The 14.5 Fr Chronic Hemodialysis Catheter with Symmetrical Tip (Palindrome™) is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown.

Device Description

The 14.5 Fr Chronic Hemodialysis Catheter (Palindrome™) has a radiopaque polydiethane shalt with two large infost was to a symmetrical tip configuration. The proximal rne distall one of the catheter a polyurethane hub assembly and sillcone extension sets.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, specifically a hemodialysis catheter. However, it does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

The document focuses on establishing substantial equivalence to a predicate device based on intended use, materials, physical characteristics, and performance characteristics, but it does not detail specific performance data or a study design.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor can I answer any of the subsequent questions regarding sample sizes, ground truth, expert involvement, or adjudication methods, as this information is not present in the provided text.

The text mentions: "Performance Data: Performance data for the 14.5 Fr Chronic Hemodialysis Catheter r en offinance Data: P Chomars and for the Predicate device with Symmetrical Tip (Palindrome™) is compared to that of the predicate device identified in this 510(K) summary. the modified device is substantially equivalent to the legally marketed device." This statement indicates that performance data was considered in the submission, but the actual data, acceptance criteria, and study details are notably absent from this summary.

Summary

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Pega. Jofa.

510(k) Premarket Notification - K033676 Palindrome 14.5 Fr Chronic Hemodialysis Catheter

FEB 2, 0 2004

Section B – Special 510(K) Summary

Date SummaryWas Prepared:	January 6, 2004
Submitter'sInformation:	Kendalla Division of Tyco Healthcare Group LP15 Hampshire StreetMansfield, MA 02048Phone: 508-261-8000Fax: 508-261-6644
Contact:	James WelshDirector, Regulatory AffairsKendalla Division of Tyco Healthcare Group LPTelephone: 508-261-8532Fax: 508-261-8461
Device TradeName:	14.5 Fr Chronic Hemodialysis Catheter with Symmetrical Tip(PalindromeTM)
Device CommonName:	Catheter, Hemodialysis, Apheresis, Intravascular

Classification Panel: Gastroenterology

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Legally Marketed Devices To William Catheter with Symmetrical Tip (Palindrome™)
The 14.5 Fr Chronic Hemodialysis Catheter with Symmetrical Tip (Palindrome M) is substantially equivalent to the Kendall's MAHURKAR MAXID 14.5 Fr Hemodialysis Catheter in intended use, materials, physical characteristics, and performance characteristics. The modifications attributed to the predicate device are onaracterforms. "The catheter tip to a symmetrical shape, and (2) use of a bi-furcated tunneler specifically accommodating the symmetrical tip configuration, and (3) process changes in printing and cuff bonding that are unrelated to the tip change.

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Section B - 510(K) Summary

Device Description:

Device Description:
The 14.5 Fr Chronic Hemodialysis Catheter (Palindrome™) has a radiopaque The 14.5 + Onfortion Homens designed in a "double D" configuration. polydiethane shalt with two large infost was to a symmetrical tip configuration. The proximal rne distall one of the catheter a polyurethane hub assembly and sillcone extension sets.

Intended Use:

Performance Data: Performance data for the 14.5 Fr Chronic Hemodialysis Catheter r en offinance Data: P Chomars and for the Predicate device
with Symmetrical Tip (Palindrome™) is compared to that of the predicate device
identified in this 510(K) summary. the modified device is substantially equivalent to the legally marketed device.

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Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 0 2004

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

Re: K033676

K033070
Trade/Device Name: Pallindrome", 14.5 Fr Hemodialysis Catheter with Symmetrical Tip Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: 78 MSD Dated: November 17, 2003 Received: November 24, 2003

Dear Mr. Welsh:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becamed the device is substantially equivalent (for the indications ferenced above and nave user.inneally marketed predicate devices marketed in interstate for use stated in the encreativent date of the Medical Device Amendments or to commerce prior to May 20, 1978, tix ecordance with the provisions of the Federal Food, Drug, devices mat have occh reclassinou in acesses, market the device, subject to the general controls and Cosmedical Act (Act). Tou may, aterersponsible to determine that the medical devices you provisions of the Act. Trowever, you are been determined as substantially equivalent under the use as components in the Kir have ethier 000 s of the act), or were legally on the market prior to premarket nonifeation process (Section Sedical Device Amendments. Please note: If you May 26, 1970, the enabilities ants in bulk (i.e., unfinished) and further process (e.g., sterilize) purchase your device components in ount (ding these components in your kit. The general you must sublin a new 910(t) of the equirements for annual registration, listing of devices, controls provisions of the revand labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (500 abov 0) . Existing major regulations affecting your device can be it may of subject to additional condentions, Title 21, Parts 800 to 898. In addition, FDA may found in the South of the 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 Flease be advised that I Dri b issualite or our device complies with other requirements of the Act that ITA has made a determination administered by other federal agencies. You must of any Federal statutes and regulations and limited to: registration (21 CFR Part Comply with an the Net 3 requirementing (21 CFR Part 801); good manufacturing practice 807), lisung (21 CFR Part 007), assist systems (QS) regulation (21 CFR Part 820); and if requirements as set roni in allo quality of 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) I ms letter will anow you to begin mationing of substantial equivalence of your device to a legally prematication. The PDF intonemal sification for your device and thus, permits your marketed proceed to the market. If you desire specific advice for your device on the labeling device to proceed to the manier. 11 year compliance at (301) 594-4616. Also, please note the regulation, prease contact the Orition of erence to premarket notification"(21 CFR Part 807.97). Tegulation chilities, "Misoranaing of your responsibilities under the Act from the 1 ou may other general mismational 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 A. Lyman

Image /page/3/Picture/5 description: The image shows a handwritten word that appears to be "for". The writing is in cursive and the letters are connected. The image is in black and white and the background is white.

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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Ko33676

Indications for Use Statement

Device Name:

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

Indications for Use:

The 14.5 Fr Chronic Hemodialysis Catheter with Symmetrical Tip (Palindrome™) The 14.5 Pr Chronic Hemodialysis Galletier man of min of 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*✓
(Per 21 CFR 801.109)
OR
Over-The-Counter Use*

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K033676

Concurrence of CDRH, Office of Device Evaluation (ODE)

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.