(143 days)
Not Found
No
The summary describes an automated endoscope reprocessor system that uses a microprocessor for control and monitoring, but there is no mention of AI or ML technologies being used for tasks like image analysis, predictive maintenance, or complex decision-making based on learned patterns. The system relies on pre-defined parameters and comparisons to stored reference values.
No.
The device is an automated endoscope reprocessor system, which is used for cleaning and high-level disinfection of medical devices, not for diagnosing, treating, or preventing disease in a patient.
No
Explanation: The device is an automated endoscope reprocessor used for cleaning and high-level disinfection of medical devices. It does not diagnose medical conditions.
No
The device is an Automated Endoscope Reprocessor System (AER), which is a physical machine that performs cleaning and high-level disinfection of medical devices. While it is microprocessor-controlled and includes software validation, it is fundamentally a hardware device with integrated software, not a software-only medical device.
Based on the provided text, the enspire™ 300 Series Automated Endoscope Reprocessor System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "effectively provide a pressure and channel monitor, clean, high-level disinfect, rinse and air purge validated immersible, semi-critical, heat sensitive medical devices including, but not limited to, flexible endoscopes and non-channeled naso-endoscopes." This describes a process for reprocessing medical devices, not for performing tests on biological samples to diagnose conditions.
- Device Description: The description details a system for cleaning and disinfecting medical devices. It mentions monitoring device integrity and channel flow, but these are related to the reprocessing process itself, not to analyzing patient samples.
- 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.)
- Detecting or measuring analytes
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is clearly intended for the reprocessing of medical instruments used in patient care, which falls under the category of medical device sterilization and disinfection, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The enspire™ 300 Series Automated Endoscope Reprocessor System is intended to effectively provide a pressure and channel monitor, clean, high-level disinfect, rinse and air purge validated immersible, semi-critical, heat sensitive medical devices including, but not limited to, flexible endoscopes and non-channeled naso-endoscopes. The validated cleaning process replaces manual cleaning for endoscopes other than duodenoscopes. Manual Cleaning of endoscopes is required prior to placement in high level disinfection only cycle.
The enspire 300 Series Automated Endoscope Reprocessor System uses Revital-Ox PAA High Level Disinfectant to provide high level disinfection of validated immersible, reusable, semi-critical, heat sensitive medical devices. It automatically mixes the Part A and Part B solutions, high level disinfects the load during a controlled cycle and rinses the load. The wash phase of the enspire 300 Series Automated Endoscope Reprocessor System cycle uses only Revital-Ox 2X Concentrate Enzymatic Detergent to perform cleaning.
The Revital-Ox PA High Level Disinfectant (HLD) is a two-part solution, which when mixed, is intended to provide high level disinfection of validated immersible, semi-critical, heat sensitive medical devices including, but not limited to, flexible endoscopes and non-channeled naso-endoscopes, when used in the enspire 300 AER.
Product codes
NZA
Device Description
The enspire 300™ Series Automated Endoscope Reprocessor System (AER) is a medical device processing system used for cleaning and high level disinfection of immersible, reusable, semi-critical, heat-sensitive devices such as flexible endoscopes and their accessories. The system consists of the enspire 300 AER, Revital-Ox 2X Concentrate Enzymatic Detergent (R2X), and Revital-Ox Peracetic Acid High Level Disinfectant (HLD).
The enspire 300 series AER is an automated, self-contained device for the effective cleaning and high level disinfection of semi-critical medical devices and their accessories. Prior to placement in the processor, users will be instructed to perform bedside (point of use) cleaning and manual leak testing. The devices will not require manual cleaning prior to processing, with the exception of duodenoscopes which will still require manual cleaning per the manufacturer's written instructions. Channel Connectors, as identified in STERIS labeling, are used to facilitate the delivery of the R2X detergent, HLD solution and rinse water to internal channels of devices that have them.
On the first process of an endoscope, the user must create a scope profile for the endoscope in the AER. The creation of the scope profile saves key endoscope attributes to the AER which are used to monitor the cycle during processing of the device. Once the device is positioned in the enspire 300 AER and optional operator ID, case ID, procedure ID and physician information is inputted, the operator initiates the processing cycle during which the Processor will create and maintain the conditions necessary for effective cleaning and high level disinfection. At the beginning of the processing cycle, an automated pressure monitor is performed to assess the integrity of the flexible endoscope. In parallel with the pressure monitor and prior to initiation of the cleaning phase, the processing system will evaluate the flow coefficient of each individual channel and compare to their respective reference value stored in the device profile created prior to first processing. The enspire 300 AER maintains inflation of the processed device throughout the process to reduce the risk of ingress of fluid in the event of any loss of integrity. At the end of the processing cycle, the cleaned and high level disinfected devices are rinsed with 0.2 micron filtered potable water followed by a dried, oil free, filtered compressed air purge to evacuate rinse water from the endoscope channels. The AER, which is micro-processor controlled and continually monitored, provides documentation of each cycle.
The enspire 300 AER utilizes Revital-Ox 2X Concentrate Enzymatic Detergent for cleaning and Revital-Ox Peracetic Acid High Level Disinfectant for high level disinfection. Revital-Ox PAA HLD is a two part solution consisting of Part A, 15% PAA, and Part B. conditioner.
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
Non-Clinical Testing:
- Simulated Use Testing:
- Cleaning: Worst-case devices were soiled and processed in triplicate trials using the cleaning phase of the processing cycle, then examined visually and sampled for quantitation of two soil markers: protein
§ 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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July 21, 2023
STERIS Corporation Gregory Land Lead Regulatory Affairs Specialist 5960 Heislev Road Mentor, Ohio 44060
Re: K230560
Trade/Device Name: enspire 300 Series Automated Endoscope Reprocessor System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NZA Dated: June 13, 2023 Received: June 13, 2023
Dear Gregory Land:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Bifeng Qian -S
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230560
Device Name
enspire 300 Series Automated Endoscope Reprocessor System
Indications for Use (Describe)
The enspire™ 300 Series Automated Endoscope Reprocessor System is intended to effectively provide a pressure and channel monitor, clean, high-level disinfect, rinse and air purge validated immersible, semi-critical, heat sensitive medical devices including, but not limited to, flexible endoscopes and non-channeled naso-endoscopes. The validated cleaning process replaces manual cleaning for endoscopes other than duodenoscopes. Manual Cleaning of endoscopes is required prior to placement in high level disinfection only cycle.
The enspire 300 Series Automated Endoscope Reprocessor System uses Revital-Ox PAA High Level Disinfectant to provide high level disinfection of validated immersible, reusable, semi-critical, heat sensitive medical devices. It automatically mixes the Part A and Part B solutions, high level disinfects the load during a controlled cycle and rinses the load. The wash phase of the enspire 300 Series Automated Endoscope Reprocessor System cycle uses only Revital-Ox 2X Concentrate Enzymatic Detergent to perform cleaning.
The Revital-Ox PA High Level Disinfectant (HLD) is a two-part solution, which when mixed, is intended to provide high level disinfection of validated immersible, semi-critical, heat sensitive medical devices including, but not limited to, flexible endoscopes and non-channeled naso-endoscopes, when used in the enspire 300 AER.
| 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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510(k) Summary enspire 300 Series Automated Endoscope Reprocessor System
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600
Contact: Gregory Land Lead Regulatory Affairs Specialist Tel: 440-392-7424
Summary Date: July 20, 2023
510(k) Number: K230560
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1. Device Name
| Trade Name: | enspire 300 Series Automated Endoscope
Reprocessor System |
|------------------------|--------------------------------------------------------------|
| Device Classification: | Class II |
| Common/usual Name: | Endoscope Cleaner and Reprocessor |
| Classification Name: | Accessories, Germicide, Cleaning, For Endoscopes |
| Classification Number: | 21 CFR 876.1500 |
| Product Code: | NZA |
2. Predicate Device
Reliance Advance Endoscope Processing System, K123768
3. Description of Device
The enspire 300™ Series Automated Endoscope Reprocessor System (AER) is a medical device processing system used for cleaning and high level disinfection of immersible, reusable, semi-critical, heat-sensitive devices such as flexible endoscopes and their accessories. The system consists of the enspire 300 AER, Revital-Ox 2X Concentrate Enzymatic Detergent (R2X), and Revital-Ox Peracetic Acid High Level Disinfectant (HLD).
The enspire 300 series AER is an automated, self-contained device for the effective cleaning and high level disinfection of semi-critical medical devices and their accessories. Prior to placement in the processor, users will be instructed to perform bedside (point of use) cleaning and manual leak testing. The devices will not require manual cleaning prior to processing, with the exception of duodenoscopes which will still require manual cleaning per the manufacturer's written instructions. Channel Connectors, as identified in STERIS labeling, are used to facilitate the delivery of the R2X detergent, HLD solution and rinse water to internal channels of devices that have them.
On the first process of an endoscope, the user must create a scope profile for the endoscope in the AER. The creation of the scope profile saves key endoscope attributes to the AER which are used to monitor the cycle during processing of the device. Once the device is positioned in the enspire 300 AER and optional operator ID, case ID, procedure ID and physician information is inputted, the operator initiates the processing cycle during which the Processor will create and maintain the conditions necessary for effective cleaning and high level disinfection. At the beginning of the processing cycle, an automated pressure monitor is performed to assess the integrity of the flexible endoscope. In parallel with the pressure monitor and prior to initiation of the cleaning phase, the processing system will evaluate the flow coefficient of each individual channel and compare to their respective
5
reference value stored in the device profile created prior to first processing. The enspire 300 AER maintains inflation of the processed device throughout the process to reduce the risk of ingress of fluid in the event of any loss of integrity. At the end of the processing cycle, the cleaned and high level disinfected devices are rinsed with 0.2 micron filtered potable water followed by a dried, oil free, filtered compressed air purge to evacuate rinse water from the endoscope channels. The AER, which is micro-processor controlled and continually monitored, provides documentation of each cycle.
The enspire 300 AER utilizes Revital-Ox 2X Concentrate Enzymatic Detergent for cleaning and Revital-Ox Peracetic Acid High Level Disinfectant for high level disinfection. Revital-Ox PAA HLD is a two part solution consisting of Part A, 15% PAA, and Part B. conditioner.
Indications for Use 4.
The enspire 300 Automated Endoscope Reprocessor System is intended to effectively provide a pressure and channel monitor, clean, high-level disinfect, rinse and air purge validated immersible. reusable, semi-critical, heat sensitive medical devices including, but not limited to, flexible endoscopes and non-channeled nasoendoscopes. The validated cleaning process replaces manual cleaning for endoscopes other than duodenoscopes. Manual Cleaning of endoscopes is required prior to placement in high level disinfection only cycle.
The enspire 300 Automated Endoscope Reprocessor System uses Revital-Ox PA High Level Disinfectant to provide high level disinfection of validated immersible, reusable, semi-critical, heat sensitive medical devices. It automatically mixes the Part A and Part B solutions; high level disinfects the load during a controlled cycle and rinses the load. The wash phase of the enspire 300 Series Automated Endoscope Reprocessor System cycle uses only Revital-Ox 2X Concentrate Enzymatic Detergent to perform cleaning.
The Revital-Ox PA High Level Disinfectant (HLD) is a two-part solution, which when mixed, is intended to provide high level disinfection of validated immersible, reusable, semi-critical, heat sensitive medical devices including, but not limited to, flexible endoscopes and non-channeled naso-endoscopes, when used in the enspire 300 AER.
న. Technological Characteristic Comparison Tables
| Feature | Proposed enspire 300 Series
AER | Predicate K123768
Reliance Advanced EPS | Comparison |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | The enspire 300 Automated
Endoscope Reprocessor
System is intended to
effectively provide a pressure | Cleaning and high level
disinfection of up to two
immersible, reusable,
heat-sensitive, semi- | Similar – both
systems provide
cleaning and
high-level |
| Feature | Proposed enspire 300 Series AER | Predicate K123768 Reliance Advanced EPS | Comparison |
| | and channel monitor, clean, high-level disinfect, rinse and air purge validated immersible, reusable, semi-critical, heat sensitive medical devices including, but not limited to, flexible endoscopes and non-channeled naso-endoscopes. The validated cleaning process replaces manual cleaning for endoscopes other than duodenoscopes. Manual Cleaning of endoscopes is required prior to placement in high level disinfection only cycle.. | critical devices such as GI flexible endoscopes, bronchoscopes and their accessories.
During the system's standardized Endoscope Processing Cycle, cleaning is achieved within the Cleaning phase, and high level disinfection is achieved within the 50 – 57°C HLD phase (4 minute generation sequence followed by a 6-minute exposure sequence).
Manual cleaning is not required prior to processing in Reliance EPS version 2. | disinfection |
| | The enspire 300 Automated Endoscope Reprocessor System uses Revital-Ox PA High Level Disinfectant to provide high level disinfection of validated immersible, reusable, semi-critical, heat sensitive medical devices. It automatically mixes the Part A and Part B solutions; high level disinfects the load during a controlled cycle and rinses the load. The wash phase of the enspire 300 Series Automated Endoscope Reprocessor System cycle uses only Revital-Ox 2X Concentrate Enzymatic Detergent to perform cleaning.
The Revital-Ox PA High Level Disinfectant (HLD) is a two-part solution, which when mixed, is intended to provide high level disinfection of validated immersible, reusable, semi critical heat sensitive | | |
| Feature | Proposed enspire 300 Series
AER | Predicate K123768
Reliance Advanced EPS | Comparison |
| | medical devices including, but
not limited to, flexible
endoscopes and non-channeled
naso-endoscopes, when used in
the enspire 300 AER. | | |
| Operating
Principles /
Technology | The enspire 300 AER provide
delivery of solutions and fluids
to endoscopes and their
accessories. Revital-Ox 2X
Concentrate Enzymatic
detergent and Revital-Ox PAA
HLD are introduced into the
enspire 300 AER to provide
cleaning and high level
disinfection. Decontamination
cycle is used to help with
routine maintenance and to
help prevent contamination of
the Reprocessor during period
of inactivity. Descaling Cycle
is used to help prevent and
remove scale build-up in the
Reprocessor. | The Reliance EPS and its
integrated endoscope
processing support
provide for delivery of
solutions and fluids to
endoscopes and their
accessories. Klenzyme
and Reliance DG are
introduced into the
Reliance EPS to provide
cleaning and high level
disinfection.
Decontamination cycles
(D-Long with CIP-200
and D-Short) are used to
prevent biofilm formation
in the Reliance EPS
Processor and ensure
effective processing
following periods of
processor inactivity | Similar - the
subject device
and the
predicate device
both use
enzymatic
cleaner and
peracetic acid
for cleaning and
high level
disinfection,
respectively.
The disinfection
differs between
the two, the
subject device
uses thermal
disinfection
while the
predicate uses
chemical. |
| Process
Parameters | The cycle parameters cannot
be altered by operator. The
critical process parameters are:
• Contact Time
• Use Dilution Temp
• Water Volume
• Chemical Volume
• Channel irrigation
flow/pressure | Standardized cycle
parameters cannot be
altered by operator. The
critical process
parameters are:
• Contact Time
• Use Dilution Temp
• Cleaning solution and
Reliance DG
concentration
• Water filter integrity | Similar- the
subject device
uses water and
chemical
volume rather
than solution
concentration.
The subject
device also
provides flow
monitoring |
| Process
Monitors | Channel irrigation flow alarms
when endoscope channel is
obstructed or disconnected, if
pressure too low or too high,
or if sensor defect is detected.
Chemical volume alarms if
chemical injected volume is | Control Handle Boot
pressure alarms if
pressure too low to
process, or if too high and
could potentially damage
scopes (specification 6.5
to 10.5 PSI) | Similar - the
proposed device
has additional
process
monitoring of
all endoscope
lumens |
| Feature | Proposed enspire 300 Series
AER | Predicate K123768
Reliance Advanced EPS | Comparison |
| | too high, too low, chemical
pump is defective or chemical
container has inadequate
volume to complete the cycle.
Water volume alarms when
water level is too high for
HLD.
Temperature alarm is triggered
when temperature is too high,
sump takes too long to heat,
RTD variance exceeded or a
sensor is defective. Alarm is
triggered if Real Time Clock
error is detected. | Detection of a fresh
Reliance DG container in
every processing cycle,
Cleaning Solution level
monitored; alarm
indicates when container
does not have sufficient
amount to complete cycle
Temperature alarms if
outside of range
Water filter integrity test
at end of each high level
disinfection cycle. | individually. |
| Design
Features | Intended for use with Revital-
Ox 2X Concentrate Enzymatic
Detergent and Revital-Ox
PAA HLD Microprocessor controlled Internal components
constructed of stainless steel,
silicone, polypropylene and
PVDF. Processor provides 0.2 micron
filtered water for rinsing Automated injection of
cleaning and HLD solutions,
with accuracy monitored by a
flow meter Uses dried, oil free and filtered
compressed air for Air Purge Automated endoscope pressure
monitor Monitors channel flow Includes a bar code scanner;
employs touchscreen display
interface Separate, optional printer | Intended for use with
Reliance DG only Microprocessor
controlled Internal components
constructed of stainless
steel, silicone,
polypropylene and
PVDF. Processor provides 0.2
micron filtered water for
washing, disinfection and
rinsing Automated injection of
solutions with accuracy
monitored by a flow
meter. Automated generation
and delivery of high level
disinfectant solution Air intake for Air Purge
is HEPA filtered Automated endoscope
leak test Barcode scanner Separate, optional printer | Similar – the
subject device
has additional
monitoring of
channel flow
and use of a
touch screen. |
| Cycle Parameters | | | |
| Pressure
Monitor | Performed at the beginning of
the cycle | Performed at the
beginning of the cycle | Same |
| Flow check | Performed at the beginning
and end of the cycle | Not present | Different – The
subject device
has a Flow |
| Feature | Proposed enspire 300 Series
AER | Predicate K123768
Reliance Advanced EPS | Comparison |
| Cleaning
Phase
Temperature | 50-55°C | 50-57°C | Check in the
cycle which
monitors the
flow to each
lumen of an
endoscope |
| Cleaning
Phase
Exposure time | 4.5 minutes wash | 5 minutes | Similar –
subject device is
quicker |
| Rinse phase
after cleaning | 30 seconds | 40 seconds | Similar –
subject device is
quicker |
| HLD phase
Temperature | 50-55°C | 50-57°C | Similar –
subject device
operates in a
narrower range
of the predicate
range |
| HLD phase
exposure time | 3 minutes | 6 minutes | Similar –
subject device is
quicker |
| Rinse Phase
after HLD
phase | 30 seconds | 40 seconds | Similar –
subject device is
quicker |
| Number of
rinses | 2 | 2 | Same |
| Air purge | Performed between each phase
and at the end of the cycle | Performed at the end of
the cycle | Same |
| Accessories | | | Comparison |
| Detergent | Revital-Ox 2X Concentrate
Enzymatic Detergent | Klenzyme | Similar – both
are enzymatic
cleaners |
| HLD | Revital-Ox PAA HLD | Reliance DG | Similar – both
are peracetic
acid based HLD |
| Chemical
Indicator | enspire 300 series AER
Process monitor. Peracetic
acid dose indicator for routine
monitoring of enspire 300
AER using Revital-Ox PAA | VERIFY Process
Indicator for Reliance
EPS. Peracetic acid dose
indicator for routine
monitoring of Reliance | Similar – both
use a chemical
indicator but the
indicator is
different |
| Feature | Proposed enspire 300 Series
AER | Predicate K123768
Reliance Advanced EPS | Comparison |
| | HLD. Chemical reaction on
indicator pad to produce color
change. | EPS using Reliance DG.
Chemical reaction on
indicator pad to produce
color change. | |
| Scope
Connectors /
Flow Units | Scope connectors are required
for all lumens of endoscopes. | Flow Units are required
only for scope channels
that do not open in the
endoscope control handle
or mechanical action is
required for valve
operation. | Similar – both
use connectors
to flush lumens
of endoscopes |
| Operator
Maintenance | Periodic replacement of water
filters. Periodic replacement
of printer tape if using the
external printer option.
Running the decontamination
cycle every 24 hours. | Periodic replacement of
water and air filters. D-
SHORT decontamination
cycle required every 54-
hours
D-LONG
decontamination cycle
required if D-SHORT not
performed within past 54
hours | Similar – both
require the
periodic
replacement of
filters and
running of
decontamination
cycles. |
Table 1. Predicate Device Comparison Table
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Table 2. HLD Device Comparison Table
| Feature | Proposed Revital-Ox PAA
HLD | Predicate Reliance DG
Dry Germicide | Comparison |
|----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Intended Use | The Revital-Ox PA High
Level Disinfectant (HLD) is a
two-part solution, which
when mixed, is intended to
provide high level
disinfection of validated
immersible, reusable, semi-
critical, heat sensitive
medical devices including,
but not limited to, flexible
endoscopes and non-
channeled naso-endoscopes,
when used in the enspire 300
AER. | The Reliance Endoscope
Processing System is
intended for washing and
high level disinfection of
up to two manually pre-
cleaned, immersible,
reusable, heat-sensitive,
semi-critical devices such
as GI flexible endoscopes,
bronchoscopes and their
accessories. High level
disinfection is achieved
within the 50-57°C HLD
phase of the endoscope
processing cycle (4-
minute generation
sequence followed by a 6-
minute exposure
sequence). | Same |
| Germicidal | High level disinfectant | High level disinfectant | Same |
| Feature | Proposed Revital-Ox PAA
HLD | Predicate Reliance DG
Dry Germicide | Comparison |
| claim
Germicide
Exposure time
for HLD (min) | 3 minutes | 10 minutes (4-minute
generation sequence
followed by a 6-minute
exposure sequence) | Similar – The
exposure time
for high level
disinfection is
quicker on the
subject device |
| Use
Temperature | 50-55°C | 50-57°C | Similar – the
operating range
is narrower and
included in the
predicate device |
| Reuse | Single Use dilution | Single Use dilution | Same |
| Active
Ingredient | Peracetic acid | Peracetic acid | Same |
| Mode of
Action | It is believed that peracetic
acid exerts its germicidal
effect by several
mechanisms:
-oxidizing sulfhydral and
sulfur bonds in proteins and
enzymes, particularly in the
cell walls1
-hydroxyl radicals produced
from PAA are bactericidal2
-PAA damages the viral
capsid and viral nucleic
acid3,4 | It is believed that
peracetic acid exerts its
germicidal effect by
several mechanisms:
| Same |
| Rinse | 2 rinses, 30 seconds each
with 0.2µ filtered water | 2 rinses, 40 seconds each,
with 0.2µ filtered water | Similar – the
rinse time of the
subject device is
quicker |
| Microbial Efficacy
Sporicidal
Activity of
Disinfectants
AOAC
Official
Method
966.04 | Meets efficacy requirements.
Bacillus subtilis
Clostridium sporogenes | Meets efficacy
requirements.
Bacillus subtilis
Clostridium sporogenes | Same |
| Confirmatory
Sporicidal
Activity of
Disinfectants | Meets efficacy requirements.5
Bacillus subtilis
Clostridium sporogene | Meets efficacy
requirements.5
Bacillus subtilis
Clostridium sporogenes | Same |
| Feature | Proposed Revital-Ox PAA
HLD | Predicate Reliance DG
Dry Germicide | Comparison |
| AOAC
Official
Method
966.04 | | | |
| Fungicidal
Activity of
Disinfectants
AOAC
Official
Method
955.17 | Solution is fungicidal.
Trichophyton interdigitale | Solution is fungicidal.
Trichophyton
mentagrophytes | Same |
| Use-Dilution
Method
AOAC,
Official
Methods
955.14,
955.15, 964.02 | Solution is bactericidal
Salmonella enterica
Staphylococcus aureus
Pseudomonas aeruginosa | Solution is bactericidal.
Salmonella choleraesuis
Staphylococcus aureus
Pseudomonas aeruginosa | Same |
| EPA Virucidal
Testing
(DIS/TSS-7,
Nov. 1981) | Process conditions are
virucidal.
Herpes simplex Type 1
Adenovirus Type 5
Poliovirus Type 1 | Process conditions are
virucidal.
Herpes simplex Type 1
Adenovirus Type 5
Poliovirus Type 1 | Same |
| Tuberculocidal
Activity
Ascenzi
Quantitative
Suspension
Test | Solution is tuberculocidal
Mycobacterium terrae | Solution is tuberculocidal
Mycobacterium terrae | Same |
| Simulated Use
Test | Meets efficacy requirement.
≥ 6 log reduction
Mycobacterium terrae in a
manual application | Meets efficacy
requirement. ≥ 6 log
reduction Mycobacterium
terrae in a manual
application | Same |
| Clinical In-use
test | Non surviving
microorganisms on
representative medical
devices tested | Non surviving
microorganisms on
representative medical
devices tested | Same |
| Bio compatibility | | | |
| Cytotoxicity
device extracts | Non-Cytotoxic per ISO
10993-5 | Non-cytotoxic per ISO
10993-5 | Same |
| Residue
Reduction | Automatic within the enspire
300 AER. 2 rinses with 0.2µ
filtered water after HLD
cycle effectively reduces | Automatic within the
Reliance Endoscope
Processor, 2 rinses with
0.2µ filtered water after | Same |
| Feature | Proposed Revital-Ox PAA
HLD | Predicate Reliance DG
Dry Germicide | Comparison |
| | germicide residues to safe
levels. | HLD cycle effectively
reduces residues
germicide residues to safe
levels. | |
| Device
Material
Compatibility | Compatible with medical
devices as established by
testing finished flexible
endoscopes through 300
cycles and rigid devices
through 150 cycles.
No functional changes have
occurred to flexible or rigid
devices.
Some materials show
cosmetic changes such as
fading of black anodized
aluminum without harm to
the base material. | Compatible with intended
flexible endoscopes and
accessories established
through testing finished
medical devices. No
device functional changes.
Some materials show
cosmetic changes such as
fading of external
markings but all remained
legible and fading of black
anodized aluminum
without harm to the base
material. | Same |
11
12
13
6. Summary of Non-Clinical Testing
Shown in Table 3 is the new testing that was performed to evaluate the enspire 300 Automated Endoscope Reprocessor System.
| Table 3. Summary of verification activities. | ||
|---|---|---|
| -- | ---------------------------------------------- | -- |
| Test | Acceptance Criteria | Result |
|---|---|---|
| Simulated Use | ||
| Testing | Cleaning: Worst-case devices were soiled and processed in | |
| triplicate trials using the cleaning phase of the processing cycle, | ||
| then examined visually and sampled for quantitation of two soil | ||
| markers: protein |