The Palindrome™ Precision Symmetric Tip Dual Lumen Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted percutaneously or by cut down. Catheters with greater than 40 cm implant length are indicated for femoral placement.

The Palindrome™ Precision RT Reverse-Tunneled Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cut down. Catheters with greater than 40 cm implant length are indicated for femoral insertion.

The Palindrome™ Precision H Chronic Catheter is indicated 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 Palindrome™ Precision SI Chronic Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters greater than 40 cm implant length are indicated for femoral insertion. 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.

The Palindrome™ Precision HSI Chronic Catheter is indicated 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 is supported by bench and animal testing.

Device Description

The Palindrome™ Precision Symmetric Tip Dual Lumen Catheter has a radiopaque shaft with two large D-shaped inner lumens designed in opposing configuration. The proximal end of the catheter features two color-coded luer adapters. The luer adapters are connected to clear extension tubes. Each extension tube contains a clamp and is connected to the catheter hub which contains suture wings. The distal end of the catheter hub is connected to the double lumen catheter shaft. The shaft contains a cuff and extends to a symmetrical distal tip configuration.

The Palindrome™ Precision RT Reverse-Tunneled Catheter will be supplied with a detached "proximal end" allowing for the catheter tip to be positioned in the vein first before the catheter shaft is pulled through the patient's subcutaneous tunnel tract in a retrograde fashion. The fully assembled Palindrome™ Precision RT Reverse-Tunneled Catheter has a 15.0 Fr. radiopaque shaft with two large D-shaped inner lumens designed in an opposing configuration. The proximal end of the catheter features two color-coded luer adapters. The luer adapters are connected to clear extension tubes. Each extension tube contains a clamp and is connected to the hub assembly which contains suture wings. The distal end of the catheter hub is connected to the double lumen catheter shaft. The shaft contains a cuff and extends to a symmetrical distal tip configuration.

The Palindrome™ Precision H Chronic Catheter with Heparin coating has a radiopaque polyurethane shaft with two D-shaped inner lumens designed in opposing 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). The heparin coating serves to reduce platelet adhesion.

The Palindrome™ Precision SI Chronic Catheter with Silver Impregnated sleeve has a radiopaque polyurethane shaft with two D-shaped inner lumens designed in opposing 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 silver impregnated sleeve permanently bonded to the outer surface of the device from the hub to the cuff. The silver impregnated sleeve serves to reduce microbial colonization on the external surface of the sleeve which is placed within the subcutaneous tunnel tract.

The Palindrome™ Precision HSI Chronic Catheter with Heparin coating and Silver Impregnated sleeve has a radiopaque polyurethane shaft with two large D-shaped inner lumens designed in opposing 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). The heparin coating serves to reduce platelet adhesion. The catheter also contains a silver impregnated sleeve permanently bonded to the outer surface of the device from the hub to the cuff. The silver impregnated sleeve serves to reduce microbial colonization on the external surface of the sleeve which is placed within the subcutaneous tunnel tract.

AI/ML Overview

The provided text describes several dialysis catheters (Palindrome™ Precision Symmetric Tip Dual Lumen Catheter, Palindrome™ Precision RT Reverse-Tunneled Catheter, Palindrome™ Precision H Chronic Catheter, Palindrome™ Precision SI Chronic Catheter, Palindrome™ Precision HSI Chronic Catheter) and their performance data. However, the information presented is from a 510(k) summary for medical device clearance, which focuses on demonstrating substantial equivalence to predicate devices rather than proving device efficacy through clinical trials. As such, many of the typical acceptance criteria and study details requested for an AI/ML or diagnostic device are not applicable or not provided in this document.

Here's an attempt to answer the questions based only on the provided text, noting where information is not available:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the format of specific thresholds for clinical performance metrics (e.g., sensitivity, specificity, accuracy) that an AI/ML or diagnostic device would typically have. Instead, it refers to "relevant acceptance criteria" in the context of engineering and material performance tests.

Acceptance Criteria Category	Reported Device Performance (or testing conducted)
Material/Mechanical Performance	The "Risk Analysis activities identified the need to conduct additional testing to confirm that the modified chronic catheters continued to meet the relevant acceptance criteria." Testing included: Dynamic flowStatic flowCatheter insertion forceThrombogenicityRecirculationMarker band integrityLong term soakMechanical hemolysisLeachabilityTensileHeparin activityHeparin concentrationHeparin durability Results Report: "The results of the performance testing show that the modified devices continue to meet the relevant product specifications."
Coating Performance (Heparin)	For Palindrome™ Precision H and HSI Chronic Catheters: "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."
Coating Performance (Silver)	For Palindrome™ Precision SI and HSI Chronic Catheters: "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."
Substantial Equivalence	"Based on non-clinical testing results, Covidien has demonstrated that the modified catheters are substantially equivalent to their respective existing catheters." (This is the primary "acceptance criterion" for 510(k) clearance).

Detailed Study Information (where applicable or derivable from the text):

Sample size used for the test set and the data provenance:
- The document mentions "bench and animal testing" for the coating performance and various "performance testing" for material and mechanical characteristics. However, specific sample sizes (number of units tested, number of animals) for these tests are not provided.
- Data Provenance: Not explicitly stated, but "bench and animal testing" implies laboratory and pre-clinical data, likely from an internal testing facility or contract research organization. There is no mention of human clinical data or geographical origin of data. The testing is retrospective in the sense that it's performed on manufactured devices to support a premarket notification.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the document describes physical medical devices (catheters) and their engineering/material performance, not a diagnostic or AI/ML device that requires expert-established ground truth. The "ground truth" here would be the physical measurement results of the various performance tests.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable for the type of device and testing described. Adjudication methods are typically for human interpretation of data in diagnostic studies.
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:
- This is not applicable. This document describes an implanted medical device, not a diagnostic imaging or AI-assisted interpretation tool. No human readers or AI assistance are involved in the performance evaluation described.
If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- This is not applicable as the device is a physical medical catheter, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the device's performance is derived from objective physical and chemical measurement results from the various performance tests (e.g., flow rates, tensile strength, heparin concentration, platelet adhesion, microbial colonization inhibition). For the coating performance, it refers to "bench and animal testing" outcomes as proof of performance.
The sample size for the training set:
- This is not applicable. The Palindrome™ Precision catheters are physical devices, not an AI/ML algorithm that requires a training set.
How the ground truth for the training set was established:
- This is not applicable as there is no training set for a physical medical catheter.

Summary

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K123196 391083

Image /page/0/Picture/1 description: The image shows the word "COVIDIEN" in bold, black letters. To the left of the word is a black square with a white plus sign inside. The plus sign is made up of smaller squares.

510(K) SUMMARY

JAN 3 1 2013

1. 510(k) Owner:

Covidien 15 Hampshire Street Mansfield, MA 02048 Telephone: (508) 452 - 1659 Fax: (508) 452 - 1659

Contact: Jennifer Sullivan Title: Sr. Regulatory Affairs Specialist Date Prepared: April 17, 2012

2. Device:

Trade Names: Palindrome™ Precision Symmetric Tip Dual Lumen Catheter Palindrome™ Precision RT Reverse-Tunneled Catheter Palindrome™ Precision H Chronic Catheter Palindrome™ Precision SI Chronic Catheter Palindrome™ Precision HSI Chronic Catheter Common Name: Catheter Classification Name: Implanted Hemodialysis Catheter Coated Implanted Hemodialysis Catheter Regulation Number: 21 CFR 876.5540 Product Code(s): MSD, NYU Classification: Class III

3. Predicate Devices:

Palindrome™ Symmetric Tip Dual Lumen Catheter	K111372
Palindrome™ RT Reverse-Tunneled Catheter
Palindrome™ H Chronic Catheter	K112477
Palindrome™ SI Chronic Catheter
Palindrome™ HSI Chronic Catheter

4. Device Description:

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5. Intended Use:

The uncoated catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted percutaneously or by cut down. Catheters with greater than 40 cm implant length are indicated for femoral placement.

The Palindrome™ Precision H Chronic Catheter 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

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adhesion on the catheter surface for up to 720 hours of dialysis treatment is supported by bench and animal testing.

The Palindrome™ Precision SI Chronic Catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters greater than 40 cm implant length are indicated for femoral insertion. 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.

The Palindrome™ Precision HSI Chronic Catheter 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 is supported by bench and animal testing.

6. Technological Characteristics:

The modified devices have the same technological characteristics as compared to their respective predicate devices.

7. Performance Data:

The existing Risk Analysis files for the chronic catheter product family were reviewed to identify the clinical risks specifically associated with the modifications related to this premarket notification. The output of Risk Analysis activities identified the need to conduct additional testing to confirm that the modified chronic catheters continued to meet the relevant acceptance criteria. The test regimen evaluated the devices' performance. Testing included; dynamic flow, static flow, catheter insertion force, thrombogenicity, recirculation, marker band integrity, long term soak, mechanical hemolysis, leachability, tensile, heparin activity, heparin concentration and heparin durability. The results of the performance testing show that the modified devices continue to meet the relevant product specifications.

The results of functional testing and design validation support the determination of substantial equivalence.

8. Conclusion:

Based on non-clinical testing results, Covidien has demonstrated that the modified catheters are substantially equivalent to their respective existing catheters.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

January 31, 2013

Covidien % Ms. Jennifer Sullivan Sr. Regulatory Affairs Specialist 15 Hampshire Street MANSFIELD MA 02048

Re: K123196

Trade/Device Name: Palindrome "Precision Symmetric Tip Dual Lumen Catheter "" Precision RT Reverse-Tunneled Catheter Palindrome Palindrome™ Precision H Chronic Catheter Palindrome™ Precision SI Chronic Catheter Palindrome™ Precision HSI Chronic Catheter Regulation Number: 21 CFR§ 876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: MSD, NYU Dated: December 13, 2012 Received: December 14, 2012

Dear Ms. Sullivan:

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. 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 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.

Image /page/3/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.

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Page 2 - Ms. Jennifer Sullivan

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Benjamin R. Fisher -S

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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Section 4 Indications for Use Statement

510(k) Number (if known): K (23) 96

K123196

Device Name: Palindrome™ Precision Symmetric Tip Dual Lumen Catheter Palindrome™ Precision RT Reverse-Tunneled Catheter Palindrome™ Precision H Chronic Catheter Palindrome™ Precision SI Chronic Catheter Palindrome™ Precision HSI Chronic Catheter

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number: K123196

Benjamin R. Fisher -S 2013.01.31 115:17 -05'00'

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.