(21 days)
Not Found
No
The device description and performance studies focus on the physical protection of endoscopes and do not mention any computational or data-driven features indicative of AI/ML.
No
The device is described as an endoscopic tip protector used for storing and transporting endoscopes to protect them from damage, not to treat or diagnose a medical condition.
No
The device is described as an endoscopic tip protector used for the physical protection of endoscopes during transport and storage, not for diagnosing any medical condition or disease.
No
The device description clearly states it is a physical product manufactured using injection molding from polypropylene, intended for physical protection of endoscopes. It does not mention any software components.
Based on the provided information, the Scope ProTech is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the Scope ProTech is for the protection of endoscopes during transport and storage. It is a physical protector for the instrument itself.
- Device Description: The description reinforces that it's a physical protector made of polypropylene.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. This is the core function of an IVD.
- Performance Studies: The performance studies focus on the device's physical performance (operating performance, compatibility, retention) and equivalence to a predicate device that is also a physical protector. There are no studies related to diagnostic accuracy or clinical outcomes related to patient diagnosis.
In summary, the Scope ProTech is a medical device, but its function is to protect another medical device (the endoscope), not to perform a diagnostic test on a patient sample.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OCU
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:
Product Code: INOV8-028S, Product Description: Scope ProTech Small, Size of scope: 2.7 to 8mm
Product Code: INOV8-028L, Product Description: Scope ProTech Large, Size of scope: 8.7 to 14.7mm
The Scope ProTech is manufactured using injection moulding using a soft polypropylene.
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
Healthcare professionals/technicians and non-patient contacting; Healthcare facility
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)
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.
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/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.
1
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
2
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 House |
| Luckyn Lane | |
| Basildon | |
| Essex | |
| SS14 3AX | |
| United Kingdom | |
| Registered Establishment Number: | n/a |
| Owner/Operator Number: | n/a |
| Contact: | Peter Ramsey |
| Managing 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 | Regulation | |
| Number | 510(k) Number | ||
| UNITED STATES | |||
| ENDOSCOPY GROUP, | |||
| INC | ENDOBOOT | 876.1500 | K951104 |
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:
| 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
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.
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 Endoscopy
Scope ProTech | US Endoscopy
Endo-Boot (K951104) | Equivalence |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Device Name | Scope ProTech | Endo-Boot™ | n/a |
| Characteristic | Meditech Endoscopy
Scope ProTech | US Endoscopy
Endo-Boot (K951104) | Equivalence |
| Indications for Use | 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. | The Endo-Boot™ is used as a
protective cover for the tip of
the endoscope or other
surgical instruments (i.e. rigid
laparoscope, laparoscopic
instruments) during storage
and transport. The Endo-
Boot™ will aid in protecting
the lens and other delicate
components from damage. | Substantially
Equivalent |
| Intended User/Location | Healthcare professionals/
technicians and non-patient
contacting
Healthcare facility | Healthcare professionals/
technicians and non-patient
contacting
Healthcare facility | Equivalent |
| Storage and transport | The Scope ProTech is
intended for use immediately
after processing in an AER
and is used during the
storage and transport to and
from the location of the
procedure | The Endo-Boot™ is intended
for use immediately after
processing in an AER and is
used during the storage and
transport to and from the
location of the procedure | Equivalent |
| Sterile | Yes, EtO sterilised | Non-sterile | Substantially
Equivalent |
| Re-use | The Scope ProTech is a sterile
single-use device and this is
stated on the packaging | The Endo-Boot™ is a single
use device and this is stated
on the packaging | Equivalent |
| Scope Sizes | The Scope ProTech is
supplied in two sizes
intended to fit a range of
scopes for each size (mm):
Scope ProTech Small 2.7 - 8
Scope ProTech Large 8.8 - 14.7 | The Endo-Boot™ is supplied
in two sizes intended to fit a
range of scopes for each size:
Endo-Boot™ small 3.0
– 8.8 mm
Endo-Boot™ large 8.8
– 15 mm | Substantially
Equivalent |
| Characteristic | Meditech Endoscopy
Scope ProTech | US Endoscopy
Endo-Boot (K951104) | Equivalence |
| Materials | The Scope ProTech is
manufactured using injection
moulding using a soft
polypropylene | The Endo-Boot™ is
manufactured from a sponge | Substantially
Equivalent |
| Instructions for use | Instructions for use included
that includes graphical
instructions, text and
relevant warnings and
cautions | Instructions for use included
that includes graphical
instructions, text and
relevant warnings and
cautions | Equivalent |
| Use on an endoscope | Slides over the distal tip of an
endoscope | Slides over the distal tip of an
endoscope | Equivalent |
| Distal tip protection | The Scope ProTech is
intended to protect the
entire distal end of the
endoscope, covering the tip
and delicate components | The Endo-Boot™ is intended
to be used on the distal end
however the placement of
the device should ensure the
distal tip of the endoscope is
uncovered | Substantially
Equivalent |
| | | | |
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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.