(167 days)
No
The summary describes an electro-mechanical system with software-based control for automated endoscope reprocessing. It mentions safety features, alarms, and record printing, but there is no mention of AI, ML, or related concepts like image processing, training data, or performance metrics typically associated with AI/ML applications in medical devices. The functionality described is consistent with traditional automated systems.
No.
The device is an automated endoscope reprocessor (disinfector) designed to high-level disinfect heat-sensitive semi-critical endoscopes, which is a process to prepare medical devices for reuse, not a device used to provide therapy directly to a patient.
No
The device is described as a reprocessing system intended to test, disinfect, and rinse flexible endoscopes. While it performs "tests" such as leak and blockage checks, these are functional checks of the endoscope itself as part of the reprocessing cycle, not diagnostic tests on a patient to identify a disease, condition, or health status. Its primary purpose is high-level disinfection.
No
The device description explicitly states it is an "electro-mechanical system" and describes hardware components and functions like flushing, rinsing, and printing records, indicating it is not software-only.
Based on the provided text, the Medivators Reprocessing Systems Modular Disinfection System (MDS) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "test, disinfect and rinse flexible endoscopes" and provide "high level disinfection of heat sensitive semi-critical endoscopes." This is a reprocessing function for medical devices used on patients, not a test performed on a sample taken from a patient to diagnose a condition.
- Device Description: The description reinforces its function as an "electro-mechanical system intended to test and high level disinfect heat sensitive semi-critical endoscopes." It describes the process of flushing, disinfecting, and rinsing the endoscopes.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health
- Using reagents or assays to detect specific substances
The MDS is a medical device used for the reprocessing of other medical devices (endoscopes) to make them safe for subsequent patient use. This falls under the category of device sterilization or disinfection, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes
FEB
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.
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.
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
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. The simulated use testing showed a >10 log reduction in the organism Mvcobacterium terrae after the endoscopes were reprocessed in the MDS. 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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Efficacy testing showed a >10 log reduction in Mycobacterium terrae and no viable organisms remaining after disinfection.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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p. 1 of 4
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 North |
| Mpls., MN 55447 | |
| USA | |
| 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.
1
p. 2 of 4
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.
2
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.
4
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.
5
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
6
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:_