The Scope ProTech is a single-use, sterile endoscopic tip protector that is intended to be used during the transport and storage of endoscopes for the protection of these delicate instruments. The Scope ProTech is intended for the protection of the distal tip and the bending rubber of endoscopes with a diameter of 2.7mm-8.0mm and 8.7mm-14.7mm. The Scope ProTech will aid in the protection of distal end, the lens and other delicate components from damage. It is not intended for use during sterilization.

Device Description

The Scope ProTech is a single-use, sterile endoscopic tip protector which provides a simple, safe, and highly effective method of protecting the delicate optics of an endoscope, while allowing the tip to 'breath' and thus not allowing biofilm to form. The Scope ProTech is available in two models to fit a range of scopes: INOV8-028S (Scope ProTech Small) for scope sizes 2.7 to 8mm and INOV8-028L (Scope ProTech Large) for scope sizes 8.7 to 14.7mm. The Scope ProTech is manufactured using injection moulding using a soft polypropylene.

AI/ML Overview

The provided text describes the Meditech Endoscopy Ltd Scope ProTech, a device intended for protecting endoscope tips during transport and storage. The submission is a 510(k) premarket notification, establishing substantial equivalence to a predicate device rather than independently proving safety and effectiveness through extensive clinical trials. Therefore, the information regarding acceptance criteria and performance studies is presented in the context of this 510(k) submission.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state acceptance criteria with numerical targets in the way a clinical trial might, as it focuses on demonstrating substantial equivalence to a predicate device. Instead, it compares characteristics of the Scope ProTech to its predicate, the US Endoscopy Endo-Boot (K951104). The "Equivalence" column in the table below effectively serves as the acceptance criteria for a 510(k) submission.

Characteristic	Acceptance Criteria (Equivalence to Predicate)	Reported Device Performance (Scope ProTech)
Device Name	n/a	Scope ProTech
Indications for Use	Substantially Equivalent	The Scope ProTech is a single-use, sterile endoscopic tip protector that is intended to be used during the transport and storage of endoscopes for the protection of these delicate instruments. It protects the distal tip and bending rubber of endoscopes with diameters of 2.7mm-8.0mm and 8.7mm-14.7mm. Aids in protection of distal end, lens, and other delicate components from damage. Not intended for use during sterilization.
Intended User/Location	Equivalent	Healthcare professionals/technicians and non-patient contacting; Healthcare facility
Storage and Transport	Equivalent	Intended for use immediately after processing in an AER and used during storage and transport to and from the location of the procedure.
Sterile	Substantially Equivalent (ProTech is sterile, predicate is non-sterile)	Yes, EtO sterilised
Re-use	Equivalent	Sterile single-use device, stated on packaging.
Scope Sizes Covered	Substantially Equivalent	2.7 - 8 mm (Small), 8.8 - 14.7 mm (Large)
Materials	Substantially Equivalent (ProTech is polypropylene, predicate is sponge)	Injection moulding using soft polypropylene
Instructions for Use	Equivalent	Instructions for use included that include graphical instructions, text and relevant warnings and cautions.
Use on an Endoscope	Equivalent	Slides over the distal tip of an endoscope.
Distal Tip Protection	Substantially Equivalent (ProTech allows complete coverage and aeration, predicate leaves tip uncovered)	Intended to protect the entire distal end of the endoscope, covering the tip and delicate components.
Clean/Dirty Identification	(Not explicitly compared as an equivalence criterion, but highlighted as a difference)	Includes tabs that identify the status of the device and prevents re-use of a used device on a clean scope.

2. Sample Size Used for the Test Set and the Data Provenance:

Sample Size: The document does not specify a numerical sample size for "test sets" in the context of human data. It states, "No clinical data was used in the submission." The testing described is non-clinical bench testing.
Data Provenance: Not applicable, as no clinical human data was used.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

Not applicable. No human experts were used to establish ground truth from clinical test sets, as no clinical data was used. The substantial equivalence argument relies on comparison of device characteristics and bench testing.

4. Adjudication Method for the Test Set:

Not applicable. No clinical test set requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

Not applicable. This device is a physical endoscopic tip protector and does not involve AI or human "readers" or diagnostic interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is not an algorithm-based device.

7. The Type of Ground Truth Used:

The "ground truth" for the substantial equivalence determination is primarily based on comparative characteristics with a legally marketed predicate device (Endo-Boot K951104) and bench testing results for mechanical performance, scope compatibility, retention performance, sterility, and shelf-life requirements. There is no "ground truth" derived from clinical outcomes or expert consensus on patient data.

8. The Sample Size for the Training Set:

Not applicable. This is not a machine learning or algorithm-based device, so there is no training set in that sense.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. There is no training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The FDA part of the logo is in blue, with the acronym "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION" next to it.

May 7, 2019

Meditech Endoscopy Ltd % Thomas Schorre Responsible Third-Party Official Accelerated Device Approval Services, LLC 6800 S.W. 40th Street. Ste. 444 Ludlum, FL 33155-3708

K191011 Re: Trade/Device Name: Scope ProTech

Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCU Dated: April 15, 2019 Received: April 16, 2019

Dear Thomas Schorre:

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.

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 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,

Shanil P. Haugen, Ph.D. Acting Assistant Division Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191011

Device Name

Scope ProTech

Indications for Use (Describe)

The Scope ProTech is a single-use, sterile endoscopic tip protector that is intended to be used during the transport and storage of endoscopes for the protection of these delicate instruments. The Scope ProTech is intended for the protection of the distal tip and the bending rubber of endoscopes with a diameter of 2.7mm-8.0mm and 8.7mm. The Scope ProTech will aid in the protection of distal end, the delicate components from damage. It is not intended for use during sterilization.

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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Image /page/3/Picture/1 description: The image contains the logo for Meditech Endoscopy. The logo features a blue circle with a stylized white "E" inside it. To the right of the circle are the words "MEDITECH" in a darker blue font, with the word "ENDOSCOPY" underneath in a lighter blue font.

510(k) Summary – Summary of Safety and Effectiveness Scope ProTech

510(k) number: K191011

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

Submitter's Identification:	Meditech Endoscopy Ltd
Address	Bowden HouseLuckyn LaneBasildonEssexSS14 3AXUnited Kingdom
Registered Establishment Number:	n/a
Owner/Operator Number:	n/a
Contact:	Peter RamseyManaging Director
Telephone:	+44 1268 534035
Email:	peter@i-medical.net
Date of Summary:	29th March 2019
Device/Proprietary Name:	Scope ProTech
Common Name:	Endoscopic Storage Cover
Classification:	Endoscope and accessories.
Type of Submission	Traditional 510(k) – New Device
Product Code:	OCU
Product Class:	II
Regulation number:	21 CFR § 876.1500
Panel	Gastroenterology/Urology

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Image /page/4/Picture/1 description: The image contains the logo for Meditech Endoscopy. The logo consists of a blue circle with a white stylized letter "E" inside it. To the right of the circle, the word "MEDITECH" is written in blue, and below it, the word "ENDOSCOPY" is written in a lighter shade of blue. The logo is clean and modern, with a focus on the company's name and area of expertise.

Ref: K191011

Substantial Equivalence:
Manufacturer	Trade Name	RegulationNumber	510(k) Number
UNITED STATESENDOSCOPY GROUP,INC	ENDOBOOT	876.1500	K951104

Description

The Scope ProTech is available in two models to fit a range of scopes:

Product Code	Product Description	Size of scope
INOV8-028S	Scope ProTech Small	2.7 to 8mm
INOV8-028L	Scope ProTech Large	8.7 to 14.7mm

Table 1: Scope ProTech™ sizes

Indications for Use

Summary of the Determination of Substantial Equivalence & Performance Data

The subject device is substantially equivalent to the predicate, K951104, the Endo-Boot and a comparison of the key characteristics is summarised in Table 2.

Characteristic	Meditech EndoscopyScope ProTech	US EndoscopyEndo-Boot (K951104)	Equivalence
Device Name	Scope ProTech	Endo-Boot™	n/a
Characteristic	Meditech EndoscopyScope ProTech	US EndoscopyEndo-Boot (K951104)	Equivalence
Indications for Use	The Scope ProTech is asingle-use, sterileendoscopic tip protectorthat is intended to be usedduring the transport andstorage of endoscopes forthe protection of thesedelicate instruments. TheScope ProTech is intendedfor the protection of thedistal tip and the bendingrubber of endoscopes witha diameter of2.7mm-8.0mm and8.7mm-14.7mm. The ScopeProTech will aid in theprotection of distal end, thelens and other delicatecomponents from damage.It is not intended for useduring sterilization.	The Endo-Boot™ is used as aprotective cover for the tip ofthe endoscope or othersurgical instruments (i.e. rigidlaparoscope, laparoscopicinstruments) during storageand transport. The Endo-Boot™ will aid in protectingthe lens and other delicatecomponents from damage.	SubstantiallyEquivalent
Intended User/Location	Healthcare professionals/technicians and non-patientcontactingHealthcare facility	Healthcare professionals/technicians and non-patientcontactingHealthcare facility	Equivalent
Storage and transport	The Scope ProTech isintended for use immediatelyafter processing in an AERand is used during thestorage and transport to andfrom the location of theprocedure	The Endo-Boot™ is intendedfor use immediately afterprocessing in an AER and isused during the storage andtransport to and from thelocation of the procedure	Equivalent
Sterile	Yes, EtO sterilised	Non-sterile	SubstantiallyEquivalent
Re-use	The Scope ProTech is a sterilesingle-use device and this isstated on the packaging	The Endo-Boot™ is a singleuse device and this is statedon the packaging	Equivalent
Scope Sizes	The Scope ProTech issupplied in two sizesintended to fit a range ofscopes for each size (mm):Scope ProTech Small 2.7 - 8Scope ProTech Large 8.8 - 14.7	The Endo-Boot™ is suppliedin two sizes intended to fit arange of scopes for each size:Endo-Boot™ small 3.0– 8.8 mmEndo-Boot™ large 8.8– 15 mm	SubstantiallyEquivalent
Characteristic	Meditech EndoscopyScope ProTech	US EndoscopyEndo-Boot (K951104)	Equivalence
Materials	The Scope ProTech ismanufactured using injectionmoulding using a softpolypropylene	The Endo-Boot™ ismanufactured from a sponge	SubstantiallyEquivalent
Instructions for use	Instructions for use includedthat includes graphicalinstructions, text andrelevant warnings andcautions	Instructions for use includedthat includes graphicalinstructions, text andrelevant warnings andcautions	Equivalent
Use on an endoscope	Slides over the distal tip of anendoscope	Slides over the distal tip of anendoscope	Equivalent
Distal tip protection	The Scope ProTech isintended to protect theentire distal end of theendoscope, covering the tipand delicate components	The Endo-Boot™ is intendedto be used on the distal endhowever the placement ofthe device should ensure thedistal tip of the endoscope isuncovered	SubstantiallyEquivalent

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Image /page/5/Picture/1 description: The image contains the logo for Meditech Endoscopy. The logo consists of a blue circular icon with a stylized letter "E" inside. To the right of the icon, the words "MEDITECH" and "ENDOSCOPY" are written in a sans-serif font, with "MEDITECH" in a darker blue and "ENDOSCOPY" in a lighter shade.

Ref: K191011

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Image /page/6/Picture/1 description: The image shows the logo for Meditech Endoscopy. The logo consists of a blue circle with a white stylized letter "E" inside it. To the right of the circle are the words "MEDITECH" in blue and "ENDOSCOPY" in a lighter shade of blue. The text is aligned to the right of the circle.

Ref: K191011

Table 2: Comparison of characteristics between Scope ProTech™ and Endo-Boot™

Discussion

The Scope ProTech and the predicate both have equivalent intended use, the user, location of use, how they are used (slide onto the distal tip and during storage/ transport of endoscopes), the scope sizes covered and their non-re-use. Both devices include a set of instructions for use that includes graphical and text information with warnings/cautions. The indications for use are substantially equivalent as the intended use is equivalent however the clarification that the Scope ProTech is sterile, single-use and should not be used during sterilisation are important additions but do not impact the safety or effectiveness.

The main areas of difference are in the sterility aspect, with the Scope ProTech provided sterile to reduce bioburden and maintain cleanliness of the endoscope after reprocessing whereas the predicate is not provided sterile; the materials used with the Scope ProTech using an injection moulded soft polypropylene that provides impact protection whereas the predicate is manufacture from the thin sponge foam; the sizes of the scopes covered is lower for the Scope ProTech (2.75mm compared to 3mm) however the Endo-Boot™ can stretch further (max 15mm compared to 14.75mm) however both the subject and predicate device cover the range of endoscopes used in clinical practice and the size coverage is identified on the product and this does not impact safety or effectiveness; the distal tip protection with the open design of the Scope ProTech allowing for complete coverage of the distal tip (allowing it to aerate) whereas the predicate has to leave the distal tip uncovered; the clean/dirty identification as the Scope ProTech includes tabs that identify the status of the device and prevents re-use of a used device on a clean scope whereas the predicate does not have this identification.

Issue 2

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Image /page/7/Picture/1 description: The image contains the logo for Meditech Endoscopy. The logo consists of a blue stylized letter "E" on the left, followed by the words "MEDITECH" in a darker blue and "ENDOSCOPY" in a lighter blue on the right. The "E" is formed by three lines that create the shape of the letter within a circle.

These differences ensure the endoscope cleanliness is not affected by the use of a Scope ProTech, provide additional protection of the reprocessed scope over the distal tip and the delicate components, prevent re-use and therefore the Scope ProTech is at least as safe and effective as the predicate.

Non-Clinical Testing

The Scope ProTech has been tested for mechanical performance across the range of scope sizes and for sterility and shelf-life requirements. The Scope ProTech™ is provided individually packaged and is provided sterile (ethylene oxide). The device does not have any patient contacting parts and has an equivalent intended use to the predicate and are used in a similar way.

The following bench tests were performed on the device:

Operating performance
. Scope compatibility and dimension
Retention performance ●

The testing performed demonstrated that the proposed device and predicate device are equivalent.

Clinical Testing

No clinical data was used in the submission.

Summary

The Scope ProTech is accompanied by instructions for use which demonstrate how the device is used safely and the labelling and instructions for use have been compared with the predicate and found to be similar for their purpose.

The Scope ProTech has been compared to similar devices and the is substantially equivalent to the predicate for the parameters and the testing has demonstrated that the device does not introduce any additional risks when used in accordance with the instructions for use.

Conclusion

Based on the information presented in this submission, it is concluded that the Scope ProTech are equivalent to the Endo-Boot (K951104) with respect to intended use, design and technological characteristics.

The Scope ProTech is as safe and effective as the predicate devices for the protection of the delicate parts of the endoscope during transport and storage. There are no new indications for use, therefore by following the FDA 510(k) "Substantial Equivalence" decision making process, https://www.fda.gov/downloads/MedicalDevices/

DeviceRegulationandGuidance/Guidanc eDocuments/UCM284443.pdf, it is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.