The Palindrome™ H 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™ 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™ 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™ H Chronic 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). The heparin coating serves to reduce platelet adhesion.

The Palindrome™ SI Chronic Catheter with Silver Impregnated sleeve 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 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™ HSI Chronic Catheter with Heparin coating and Silver Impregnated sleeve 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). 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

This document describes the premarket notification (510(k)) for the Palindrome™ H Chronic Catheter, Palindrome™ SI Chronic Catheter, and Palindrome™ HSI Chronic Catheter by Covidien. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to maintaining the relevant product specifications and biocompatibility, as demonstrated by the predicate devices. The study performed aims to show that the modifications do not negatively impact these established performance characteristics.

Acceptance Criteria Category	Specific Acceptance Criteria (Implied)	Reported Device Performance
Functional Performance	Device resistance to kink	"The results... show that the modified devices continue to meet the relevant product specifications."
	Device resistance to leak	"The results... show that the modified devices continue to meet the relevant product specifications."
	Device resistance to burst	"The results... show that the modified devices continue to meet the relevant product specifications."
	Catheter collapse resistance	"The results... show that the modified devices continue to meet the relevant product specifications."
	Fatigue resistance	"The results... show that the modified devices continue to meet the relevant product specifications."
	Tensile strength at various points	"The results... show that the modified devices continue to meet the relevant product specifications."
	Heparin activity (for H & HSI)	"The results... show that the modified devices continue to meet the relevant product specifications."
	Heparin concentration (for H & HSI)	"The results... show that the modified devices continue to meet the relevant product specifications."
	Coating durability (for H & HSI)	"The results... show that the modified devices continue to meet the relevant product specifications."
	Sleeve adhesion (for SI & HSI)	"The results... show that the modified devices continue to meet the relevant product specifications."
Biocompatibility	Meet ISO 10993 standards for medical devices	"The results of the biocompatibility testing show that the modified devices continue to be biocompatible for its intended use."
Material Equivalence	Material characteristics equivalent where applicable	"Material characterization testing was included to show material equivalence where applicable."

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

The document does not explicitly state the specific sample sizes used for each individual functional or biocompatibility test. It mentions "bench top functional testing" and "biocompatibility testing," which are typically done on a representative sample of devices.

Data Provenance: The testing mentioned is benchtop and likely conducted by the manufacturer (Covidien). The document also mentions "animal testing" supports the performance of the heparin coating and silver-impregnated sleeve in the "Indications for Use" section, but the details of this animal testing are not provided in the "Performance Data" section. It's retrospective in the sense that the testing was performed to support a pre-market submission, not as part of an ongoing clinical trial. There is no information regarding the country of origin of the data beyond the manufacturer being based in Mansfield, MA, USA.

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

Not applicable. This submission is for a medical device seeking substantial equivalence based on in vitro (benchtop) and in vivo (animal) performance data, not a diagnostic device requiring expert interpretation of results to establish ground truth for a test set. The "ground truth" here is adherence to established engineering specifications and biocompatibility standards.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is not a study requiring human expert adjudication of a test set in the traditional sense of diagnostic accuracy. The results of the functional and biocompatibility tests are assessed against pre-defined specifications and standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is typically performed for diagnostic imaging devices where human readers interpret images. This device is a catheter, and the performance data presented is based on physical and biological testing, not human interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense. The described performance testing (benchtop functional and biocompatibility) represents the "standalone" performance of the device without human intervention or interpretation during the performance assessment itself. The device's physical and material properties are tested directly.

7. The Type of Ground Truth Used

The ground truth used for this submission is:

Engineering Specifications/Product Specifications: For functional performance, the device is evaluated against pre-defined requirements for resistance to kink, leak, burst, collapse, fatigue, tensile strength, heparin activity/concentration/durability, and sleeve adhesion.
International Standards: For biocompatibility, adherence to ISO 10993 (Biological Evaluation of Medical Devices) is the ground truth.
Material Equivalence: The ground truth for material characterization is the equivalence to the materials used in the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set" in this context. The study is evaluating the physical and biological performance of a medical device.

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

Not applicable, as there is no training set for this device clearance.

Summary

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K112477

Page 1 of 3

SEP 2 8 2011

COVIDIEN

510(K) SUMMARY

1. 510(k) Owner:

Covidien 15 Hampshire Street Mansfield, MA 02048 Telephone: (508) 261 - 6596 (508) 261 - 8149 Fax:

Contact: Mr. Wing Ng Title: Manager, Regulatory Affairs Date Prepared: August 23, 2011

2. Device:

Trade Names: Palindrome™ H Chronic Catheter Palindrome™ SI Chronic Catheter Palindrome™ 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™ H Chronic Catheter (K060509) Palindrome™ SI Chronic Catheter (K060972) Palindrome™ HSI Chronic Catheter (K062671) Modified Chronic Hemodialysis Catheters (K111372)

4. Device Description:

The Palindrome™ SI Chronic Catheter with Silver Impregnated sleeve has a radiopaque polyurethane shaft with two large inner lumens designed in a "double D" configuration.

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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.

5. Intended Use:

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

The Palindrome™ 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™ 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:

Bench top functional testing was completed to support substantial equivalence between the modified device and the current device. The test regimen evaluated the devices'

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K11 24.77 Page 3 of 3

resistance to kink, leak, burst, catheter collapse, fatigue, and the tensibe strength at various points of the catheter. Functional testing also evaluated heparin activity, heparin concentration, coating durability, and sleeve adhesion. The results of the performance testing show that the modified devices continue to meet the relevant product specifications.

Biocompatibility testing per ISO 10993: Biological Evaluation of Medical Devices was completed to support biocompatibility between the modified device and the current device. Material characterization testing was included to show material equivalence where applicable. The results of the biocompatibility testing show that the modified devices continue to be biocompatible for its intended use.

The results of functional testing, biocompatibility testing, and material analytical testing support the determination of substantial equivalence.

8. Conclusion:

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

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure or a flame, composed of three curved lines.

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

Mr. Wing Ng Manager, Regulatory Affairs Covidien Vascular Therapies 15 Hampshire Street MANSFIELD MA 02048

SEP 2 8 2011

Re: K112477

Trade/Device Name: Palindrome™ H Chronic Catheter Palindrome™ SI Chronic Catheter Palindrome™ HSI Chronic Catheter Regulation Number: 21 CFR $876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: NYU, MSD Dated: August 23, 2011 Received: August 29, 2011

Dear Mr. Ng:

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 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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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 (OS) 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,

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Section 4 Indications for Use Statement

510(k) Number (if known):

K112477

Device Name: Palindrome™ H Chronic Catheter Palindrome™ SI Chronic Catheter Palindrome™ HSI Chronic Catheter

Indications for Use:

Prescription Use (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)

Contufenee of CORH, Ofice
Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
K112477
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.