The large-bore two-lumen catheter is indicated for temporary or short-term hemodialysis and apheresis. It may be inserted in the subclavian or femoral veins.

Device Description

The device is a dual-lumen, polyurethane catheter, 14 French in size, with two independent non-communicating lumens, extension lines, Luer hubs and extension line clamps. Each lumen exits at the distal end of the catheter through individual ports spaced at a given distance apart. A soft tip that is more pliable than the catheter body is grafted onto the distal tip of the catheter. At the proximal end of the juncture hub the lumens are connected to clear separate extension lines. Each extension line contains either a red or blue clamp. The colored clamps indicate arterial flow (outflow) or venous flow (inflow). Also, centimeter markings are placed along the length of the indwelling catheter body to facilitate proper positioning. The catheter is available in a length of 16cm and is identical in appearance and function to the other manufactured catheter products aforementioned in section 3b. Moreover, the ARROW 14 Fr Hemodialysis Catheter is also identical to the ARROW predicate catheter with the exception of French size.

An ARROW 14 Fr Hemodialysis Two-Lumen Catheterization Kit consists of a dual-lumen catheter packaged with various accessory components that are required during catheterization. These components include combinations of the following: spring wire guides, dilators, introducer needles, catheter over needle assemblies, syringes, pressure transduction probes, scalpels, disposal cups and medication. Moreover, the kit also includes labeling information including instructions for use, contents sheet and various unit package labels. The contents of the kit are contained in tray and wrapped with in an absorbent cloth. The wrapped kit is then packaged into another tray and sealed with Tyvek lidstock. The complete trays are placed in shipping containers, labeled and sterilized.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the ARROW 14 Fr Hemodialysis Two-Lumen Catheterization Kit:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list numerical acceptance criteria for each test. Instead, it states that "The results of the laboratory tests demonstrated that the device is safe, and as effective as the legally marketed predicate device." This implies a comparison to a predicate device and meeting equivalent performance.

Test	Acceptance Criteria (Implied)	Reported Device Performance	Comments
Tensile tests (Blue tip to catheter body, Catheter body to juncture hub, Extension lines to juncture hub)	Equivalent to predicate device	Demonstrated safety and effectiveness equivalent to predicate	No specific numerical values provided in the summary.
Flow rate test	Equivalent to predicate device	Demonstrated safety and effectiveness equivalent to predicate	No specific numerical values provided in the summary.
Prime volume test	Equivalent to predicate device	Demonstrated safety and effectiveness equivalent to predicate	No specific numerical values provided in the summary.
Flex fatigue	Equivalent to predicate device	Demonstrated safety and effectiveness equivalent to predicate	No specific numerical values provided in the summary.
Recirculation	Equivalent to predicate device	Demonstrated safety and effectiveness equivalent to predicate	No specific numerical values provided in the summary.
Kink test	Equivalent to predicate device	Demonstrated safety and effectiveness equivalent to predicate	No specific numerical values provided in the summary.
Shelf-Life; mechanical age testing	Equivalent to predicate device	Demonstrated safety and effectiveness equivalent to predicate	No specific numerical values provided in the summary.
Mechanical hemolysis	Equivalent to predicate device	Demonstrated safety and effectiveness equivalent to predicate	No specific numerical values provided in the summary.

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

The document does not provide the specific sample sizes used for each of the performance tests. It only lists the types of tests conducted.

The data provenance is not explicitly stated as 'country of origin' or 'retrospective/prospective'. However, since these are laboratory performance tests for a medical device seeking FDA clearance, they would typically be conducted in a controlled, prospective manner by the manufacturer (ARROW International, Inc., based in the USA).

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

This information is not applicable and not provided in the document. The "ground truth" for a medical device's physical and functional performance tests (like tensile strength, flow rate) is established through standardized engineering and laboratory testing protocols, not through expert human review of data in the same way, for example, a diagnostic imaging device might require expert radiologist review. The document focuses on objective physical and functional characteristics.

4. Adjudication Method for the Test Set

This is not applicable to the type of performance testing described. Adjudication methods (like 2+1, 3+1) are typically used for studies involving human interpretation or subjective assessments, such as clinical trials or diagnostic imagery reviews, where multiple readers might have differing opinions. For physical device performance tests, the results are typically quantitative and objectively measured.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. The device described is a hemodialysis catheter, which is a physical medical device, not an AI-powered diagnostic tool requiring human interpretation. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers would not be relevant to this product.

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

This is not applicable for the reasons stated in point 5. The device itself is not an algorithm. The performance tests are for the physical integrity and function of the catheter.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests listed (tensile, flow rate, prime volume, flex fatigue, recirculation, kink, shelf-life, mechanical hemolysis) would be objective laboratory measurements based on established engineering and materials science principles, and comparison to the performance of the legally marketed predicate device.

8. The Sample Size for the Training Set

There is no "training set" in the context of this device's performance testing. The listed tests are for verification and validation of the device's physical and functional properties, not for training a machine learning model.

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

As there is no training set for an AI/algorithm in this context, this point is not applicable.

Summary

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MAY 2 6 1999

Special 510(k): Device Modification 14 Fr Hemodialysis Two-Lumen Catheterization Kit Page 8 of 15

Section 5 - 510(k) Summary

a. Submitter

ARROW International, Inc. 2400 Bernville Road Reading, PA 19605

Contact Person: Thomas D. Nickel Vice President, Regulatory Affairs and Quality Assurance 610-478-3137

Date summary prepared: April 22, 1999

b. Device

Trade Name: Two-Lumen Hemodialysis Catheterization Kit

Common Name: Hemodialysis Catheter

Classification Name: Blood Access Device and Accessories (non-implanted version).

Legally marketed device to which the device is substantially equivalent ن

The device is substantially equivalent to the current legally ARROW 12 Fr Large-Bore Dual Lumen Hemodialysis Catheterization Kit. Moreover, the subject device also has similar mechanical properties compared to the legally marketed Vas~Cath® Niaqara™ Catheter,

d. Description of device

1. 14 Fr Two-Lumen Hemodialysis Catheter

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Special 510(k): Device Modification 14 Fr Hemodialysis Two-Lumen Catheterization Kit Page 9 of 15

Image /page/1/Picture/1 description: The image shows the text "K991431" on the top line and "p. 2/2" on the bottom line. The text is written in a simple, sans-serif font and appears to be handwritten. The numbers are clearly legible, and the overall image has a clean, straightforward appearance.

2. 14 Fr Hemodialysis Two-Lumen Catheterization Kit

An ARROW 14 Fr Hemodialysis Two-Lumen Catheterization Kit consists of a duallumen catheter packaged with various accessory components that are required during catheterization. These components include combinations of the following: spring wire guides, dilators, introducer needles, catheter over needle assemblies, syringes, pressure transduction probes, scalpels, disposal cups and medication. Moreover, the kit also includes labeling information including instructions for use, contents sheet and various unit package labels. The contents of the kit are contained in tray and wrapped with in an absorbent cloth. The wrapped kit is then packaged into another tray and sealed with Tyvek lidstock. The complete trays are placed in shipping containers, labeled and sterilized.

e. Intended use of the device

The large-bore two-lumen catheter is indicated for temporary or short-term hemodialysis and apheresis. It may be inserted in the subclavian or femoral veins.

f. Technological characteristics

The device has the same exact technological characteristics as the predicate.

The performance tests included in the submission include:

1. Tensile tests
- a) Blue tip to catheter body
- b) Catheter body to juncture hub
- c) Extension lines to juncture hub
1. Flow rate test
1. Prime volume test
1. Flex fatigue
1. Recirculation
1. Kink test
1. Shelf-Life; mechanical age testing
1. Mechanical hemolysis

The results of the laboratory tests demonstrated that the device is safe, and as effective as the legally marketed predicate device.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a symbol that appears to be three stylized human profiles facing to the right, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 6 1999

Thomas D. Nickel Vice President. Regulatory Affairs and Quality Assurance Arrow International, Inc. 2400 Bernville Road Reading, Pennsylvania 19605

Re: K991431

Trade Name: 14 Fr Two-Lumen Hemodialysis Catheterization Kit Regulatory Class: II Product Code: 78 MPB Classification: 21 CFR §876.5540 Dated: April 22, 1999 Received: April 26, 1999

Dear Mr. Nickel:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 (the Act). You may, therefore, market the device, subject to the general controls provisions of 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 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/tray. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may

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Page 2 - Thomas D. Nickel

result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

FDA notes that your device will contain sutures for which you have provided evidence that the suture characteristics are not altered by the sterilization process used for the device. However, you should be aware of the following additional information regarding the inclusion of a suture as a component of your device:

The labeling, packaging and method of sterilization of the suture cannot be changed 1. without prior notification, review and clearance by FDA.
1. The supplier of the sutures used in your device cannot be changed without prior notification, review and clearance by FDA.

In addition, we have determined that your device kit contains povidone-iodine ointment, povidone-iodine swabsticks, and lidocaine, which are subject to regulation as drugs.

Our substantially equivalent determination does not apply to the drug components of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug components. For information on applicable Agency requirements for marketing these drugs, we suggest you contact:

Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0101

This letter will allow you to begin marketing your device as described in your 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 our labeling regulation (21 CFR Part 801 and additionally 809 for in vitro diagnostic devices). please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general

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Page 3 -- Thomas D. Nickel

information on your responsibilities under the Act, may be obtained from the Division of Small Manufacturers 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,

SABER, said S. Saleh, MD

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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199102 1

Section 6 – Indications for use

Device name: 14 Fr. Two-Lumen Hemodialysis Catheterization Set

Indications for use:

The large-bore two-lumen catheter is indicated for temporary or short-term hemodialysis and apheresis. It may be inserted in the subclavian or femoral veins.

Signature

(Division Sign-Off) (Division Sign-Off)
Division of Reproductive, Abdominal, ENT, Division of Ropal Devices 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.