(29 days)
Duraspan™ Long-Term Hemodialysis Catheter (Ultra)
Not Found
No
The summary describes a physical medical device (a dialysis catheter) and its function, without mentioning any software, algorithms, or data processing that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is indicated for providing vascular access for hemodialysis, hemoperfusion, or apheresis therapy, which are forms of medical treatment.
No
The device is a long-term dialysis catheter used for vascular access for hemodialysis, hemoperfusion, or apheresis therapy. Its purpose is to facilitate treatment by allowing blood removal and return, not to diagnose a condition.
No
The device description clearly describes a physical catheter and associated hardware components for vascular access.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The r4 Duraspan™ and Duraspan™ Ultra long-term dialysis catheters are designed to provide vascular access for hemodialysis, hemoperfusion, or apheresis therapy. They are inserted directly into the patient's veins to facilitate the flow of blood to and from a machine that processes the blood.
- Lack of Specimen Examination: The device itself does not examine or analyze any specimens taken from the body. It is a conduit for blood flow during a therapeutic procedure.
- "In-vitro and animal testing" mention: While the description mentions that the ability of the Biomimetic Coating to reduce platelet adhesion and thrombus accumulation is supported by "in-vitro and animal testing," this refers to the testing methods used to evaluate the device's performance, not the device's intended use as an IVD.
In summary, the Duraspan™ catheters are therapeutic devices used for facilitating a medical procedure (dialysis/apheresis), not for diagnosing or providing information about a patient's condition through the examination of specimens.
N/A
Intended Use / Indications for Use
The r4 Duraspan™ and the Duraspan™ Ultra long-term dialysis catheter is indicated for attaining short and long term (>30 days) vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, external jugular vein, subclavian vein or femoral vein. Catheters 40 cm and longer are for femoral vein insertion. The ability of the Biomimetic Coating to reduce platelet adhesion and thrombus accumulation is supported exclusively by in-vitro and animal testing.
Product codes
MSD
Device Description
The Duraspan™ Dialysis Catheter is designed for patients with End Stage Renal Disease needing chronic hemodialysis. The catheter is inserted percutaneously through the Subclavian or Jugular veins and placed in the venous system of the patient. Once in place, the catheters two proximal luer connectors are connected to a hemodialysis machine's blood lines. The machine's pump draws blood through the proximal lumen, indicated with the red connector, removing blood from the patient. The blood is processed in the hemodialysis filter or apheresis centrifuge. The blood is then returned through the lumen, marked by a blue connector, exiting out the most distal tip. The tip of the catheter is staggered to reduce recirculation of the blood.
The catheters include female luer locking adapters and a tissue ingrowth cuff for fixing the catheters in a subcutaneous tunnel. The Duraspan™ kit includes a catheter and introduction components. The catheter is supplied sterile.
The Duraspan 114 product line has catheters in a 15.5 Fr dual lumen. The catheters come in a variety of lengths (24-55cm) for patient specificity and access preference.
The Duraspan 104 is similar to the Duraspan ™ Ultra with a reduced tip stagger to address the variability of the dimensions of the vena cava in patients allowing for appropriate positioning of the arterial and venous lumens within the vena cava and right atrium.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
internal jugular vein, external jugular vein, subclavian vein 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)
The Duraspan ™ was thoroughly tested with tests based on existing standards and test methods and demonstrates that the Duraspan ™ is substantially equivalent to the listed predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Duraspan™ Long-Term Hemodialysis Catheter (Ultra)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
510(K) SUMMARY
SUBMITTER:
r4 Vascular, Inc. 7550 Meridian Circle Suite 150 Maple Grove, Minnesota 55369 EEB 1 8 2010
ESTABLISHMENT REGISTRATION NUMBER: 3006242715
CONTACT:
| Laurie Lewandowski | |
|---|---|
| Director, Quality and Regulatory Affairs | |
| Telephone: | (612) 770-4038 (cell) |
| Telephone: | (763) 494-8400 (office) |
| Fax: | (763) 494-8484 |
| Email: | lalew@r4vascular.com |
DATE PREPARED:
May 20, 2009
NAME OF MEDICAL DEVICE:
| Proprietary Name: | Duraspan™ Long-Term Hemodialysis Catheter |
|---|---|
| Common/Usual Name: | Long Term Hemodialysis Catheter |
| Classification Name: | 78 MSD - Catheter, Hemodialysis, Implanted |
DEVICE CLASSIFICATION:
| Classification Panel: | Gastroenterology and Urology |
|---|---|
| Regulatory Class: | III |
| Product Code: | MSD |
| Regulation Number: | 21 CFR 876.5540 |
PREDICATE DEVICES:
| Proprietary Name: | Duraspan™ Long-Term Hemodialysis Catheter (Ultra) |
|---|---|
| Common/Usual Name: | Long-Term Hemodialysis Catheter |
| Classification Name: | 78 MSD - Catheter, Hemodialysis, Implanted |
1
K100169. Page 2 of 2.
DEVICE DESCRIPTION:
The Duraspan™ Dialysis Catheter is designed for patients with End Stage Renal Disease needing chronic hemodialysis. The catheter is inserted percutaneously through the Subclavian or Jugular veins and placed in the venous system of the patient. Once in place, the catheters two proximal luer connectors are connected to a hemodialysis machine's blood lines. The machine's pump draws blood through the proximal lumen, indicated with the red connector, removing blood from the patient. The blood is processed in the hemodialysis filter or apheresis centrifuge. The blood is then returned through the lumen, marked by a blue connector, exiting out the most distal tip. The tip of the catheter is staggered to reduce recirculation of the blood.
The catheters include female luer locking adapters and a tissue ingrowth cuff for fixing the catheters in a subcutaneous tunnel. The Duraspan™ kit includes a catheter and introduction components. The catheter is supplied sterile.
The Duraspan 114 product line has catheters in a 15.5 Fr dual lumen. The catheters come in a variety of lengths (24-55cm) for patient specificity and access preference.
The Duraspan 104 is similar to the Duraspan ™ Ultra with a reduced tip stagger to address the variability of the dimensions of the vena cava in patients allowing for appropriate positioning of the arterial and venous lumens within the vena cava and right atrium.
INTENDED USE/INDICATION FOR USE:
The r4 Duraspan 100 long-term dialysis catheter is indicated for attaining short and long term (>30 days) vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, external jugular vein, subclavian vein or femoral vein. Catheters 40 cm and longer are for femoral vein insertion. The ability of the Biomimetic Coating to reduce platelet adhesion and thrombus accumulation is supported exclusively by in-vitro and animal testing.
TECHNOLOGICAL COMPARISON TO PREDICATE DEVICES:
Technologically the Duraspan ' is identical to the r4 Duraspan Ultra in terms of design and performance. The only difference is a reduced tip stagger. The Duraspan ™ was thoroughly tested with tests based on existing standards and test methods and demonstrates that the Duraspan ™ is substantially equivalent to the listed predicates.
There are no new questions raised regarding safety or efficacy of the Duraspan"M catheter.
CONCLUSIONS
Based on indications for use, technological characteristics and performance testing the Duraspan™ catheters met the requirements for its intended use and the Duraspan™ is substantially equivalent in design, materials, sterilization, principles of operation and indications for use to current commercially available catheters/cited predicates.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Ms. Laurie Lewandowski Director, Quality and Regulatory Affairs r4 Vascular, Inc. 7550 Meridian Circle Suite 150 MAPLE GROVE MN 55369
FEB 1 8 2010
Re: K100169
Trade/Device Name: Duraspan™ Long-Term Hemodialysis Catheter Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: MSD Dated: January 18, 2010 Received: January 20, 2010
Dear Ms. Lewandowski:
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 - Ms. Laurie Lewandowski
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,
C. Herbert Kemmer
Janine M. Morris, Director (Acting) Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K100169
Device Name:
Duraspan™ Long-Term Hemodialysis Catheter
Indications for Use:
The r4 Duraspan™ and the Duraspan™ Ultra long-term dialysis catheter is indicated for attaining short and long term (>30 days) vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, external jugular vein, subclavian vein or femoral vein. Catheters 40 cm and longer are for femoral vein insertion. The ability of the Biomimetic Coating to reduce platelet adhesion and thrombus accumulation is supported exclusively by in-vitro and animal testing.
Prescription Use: X AND/OR Over-the-Counter Use: Part 21 CFR 801 Subpart D) (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, Abdominal and Radiological Devices 510(k) Number