K Number
K172677
Device Name
Advantage Plus Pass-Thru
Manufacturer
Date Cleared
2017-12-19

(105 days)

Product Code
Regulation Number
876.1500
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Advantage Plus Pass-Thru Endoscope Reprocessing System tests, washes, disinfect and rinses endoscopes, such as fiberoptic and video endoscopes between patient uses. The Advantage Plus Pass-Thru system is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes and related accessories. Manual cleaning of endoscopes is required prior to disinfection in the Advantage Plus Pass-Thru System. The Advantage Plus Pass-Thru Endoscope Reprocessing System uses Rapicide PA High Level Disinfectant to provide high level disinfection of endoscopes when used according to the directions for use. The system uses Intercept Plus Detergent in its washing cycle at a concentration of 0.5%. Rapicide PA Test Strips are used after the disinfection cycle to ensure that the used disinfectant is above the minimum recommended concentration (MRC) of 850 ppm 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 -Contact Time: 5 minutes Temperature: 30°C MRC: 850ppm
Device Description
The Advantage Plus Pass-Thru is an electro-mechanical Automatic Endoscope Reprocessor (AER) intended to high-level disinfect pre-cleaned endoscopes and their related accessories by exposing them to a peracetic acid based disinfectant – Rapicide PA disinfectant solution (cleared under 510k – K082988). The subject device is closely related to its predicate the Advantage Plus Endoscope Reprocessing System cleared in 510k – K082988 and K102996 but differs in that it is designed in a "pass-thru" configuration. The subject device is intended to be built into a wall which separates 'clean' and 'dirty' sides. It provides the ability to load an endoscope from the dirty side and unload the disinfected endoscope from the clean side, thus preventing potential mix-up between high level disinfected and contaminated endoscopes. Contaminated endoscopes are placed in the subject device from the 'dirty' side and appropriate connections to the endoscope channels are made. The system is designed to test for proper channel connectivity, channel blockages and leaks in the outer endoscope sheath. After the endoscope passes these tests, the system proceeds to the washing cycle with Intercept Plus detergent, and the highlevel disinfection cycle. In the high-level disinfection cycle, Rapicide PA HLD is diluted by the incoming water to a minimum concentration of 850 ppm of peracetic acid. The system measures and maintains the temperature of this disinfectant solution to ensure that it is above the minimum recommended temperature of 30℃ for Rapicide PA for effective High Level Disinfection to occur. Following the 5 minute disinfectant contact time, the user takes a sample to test for MRC (850 ppm of peracetic acid). Once the MRC test passes, the disinfectant is emptied from basin and drained out of the AER. The endoscope is then rinsed, dried and removed from the 'clean side' of the AER.
More Information

No
The summary describes an electro-mechanical system for endoscope reprocessing with automated cycles and parameter monitoring. There is no mention of AI, ML, image processing, or any data analysis techniques that would suggest the use of such technologies. The performance studies focus on disinfection efficacy and system functionality, not on the performance of an AI/ML algorithm.

No
This device is an endoscope reprocessor, designed to clean and disinfect medical devices (endoscopes) between uses, not to provide therapy directly to a patient.

No

The device is an endoscope reprocessor designed to clean and high-level disinfect endoscopes, not to diagnose medical conditions in patients. It performs tests on the endoscope itself (e.g., channel connectivity, blockages, leaks) and on the disinfectant strength, but these are functional checks of the reprocessing system, not diagnostic tests on a patient.

No

The device description explicitly states it is an "electro-mechanical Automatic Endoscope Reprocessor (AER)" and details its physical components and functions (testing, washing, disinfecting, rinsing, measuring temperature, etc.). While it mentions software validation, the core device is a piece of hardware with integrated software, not a standalone software product.

Based on the provided text, the Advantage Plus Pass-Thru Endoscope Reprocessing System itself is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • Definition of IVD: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
  • Intended Use: The primary intended use of the Advantage Plus Pass-Thru system is to reprocess endoscopes (clean, disinfect, and rinse) between patient uses. This is a process performed on a medical device (the endoscope), not on a human specimen.
  • Device Description: The description details an electro-mechanical system for cleaning and disinfecting endoscopes.
  • Rapicide PA Test Strips: While the system uses Rapicide PA Test Strips, which are IVD devices (as they test the concentration of the disinfectant solution), the reprocessing system itself is not performing an in vitro diagnostic test on a human specimen. The test strips are a component used to verify the effectiveness of the disinfection process within the system.

Therefore, the Advantage Plus Pass-Thru Endoscope Reprocessing System is a medical device used for the reprocessing of other medical devices (endoscopes), but it does not fit the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

Advantage Plus Pass-Thru Endoscope Reprocessing System tests, washes, disinfect and rinses endoscopes, such as fiberoptic and video endoscopes between patient uses. The Advantage Plus Pass-Thru system is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes and related accessories. Manual cleaning of endoscopes is required prior to disinfection in the Advantage Plus Pass-Thru System.

The Advantage Plus Pass-Thru Endoscope Reprocessing System uses Rapicide PA High Level Disinfectant to provide high level disinfection of endoscopes when used according to the directions for use. The system uses Intercept Plus Detergent in its washing cycle at a concentration of 0.5%.

Rapicide PA Test Strips are used after the disinfection cycle to ensure that the used disinfectant is above the minimum recommended concentration (MRC) of 850 ppm 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 -Contact Time: 5 minutes Temperature: 30°C MRC: 850ppm

Product codes

FEB

Device Description

The Advantage Plus Pass-Thru is an electro-mechanical Automatic Endoscope Reprocessor (AER) intended to high-level disinfect pre-cleaned endoscopes and their related accessories by exposing them to a peracetic acid based disinfectant – Rapicide PA disinfectant solution (cleared under 510k – K082988).

The subject device is closely related to its predicate the Advantage Plus Endoscope Reprocessing System cleared in 510k – K082988 and K102996 but differs in that it is designed in a "pass-thru" configuration. The subject device is intended to be built into a wall which separates 'clean' and 'dirty' sides. It provides the ability to load an endoscope from the dirty side and unload the disinfected endoscope from the clean side, thus preventing potential mix-up between high level disinfected and contaminated endoscopes.

Contaminated endoscopes are placed in the subject device from the 'dirty' side and appropriate connections to the endoscope channels are made. The system is designed to test for proper channel connectivity, channel blockages and leaks in the outer endoscope sheath. After the endoscope passes these tests, the system proceeds to the washing cycle with Intercept Plus detergent, and the highlevel disinfection cycle. In the high-level disinfection cycle, Rapicide PA HLD is diluted by the incoming water to a minimum concentration of 850 ppm of peracetic acid. The system measures and maintains the temperature of this disinfectant solution to ensure that it is above the minimum recommended temperature of 30℃ for Rapicide PA for effective High Level Disinfection to occur. Following the 5 minute disinfectant contact time, the user takes a sample to test for MRC (850 ppm of peracetic acid). Once the MRC test passes, the disinfectant is emptied from basin and drained out of the AER. The endoscope is then rinsed, dried and removed from the 'clean side' of the AER.

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 conducted the following testing to demonstrate the substantial equivalence of Advantage Plus Pass Thru AER –

  • Performance Testing Identical performance testing has been conducted on the subject and . predicate devices to ensure the Advantage Plus Pass-Thru meets equivalent acceptance criteria as the Advantage Plus. This testing confirms the subject device performs with the same safety and effectiveness as the predicate device, please refer to the table below for a brief discussion of the performance testing.
Performance TestingAcceptance CriteriaResults
Simulated-Use Testing -
Demonstrates that when used as indicated, the
system high level disinfects endoscopes using
Rapicide PA HLD and Intercept Plus detergent.Achieve 6-log reduction of the test
organism in each endoscope
channel and endoscope exterior.Pass
Clinical In-Use Testing -
Demonstrates that when used as indicated, the
system high level disinfects nominal endoscopes
using Rapicide PA HLD after patient/clinical use.Demonstrate no viable organisms
remain after reprocessing.Pass
Water-Line/Self-Disinfection Cycle Testing -
Evaluation of the bactericidal effectiveness of
the self-disinfection cycle (SDC) and additional
subject device biofilm analysis by quantitative
Polymerase Chain Reaction gene expression.Survivors after the SDC must be ≤
10 CFU of test organism per 100
mL.
Absence of biofilm formation
following self-disinfection cycle.Pass
Rinse Residual Testing -
Evaluation of residual levels of Rapicide PA and
Intercept Plus to demonstrate that endoscopes
reprocessed in the AER are safe for both
patients and users.Any chemistry residuals must be
equal to or lower than the lowest
reports LD50 exposure with a 10-
fold safety margin.Pass
Material Compatibility -
Demonstrates the system compatibility with
Rapicide PA High Level Disinfectant and subject
device compatibility with Intercept Plus
Detergent.Acceptance criteria included
dimensional and weight changes

§ 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 19, 2017

Medivators Inc. Megan Skaar Regulatory Affairs Specialist 14605 28th Avenue North Minneapolis, Minnesota 55447

Re: K172677

Trade/Device Name: Advantage Plus Pass Thru Automated Endoscope Reprocessing System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: FEB Dated: November 20, 2017 Received: November 21, 2017

Dear Megan Skaar:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

1

the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K172677

Device Name

Advantage Plus Pass Thru Endoscope Reprocessing System

Indications for Use (Describe)

Advantage Plus Pass-Thru Endoscope Reprocessing System tests, washes, disinfect and rinses endoscopes, such as fiberoptic and video endoscopes between patient uses. The Advantage Plus Pass-Thru system is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes and related accessories. Manual cleaning of endoscopes is required prior to disinfection in the Advantage Plus Pass-Thru System.

The Advantage Plus Pass-Thru Endoscope Reprocessing System uses Rapicide PA High Level Disinfectant to provide high level disinfection of endoscopes when used according to the directions for use. The system uses Intercept Plus Detergent in its washing cycle at a concentration of 0.5%.

Rapicide PA Test Strips are used after the disinfection cycle to ensure that the used disinfectant is above the minimum recommended concentration (MRC) of 850 ppm 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 -Contact Time: 5 minutes Temperature: 30°C MRC: 850ppm

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Medivators, a Cantel Medical Company. The logo consists of a blue circular icon with several curved lines inside, followed by the word "MEDIVATORS" in large, blue, sans-serif font. Below the company name is the text "A Cantel Medical Company" in a smaller, blue, sans-serif font.

510(k) Summary

510(k) Number:K172677
Manufacturer:Medivators Inc., a Cantel Medical Company
Address:14605 28th Avenue North
Minneapolis, MN 55447
(763) 553-3300
Official Contact:Megan Skaar
Regulatory Affairs Specialist, Medivators Inc.
Date:19 December 2017
Trade Name:
Common Name:
Classification Name:
Product Code:
Device Class:
Regulation No:Advantage Plus Pass Thru Endoscope Reprocessing System
Accessories, Cleaning, For Endoscope
Endoscope and accessories
FEB
II
Subject Device - Advantage Plus Pass Thru Endoscope Reprocessing System,
876.1500
Predicate Device Trade Name - Medivators Advantage Plus Endoscope
Reprocessing System and Rapicide PA High Level Disinfectant (K082988 and
K102996), 876.1500

1. Indications for Use

Advantage Plus Pass-Thru Endoscope Reprocessing System tests, washes, disinfects and rinses endoscopes, such as fiberoptic and video endoscopes, between patient uses. The Advantage Plus Pass-Thru system is indicated to provide high level disinfection of heat sensitive semi-critical endoscopes and related accessories. Manual cleaning of endoscopes is required prior to disinfection in the Advantage Plus Pass-Thru System.

The Advantage Plus Pass-Thru Endoscope Reprocessing System uses Rapicide PA High Level Disinfectant to provide high level disinfection of endoscopes when used according to the directions for use. The system uses Intercept Plus Detergent in its washing cycle at a concentration of 0.5%.

Rapicide PA Test Strips are used after the disinfection cycle to ensure that the disinfectant is above the minimum recommended concentration (MRC) of 850 ppm peracetic acid when used; this confirms that the disinfectant was above MRC during the entire disinfection cycle. Rapicide PA should be used under the following contact conditions -

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Image /page/4/Picture/0 description: The image shows the logo for Medivators, a Cantel Medical Company. The logo consists of a blue circular graphic on the left, followed by the word "MEDIVATORS" in blue, sans-serif font. Below the word "MEDIVATORS" is the text "A Cantel Medical Company" in a smaller, sans-serif font, also in blue. The overall design is clean and corporate, conveying a sense of professionalism and reliability.

Contact Time: 5 minutes Temperature: 30°C MRC: 850ppm

2. Device Description

The Advantage Plus Pass-Thru is an electro-mechanical Automatic Endoscope Reprocessor (AER) intended to high-level disinfect pre-cleaned endoscopes and their related accessories by exposing them to a peracetic acid based disinfectant – Rapicide PA disinfectant solution (cleared under 510k – K082988).

The subject device is closely related to its predicate the Advantage Plus Endoscope Reprocessing System cleared in 510k – K082988 and K102996 but differs in that it is designed in a "pass-thru" configuration. The subject device is intended to be built into a wall which separates 'clean' and 'dirty' sides. It provides the ability to load an endoscope from the dirty side and unload the disinfected endoscope from the clean side, thus preventing potential mix-up between high level disinfected and contaminated endoscopes.

Contaminated endoscopes are placed in the subject device from the 'dirty' side and appropriate connections to the endoscope channels are made. The system is designed to test for proper channel connectivity, channel blockages and leaks in the outer endoscope sheath. After the endoscope passes these tests, the system proceeds to the washing cycle with Intercept Plus detergent, and the highlevel disinfection cycle. In the high-level disinfection cycle, Rapicide PA HLD is diluted by the incoming water to a minimum concentration of 850 ppm of peracetic acid. The system measures and maintains the temperature of this disinfectant solution to ensure that it is above the minimum recommended temperature of 30℃ for Rapicide PA for effective High Level Disinfection to occur. Following the 5 minute disinfectant contact time, the user takes a sample to test for MRC (850 ppm of peracetic acid). Once the MRC test passes, the disinfectant is emptied from basin and drained out of the AER. The endoscope is then rinsed, dried and removed from the 'clean side' of the AER.

3. Comparison and Summary of Technological Characteristics for the Subject and Predicate Devices

The subject device – Advantage Plus Pass-Thru Endoscope Reprocessing System and its predicate device – Advantage Plus Endoscope Reprocessing System are very closely related and have the same intended use and fundamental technology.

Similarities Between Subject and Predicate Device

The Advantage Plus Pass-Thru and its predicate device have the same scientific technology including principle of operation, features and materials. Both devices have high level disinfection cycle. They use the same disinfectant chemistry – Rapicide PA under the same use conditions (30°C for 5 minutes at MRC of 850 ppm PAA) to high level disinfect endoscopes. They have identical chemistry dosing mechanisms to produce equivalent concentration of disinfection solution. Additionally, both

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Image /page/5/Picture/0 description: The image shows the logo for Medivators, a Cantel Medical Company. The logo consists of a blue circular graphic on the left, which has several curved lines inside. To the right of the graphic is the word "MEDIVATORS" in a bold, blue sans-serif font, with the text "A Cantel Medical Company" in a smaller font below it.

the devices have the same fluid flow rate and pathway. The Advantage Plus Pass-Thru System is constructed of the same materials, metals and polymers, as its predicate device.

Differences Between Subject and Predicate Device

The subject device provides the ability to load an endoscope into the AER from the dirty, contaminated side and unload the disinfected scope from the clean side - creating the pass-thru system. To facilitate this system configuration, the basin door arrangement was altered from the arrangement of the predicate device. There were no changes in critical parameters to achieve high level disinfection with the alteration of a pass-thru door configuration. Verification of software and performance testing on the subject device pass-thru configuration demonstrates the configuration difference between the subject device and the predicate device does not impact the safety and effectiveness profile of the devices. The pass-thru configuration of the subject AER physically separates the 'clean' and 'dirty' sides of the reprocessing unit and hence reduces the risk of cross contamination as demonstrated in the performance testing outlined in Table 2 below.

Performance bench testing, included in Section 4 of this summary, supports substantial equivalence of the pass-thru system configuration. A device comparison table which supports substantial equivalence of the subject device to the predicate device is provided below –

| Important Parameters | Subject Device – Advantage Plus
Pass-Thru | Predicate Device - Advantage Plus
(cleared under 510k - K082988
and K102996) | |
|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Advantage Plus Pass-Thru
Endoscope Reprocessing System
tests, washes, disinfects and rinses
endoscopes, such as fiberoptic and
video endoscopes, between
patient uses. The Advantage Plus
Pass-Thru system is indicated to
provide high level disinfection of
heat sensitive semi-critical
endoscopes and related
accessories. Manual cleaning of
endoscopes is required prior to
disinfection in the Advantage Plus
Pass-Thru System.
The Advantage Plus Pass-Thru
Endoscope Reprocessing System
uses Rapicide PA High Level
Disinfectant to provide high level | Medivators Advantage Plus
Endoscope Reprocessing System
tests, washes, disinfects and rinses
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 and
related accessories. Manual
cleaning of endoscopes is not
required prior to disinfection in the
Advantage Plus Pass-Thru System.
The Advantage Plus Endoscope
Reprocessing System uses Rapicide
PA High Level Disinfectant to
provide high level disinfection of | |
| disinfection of endoscopes when
used according to the directions
for use. | | endoscopes when used according
to the directions for use. | |
| Product Code | FEB | FEB | |
| FDA Regulation | 21 CFR§ 876.1500 | 21 CFR§ 876.1500 | |
| Pass-Thru Configuration/
AER separates Clean and
Dirty Side? | Yes | No | |
| Type of Machine Function | Electro-mechanical | Electro-mechanical | |
| System Technology Features | The system performs endoscope
connection test, leak and channel
blockage test, washing (cleaning),
disinfection and rinsing. The cycle
steps for each basin are
monitored. Built in safety features
and alarms. | The system performs endoscope
connection test, leak and channel
blockage test, washing (cleaning),
disinfection and rinsing. The cycle
steps for each basin are
monitored. Built in safety features
and alarms. | |
| | Disinfection time,
temperature and minimum
recommended
concentration | Rapicide PA - 5 minutes at 30°C;
850ppm Peracetic acid MRC | Rapicide PA - 5 minutes at 30°C;
850ppm Peracetic acid MRC |
| | | Detergent used in cleaning
cycle | Intercept Plus Detergent |
| | Disinfection efficacy | | >106 log reduction of
Mycobacterium terrae |
| Manual cleaning required
before use? | | Yes | Yes (per K082988) however if the
automated cleaning cycle is used,
manual cleaning is not required
(per K102988) |
| Performs leak test? | Yes | Yes | |
| Performs channel
connection and blockage
test? | Yes | Yes | |
| Post-disinfection treatment | Optional alcohol purge followed by
air purge of endoscope channels | Optional alcohol purge followed by
air purge of endoscope channels | |

Table 1 – Predicate Comparison Table

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Image /page/6/Picture/0 description: The image shows the logo for Medivators, a Cantel Medical Company. The logo consists of a blue circular graphic on the left, followed by the word "MEDIVATORS" in a bold, blue sans-serif font. Below the company name, in a smaller font, is the text "A Cantel Medical Company," also in blue. The overall design is clean and corporate, conveying a sense of professionalism and reliability.

4. Summary of Non-Clinical Performance Data

Medivators has conducted the following testing to demonstrate the substantial equivalence of Advantage Plus Pass Thru AER –

  • Performance Testing Identical performance testing has been conducted on the subject and . predicate devices to ensure the Advantage Plus Pass-Thru meets equivalent acceptance criteria as the Advantage Plus. This testing confirms the subject device performs with the same safety

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Image /page/7/Picture/0 description: The image contains the logo for MEDIVATORS, a Cantel Medical Company. The logo consists of a blue circular graphic on the left, featuring several curved lines. To the right of the graphic is the word "MEDIVATORS" in a bold, blue sans-serif font. Below "MEDIVATORS" is the text "A Cantel Medical Company" in a smaller, lighter blue font.

and effectiveness as the predicate device, please refer to the table below for a brief discussion of the performance testing.

Table 2 – Comparison of Non-Clinical Performance Tests for the Predicate and Subject Devices
------------------------------------------------------------------------------------------------
Performance TestingAcceptance CriteriaResults
Simulated-Use Testing -
Demonstrates that when used as indicated, the
system high level disinfects endoscopes using
Rapicide PA HLD and Intercept Plus detergent.Achieve 6-log reduction of the test
organism in each endoscope
channel and endoscope exterior.Pass
Clinical In-Use Testing -
Demonstrates that when used as indicated, the
system high level disinfects nominal endoscopes
using Rapicide PA HLD after patient/clinical use.Demonstrate no viable organisms
remain after reprocessing.Pass
Water-Line/Self-Disinfection Cycle Testing -
Evaluation of the bactericidal effectiveness of
the self-disinfection cycle (SDC) and additional
subject device biofilm analysis by quantitative
Polymerase Chain Reaction gene expression.Survivors after the SDC must be ≤
10 CFU of test organism per 100
mL.
Absence of biofilm formation
following self-disinfection cycle.Pass
Rinse Residual Testing -
Evaluation of residual levels of Rapicide PA and
Intercept Plus to demonstrate that endoscopes
reprocessed in the AER are safe for both
patients and users.Any chemistry residuals must be
equal to or lower than the lowest
reports LD50 exposure with a 10-
fold safety margin.Pass
Material Compatibility -
Demonstrates the system compatibility with
Rapicide PA High Level Disinfectant and subject
device compatibility with Intercept Plus
Detergent.Acceptance criteria included
dimensional and weight changes