(36 days)
Not Found
No
The description focuses on electro-mechanical fluid delivery via a peristaltic pump and tubing, with no mention of AI or ML technologies. The performance studies are related to fluid delivery and tubing durability, not algorithmic performance.
No.
The device is described as an electro-mechanical device intended to pump fluids through endoscope channels during manual cleaning, not for direct therapeutic treatment of a patient.
No
The device is an endoscope flushing aid used for cleaning endoscopes, not for diagnosing medical conditions.
No
The device description explicitly states it is an "electro-mechanical device" and utilizes an "external peristaltic pump" and "connection tubing," indicating the presence of hardware components beyond just software.
Based on the provided text, the 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 of endoscope reprocessing. This is a cleaning and reprocessing function, not a diagnostic test performed on a biological sample.
- Device Description: The description reinforces that the device is used for delivering cleaning fluids and rinse water 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.
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. The SCOPE BUDDY PLUS is a device used to facilitate the cleaning of medical equipment.
N/A
Intended Use / Indications for Use
SCOPE BUDDY PLUS Endoscope Flushing Aid is an electro-mechanical device intended to pump fluids through the channels of flexible, immersible endoscopes during the manual cleaning process of endoscope reprocessing.
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. The minimum fluid volumes are defined by the endoscope manufacturer. SCOPE BUDDY PLUS Endoscope Flushing Aid 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 a volume of fluid to the endoscope channels which exceeds the minimum fluid volumes specified by the endoscope manufacturer. 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)
Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5-2 below.
Test: Fluid Delivery Flow Rate Verification
Acceptance Criteria: Meet manufacturers minimum requirements for individual channel flushing volumes.
Conclusion: PASS
Test: Tubing Durability Verification
Acceptance Criteria: The 24-hour tubing shall withstand at least 40 full automatic cycles without leaking.
Conclusion: PASS
Test: Software Verification
Acceptance Criteria: Verification steps outlined in procedure must be met for acceptance of the protocol.
Conclusion: 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 14, 2022
Medivators Inc Mark Arnold Principal Regulatory Affairs Specialist 14605 28th Ave North Minneapolis, Minnesota 55447
Re: K213833
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: December 7, 2021 Received: December 9, 2021
Dear Mark Arnold:
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 (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213833
Device Name SCOPE BUDDY PLUS Endoscope Flushing Aid
Indications for Use (Describe)
SCOPE BUDDY PLUS Endoscope Flushing Aid is an electro-mechanical device intended to pump fluids through the channels of flexible, immersible endoscopes during the manual cleaning process of endoscope reprocessing.
| 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 circle with several horizontal lines running through it, followed by the word "MEDIVATORS" in blue, sans-serif font. Below the company name is the text "A Cantel Medical Company" in a smaller, sans-serif font, also in blue.
510(k) Summary For SCOPE BUDDY PLUS Endoscope Flushing Aid
Medivators Inc 14605 28th Avenue North Minneapolis, MN 55447
- Contact: Mark Arnold Principal Regulatory Affairs Specialist Tel: 844-348-5636 Fax: 844-348-5637
Summary Date: January 13, 2022
Medivators Inc = 14605 28th Avenue North ▪ Minneapolis, MN 55447 USA ▪ 800-328-3345
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1. Device Name
| Trade Name: | SCOPE BUDDY PLUS Endoscope Flushing Aid |
|---|---|
| Device Class: | II |
| Common/Generic Name: | Circulating Pump |
| Classification Name: | Accessories, Cleaning, For Endoscope |
| Classification Number: | 21 CFR 276.1500 |
| Product Code: | FEB |
2. Predicate Device
SCOPE BUDDY PLUS Endoscope Flushing Aid, cleared under K162128
3. Description of Device
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. The minimum fluid volumes are defined by the endoscope manufacturer. SCOPE BUDDY PLUS Endoscope Flushing Aid 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 a volume of fluid to the endoscope channels which exceeds the minimum fluid volumes specified by the endoscope manufacturer. 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.
Indications for Use 4.
SCOPE BUDDY PLUS Endoscope Flushing Aid is an electro-mechanical device intended to pump fluids through the channels of flexible, immersible endoscopes during the manual cleaning process of endoscope reprocessing.
5
5. Summary of Technical Characteristics
A comparison of technical characteristics versus the predicate is summarized in Table 5-1 below.
| Feature | Subject Device – SCOPE
BUDDY PLUS Endoscope
Flushing Aid | Predicate Device – SCOPE
BUDDY PLUS Endoscope
Flushing Aid (K162128) | Comparison |
|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for Use | SCOPE BUDDY PLUS
Endoscope Flushing Aid is an
electro-mechanical device
intended to pump fluids through
the channels of flexible,
immersible endoscopes during
the manual cleaning process of
endoscope reprocessing. | 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. | Same |
| Type of Machine Function | Electro-mechanical | Electro-mechanical | Same |
| Connection Tubing | 24-hour connection tubing | 24-hour connection tubing | Same |
| Air Purge | Yes | Yes | Same |
| Cleans or
Reprocesses the
Exterior of
Endoscopes | No | No | Same |
| Performs Leak Test | No | No | Same |
| Automatic
Detergent
Dosing | Yes | Yes | Same |
| Temperature
Monitoring | Yes | Yes | Same |
| Software
Controlled User
Interface | Yes | Yes | Same |
| 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 | Same |
| Mechanism of
Action | External peristaltic fluid pump
with built-in timer | External peristaltic fluid
pump with built-in timer | Same |
| Feature | Subject Device – SCOPE
BUDDY PLUS Endoscope
Flushing Aid | Predicate Device – SCOPE
BUDDY PLUS Endoscope
Flushing Aid (K162128) | Comparison |
| Schematic Flow | Flushing liquids are placed into a
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. | Flushing liquids are placed
into a 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. | Same |
| 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 set by an adjustable timer, and
the range 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 set by an adjustable
timer, and the range is
sufficient to deliver cleaning
liquid volumes that meet or
exceed the endoscope
manufacturer's requirements | Same |
6
MEDIVATORS INC Special 510(k) PREMARKET NOTIFICATION Modification to SCOPE BUDDY PLUS Endoscope Flushing Aid
Table 5-1: Physical Description and Technological Properties vs the Predicate Device
Summary of Non-Clinical Performance Data 6.
Performance testing to demonstrate substantial equivalence to the predicate has been completed and is summarized in Table 5-2 below.
| Test | Acceptance Criteria | Conclusion |
|---|---|---|
| Fluid Delivery Flow Rate | ||
| Verification | Meet manufacturers | |
| minimum requirements for | ||
| individual channel flushing | ||
| volumes. | PASS |
7
MEDIVATORS INC Special 510(k) PREMARKET NOTIFICATION Modification to SCOPE BUDDY PLUS Endoscope Flushing Aid
| Test | Acceptance Criteria | Conclusion |
|---|---|---|
| Tubing Durability | ||
| Verification | The 24-hour tubing shall | |
| withstand at least 40 full | ||
| automatic cycles without | ||
| leaking. | PASS | |
| Software Verification | Verification steps outlined in | |
| procedure must be met for | ||
| acceptance of the protocol. | PASS |
Table 5-2: Summary of Non-Clinical Performance Data
7. Conclusion
Based on the conclusions for 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 (K162128), Class II (21 CFR 876.1500), product code FEB.