The Palindrome Emerald 14.5 fr Cuffed catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. 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. It may be inserted either percutaneously or by cutdown.

Device Description

The Palindrome™ Emerald™ 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating 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. Results of in-vitro studies using bovine blood against an uncoated catheter demonstrate a 60% reduction in platelet adhesion along the catheter surface of the proposed device.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

Device: Palindrome™ Emerald™ 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating

Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Reduce platelet adhesion on the catheter surface.	60% reduction in platelet adhesion (in-vitro) at p<0.05.
Maintain heparin activity levels.	Maintained heparin activity levels at twice the minimum required for 60% platelet reduction for up to 720 hours of simulated dialysis.
Reduce thrombus formation.	82% reduction in total thrombus formation (in-vivo) at p<0.05.
Durability of the coating.	After 720 hours of continuous flow in simulated dialysis, 60% to 70% of heparin activity remained, which is significantly above the established efficacy threshold. The established efficacy threshold required 43% of the Palindrome Emerald catheter's heparin activity to achieve a 60% reduction in platelet adhesion.

Detailed Study Information:

Sample size used for the test set and the data provenance:
- In-vitro circulating blood loop test: Not explicitly stated, but the test involved comparing a coated catheter to an uncoated control.
- Coating durability test: Involved one catheter subjected to simulated dialysis conditions for 720 hours, with measurements taken periodically.
- In-vivo ovine model: 6 sheep were used. Each sheep had both a coated and non-coated catheter implanted.
- Data Provenance: The studies were conducted as bench (in-vitro) and animal (in-vivo) testing. The animals used were sheep (ovine model). The origin of the in-vitro blood (bovine blood) is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" here is objective measurement data from experiments (e.g., platelet count, thrombus weight, heparin activity), not expert interpretation of images or observations requiring multiple human readers.
Adjudication method for the test set: Not applicable, as there was no subjective assessment requiring adjudication. Outcomes were determined by quantitative measurements. In the in-vitro test, retrieved catheters were visually inspected and then placed in a gamma counter for quantification. In the in-vivo test, gravimetric analysis was performed.
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 a medical device for direct patient contact/treatment, not an AI diagnostic or interpretive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical catheter, not a standalone algorithm.
The type of ground truth used: Experimental measurement data:
- Quantification of radiolabeled platelet adhesion via gamma counter.
- Gravimetric analysis of thrombus weight.
- Measurement of heparin activity levels.
The sample size for the training set: Not applicable. This is not a machine learning model, so there is no training set. The term "training set" is usually reserved for AI/ML contexts.
How the ground truth for the training set was established: Not applicable. See point 7.

Summary

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JUN 2 3 2006

0509 page 1 of 4

510(k) Summary

Date SummaryWas Prepared:	June 16, 2006
Submitter'sInformation:	Kendalla Division of Tyco Healthcare Group LP15 Hampshire StreetMansfield, MA 02048Phone: 508-261-8000Fax: 508-261-6644
Contact:	Keith MartinManager, Regulatory AffairsKendalla Division of Tyco Healthcare Group LPTelephone: 508-261-8440Fax: 508-261-8461
Device TradeName:	Palindrome™ Emerald™ 14.5 Fr Chronic HemodialysisCatheter with Heparin Coating
Device CommonName:	Catheter, Hemodialysis, Apheresis, Intravascular
Classification Panel:	Gastroenterology

Legally Marketed Devices to Which Substantial Equivalence is Claimed:

The Palindrome™ Emerald™ 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating is substantially equivalent to the Kendall Palindrome™ 14.5 Fr Chronic Hemodialysis Catheter with Slotted Symmetrical Tip (K043272) in intended use, materials, physical characteristics, and performance characteristics. The modification attributed to the predicate device is the addition of a heparin coating to the surface of the catheter, 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 reducing platelet adhesion along the catheter surface. The following are predicate devices for the heparin coating:

MedComp® Duo-Coat Double Lumen Hemodialysis Catheter (K991320) .
Medtronic AFFINITY Hollow Fiber Oxygenator with Trillium Biosurface (K973760) .

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K060509 page 2 of 4

Device Description:

Intended Use:

Performance Data:

Performance data for the Palindrome™ Emerald™ 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating 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 demonstrates that the coated catheter had 60% less platelets adhered to the surface compared with the uncoated catheter.

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KC6C5C7 page 3 of 4

Image /page/2/Figure/2 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. There are two bars, one labeled "Coated" and the other "Uncoated". The "Coated" bar is at approximately 40, while the "Uncoated" bar is at 100.

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/5 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°C 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™ Emerald™ catheter heparin activity remains after 720 hours of continuous flow. This heparin activity is significantly above the minimum heparin activity established during in-vitro blood flow evaluations to achieve a 60% reduction in platelet adhesion.

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K0605C9

Image /page/3/Figure/2 description: The image shows a line graph of % Heparin Activity vs Shear Flow Duration (Continuous Flow Hours) at 37 Deg. C Saline. The x-axis ranges from 0 to 800, and the y-axis ranges from 0% to 100%. The graph shows that the % Heparin Activity decreases from 100% to around 60% between 0 and 160 hours, then fluctuates between 60% and 70% for the remainder of the time. There is also a horizontal line at 40% labeled "established efficacy threshold*".

Coating Durability Testing

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™ Emerald™ catheter heparin activity still provides a 60% reduction in platelet adhesion on the catheter surface.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

JUN 2 3 2006

Mr. Keith Martin Manager, Regulatory Affairs Kendall/Tyco Healthcare Group. LP 15 Hampshire Street MANSFIELD MA 02048

Re: K060509

Trade/Device Name: Palindrome™ Emerald™ 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating, 19 cm, 23 cm, 28 cm, and 33 cm. Regulation Number: 21 CFR 876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: NYU Dated: May 19, 2006 Received: May 22, 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, Orug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general cols bols provisions of the Act. However, you are responsible to determine that the medical dences 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., ster jUze) 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 de yoes, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

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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.

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 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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Indications for Use

Device Name:

Palindrome™ Emerald™ 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating

Indications for Use:

The Palindrome Emerald 14.5 fr Cuffed catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. 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 pench and animal testing. It may be inserted either percutaneously or by cutdown.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use

Nancy C. Brogdon

(Division Sign-Off vision of Reproductive, Abdom and Radiological Devi 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.