(350 days)
The O3Z Ozone System is an optional accessory for the Solution Delivery Systems (SDS) manufactured by GE Infrastructure, Water & Process Technologies and is intended to be used for disinfection of the SDS bicarb mixing and distribution system. The mix tank of the SDS system is filled with either RO or deionized water and the mix tank ozone concentration is increased to 0.70 mg/L. The solution is then distributed to the distribution tank of the SDS system. From the distribution tank, the ozonated water is distributed throughout the distribution loop of the SDS system until a minimum ozone concentration level of 0.30 mg/L is established at the end of the SDS bicarb distribution loop. The solution is then recirculated for a minimum of 15 minutes throughout the distribution system. To complete the disinfection process, the system is then rinsed with RO or deionized water until the system is residual free of ozone.
The Ozone Generating System attaches to the Solution Delivery System (SDS) through a valve bypass system and an injector. It is wall mounted in the vicinity of the SDS and is connected to the injector, which is installed in the output piping of the mix pump. The SDS mix tank is filled with RO or DI water; the bypass valves are manually configured for ozone production and then the mix pump is started, causing the injector to draw O3/air mixture into solution. When the proper concentrations of ozone are achieved, the ozonated water is re-circulated throughout the mixing and delivery system to disinfect the fluid path.
Here's an analysis of the provided information regarding the O3Z Ozone System, focusing on acceptance criteria and the supporting study:
The provided document, K043207, is a 510(k) summary for the O3Z Ozone System. It outlines the intended use, device description, and a general statement about performance. However, it does not contain the detailed study results, specific acceptance criteria, or the methodology typically found in a full study report. The information provided is high-level and intended for regulatory submission for substantial equivalence.
Based on the available text, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance | Comments |
|---|---|---|
| Disinfection Efficacy: Reduction of microorganisms to acceptable levels. | "The disinfection process was effective, reliable and consistent in reducing microorganisms with high total organism counts to acceptable levels after disinfection." | This statement is general and lacks specific quantitative thresholds (e.g., log reduction, specific organism counts). The "acceptable levels" are not defined. |
| Ozone Concentration in Mix Tank: Achieve 0.70 mg/L. | "the mix tank ozone concentration is increased to 0.70 mg/L." | This is a target concentration for system operation, not an efficacy outcome. |
| Ozone Concentration at Distribution Loop End: Maintain a minimum of 0.30 mg/L. | "a minimum ozone concentration level of 0.30 mg/L is established at the end of the SDS bicarb distribution loop." | This is a target concentration for system operation, not an efficacy outcome. |
| Recirculation Time: Minimum 15 minutes. | "The solution is then recirculated for a minimum of 15 minutes throughout the distribution system." | This is a procedural step, not an efficacy outcome. |
| Ozone Removal/Rinsing: System residual-free of ozone. | "the system is then rinsed with RO or deionized water until the system is residual free of ozone." | This is a post-disinfection operational criterion. |
Missing Information:
- Specific quantitative microbial reduction targets (e.g., "reduce total viable counts by 6-log").
- Definition of "acceptable levels" for microorganisms.
- Specific types of microorganisms tested (e.g., bacteria, fungi, viruses).
- Quantitative results of the testing (e.g., initial counts, final counts, percentage reduction).
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the disinfection efficacy testing (e.g., number of systems tested, number of disinfection cycles).
Data Provenance: The study was conducted by the manufacturer, GE Infrastructure, Water & Process Technologies, as part of their 510(k) submission. It is implicitly a prospective study to demonstrate the performance of their device prior to marketing. The country of origin for the data is USA (Minnetonka, Minnesota, where the manufacturer is located).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the given text. For a disinfection efficacy study, "ground truth" would typically be established by microbiological laboratory testing, not by expert consensus on images or interpretations. The qualifications of the microbiologists or laboratory personnel conducting the tests are not mentioned.
4. Adjudication Method (for the test set)
Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation of data (e.g., image-based diagnostics) where discrepancies between readers need to be resolved. This is a disinfection efficacy study, not an interpretation study. Therefore, an adjudication method in the traditional sense is not applicable or mentioned. The "ground truth" (microbiological counts) would be objective measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study is not applicable to this type of device (an ozone generator for disinfection). MRMC studies are used to evaluate the impact of a new diagnostic method or AI on human reader performance for tasks involving interpretation (e.g., radiologists reading medical images). The O3Z Ozone System is a physical disinfection system, not an interpretive diagnostic tool. Therefore, no "human readers improve with AI vs without AI" effect size would be relevant or studied here.
6. Standalone Performance
Yes, a standalone performance study was done. The statement "Testing of the ozone generator demonstrated that the disinfection process was effective..." refers to the performance of the device itself (the algorithm, if you consider the ozone generation and delivery process as controlled by an algorithm, or more simply, the device's mechanism of action) in achieving disinfection. The results are based on the device operating independently to achieve the stated purpose.
7. Type of Ground Truth Used
The ground truth used for this study would be microbiological testing results. This involves quantifying the number of viable microorganisms before and after the disinfection process to demonstrate reduction. The document implies this without detailing the specific assays or methods.
8. Sample Size for the Training Set
This device likely does not have a "training set" in the context of machine learning. It's a physical system for disinfection. The design and optimization of the system (e.g., ozone concentration, flow rates, cycle times) would have been developed through engineering studies, prototypes, and empirical testing, rather than training a machine learning model on a large dataset. Therefore, the concept of a "training set" sample size is not applicable here.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, the concept of a "training set" is not applicable here as it's not an AI/ML-based device. The parameters for optimal disinfection (e.g., 0.70 mg/L ozone concentration, 0.30 mg/L minimum at the end of the loop, 15 minutes recirculation) would have been established through a combination of:
- Scientific literature on ozone's antimicrobial properties.
- Laboratory benchtop studies identifying effective ozone concentrations and contact times for relevant microorganisms.
- Engineering testing and optimization on prototype systems to ensure reliable generation, distribution, and measurement of ozone within the SDS system.
- Potentially, pilot studies with a limited number of systems.
These studies would have used microbiological assays (quantification of live microorganisms) as their "ground truth" to determine the efficacy of different ozone concentrations and contact times.
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GE Infrastructure Water & Process Technologies
510(k) SUMMARY
DATE PREPARED:
November 2, 2005
SUBMITTER 1.
GE Infrastructure, Water & Process Technologies 5951 Clearwater Drive Minnetonka, MN 55343-8995
CONTACT PERSON 2.
Name: Charlene Nash Phone: (952) 988-6359 Fax: (952) 988-6136 Email: Charlene.nash@ge.com
DEVICE IDENTIFICATION 3.
Ozone Generator/Ozone Generating System Common Name:
Trade Name/Proprietary Name:
O3Z Ozone System used on the Solution Delivery Systems (SDS) manufactured by GE Infrastructure, Water & Process Technologies
CLASSIFICATION NAME AND REFERENCE 4.
Classification Names: Tank, Holding, Dialysis and Accessories
Classification: Class II, 21 CFR 876.5820 Panel: Gastroenterology Product Code: FIN
PREMARKET NOTIFICATION NUMBER: K043207 ട.
General Electric Company 5951 Clearwater Drive Minnetonko, MN 55343-8995 USA
T 952-933-2277 952-988-6056 F
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- The O3Z Ozone System is an optional accessory for the INDICATION FOR USE: ട. Solution Delivery Systems (SDS) manufactured by GE Infrastructure, Water & Process Technologies, and is intended to be used for disinfection of the SDS bicarb mixing and distribution system. The mix tank of the SDS system is filled with either RO or deionized water and the mix tank ozone concentration is increased to 0.70 mg/L. The solution is then distributed to the distribution tank of the SDS system. From the distribution tank, the ozonated water is distributed throughout the distribution loop of the SDS system until a minimum ozone concentration level of 0.30 mg/L is established at the end of the SDS bicarb distribution loop. The solution is then recirculated for a minimum of 15 minutes throughout the distribution system. To complete the disinfection process, the system is then rinsed with RO or deionized water until the system is residual free of ozone.
- The Ozone Generating System attaches to the Solution 7. DEVICE DESCRIPTION: Delivery System (SDS) through a valve bypass system and an injector. It is wall mounted in the vicinity of the SDS and is connected to the injector, which is installed in the output piping of the mix pump. The SDS mix tank is filled with RO or DI water; the bypass valves are manually configured for ozone production and then the mix pump is started, causing the injector to draw O3/air mixture into solution. When the proper concentrations of ozone are achieved, the ozonated water is re-circulated throughout the mixing and delivery system to disinfect the fluid path.
- STATEMENT OF SUBSTANTIAL EQUIVALENCE: The ozone generator for system 8. disinfection is substantially equivalent in technological characteristics of the Karlson Ozone Sterilizer (K873200). It is substantially equivalent in intended use to Minncare®, which is commonly used in hemodialysis clinics to disinfect the reverse osmosis water purification equipment and the water distribution loop and Renalin® (K830575), another common disinfectant used in dialysis clinics primarily to reprocess dialyzers and disinfect dialysis machines.
PERFORMANCE: SAFETY AND EFFECTIVENESS INFORMATION 9.
Testing of the ozone generator demonstrated that the disinfection process was effective, reliable and consistent in reducing microorganisms with high total organism counts to acceptable levels after disinfection when used in accordance with the Operation and Maintenance Manual for the Ozone Generating System.
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General Electric Company 5951 Clearwater Drive Minnetonka, MN 55343-8995
952-933-2277 952-988-6056
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains an abstract image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 4 2005
Ms. Charlene Nash Quality Assurance & Regulatory Affairs Manager GE Infrastructure Water & Process Technologies GE Osmonics, Minnetonka Medical Operations 5951 Clearwater Drive Minnetonka, Minnesota 55343
Re: K043207
Trade/Device Name: 03Z 0Zone System Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis System and Accessories Regulatory Class: II Product Code: NII Dated: October 14, 2005 Received: October 19, 2005
Dear Ms. Nash:
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 (PMA), 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.
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Page 2 - Ms. Nash
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.
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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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.
Chiu Lin, Ph.D.
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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GE Infrastructure, Water & Process Technologies 5951 Clearwater Drive Minnetonka, MN 55343-8995
510(k) Number (if known): K043207
Device Name:
OzZ Ozone System used on the Solution Delivery Systems (SDS) manufactured by GE Infrastructure, Water & Process Technologies
Indications for Use Statement
The OzZ Ozone System is an optional accessory for the Solution Delivery Systems (SDS) manufactured by GE Infrastructure, Water & Process Technologies and is intended to be used for disinfection of the SDS bicarb mixing and distribution system. The mix tank of the SDS system is filled with either RO or deionized water and the mix tank ozone concentration is increased to 0.70 mg/L. The solution is then distributed to the distribution tank of the SDS system. From the distribution tank, the ozonated water is distributed throughout the distribution loop of the SDS sustem until a minimum ozone concentration level of 0.30 mg/L is established at the end of the SDS bicarb distribution loop. The solution is thenrecirculated for a minimum of 15 minutes throughout the distribution system. To complete the disinfection process, the system is then rinsed with RO or deionized water until the system is residual free of ozone.
Concurrence of CDRH, Office of Device Evoluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use X
Shiela A. Murphy, MD 10/3/00
Division Sign Off
sion of Anesthesiology. General Hospital Infection Control. Dantal Devices
510(k) Number: K043207
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”