NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (28CM) NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (24CM)
K121933 · Marvao Medical Devices, Ltd. · MSD · Mar 14, 2013 · Gastroenterology, Urology
Device Facts
Record ID
K121933
Device Name
NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (28CM) NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (24CM)
Applicant
Marvao Medical Devices, Ltd.
Product Code
MSD · Gastroenterology, Urology
Decision Date
Mar 14, 2013
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.5540
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The NexSite HD, Hemodialysis Catheter for long term use is indicated for use in attaining long term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is primarily inserted in the internal jugular vein of an adult patient. Alternate insertion sites include the subclavian vein.
Device Story
Long-term hemodialysis/apheresis catheter; polyurethane construction; includes Dacron cuff and subcutaneous Dermal Ingrowth Support Collar (DISC) to minimize movement. Provided sterile, single-use; includes placement accessories (tunneler, guidewire, introducer/dilator, scalpel). Inserted percutaneously by clinicians, primarily in internal jugular vein. Facilitates blood access for dialysis/apheresis procedures; provides stable, long-term vascular access for patients requiring chronic treatment.
Clinical Evidence
No clinical data. Safety and effectiveness demonstrated via in vitro bench testing (visual/dimensional, joint strength, pressure, flow rate, recirculation, radiopacity, corrosion resistance) and in vivo implantation studies.
Technological Characteristics
Polyurethane catheter with Dacron cuff and subcutaneous Dermal Ingrowth Support Collar (DISC). Available in 24cm and 28cm lengths. Blood contact >30 days. Sterilized via ethylene oxide. Complies with ISO 10555-1:2004.
Indications for Use
Indicated for long-term vascular access for hemodialysis and apheresis in adult patients; primarily inserted in internal jugular vein, with subclavian vein as alternate site.
Regulatory Classification
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).
Special Controls
*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.
Predicate Devices
Medcomp® Hemo-Flow® Long Term Hemodialysis Catheter (K994105)
Marvao NexSite 9Fr Dual Lumen Critical Care Central Venous Catheter (K110627)
Submission Summary (Full Text)
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KI21933
page 1 of 2
1 4 2013
| | MAR |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5. 510(k) Summary | |
| General Information | |
| Date Compiled | March 13, 2013 |
| Classification | Class III, 21 CFR § 876.5540, Blood Access Devices and Accessories, Product code MSD (Catheter, Hemodialysis, Implanted) |
| Trade Name | NexSite™ HD, Hemodialysis Catheter for long term use |
| Model Numbers | NEXHD1552801: NexSite HD, Hemodialysis Catheter for long term use (2 cm)<br>NEXHD1552401: NexSite HD, Hemodialysis Catheter for long term use (24 cm) |
| Submitter | Marvao Medical Devices, Ltd.<br>GMIT Innovation in Business Centre, Dublin Road<br>Galway, Ireland |
| Contact | Marybeth Gamber<br>Boston Biomedical Associates<br>386 West Main Street, Suite 7<br>Northborough, MA 01532<br>Phone: (508) 351-8632 ext 206<br>Fax: (508) 351-8637 |
## Intended Use
The NexSite HD, Hemodialysis Catheter for long term use is indicated for use in attaining long term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is primarily inserted in the internal jugular vein of an adult patient. Alternate insertion sites include the subclavian vein.
Predicate Devices
| Medcomp® Hemo-Flow® Long Term Hemodialysis Catheter | K994105 |
|---------------------------------------------------------------------|---------|
| Manufactured by Medcomp | |
| Marvao NexSite 9Fr Dual Lumen Critical Care Central Venous Catheter | K110627 |
| Manufactured by Marvao Medical Devices, Ltd. | |
#### Device Description
The NexSite HD, Hemodialysis Catheter for long term use is a long term catheter intended for use in attaining long term vascular access for hemodialysis and apheresis. The polyurethane NexSite HD, Hemodialysis Catheter for long term use is available in two lengths, 24cm and 28cm, and has a Dacron cuff distal to the bifurcation hub. A Polyurethane/Dacron Dermal Ingrowth Support Collar (DISC) supplied with the Catheter is implanted subcutaneously, and is
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K121933
pg. 2 of 2
intended to minimize Catheter movement. The Catheter and DISC are packaged with accessories (stainless steel Tunneler and Sleeve, 0.038" Guidewire, 16Fr Introducer/Dilator, Coring Scalpel and Luer Caps) that are used to facilitate catheter placement.
The NexSite HD, Hemodialysis Catheter for long term use is provided as a sterile, single-use device, and is sterilized using a validated ethylene oxide process. The NexSite HD, Hemodialysis Catheter for long term use is a blood contact device with greater than 30 days of exposure.
#### Comparison to Predicate Devices
Comparison testing was performed on pre-defined characteristics using finished NexSite™ HD devices and commercial predicate devices (K994105 and K110627). The test results support the substantial equivalence of the NexSite™ HD device to the predicate devices.
#### Testing
In vitro testing was performed on the NexSite HD, Hemodialysis Catheter for long term use to assure reliable design and performance in accordance with ISO 10555-1:2004. The non-clinical tests performed include visual and dimensional, catheter joint strength, catheter pressure, catheter flow rate testing, catheter recirculation testing, radiopacity and corrosion resistance. The test results demonstrate that the NexSite™ HD, Hemodialysis Catheter for longterm use meets the requirements in the applicable standards and is substantially equivalent to legally marketed predicate devices.
In vivo implantation studies were also performed to demonstrate that the device would perform as intended. Clinical studies were not deemed necessary since in vivo and in vitro testing were sufficient to demonstrate safety and effectiveness by way of comparison to a legally marketed predicate device.
#### Guidance
The FDA Guidance on Premarket Notification (510(k) Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/95, was utilized in order to meet the FDA requirements for content and organization of this submission.
#### Summary of Substantial Equivalence
Marvao Medical believes the NexSite HD, Hemodialysis Catheter for long term use is substantially equivalent to the predicate products. The indications for use, methods of operation, design and materials used are either identical or substantially equivalent to existing legally marketed predicate products.
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# DEPARTMENT OF HEALTH & HUMAN SERVICES
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 eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
#### Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
### March 14, 2013
Marvao Medical Devices, Ltd. % Ms. Marybeth Gamber Consultant Boston Biomedical Associates, LLC 386 West Main Street, Suite 7 NORTHBOROUGH MA 01532
Re: K121933
Trade/Device Name: NexSite™ HD, Hemodialysis Catheter for long term use Regulation Number: 21 CFR§ 876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: MSD Dated: March 6, 2013 Received: March 7, 2013
Dear Ms. Gamber:
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, Orve 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, lusting 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 davine can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FTDA 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.
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Page 2 - Ms. Marybeth Gamber
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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
ElaineHBlyskun-S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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#### 4. Indications for Use Statement
510(k) Number K121933
NexSite™ HD, Hemodialysis Catheter for long term use Device Name:
The NexSite HD, Hemodialysis Catheter for long term use is Indications for Use: indicated for use in attaining long term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is primarily inserted in the internal jugular vein of an adult patient. Alternate insertion sites include the subclavian vein.
Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Per 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)
Image /page/4/Picture/9 description: The image shows the name "Elaine H. Blyskun -S" in a bold, sans-serif font. The letters are black against a white background. The letters "H.Blyskun" appear to be filled with a pattern of smaller text or symbols, giving them a textured appearance.
for Benjamin Fisher
Division Sian-Off f Reproductive, Gastro-Renal, and
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