Baxter's Cycler Drainage Bag product line currently consists of a sterile 15L Cycler Drainage Bag (5C4145P). This 15 L Cycler Drainage Bag is a single use device intended for the collection of effluent during Automated Peritoneal Dialysis (APD) Therapy and can be used with Baxter's APD Sets with Cassette, Manifold Sets and Extension Sets. The purpose of this drain bag is to allow the collection of the spent effluent in the event that a patient does not have access to a drain from the location where APD therapy is performed. The basis for this submission is the addition of a non-sterile version of the 15L Cycler Drainage Bag to the current product line. The product line does not come into direct or indirect contact with the patient's body tissue. The intended use, material, design, and function of the proposed device will be the same as the currently marketed 15 L Cycler Drainage Bag.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a new non-sterile version of Baxter's 15L Cycler Drainage Bag (product code 5C4145NS), comparing it to the currently marketed sterile version (5C4145P) which serves as the predicate device. The primary difference is the sterility status.

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria	Reported Device Performance (Implied)
Capacity/Leak (5C4145P)	The product shall hold 16 liters of water for 24 hours without leak.	Met
Capacity/Leak (5C4145NS)	The product shall hold 16 liters of water for 48 hours without leak.	Met
Drain Line Spike/Leak	Force to spike drain line connector shall be no more than 35 lbf with no leak at 8psig for 10 seconds.	Met
Drain Line Spike Removal (5C4145P)	Force to remove spike connector after a 24-hour therapy shall be no less than 3 lbf.	Met
Drain Line Spike Removal (5C4145NS)	Force to remove spike connector after a 48-hour therapy shall be no less than 3 lbf.	Met
Clamp Closure Force	Manual shut-off clamp closure force on tubing lines shall be no more than 26 lbf.	Met
Clamp Opening Force	Manual shut-off clamps on lines shall open with a force no more than 10 lbf.	Met
Bioburden Measurement	The drain bag shall have less than or equal to 100 CFUs per set.	Met
Microbial Travel (5C4145NS)	Upper boundaries for bacterial travel distance for both ascending and descending positions at 35-39℃ after 48 hours are less than the distance required to contaminate the APD cassette.	Met (demonstrated mitigation of contamination risk)
Cycler System Level (5C4145NS)	For both the HomeChoice and HomeChoice Claria cyclers: Under least favorable conditions, the drain flow rate lower bound > 50ml/min.	Met
Spike Tip Protector Removal Force (5C4145P)	The axial force to remove the spike tip protector shall not be less than 4.5 N (1.0 lbf) or greater than 45 N (10.0 lbf).	Met
Pull Ring Tip Protector Removal Force (5C4145P)	The axial force to remove the pull ring tip protector shall not be less than 4.5 N (1.0 lbf) or greater than 54 N (12.0 lbf).	Met
Solvent Bond Leak Strength (5C4145P)	The subsystem, after being subjected to a 5 lbf pull force shall not leak when subjected to 8 psig pressure for 10 seconds.	Met
Connection Duration Test (5C4145P)	Drain bag and APD sets connected after 48 hours.	Met
Biocompatibility	Evaluation in accordance with ISO-10993 Biological Evaluation of Medical Devices Part 1, classified as "non-contact".	Biocompatibility standards met for non-contact device.
Sterilization (5C4145P)	Sterility Assurance Level (SAL) of 10^-6 according to ANSI/AAMI ST67:2019 and ANSI/AAMI/ISO 11135-1:2014.	Met (for sterile version; not applicable to the proposed non-sterile version)
Shelf Life	5 years	Supported by aging testing.

Note: The document states that "All results meet the acceptance criteria," therefore, the reported device performance for all listed criteria is implicitly "Met."

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

The document does not explicitly state the sample sizes for each specific test or the data provenance (e.g., country of origin) for the test sets. The tests are described as "design verification tests" conducted by Baxter Healthcare Corporation. It is implied these are internal company tests, so the data provenance would be internal to Baxter, likely in the US (where Baxter is headquartered). The studies appear to be prospective, as they were conducted to support the premarket notification for a new product configuration.

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 tests described are largely objective engineering and microbiological performance tests (e.g., leak tests, force measurements, bioburden, microbial travel), which typically rely on predefined specifications and instrumentation rather than expert consensus on a "ground truth" in the diagnostic sense.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, the tests are objective performance evaluations against established engineering and safety specifications, not subjective assessments requiring adjudication.

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:

Not applicable. This device is a medical accessory (drainage bag), not a diagnostic imaging or AI-enabled device. Therefore, MRMC studies and AI-related effectiveness are not relevant.

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

Not applicable. This device is a medical accessory, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance tests outlined (Capacity/Leak, Drain Line Spike/Leak, Clamp forces, Bioburden, Microbial travel, Cycler System Level, Removal forces, Solvent Bond Leak Strength, Connection Duration) is based on engineering specifications, established industry standards (e.g., ISO, AAMI), and risk analyses. For biocompatibility, it's adherence to ISO-10993. For microbial travel, it's the lack of contamination reaching a critical point (APD cassette). These are objective, measurable criteria, not subjective human interpretations.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical accessory, not an AI/machine learning algorithm requiring a training set.

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

Not applicable. No training set is involved.

Summary

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March 18, 2022

Baxter Healthcare Corporation c/o Maninee Patel Associate Director, Regulatory Affairs One Baxter Parkway Deerfield, Illinois 60015

Re: Trade/Device Name: 15L Cycler Drainage Bag Regulation Number: 21 CFR 876.5630 Regulation Name: Peritoneal Dialysis System And Accessories Regulatory Class: II Product Code: KDJ Received: December 22, 2021

Dear Maninee Patel:

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 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

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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 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,

for Gema Gonzalez Acting 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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ADDITIONAL CONSIDERATIONS

The following are FDA suggestions, recommendations, or requests that did not preclude a favorable decision on the marketing application. A complete response to additional considerations is not required.

Sterility

In Appendix 14-2, you provided a test report for accelerated aging using the sterile version of your Drainage Bag. However, in this test report you have stated that the Q10 was equal to 3. Per ASTM F1980-16, "Using the Arrhenius equation with Q10 equal to 2 is a common and conservative means of calculating an aging factor. NOTE 6-A more aggressive reaction rate coefficient, for example, Q10 = 2.2 to 2.5, may be used if the system under investigation is sufficiently well characterized in the literature. The level and nature of damage must be similar to that reported in the literature to ensure that the reaction rate coefficient and accelerated aging temperature are maintained within appropriate boundaries. This is the responsibility of the manufacturer." Therefore, it is recommended that the Q10 equal 2 for accelerated aging to support packaging. In future submissions, please conduct accelerated aging using a 010 equal to 2.

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K214016

Device Name 15L Cycler Drainage Bag

Indications for Use (Describe)

This bag is intended for the collection of effluent during Automated Peritoneal Dialysis (APD) Therapy.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

September 30, 2021

OWNER:

Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015

CONTACT PERSON:

Maninee Patel, PharmD Associate Director, Global Regulatory Affairs 32650 N Wilson Road Round Lake, IL 60073 Telephone: (224)217-7875

IDENTIFICATION OF THE DEVICE:

Common Name: Peritoneal dialysis system and accessories Trade/Device Name: 15L Cycler Drainage Bag Classification Panel: Gastroenterology/Urology Regulation Number: 21 CFR 876.5630 Regulation Name: Peritoneal Dialysis Tubing Kit Product Code: KDJ

Product Code	Description
5C4145P (currently marketed)	15L Cycler Drainage Bag (sterile)
5C4145NS (proposed)	15L Cycler Drainage Bag (non-sterile)

Table 1. Current and Proposed Device Configuration

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PREDICATE DEVICE:

Device	Company	Predicate 510(k)	Clearance Date	Product Codes
CyclerDrainage Set15L CyclerDrainageBag(currentlymarketed)	Baxter HealthcareCorporation(Submitted byTravenolLaboratories)	K791899	November 13, 1979	5C41455C4145P(currentlymarketed)

Table 2. Predicate Device

DESCRIPTION OF THE DEVICE:

Baxter's Cycler Drainage Bag product line currently consists of a sterile 15L Cycler Drainage Bag (5C4145P). This 15 L Cycler Drainage Bag is a single use device intended for the collection of effluent during Automated Peritoneal Dialysis (APD) Therapy and can be used with Baxter's APD Sets with Cassette, Manifold Sets and Extension Sets. The purpose of this drain bag is to allow the collection of the spent effluent in the event that a patient does not have access to a drain from the location where APD therapy is performed. This product line has been previously cleared under 510(k) premarket notification K791899 (cleared on November 13, 1979).

The basis for this submission is the addition of a non-sterile version of the 15L Cycler Drainage Bag to the current product line. The product line does not come into direct or indirect contact with the patient's body tissue. The intended use, material, design, and function of the proposed device will be the same as the currently marketed 15 L Cycler Drainage Bag.

INDICATIONS FOR USE:

This bag is intended for the collection of effluent during APD Therapy.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:

In Table 3, the proposed device (5C4145NS) is compared to the currently marketed version of the predicate device (5C4145P).

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	Features	Predicate Device15L Cycler DrainageBag( Product Code:5C4145P – currentlymarketed)	ProposedDevice15L CyclerDrainage Bag(Product Code:5C4145NS)	Assessment of Differences
	Indications forUse	This bag is intended forthe collection of effluentduring APD Therapy.	Same	Not Applicable
	Sterile and Non-Pyrogenic	Yes	No	Sterilization of the drain bag is notrequired for the patient to performtherapy and collect effluent safely.Testing demonstrates that controlof product bioburden, the length ofthe drain line, and the flow rate ofspent dialysate adequately mitigatethe risk of contamination of thepatient peritoneum from pathogensoriginating in the drain bag.Instructions for Use were updatedaccordingly to ensure no increasedrisk for patient.
	PumpCompatibility andElectromechanicalDeviceCompatibility	Homechoice,Homechoice Claria, andAmia	Same	Not Applicable
	Single Use	Yes	Same	Not Applicable
	Materials
	Drain BagInlet andOutlet Tubing	Polyvinyl Chloride(PVC)
	Outlet Clamp	Polypropylene (PP)
	Inlet Clamp	High DensityPolyethylene (HDPE)	Same	Not Applicable
	Drain LineAdapter	Acrylonitrile ButadieneStyrene (ABS)
	SpikeConnector	ABS
	Pull Ring Cap	Low DensityPolyethylene (LDPE)	Same	Not Applicable
	Tip Protector	LDPE
Features	Predicate Device15L Cycler DrainageBag(Product Code:5C4145P – currentlymarketed)	Proposed Device15L CyclerDrainage Bag(Product Code:5C4145NS)	Assessment of Differences
Flow WrapPouch	HDPE Film
Carton	Corrugated Cardboard

Table 3. Device Comparison

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Table 3. Device Comparison

DISCUSSION OF NONCLINICAL TESTS:

Baxter Healthcare Corporation conducts risk analyses to determine the design verification tests that need to be conducted based on the proposed change. All results meet the acceptance criteria, and support that the devices presented in this premarket notification are appropriately designed for their intended use.

Table 4. Peformance Data
Test	ProductCode Tested	Requirements
Capacity/Leak	5C4145P	The product shall hold 16 liters of water for 24 hours withoutleak.
	5C4145NS	The product shall hold 16 liters of water for 48 hours withoutleak.
Drain Line Spike/Leak	5C4145P,5C4145NS	Force to spike drain line connector shall be no more than 35lbf with no leak at 8psig for 10 seconds.
Drain Line SpikeRemoval	5C4145P	Force to remove spike connector after a 24-hour therapyshall be no less than 3 lbf.
	5C4145NS	Force to remove spike connector after a 48-hour therapyshall be no less than 3 lbf.
Clamp Closure Force	5C4145P,5C4145NS	Manual shut-off clamp closure force on tubing lines shall beno more than 26 lbf.
Clamp Opening Force	5C4145P,5C4145NS	Manual shut-off clamps on lines shall open with a force nomore than 10 lbf.
BioburdenMeasurement	5C4145P,5C4145NS	The drain bag shall have less than or equal to 100 CFUs perset.

Performance Data:

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Baxter

Table 4. Peformance Data
Test	ProductCode Tested	Requirements
Microbial Travel	5C4145NS	Upper boundaries for bacterial travel distance for bothascending and descending positions at 35-39℃ after 48hours are less than the distance required to contaminate theAPD cassette.
Cycler System Level	5C4145NS	For both the HomeChoice and HomeChoice Claria cyclers:Under least favorable conditions, the drain flow rate lowerbound > 50ml/min.
Spike Tip ProtectorRemoval Force	5C4145P	The axial force to remove the spike tip protector shall not beless than 4.5 N (1.0 lbf) or greater than 45 N (10.0 lbf).
Pull Ring Tip ProtectorRemoval Force	5C4145P	The axial force to remove the pull ring tip protector shall notbe less than 4.5 N (1.0 lbf) or greater than 54 N (12.0 lbf).
Solvent Bond LeakStrength	5C4145P	The subsystem, after being subjected to a 5 lbf pull forceshall not leak when subjected to 8 psig pressure for 10seconds.
Connection DurationTest	5C4145P	Drain bag and APD sets connected after 48 hours.

Biocompatibility:

The biocompatibility evaluation of this product line was conducted in accordance with ISO-10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, as recognized by the FDA. The 15L Cycler Drainage Bags presented in this premarket notification do not come into direct or indirect contact with the patient's body tissue and are classified as "non-contact" in accordance with 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 Sept 4, 2020).

Sterilization:

The sterile version of the 15L Cycler Drainage Bag (5C4145P) is sterilized with ethylene oxide (EO) gas. The product is in the bioburden (sub) category "Bag Device labeled sterile fluid path". The EO cycles used on this product to provide a 106 Sterility Assurance Level (SAL) for this (sub) category were established and validated at the manufacturing facilities as described in ANSI/AAMI ST67:2019 Sterilization of Health Care Products - requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile". Requirements for products labeled 'sterile' and the sterilization process for the proposed device are also compliant to ANSI/A AMI/ISO 11135-1:2014 Sterilization of Health Care Products - Ethylene Oxide - Part 1:

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Haxter

Requirements for development, validation, and routine control of sterilization process for medical devices.

Shelf Life:

Baxter has performed aging testing to support a shelf-life claim of 5 (five) years.

CONCLUSION:

The non-clinical data demonstrate that the proposed device is substantially equivalent and performs comparably to the predicate device that is legally 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.