The 14.5 Fr Chronic Hemodialysis Catheter with Slotted Symmetrical Tip (Palindrome™) is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted percutaneously or by cut down. Catheters greater than 40 cm implant length are indicated for femoral placement.

Device Description

The 14.5 Fr Chronic Hemodialysis Catheter (Palindrome™) 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 configuration. The proximal end of the catheter shaft contains a polyurethane hub assembly and silicone extension sets.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for a medical device (Palindrome 14.5Fr Chronic Hemodialysis Catheter with slotted symmetrical tip). It asserts substantial equivalence to a predicate device and includes details about its description, intended use, and regulatory classification.

However, the document does not contain any information regarding specific acceptance criteria, a study proving the device meets those criteria, or details regarding performance metrics, sample sizes for testing/training, expert involvement, or comparative effectiveness studies. The "Performance Data" section simply states that verification/validation results demonstrate substantial equivalence to the predicate device based on comparison, but offers no specific data or methodology.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer the specific questions about study details regarding AI or human reader improvement, as this information is not present in the provided text.

The document primarily focuses on regulatory approval and substantial equivalence with a predicate device, rather than a detailed performance study against specific acceptance criteria.

Summary

{0}------------------------------------------------

Fage Inf 2

Image /page/0/Picture/1 description: The image shows the word "KENDALL" in all caps. The font is a serif font, and the letters are bold. The word is centered in the image and takes up most of the space.

REET, MANSFIELD, MASSACHUSETTS 02048 · (508) 261-8000

510(k) Premarket Notification Palindrome 14.5Fr Chronic Hemodialysis Catheter with slotted symmetrical tip

Section B - 510(K) Summary

Date SummaryWas Prepared:	November 24, 2004
Submitter'sInformation:	Kendalla Division of Tyco Healthcare Group LP15 Hampshire StreetMansfield, MA 02048Phone: 508-261-8000Fax: 508-261-8461
Contact:	James WelshDirector, Regulatory AffairsKendalla Division of Tyco Healthcare Group LPTelephone: 508-261-8532Fax: 508-261-8461
Device Trade
Name:	14.5 Fr Chronic Hemodialysis Catheter with Slotted Symmetrical Tip(PalindromeTM)
Device CommonName:	Catheter, Hemodialysis, Apheresis, Intravascular

Classification Panel: Gastroenterology

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

The new style of 14.5 Fr Chronic Hemodialysis Catheter with Slotted Symmetrical Tip (Palindrome™) is substantially equivalent to the existing sizes of 14.5 Fr Palindrome™ Hemodialysis Catheter in intended use, materials, physical characteristics, and performance characteristics. The modifications attributed to the predicate device are the addition of side openings (slots) near the tip.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the word "KENDALL" in all capital letters. The font is a simple, sans-serif style with thick, uniform strokes. The letters are evenly spaced and aligned horizontally, creating a clear and legible presentation of the name.

15 HAMPSHIRE STREET, MANSFIELD, MASSACHUSETTS 02048 • (508) 261-8000

510(k) Premarket Notification Palindrome 14.5Fr Chronic Hemodialysis Catheter with slotted symmetrical tip

Section B - 510(K) Summary

Device Description:

Intended Use:

The 14.5 Fr Chronic Hemodialysis Catheter with Slotted Symmetrical Tip (Palindrome™) is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Implantable lengths greater than 40cm are intended for femoral placement

Performance Data: Performance data for the slotted tip configurations of the 14.5 Fr Chronic . 07/07/2019 Catheter with Symmetrical Tip (Palindrome™) is compared to the 11:51 PM
Hemodialysis Catheter with Symmetrical Tip (Palindrome™) is compared to that of the predicate device identified in this 510(K) summary. Results of verification / validation demonstrate that the new tip configuration is substantially equivalent to the legally marketed device.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 22 2004

Mr. James Welsh Director, Regulatory Affairs Kendall A Division of Tyco Healthcare Group, LP 15 Hampshire Street MANSFIELD MA 02048

Re: K043272

K.043272
Trade/Device Name: 14.5 Fr Chronic Hemodialysis Catheter with Slotted Symmetrical Tip (Palindrome ™) Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: 78 MSD Dated: November 24, 2004 Received: November 26, 2004

Dear Mr. Welsh:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section >10(x) premained insubstantially equivalent (for the indications referenced above and nave decimined the devices marketed predicate devices marketed in interstate for use stated in the Ciclosure) to legally management of the Medical Device Amendments of to commerce prior to May 28, 1776, the enatified in accordance with the provisions of the Federal controls devices that have been reclassified in accessed in the device, subject to the general controls and Cosment Act (rec). Tou may, alectresponsible to determine that the medical devices your provisions of the Act. "However, you are reen determined as substantially equivalent under the program use as components in the Kir have enner occh of the act), or were legally on the market prior to
premarket notification process (Section 510(k) of the act), or were legally premarket notification process (Declient Process (Device Amendments. Please note: If your May 26, 1970, the chacinent and of the (i.e., unfinished) and further process (e.g., sterilize) purchase your device components in oan (ding these components in your kit. The general you must submit a new 310(tr) overte requirements for annual registration, listing of devices, controls provisions of the Fee md labeling, and prohibitions against misbranding and adultcration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), IT your device is classified (see above) the extine was regulations affecting your device can be It may be subject to additional comreisers . Title 21, Parts 800 to 898. In addition, FDA may found in the South of and of concerning your device in the Federal Register.

{3}------------------------------------------------

Page 2 - Mr. James Welsh

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 (301) 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/dsma/dsmamain.html.

Sincerely yours,

David H. Lippman

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

Enclosure

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the word "KENDALL" in all capital letters. The font is a bold, sans-serif typeface. The letters are evenly spaced and the word is centered.

15 HAMPSHIRE STREET, MANSFIELD, MASSACHUSETTS 02048 · (508) 261-8000

510(k) Premarket Notification Palindrome 14.5Fr Chronic Hemodialysis Catheter with slotted symmetrical tip

Appendix 1

Indications for Use Statement

Device Name:

14.5 Fr Chronic Hemodialysis Catheter with Slotted Symmetrical Tip (Palindrome™)

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use_

Daniel R. Hysom

(Division Si Division of Reproductive, Abdominal, 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.