These sets are used during Peritoneal Dialysis therapy to transfer peritoneal dialysis solution to the patient catheter from the source solution container.

Device Description

The MiniCap Extended Life PD Transfer Set with Twist Clamp – Code 5C4482A and MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483 are single use, sterile, non-pyrogenic devices for use with Baxter peritoneal dialysis systems. A Transfer Set is connected to a Titanium Adapter that is at the end of an implanted peritoneal catheter. The Transfer Sets stay connected to the patient and allow for the exchange of peritoneal dialysis solution into and out of the peritoneal cavity as prescribed.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding Baxter Healthcare Corporation's MiniCap Extended Life PD Transfer Sets. It focuses on demonstrating substantial equivalence to a legally marketed predicate device, not on proving that a device meets specific acceptance criteria through a study as one might conduct for a new AI/software-as-a-medical-device (SaMD) product.

Therefore, the requested information (acceptance criteria, details of a study proving device performance, sample sizes, ground truth establishment, MRMC studies, etc.) is not applicable to this type of FDA submission (510(k) for a physical medical device, specifically a transfer set for peritoneal dialysis).

Here's why and what information is provided:

Why the requested information is not applicable:

Device Type: The "device" in question is a physical medical device (Peritoneal Dialysis Transfer Set), not an AI/software product. The typical acceptance criteria and study designs for SaMD (which would involve accuracy, sensitivity, specificity, human reader performance, etc.) do not apply here.
Submission Type (510(k)): A 510(k) submission aims to demonstrate "substantial equivalence" to a predicate device already on the market. It does not require a full clinical trial or a study proving independent performance against specific clinical acceptance criteria in the same way a PMA (Premarket Approval) or a SaMD submission might. The focus is on showing the new device is as safe and effective as a previously cleared device, not necessarily proving new clinical benefit or performance from scratch.
Nature of Changes: The document explicitly states the primary change is a "material change" from Dichlorobenzoyl peroxide cured silicone to platinum cured silicone for the tubing. This triggers a need to demonstrate that this material change does not negatively impact the device's fundamental function, safety, or biocompatibility.

What information is provided in the document and how it relates to device proving safety and effectiveness for a 510(k):

Instead of a "study proving the device meets acceptance criteria" in the AI/SaMD sense, the document details "non-clinical tests" and "performance data" that support the device's safety and functional equivalence after a material change.

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: While not presented in a formal table with specific numerical targets like for an AI model's operating characteristics, the document implies acceptance criteria by stating "All results meet their acceptance criteria." These criteria would be tied to the functional tests described, ensuring the device performs as intended (e.g., no leaks, proper flow rate, withstands pressure, biocompatibility).
- Reported Device Performance: Instead of performance metrics like accuracy, the "performance data" section lists the types of tests conducted:
  - Visual Inspection
  - Initial Pressure Test (clamp in closed position)
  - Cycling (conditioning step prior to pressure tests)
  - 8 psi Pressure Test Post Cycling (clamp in both open and closed position)
  - 5 lb Pull of Tubing to Barb Connection
  - Functionality after Iodine Exposure (over 48 hours continuous and 6 months simulated use)
  - Flow Rate (after iodine exposure)
  - Shelf Life
- Biocompatibility Testing: Per ISO 10993-1 and FDA Guidance: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Sub-chronic Toxicity, Genotoxicity, Implantation, Hemolysis, Extractables and Leachables (per ISO 9003-18:2020), Toxicological Evaluation (per ISO 10993-17:2002).
- No specific numerical results are provided in this summary document, only the types of tests performed and the general conclusion that "The non-clinical data supports the safety of the proposed devices and demonstrates that the proposed devices perform comparably to the predicate device that is currently marketed for the same intended use."
Sample sizes used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test in this summary. For physical device testing, sample sizes are typically determined by statistical methods for device reliability, manufacturing process validation, and regulatory standards (e.g., ISO, ASTM standards for material testing, biocompatibility). These are generally much smaller than data sets for AI models.
- Data Provenance: Not applicable. These are laboratory/bench tests, not clinical data from patients or specific countries.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth, in the context of AI models, refers to verified labels (e.g., disease presence/absence in an image). For a physical medical device like this, "ground truth" would be the engineering specifications and performance standards established by the manufacturer and relevant regulatory bodies. Experts involved would be engineers, material scientists, toxicologists, and quality control professionals.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. This is a concept used in medical image annotation or clinical trial data interpretation by multiple readers. For physical device testing, results are typically objective (e.g., pass/fail a pressure test) and follow standardized protocols.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a physical medical device, not an AI or imaging diagnostic device. MRMC studies are not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth: For this device, the "ground truth" is defined by established engineering specifications, material properties, and performance standards expected for a product of this type. It's based on objective measurements from laboratory tests and compliance with recognized standards (e.g., ISO 10993 for biocompatibility).
The sample size for the training set:
- Not Applicable. This is not an AI/ML model.
How the ground truth for the training set was established:
- Not Applicable. This is not an AI/ML model.

In summary: The provided document is a regulatory letter for a 510(k) submission of a physical medical device undergoing a material change. The information required for your query predominantly applies to software/AI medical devices, particularly those involving image analysis or diagnostic support. The "study" mentioned in the document refers to a series of non-clinical functional and biocompatibility tests designed to ensure the modified physical device maintains safety and performance comparable to its predicate.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

March 12, 2024

Baxter Healthcare Brad Roynon Associate Director, Regulatory Affairs 2512 W. Illinois Route 120 Round Lake, Illinois 60073

Re: K231849

Trade/Device Name: MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483 Regulation Number: 21 CFR 876.5630 Regulation Name: Set, Administration, For Peritoneal Dialysis Regulatory Class: Class II Product Code: KDJ Dated: February 15, 2024 Received: February 15, 2024

Dear Brad Roynon:

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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.

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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Maura Rooney -S

Maura Rooney Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity

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and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K231849

Device Name

MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483

Indications for Use (Describe)

These sets are used during Peritoneal Dialysis therapy to transfer peritoneal dialysis solution to the patient catheter from the source solution container.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Section 5. 510(k) Summary

JUNE 23, 2023

OWNER:

Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015

CONTACT PERSON:

Brad Roynon Assoc. Director, Global Regulatory Affairs Kidney Care PD 25212 W. Illinois Route 120 Round Lake, IL 60073 Telephone: +1.262.581.7157 Fax: +1.224.270.4119

IDENTIFICATION OF THE DEVICE:

Common Name: Transfer Sets Trade/Device Name: MiniCap Extended Life PD Transfer Set with Twist Clamp – Code 5C4482A MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483 Classification Panel: 78 Gastroenterology/Urology Regulation Number: 21 CFR 876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: Class II Product Code: KDJ

Table 1. Baxter Product Code(s) for Transfer Sets

Baxter Code Number	Name
5C4482A	MiniCap Extended Life PD Transfer Set with TwistClamp
5C4483	MiniCap Extended Life PD Transfer Set with TwistClamp - Extra Short

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PREDICATE DEVICE:

			Table 2. Predicate Device(s)
--	--	--	------------------------------

Device	Company	Predicate 510(k)	Clearance Date
MiniCap Extended LifePD Transfer Sets	Baxter HealthcareCorporation	K152675	10/29/2015

DESCRIPTION OF THE DEVICE:

INDICATIONS FOR USE:

These sets are used during Peritoneal Dialysis therapy to transfer peritoneal dialysis solution to the patient catheter from the source solution container.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:

The proposed devices have equivalent technological characteristics as Baxter's currently legally marketed Transfer Sets cleared under 510(k) premarket notification K152675 (cleared on October 29, 2015). The intended use, design and function of the proposed devices are equivalent to the predicate device.

Features	Predicate DeviceCleared underK152675	Proposed DeviceTransfer Sets	Discussion ofDifferences
Intended Use	This set is usedduring Peritonealdialysis therapy totransfer peritonealdialysis solution tothe patient catheterfrom the sourcesolution container.	These sets are used duringPeritoneal Dialysis therapy totransfer peritoneal dialysissolution to the patient catheterfrom the source solutioncontainer.	N/A
Features	Predicate DeviceCleared underK152675	Proposed DeviceTransfer Sets	Discussion ofDifferences
Indications forUse	This set is usedduring Peritonealdialysis therapy totransfer peritonealdialysis solution tothe patient catheterfrom the sourcesolution container.	These sets are used duringPeritoneal Dialysis therapy totransfer peritoneal dialysissolution to the patient catheterfrom the source solutioncontainer.	N/A
Contraindications	Do not use povidone-iodine to connect theTransfer Set to theBaxter TitaniumAdapter if there is aknown history ofallergic reaction toiodine. Use otherdisinfectants orantiseptic agents thatdo not contain iodine,hydrogen peroxide,alcohol or bleach.	Do not use povidone-iodine toconnect the Transfer Set to theBaxter Titanium Adapter if thereis a known history of allergicreaction to iodine. Use otherdisinfectants or antiseptic agentsthat do not contain iodine,hydrogen peroxide, alcohol orbleach or chlorhexidine gluconate.	Under a previouschange,chlorhexidinegluconate wasadded to theContraindicationssection.
Sterile	Yes (EO)	Same	N/A
Non-Pyrogenic	Yes	Same	N/A
Single Use	Yes	Same	N/A
Fluid Path Materials
Tubing5C4482A/5C4483	Silicone(DichlorobenzoylPeroxide Cured)	Silicone (Platinum Cured)	The proposedtubing materialhas passedfunctional testingfor its intendeduse. Designcontrol activitieshave confirmedthat there is noimpact to safetyor effectiveness.
Female Connector5C4482A/5C4483	Polyester	Same	N/A
Catheter Adapter5C4482A/5C4483	Polyester	Same	N/A

Table 3. Device Comparison

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Table 3. Device Comparison

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DISCUSSION OF NONCLINICAL TESTS:

Baxter Healthcare Corporation conducts risk analysis to determine the design verification tests that need to be conducted based on the change being proposed. All results meet their acceptance criteria and support the idea that the proposed device is appropriately designed for its intended use.

Performance Data:

The following functional testing was performed to ensure proper design and function of the devise based on the change to the material from Dichlorobenzoyl peroxide cured silicone to platinum cured silicone:

Visual Inspection
Initial Pressure Test (clamp in closed position)
Cycling (conditioning step prior to pressure tests)
8 psi Pressure Test Post Cycling (clamp in both open and closed position)
5 lb Pull of Tubing to Barb Connection
Functionality after Iodine Exposure (over 48 hours continuous and 6 months simulated use)
Flow Rate (after iodine exposure)
Shelf Life

Biocompatibility:

Biocompatibility assessment has been conducted on all materials to the category of external communicating devices with tissue bone dentin and indirect blood path contact for long-term contact duration. The biocompatibility evaluation for these devices was conducted in accordance with ISO 10993-1, "Biological evaluation of medical devices -Part 1: Evaluation and testing", as recognized by the FDA, and FDA Guidance Document, "Use of International Standard ISO 10993-1: Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process'', issued June 16, 2016. The battery of testing included:

Cytotoxicity
Sensitization
Intracutaneous Reactivity
Acute Systemic Toxicity

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K231849 Page 5 of 5

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Material Mediated Pyrogenicity ●
Sub-chronic Toxicity
Genotoxicity
Implantation ●
Hemolysis

In addition, extractables and leachables was performed and a toxicological evaluation completed for the change to platinum cured silicone. The extractables and leachables testing was performed per ISO 9003-18:2020, "Biological evaluation of medical devices - Part 18: Chemical characterization of materials". The toxicological evaluation was performed per ISO 10993-17:2002, "Biological evaluation of medical devices – Part 17: Establishment of allowable limits for leachable substances".

Physical or Chemical Information (extractables & leachables)
. Toxicological Evaluation

CONCLUSION:

The non-clinical data supports the safety of the proposed devices and demonstrates that the proposed devices perform comparably to the predicate device that is currently marketed for the same intended use.

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.