(142 days)
Not Found
No
The description focuses on electro-mechanical fluid delivery via a peristaltic pump and software validation for basic functionality, with no mention of AI or ML concepts, data sets, or performance metrics typically associated with such technologies.
No
The device is described as an aid for the manual cleaning process of endoscopes, not for treating a disease or condition in a patient. It facilitates the delivery of fluids for cleaning but does not have a direct therapeutic effect on a patient.
No
The device is described as an endoscope flushing aid used during the manual cleaning process for endoscopes. Its function is to pump fluids, such as detergent solution and rinse water, through endoscope channels. It does not perform any diagnostic function (e.g., detecting disease, analyzing medical conditions, or providing medical insights based on patient data).
No
The device description explicitly states it utilizes an "external peristaltic pump" and "connection tubing," which are hardware components, making it an electro-mechanical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to pump fluids through endoscope channels during the manual cleaning process. This is a process related to the reprocessing of a medical device (an endoscope), not a diagnostic test performed on a biological sample.
- Device Description: The description reinforces that the device is used for delivering cleaning and rinsing fluids to endoscope channels. It explicitly states it is not an endoscope washer-disinfector and does not make claims about cleaning or disinfection efficacy.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on the physical process of cleaning a medical instrument.
N/A
Intended Use / Indications for Use
Scope Buddy Plus Endoscope Flushing Aid is an electro-mechanical device intended to pump fluids through channels of flexible, immersible endoscopes during the endoscope manual cleaning process.
Product codes (comma separated list FDA assigned to the subject device)
FEB
Device Description
The subject device is intended to provide fluid delivery to endoscope channels in the same manner as a manual syringe would be used during the manual cleaning phase of endoscope reprocessing as defined by the endoscope manufacturer's instructions. The subject device utilizes an external peristaltic pump and 24-hour multi-use connection tubing (tubing used for 24 hours with multiple endoscopes and then discarded) to deliver specific volumes of detergent solution and rinse water to the endoscope channels during the manual cleaning phase. These fluid volumes are defined by the endoscope manufacturer. Scope Buddy Plus is intended to be used only during the manual cleaning phase of endoscope reprocessing, in conjunction with the instructions and labeling provided by the endoscope manufacturer, to deliver an endoscope manufacturer specified volume of fluid to the endoscope channels. The subject device is not an endoscope washer-disinfector and does not bear labeling claims for direct cleaning efficacy or high-level disinfection efficacy for endoscope reprocessing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Medivators has conducted the following testing to demonstrate the substantial equivalence of Scope Buddy Plus:
- Functional Performance Testing
- Detergent Dosing to demonstrate the ability of the subject device to dose a set volume of O detergent.
- Fluid Delivery Flow Rate to determine the flushing times required by the subject device o to meet endoscope manufacturers' requirements for fluid volumes delivered to endoscope channels during manual cleaning.
- . Electrical Safety and Electromagnetic Compatibility in accordance with IEC 61010-1 and IEC 61326-1. respectively.
- Software Validation as recommended per FDA's guidance for the Content of Premarket ● Submissions for Software Contained in Medical Devices.
- Human Factors/Usability Evaluation to validate that users can safely and effectively use the ● subject device per IEC 62366-1 and FDA's guidance for Applying Human Factors and Usability Engineering to Medical Devices.
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 is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure with three faces in profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 21, 2016
Medivators Inc. Kristin Padilla Regulatory Affairs Associate 14605 28th Ave. North Minneapolis, Minnesota 55447
Re: K162128
Trade/Device Name: Scope Buddy Plus Endoscope Flushing Aid Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FEB Dated: November 23, 2016 Received: November 28, 2016
Dear Kristin Padilla:
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,
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) K162128
Device Name Scope Buddy Plus Endoscope Flushing Aid
Indications for Use (Describe)
Scope Buddy Plus Endoscope Flushing Aid is an electro-mechanical to pump fluids through channels of flexible, immersible endoscopes during the endoscope manual cleaning process.
| 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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Image /page/3/Picture/0 description: The image shows the logo for Medivators, a Cantel Medical Company. The logo consists of a blue circular graphic on the left, followed by the word "MEDIVATORS" in blue, all caps. Below "MEDIVATORS" is the text "A Cantel Medical Company" in a smaller blue font. The circular graphic appears to be a stylized representation of waves or lines.
510(k) Summary
| Date Prepared: | December 12, 2016 |
|---|---|
| Manufacturer: | Medivators Inc., a Cantel Medical Company |
| Address: | 14605 28th Avenue North |
| Minneapolis, MN 55447 | |
| (800) 328-3345 | |
| Official Contact: | Kristin Bergeson Padilla |
| Regulatory Affairs Associate, Medivators Inc. | |
| Trade Name: | Scope Buddy Plus Endoscope Flushing Aid |
| Common Name: | Accessories, Cleaning, For Endoscope |
| Classification Name: | Endoscope and accessories |
| Product Code: | FEB |
| Device Class: | II |
| Regulation No: | 876.1500 |
Medivators Inc. has supplied the following information to the US Food and Drug Administration to support substantial equivalence of Scope Buddy Plus to other endoscope flushing aid devices currently cleared for sale in the United States of America.
1. Intended Use
Scope Buddy Plus Endoscope Flushing Aid is an electro-mechanical device intended to pump fluids through channels of flexible, immersible endoscopes during the endoscope manual cleaning process.
2. Device Description
The subject device is intended to provide fluid delivery to endoscope channels in the same manner as a manual syringe would be used during the manual cleaning phase of endoscope reprocessing as defined by the endoscope manufacturer's instructions. The subject device utilizes an external peristaltic pump and 24-hour multi-use connection tubing (tubing used for 24 hours with multiple endoscopes and then discarded) to deliver specific volumes of detergent solution and rinse water to the endoscope channels during the manual cleaning phase. These fluid volumes are defined by the endoscope manufacturer. Scope Buddy Plus is intended to be used only during the manual cleaning phase of endoscope reprocessing, in conjunction with the instructions and labeling provided by the endoscope manufacturer, to deliver an endoscope manufacturer specified volume of fluid to the endoscope channels. The subject device is not an endoscope washer-disinfector and does not bear labeling claims for direct cleaning efficacy or high-level disinfection efficacy for endoscope reprocessing.
3. Comparison to Other Devices in Commercial Distribution Within the United States
Scope Buddy Plus is equivalent in intended use, function and fundamental technology to its predicate device, Fluid Pump CP-3 cleared under 510(k) K914524.
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Image /page/4/Picture/0 description: The image shows the logo for Medivators, a Cantel Medical Company. The logo consists of a blue circular graphic on the left, followed by the word "MEDIVATORS" in blue, sans-serif font. Below the company name, the text "A Cantel Medical Company" is written in a smaller, blue, sans-serif font. The overall design is clean and corporate, reflecting the company's medical focus.
Similarities Between Subject and Predicate Devices
Scope Buddy Plus and its predicate device, Fluid Pump CP-3, have the same intended use, fundamental technology and performance. Both the subject device and the predicate device are similar in that the intended use replicates the mechanical means of fluid delivery to endoscope channels in the same manner as a manual syringe would be used. Both devices are used during the manual cleaning phase of endoscope reprocessing to deliver fluid volumes to the endoscope channels according to the endoscope manufacturer's instructions. Both devices are similar in fundamental technology and general performance.
Differences Between Subject and Predicate Devices
The main notable differences between the subject device, Scope Buddy Plus, and the predicate, Fluid Pump CP-3, are the connection tubing and software. Scope Buddy Plus utilizes an external peristaltic pump with 24-hour multi-use connection tubing (tubing used for 24 hours with multiple endoscopes and then discarded) while the predicate device utilizes internal fluid pumps with reusable tubing set connections. The subject device utilizes a software controlled user interface while the predicate device utilizes analog circuitry control. In addition, the subject device does not bear labeling claims for direct cleaning efficacy or high-level disinfection efficacy for endoscope reprocessing while the predicate device bears cleaning and disinfection efficacy claims.
A device comparison table which supports substantial equivalence of the subject device to the predicate device is provided below:
| Device Parameters | Subject Device – Scope Buddy Plus
Endoscope Flushing Aid | Predicate Device – Fluid Pump CP-3
(K914524) |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Trade Name | Scope Buddy Plus Endoscope Flushing Aid | Fluid Pump CP-3 |
| Regulation Number | 876.1500 | 876.1500 |
| Device Class | Class II | Class II |
| Certification Panel | Gastroenterology/Urology | Gastroenterology/Urology |
| Product Code | FEB | FEB |
| Intended Use | To pump fluids through the channels
of flexible, immersible endoscopes | To pump fluids through the channels of
flexible, immersible endoscopes |
| Type of Machine
Function | Electro-mechanical | Electro-mechanical |
| Connection Tubing | 24 hour multi-use connection tubing | Reusable tubing set connections |
| Software Controlled
User Interface | Yes | No |
| Fluid Delivery Flow
Rate Performance | 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 |
| Mechanism of Action | External peristaltic fluid pump with
built-in timer | Internal fluid pump with built-in timer |
| Schematic Flow | Flushing liquids are placed into a | Flushing liquids are placed into a |
Table 1 - Device Comparison Table
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Image /page/5/Picture/0 description: The image shows the logo for Medivators, a Cantel Medical Company. The logo consists of a blue circular graphic on the left, which contains several horizontal lines. To the right of the graphic is the word "MEDIVATORS" in blue, with the text "A Cantel Medical Company" in a smaller font below it.
| | container, pre-cleaning basin or sink.
A tubing set pulls fluid from the
container, basin or sink via action from
the external peristaltic pump. The fluid
continues to flow through the tubing
set which is connected to the
endoscope channels. The fluid is then
pumped through the endoscope
channels. | medical washing tray. An intake tubing
set pulls fluid from the washing tray and
into and through two internal fluid
pumps. 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. |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. |
| Time for Cleaning
Liquid Circulation | Variable, the length of the cleaning
liquid circulation time is sufficient to
deliver cleaning liquid volumes that
meet or exceed the endoscope
manufacturer's requirements. | Variable, the length of the cleaning
liquid circulation time is determined by
setting a timer. |
4. Summary of Non-Clinical Performance Data
Medivators has conducted the following testing to demonstrate the substantial equivalence of Scope Buddy Plus:
- Functional Performance Testing
- Detergent Dosing to demonstrate the ability of the subject device to dose a set volume of O detergent.
- Fluid Delivery Flow Rate to determine the flushing times required by the subject device o to meet endoscope manufacturers' requirements for fluid volumes delivered to endoscope channels during manual cleaning.
- . Electrical Safety and Electromagnetic Compatibility in accordance with IEC 61010-1 and IEC 61326-1. respectively.
- Software Validation as recommended per FDA's guidance for the Content of Premarket ● Submissions for Software Contained in Medical Devices.
- Human Factors/Usability Evaluation to validate that users can safely and effectively use the ● subject device per IEC 62366-1 and FDA's guidance for Applying Human Factors and Usability Engineering to Medical Devices.
5. Conclusion
Scope Buddy Plus is substantially equivalent to predicate device Fluid Pump CP-3 cleared under 510(k) K914524. Based on the intended use, fundamental technology and performance data, the subject device Scope Buddy Plus is substantially equivalent to and is as safe and as effective as the legally marketed predicate device.