(288 days)
No
The device description and performance studies focus on the physical characteristics, materials, and mechanical performance of a dialysis catheter. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is a dialysis catheter used for hemodialysis and apheresis, which are therapeutic procedures aimed at treating specific medical conditions.
No
The NMI Dialysis Catheter is designed to provide long-term vascular access for hemodialysis and apheresis, which are treatment procedures. It does not collect or analyze data to diagnose a condition.
No
The device description clearly details a physical catheter made of Carbothane with lumens, tips, side holes, a cuff, hub, suture wing, and extension legs. It also mentions a procedure kit with accessories for insertion. This is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "attaining long-term vascular access for hemodialysis and apheresis in adults." This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The description details a catheter designed for insertion into a blood vessel to facilitate the removal and return of blood. This is a medical device used for treatment (hemodialysis, apheresis), not for analyzing samples outside the body.
- Lack of Diagnostic Function: The device does not perform any tests or analyses on biological samples (like blood, urine, tissue, etc.) to provide diagnostic information. It's a tool for accessing the vascular system for a medical procedure.
- Performance Studies: The performance studies focus on the physical and functional characteristics of the catheter itself (tensile strength, recirculation, hemolysis, thromboresistance), not on the accuracy or reliability of a diagnostic test.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that definition.
N/A
Intended Use / Indications for Use
The NMI Dialysis Catheter with ENDEXO Technology is indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Catheters greater than 40 cm are intended for femoral vein insertion.
The NMI Dialysis Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis in adults.
Catheters greater than 40 cm are intended for femoral vein insertion.
Product codes
MSD
Device Description
The NMI Dialysis Catheter (NMI DC) is a Carbothane, double lumen catheter used to remove and return blood during hemodialysis and apheresis. The catheter lumens are 'D' shaped, open at the distal tip with a total of 4 side holes (two at venous tip, two at arterial tip). The distal venous tip extends beyond the arterial lumen to reduce recirculation. The distal tip is tapered and curved to facilitate insertion. The distal tip also includes a guidewire lumen to facilitate insertion by the optional guidewire placement technique.
The proximal section of the device contains a fixed polyester cuff that allows for tissue ingrowth for long term placement, an integrated bifurcation hub, suture wing, and extension leg set with colorcoded occlusion clamps and luer connectors (red and blue for the arterial and venous lumens respectively). The lumen priming volumes are printed on the clamps. The procedure kit includes the necessary accessories to correctly insert the catheter.
The catheters are intended to be inserted percutaneously and are primarily placed in the right internal jugular vein of an adult patient. This implantation procedure is recommended to be carried out under direct fluoroscopic guidance.
The catheter shaft, bifurcation, and extension legs incorporate Endexo polymer for improved resistance to thrombus formation on the surfaces of the catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
right internal jugular vein, femoral vein
Indicated Patient Age Range
adults
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 performance evaluation of the NMI DC included testing conducting in accordance with the following FDA guidance documents and international standards:
- EN ISO 10555-1:2009, Sterile, Single Use Intravascular Catheters Part 1: General . Requirements
- EN ISO 10555-3:1997, Sterile, Single Use Intravascular Catheters Part 3: Central Venous . Catheters
- . FDA 's "Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheter dated March 16, 1995.
- . Biocompatibility per ISO 10993-1
The proposed NMI DC successfully passed relevant testing per the above Guidance and standards including:
- Internal Product Specification Requirements .
- . Tensile Testing
- . Recirculation Testing
- Mechanical Hemolysis
- . Priming Volume
- Catheter Interface Compatibility .
- In-Vitro and In-Vivo Thromboresistance Testing .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
K131260 Page 1 of 3
FEB 1 4 2014
510(k) Summary for the NMI Dialysis Catheter
Date prepared: 11-Feb-2014
A. Sponsor
Navilyst Medical, Inc. 26 Forest Street Marlborough, MA 01752
B. Contact
Lorraine M. Hanley Vice President. Global Regulatory Affairs 508-494-1129
Or
Wanda M. Carpinella Director, Global Regulatory Affairs 508-658-7929
C. Device Name
Trade Name: Common/Usual name: Classification Name:
NMI Dialysis Catheter (NMI DC) Catheter, Hemodialysis, Implanted Blood Access Device and Accessories 21CFR8876.5540, Class III
Classification Panel:
D. Predicate Device(s)
Common/Usual name:
Catheter, Hemodialysis. Implanted
Blood Access Device and Accessories 21CFR$876.5540, Class III
Gastroenterology/Urology
Gastroenterology/Urology
Classification Panel:
Classification Name:
Premarket Notification(s): K121089, K101843
1
E. Device Description
The NMI Dialysis Catheter (NMI DC) is a Carbothane, double lumen catheter used to remove and return blood during hemodialysis and apheresis. The catheter lumens are 'D' shaped, open at the distal tip with a total of 4 side holes (two at venous tip, two at arterial tip). The distal venous tip extends beyond the arterial lumen to reduce recirculation. The distal tip is tapered and curved to facilitate insertion. The distal tip also includes a guidewire lumen to facilitate insertion by the optional guidewire placement technique.
The proximal section of the device contains a fixed polyester cuff that allows for tissue ingrowth for long term placement, an integrated bifurcation hub, suture wing, and extension leg set with colorcoded occlusion clamps and luer connectors (red and blue for the arterial and venous lumens respectively). The lumen priming volumes are printed on the clamps. The procedure kit includes the necessary accessories to correctly insert the catheter.
The catheters are intended to be inserted percutaneously and are primarily placed in the right internal jugular vein of an adult patient. This implantation procedure is recommended to be carried out under direct fluoroscopic guidance.
The catheter shaft, bifurcation, and extension legs incorporate Endexo polymer for improved resistance to thrombus formation on the surfaces of the catheter.
F. Intended Use
The NMI Dialysis Catheter with ENDEXO Technology is indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Catheters greater than 40 cm are intended for femoral vein insertion.
G. Summary of Similarities and Differences in Technological Characteristics and Performance
The proposed device has similar materials, design and technological characteristics as predicate catheters. Both the NMI DC and predicate DuraMax Dialysis catheter are, in brief, intended for patients who require long-term vascular access for hemodialysis and apheresis. The only difference is the catheter, bifurcation and extension legs material. Both the proposed NMI DC and predicate DuraMax Dialysis catheter devices consist of a radiopaque polyurethane catheter shaft with barium sulfate for radiopacity; however the proposed NMI DC catheter shaft, bifurcation and extension legs also contain Endexo, a polymer technology which results in a material formulation that reduces the accumulation of thrombus. The predicate NMI PICC III catheter shaft also contains Endexo and a radiopaque polyurethane catheter shaft with barium sulfate for radiopacity.
2
H. Performance Data
The performance evaluation of the NMI DC included testing conducting in accordance with the following FDA guidance documents and international standards:
- EN ISO 10555-1:2009, Sterile, Single Use Intravascular Catheters Part 1: General . Requirements
- EN ISO 10555-3:1997, Sterile, Single Use Intravascular Catheters Part 3: Central Venous . Catheters
- . FDA 's "Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheter dated March 16, 1995.
- . Biocompatibility per ISO 10993-1
The proposed NMI DC successfully passed relevant testing per the above Guidance and standards including:
- Internal Product Specification Requirements .
- . Tensile Testing
- . Recirculation Testing
- Mechanical Hemolysis �
- . Priming Volume
- Catheter Interface Compatibility .
- In-Vitro and In-Vivo Thromboresistance Testing .
I. Conclusion
.
Based on successful results of testing and on responses to questions posed in FDA 's 510(k) Decision Making Tree, the proposed device is determined to be substantially equivalent to the predicate devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three overlapping, curved shapes that resemble ribbons or banners.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 14, 2014
Navilyst Medical, Inc. Lorraine M. Hanley Vice President, Global Regulatory Affairs 26 Forest Street Marlborough, MA 01752
Re: K131260
Trade/Device Name: NMI Dialysis Catheter Regulation Number: 21 CFR§ 876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: MSD Dated: January 14, 2014 Received: January 15, 2014
Dear Lorraine M. Hanley,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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. 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 device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 - Lorraine M. Hanley
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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,
Image /page/4/Picture/6 description: The image shows the text "Benjamin Fisher-S". The words are written in a simple, sans-serif font. The text is horizontally aligned and appears to be part of a logo or heading. The letters "BFA" are stylized in a unique way.
Benjamin R. Fisher. Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Indications for Use
______________________________________________________________________________________________________________________________________________________________________________ 510(k) Number (if Known):
Device Name: NMI Dialysis Catheter
Indications for Use:
The NMI Dialysis Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis in adults.
Catheters greater than 40 cm are intended for femoral vein insertion.
Prescription Use (21 CFR 801 Subpart D) X And/Or
AND/OR Over-The-Counter Use: (21 CFR 801 Subpart C)
ت
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Benjamin 2014.02 -05'00'