(152 days)
Not Found
No
The summary describes a water purification system using reverse osmosis, with no mention of AI or ML capabilities in its intended use, device description, or performance studies.
No
The device is a water purification system intended to be used as a dialysis accessory device, not a therapeutic device itself. Its function is to produce purified water for dialysis, rather than directly treat a medical condition.
No
Explanation: The device is described as a water purification system intended to produce water for dialysis fluid, acting as a dialysis accessory device. It does not perform any diagnostic functions like detecting, monitoring, or diagnosing diseases.
No
The device description clearly states it is a "water purification unit" and describes a physical process (reverse osmosis), indicating it is a hardware device with a physical function, not software only.
Based on the provided information, the Gambro WRO 300 Water Purification System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to produce purified water for preparing dialysis fluid. This water is used in conjunction with a dialysis machine to treat a patient, not to perform a diagnostic test on a sample taken from a patient.
- Device Description: The description reinforces the purpose of producing water for dialysis, again not for diagnostic testing.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly described as a dialysis accessory device that purifies water for use in the dialysis process. This is a therapeutic support function, not a diagnostic one.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FIP
Device Description
The Gambro WRO 300 water purification unit is designed to be used as a dialysis accessory device to produce water used to prepare and dilute dialysis concentrate to form dialysis fluid by using the reverse osmosis concept. It 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 unit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Gambro WRO 300 water purification unit is designed to be used as a dialysis accessory device to produce water used to prepare and dilute dialysis concentrate to form dialysis fluid by using the reverse osmosis concept. It 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 unit. Testing verified that the reverse osmosis method used in the WRO 300 produces purified water for use in Dialysis.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS CAMBRO WRO 300(K) SUMMAN OF SHE ATION SYSTEM FOR HEMODIALYSIS 510(k) Number: __ K 042797_
MAR 9 - 2005
A. Submitter's Information
| Name: | Gambro Renal Products |
|---|---|
| Address: | 10810 West Collins Avenue |
| Lakewood, Colorado 80215 | |
| USA | |
| Phone: | 303-542-5075 |
| Fax: | 303-542-5138 |
| Contact: | Rod J. Rylands |
| Quality and Regulatory Director | |
| Gambro Renal Products International Sales |
B. Device Information
| Classification name: | Water Purification System For
Hemodialysis [21 CFR 876.5665] |
|------------------------------------|-----------------------------------------------------------------|
| Common or usual name: | Water Purification System For
Hemodialysis |
| Proprietary Name(s): | WRO 300 Water Purification System
For Hemodialysis |
| Product Code Classification Panel: | FIP/Gastroenterology-Urology |
| Device Classification: | Class II per 21 CFR 876.5665 |
| C. Predicate Device Information | |
| Predicate Device Name: | Gambro WRO 10-01 |
|---|---|
| FDA Clearance: | K811678 |
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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS GAMBRO WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS 510(k) Number: _ Ko42797
D. Substantial Equivalence
The proposed Gambro WRO 300 Water Purification System is substantially Fire proposed Gambro WRO 10-01 Water Purification System. The current Cambro WRO 10-01 Water Purification System has been cleared for marketing / sale in the United States under 510K Notification – K811678.
E. Device Description
The Gambro WRO 300 water purification unit is designed to be used as a dialysis The Gallerice to produce water used to prepare and dilute dialysis concentrate aooosory arried to proving the reverse osmosis concept. It 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 unit.
F. 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.
G. Summary of Non-Clinical Tests Submitted
The Gambro WRO 300 water purification unit is designed to be used as a dialysis accessory device to produce water used to prepare and dilute dialysis concentrate to form dialysis fluid by using the reverse osmosis concept. It 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 unit. Testing verified that the reverse osmosis method used in the WRO 300 produces purified water for use in Dialysis.
H. Summary of Clinical Tests Submitted - Not Applicable
signature
7 October 2004
Rod J. Rylands Quality and Regulatory Director Gambro Renal Products International Sales
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Image /page/2/Picture/2 description: The image shows a circular seal with text around the perimeter and a stylized bird in the center. The text around the perimeter appears to be the name of a government department or agency. The bird in the center has three lines extending from its head, possibly representing wings or feathers.
MAR 9 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Thomas B. Dowell Regulatory Project Manager Gambro® Renal Products 10810 W. Collins Avenue LAKEWOOD CO 80215
Re: K042797
Trade/Device Name: Gambro WRO 300 Water Purification System for Hemodialysis Regulation Number: 21 CFR §876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: 78 FIP Dated: March 2, 2005 Received: March 4, 2005
Dear Mr. Dowell:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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); 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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Higdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
| 510(k) Number (if known) | K042797 |
|---|---|
| Device Name | Gambro WRO 300 Water Purification System |
| 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. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801. 109) | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| ---------------------------------------- | ----------------------------- | ---- | ---------------------- |
| (Division Sign-Off) | Vance C. Bragdon |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K042797 |