The Gambro WRO 300 Water Purification Unit is intended to be used as a dialysis accessory to produce water through reverse osmosis for one hemodialysis equipment.

The WRO 300 can be connected to hemodialysis equipment used both in hospitals and in home environments, in conjunction with appropriate pre and post treatment units, as a part of a water treatment system designed to meet current AAMI and Federal (U.S.) standards.

The Gambro WRO 300 H Water Purification Unit is intended to be used as a dialysis accessory to produce water through reverse osmosis for one hemodialysis equipment.

The WRO 300 H can be connected to hemodialysis equipment used both in hospitals and in home environments, in conjunction with appropriate pre and post treatment units, as a part of a water treatment system designed to meet current AAMI and Federal (U.S.) standards.

Device Description

The Gambro WRO 300 and WRO 300 H Water Purification Units are dialysis accessories that produce water through reverse osmosis for one hemodialysis equipment.

They are both designed to maintain the low microbiological level in their flow path by the use of regular disinfection as a regular maintenance. Both WRO 300 and WRO 300 H Water Purification Units are designed with chemical disinfection capability. The WRO 300 H Water Purification Unit is also designed with heat disinfection capability.

WRO 300 or WRO 300 H Water Purification Unit is intended for use in conjunction with one dialysis machine, provided that the input flow and pressure demands correspond to the output of the WRO 300 or WRO 300 H Water Purification Unit.

WRO 300 and WRO 300 H Water Purification Units utilize the Reverse Osmosis Principle. A high pressure pump forces the water through the RO membrane. The product water is further distributed to the dialysis machine.

Reverse osmosis (RO) is a membrane process that is the most widely used technique for purification of water for dialysis. When the feed water is in contact with the semipermeable membrane (the most vital part of the system) and a high pressure is applied, water will flow through the membrane to the product water side. Most of the other constituents (dissolved salts, particles, bacteria and pyrogens) will remain on the feed water side of the membrane and be flushed to drain as reject water. The membrane material used for the WRO 300 and WRO 300 H Water Purification Units are Polyamide Thin-Film Composite.

An acceptable quality of the feed water is required. The feed water is usually pretreated with such as active carbon filters, softener, and particle filters before it is supplied to the WRO 300 or WRO 300 H Water Purification Unit. Depending on the local water quality and regulations different pretreament equipment may be required.

Gambro WRO 300 and WRO 300 H Water Purification units contain the same software package (version P4.2) which is intended for controlling water production and disinfection / clanning of the flow path of the WRO.

The software also supports Heat Disinfection in the WRO 300 H Water Purification Unit.

AI/ML Overview

The provided text describes the WRO 300 and WRO 300 H Water Purification Units by Gambro Renal Products, Inc. and their substantial equivalence to a predicate device for use in hemodialysis.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria are derived from the performance specifications compared to the predicate device and relevant standards. The reported device performance indicates that both the WRO 300 and WRO 300 H meet these criteria.

Acceptance Criteria	Reported Device Performance (WRO 300 & WRO 300 H)
Feed Water Supply:
Input	Min. 3.0 l/min required
Pressure	0.15 to 0.8 MPa during operation
Temperature	+5 to +30°C
Hardness	recommendation < 1 °dH (WRO 300)
	recommendation < 0.3 °dH (WRO 300 H)
Product Water:
Output flow (WRO 300)	Minimum 1.1 l/min at 10°C
Output flow (WRO 300 H)	Minimum 1.2 l/min at 10°C
Product water pressure	0.12 to 0.6 MPa during RUN mode
Rejection rates: Total dissolved salts	>96%
Rejection rates: Bacteria and endotoxin	>99%
Drain requirements:
Operation	1.2 ±0.1 l/min
Peak flow (rinse)	3.0 l/min
Reverse osmosis membrane:
Material	Polyamide, thin film composite
Configuration	Spiral wound
pH-tolerance	2-11
Disinfection and cleaning:
Chemical disinfection	Chemical disinfection supported
Heat disinfection (WRO 300 H only)	Heat disinfection supported, no effect on safety or membrane performance
Ambient Temperature	+10 to +40 °C
Electrical safety	Compliant with IEC 60601-1
Electromagnetic compatibility	Compliant with IEC 60601-1-2
Biocompatibility	Compliant with ISO 10993-5, ANSI/AAMI RD62, ISO/FDIS 13959, European Pharmacopoeia 5th ed.
Software validation	Software version P4.2 validated
Membrane life expectancy	Meets requirements
User interface/control system	Meets requirements
Physical ergonomics	Meets requirements
Maintenance and reliability	Meets requirements
Heat disinfection procedure (WRO 300 H)	Coolest spot in flow path at least 80°C, with 5 log reduction for all positions
Microbial retention by RO membrane	Evaluated and meets requirements

Study Information:

The provided text describes a non-clinical performance data assessment to establish substantial equivalence with a predicate device (Gambro WRO 300 Water Purification System, K042797). It explicitly states that clinical performance data is "Not applicable for this submission." This indicates that no human trials or studies were conducted for this submission.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify sample sizes for the non-clinical tests. It refers to "testing results of the R.O. Membrane," implying a physical testing of the device and its components.
- Data provenance: The testing was performed internally by the manufacturer (Gambro Renal Products, Inc.) and by "external independent personnel." The country of origin for the testing data is not explicitly stated, but the submitter's address is in Lakewood, Colorado, USA. The nature of the testing (verification and validation of software, and functional/performance/safety requirements) suggests prospective testing conducted specifically for this submission, rather than retrospective data analysis from previous use.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document states that the assessment was performed by "internal and external independent personnel with the appropriate skills." It does not specify the number of experts or their specific qualifications (e.g., years of experience, specific certifications).
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The document does not describe an adjudication method as it pertains to expert reviews of interpretations for a test set. The nature of the evaluation involves technical testing against established standards and specifications, not subjective interpretation requiring adjudication.
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 MRMC comparative effectiveness study was done. This device is a water purification unit, not an imaging or diagnostic AI device that would involve human readers or AI assistance in interpretation. The submission explicitly states "Assessment of clinical performance data: Not applicable for this submission."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable in the context of a water purification unit. The device itself performs the function (water purification) autonomously once set up. The "software package (version P4.2)" controls water production and disinfection/cleaning. The software's performance was verified and validated, which could be considered a form of standalone testing of the algorithm's functional correctness for its intended purpose. However, it's not "algorithm only" in the sense of a diagnostic AI without human input to the diagnostic process.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is established by technical specifications, functional requirements, and compliance with international standards. For example, for water quality, the ground truth is defined by specific rejection rates (e.g., >96% for total dissolved salts, >99% for bacteria and endotoxin) and physical parameters (e.g., output flow, pressure, temperature). For safety, the ground truth is compliance with electrical safety and EMC standards. For the heat disinfection on the WRO 300 H, the ground truth includes a minimum temperature of 80°C and a 5 log reduction for all positions.
The sample size for the training set:
- This document describes a non-clinical assessment for a physical device, not an AI/ML model for which a "training set" in the traditional sense would apply. Therefore, no training set sample size is mentioned or relevant.
How the ground truth for the training set was established:
- As there is no training set mentioned, this question is not applicable. The ground truth for the device's performance is established through adherence to engineering specifications, performance tests, and compliance with recognized industry standards.

Summary

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K093608
PAGE 1 OF 6

Traditional 510(k) WRO 300 and WRO 300 H

JUL 2 9 2010

510(K) SUMMARY

Submitter's Name	Gambro Renal Products, Inc.
Address	14143 Denver West Parkway, Suite 400Lakewood, Colorado 80401
Establishment Registration Number	2087532
Contact Person	Kae Miller, Regulatory Affairs Manager
Telephone Number	303.222.6724
Fax Number	303.222.6916
Date of Summary	July 23, 2010

Device
Name of the Device	WRO 300Catalogue Number: 107364WRO 300 HCatalogue Number: 107365
Common or Usual Name	Water Purification Unit
Classification Name	Subsystem, Water treatment
Device Class	II
Product Code	78FIP
Regulation Number	876.5665

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Gambro CONFIDENTIAL

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K093608
PAGE 2 OF 6

Traditional 510(k) WRO 300 and WRO 300 H

510(k) SUMMARY, continued

	Legally Marketed Device (Predicate Device)
Name of the Device	Gambro WRO 300 Water Purification System For Hemodialysis
Catalogue Number	107364
Classification Name	Subsystem, Water treatment
Device Class	II
Product Code	78FIP
Regulation Number	876.5665
510(k) number	K042797

Image /page/1/Picture/5 description: The image shows two water softener systems. The systems are gray and have a digital display on the front. The systems are standing next to each other on a dark surface. The background is a light gray color.

	WRO 300	WRO 300 H
Weight	29 kg	33 kg
Height	563 mm	563 mm
Depth	Max 520 mmFootprint 380 mm	Max 520 mmFootprint 380 mm
Width	Max 205 mmFootprint 185 mm	Max 205 mmFootprint 185 mm
Internal fluid volume	Approximately 3.5 liters excluding the product water loop

The Gambro WRO 300 and WRO 300 H Water Purification Units are dialysis accessories that produce water through reverse osmosis for one hemodialysis equipment.

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Gambro CONFIDENTIAL

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K093608
PAGE 3 OF 6

Traditional 510(k) WRO 300 and WRO 300 H

The software also supports Heat Disinfection in the WRO 300 H Water Purification Unit.

INDICATIONS FOR USE WRO 300:

The Gambro WRO 300 Water Purification Unit is intended to be used as a dialysis accessory to produce water through reverse osmosis for one hemodialysis equipment.

INDICATIONS FOR USE WRO 300 H:

The Gambro WRO 300 H Water Purification Unit is intended to be used as a dialysis accessory to produce water through reverse osmosis for one hemodialysis equipment.

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Gambro CONFIDENTIAL

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Traditional 510(k)

510(k) SUMMARY, contin

DEVICE COMPARISON TABLE
in the following table the WRO 300 H are compared with the predicate device WRO 300 (K0427)

	PREDICATEWRO 300 (K042797)SW1.0	WRO 300SW P4.2	WRO 300 HSW P4.2
Indications forUse	The Gambro WRO 300 Water PurificationSystem is intended to be used as a dialysisaccessory device in conjunction with onedialysis machine to produce water used toprepare and dilute dialysis concentrate toform dialysis fluid by using the reverseosmosis concept.	The Gambro WRO 300 WaterPurification Unit is intended to be usedas a dialysis accessory to produce waterthrough reverse osmosis for onehemodialysis equipment.The WRO 300 can be connected tohemodialysis equipment used both inhospitals and in home environments, inconjunction with appropriate pre andpost treatment units, as a part of a watertreatment system designed to meetcurrent AAMI and Federal (U.S.)standards.	The Gambro WRO 300 H Water PurificationUnit is intended to be used as a dialysisaccessory to produce water through reverseosmosis for one hemodialysis equipment.The WRO 300 H can be connected tohemodialysis equipment used both in hospitalsand in home environments, in conjunction withappropriate pre and post treatment units, as apart of a water treatment system designed tomeet current AAMI and Federal (U.S.)standards.
Feed WaterSupply	Input: 3.0 l/min requiredPressure: 0.2 to 0.8 MPaTemperature: +5 to +30°CHardness: recommendation < 1 °dH(20 ppm as CaCO3).	Input: Min. 3.0 l/min requiredPressure: 0.15 to 0.8 MPa duringoperationTemperature: +5 to +30°CHardness: recommendation < 1 °dH	Input: Min. 3.0 l/min requiredPressure: 0.15 to 0.8 MPa duringoperationTemperature: +5 to +30°CHardness: recommendation < 0.3 °dH

Page 22 of 54
Revised July 23, 201

mbro CONFIDENTL

K093608

PAGE 4 OF 6

ਟ

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Gambro Renal Products, Inc.
14143 Denver West Parkway, Suite 400
Lakewood, Colorado 80401

Traditional 510(k)
WRO 300 and WRO 300 H

	PREDICATEWRO 300 (K042797)	WRO 300	WRO 300 H
	SW1.0	SW P4.2	SW P4.2
	Output flow:
	Minimum 1.1 l/min at 10°C.Product water loop: Maximum 20 meters (2x 10m). Designed for flexible, rein-forcedtubing 8 mm x 2.5 mm.	Output flow:Minimum 1.1 l/min at 10°C.Product water loop: Maximum 20meters (2 x 10m). Designed forflexible, rein-forced tubing.	Output flow:Minimum 1.2 l/min at 10°C.Product water loop: Maximum 2 meters(2 x 1m). Designed for flexible, rein-forced tubing.
Product water	Product water pressure: 0.12 to 0.6 MPaduring RUN mode.	Product water pressure: 0.12 to 0.6MPa during RUN mode.	Product water pressure: 0.12 to 0.6 MPa duringRUN mode.
	Rejection rates:	Rejection rates:	Rejection rates:
	Total dissolved salts: >95%.Bacteria and endotoxin: >99%.	Total dissolved salts: >96%.Bacteria and endotoxin: >99%.	Total dissolved salts: >96%.Bacteria and endotoxin: >99%.
Drainrequirements	Operation: 1.2 ±0.1 l/min.Peak flow (rinse): 3.0 l/min	Operation: 1.2 ±0.1 l/min.Peak flow (rinse): 3.0 l/min	Operation: 1.2 ±0.1 l/min.Peak flow (rinse): 3.0 l/min
Reverse osmosismembrane	Material:Polyamide, thin film composite.Configuration: Spiral wound.pH-tolerance:2-11	Material:Polyamide, thin film composite.Configuration: Spiral wound.pH-tolerance:2-11	Material:Polyamide, thin film composite.Configuration: Spiral wound.pH-tolerance:2-11
Disinfection andcleaning	Chemical disinfection.Cleaning.	Chemical disinfection.Cleaning.	Chemical disinfection.Cleaning.Heat disinfection.
Ambient	Temperature:+ 10 to + 40 °C	Temperature:+ 10 to + 40 °C	Temperature:+ 10 to + 40 °C

mbro CONFIDENTIA

Page 23 of 54
Revised July 23, 2016

K093608
PAGE 5 OF 6

こ

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WRO 300 and WRO 300 H

510(k) SUMMARY, continued

Assessment of non-clinical performance data

The non-clinical testing applied to the Gambro WRO 300 H Water Purification Units, equipped with the software version P4.2, in order to determine the substantial equivalence with the predicate device, included:

verification and validation of the software changes, with static and dynamic software testing, and . regression testing,
verification and validation of the functional, performance and safety requirements related to ●
- O the membrane life expectancy;
- user interface/control system o
- disinfection both chemical and heat 0
- physical ergonomics O
- maintenance and reliability ಂ
compliance with international standard on electrical safety (IEC 60601-1),
compliance with international standard on electromagnetic compatibility (IEC 60601-1-2).

The assessment was performed by internal and external independent personnel with the appropriate skills.

Assessment of clinical performance data

Not applicable for this submission.

Conclusion

Testing results of the R.O. Membrane (rejection of total dissolved salts, bacteria and endotoxins), output flow, water pressure, drain flow, electrical safety (in accordance to IEC 60601-1), electromagnetic compatibility (in accordance to IEC 60601-1-2), biocompatibility (in accordance with ISO 10993-5, ANSI/AAMI RD62, ISO/FDIS 13959, European Pharmacopoeia 5th ed.), and software validation demonstrate that the WRO 300 and WRO 300H with software version 4.2 meets all performance specifications equivalent to the predicate device.

In addition, testing conducted on the WRO 300H confirmed that heat disinfection did not affect safety or membrane performance, and performed equivalent to predicate device disinfection capability for the purpose of ensuring low microbiological level in the flow path. In addition to standards tests applicable for reverse osmosis, testing specific to the heat disinfection included:

· Biocompability test (in accordance with ISO 10993-5, ANSI/AAMI RD62, ISO/FDIS 13959, European Pharmacopoeia 5th ed.) of extract from the hydraulic flow path after RO membrane
. Validation of heat disinfection procedure in regards to temperature in flow path during Heat disinfection (coolest spot in flow path at least 80° C, with 5 log reduction for all positions)
Evaluation of Microbial retention by the RO membrane

. Page 24 of 54 Revised July 23, 2010

Gambro CONFIDENTIAL

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Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN" written around the left side of the circle. Inside the circle is a stylized image of a person with their arms outstretched.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G60 Silver Spring, MD 20993-0002

Ms. Kae Miller Regulatory Affairs Manager Gambro Renal Products, Inc. 14143 Denver West Parkway, Suite 400 LAKEWOOD CO 80401

2 5 2010

Re: K093608 Trade/Device Name: WRO 300 and WRO 300 H Regulation Number: 21 CFR §876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: FIP Dated: July 26, 2010 Received: July 27, 2010

Dear Ms. Miller:

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. 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

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Page 2 -

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K093605

Traditional 510(k) WRO 300 and WRO 300 H

Indications for Use

510(k) Number (if known):

JUL 2 9 2010

Device Name: WRO 300

Indications for Use WRO 300:

The Gambro WRO 300 Water Purification Unit is intended to be used as a dialysis accessory to produce water through reverse osmosis for one hemodialysis equipment.

WRO 300 can be connected to hemodialysis equipment used both in home environments, in conjunction with appropriate pre and post treatment units, as a part of a water treatment system designed to meet current AAMI and Federal (U.S.) standards.

Device Name: WRO 300 H

Indications for Use WRO 300 H:

The Gambro WRO 300 H Water Purification Unit is intended to be used as a dialysis accessory to produce water through reverse osmosis for one hemodialysis equipment.

WRO 300 H can be connected to hemodialysis equipment used both in hospitals and in home environments, in conjunction with appropriate pre and post treatment units, as a part of a water treatment system designed to meet current AAMI and Federal (U.S.) standards.

Halul Leen

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devi 510(k) Number.

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 18 of 54

Gambro CONFIDENTIAL

Attachment 1 - 1

Regulation Number and Section

§ 876.5665 Water purification system for hemodialysis.

(a)
Identification. A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.(b)
Classification. Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.