(155 days)
Not Found
No
The description focuses on automated mechanical processes, data management, and step-by-step guidance, with no mention of AI or ML algorithms for decision-making, analysis, or pattern recognition.
No
This device is for cleaning and reprocessing endoscopes, not for diagnosing, treating, or preventing disease in a patient. It is an aid for maintaining medical equipment.
No
This device is designed to assist with the cleaning and reprocessing of flexible endoscopes, not to diagnose a medical condition in a patient. Its functions include leak testing, detergent dosing, channel flushing, and process documentation, all related to endoscope maintenance.
No
The device description explicitly mentions hardware components such as automated scope inflation, precision chemical dosing, automated channel flushing with pulsating fluid technology, a USB drive and port, a barcode scanner, and electrical safety testing. This indicates it is a system with significant hardware components, not solely software.
Based on the provided information, the Acu-sInQ Complete Endoscope Cleaning Aid System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to assist in the manual cleaning of flexible endoscopes. This is a process related to the reprocessing of medical devices, not the diagnosis of diseases or conditions using samples taken from the human body.
- Device Description: The device description details functions related to cleaning, leak testing, dosing, flushing, and documentation of the cleaning process. These are all activities performed on the endoscope itself, not on patient samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples from the human body to provide information for diagnosis, monitoring, or screening. The Acu-sInQ system's function is entirely focused on the cleaning and reprocessing of a medical device (the endoscope).
N/A
Intended Use / Indications for Use
The Acu-sInQ Complete Endoscope Cleaning Aid System is intended to assist manual flexible endoscope cleaning according to the instructions provided by the endoscope manufacturer, by facilitating performance of a leak test, accurate detergent dosing with water temperature monitoring, channel flushing, rinsing, and process documentation.
Product codes
FEB
Device Description
The Acu-sInQ Complete Endoscope Cleaning Aid System is used in the reprocessing room of a hospital or endoscopy center, and aids technicians by providing a step-by-step cleaning sequence of flexible endoscopes for process management and reports.
The Acu-sInQ Complete Endoscope Cleaning Aid System is a 4-in-1 system with automated scope inflation for performance of a leak test, precision chemical dosing, and automated channel flushing with pulsating fluid technology for main and auxiliary flush ports. The System also provides:
- Data management via printout with every cycle
- USB drive and port output for capture and recording of process data and chemical usage
- Software to enable transfer of data between system and Customer's PC
- Barcode scanner to input endoscope serial number and technician ID which aids in documentation process
- Pre-loading with Customer's endoscope inventory
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
The Acu-sInQ Complete Endoscope Cleaning Aid System is used in the reprocessing room of a hospital or endoscopy center, and aids technicians.
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)
The non-clincal performance testing demonstrated that the subject device met the acceptance criteria for each test that is identified and summarized in Table 5-2 below.
Test: Fluid Flushing (open)
Acceptance Criteria: Device provides consistent fluid flushing volume when not connected to an endoscope.
Conclusion: PASS
Test: Fluid Flushing (Endoscope)
Acceptance Criteria: Device provides consistent fluid flushing volume when connected to an endoscope.
Conclusion: PASS
Test: Dosing
Acceptance Criteria: Accuracy of dose of +/- 5%
Conclusion: PASS
Test: Temperature Accuracy
Acceptance Criteria: Accuracy of temperature of +/- 5%
Conclusion: PASS
Test: Electrical Safety
Acceptance Criteria: Compliant with IEC 61010-1
Conclusion: PASS
Test: Electromagnetic Compatibility
Acceptance Criteria: Compliant with IEC 61326-1
Conclusion: PASS
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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December 14, 2018
STERIS Corporation Gregory Land Senior Regulatory Affairs Specialist 5960 Heisley Road Mentor, Ohio 44060
Re: K181865
Trade/Device Name: Acu-sInQ Complete Endoscope Cleaning Aid System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FEB Dated: November 13, 2018 Received: November 14, 2018
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Clarence W. Murray lii III -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) K181865
Device Name
Acu-sInQ Complete Endoscope Cleaning Aid System
Indications for Use (Describe)
The Acu-sInQ Complete Endoscope Cleaning Aid System is intended to assist manual flexible endoscope cleaning according to the instructions provided by the endoscope manufacturer, by facilitating performance of a leak test, accurate detergent dosing with water temperature monitoring, channel flushing, rinsing, and process documentation.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary For Aqu-sInQ Complete Endoscope Cleaning Aid System
STERIS Corporation 5960 Heisley Road Mentor, OH 44060
Contact: Gregory Land Senior Regulatory Affairs Specialist Tel: 440-392-7424 Fax: 440-357-9198
November 9, 2018 Summary Date:
Premarket Notification Number: K181865
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
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1. Device Name
| Trade Name: | Acu-sInQ Complete Endoscope Cleaning Aid
System |
|------------------------|----------------------------------------------------|
| Device Class: | II |
| Common/usual Name: | Circulating pump |
| Classification Name: | Accessories, Cleaning, For Endoscope |
| Classification Number: | 21 CFR 876.1500 |
| Product Code: | FEB |
2. Predicate Device
US Endoscopy Fluid Pump CP-3, cleared under K914524.
3. Description of Device
The Acu-sInQ Complete Endoscope Cleaning Aid System is used in the reprocessing room of a hospital or endoscopy center, and aids technicians by providing a step-by-step cleaning sequence of flexible endoscopes for process management and reports.
The Acu-sInQ Complete Endoscope Cleaning Aid System is a 4-in-1 system with automated scope inflation for performance of a leak test, precision chemical dosing, and automated channel flushing with pulsating fluid technology for main and auxiliary flush ports. The System also provides:
- Data management via printout with every cycle
- USB drive and port output for capture and recording of process data and chemical usage
- Software to enable transfer of data between system and Customer's PC
- Barcode scanner to input endoscope serial number and technician ID which aids in documentation process
- Pre-loading with Customer's endoscope inventory
Indications for Use 4.
The Acu-sInQ Complete Endoscope Cleaning Aid System is intended to assist manual flexible endoscope cleaning according to the instructions provided by the endoscope manufacturer, by facilitating performance of a leak test, accurate
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detergent dosing with water temperature monitoring, channel flushing, rinsing, and process documentation.
5. Technical Characteristics Comparison Table
A comparison of technical characteristics versus the predicate is summarized in Table 5-1
| Feature | Acu-sInQ Complete Endoscope
Cleaning Aid
(proposed) | Fluid Pump CP-3 Predicate
(K914524) | Comparison | | | |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|---------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Indications
for Use | The Acu-sInQ Complete
Endoscope Cleaning Aid
System is intended to assist
manual flexible endoscope
cleaning according to the
instructions provided by the
endoscope manufacturer, by
facilitating performance of a
leak test, accurate detergent
dosing with water temperature
monitoring, channel flushing,
rinsing, and process
documentation. | The Fluid pump CP #3 is
intended to pump fluid media
thru the channels of endoscope
and accessories with lumens.
The various fluid media that
are compatible are soapy
water, enzyme/water solution,
water, 70% alcohol, and liquid
disinfectants. The pump will
also pump minimal amounts of
air to help purge the channels
or lumens of droplets of fluid
media. Consult with
instrument manufacturer for
fluid media compatibility. | Both devices are
intended to flush
fluid through the
channel of an
endoscope to aid
in the manual
cleaning process.
The subject
device has the
added
functionality to
assist the user
with additional
steps of the
endoscope
cleaning process,
leak test,
detergent dosing
and temperature
monitoring. | | | |
| Feature | Acu-sInQ Complete Endoscope
Cleaning Aid
(proposed) | Fluid Pump CP-3 Predicate
(K914524) | Comparison | | | |
| Operating
Principles/
Technology | A microprocessor controlled
unit operates internal pumps
to aid in the cleaning of
endoscopes. An internal air
pump pressurizes an
endoscope through a dedicated
leak test tubing to perform a
leak test. A detergent tube is
placed in a container of
detergent and a peristaltic
pump pulls the detergent
through the tubing, the
detergent is then expelled
through a discharge tube into
the cleaning solution. A
tubing set pulls fluid from the
cleaning solution through a
peristaltic pump and discharge
tubing set where it is expelled
through the endoscope
channels. | Flushing fluids are placed into
a container, pre-cleaning basin
or sink. A tubing set pulls
fluid from the container, basin,
or sink into and through an
internal fluid pump. The fluid
is then expelled from the
pumps through discharge
tubing sets which are
connected to the endoscope
channels. The fluid is then
pumped through the endoscope
channels. | Both devices
utilize
electronically
controlled flush
pumps to flush
fluid through the
channels of an
endoscope. The
predicate device
is controlled
through analog
circuits while the
subject device
uses software. | | | |
| Software
Controlled
User
Interface | Yes | No | The subject
device uses
software to
control the unit
whereas the
predicate device
uses analog
circuits to control
to device. | | | |
| Fluid
Delivery
Flow Rate | Meet or exceed the endoscope
manufacturer's requirements
for fluid delivery through
endoscope channels | Meet or exceed the endoscope
manufacturer's requirements
for fluid delivery through
endoscope channels | Same | | | |
| Mechanism
of Action | Software controlled air pump,
peristaltic pump and flush
pump | Internal flush pumps with
built-in timer | Like the
predicate device
the subject device
has a flush pump.
Additionally the
subject device
uses an air pump
and peristaltic
pump for leak
testing and
detergent dosing. | | | |
| Feature | Acu-sInQ Complete Endoscope
Cleaning Aid
(proposed) | Fluid Pump CP-3 Predicate
(K914524) | Comparison | | | |
| Amount of
Cleaning
Liquid | Amount sufficient to meet or
exceed the endoscope
manufacturer's requirements
for volume of fluid delivery
through endoscope channels. | Amount sufficient to meet or
exceed the endoscope
manufacturer's requirements
for volume of fluid delivery
through endoscope channels. | Same | | | |
| | | | | Time for
Cleaning
Liquid
Circulation | Variable, the length of the
cleaning liquid circulation
time is determined by setting a
timer. | Variable, the length of the
cleaning liquid circulation time
is determined by setting a
timer. |
Table 5-1. Physical Description and Technological Properties vs the Predicate Device.
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6. Summary of Nonclinical Tests
The non-clincal performance testing demonstrated that the subject device met the acceptance criteria for each test that is identified and summarized in Table 5-2 below.
| Test | Acceptance Criteria | Conclusion |
|---|---|---|
| Fluid Flushing | ||
| (open) | Device provides consistent fluid flushing volume | |
| when not connected to an endoscope. | PASS | |
| Fluid Flushing | ||
| (Endoscope) | Device provides consistent fluid flushing volume | |
| when connected to an endoscope. | PASS | |
| Dosing | Accuracy of dose of $\pm$ 5% | PASS |
| Temperature | ||
| Accuracy | Accuracy of temperature of $\pm$ 5% | PASS |
| Electrical Safety | Compliant with IEC 61010-1 | PASS |
| Electromagnetic | ||
| Compatibility | Compliant with IEC 61326-1 | PASS |
Table 5-2. Summary of Non-clinical Testing
7. Conclusion
Based on the conclusions from the 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 (K914524), Class II (21 CFR 876.1500), product code FEB.