safety or effectiveness?
Yes. The new characteristics could affect safety or effectiveness of the device.
Do the new characteristics raise new types of safety and effectiveness questions?
No. There are no new types of safety and effectiveness questions.
Do accepted scientific methods exist for assessing effects of the new characteristics?
Yes. Design performance is in compliance with the FDA's Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/ 95.
Biocompatibility of materials are in compliance with the requirements of ISO-10993. Biological Evaluation of Medical Devices Part-1: Evaluation and Testing, and the FDA-Modified ISO 10993 Test Profile for externally communicating, blood-contacting, long-term devices.
Are performance data available to assess effects of new characteristics?
Yes. Verification testing was performed according to protocols based on the above-referenced guidance document recommendations and additional standards.
ર૦
2
Do performance data demonstrate equivalence?
Yes. Performance data gathered in design verification testing demonstrated that the Groshong® NXT PICC is substantially equivalent to the predicate 5 Fr DL Groshong® PICC (design).
6.6 Nonclinical Performance Testing
Testing was performed using the Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/95 included assessments of:
Dimensions Priming Volume Flow Rate Tensile, Elongation and Stiffness (Modulus) of Catheter Shaft Tensile, Elongation and Stiffness (Modulus) of Extension Leg Tubing Tensile: Extension Leg to Connector Tensile Extension Leg to Bifurcation Tensile Catheter Shaft to Bifurcation Tensile Catheter Tip Tensile Assembly Leak (Leak at Hub) Catheter Burst: Assembly Extension Leg tubing Catheter Collapse Catheter Flexural Fatigue Tolerance (Cyclic Flexure)
Additional non-guidance testing performed: Creep (Static) Radiopacity Valve Function Stylet Drag
Guidance testing not performed: Biocompatibility. No new materials were used
6.8 Conclusion
The 5 Fr DL Groshong® NXT PICC is substantially equivalent in design and intended use to the predicate device 5 Fr DL Groshong® PICC, K904558, cleared February 11, 1991 and has the same indication for use as the 3.0 Fr Groshong® PICC Procedure Tray, K926331, cleared March 11, 1994.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with three heads or profiles facing to the right, with flowing lines beneath them.
Public Health Service
Food and Drug Administrat 9200 Corporate Boulevard Rockville MD 20850
EC 1 8 200
Ms. Peggy Keiffer Senior Regulatory Affairs Manager C.R. Bard, Incorporated Bard Access Systems, Incorporated 5425 W. Amelia Earhart Drive Salt Lake City, Utah 84116
Re: K023374
Trade/Device Name: 5 Fr Dual Lumen Groshong® NXT PICC Catheter Regulation Number: 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: October 3, 2002 Received: October 8, 2002
Dear Ms. Keiffer:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
4
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. ·
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Romoe
Fimothy A. Ulatowski Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Section 1-B
5 Fr Dual Lumen Groshong® NXT PICC Catheter 510(k)
INDICATION(S) FOR USE STATEMENT*
I state in my capacity as Senior Regulatory Affairs Manager of Bard Access Systems, that this notification [510(k)] for the following devices, 5 Fr Dual Lumen Groshiong® NXT PICC Catheter, are indicated for the following:
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.
Buzzy Krife
Peggy Keiffer
Typed Name:
Senior Regulatory Affairs Manager
Date:
10.4.02
*Suggested language and format to meet the requirements of sections 513(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and sections 807.92(a)(5) and 801.4 of the Code of Federal Regulations, Title 21.
Concurrence of Office of Device Evaluation
510(k) Number
40.233.4
510(k) Number: Jr
Division Sign-Off Office of Device Evaluation
Paltico Cuente
ivision Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
0000006
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