(184 days)
Not Found
No
The summary describes a standard medical device (dialysis catheter) and its physical characteristics. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
Yes
The device is indicated for use in therapies such as hemodialysis, hemoperfusion, and apheresis, which are therapeutic treatments.
No
Explanation: The device, a short-term dialysis catheter, is indicated for providing vascular access for therapies like hemodialysis, hemoperfusion, and apheresis, which are treatments, not diagnostic procedures.
No
The device description clearly describes a physical catheter made of polyurethane with hardware components like lumens, luer connectors, and a suture wing. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states that this device is a catheter intended for vascular access for procedures like hemodialysis, hemoperfusion, and apheresis. These procedures involve directly accessing the patient's bloodstream for treatment, not for analyzing samples taken from the body.
- Anatomical Site: The device is inserted into veins (jugular, subclavian, femoral), which is a direct interaction with the patient's circulatory system, not for collecting samples for external analysis.
The information provided describes a device used in vivo (within the living body) for therapeutic purposes, not for diagnostic testing of samples in vitro.
N/A
Intended Use / Indications for Use
The intended use of the Short-Term Dialysis Catheter is attaining temporary/short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, or apheresis therapy via the jugular, subclavian, or femoral vein.
"Niagara Dual Lumen Catheters are indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion and apheresis therapy via the jugular, subclavian or femoral vein.
Flexxicon II Dual Lumen Catheters are "Indicated for use in attaining temporary vascular access for hemodialysis, hemoperfusion and apheresis treatments. They are intended to be inserted in the subclavian, jugular or femoral vein, as required."
Product codes (comma separated list FDA assigned to the subject device)
78 MPB
Device Description
Short-Term Dialysis Catheters as currently distributed by BAS are dual lumen catheters, available in straight and precurved configurations with multiple insertion lengths. Catheters are made from soft polyurethane containing barium sulfate to provide radiopacity. Colored luer connectors identify the arterial (red) and venous (blue) lumens. Each extension has an atraumatic occlusion clamp, which closes the access to the catheter. A fixed, rotatable suture wing is located at the bifurcation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
jugular, subclavian, or femoral vein
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)
Bench testing was performed according to the above referenced standards and guidance document recommendations. The test results met the requirements. Performance data demonstrate that the Short-Term Dialysis Catheters with new luer connectors are substantially equivalent to the predicate Short-Term Dialysis Catheters.
Only those tests applicable to the luer connection were conducted: Dimensions; Tensile strength of catheter body to hub attachment [For this project, extension leg to hub attachment]; Leakage at hub; Catheter burst pressure (positive internal pressure).
Biocompatibility testing results met 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, which is worse case for these short-term devices.
All test results confirm the modified devices to be substantially equivalent to the 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
§ 876.5540 Blood access device and accessories.
(a)
Identification. A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.(1) The implanted blood access device is a prescription device and consists of various flexible or rigid tubes, such as catheters, or cannulae, which are surgically implanted in appropriate blood vessels, may come through the skin, and are intended to remain in the body for 30 days or more. This generic type of device includes various catheters, shunts, and connectors specifically designed to provide access to blood. Examples include single and double lumen catheters with cuff(s), fully subcutaneous port-catheter systems, and A-V shunt cannulae (with vessel tips). The implanted blood access device may also contain coatings or additives which may provide additional functionality to the device.
(2) The nonimplanted blood access device consists of various flexible or rigid tubes, such as catheters, cannulae or hollow needles, which are inserted into appropriate blood vessels or a vascular graft prosthesis (§§ 870.3450 and 870.3460), and are intended to remain in the body for less than 30 days. This generic type of device includes fistula needles, the single needle dialysis set (coaxial flow needle), and the single needle dialysis set (alternating flow needle).
(3) Accessories common to either type include the shunt adaptor, cannula clamp, shunt connector, shunt stabilizer, vessel dilator, disconnect forceps, shunt guard, crimp plier, tube plier, crimp ring, joint ring, fistula adaptor, and declotting tray (including contents).
(b)
Classification. (1) Class II (special controls) for the implanted blood access device. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible. Material names and specific designation numbers must be provided.
(ii) Performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(A) Pressure versus flow rates for both arterial and venous lumens, from the minimum flow rate to the maximum flow rate in 100 milliliter per minute increments, must be established. The fluid and its viscosity used during testing must be stated.
(B) Recirculation rates for both forward and reverse flow configurations must be established, along with the protocol used to perform the assay, which must be provided.
(C) Priming volumes must be established.
(D) Tensile testing of joints and materials must be conducted. The minimum acceptance criteria must be adequate for its intended use.
(E) Air leakage testing and liquid leakage testing must be conducted.
(F) Testing of the repeated clamping of the extensions of the catheter that simulates use over the life of the device must be conducted, and retested for leakage.
(G) Mechanical hemolysis testing must be conducted for new or altered device designs that affect the blood flow pattern.
(H) Chemical tolerance of the device to repeated exposure to commonly used disinfection agents must be established.
(iii) Performance data must demonstrate the sterility of the device.
(iv) Performance data must support the shelf life of the device for continued sterility, package integrity, and functionality over the requested shelf life that must include tensile, repeated clamping, and leakage testing.
(v) Labeling of implanted blood access devices for hemodialysis must include the following:
(A) Labeling must provide arterial and venous pressure versus flow rates, either in tabular or graphical format. The fluid and its viscosity used during testing must be stated.
(B) Labeling must specify the forward and reverse recirculation rates.
(C) Labeling must provide the arterial and venous priming volumes.
(D) Labeling must specify an expiration date.
(E) Labeling must identify any disinfecting agents that cannot be used to clean any components of the device.
(F) Any contraindicated disinfecting agents due to material incompatibility must be identified by printing a warning on the catheter. Alternatively, contraindicated disinfecting agents must be identified by a label affixed to the patient's medical record and with written instructions provided directly to the patient.
(G) Labeling must include a patient implant card.
(H) The labeling must contain comprehensive instructions for the following:
(
1 ) Preparation and insertion of the device, including recommended site of insertion, method of insertion, and a reference on the proper location for tip placement;(
2 ) Proper care and maintenance of the device and device exit site;(
3 ) Removal of the device;(
4 ) Anticoagulation;(
5 ) Management of obstruction and thrombus formation; and(
6 ) Qualifications for clinical providers performing the insertion, maintenance, and removal of the devices.(vi) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices that include subcutaneous ports must include the following:
(A) Labeling must include the recommended type of needle for access as well as detailed instructions for care and maintenance of the port, subcutaneous pocket, and skin overlying the port.
(B) Performance testing must include results on repeated use of the ports that simulates use over the intended life of the device.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(vii) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices with coatings or additives must include the following:
(A) A description and material characterization of the coating or additive material, the purpose of the coating or additive, duration of effectiveness, and how and where the coating is applied.
(B) An identification in the labeling of any coatings or additives and a summary of the results of performance testing for any coating or material with special characteristics, such as decreased thrombus formation or antimicrobial properties.
(C) A Warning Statement in the labeling for potential allergic reactions including anaphylaxis if the coating or additive contains known allergens.
(D) Performance data must demonstrate efficacy of the coating or additive and the duration of effectiveness.
(viii) The following must be included for A-V shunt cannulae (with vessel tips):
(A) The device must comply with Special Controls in paragraphs (b)(1)(i) through (v) of this section with the exception of paragraphs (b)(1)(ii)(B), (b)(1)(ii)(C), (b)(1)(v)(B), and (b)(1)(v)(C), which do not apply.
(B) Labeling must include Warning Statements to address the potential for vascular access steal syndrome, arterial stenosis, arterial thrombosis, and hemorrhage including exsanguination given that the device accesses the arterial circulation.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(2) Class II (performance standards) for the nonimplanted blood access device.
(3) Class II (performance standards) for accessories for both the implanted and the nonimplanted blood access devices not listed in paragraph (b)(4) of this section.
(4) Class I for the cannula clamp, disconnect forceps, crimp plier, tube plier, crimp ring, and joint ring, accessories for both the implanted and nonimplanted blood access device. The devices subject to this paragraph (b)(4) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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Page 1 of 3
JUL 3 0 2003
Short-Term Catheter Connector Change Abbr. 510(k)
Short-Term Dialysis Catheter Luer Connector Change 510(k) Summary of Safety and Effectiveness 21 CFR 807.92(a).
General Information:
| Submitter Name: | Bard Access Systems, Inc.
[Wholly owned Subsidiary of C. R. Bard, Inc.]
[Distributor for Vas-Cath, Inc.] |
|----------------------|----------------------------------------------------------------------------------------------------------------|
| Address: | 5425 W. Amelia Earhart Drive
Salt Lake City, UT 84116 |
| Telephone Number: | (801) 595-0700 ext. 5525 |
| Fax Number: | (801) 595-5425 |
| Contact Person: | Glenn Norton |
| Date of Preparation: | January 24, 2003 |
Device Information:
| Device Names: | NiagaraTM Dual Lumen Catheter
Vas-Cath Flexxicon II® Dual Lumen Dialysis Catheter |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------|
| Trade Names: | NiagaraTM, Flexxicon II® |
| Common/Usual Name: | Short-Term Hemodialysis Catheter |
| Classification Name: | 78 MPB - Catheter, Hemodialysis, Non-implanted
21 CFR 876.5540(b)(2) – Class II
Non-Implanted Blood Access Device |
| Classification Panel: | Gastroenterology and Renal |
Predicate Devices:
(As described above)
| ♦ Niagara Dual Lumen Catheter | K965178 |
|---|---|
| ♦ Vas-Cath Flexxicon II Dual Lumen Dialysis Catheter | K914162 |
Summary of Change:
The modification to the Short-Term Dialysis Catheters is a change of material, design, and bonding, process for the luer connectors.
Device Description:
Short-Term Dialysis Catheters as currently distributed by BAS are dual lumen catheters, available in straight and precurved configurations with multiple insertion lengths. Catheters are made from soft polyurethane containing barium sulfate to provide radiopacity. Colored luer connectors identify the arterial (red) and venous (blue) lumens. Each extension has an atraumatic occlusion clamp, which closes the access to the catheter. A fixed, rotatable suture wing is located at the bifurcation.
Intended Use of Devices:
The intended use of the Short-Term Dialysis Catheter is attaining temporary/short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, or apheresis therapy via the jugular, subclavian, or femoral vein.
Image /page/0/Picture/18 description: The image shows a sequence of numbers. The numbers are 00009. The numbers are black and the background is white. The numbers are in a simple font.
1
Ko30268 P39
Short-Term Catheter Connector Change Abbr. 510(k)
This is the same intended use as previously cleared for the Niagara Dual Lumen Catheter, K965178, concurrence date August 19, 1997, and for the Vas-Cath Flexxicon II Dual Lumen Dialysis Catheter, K914162, concurrence date July 1, 1993.
Technological Comparison to Predicate Device:
The technological characteristics of the modified Short-Term Dialysis Catheters are substantially equivalent to those of the predicate Short-Term Dialysis Catheters in terms of intended use, application, user population, design, performance, labeling, and sterilization method. The modification raises no new concerns of safety or effectiveness.
All aspects of the modified devices are identical to the predicate devices except for the luer connector hub material and design. All performance testing conducted focused on the qualification of the new connector only.
510(k) Substantial Equivalence Decision Tree:
New devices are compared to Marketed Devices?
Yes.
Do the new devices have the same indication statement as their predicates?
Yes.
Do the new devices have the same technological characteristics, eg. design, material, etc.?
Not in all respects. The principles of operation and basic design are the same. The old blue and red luer connectors are being replaced with blue and red luer connectors made of a new material/design. The PC luer connectors are made of a different material, have a modified design, and use a different bonding process. The catheters remain the same in all other respects.
Could the new characteristics affect safety or effectiveness?
Yes. The new material and design of the connector and the extension tubing/connector bond integrity could affect the safety or effectiveness of the devices.
Do the new characteristics raise new types of safety and effectiveness questions?
No. There are no new types of safety and effectiveness questions. The safety and effectiveness questions are the same for all short-term dialysis catheters.
Do accepted scientific methods exist for assessing effects of the new characteristics?
Yes. Reliance was placed on recognized standards to evaluate the device's performance. (See Non-Clinical Performance Data below.)
Are performance data available to assess effects of new characteristics?
Yes. Bench testing was performed according to the above referenced standards and guidance document recommendations. The test results met the requirements.
Do performance data demonstrate equivalence?
Yes. Performance data demonstrate that the Short-Term Dialysis Catheters with new luer connectors are substantially equivalent to the predicate Short-Term Dialysis Catheters.
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K03026B Page 3 of 3
Short-Term Catheter Connector Change Abbr. 510(k)
Non-Clinical Performance Data
As this change is being submitted via Abbreviated 510(k), the modification of the luer connector was done with conformance to a recognized standards:
ISO 594-1:1986, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General Requirements
ISO 594-2:1986, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock Fittings.
In addition, design verification testing was conducted in conformance of FDA's Guidance on Premarket Notification [510/k]] Submission for Short-Term and Lone-Term Intravascular Catheters, dated 3/16/95, to in-house protocols, and performed or evaluated based on the following FDA Guidances and recognized standards:
- Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term ● Intravascular Catheters, dated 3/16/95
- ISO 10555-1:1997, Sterile, single-use intravascular catheters, Part 1. General requirements ●
- ISO 10555-3:1997, Sterile, single-use intravascular catheters, Part 3. Central venous catheters
- AAMI/ANSI/JSO-10993-1: 1997, Biological evaluation of medical devices -- Part 1: Evaluation and ● testing, and the FDA Modified ISO 10993 Test Profile
- AAMI/ANSI/ISO 11135:1994, Medical devices Validation and routine control of ethylene oxide ● sterilization
Only those tests applicable to the luer connection were conducted: Dimensions; Tensile strength of catheter body to hub attachment /For this project, extension leg to hub attachment]; Leakage at hub; Catheter burst pressure (positive internal pressure).
Biocompatibility testing results met 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, which is worse case for these short-term devices.
All test results confirm the modified devices to be substantially equivalent to the predicate devices.
Conclusions:
The Short-Term Dialysis Catheters with new luer connectors met all the performance criteria of the tests performed and, based on FDA 's decision tree, are substantially equivalent to the predicate Short-Term Dialysis Catheters devices, specifically, the Niagara Dual Lumen Catheter, K965178, concurrence date August 19, 1997; and the Vas-Cath Flexxicon II Dual Lumen Dialysis Catheter, K914162, concurrence date July 1, 1993.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often used as a symbol of medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.
Public Health Service
JUL 3 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Glenn Norton Sr. Regulatory Affairs Specialist C.R. Bard, Inc. Bard Access Systems, Inc. 5425 W. Amelia Earhart Drive SALT LAKE CITY UT 84116
Re: K030268
Trade/Device Name: Niagara™ and Flexxicon® II Temporary Dual Lumen Catheters (luer connector change) Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: II Product Code: 78 MPB Dated: May 29, 2003 Received: May 30, 2003
Dear Mr. Norton:
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 (the Act). You may, therefore, market the device, subject to the general controls provisions of Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. 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 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
4
Page 2 - Mr. Glenn Norton
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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
In addition, we have determined that your device kit contains Xylocaine HCL, 1%, and PVP Swabsticks, which are subject to regulation as drugs.
Our substantially equivalent determination does not apply to the drug component[s] of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing vour device with the drug components. For information on applicable Agency requirements for marketing these drugs, we suggest you contact:
Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0101
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, please contact the Office of Compliance at (301) 594-4616. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/dsma/dsmamain.html
Sincerely yours,
Daniel A. Seymor
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Short-Term Catheter Connector Change Abbr. 510(k)
Section 1-B
Luer Connector Change for Short-Term Dialysis Catheters Abbreviated 510(k)
INDICATION(S) FOR USE STATEMENT*
I state in my capacity as Senior Regulatory Affairs Specialist of Bard Access Systems, that this notification [510(k)] for the following devices, Short-Term Hemodialysis Catheters, specifically Niagara and Flexxicon II. are indicated for the following:
"Niagara Dual Lumen Catheters are indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion and apheresis therapy via the jugular, subclavian or femoral vein.
Flexxicon II Dual Lumen Catheters are "Indicated for use in attaining temporary vascular access for hemodialysis, hemoperfusion and apheresis treatments. They are intended to be inserted in the subclavian, jugular or femoral vein, as required."
Signature of 510(k) Submitter:
Printed Name of Submitter:
Glenn Norton
Date:
1.24.2003
*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
Division Sign-Off
Office of Device Evaluation
Division Sign-O Division of Reproductive, Abdominal, and Radiological Device 5100k) Number
prescription User
000005