(251 days)
Not Found
No
The summary describes a water purification unit using reverse osmosis and standard software control for water production and disinfection. There is no mention of AI or ML capabilities.
No.
The device is a water purification unit that produces water for hemodialysis equipment, acting as an accessory rather than directly providing therapy.
No
The device is a water purification unit intended to produce water for hemodialysis equipment, not to diagnose medical conditions.
No
The device description clearly details physical components such as a high pressure pump, RO membrane, and connections for pre and post treatment units, indicating it is a hardware device with integrated software for control.
Based on the provided text, the Gambro WRO 300 and WRO 300 H Water Purification Units are not IVD (In Vitro Diagnostic) devices.
Here's why:
- Intended Use: The intended use is to produce water through reverse osmosis for hemodialysis equipment. This is a process that prepares water for use in a medical procedure performed on a patient, not for testing samples in vitro (outside the body).
- Device Description: The description focuses on the mechanical and chemical processes of water purification (reverse osmosis, disinfection) and its connection to hemodialysis machines. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The text does not describe any features or functions typical of IVD devices, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Using reagents or assays for testing
The device is clearly described as a "dialysis accessory" that provides purified water for the hemodialysis process. This is a supportive function for a medical treatment, not a diagnostic function.
N/A
Intended Use / Indications for Use
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.
Product codes
78FIP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals and in home environments
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- the membrane life expectancy;
- user interface/control system
- disinfection both chemical and heat
- physical ergonomics
- 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.
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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 Input: Min. 3.0 l/min required
Pressure: 0.15 to 0.8 MPa during
operation
Temperature: +5 to +30°C
Hardness: recommendation Input: Min. 3.0 l/min required
Pressure: 0.15 to 0.8 MPa during
operation
Temperature: +5 to +30°C
Hardness: recommendation 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
- 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
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