(167 days)
Medivators Reprocessing Systems Modular Disinfection System (MDS) for Endoscope Reprocessing tests, disinfects and rinses flexible endoscopes. such as fiberoptic and video endoscopes between patient uses. The MDS is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes. It is indicated for use with FDA cleared, liquid high level disinfectants.
The MDS does not replace manual cleaning of endoscopes, they must be precleaned and cleaned according to the endoscope manufacturer's instructions and professional guidelines prior to reprocessing them in the MDS.
The Modular Disinfection System (MDS) is an electro-mechanical system intended to test and high level disinfect heat sensitive semi-critical endoscopes. It is not intended for reprocessing rigid endoscopes. The machine can use any FDA cleared, reusable liquid germicide which is on the market that is labeled for high level endoscope disinfection. The testing provided to the FDA used both Medivators Rapicide® High Level Disinfectant and Cidex® OPA High Level Disinfectant.
The MDS does not replace manual cleaning of endoscopes, they must be precleaned and cleaned according to the endoscope manufacturer's instructions and professional guidelines prior to reprocessing them in the MDS.
During its software based reprocessing cycle, the machine tests the endoscopes for leaks and blockages. Before and during the machine eveles, connectivity with the machine through the connector blocks is evaluated. If the scopes pass these tests, they are flushed with water and detergent, disinfected and rinsed. The disinfection cycle takes approximately 30 minutes. The MDS is capable of asynchronously reprocessing two scopes at a time.
The machine has many built in safety features which stop the cycle and alarm when certain conditions exist which could indicate that disinfection might be compromised. These alarms and causes are defined in the directions for use for the product.
The machine also prints records by endoscope serial number indicating the results of testing, disinfection, number of disinfections, etc. which are required for permanent records.
The provided text describes the Medivators Reprocessing Systems Modular Disinfection System (MDS) for Endoscope Reprocessing. The acceptance criteria and supporting studies are detailed, particularly focusing on its ability to achieve high-level disinfection.
Here's an organized breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Efficacy (Simulated Use) | Achieve specific log reduction in target organism after reprocessing. (Implied from FDA Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors) | ">10^6 log reduction in the organism Mycobacterium terrae after endoscopes were reprocessed in the MDS." |
| Efficacy (In-Use Testing) | No viable organisms remaining on endoscopes after the disinfection cycle. | "No viable organisms remained on the endoscopes following the disinfection cycle." |
| Material Compatibility | Materials used in the MDS should not significantly deteriorate over their use life when exposed to disinfectants. Filters should be compatible with common disinfectants. | "The effect of disinfectants (Rapicide and Cidex OPA) on the materials used in the MDS was evaluated and showed that the materials had no significant deterioration over their use life." "Studies were also presented to show that the filters used in the water filtration system were compatible with common disinfectants." |
| Biocompatibility | Amount of disinfectant residue left on endoscopes and in the MDS after cycles should be below determined safe levels for patients and users. | "The results of the testing showed that any remaining residues would not have an effect on patients or users of the machine." |
| Performance Data | Machine performs required functions (leak check, blockage check, connectivity checks, disinfection cycle, rinse cycles, drying cycles). Error messages function correctly. Critical parameters (e.g., temperature) maintained. Self-disinfection cycle functions. Water filtration system functions, alarms correctly, and remains bacterial retentive. | "Data was provided to the FDA to show that the machine performs as required. This evaluation included testing to show that the leak check, blockage check, connectivity checks, disinfection cycle, rinse cycles, and drying cycles performed correctly." "Any error messages were tested to ensure they function properly to notify users of any possible failure modes." "Testing was performed to show that all critical parameters of the machine function correctly." "Testing was presented that showed that disinfectants which require heating remained at their required temperature for the length of time required in the labeling for the disinfectant." "Testing was completed that showed that the MDS self disinfection cycle works properly by disinfecting all areas of the machine, including the water filtration system." "Studies were performed to show that the water filtration system will function appropriately over time and that the machine will alarm if water filters are plugged to a point which will lower the water pressure below required input. This study also showed that the filters remained bacterial retentive even when plugged to a point that causes the machine to alarm." |
The document describes the studies undertaken to demonstrate the substantial equivalence of the Medivators Reprocessing Systems Modular Disinfection System (MDS) for Endoscope Reprocessing. Here's a breakdown of the additional requested information:
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document does not explicitly state the numerical sample size for the "simulated use" or "in use" efficacy testing in terms of the number of endoscopes or cycles performed. It only reports the outcome.
- Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given the context of a 510(k) submission to the FDA, it is highly likely that the testing was conducted prospectively in a controlled environment to demonstrate device performance for regulatory approval in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This information is not provided in the document. For a disinfection device, "ground truth" would typically be established by microbiological laboratory results (e.g., colony counts) rather than expert consensus on interpretation of images or clinical outcomes. The document refers to "standard methods defined by the FDA guidance document," implying standardized microbiological assays.
4. Adjudication Method for the Test Set
- This information is not provided in the document. Adjudication methods (e.g., 2+1, 3+1) are usually relevant for human-interpreted diagnostic tasks, not for the objective microbiological or performance testing described for this device.
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
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or data, often comparing human performance with and without AI assistance. The Medivators MDS is an automated endoscope reprocessor, not a diagnostic imaging device with an AI component for human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, a standalone performance assessment was conducted for the device's critical functions. The entire testing regimen described for the MDS (efficacy, material compatibility, biocompatibility, and performance data) evaluates the device's automated capabilities and its output (disinfected endoscopes, residue levels, functional checks) without requiring human intervention in the core disinfection process. The device itself is an "algorithm only" type of system in the sense that its operational cycles are software-based and automated.
7. The Type of Ground Truth Used
- The ground truth for the efficacy testing was established through microbiological culture results. Specifically, for simulated use, it was the quantitative reduction of Mycobacterium terrae, and for in-use testing, it was the absence of viable organisms.
- For other tests (material compatibility, biocompatibility, performance data), the ground truth was based on objective measurements against defined thresholds or operational parameters (e.g., deterioration levels, residual chemical levels deemed safe, correct functioning of mechanical aspects like leak checks, temperature maintenance, proper alarm activation).
8. The Sample Size for the Training Set
- The Medivators MDS is a physical medical device (an automated endoscope reprocessor), not an AI/machine learning algorithm requiring a "training set" in the conventional sense. Therefore, the concept of a "training set" in this context is not applicable, and no information is provided. Its internal "rules" are programmed, not learned from a dataset.
9. How the Ground Truth for the Training Set Was Established
- As explained above, there is no "training set" or "ground truth for a training set" applicable to this type of device in the context of machine learning. The device's operational parameters and safety features are based on engineering design, scientific principles of disinfection, and compliance with regulatory guidelines (e.g., FDA guidance).
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Medivators Reprocessing Systems Modular Disinfection System for Endoscope Reprocessing
510(k) Summary of Safety and Effectiveness
JUN 1 4 2007
| Manufacturer: | Medivators Reprocessing Systems, a Division of Minntech Corporation |
|---|---|
| Address: | 14605 28th Avenue NorthMpls., MN 55447USA |
| Official Contact: | Lynn Lueders |
Director, Regulatory Affairs
Medivators has supplied the following information to the U.S. Food and Drug Administration to support substantial equivalence of the Medivators Reprocessing Systems Modular Disinfection System (MDS) for Endoscope Reprocessing to other endoscope reprocessors currently marketed in the U.S.
1. Device Description
The Modular Disinfection System (MDS) is an electro-mechanical system intended to test and high level disinfect heat sensitive semi-critical endoscopes. It is not intended for reprocessing rigid endoscopes. The machine can use any FDA cleared, reusable liquid germicide which is on the market that is labeled for high level endoscope disinfection. The testing provided to the FDA used both Medivators Rapicide® High Level Disinfectant and Cidex® OPA High Level Disinfectant.
The MDS does not replace manual cleaning of endoscopes, they must be precleaned and cleaned according to the endoscope manufacturer's instructions and professional guidelines prior to reprocessing them in the MDS.
During its software based reprocessing cycle, the machine tests the endoscopes for leaks and blockages. Before and during the machine eveles, connectivity with the machine through the connector blocks is evaluated. If the scopes pass these tests, they are flushed with water and detergent, disinfected and rinsed. The disinfection cycle takes approximately 30 minutes. The MDS is capable of asynchronously reprocessing two scopes at a time.
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The machine has many built in safety features which stop the cycle and alarm when certain conditions exist which could indicate that disinfection might be compromised. These alarms and causes are defined in the directions for use for the product.
The machine also prints records by endoscope serial number indicating the results of testing, disinfection, number of disinfections, etc. which are required for permanent records.
2. Intended Use
Medivators Reprocessing Systems Modular Disinfection System (MDS) for Endoscope Reprocessing tests, disinfects and rinses flexible endoscopes, such as fiberoptic and video endoscopes between patient uses. The MDS is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes. It is indicated for use with FDA cleared, liquid high level disinfectants.
The MDS does not replace manual cleaning of endoscopes, they must be precleaned and cleaned according to the endoscope manufacturer's instructions and professional guidelines prior to reprocessing them in the MDS.
3. Comparison to Another Device in Commercial Distribution Within the United States
The MDS is equivalent in function and indications to the Medivators DSD-91ETM Endoscope Disinfector. This machine was found to be substantially equivalent in 1994 (K914145). Both machines have the same indications for use, the same methods of providing disinfection, can use the same reuseable disinfectants at the same temperatures and times. Both machines can reprocess two scopes asynchronously, one in each bay.
Summary of Testing 4.
Medivators has provided testing to show that the MDS is safe and effective for its intended use following the requirements listed in the FDA's Guidance on Premarket Notification [510(k)] Submissions for Automated Endoscope Washers, Washer/Disinfectors, and Disinfectors Intended for Use in Health Care Facilities (dated August 1993). This testing included:
Efficacy Testing
The MDS was tested using standard methods defined by the FDA guidance document. This testing included simulated use and in use testing.
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The simulated use testing showed a >10° log reduction in the organism Mvcobacterium terrae after the endoscopes were reprocessed in the MDS.
663876
In use testing showed no viable organisms remained on the endoscopes following the disinfection cycle.
Additional in-use testing was performed to show that the MDS provided disinfected endoscopes when exposed to the entire endoscope cycle of disinfecting and rinsing.
Material Compatibility
The effect of disinfectants (Rapicide and Cidex OPA) on the materials used in the MDS was evaluated and showed that the materials had no significant deterioration over their use life. Studies were also presented to show that the filters used in the water filtration system were compatible with common disinfectants.
Biocompatibility
The amount of disinfectant residue left on endoscopes and in the MDS after the disinfection and rinsing cycles was evaluated and compared to determined safe levels. The results of the testing showed that any remaining residues would not have an effect on patients or users of the machine.
Performance Data
Data was provided to the FDA to show that the machine performs as required. This evaluation included testing to show that the leak check. blockage check, connectivity checks, disinfection cvcle, rinse cycles, and drying cycles performed correctly. Any error messages were tested to ensure they function properly to notify users of any possible failure modes. Testing was performed to show that all critical parameters of the machine function correctly.
Testing was presented that showed that disinfectants which require heating remained at their required temperature for the length of time required in the labeling for the disinfectant.
Testing was completed that showed that the MDS self disinfection cvcle works properly by disinfecting all areas of the machine, including the water filtration system.
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Studies were performed to show that the water filtration system will function appropriately over time and that the machine will alarm if water filters are plugged to a point which will lower the water pressure below required input. This study also showed that the filters remained bacterial retentive even when plugged to a point that causes the machine to alarm.
5. Summary of Substantial Equivalence
Minntech Corporation has provided the above information in the form of a 510(k) to support the claim that the MDS is safe and effective when used in accordance with the device labeling.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medivators Reprocessing Systems C/O Ms. Lynn Lueders Director, Regulatory Affairs A Minntech Corporation Business Group 14605 28th Avenue, North Minneapolis, Minnesota 55447-4822
JUN 1 4 2007
Re: K063876
Trade/Device Name: Medivators Reprocessing Systems Modular Disinfection System for Endoscope Reprocessing Regulation Number: 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FEB Dated: May 6, 2007 Received: June 7, 2007
Dear Ms. Lueders:
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. Lueders
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.
Chris Liu, 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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Indications for Use
510(k) Number (if Known): K063876
Device Name:
Medivators Reprocessing Systems Modular Disinfection System for Endoscope Reprocessing
Indications for Use:
Medivators Reprocessing Systems Modular Disinfection System (MDS) for Endoscope Reprocessing tests, disinfects and rinses flexible endoscopes. such as fiberoptic and video endoscopes between patient uses. The MDS is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes. It is indicated for use with FDA cleared, liquid high level disinfectants.
The MDS does not replace manual cleaning of endoscopes, they must be precleaned and cleaned according to the endoscope manufacturer's instructions and professional guidelines prior to reprocessing them in the MDS.
AND/OR Prescription Use (Part 21 CFR 801 Subpart D)
Over-the C
(21 CFR 801
Over-the Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(
Children of Anesthesiology, General Hospital, infection of Anesthestology, Gene
C10(k) Number:_
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.