The MiniCap Extended Life PD Transfer Sets 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 allows for the exchange of peritoneal dialysis solution into and out of the peritoneal cavity as prescribed.

AI/ML Overview

The provided document describes the K192705 premarket notification for the "MiniCap Extended Life PD Transfer Sets." The acceptance criteria and the study performed to prove the device meets these criteria are outlined in the "DISCUSSION OF NONCLINICAL TESTS" and "Performance Data" sections.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" alongside "reported device performance" with specific quantitative results. Instead, it states that "All results meet their acceptance criteria." The performance data is described as a list of functional tests performed to ensure proper design and function. The acceptance criteria for these tests are implied to be satisfactory performance without specific pass/fail values mentioned.

Acceptance Criteria (Implied)	Reported Device Performance
Proper design and function for intended use	All functional test results met their acceptance criteria
Biocompatibility in accordance with ISO-10993 and FDA Guidance	All biocompatibility tests passed
Visual integrity	Visual Inspection passed
Pressure integrity in closed position	Initial Pressure Test (clamp in closed position) passed
Durability after conditioning	Cycling (Conditioning Step Prior to Pressure Tests) performed successfully
Pressure integrity after cycling (closed position)	8 psi Pressure Test Post Cycling (clamp in closed position) passed
Pressure integrity after cycling (open position)	8 psi Pressure Test Post Cycling (clamp in open position) passed
Strength of tubing-to-barb connections	5 lb Pull of Tubing to Barb Connections passed
Absence of cytotoxicity	Cytotoxicity test passed
Absence of sensitization	Sensitization test passed
Absence of intracutaneous reactivity	Intracutaneous reactivity test passed
Absence of acute systemic toxicity	Acute Systemic toxicity test passed
Absence of material-mediated pyrogenicity	Material Mediated Pyrogenicity test passed
Absence of sub-chronic toxicity	Sub-chronic Toxicity test passed
Absence of genotoxicity	Genotoxicity test passed
Absence of hemolysis	Hemolysis test passed
Acceptable levels of extractables and leachables	Physical or Chemical Information (Extractables & Leachables) assessment passed

2. Sample size used for the test set and the data provenance

The document does not specify the sample size for any of the functional or biocompatibility tests. It also does not explicitly state the provenance of the data (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The document outlines non-clinical testing, which typically involves laboratory testing rather than expert-based ground truth establishment as seen in diagnostic device studies.

4. Adjudication method for the test set

This information is not applicable and is not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple experts are resolving discrepancies in observational data. This document describes non-clinical laboratory testing.

5. 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

A multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This document describes non-clinical testing of a medical device (transfer sets), not a diagnostic algorithm involving human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical medical device (transfer sets), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the functional tests, the "ground truth" would be established by predefined engineering specifications and performance standards relative to the device's intended use. For biocompatibility, the ground truth is established by the accepted standards within ISO 10993 and FDA guidance documents, which define what constitutes a biologically safe material for medical device contact. It's based on objective laboratory measurements and analyses, not expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set

This is not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

This is not applicable as there is no training set for this device.

Summary

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October 25, 2019

Baxter Healthcare Kimberly Garcia Associate, Regulatory Affairs 32650 N. Wilson Road Round Lake, IL 60073

Re: K192705

Trade/Device Name: MiniCap Extended Life PD Transfer Sets Regulation Number: 21 CFR 876.5630 Regulation Name: Peritoneal dialysis system and accessories Regulatory Class: II Product Code: KDJ Dated: September 25, 2019 Received: September 27, 2019

Dear Kimberly Garcia:

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/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.

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

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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/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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/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,

for

Carolyn Y. Neuland, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity 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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Indications for Use

510(k) Number (if known)

Device Name

MiniCap Extended Life PD Transfer Sets

Indications for Use (Describe)

This set is used during Peritoneal Dialysis therapy to transfer peritoneal dialysis solution to the patient from the source solution container.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the text 'K192705' and 'Page 1 of 5' at the top. Below that is the word 'Baxter' in a large, bold, blue font. The text and logo appear to be part of a document or report.

Section 5. 510(k) Summary

September 25, 2019

OWNER:

Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015

CONTACT PERSON:

Kimberly Garcia Associate, Global Regulatory Affairs 32650 N Wilson Road Round Lake, IL 60073 Telephone: 224-270-4401 Fax: 224-270-4119

IDENTIFICATION OF THE DEVICE:

Common Name: Transfer Sets Trade Name or Proprietary Name: MiniCap Extended Life PD Transfer Sets Classification Panel: 78 Gastroenterology/Urology Classification: Set, Administration, For Peritoneal Dialysis, Disposable Regulation Number: 21 CFR 876.5630 Regulation Name: Set, Administration, For Peritoneal Dialysis Regulatory Class: Class II Product Code: KDJ

Baxter Code Number	Name
5C4482	MiniCap Extended Life PD Transfer Set with TwistClamp
5C4483b	MiniCap Extended Life PD Transfer Set with TwistClamp - Extra Short

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

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PREDICATE DEVICE:

Device	Company	Predicate 510(k)	Clearance Date
Extended Life CAPDTransfer Set, PeritonealDialysis TitaniumCatheter Adapter andLocking Cap forTitanium CatheterAdaptera	Baxter HealthcareCorporation	K152675	10/29/2015

Table 2. Predicate Device(s)

a 510(k) K152675 was a bundled submission for both the Extended Life CAPD Transfer Set as well as the Peritoneal Dialysis Titanium Catheter Adapter and Locking Cap for Titanium Catheter Adapter. This 510(k) will only utilize the Extended Life CAPD Transfer Set as a predicate device

b Product Code 5C4483 is included within this submission; however, no updates are being made to this device since it was cleared in K152675.

DESCRIPTION OF THE DEVICE:

INDICATIONS FOR USE:

This set is 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 device has 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	Current Transfer Sets	ProposedTransfer Sets	Discussion ofDifferences
Intended use	This set is used duringPeritoneal dialysis therapyto transfer peritonealdialysis solution to the	Same	N/A

Table 3. Device Comparison

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ATT105100C

Features	Current Transfer Sets	ProposedTransfer Sets	Discussion ofDifferences
	patient catheter from thesource solution container.
Indications for use	This set is used duringPeritoneal dialysis therapyto transfer peritonealdialysis solution to thepatient catheter from thesource solution container	Same	N/A
Contraindications	Do not use povidone-iodineto connect the Transfer Setto the Baxter TitaniumAdapter if there is a knownhistory of allergic reactionto iodine. Use otherdisinfectants or antisepticagents that do not containiodine, hydrogen peroxide,alcohol or bleach.	Same	N/A
Sterile	Yes (EO)	Same	N/A
Non-Pyrogenic	Yes	Same	N/A
Single Use	Yes	Same	N/A
Fluid Path Materials
Tubing 5C4482	Silicone (DichlorobenzoylPeroxide Cured)	Silicone (PlatinumCured)	The proposed tubingmaterial has passedfunctional testing for itsintended use. Designcontrol activities haveconfirmed that there isno impact to safety oreffectiveness.
Tubing 5C4483	Silicone (DichlorobenzoylPeroxide Cured)	Same	N/A
Female Connector5C4482/5C4483	Polyester	Same	N/A
Catheter Adapter5C4482/5C4483	Polyester	Same	N/A

Table 3. Device Comparison

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 that the proposed device is appropriately designed for its intended use.

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Performance Data:

The following functional testing was performed to ensure proper design and function of the devices 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 closed position) ●
8 psi Pressure Test Post Cycling (clamp in open position ●
5 lb Pull of Tubing to Barb Connections ●

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, "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 ●
Material Mediated Pyrogenicity ●
. Sub-chronic Toxicity
Genotoxicity .
Hemolysis .
Physical or Chemical Information (Extractables & Leachables) .

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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.