(14 days)
Not Found
No
The description details automated processes controlled by a microprocessor, but there is no mention of AI or ML algorithms being used for tasks like image analysis, predictive maintenance, or adaptive control based on learned patterns. The monitoring of flow coefficients against stored reference values is a rule-based comparison, not indicative of AI/ML.
No
This device is an automated endoscope reprocessor, intended to clean and high-level disinfect medical devices, not to directly treat or diagnose a disease or condition in a patient.
No
The device is an automated endoscope reprocessor system, used for cleaning, disinfecting, rinsing, and air purging medical devices like flexible endoscopes. While it has monitoring capabilities (pressure and channel monitoring), these are for ensuring the integrity of the endoscope during reprocessing, not for diagnosing patient conditions or diseases.
No
The device description clearly outlines a physical system (Automated Endoscope Reprocessor) that performs cleaning and disinfection processes on medical devices. While it is microprocessor-controlled, it is not solely software.
Based on the provided text, the enspire™ 300 Series Automated Endoscope Reprocessor System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The enspire 300 Series Automated Endoscope Reprocessor System is designed to clean and high-level disinfect medical devices, specifically flexible endoscopes and similar instruments. It processes the medical device itself, not a specimen from a patient.
- Intended Use: The intended use clearly states its purpose is to reprocess medical devices, not to diagnose or provide information about a patient's health through analysis of biological samples.
Therefore, the device falls under the category of a medical device used for reprocessing other medical devices, not an IVD.
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, 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.
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 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 (comma separated list FDA assigned to the subject device)
NZA
Device Description
The enspire 300™ Series Automated Endoscope Reprocessor (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.
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 pre-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 confirm 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 prevent 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical testing was performed to evaluate the modified device.
Test Performed: Performance testing with replacement pre-filters.
Acceptance Criteria: The modification does not affect the performance of the device.
Result: Pass.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
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October 3, 2023
Steris Corporation Nalepka Jennifer Manager, Regulatory Affairs 5960 Heisley Road Mentor, Ohio 44060
Re: K232918
Trade/Device Name: enspire 300 Series Automated Endoscope Reprocessor Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: NZA Dated: September 19, 2023 Received: September 19, 2023
Dear Nalepka Jennifer:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
enspire 300 Series Automated Endoscope Reprocessor
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, 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.
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 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 nasoendoscopes, 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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4
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510(k) Summary K232918 enspire 300 Series Automated Endoscope Reprocessor
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600
Contact: Jennifer Nalepka Manager, Regulatory Affairs Tel: 440-392-7458
Summary Date: October 2, 2023
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
5
Device Name 1.
Trade Name:
Device Classification: Common/usual Name: Classification Name: Classification Number: Product Code:
enspire 300 Series Automated Endoscope Reprocessor Class II Endoscope Cleaner and Reprocessor Accessories, Germicide, Cleaning, For Endoscopes 21 CFR 876.1500 NZA
2. Predicate Device
enspire 300 Series Automated Endoscope Reprocessor, K230560
Description of Device 3.
The enspire 300™ Series Automated Endoscope Reprocessor (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.
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 pre-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 confirm 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 prevent 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.
6
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.
4. Indications for Use
The enspire 300 Automated Endoscope Reprocessor 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 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 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.
Technological Characteristic Comparison Tables ട്.
| Feature | Proposed
enspire 300 Series AER | Predicate
enspire 300 Series AER
(K230560) | Comparison |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Indications for
Use | The enspire 300 Automated
Endoscope Reprocessor 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 naso-
endoscopes. The validated
cleaning process replaces
manual cleaning for endoscopes
other than duodenoscopes. | The enspire 300 Automated
Endoscope Reprocessor 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 naso-
endoscopes. The validated
cleaning process replaces
manual cleaning for endoscopes
other than duodenoscopes. | Identical |
| Feature | Proposed
enspire 300 Series AER | Predicate
enspire 300 Series AER
(K230560) | Comparison |
| | Manual Cleaning of endoscopes
is required prior to placement in
high level disinfection only
cycle. | Manual Cleaning of endoscopes
is required prior to placement in
high level disinfection only
cycle. | |
| | The enspire 300 Automated
Endoscope Reprocessor 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 cycle uses only
Revital-Ox 2X Concentrate
Enzymatic Detergent to perform
cleaning. | The enspire 300 Automated
Endoscope Reprocessor 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 cycle uses only
Revital-Ox 2X Concentrate
Enzymatic Detergent to perform
cleaning. | |
| 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 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. | Identical |
| Process
Parameters | The cycle parameters cannot be
altered by operator. The critical
process parameters are:
● Contact Time
● Use Dilution Temp
● Water Volume
● Chemical Volume | The cycle parameters cannot be
altered by operator. The critical
process parameters are:
● Contact Time
● Use Dilution Temp
● Water Volume
● Chemical Volume | Identical |
| Feature | Proposed
enspire 300 Series AER | Predicate
enspire 300 Series AER
(K230560) | Comparison |
| | • Channel irrigation
flow/pressure | • Channel irrigation
flow/pressure | |
| 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 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. | 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 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. | Identical |
| 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 pre-
filtered water and the
proposed filters have a new
support material.
• 0.2 micron filtered water
used 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 | • 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 pre-
filtered water
• 0.2 micron filtered water
used 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 | Similar - function
and
biocompatibility of
pre-filter is
unchanged. |
| Feature | Proposed
enspire 300 Series AER | Predicate
enspire 300 Series AER
(K230560) | Comparison |
| | Includes a bar code scanner; employs touchscreen display interface Separate, optional printer | Separate, optional printer | |
| Cycle Parameters | | | Comparison |
| Pressure
Monitor | Performed at the beginning of
the cycle | Performed at the beginning of
the cycle | Identical |
| Flow check | Performed at the beginning and
end of the cycle | Performed at the beginning and
end of the cycle | Identical |
| Cleaning
Phase
Temperature | 50-55°C | 50-55°C | Identical |
| Cleaning
Phase
Exposure time | 4.5 minutes wash | 4.5 minutes wash | Identical |
| Rinse phase
after cleaning | 30 seconds | 30 seconds | Identical |
| HLD phase
Temperature | 50-55°C | 50-55°C | Identical |
| HLD phase
exposure time | 3 minutes | 3 minutes | Identical |
| Rinse Phase
after HLD
phase | 30 seconds | 30 seconds | Identical |
| Number of
rinses | 2 | 2 | Identical |
| Air purge | Performed between each phase
and at the end of the cycle | Performed between each phase
and at the end of the cycle | Identical |
| Accessories | | | Comparison |
| Detergent | Revital-Ox 2X Concentrate
Enzymatic Detergent | Revital-Ox 2X Concentrate
Enzymatic Detergent | Identical |
| HLD | Revital-Ox PAA HLD | Revital-Ox PAA HLD | Identical |
| Chemical
Indicator | enspire 300 series AER Process
monitor. Peracetic acid dose
indicator for routine monitoring
of enspire 300 AER using
Revital-Ox PAA HLD.
Chemical reaction on indicator
pad to produce color change. | enspire 300 series AER Process
monitor. Peracetic acid dose
indicator for routine monitoring
of enspire 300 AER using
Revital-Ox PAA HLD.
Chemical reaction on indicator
pad to produce color change. | Identical |
| Scope
Connectors /
Flow Units | Scope connectors are required
for all lumens of endoscopes. | Scope connectors are required
for all lumens of endoscopes. | Identical |
| 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
filters. Periodic replacement of
printer tape if using the external
printer option. Running the
decontamination cycle every 24
hours. | Identical |
Table 1. Predicate Device Comparison Table
7
STERIS Traditional 510(k) PREMARKET NOTIFICATION enspire 300 Series Automated Endoscope Reprocessor
8
STERIS Traditional 510(k) PREMARKET NOTIFICATION enspire 300 Series Automated Endoscope Reprocessor
9
STERIS Traditional 510(k) PREMARKET NOTIFICATION enspire 300 Series Automated Endoscope Reprocessor
10
6. Summary of Non-Clinical Testing
Shown in Table 2 is the new testing that was performed to evaluate the modified device.
| Verification Activity | Description |
|---|---|
| ----------------------- | ------------- |
| Test | Acceptance Criteria | Result |
|---|---|---|
| Performance testing with | ||
| replacement pre-filters | The modification does not affect the | |
| performance of the device. | Pass |
7. Conclusion
Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as well as or better than the legally marketed predicate device (K230560), Class II (21 CFR 876.1500), product code NZA.