Argyle(TM) Peritoneal Dialysis Catheter and Kits:
The peritoneal catheter is indicated for acute and chronic peritoneal dialysis.
The peritoneal dialysis catheter may be inserted using open, laparoscopic or percutaneous surgical techniques.

Argyle (TM) Presternal Peritoneal Catheter and Kits:
The presternal peritoneal catheter is indicated for acute and chronic peritoneal dialysis.
The Peritoneal Dialysis catheter may be inserted using open, laparoscopic or percutaneous surgical techniques.

Argyle(TM) Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter:
The Two Part Titanium Luer Adapter is indicated for acute and chronic peritoneal dialysis, to be used with the Argyle(TM) Peritoneal Dialysis Catheter and the Argyle(TM) Presternal Peritoneal Dialysis Catheter. The Two Part Titanium Luer Adapted to provide a permanent threaded closure when used with a standard continuous ambulatory peritoneal dialysis (CAPD) transfer set.

Argyle(TM) Adult Peritoneal Dialysis Accessory Titanium Catheter Extender
The Titanium Catheter Extender is indicated for acute and chronic peritoneal dialysis, to be used with the Argyle(TM) Peritoneal Dialysis Catheter and the Argyle(TM) Presternal Peritoneal Dialysis Catheter.
The adult catheter extender is used to extend a catheter by connecting two portions of the peritoneal catheter tubing.

Device Description

The Argyle™ Peritoneal Dialysis Catheter products are single lumen catheters for acute and chronic peritoneal dialysis to allow consistent bi-directional flow of dialysate into and out of the abdominal cavity. One or more cuffs are bonded on to the catheter tubing, which allows for tissue ingrowth to maintain placement of the catheter. All catheters are made of translucent silicone rubber tubing containing a radiopaque stripe, with felt cuffs available to provide catheter stabilization by virtue of tissue in-growth.

The Argyle™ peritoneal dialysis catheter comes in a variety of lengths and cuff configurations including straight, curled, and Swan Neck catheter styles. The Argyle™ peritoneal dialysis catheter kit contains the basic items needed to insert a peritoneal catheter: a straight or Swan Neck Tenckhoff or Curl Cath catheter with single or double cuff (specified at time of order), a 16 Fr/Ch pull-apart introducer, an 18 G introducer needle, a 12 mL syringe, a J/straight guidewire, tunneling stylet, #11 scalpel, gauze sponges, Beta-Cap™ adapter, cap, clamp, and instructions.

The Argyle™ presternal peritoneal dialysis catheters include the curl catheter and Swan Neck catheter styles. The curl catheter segment contains a felt cuff. The Swan Neck Presternal catheter is a segment of catheter tubing with a Swan Neck bend and two cuffs. It is connected by a double-barbed connector to the intraperitoneal segment of the curl catheter. The Argyle™ presternal peritoneal dialysis catheter kit contains the basic items needed to insert a peritoneal catheter: a 16 Fr/Ch pull-apart introducer, an 18 G introducer needle, a 12 mL syringe, a J/straight guidewire, tunneling stylet, #11 scalpel, gauze sponges, Beta-CapTM adapter, cap, clamp, titanium connector, and instructions.

The titanium adapter is a two-piece luer-lock system with a barbed end and a threaded cover. The adapter is designed to provide a permanent threaded closure when used with a standard CAPD transfer set.

The adult catheter extender is double barbed and made of titanium. The adult catheter extender is used to extend a catheter by connecting two portions of the peritoneal catheter tubing.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format. Instead, it indicates that "All performance testing met acceptance criteria." The performance evaluation is primarily focused on biocompatibility and design verification for the expanded indication of laparoscopic insertion.

Acceptance Criteria Category	Reported Device Performance
Biocompatibility (ISO 10993-1)	Tests conducted for Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Subchronic Toxicity, Genotoxicity (AMES, Mouse Micronucleus), Implantation, and Chronic Toxicity.
	All biocompatibility tests results met ISO 10993 requirements and were deemed acceptable.
Design Verification for Laparoscopic Insertion	Evaluation of insertion through a 7mm/8mm port (trocar).
	Validation testing by clinicians was performed for laparoscopic insertion.
MR Status Verification	Tests conducted to verify MR Safe or MR Conditional status.
	Argyle™ peritoneal dialysis catheters with silicone tubing and radiopaque stripe are MR Safe.
	Argyle™ presternal peritoneal dialysis catheters plus titanium connectors are MR Conditional.
Overall Performance	No specific quantitative metrics provided.
	"All performance testing met acceptance criteria and supports the determination of substantial equivalence to the predicate devices and accessories."

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

Sample Size for Test Set: Not explicitly stated for each test. The document refers to "the PD Catheter" for biocompatibility testing and "the proposed device" for design verification, implying a sufficient number of devices were tested to meet the respective standards, but no specific count is given.
Data Provenance: The document does not specify the country of origin of the data. The studies appear to be retrospective in the sense that they were conducted for regulatory submission to demonstrate equivalence and safety (i.e., not a new clinical trial generating prospective data on patient outcomes).

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

Number of Experts: Not specified.
Qualifications of Experts: It mentions "validation testing by clinicians" for the laparoscopic insertion and "Good Laboratory Practice (GLP)" for biocompatibility, implying qualified professionals were involved, but specific qualifications (e.g., years of experience, specialty) are not detailed.

4. Adjudication Method for the Test Set

No specific adjudication method (e.g., 2+1, 3+1) is mentioned or implied, as the studies are primarily about device performance against technical standards and benchmarks rather than diagnostic accuracy requiring expert consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done. This submission is for a medical device (catheter and accessories), not a diagnostic imaging AI algorithm. Therefore, the concept of human readers improving with or without AI assistance is not applicable.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

No standalone performance study for an algorithm was done. This device is a physical medical device, not an AI algorithm.

7. Type of Ground Truth Used

The concept of "ground truth" as typically applied to AI performance (e.g., expert consensus for image findings, pathology reports) is not directly applicable here. For this medical device, the "ground truth" or reference standards are:

Biocompatibility: Established international standards (ISO 10993-1) and their associated testing protocols.
Design Verification (Laparoscopic Insertion): Engineering specifications, validated insertion methods, and clinician feedback on feasibility and safety during simulated use.
MR Status: Established testing procedures and standards for determining MR compatibility (e.g., ASTM F2503).

8. Sample Size for the Training Set

Not applicable. This submission is for a physical medical device. There is no AI model involved that would require a training set.

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

Not applicable. As there is no AI model, there is no training set or associated ground truth.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 27, 2018

Covidien, llc Carol Ming Sr. Regulatory Affairs Specialist 15 Hampshire Street Mansfield, MA 02048

Re: K180485

Trade/Device Name: Argyle™ Peritoneal Dialysis Catheter and Kits; Argyle™ Presternal Peritoneal Dialysis Catheter and Kits; Argyle™ Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter; Argyle™ Adult Peritoneal Dialysis Accessory Titanium Catheter Extender Regulation Number: 21 CFR& 876.5630 Regulation Name: Peritoneal Dialysis System and Accessories Regulatory Class: II Product Code: FJS, FKO Dated: June 26, 2018 Received: June 27, 2018

Dear Carol Ming:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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/tray. The general controls 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.

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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.

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Joyce M. Whang -S

for

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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Indications for Use

510(k) Number (if known) K180485

Device Name

Argyle(TM) Peritoneal Dialysis Catheter and Kits; Argyle(TM) Presternal Peritoneal Dialysis Catheter and Kits; Argyle(TM) Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter; Argyle(TM) Adult Peritoneal Dialysis Accessory Titanium Catheter Extender

Indications for Use (Describe)

Argyle(TM) Peritoneal Dialysis Catheter and Kits:

The peritoneal catheter is indicated for acute and chronic peritoneal dialysis.

The peritoneal dialysis catheter may be inserted using open, laparoscopic or percutaneous surgical techniques.

Argyle (TM) Presternal Peritoneal Catheter and Kits:

The presternal peritoneal catheter is indicated for acute and chronic peritoneal dialysis.

The Peritoneal Dialysis catheter may be inserted using open, laparoscopic or percutaneous surgical techniques.

Argyle(TM) Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter:

The Two Part Titanium Luer Adapter is indicated for acute and chronic peritoneal dialysis, to be used with the Argyle(TM) Peritoneal Dialysis Catheter and the Argyle(TM) Presternal Peritoneal Dialysis Catheter. The Two Part Titanium Luer Adapted to provide a permanent threaded closure when used with a standard continuous ambulatory peritoneal dialysis (CAPD) transfer set.

Argyle(TM) Adult Peritoneal Dialysis Accessory Titanium Catheter Extender

The Titanium Catheter Extender is indicated for acute and chronic peritoneal dialysis, to be used with the Argyle(TM) Peritoneal Dialysis Catheter and the Argyle(TM) Presternal Peritoneal Dialysis Catheter.

The adult catheter extender is used to extend a catheter by connecting two portions of the peritoneal catheter tubing.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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K180485 Page 1 of 5

510(k) Summary 5.

5.1 Submitter

	Covidien, llc15 Hampshire StreetMansfield, MA 02048
Contact Person:	Carol MingSr. Regulatory Affairs SpecialistPhone: 508.452.1443
Date Prepared:	July 27, 2018

5.2 Device Names and Classifications:

Trade Name:	Argyle™ Peritoneal Dialysis Catheter and Kits
Common Name:	Peritoneal catheter (PD catheter)
Regulation Number:	21 CFR 876.5630
Regulation Name:	Peritoneal Dialysis System and Accessories
Product Code:	FJS
Classification:	Class II
Trade Name:	Argyle™ Presternal Peritoneal Dialysis Catheter and Kits
Common Name:	Peritoneal catheter (PD catheter)
Regulation Number:	21 CFR 876.5630
Regulation Name:	Peritoneal Dialysis System and Accessories
Product Code:	FJS
Classification:	Class II
Trade Name:	Argyle™ Peritoneal Dialysis Accessory Two Part Titanium LuerAdapter
Common Name:	Titanium Connector (2 part)
Regulation Number:	21 CFR 876.5630
Regulation Name:	Peritoneal Dialysis System and Accessories
Product Code:	FKO
Classification:	Class II
Trade Name:	Argyle™ Adult Peritoneal Dialysis Accessory Titanium CatheterExtender
Common Name:	Titanium catheter extender
Regulation Number:	21 CFR 876.5630
Regulation Name:	Peritoneal Dialysis System and Accessories
Product Code:	FJS
Classification:	Class II

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5.3 Predicate Device

Flex-Neck® ExxTended™ PD Catheter & Accessories, FJS, K071167

Device Description 5.4

The adult catheter extender is double barbed and made of titanium. The adult catheter extender is used to extend a catheter by connecting two portions of the peritoneal catheter tubing.

Model Names/Types	Indications
Peritoneal Dialysis Catheter and Kits	The peritoneal catheter is indicated for acute andchronic peritoneal dialysis.The peritoneal dialysis catheter may be insertedusing open, laparoscopic or percutaneous surgicaltechniques.

5.5 Indications for Use

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Model Names/Types	Indications
Presternal Peritoneal Catheters and Kit	The presternal peritoneal catheter is indicated foracute and chronic peritoneal dialysis.The Peritoneal Dialysis catheter may be insertedusing open, laparoscopic or percutaneous surgicaltechniques.
Peritoneal Dialysis Accessory TwoPart Titanium Luer Adapter	The Two Part Titanium Luer Adapter is indicatedfor acute and chronic peritoneal dialysis, to beused with the Argyle(TM) Peritoneal DialysisCatheter and the Argyle(TM) PresternalPeritoneal Dialysis Catheter.The Two Part Titanium Luer Adapter is designedto provide a permanent threaded closure whenused with a standard continuous ambulatoryperitoneal dialysis (CAPD) transfer set.
Adult Peritoneal Dialysis AccessoryTitanium Catheter Extender	The Titanium Catheter Extender is indicated foracute and chronic peritoneal dialysis, to be usedwith the Argyle(TM) Peritoneal Dialysis Catheterand the Argyle(TM) Presternal PeritonealDialysis Catheter.The adult catheter extender is used to extend acatheter by connecting two portions of theperitoneal catheter tubing.

Comparison to Predicate Device 5.6

This submission addresses the Peritoneal Dialysis Catheter and Kits and the Peritoneal Dialysis Presternal Catheter and Kits. Also included in the submission are accessories used with these devices, the Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter and the Adult Peritoneal Dialysis Accessory Titanium Catheter Extender. The new information presented in this submission is for the addition of the laparoscopic placement to the indications for use in the IFUs for the PD catheters and kits. In addition, the MR status of the devices in this submission is being added to the IFUs for the devices.

The Merit device, the Flex-Neck® ExxTended™ PD Catheter & Accessories, is being used as a predicate device as the IFU for the Flex-Neck® ExxTended™ PD Catheter & Accessories includes the option for laparoscopic placement in the indications for use statement. The updates to the IFUs did not entail any design changes to the subject devices.

The predicate and proposed PD catheter devices and accessories are the same devices and accessories, as this submission addresses only adding an indication to the Instructions for Use (IFU) for inserting the peritoneal dialysis catheters through a port, laparoscopically. The IFUs for the devices are also being updated to indicate the devices as having MR Safe or MR Conditional status.

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The PD catheters and accessories have an equivalent design, materials and principles of operation and technology when compared to the predicate device. The indications for use of the PD catheters is being updated to include an indication for laparoscopic placement. The MR Safe or MR Conditional status of the devices and accessories is also being included in the updated IFUs for these products.

Intended Use: Peritoneal Dialysis catheters are intended to provide access for acute and ● chronic peritoneal dialysis. The catheter functions as a means to deliver and extract peritoneal dialysis solution in and out of the patient's peritoneal cavity.
Materials: The materials of the proposed PD Catheters and accessories are the same as ● the predicate devices.
. Principles of Operation and Technology: The technology of the proposed devices and accessories and the predicate device is the same.
Performance: The performance of the proposed PD Catheters and accessories remains unchanged and continues to meet the performance specifications.

Performance Data 5.7

Biocompatibility:

The biocompatibility evaluation was conducted for an externally communicating, tissue/bone/dentin, and permanent duration (>30 days) device. The series of testing was conducted utilizing the PD Catheter and using Good Laboratory Practice (GLP). The testing procedures are based on the requirements of ISO 10993-1 and the following series of testing was conducted utilizing the Argyle Peritoneal Dialysis Catheter:

. Cytotoxicity
Sensitization
Irritation

Acute Systemic Toxicity ●
Subchronic Toxicity ●
- Genotoxicity
  - o AMES
    - o
    - 0 Mouse Micronucleaus
Implantation
Chronic Toxicity ●

The results of the biocompatibility tests conducted on the PD catheter meet the ISO 10993 requirements and have been deemed acceptable.

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Performance Testing:

Design verification testing was performed with the proposed device to support the indication expansion for laparoscopic insertion, including evaluation of insertion through a 7mm/8mm port (trocar).

The updates being made to the IFUs to include insertion through a port under laparoscopic visualization was subjected to validation testing by clinicians. Finally, test results are included to verify that the catheters and accessories are MRI Safe or MR Conditional. The IFUs for the catheters and accessories have been updated to include that information.

All performance testing met acceptance criteria and supports the determination of substantial equivalence to the predicate devices and accessories.

Performance Testing (Animal)

None Provided

Performance Testing (Clinical)

None Provided

5.8 Conclusions

Medtronic has demonstrated that the Peritoneal Dialysis (PD) Catheters are substantially equivalent to the predicate device and supports the update to the indications for use to include the laparoscopic placement indication.

In addition, Argyle™ peritoneal dialysis catheter's manufactured with silicone tubing and radiopaque stripe strip are considered to be MR Safe, while the Argyle™ presternal peritoneal dialysis catheters plus titanium connectors are considered MR Conditional.

Regulation Number and Section

§ 876.5630 Peritoneal dialysis system and accessories.

(a)
Identification. (1) A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.(2) The peritoneal access device is a flexible tube that is implanted through the abdominal wall into the peritoneal cavity and that may have attached cuffs to provide anchoring and a skin seal. The device is either a single use peritioneal catheter, intended to remain in the peritoneal cavity for less than 30 days, or a long term peritoneal catheter. Accessories include stylets and trocars to aid in the insertion of the catheter and an obturator to maintain the patency of the surgical fistula in the abdominal wall between treatments.
(3) The disposable administration set for peritoneal dialysis consists of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysate filter to trap and remove contaminating particles.
(4) The source of dialysate may be sterile prepackaged dialysate (for semiautomatic peritoneal dialysate delivery systems or “cycler systems”) or dialysate prepared from dialysate concentrate and sterile purified water (for automatic peritoneal dialysate delivery systems or “reverse osmosis” systems). Prepackaged dialysate intended for use with either of the peritoneal dialysate delivery systems is regulated by FDA as a drug.
(b)
Classification. Class II (special controls). The following accessories are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9: A catheter finger grip that is non-patient contacting and intended for single use with a peritoneal catheter; a continuous ambulatory peritoneal dialysis (CAPD) belt; and a catheter stand that does not include weigh scales.