(67 days)
Not Found
No
The description focuses on the physical characteristics and intended use of a hemodialysis catheter, with no mention of AI or ML capabilities.
Yes
The device is indicated for use in attaining long-term vascular access for hemodialysis and apheresis, which are therapeutic medical procedures.
No
Explanation: The device description indicates that the DuraFlow™ 2 Chronic Hemodialysis Catheter is used for attaining long-term vascular access for hemodialysis and apheresis, which are treatment procedures, not diagnostic ones. There is no mention of the device being used to identify or analyze a disease or medical condition.
No
The device description clearly details a physical catheter and associated hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The DuraFlow™ 2 Chronic Hemodialysis Catheter is a medical device used to provide vascular access for hemodialysis and apheresis. It is inserted directly into a vein to allow blood to be drawn out and returned to the body. It does not perform any diagnostic testing on a sample.
The description clearly states its purpose is for "attaining long-term vascular access" and "obtaining blood access for hemodialysis and apheresis." This is a therapeutic and access-related function, not a diagnostic one.
N/A
Intended Use / Indications for Use
The DuraFlow™ 2 Chronic Hemodialysis Catheter and Procedure Kit is indicated for use in attaining long-term vascular access for hemodialysis and apheresis.
It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient.
Alternative Insertion sites include the subclavian vein as required.
Catheters greater than 40 cm are intended for femoral vein insertion.
This catheter is indicated for > 30 days long-term placement.
Product codes (comma separated list FDA assigned to the subject device)
MSD
Device Description
The DuraFlow™ 2 Chronic Hemodialysis Catheter is a dual lumen. 15.5FR catheter and is available in multiple lengths, in straight configurations. The catheter lumens are D-shaped and made from radiopaque Carbothane.
The distal end design is a fixed length step tip with side-holes. The distal venous lumen extends past the arterial lumen. The proximal section of the device contains a fixed polyester cuff that allows for tissue in growth for long term placement, an integrated bifurcation hub, suture wing, and extension leg set with color-coded occlusion clamps and luer connectors (red and blue for the arterial and venous lumens respectively). The lumen priming volumes are printed on the ID tags clamps. The procedure kit includes the necessary accessories to correctly insert the catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
internal jugular vein, subclavian vein, femoral vein
Indicated Patient Age Range
adult
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The safety and performance of the DuraFlow™ 2 Chronic Hemodialysis Catheter has been substantiated through extensive non-clinical testing including shaft tensile strength, joint strength, leakage, flow rate, mechanical hemolysis and kit component compatibility.
Results of testing show that the DuraFlow™ 2 Chronic Hemodialysis Catheter and Procedure Kit can reliably perform as a conventional hemodialysis catheter for obtaining blood access for hemodialysis and apheresis. No new questions of safety or effectiveness have been raised.
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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Image /page/0/Picture/0 description: The image shows text related to AngioDynamics, Inc. The text mentions "K110936 - DuraFlow™ 2 Chronic Hemodialysis Catheter and Procedure Kit 510(k)". The text also mentions "Premarket Notification".
5. 510(K) SUMMARY AS REQUIRED BY 21 CFR 807.92
JUN 1 0 2011
Submitter: AngioDynamics Inc. 14 Plaza Drive Latham, New York 12110 Tel. 518-795-1400 Fax 518-795-1402
Contact: David Greer AngioDynamics Inc. 14 Plaza Drive Latham, New York 12110 Tel. 518-795-1400 ext. 1676 Fax 518-795-1402
Date Summary was Prepared: 01-April-2011
Device Proprietary Name: DuraFlowTM 2 Chronic Hemodialysis Catheter and Procedure Kit Classification Name: Catheter, Hemodialysis, Implanted Device Product Code: MSD
Predicate Device(s): The DuraFlow™ 2 Chronic Hemodialysis Catheter and Procedure Kit is substantially equivalent to the following device:
| Device Name | Manufacturer | 510(k) No. |
|---|---|---|
| AngioDynamics® DuraMax® Catheter and | AngioDynamics® | K101843, cleared |
| Procedure Kit | AngioDynamics® | 10/20/2010 |
Device Description:
The DuraFlow™ 2 Chronic Hemodialysis Catheter is a dual lumen. 15.5FR catheter and is available in multiple lengths, in straight configurations. The catheter lumens are D-shaped and made from radiopaque Carbothane.
The distal end design is a fixed length step tip with side-holes. The distal venous lumen extends past the arterial lumen. The proximal section of the device contains a fixed polyester cuff that allows for tissue in growth for long term placement, an integrated bifurcation hub, suture wing, and extension leg set with color-coded occlusion clamps and luer connectors (red and blue for the arterial and venous lumens respectively). The lumen priming volumes are printed on the ID tags clamps. The procedure kit includes the necessary accessories to correctly insert the catheter.
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1
Statement of Intended Use:
The intended use of the DuraFlow™ 2 Chronic Hemodialysis Catheter and Procedure Kit is identical to the intended use of the predicate. DuraMax Hemodialysis Catheter and Procedure Kit that was cleared via K101843.
Specifically, the AngioDynamics, Inc. DuraFlow™ 2 Chronic Hemodialysis Catheter is intended for use in attaining long-term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternative insertion sits include the subclavian vein as required. Catheters greater than 40cm are intended for femoral vein placement. The catheter is indicated for > 30 days long-term placement.
Substantial Equivalence:
As compared to the predicate DuraMax Chronic Hemodialysis Catheter and Procedure Kit (K101843) , the DuraFlow™ 2 Chronic Hemodialysis Catheter and Procedure Kit incorporates a revision to the catheter tip as well as modification to the sidehole configuration.
Discussion of Nonclinical Tests:
The safety and performance of the DuraFlow™ 2 Chronic Hemodialysis Catheter has been substantiated through extensive non-clinical testing including shaft tensile strength, joint strength, leakage, flow rate, mechanical hemolysis and kit component compatibility.
Results of testing show that the DuraFlow™ 2 Chronic Hemodialysis Catheter and Procedure Kit can reliably perform as a conventional hemodialysis catheter for obtaining blood access for hemodialysis and apheresis. No new questions of safety or effectiveness have been raised.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 1 0 2011
Mr. David A. Greer Manager, Regulatory Affairs Angiodynamics, Inc. 14 Plaza Drive LATHAM NY 12110
Re: K110936
Trade/Device Name: DuraFlow" 2 Chronic Hemodialysis Catheter and Procedure Kit Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: MSD Dated: April 1, 2011 Received: April 4, 2011
Dear Mr. Greer:
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 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). You may, therefore, market the device, subject to the general controls provisions of the 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 legally 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, and 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.
3
Page 2 - Mr. David Greer
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Rogn 20 Why
6 Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
4. INDICATIONS FOR USE STATEMENT
Indications for Use
510(k) Number (if known): New Application K110936
Device Name: DuraFlow™ 2 Chronic Hemodialysis Catheter and Procedure Kit
Indications for Use: The DuraFlow™ 2 Chronic Hemodialysis Catheter and Procedure Kit is indicated for use in attaining long-term vascular access for hemodialysis and apheresis.
It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient.
Alternative Insertion sites include the subclavian vein as required.
Catheters greater than 40 cm are intended for femoral vein insertion.
This catheter is indicated for > 30 days long-term placement.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Gastro-Renal, and | |
| Urological Devices | |
| 510(k) Number | K110936 |
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