The NexSite HD Hemodialysis Step Tip 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. Catheters greater than 40cm are indicated for femoral vein insertion.

Device Description

The proposed device, the NexSite HD Hemodialysis Step Tip Catheter for long term use is a long term catheter intended for use in attaining long term vascular access for hemodialysis and apheresis. The proposed device is available in the following models below and has a Dacron cuff distal to the bifurcation hub.

Models:

NexSite HD Hemodialysis Step Tip Catheter for long term use (24cm) NexSite HD Hemodialysis Step Tip Catheter for long term use (28cm) NexSite HD Hemodialysis Step Tip Catheter for long term use (32cm) NexSite HD Hemodialysis Step Tip Catheter for long term use (36cm) NexSite HD Hemodialysis Step Tip Catheter for long term use (40cm) NexSite HD Hemodialysis Step Tip Catheter for long term use (55cm)

A Dermal Ingrowth Support Collar (DISC), manufactured from polyurethane and Dacron®. and supplied with the Catheter, is implanted subcutaneously, and is intended to assist with the direction of the catheter. The Catheter and DISC are packaged with accessories (stainless steel Tunneler and Sleeve, 0.038" Guidewire, 16Fr Introducer/Dilator, and Luer Caps) that are used to facilitate catheter placement.

The NexSite HD Hemodialysis Step Tip Catheter for long term use is provided as a sterile, singleuse device, and is sterilized using a validated ethylene oxide process. It is a blood contact device with greater than 30 days of exposure.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the NexSite™ HD Hemodialysis Step Tip Catheter. It outlines the device, its intended use, comparison to predicate devices, and performance data. However, it does not include detailed acceptance criteria or a study that specifically proves the device meets those acceptance criteria in the format typically used for AI-driven software or diagnostic tests.

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices through a combination of in vitro and in vivo testing. The acceptance criteria mentioned are general, pertaining to the requirements in applicable standards and specifications for the catheter's physical and functional properties, rather than performance metrics related to an algorithm's output.

Here's an attempt to answer your questions based on the provided text, recognizing that it's for a physical device, not an AI or diagnostic tool:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria and reported numerical device performance metrics in the way one might expect for a diagnostic or AI device (e.g., sensitivity, specificity, AUC with associated thresholds). Instead, it states that the device "meets the requirements in the applicable standards and specifications."

Acceptance Criteria Category (Implied)	Reported Device Performance
Physical & Functional Properties
Visual and Dimensional conformity	Meets requirements
Priming Volume	Meets requirements
Catheter Leakage	Meets requirements
Catheter Joint Strength	Meets requirements
Catheter Pressure	Meets requirements
Catheter Flow Rate	Meets requirements
Catheter Recirculation	Meets requirements
Catheter Clamp Fatigue	Meets requirements
Mechanical Hemolysis	Meets requirements
Chemical Tolerance to Disinfectants	Meets requirements
Radiopacity	Meets requirements
Corrosion Resistance	Meets requirements
Biocompatibility/Safety (In Vivo)	Performs as intended

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated for specific tests. The document mentions "finished proposed NexSite™ HD Step Tip catheters" were used for comparative performance testing, and "in vivo implantation studies were also performed." The exact number of catheters or animal subjects is not provided.
Data Provenance: Not specified (e.g., country of origin). The studies appear to be internal testing ("In vitro testing was performed on the NexSite HD Hemodialysis Step Tip Catheter"). The in vivo studies were also performed to demonstrate the device would perform as intended, but details on their nature (e.g., animal or human, retrospective or prospective) are lacking, though the context suggests animal models for a physical device before human use. Given it's a 510(k) for a physical device, no "data provenance" in the clinical data sense is typically required beyond the testing performed to demonstrate substantial equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This question is not applicable to the provided document. The "ground truth" for this medical device (a catheter) is based on engineering specifications, material properties, and biological compatibility standards, not on expert interpretations of data like in an AI diagnostic. The safety and effectiveness are evaluated against these standards and through performance testing, not through expert consensus on diagnostic labels.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication method described as would be for a diagnostic or AI system. The tests are objective measurements against defined standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted device for diagnostic interpretation. It is a physical medical device (catheter).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

Compliance with ISO 10555-1:2013 (Sterile, single-use intravascular catheters — Part 1: General requirements).
Adherence to internal specifications derived from the design and intended use of the catheter, and comparison to legally marketed predicate devices.
Results from in vitro and in vivo studies demonstrating functional performance and biocompatibility.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This is not a machine learning or AI device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 8, 2016

Marvao Medical Devices, Ltd. % Joseph DePaolo Regulatory Manager Boston Biomedical Associates 100 Crowley Drive, Suite 216 Marlborough, MA 01752

K161026 Re:

Trade/Device Name: NexSite™ HD Hemodialysis Step Tip Catheter for long term use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm) Regulation Number: 21 CFR§ 876.5540 Regulation Name: Blood Access Device and Accessories Regulatory Class: II Product Code: MSD Dated: July 5, 2016 Received: July 6, 2016

Dear Joseph DePaolo:

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/tray. 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. 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

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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 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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 yours,

Douglas Silverstein -S 2016.08.09 10:56:34 -04'00'

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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Indications for Use

510(k) Number (if known) K161026

Device Name

NexSite™ HD Hemodialysis Step Tip Catheter for long term use (24 cm, 32 cm, 36 cm, 40 cm, 55 cm)

Indications for Use (Describe)

The NexSite HD Hemodialysis Step Tip Catheter for long term 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. Catheters greater than 40cm are indicated for femoral vein insertion.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21CFR Part 807.92.

I. SUBMITTER

Name:	Marvao Medical Devices, Ltd.
Address:	GMIT Innovation in Business Centre, Dublin RoadGalway, Ireland
Phone:	+353 (0)91 759 301
Fax:	+353 (0)91 762 055
Contact Person:	Joseph DePaoloBoston Biomedical Associates386 West Main Street, Suite 7Northborough, MA 01532jdepaolo@boston-biomedical.comPhone: (508) 691-7026Fax: (508) 351-8637
II. DEVICE
Device/Trade Name:Date of Preparation:Common Name:Classification Name:Classification Number:Product Code/ Classification Panel:	NexSite™ HD Hemodialysis Step Tip Catheter for longterm use (24 cm, 28 cm, 32c m, 36 cm, 40 cm, 55 cm)August 4, 2016Blood access devices and accessoriescatheter, hemodialysis, implanted876.5540MSD/Gastroenterology /Urology
III.PREDICATE DEVICE(S):
K121933 / K133796 /K140492	Marvao NexSite HD Hemodialysis Catheter for longterm use, Manufactured by Marvao MedicalDevices, Ltd.
K143567	Marvao NexSite HD Hemodialysis Split Tip

510(k) Summary Page 1 of 3

Catheter for long term use, Manufactured by

Marvao Medical Devices, Ltd.

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IV. DEVICE DESCRIPTION

Models:

V. INTENDED USE

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

The descriptive characteristics of the proposed device and the identified predicates were compared and determined to be substantially equivalent in terms of intended use, dimensions, materials, and basic design. Comparative performance testing using finished proposed NexSite™ HD Step Tip catheters and identified predicate devices was completed. The test results support the substantial equivalence of the proposed NexSite™ HD Step Tip catheter to the predicate devices.

VII. PERFORMANCE DATA

In vitro testing was performed on the NexSite HD Hemodialysis Step Tip Catheter to assure reliable design and performance in accordance with ISO 10555-1:2013.. The non-clinical tests performed include visual and dimensional, priming volume, catheter leakage, catheter joint strength, catheter pressure, catheter flow rate testing, catheter recirculation testing, catheter clamp

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fatigue testing, mechanical hemolysis, chemical tolerance to disinfectant agents, radiopacity and corrosion resistance. The test results demonstrate that the NexSite™ HD Hemodialysis Step Tip Catheter meets the requirements in the applicable standards and specifications, 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, as well as the t Guidance Industry and Food and Drug Administration Staff Implanted Blood Access Devices for Hemodialysis, January 21, 2016.

VIII. CONCLUSIONS

Marvao Medical Devices, Ltd. believes the proposed NexSite HD Hemodialysis Step Tip Catheter for long term use is substantially equivalent to legally marketed predicate devices. The indications for use, methods of operation, design and materials used are either identical or substantially equivalent to existing legally marketed predicate products. In addition, performance testing supports substantial equivalence of the proposed and predicate devices.

510(k) Summary Page 3 of 3

Regulation Number and Section

§ 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.