(129 days)
No
The summary describes an electro-mechanical system for endoscope reprocessing with built-in safety features and performance monitoring, but there is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is an endoscope reprocessor, designed to disinfect flexible endoscopes, not to treat or diagnose a disease or condition in a patient.
No
The device is an automated endoscope reprocessor that cleans, disinfects, and rinses flexible endoscopes. While it checks for blockages and leaks in endoscopes as part of its reprocessing cycle, its primary function is disinfection, not diagnosing a medical condition or disease in a patient.
No
The device description clearly states it is an "electro-mechanical system" and describes various hardware components and functions like testing for blockages and leaks, washing, rinsing, drying, and printing records. This indicates it is a physical device with integrated software, not a software-only medical device.
Based on the provided text, the Medivators Advantage Plus Endoscope Reprocessing System, along with the Rapicide PA High Level Disinfectant and Rapicide PA Test Strips, is an In Vitro Diagnostic (IVD) device.
Here's why:
- The Rapicide PA Test Strips are explicitly described as being used "after the disinfection cycle to ensure that the used disinfectant is above the minimum recommended concentration (850ppm peracetic acid)". This is a key characteristic of an IVD. IVDs are used to examine specimens derived from the human body or to provide information about a physiological state, disease, or condition. In this case, the test strips are examining a "specimen" (the used disinfectant) to provide information about its efficacy (whether it's still at a concentration capable of high-level disinfection).
While the Advantage Plus system itself is primarily a medical device for reprocessing endoscopes, the inclusion and intended use of the Rapicide PA Test Strips, which perform a test on a substance to determine its suitability for a medical process, brings the overall system under the umbrella of devices that include an IVD component.
Therefore, the system as a whole, including the test strips, fits the definition of a device that includes an IVD component.
N/A
Intended Use / Indications for Use
Medivators Advantage Plus Endoscope Reprocessing System tests, washes, disinfects and rinses flexible endoscopes, such as fiberoptic and video endoscopes between patient uses. The Advantage Plus system is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes. Manual cleaning of endoscopes is required prior to placement in the Advantage Plus system.
Rapicide PA High Level Disinfectant is intended for use with the Advantage Plus Endoscope Reprocessing System to provide high level disinfection of endoscopes when used according to the directions for use. Rapicide PA Test Strips are used after the disinfection cycle to ensure that the used disinfectant is above the minimum recommended concentration (850ppm peracetic acid); this ensures that the disinfectant was above MRC during the entire disinfection cycle. Rapicide PA should be used under the following contact conditions:
Claim: High Level Disinfection
Time: 5 minutes
Temperature: 30(℃)
Minimum Recommended Concentration of Peracetic Acid (MRC): 850ppm
Product codes (comma separated list FDA assigned to the subject device)
FEB
Device Description
The Advantage Plus AER is an electro-mechanical system intended to test, wash, and high level disinfect flexible fiberoptic and video endoscopes between uses. It is not intended for reprocessing rigid endoscopes. The Advantage is capable of asynchronously reprocessing two scopes at a time.
The Advantage Plus system uses the peracetic acid based Rapicide PA High Level Disinfectant. The Advantage Plus is a single use system in that it mixes the Part A and Part B of the Rapicide PA with water immediately prior to reprocessing and the disinfectant is not reused.
Endoscopes must be pre-cleaned and manually cleaned to SGNA and facility guidelines prior to placing in the system for reprocessing.
After the scopes are connected to the AER, the system tests the endoscopes for blockages in the channels and leaks in the outer skin, and then proceeds to the washing step. The system also includes an optional channel connectivity test to verify proper connection of the fluid channels for reprocessing. If the endoscopes pass the blockage and leak tests and the washing cycle has been completed, the system proceeds to rinse the instruments and begins the disinfection cycle.
For the disinfection cycle, the incoming water is mixed with the two part germicide in the basin. The temperature of the incoming water is monitored to ensure that water temperature is within the operating constraints (30℃) required for disinfection after the water and germicide are mixed together. Following the 5 minute disinfectant contact time, the user takes a sample to test for MRC and then the disinfectant is emptied from the basin into the drain from the machine. Following disinfection, the endoscopes are rinsed and dried by the machine, either by filtered air or an optional alcohol rinse, and are then removed from the machine for the next use.
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.
Rapicide PA High Level Disinfectant is a peracetic acid based, two part disinfectant. Part A contains the active ingredients and Part B contains anticorrosive agents and surfactants. Part A and Part B are mixed in the machine and diluted with water. The Minimum Recommended Concentration (MRC) of Rapicide PA is 850 ppm of peracetic acid. A test strip is used to ensure that the use solution is above the MRC.
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 Advantage Endoscope Reprocessing system and Rapicide PA are safe and effective for their 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) and the Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants (January 3, 2000).
Efficacy Testing Summary:
- Sporicidal tests (Clostridium sporogenes and Bacillus subtilis spores): Total Kill
- Confirmatory Sporicidal tests (Clostridium sporogenes and Bacillus subtilis spores): Total Kill
- Tuberculocidal tests (Mycobacterium bovis (BCG)): Total Kill
- Virucidal tests (Polio virus type 2): Complete Inactivation
- Virucidal tests (Herpes simplex virus type 1): Complete Inactivation
- Virucidal tests (Human Immunodeficiency Virus type 1): Complete Inactivation
- Fungicidal tests (Trichophyton mentagrophytes): Total Kill
- Use-Dilution tests (Pseudomonas aeruginosa, Staphylococcus aureus, Salmonella choleraesuis): Total Kill
- Simulated-Use tests (Mycobacterium terrae): >6 log Reduction
- In-Use tests (Clinically Used Scopes): Total Kill
Material Compatibility: The effect of disinfectant on the materials used in endoscopes and in the AER system was evaluated and showed that the endoscopes and AER materials showed no significant deterioration over time. Studies were also presented to show that the filters used in the water filtration system were compatible with Rapicide PA.
Biocompatibility: The amount of disinfectant residue left on endoscopes 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.
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, washing cycle, 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 provided that showed that the disinfectant remained at its required temperature for the length of time required for high level disinfection. Testing was completed that showed that the Advantage Plus 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.)
See "Summary of Performance Studies" for details on efficacy and performance tests.
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.
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).
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.
0
Medivators Advantage Plus Endoscope Reprocessing System and Rapicide PA High Level Disinfectant
FEB 1 3 2009
510(k) Summary of Safety and Effectiveness
| Manufacturer: | Medivators Reprocessing Systems, a Division of Minntech
Corporation |
|---------------|------------------------------------------------------------------------|
| Address: | 14605 28th Avenue North
Mpls., MN 55447
USA |
Lynn Lueders Official Contact: Director, Regulatory Affairs
Medivators has supplied the following information to the U.S. Food and Drug Administration to support substantial equivalence of the Advantage Plus Endoscope Reprocessing System and Rapicide PA High Level Disinfectant to other endoscope reprocessors and high level disinfectants currently marketed in the U.S.
1. Device Description
The Advantage Plus AER is an electro-mechanical system intended to test, wash, and high level disinfect flexible fiberoptic and video endoscopes between uses. It is not intended for reprocessing rigid endoscopes. The Advantage is capable of asynchronously reprocessing two scopes at a time.
The Advantage Plus system uses the peracetic acid based Rapicide PA High Level Disinfectant. The Advantage Plus is a single use system in that it mixes the Part A and Part B of the Rapicide PA with water immediately prior to reprocessing and the disinfectant is not reused.
Endoscopes must be pre-cleaned and manually cleaned to SGNA and facility guidelines prior to placing in the system for reprocessing.
After the scopes are connected to the AER, the system tests the endoscopes for blockages in the channels and leaks in the outer skin, and then proceeds to the washing step. The system also includes an optional channel connectivity test to verify proper connection of the fluid channels for reprocessing. If the endoscopes pass the blockage and leak tests and
1
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the washing cycle has been completed, the system proceeds to rinse the instruments and begins the disinfection cycle.
For the disinfection cycle, the incoming water is mixed with the two part germicide in the basin. The temperature of the incoming water is monitored to ensure that water temperature is within the operating constraints (30℃) required for disinfection after the water and germicide are mixed together. Following the 5 minute disinfectant contact time, the user takes a sample to test for MRC and then the disinfectant is emptied from the basin into the drain from the machine. Following disinfection, the endoscopes are rinsed and dried by the machine, either by filtered air or an optional alcohol rinse, and are then removed from the machine for the next use.
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.
Rapicide PA High Level Disinfectant is a peracetic acid based, two part disinfectant. Part A contains the active ingredients and Part B contains anticorrosive agents and surfactants. Part A and Part B are mixed in the machine and diluted with water. The Minimum Recommended Concentration (MRC) of Rapicide PA is 850 ppm of peracetic acid. A test strip is used to ensure that the use solution is above the MRC.
Intended Use 2.
Medivators Advantage Plus Endoscope Reprocessing System tests, washes, disinfects and rinses flexible endoscopes, such as fiberoptic and video endoscopes between patient uses. The Advantage Plus system is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes.
Rapicide PA High Level Disinfectant is intended for use with the Advantage Plus Endoscope Reprocessing System to provide high level disinfection of endoscopes when used according to the directions for use.
2
Rapicide PA Test Strips are used after the disinfection cycle to ensure that the used disinfectant is above the minimum recommended concentration (850ppm peracetic acid); this ensures that the disinfectant was above MRC during the entire disinfection cycle.
Rapicide PA should be used under the following contact conditions:
| Claim | Time | Temperature | Minimum Recommended
Concentration of
Peracetic Acid
(MRC) |
|----------------------------|-----------|-------------|--------------------------------------------------------------------|
| High Level
Disinfection | 5 minutes | 30(°C) | 850ppm |
3. Comparison to Another Device in Commercial Distribution Within the United States
The Advantage Plus is equivalent in function and indications to the Medivators MDS Endoscope Reprocessing System (K063876) and the Advanced Sterilization Products' EvoTech™ Integrated Endoscope Disinfection System (K061899). All of the machines have the same indications for use and the same methods of providing disinfection.
Rapicide PA High Level Disinfectant is equivalent in indications and usage to Acecide High Level Disinfectant and Sterilant (K041984) and Peract 20 Liquid Sterilant (K960513). All of the products are peracetic acid based germicides labeled for providing high level disinfection to flexible endoscopes.
Summary of Testing 4.
Medivators has provided testing to show that the Advantage Endoscope Reprocessing system and Rapicide PA are safe and effective for their 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) and the Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants (January 3, 2000).
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The efficacy testing for Rapicide PA is summarized in the table below:
| Tests | Organisms | Results |
|---|---|---|
| Sporicidal | Clostridium sporogenes and | |
| Bacillus subtilis spores | Total Kill | |
| Confirmatory | ||
| Sporicidal | Clostridium sporogenes and | |
| Bacillus subtilis spores | Total Kill | |
| Tuberculocidal | Mycobacterium bovis (BCG) | Total Kill |
| Virucidal | Polio virus type 2 | Complete Inactivation |
| Virucidal | Herpes simplex virus type 1 | Complete Inactivation |
| Virucidal | Human Immunodeficiency Virus | |
| type 1 | Complete Inactivation | |
| Fungicidal | Trichophyton mentagrophytes | Total Kill |
| Use-Dilution | Pseudomonas aeruginosa | |
| Staphylococcus aureus Salmonella | ||
| choleraesuis | Total Kill | |
| Simulated-Use | Mycobacterium terrae | >6 log Reduction |
| In-Use | Clinically Used Scopes | Total Kill |
Efficacy Testing Summary Table
Material Compatibility
The effect of disinfectant on the materials used in endoscopes and in the AER system was evaluated and showed that the endoscopes and AER materials showed no significant deterioration over time. Studies were also presented to show that the filters used in the water filtration system were compatible with Rapicide PA.
Biocompatibility
The amount of disinfectant residue left on endoscopes 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.
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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, washing cycle, disinfection cycle, rinse cvcles, 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 provided that showed that the disinfectant remained at its required temperature for the length of time required for high level disinfection.
Testing was completed that showed that the Advantage Plus 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.
Summary of Substantial Equivalence 5.
Medivators has provided the above information in the form of a 510(k) to support the claim that the Advantage Plus Endoscope Reprocessing System and Rapicide PA are safe and effective when used in accordance with the device labeling.
5
Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services, USA. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black against a white background. The logo is simple and recognizable, representing the department's role in providing health and human services to the United States.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 3 2009
Medivators Reprocessing Systems C/o Ms. Lynn Lueders Director, Regulatory Affairs Minntech Corporation 14605 28th Avenue North Minneapolis, Minnesota 55447-4822
Re: K082988
Trade/Device Name: Medivators Advantage Plus Endoscope Reprocessing System and Rapicide PA High Level Disinfectant Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FEB
Dated: January 28, 2009
Received: January 29, 2009
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 Ford, 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.
6
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 Center for Devices and Radiological Health's (CDRH's) Òffice of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Anthony D. Matosian
Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if Known):
Device Name:
Medivators Advantage Plus Endoscope Reprocessing System and Rapicide PA High Level Disinfectant
Indications for Use:
Medivators Advantage Plus Endoscope Reprocessing System tests, washes, disinfects and rinses flexible endoscopes, such as fiberoptic and video endoscopes between patient uses. The Advantage Plus system is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes. Manual cleaning of endoscopes is required prior to placement in the Advantage Plus system.
Rapicide PA High Level Disinfectant is intended for use with the Advantage Plus Endoscope Reprocessing System to provide high level disinfection of endoscopes when used according to the directions for use. Rapicide PA Test Strips are used after the disinfection cycle to ensure that the used disinfectant is above the minimum recommended concentration (850ppm peracetic acid); this ensures that the disinfectant was above MRC during the entire disinfection cycle. Rapicide PA should be used under the following contact conditions:
| Claim | Time | Temperature | Minimum
Recommended
Concentration of
Peracetic Acid
(MRC) |
|----------------------------|-----------|-------------|-----------------------------------------------------------------------|
| High Level
Disinfection | 5 minutes | 30(℃) | 850ppm |
Over-the Counter Use X AND/OR Prescription Use (21-EFR-801 Subpart-C) >(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
GCT fa SSM
(Division Sign-Off) (Division of Anasthesiology, General Hospital infection Schrol, Dental Devices
510(k) Number: