The performance of the heparin coating on this catheter in reducing platelet adhesion on the catheter surface for up to 720 hours of dialysis treatment is supported by bench and animal testing.

The performance of the silver impregnated sleeve in reducing colonization on the catheter surface for up to 30 days is supported by bench and animal testing.

Device Description

The proposed Kendall 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome™ Sapphire™) has a radiopaque polyurethane shaft with two large inner lumens designed in a "double D" configuration. The distal end of the catheter extends to a symmetrical tip. The proximal end of the catheter shaft contains a polyurethane hub assembly and silicone extension sets. The catheter contains a heparin coating on its surface, from the tip of the catheter to the cuff on the external surface, and throughout the entire length on the internal surface (tip to luer adapters), for the purpose of reduction of platelet adhesion. The proposed catheter also contains a silver impregnated sleeve permanently bound to the outer surface of the device from the hub to the cuff for the purpose of reducing microbial colonization on the external surface of the catheter in the subcutaneous tunnel tract.

AI/ML Overview

The provided document describes a Special 510(k) submission for a device modification: the Kendall 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome™ Sapphire™). The modification involves adding a silver impregnated sleeve to an existing device (Kendall's 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating - Palindrome™ Emerald™).

Here's an analysis of the acceptance criteria and the supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Performance Characteristic	Acceptance Criteria	Reported Device Performance
Heparin Coating Performance
Platelet Adhesion Reduction (in-vitro)	≥ 60% reduction in platelet adhesion	60% reduction in platelet adhesion (p<0.05)
Heparin Activity (Coating Durability)	Maintain heparin activity levels at twice the minimum required for 60% reduction of platelet adhesion.	Maintained heparin activity levels at above the minimum efficacy threshold (which is 43% of initial activity) for 720 hours of simulated dialysis, with 60-70% of initial activity remaining.
Thrombus Formation Reduction (in-vivo)	Significant reduction in thrombus formation	82% reduction in total thrombus formation (p<0.05) over 24 days
Silver Impregnated Sleeve Performance
Microbial Colonization Reduction (in-vitro)	Significant reduction in microbial colonization	Between 2.1 and 5.5 log10 reductions against S. aureus, Coagulase-negative Staphylococcus, C. albicans, E. coli
Microbial Colonization Reduction (in-vivo)	Significant reduction in microbial colonization	Between 2.5 and 4.9 log10 reduction against S. aureus (clinical isolate)
Silver Loading / Biocompatibility	Safe levels of silver loading for biocompatibility and non-toxicity; controlled release.	Biocompatibility testing at highest silver loading passed; total silver amount confirmed safe versus toxicity/exposure limits; silver elution demonstrated controlled release.
No Impact on Catheter Performance	Silver sleeve should not negatively affect catheter safety and performance.	Confirmed that the presence of the silver impregnated sleeve did not affect the safety and catheter performance.

2. Sample Size and Data Provenance

Test Set (for Heparin Coating Performance):

In-vitro circulating blood loop test: Sample size not explicitly stated for individual catheters, but "uncoated control" implies multiple comparisons. Data provenance is a bench test using fresh heparinized bovine blood.
Coating durability test: Sample size not explicitly stated, but "the catheter was subjected to 720 hours of simulated dialysis". Data provenance is an in-vitro simulation.
In-vivo ovine model: Six sheep. Each sheep had both a coated and non-coated catheter. Data provenance is prospective animal testing (ovine model).

Test Set (for Silver Impregnated Sleeve Performance):

Biocompatibility testing: Not specified, but typically involves a battery of tests with multiple samples. Data provenance not specified (likely lab-based).
Total silver amount in sleeve determination: Not specified. Data provenance not specified (likely lab-based).
Silver elution: Not specified, but likely multiple samples over time. Data provenance not specified (likely lab-based).
In-vitro studies (microbial colonization): Sample size not specified for each microbial challenge, but tests were "after repeated challenges". Data provenance is in-vitro laboratory testing with clinical isolates.
In-vivo studies (microbial colonization): Not specified (e.g., number of rabbits or catheters). Data provenance is prospective animal testing (rabbit infection model) with a clinical isolate.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. The reported studies are primarily bench and animal testing, not human user studies requiring expert adjudication or ground truth establishment in the clinical sense.

4. Adjudication Method for the Test Set:

Not applicable for these types of studies. The end results are quantitative measurements (e.g., platelet counts, thrombus weight, microbial log reduction, heparin activity).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The studies are focused on the device's functional performance in bench and animal models, not on human reader performance, with or without AI assistance, or direct human clinical outcomes.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Studies:

Not applicable. This device is a medical catheter, not an AI algorithm. The performance evaluation is for the physical device and its coatings.

7. Type of Ground Truth Used:

For Heparin Coating:
- In-vitro platelet adhesion: Quantitative measurement of radiolabeled platelet counts on catheter surfaces.
- In-vivo thrombus formation: Gravimetric analysis of extracted thrombus from catheter surfaces.
- Heparin activity: Chemical assay to measure heparin levels.
For Silver Impregnated Sleeve:
- Microbial colonization: Quantitative measurement of microbial load (e.g., colony-forming units, reported as log10 reduction).
- Biocompatibility: Standardized toxicological endpoints (e.g., cytotoxicity, sensitization, irritation).
- Silver elution/content: Analytical chemistry techniques.

8. Sample Size for the Training Set:

Not applicable. This is a medical device and its coatings undergoing performance testing, not a machine learning model.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for a machine learning model.

Summary

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K062671 fige 1.t'4

Special 510(k) : Device Modification Special 14.5 Fr Chronic Hounteanon
Kendall 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome™ Sapphire™)

510(k) Summary

Date SummaryWas Prepared:	November 1, 2006	NOV - 3 2006
Submitter'sInformation:	Kendall, a Division of Tyco Healthcare Group LP15 Hampshire StreetMansfield, MA 02048Phone: 508-261-8000Fax: 508-261-6644
Contact:	Keith MartinManager, Regulatory AffairsKendall, a Division of Tyco Healthcare Group LPTelephone: 508-261-8440Fax: 508-261-8461
Device TradeName:	14.5 Fr Chronic Hemodialysis Catheter with Heparin Coatingand Silver Impregnated Sleeve (Palindrome™ Sapphire™)
Device CommonName:	Catheter, Hemodialysis, Implanted, Coated
Classification Panel:	Gastroenterology

Legally Marketed Devices to Which Substantial Equivalence is Claimed:

The Kendall 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome™ Sapphire™) is substantially equivalent to Kendall's 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating (Palindrome™ Emerald™, K060509) in intended use, materials, physical characteristics, and performance characteristics. The modification attributed to the predicate device is the addition of a silver impregnated sleeve to the external surface of the catheter from the hub to the cuff to reduce catheter colonization in the subcutaneous tunnel tract. This silver impregnated sleeve is the same sleeve used on the Kendall 14.5 Fr Chronic Hemodialysis Catheter with Silver Impregnated Sleeve (Palindrome™ Ruby™) cleared for marketing via K060972 on August 4, 2006. K060972 is within the same device classification regulation (876.5540) as the unmodified predicate device, and has the same intended use. No other modifications have been made to either the silver impregnated sleeve or the predicate device, including the heparin coating.

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ct 2671 page 2 of 4

Special 510(k) : Device Modification Kendall 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome™ Sapphire™)

Device Description:

The proposed Kendall 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome™) Sapphire™) has a radiopaque polyurethane shaft with two large inner lumens designed in a "double D" configuration. The distal end of the catheter extends to a symmetrical tip. The proximal end of the catheter shaft contains a polyurethane hub assembly and silicone extension sets. The catheter contains a heparin coating on its surface, from the tip of the catheter to the cuff on the external surface, and throughout the entire length on the internal surface (tip to luer adapters), for the purpose of reduction of platelet adhesion. The proposed catheter also contains a silver impregnated sleeve permanently bound to the outer surface of the device from the hub to the cuff for the purpose of reducing microbial colonization on the external surface of the catheter in the subcutaneous tunnel tract.

Indications / Intended Use:

The Kendall 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome™ Sapphire™) is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. The performance of the heparin coating on this catheter in reducing platelet adhesion on the catheter surface for up to 720 hours of dialysis treatment is supported by bench and animal testing. The performance of the silver impregnated sleeve in reducing colonization on the catheter surface for up to 30 days was supported by bench and animal testing.

Performance Data:

Performance data for the Kendall 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome™ Sapphire™) is compared to that of the predicate device identified in this 510(K) summary. Results of verification / validation demonstrate that the modified device is substantially equivalent to the legally marketed device.

Test Summary:

The performance of the heparin coating on this catheter in reducing platelet adhesion on the catheter surface for up to 720 hours of dialysis treatment is supported by:

A two hour circulating blood loop test demonstrating a 60% reduction in platelet adhesion on the catheter surface at p<0.05.
A coating durability test, where the catheter was subjected to 720 hours of simulated dialysis . conditions and maintained heparin activity levels at twice the minimum activity level required to achieve a 60% reduction in platelet adhesion.
An in-vivo ovine model using six sheep (periodically perfused to simulate dialysis for 24 . days) where the reduction in thrombus formation was 82% at p<0.05.

Test Method Details:

In-vitro evaluations of the coated catheters were performed using a test model which incorporates fresh heparinized bovine blood to assess the relative thromboresistance of the coated catheter as compared to a non-coated catheter. The blood, with radiolabeled autologous platelets, was circulated for 2 hours. Retrieved catheters were visually inspected and then placed in a gamma counter for quantification of platelet adhesion on the catheter surface. The radioactivity data

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062671 fzyz374

Special 510(k) : Device Modification Kendall 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome™ Sapphire™)

demonstrates that the coated catheter had 60% less platelets adhered to the surface compared with the uncoated catheter.

Image /page/2/Figure/3 description: The image is a bar graph titled "Catheter Surface Platelet Adhesion (Gamma counts)". The y-axis is labeled "Platelet count (% CPM of uncoated)" and ranges from 0 to 120. The graph compares coated and uncoated catheters, showing that the coated catheter has a platelet count of approximately 40, while the uncoated catheter has a platelet count of 100.

Total end-point platelet accumulation normalized to the uncoated control.

In-vivo evaluations of the coated catheters were performed using an ovine model. The testing was conducted on 6 sheep with a coated and non-coated catheter implanted into the right and left internal jugular veins of the same sheep. Routine blood perfusion sessions were performed on both catheters to simulate dialysis. Gravimetric analysis performed on the thrombus extracted from the external surfaces of both the coated and non-coated catheters demonstrated an 82% reduction in total thrombus formation after an average of 24 days of implantation as compared to a non-coated catheter.

Image /page/2/Figure/6 description: The image is a bar graph titled "End-Point Thrombus (In-Vivo Ovine Model)". The y-axis is labeled "Thrombus % of Uncoated" and ranges from 0 to 120. There are two bars, one labeled "Coated" which has a value of approximately 20, and one labeled "Uncoated" which has a value of 100.

The durability of the coating was assessed in an in-vitro test model that simulates the dynamic flow environment of a dialysis session. The model involves 37℃ Saline flowing through the internal surfaces and around the external surfaces of the catheter for a time period that simulates over 12 months of dialysis sessions on the ID of the catheter and over 30 days on the OD of the catheter. The chart below shows that between 60% and 70% of the Palindrome™ Sapphire™ catheter heparin activity remains after 720 hours of continuous flow. This heparin activity is significantly

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K062671 Page 444

Special 510(k) : Device Modification Kendall 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome™ Sapphire™)

above the minimum heparin activity established during in-vitro blood flow evaluations to achieve a 60% reduction in platelet adhesion.

Image /page/3/Figure/3 description: The image is a graph showing '% Heparin Activity' on the y-axis and 'Shear Flow Duration (Continuous Flow Hours)' on the x-axis. The graph shows a line that starts at 100% activity at 0 hours, then decreases to around 72% at 80 hours, and further decreases to 60% at 160 hours. After 160 hours, the line increases slightly to around 69% at 320 hours, and then remains relatively stable at around 63-64% for the rest of the duration, up to 720 hours. There is also a horizontal line at around 41% labeled 'established efficacy threshold*'.

Coating Durability Testing

37 Deg. C Saline

The established efficacy threshold was determined in an in-vitro circulating bovine blood model using coated catheters with varying levels of heparin activity. The blood, with radiolabeled autologous platelets, was circulated for 2 hours. Platelet counts were quantified for each of the coated catheters with varying heparin activity levels and compared to the uncoated catheter. The results demonstrated that a catheter with 43% of the Palindrome™ catheter heparin activity still provides a 60% reduction in platelet adhesion on the catheter surface.

Safety and Effectiveness:

Testing conducted on the proposed device confirmed that the presence of the silver impregnated sleeve did not affect the safety and catheter performance of the device. In addition to the standard tests applicable to intravascular catheters published by ASTM. ISO, and KDOQI guidelines, testing specific to the silver impregnated sleeve included:

Biocompatibility testing at highest level of silver loading .
Determination of total silver amount in sleeve to confirm safety versus toxicity and exposure . limits
Silver elution to demonstrate controlled release .
In-vitro studies demonstrating a significant reduction, between 2.1 and 5.5 log10 reductions, . in the amount of microbial colonization on the silver impregnated sleeve after repeated challenges with Staphylococcus aureus, Coagulase-negative Staphylococcus, Candida albicans, and Escherichia coli (all clinical isolates).
In-vivo studies demonstrating a significant reduction, between 2.5 and 4.9 login reduction in . the amount of microbial colonization on the silver impreganted sleeve after repeated subcutaneous inoculation of Staphylococcus aureus (clinical isolate) in a rabbit infection model.

The results of these tests demonstrate that the Kendall 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome™ Sapphire™) is safe and effective.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Keith Martin Manager, Regulatory Affairs & Scientific Services Kendall A Division of TYCO Healthcare Group LP 15 Hampshire Street MANSFIELD MA 02048

NOV - 3 2006

Re: K062671

Trade/Device Name: Kendall 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome" Sapphire "), 19cm, 23cm, 28cm and 33cm Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: MSD Dated: October 10, 2006 Received: October 11, 2006

Dear Mr. Martin:

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). 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.

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Page 2 - Mr. Keith Martin

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 (21 CFR Part 807); listing (21 CFR Part 807), labeling (21 CFR Part 801); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on the labeling regulation, please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR Part 807.97). 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) 443-6597, or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Nancy Brogdon
Nancy C. Brogdon

Nancy C. Brogdon Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K06267/

Special 510(k) : Device Modification Special 14.5 Fr Chronic Homodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome™ Sapphire™)

Appendix 1 Indications for Use

510(k) Number (if known):

Device Name:

Kendall 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindromc™ Sapphire™)

Indications for Use:

The performance of the heparin coating on this catheter in reducing platelet adhesion on the catheter surface for up to 720 hours of dialysis treatment is supported by bench and animal testing.

The performance of the silver impregnated sleeve in reducing colonization on the catheter surface for up to 30 days is supported by bench and animal testing.

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use __

Please Do Not Write Below This Line – Continue On Another Page If Needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

) Nancy Brogdon

(Division Sic Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

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.