The Cycler Drain Bag Set is indicated for use by patients with acute and stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The Cycler Drain Bag Set is an optional receptacle that connects to the Luer-lock end of a Cycler Set drain line in order to collect patient effluent during PD treatments. This device is to be used only with Fresenius Medical Care (FMCNA) Cyclers and Cycler Sets.

Device Description

The Drain Bag Set (tubings and flexible bags) is a passive, closed drainage system used as an optional receptacle during an APD treatment. The Drain Bag Set is used to collect effluent in bags rather than letting the effluent flow directly to a drain. The Drain Bag Set connects to the drain line of a cycler set to collect patient effluent by means of gravity and the pumping action of a Peritoneal Dialysis (PD) cycler. The Drain Bag Set connects to the drain line using a standard Luer lock connection. The Drain Bag Set consists of three (3) interconnected 7-liter drain bags, each with a sampling port and an occluding clamp. The tubing lines that connect each drain bag to the drain line have a snap-disconnect tubing segment. This tubing segment allows the user to disconnect individual bags by snapping the tubing apart.

AI/ML Overview

The provided document describes the acceptance criteria and performance data for the Cycler Drain Bag Set (K173363), a medical device used in peritoneal dialysis.

Here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Test Conducted	Acceptance Criteria	Reported Device Performance
Drop Test	The drain bag shall not leak (visual inspection). Acceptance criteria from ISO 15747:2010 were applied.	Pass, results within acceptance criteria
Internal Pressure Test	The drain bag shall not leak (visual inspection). Acceptance criteria from ISO 15747:2010 were applied.	Pass, results within acceptance criteria
Hanger Holes Tensile Strength	The drain bag hanger holes shall withstand a tensile load of 15 N for 60 minutes. Acceptance criteria from ISO 15747:2010 were applied.	Pass, results within acceptance criteria
Film Roughness Test	The drain bag's film shall have a roughness ≤ 0.75 µm (Roughness Average).	Pass, results within acceptance criteria
Tensile Strength of Bonding	All bonded engagements between plastic composites shall require >10 lbf to detach.	Pass, results within acceptance criteria
Maintenance of Sterility testing	Acceptance criteria from ISO 11607-1:2006/(R)2010 - A1:2014 were applied.	Pass, results within acceptance criteria
Male Luer lock connector testing	Acceptance criteria from ISO 594-2:1998 were applied.	Pass, results within acceptance criteria
Drain Bag Set Capacity	The Drain Bag Set shall hold at least 24 L of water (volume ≥ 24 L).	Pass, results within acceptance criteria
Sampling Port Leakage Test	The sampling port shall not leak after being punctured with a 23 gauge needle one time for 15 seconds and subjected to a pressure of 20 kPa under water for 15 seconds. Acceptance criteria from ISO 15747:2010 were applied.	Pass, results within acceptance criteria
Snap Connector Breakage Test	The snap connector shall have a break point between 60 oz-in and 120 oz-in.	Pass, results within acceptance criteria
Clamp Test	No leaks past the clamp. Acceptance criteria from ISO 8638:2010 were applied.	Pass, results within acceptance criteria
Vibratory (ship) Testing	No tubing kinks or loose or damaged components.	Pass, results within acceptance criteria

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

The document does not specify the exact sample sizes used for each individual test. It states "The samples" were used for various tests (e.g., sampling port leakage test) but doesn't quantify how many samples.

The data provenance is from in-house laboratory testing performed by Fresenius Medical Care. It is not externally sourced and is not described as retrospective or prospective clinical data. The tests performed are primarily engineering and material science tests according to established ISO and ASTM standards.

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

This information is not applicable and therefore not provided in the document. The tests performed are objective, quantitative engineering and material assessments against pre-defined industry standards (e.g., ISO, ASTM). They do not involve expert interpretation or clinical ground truth determination in the way a diagnostic AI device would.

4. Adjudication Method for the Test Set

This information is not applicable. Since the tests are objective physical and performance assessments against documented standards, there is no need for an adjudication method by experts. The results are "Pass" or "Fail" based on whether the measured values meet the specified criteria.

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

This information is not applicable. The device is a physical medical accessory (drain bag set) and does not involve AI or human reader interpretation for its function. Therefore, no MRMC comparative effectiveness study was performed.

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

This information is not applicable. As mentioned, the device is a physical accessory and does not contain any algorithms or software.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests conducted is based on established international and industry standards (ISO 15747:2010, ISO 11607-1:2006/(R)2010 - A1:2014, ISO 594-2:1998, ISO 8638:2010, ASTM D4169-14) and pre-defined engineering specifications (e.g., film roughness ≤ 0.75 µm, tensile strength >10 lbf, break point between 60 oz-in and 120 oz-in, capacity ≥ 24 L). These are objective, measurable criteria.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical device, and the testing described here is for performance verification. There is no "training set" in the context of machine learning or AI algorithms.

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

This information is not applicable for the same reasons as point 8.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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.

January 24, 2018

Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann Senior Director, Regulatory Affairs 920 Winter Street Waltham, MA 02451

Re: K173363

Trade/Device Name: Cycler Drain Bag Set Regulation Number: 21 CFR& 876.5630 Regulation Name: Peritoneal Dialysis System and Accessories Regulatory Class: II Product Code: KDJ Dated: October 25, 2017 Received: October 26, 2017

Dear Denise Oppermann:

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. 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.

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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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-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,

Image /page/1/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold, sans-serif font. The text is black and appears to be centered on a white background. The letters are well-defined and easy to read.

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) K173363

Device Name Cycler Drain Bag Set

Indications for Use (Describe)

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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Image /page/3/Picture/1 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing chevrons stacked on top of each other. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line. The entire logo is in blue.

510(K) SUMMARY ട.

This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR §807.92.

5.1. Submitter's Information

Name:	Fresenius Medical Care Renal Therapies Group, LLC
Address:	920 Winter StreetWaltham, MA02451-1457
Phone:	(781) 699-4479
Fax:	(781) 699-9635
Contact Person:	Denise OppermannSenior Director Regulatory Affairs – Devices
Preparation Date:	October 27, 2017

5.2. Device Name

Trade Name:	Cycler Drain Bag Set
Common Name:	Drain Bag Set
Classification Name:	Peritoneal Dialysis System and Accessories
Regulatory Class:	Class II per 21 CFR §876.5630
Product Code:	KDJ
Classification Panel:	Gastroenterology/Urology

5.3. Legally Marketed Predicate Device

The legally marketed predicate device is the Peritoneal Dialysis Drainage Set (K895991). This predicate has not been subject to a design-related recall.

5.4. Device Description

5.4.1. Device Identification

The Cycler Drain Bag Set (hereinafter referred to as "Drain Bag Set") is the subject of this 510(k).

5.4.2. Device Characteristics

The Drain Bag Set is a new, single-use device designed to collect patient effluent during the drain phase of an Automated Peritoneal Dialysis (APD) treatment. The Drain Bag Set is provided sterile and non-pyrogenic. The Drain Bag Set is sterilized using ethylene oxide (EO).

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Image /page/4/Picture/1 description: The image shows the logo for Fresenius Medical Care. On the left is a blue symbol that looks like three chevrons stacked on top of each other, pointing downwards. To the right of the symbol is the text "FRESENIUS MEDICAL CARE" in blue, with "FRESENIUS" on top of "MEDICAL CARE".

5.4.3. Environment of Use

The Drain Bag Set is used in both healthcare and home environments.

Brief Written Description of the Device 5.4.4.

5.4.5. Materials of Use

The component materials of the Drain Bag Set 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 Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (16 June 2016).

Drain Bag Set Components	Material
Drain bag
Tubing	Polyvinyl Chloride(PVC)
Male Luer lock adapter
Vented cap for adapter
Clamp	Polypropylene (PP)
Triple “Y” connector
Snap-disconnect tubing segment	Polycarbonate (PC)
Sampling port	PC, Siliprene

The Drain Bag Set components are composed of the following materials:

Key Performance Characteristics 5.4.6.

The Drain Bag Set is designed to be compatible with the Luer lock end of the Cycler Set drain line of Fresenius PD Cycler Sets. The drain bags have sampling ports that enable effluent sampling as needed. Each drain bag has a 7-liter nominal capacity and 8-liter maximum capacity.

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Image /page/5/Picture/1 description: The image shows the logo for Fresenius Medical Care. On the left is a blue symbol that looks like three downward-pointing chevrons stacked on top of each other. To the right of the symbol is the text "FRESENIUS MEDICAL CARE" in blue, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

5.5. Intended Use

The Drain Bag Set is intended for use by patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis in a healthcare facility or at home. It is designed for use as an optional receptacle to collect patient effluent during an APD treatment with Fresenius PD Cyclers and Fresenius PD Cycler Sets.

Indications for Use 5.6.

The Cycler Drain Bag Set is indicated for use by patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The Cycler Drain Bag Set is an optional receptacle that connects to the Luer-lock end of a Cycler Set drain line in order to collect patient effluent during PD treatments. This device is to be used only with Fresenius Medical Care (FMCNA) Cyclers and Cycler Sets.

5.7. Comparison of Technological Characteristics with the Predicate Device

The following technological characteristics of the Drain Bag Set are equivalent to the predicate Peritoneal Dialysis Drainage Set (K895991).

Similar principle of operation
Similar design characteristics
Same sterilization method
Same intended use

5.8. Performance Data

A summary of testing conducted to support the determination of substantial equivalence is as follows:

TestConducted	Test Method Description	AcceptanceCriteria	Results/Conclusion
Drop Test	The drain bag was filled to capacitywith water and dropped from a heightof 0.25 m.The test was performed in accordancewith ISO 15747:2010 PlasticContainers for Intravenous Injections.	The drain bag shallnot leak (visualinspection).Acceptance criteriafrom ISO 15747:2010were applied.	Pass, resultswithinacceptancecriteria
TestConducted	Test Method Description	AcceptanceCriteria	Results/Conclusion
Internal PressureTest	The drain bags were exposed to aninternal pressure of 50 kPa between twoplane parallel plates maintaining thepressure for 15 minutes.The test was performed in accordancewith ISO 15747:2010 PlasticContainers for Intravenous Injections.	The drain bag shallnot leak (visualinspection)Acceptance criteriafrom ISO 15747:2010were applied.	Pass, resultswithinacceptancecriteria
Hanger HolesTensile Strength	The drain bags were filled to capacitywith water and were hung on a medicalhooking pole by attaching a load of 3.5lbs (15 N) for 60 minutes.The test was performed in accordancewith ISO 15747:2010 PlasticContainers for Intravenous Injections.	The drain bag hangerholes shall withstanda tensile load of 15 Nfor 60 minutes.Acceptance criteriafrom ISO 15747:2010were applied.	Pass, resultswithinacceptancecriteria
Film RoughnessTest	The drain bag film roughness wasmeasured in three different locations –bottom, middle, and top of the bag–with a roughness meter.	The drain bag's filmshall have aroughness ≤ 0.75 µm(Roughness Average)	Pass, resultswithinacceptancecriteria
Tensile Strengthof BondingEngagements	A pull-off test was performed using theapplicable fixture for each bondedengagement with the Instron machine.	All bondedengagements betweenplastic compositesshall require >10 lbfto detach.	Pass, resultswithinacceptancecriteria
Maintenance ofSterility testing	The vented cap was validated as asterile barrier via the dust drummicrobial challenge test perANSI/AAMI/ISO 11607-1:2006/(R)2010 - A1:2014 Packaging forterminally sterilized medical devices –Part 1: Requirements for materials,sterile barrier systems, and packaging.	Acceptance criteriafrom ISO 11607-1:2006/(R) 2010 -A1:2014 wereapplied.	Pass, resultswithinacceptancecriteria
Male Luer lockconnectortesting	The eight (8) Male Luer lock connectortests were performed in accordancewith ISO 594-2:1998 Conical Fittingswith 6% (Luer) Taper for Syringes,Needles and certain other MedicalEquipment. Part 2: Local Fittingsstandard.	Acceptance criteriafrom ISO 594-2:1998were applied.	Pass, resultswithinacceptancecriteria
TestConducted	Test Method Description	AcceptanceCriteria	Results/Conclusion
Drain Bag SetCapacity	The drain bags were filled to capacitywith water and it was observed if theywere able to contain such volume.	The Drain Bag Setshall hold at least 24L of water (volume ≥24 L)	Pass, resultswithinacceptancecriteria
Sampling Port(i.e., injectionsite) LeakageTest	The sampling port was punctured usinga 23 gauge needle for 15 seconds andwas then exposed to an internal airpressure of 20 kPa. The samples weresubmerged in water for 15 seconds andair leakages were inspected.The test was performed in accordancewith ISO 15747:2010 PlasticContainers for Intravenous Injections.	The sampling portshall not leak afterbeing punctured witha 23 gauge needleone time for 15seconds andsubjected to apressure of 20 kPaunder water for 15seconds.Acceptance criteriafrom ISO 15747:2010were applied.	Pass, resultswithinacceptancecriteria
Snap ConnectorBreakage Test	The snap connector was placed in apoka-yoke mechanism and subjected toa compression test with the Instronmachine starting from the injectionpoint (0°) and testing at 90°, 180°, and270°.	The snap connectorshall have a breakpoint between 60 oz-in and 120 oz-in	Pass, resultswithinacceptancecriteria
Clamp Test	After activating the clamp on thetubing, the tubing was submerged andpressurized to 15 psi for 10 minutes.Any leaks past the clamp wereobserved.This test method was adopted from ISO8638:2010 Section 5.5.1.1Cardiovascularimplants and extracorporeal systems –Extracorporeal blood circuit forhemodialyzers, hemodiafilters andhemofilters	No leaks past theclamp.Acceptance criteriafrom ISO 8638:2010were applied.	Pass, resultswithinacceptancecriteria
TestConducted	Test Method Description	AcceptanceCriteria	Results/Conclusion
Vibratory (ship)Testing	A simulated shipping distribution testwas performed using rotary motion.The package was exposed to repetitiveshocks for a period of 60 minutes witha frequency of 270 cycles per minute.The test was performed in accordancewith ASTM D4169-14 StandardPractice for Performance Testing ofShipping Containers and Systems	No tubing kinks orloose or damagedcomponents	Pass, resultswithinacceptancecriteria

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Image /page/6/Picture/1 description: The image contains the Fresenius Medical Care logo. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing chevrons stacked on top of each other. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

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Image /page/7/Picture/1 description: The image contains the logo for Fresenius Medical Care. On the left side of the logo, there are three blue chevron shapes stacked on top of each other, pointing downwards. To the right of the chevrons, the text "FRESENIUS MEDICAL CARE" is written in blue, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

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Image /page/8/Picture/1 description: The image contains the logo for Fresenius Medical Care. On the left side of the logo is a blue symbol that consists of three downward-pointing chevrons stacked on top of each other. To the right of the symbol is the text "FRESENIUS MEDICAL CARE" in a bold, sans-serif font, also in blue. The words "FRESENIUS" and "MEDICAL CARE" are stacked on top of each other.

Results of the design verification tests met the design requirements for the proposed device and demonstrated that, like the predicate device, it is safe and effective for its intended use.

5.8.1. Biocompatibility Testing

No biocompatibility tests were performed.

Human Factors Validation Testing 5.8.2.

The Drain Bag Set was validated for its safe and effective use in accordance with FDA guidance Applying Human Factors and Usability Engineering to Medical Devices (03 February 2016).

5.8.3. Software Verification and Validation Testing

Not applicable. The Drain Bag Set does not contain software.

Mechanical and Acoustic Testing 5.8.4.

No mechanical or acoustic tests were performed.

5.8.5. Animal Studies

No animal studies were performed.

5.8.6. Clinical Studies

No clinical studies were performed.

5.9. Conclusion

The intended use, design, principle of operation, and sterilization method of the Drain Bag Set is the same as that of the predicate device. FMCRTG concludes that within the meaning of the Medical Device Amendments Act of 1976, the Drain Bag Set device is safe and effective for its 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.