(270 days)
Not Found
No
The description focuses on mechanical assistance for cleaning and flushing, with no mention of AI or ML terms or functionalities.
No.
The device is for cleaning flexible endoscopes, not for treating patients.
No
The device is described as a flushing sink for cleaning endoscopes, which is a reprocessing function, not a diagnostic one. Its purpose is to assist in the mechanical cleaning process of endoscopes.
No
The device description clearly outlines a physical sink with mechanical assistance for flushing endoscope channels, requiring performance testing related to flushing, detergent injection, and electrical/electromagnetic compatibility, indicating it is a hardware device.
Based on the provided information, the Scope-Assist Flushing Sink is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to assist in the manual cleaning process of flexible endoscopes by flushing their channels with detergent and water, soaking and wiping exterior surfaces, and performing wet leak testing. This is a cleaning and reprocessing function for a medical device (the endoscope), not a diagnostic test performed on a biological sample.
- Device Description: The description focuses on the mechanical functions of the sink for cleaning and testing the endoscope itself. It does not mention analyzing biological samples or providing diagnostic information about a patient's health.
- Lack of IVD Characteristics: IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Scope-Assist Flushing Sink does not interact with or analyze such specimens.
- Performance Studies: The performance studies focus on the cleaning and flushing capabilities of the sink, detergent delivery, and electrical/electromagnetic safety. These are relevant to a cleaning device, not an IVD.
In summary, the Scope-Assist Flushing Sink is a device used in the reprocessing of medical equipment (endoscopes), not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Scope-Assist Flushing Sink is indicated for flushing the channels of flexible endoscopes according to the endoscope manufacturer's instructions.
Product codes (comma separated list FDA assigned to the subject device)
FEB
Device Description
The Scope-Assist Flushing Sink is designed to mechanically assist the channel flushing portion of an endoscope's manual cleaning process. The sink facilitates compliance with endoscope manufacturer's cleaning requirements by:
• Providing a means of flushing flexible endoscope channels with detergent solution
• Providing a means of flushing endoscope channels with water
• Providing an environment for soaking and manual wiping/brushing of flexible endoscope exterior surfaces and accessories
• Providing an environment to perform wet leak testing of endoscopes The Scope-Assist Flushing Sink is designed:
• To be used where the facility performs its endoscope cleaning functions, such as in soiled utility rooms, central processing decontamination areas, or endoscope cleaning (reprocessing) areas.
• To be used with Tergal 800 Detergent
The Scope-Assist Flushing Sink is not designed:
● To be used at bedside, in critical care units, or in sterile environments
● To be used as a terminal process or as part of the manual high level disinfection process
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
To be used where the facility performs its endoscope cleaning functions, such as in soiled utility rooms, central processing decontamination areas, or endoscope cleaning (reprocessing) areas.
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)
Performance testing conducted with the Scope-Assist Flushing Sink:
● Flushing performance testing to demonstrate the device is able to meet or exceed the endoscope manufacturer's flushing requirements in the specified flushing times.
● Detergent Injection testing to demonstrate the device is able to consistently and reliably deliver the correct amount of detergent.
● Detergent Compatibility testing to demonstrate the use of Tergal detergent is compatible with the materials in the flow path of the sink.
● Electrical safety testing according to IEC 61010-1
● Electromagnetic compatibility testing according to IEC 60601-1-2
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, forming a single abstract shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 28, 2017
Custom Ultrasonics Inc. Elizabeth Lazaro Regulatory Affairs Director 144 Railroad Drive Ivyland. Pennsylvania 18974
Re: K162120
Trade/Device Name: Scope-Assist Flushing Sink Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FEB Dated: March 28, 2017 Received: March 29, 2017
Dear Elizabeth Lazaro:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162120
Device Name Scope-Assist Flushing Sink
Indications for Use (Describe)
The Scope-Assist Flushing Sink is indicated for flushing the channels of flexible endoscopes according to the endoscope manufacturer's instructions.
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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K162120
510(k) Summary of Substantial Equivalence of Safety and Efficacy
| Submitter: | Custom Ultrasonics Inc. | |
|---|---|---|
| Address: | 144 Railroad Drive | |
| Ivyland, PA 18974 | ||
| Telephone: | 215-364-1477 | |
| Contact Person: | Elizabeth Lazaro | |
| Title: | Regulatory Affairs Director | |
| e-mail: | elizabeth.lazaro@customultrasonics.com | |
| Date Prepared: | April 19, 2017 | |
| Name of Device: | Scope-Assist Flushing Sink | |
| Classification Name: | Endoscope and accessories | |
| Product Code: | FEB | |
| Regulation: | 21 CFR 876.1500 | |
| Device Classification: | Class II | |
| Predicate Device: | PSK System (K000216) | |
| Indications for Use: | The Scope-Assist Flushing Sink is indicated for flushing the channels of flexible | |
| endoscopes according to the endoscope manufacturer's instructions. | ||
| Device Description: | The Scope-Assist Flushing Sink is designed to mechanically assist the channel flushing | |
| portion of an endoscope's manual cleaning process. The sink facilitates compliance with | ||
| endoscope manufacturer's cleaning requirements by: | ||
| • Providing a means of flushing flexible endoscope channels with detergent solution | ||
| • Providing a means of flushing endoscope channels with water | ||
| • Providing an environment for soaking and manual wiping/brushing of flexible | ||
| endoscope exterior surfaces and accessories | ||
| • Providing an environment to perform wet leak testing of | ||
| endoscopes The Scope-Assist Flushing Sink is designed: | ||
| • To be used where the facility performs its endoscope cleaning functions, such as in | ||
| soiled utility rooms, central processing decontamination areas, or endoscope cleaning | ||
| (reprocessing) areas. | ||
| • To be used with Tergal 800 Detergent | ||
| The Scope-Assist Flushing Sink is not designed: | ||
| ● | To be used at bedside, in critical care units, or in sterile environments | |
| ● | To be used as a terminal process or as part of the manual high level disinfection process | |
| Performance Data: | Performance testing conducted with the Scope-Assist Flushing Sink: | |
| ● | Flushing performance testing to demonstrate the device is able to meet or exceed the endoscope manufacturer's flushing requirements in the specified flushing times. | |
| ● | Detergent Injection testing to demonstrate the device is able to consistently and reliably deliver the correct amount of detergent. | |
| ● | Detergent Compatibility testing to demonstrate the use of Tergal detergent is compatible with the materials in the flow path of the sink. | |
| ● | Electrical safety testing according to IEC 61010-1 | |
| ● | Electromagnetic compatibility testing according to IEC 60601-1-2 |
4
The Scope-Assist Flushing Sink is equivalent to the PSK System for flushing liquids through Equivalency: various channels of a flexible endoscope.
| Substantial Equivalence Table | |||
|---|---|---|---|
| Trade Name | Scope-Assist Flushing | ||
| Sink | PSK System | ||
| Device Parameters | Subject Device | Predicate Device | Equivalence |
| Intended Use: | Flush the channels of | ||
| flexible endoscopes | Flush the channels of | ||
| flexible endoscopes | Same | ||
| Technological Characteristics: | Pump used to deliver fluids | ||
| through endoscope's | |||
| internal channels | Pump used to deliver fluids | ||
| through endoscope's | |||
| internal channels | Same | ||
| Ability to flush all channels | |||
| simultaneously | Ability to flush all channels | ||
| simultaneously | Same | ||
| Endoscope Processing Capacity: | (1) | (1) | Same |
| Connector Tubing: | Color coded endoscope | ||
| specific adapters used to | |||
| connect scope to flushing | |||
| source | Color coded endoscope | ||
| specific adapters used to | |||
| connect scope to flushing | |||
| source | Same | ||
| Water Source: | Potable tap water | Potable tap water | Same |
| Amount of Fluid Delivered: | 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 Fluid Circulation: | Variable, the length of the | ||
| fluid circulation time is | |||
| sufficient to deliver fluid | |||
| volumes that meet or | |||
| exceed the endoscope | |||
| manufacturer's | |||
| requirements | Variable, the length of the | ||
| fluid circulation time is | |||
| sufficient to deliver fluid | |||
| volumes that meet or | |||
| exceed the endoscope | |||
| manufacturer's | |||
| requirements | Same |
Scope-Assist Flushing Sink
Custom Ultrasonics Inc.
5
Conclusion:
Based on the intended use and performance testing data, the Scope-Assist Flushing Sink meets the requirements for flushing the internal channels of a flexible endoscope and is substantially equivalent to the predicate device. In addition, the Scope-Assist Flushing Sink, as demonstrated by electrical safety and electromagnetic compatibility testing, demonstrates substantial equivalence.