Who is the manufacturer of GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H?

Gambro Renal Products, Inc. filed the 510(k) submission for GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H (K093608).

What is the FDA product code for GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H?

FIP. It is classified under 21 CFR 876.5665 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H

K093608 · Gambro Renal Products, Inc. · FIP · Jul 29, 2010 · Gastroenterology, Urology

Device Facts

Record ID	K093608
Device Name	GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H
Applicant	Gambro Renal Products, Inc.
Product Code	FIP · Gastroenterology, Urology
Decision Date	Jul 29, 2010
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5665
Device Class	Class 2

Intended Use

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 Story

Water purification units for hemodialysis; utilize reverse osmosis (RO) to produce purified water for single dialysis machine. Input: feed water (pretreated via carbon/softener/particle filters). Operation: high-pressure pump forces water through polyamide thin-film composite RO membrane; dissolved salts, bacteria, pyrogens flushed as reject water. WRO 300 H includes heat disinfection; both support chemical disinfection. Used in hospitals or home environments; operated by clinicians or patients. Output: purified water for dialysis fluid preparation. Benefits: maintains low microbiological levels in flow path; ensures water quality for hemodialysis.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing: RO membrane performance (rejection of salts, bacteria, endotoxins), output flow, water pressure, drain flow, electrical safety, EMC, and biocompatibility (ISO 10993-5, ANSI/AAMI RD62, ISO/FDIS 13959). Heat disinfection validation confirmed 5-log microbial reduction and maintenance of membrane integrity.

Technological Characteristics

Reverse osmosis system; polyamide thin-film composite spiral-wound membrane. Energy: electrical (high-pressure pump). Connectivity: standalone. Software: version P4.2. Disinfection: chemical (both), heat (WRO 300 H). Compliance: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), ISO 10993-5 (biocompatibility).

Indications for Use

Indicated for use as a dialysis accessory to produce reverse osmosis water for one hemodialysis machine in hospital or home settings. Used in conjunction with pre/post-treatment units to meet AAMI/Federal water standards.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Gambro WRO 300 Water Purification System For Hemodialysis (K042797)

Related Devices

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K111740 — AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION · Ameriwater · Oct 5, 2011
K200670 — EON Portable RO Water Purification System · Mar Cor Purification, Inc. · Apr 16, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ 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 400 Lakewood, 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 300 Catalogue Number: 107364 WRO 300 H Catalogue Number: 107365 | | Common or Usual Name | Water Purification Unit | | Classification Name | Subsystem, Water treatment | | Device Class | II | | Product Code | 78FIP | | Regulation Number | 876.5665 | : : . Page 19 of 54 Revised July 23, 2010 Gambro CONFIDENTIAL .. {1}------------------------------------------------ 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 mm Footprint 380 mm | Max 520 mm Footprint 380 mm | | Width | Max 205 mm Footprint 185 mm | Max 205 mm Footprint 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. 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. Page 20 of 54 Revised July 23, 2010 Gambro CONFIDENTIAL {2}------------------------------------------------ K093608 PAGE 3 OF 6 Traditional 510(k) WRO 300 and WRO 300 H 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. #### 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. 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. #### 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. 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. Page 21 of 54 Revised July 29, 2010 Gambro CONFIDENTIAL {3}------------------------------------------------ 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) | | PREDICATE WRO 300 (K042797) SW1.0 | WRO 300 SW P4.2 | WRO 300 H SW P4.2 | |------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The Gambro WRO 300 Water Purification System is intended to be used as a dialysis accessory device in conjunction with one dialysis machine to produce water used to prepare and dilute dialysis concentrate to form dialysis fluid by using the reverse osmosis concept. | 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. | | Feed Water Supply | Input: 3.0 l/min required Pressure: 0.2 to 0.8 MPa Temperature: +5 to +30°C Hardness: recommendation < 1 °dH (20 ppm as CaCO3). | 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 | Input: Min. 3.0 l/min required Pressure: 0.15 to 0.8 MPa during operation Temperature: +5 to +30°C Hardness: recommendation < 0.3 °dH | Page 22 of 54 Revised July 23, 201 mbro CONFIDENTL ## K093608 PAGE 4 OF 6 ਟ {4}------------------------------------------------ | Gambro Renal Products, Inc. | |--------------------------------------| | 14143 Denver West Parkway, Suite 400 | | Lakewood, Colorado 80401 | Traditional 510(k) WRO 300 and WRO 300 H | | PREDICATE WRO 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 (2 x 10m). Designed for flexible, rein-forced tubing 8 mm x 2.5 mm. | Output flow: Minimum 1.1 l/min at 10°C. Product water loop: Maximum 20 meters (2 x 10m). Designed for flexible, 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 MPa during RUN mode. | Product water pressure: 0.12 to 0.6 MPa during RUN mode. | Product water pressure: 0.12 to 0.6 MPa during RUN 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%. | | Drain requirements | 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 osmosis membrane | 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 and cleaning | 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 {5}------------------------------------------------ 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 {6}------------------------------------------------ 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 11111. 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 {7}------------------------------------------------ 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 {8}------------------------------------------------ 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