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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the Gambro WRO 300 Water Purification System, focusing on the requested acceptance criteria and study details.

Based solely on the provided 510(k) summary, the device is a water purification system for hemodialysis, not an AI/ML powered device. Therefore, many of the requested fields related to AI/ML device performance (like MRMC studies, standalone algorithm performance, number of experts for ground truth, sample sizes for test/training sets, adjudication methods, and effect sizes) are not applicable to this document.

The acceptance criteria for such a device are primarily focused on meeting specific water quality standards for hemodialysis, and the "study" is typically a non-clinical verification or validation demonstrating that the system produces water meeting those standards.

Here's the information extracted and interpreted based on the context of a medical device submission for a water purification system:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Implied)	Reported Device Performance
Primary Function: Water Purification for Hemodialysis	Produce water suitable for preparing and diluting dialysis concentrate to form dialysis fluid.	"Testing verified that the reverse osmosis method used in the WRO 300 produces purified water for use in Dialysis." (This broadly states the function is met, without specific quantifiable metrics in this summary).
Method of Purification	Utilize the reverse osmosis concept effectively.	"employs the reverse osmosis concept." "Testing verified that the reverse osmosis method used in the WRO 300 produces purified water..."
Compatibility with Dialysis Machines	Compatible for use with one dialysis machine, with appropriate input flow and pressure demands.	"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."
Substantial Equivalence to Predicate Device	Demonstrated to be substantially equivalent to the Gambro WRO 10-01 Water Purification System (K811678).	"The proposed Gambro WRO 300 Water Purification System is substantially equivalent to the Gambro WRO 10-01 Water Purification System." (This is the regulatory acceptance, implying performance is at least equivalent).

Note: The provided 510(k) summary is a high-level overview. Detailed performance specifications, such as specific particulate counts, conductivity, ion levels, or bacterial limits, which would constitute the explicit "acceptance criteria" for purified water, are typically found in the full design verification and validation reports, and accompanying standards (e.g., AAMI standards for water for hemodialysis), which are not part of this summary document. The "reported device performance" here is limited to the statements made in the summary.

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

Sample Size for Test Set: Not applicable in the context of an AI/ML device. For this hardware device, the "test set" would refer to the number of units tested or the number of batches of water processed. This is not specified in the summary.
Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for this type of device and submission summary. The testing mentioned ("Testing verified that the reverse osmosis method...") would have been internal engineering and quality testing, likely conducted at the manufacturer's facilities.

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

Not Applicable. This is a hardware device. "Ground truth" in the AI/ML sense (e.g., expert annotation of images) is not relevant. The "ground truth" for a water purification system is objectively measurable chemical and biological properties of the water, verified by laboratory analysis, often against established standards.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not Applicable. This concept is for resolving discrepancies in expert labeling or decision-making for AI/ML validation. For a hardware device, "adjudication" would refer to how test results are accepted or rejected, typically against specified engineering tolerances or regulatory standards, handled by quality control/assurance personnel.

5. 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

Not Applicable. This device is a water purification system, not an AI/ML diagnostic aid. Human readers, cases, or AI assistance are not relevant to its function.

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

Not Applicable. This device is a hardware system, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Objective Measurements/Standards Compliance: The "ground truth" for this device would be established through objective analytical measurements of the purified water's chemical, physical, and microbiological properties, compared against established regulatory standards for water used in hemodialysis (e.g., AAMI standards, or other national/international standards). For example, conductivity measurements, specific ion concentrations, endotoxin levels, and bacterial counts.

8. The Sample Size for the Training Set

Not Applicable. This is a hardware device; it does not have a "training set" in the context of machine learning.

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

Not Applicable. No training set exists for this hardware device.

Summary

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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 AvenueLakewood, Colorado 80215USA
Phone:	303-542-5075
Fax:	303-542-5138
Contact:	Rod J. RylandsQuality and Regulatory DirectorGambro Renal Products International Sales

B. Device Information

Classification name:	Water Purification System ForHemodialysis [21 CFR 876.5665]
Common or usual name:	Water Purification System ForHemodialysis
Proprietary Name(s):	WRO 300 Water Purification SystemFor 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

G. Summary of Non-Clinical Tests Submitted

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.

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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
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(Division Sign-Off)	Vance C. Bragdon
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K042797

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.