(326 days)
When properly installed: (i) the ScopeSeal® Duodenoscope Protective barrier at the scope's distal end to significantly reduce the level of contamination of the distal end during use and prior to reprocessing, and (ii) the ScopeSeal®'s working channel also provides a protective barrier sealing the duodenoscope's elevator area during use, and (iii) the ScopeSeal® device provides an additional protective benefit after use when kept in place during the ScopeSeal Pre-Cleaning Procedure™ performed after use.
The ScopeSeal® is compatible for use with the Olympus Duodenoscope Model TJF-Q180V.
The GI Scientific ScopeSeal® Duodenoscope Protective Device is provided as a sterile, single-use device that attaches to the distal end of a duodenoscope. When properly installed the device creates a protective barrier or shield that seals the distal end of the duodenoscope to protect it from contamination during the procedure. The device is designed to preserve the mechanical and optical functionality of the duodenoscope. The ScopeSeal® Duodenoscope Protective Device includes a flexible Working Channel Extension™ that seals against the end of the duodenoscope's working channel, providing a sealed, passageway from the end of the duodenoscope's working channel through the ScopeSeal® device's working channel extension and out to the patient's gastrointestinal tract. This element of ScopeSeal®'s design allows instruments to be passed down the duodenoscope's working channel, through the ScopeSeal® device's Working Channel Extension™, and out to the patient's gastrointestinal tract, without instruments coming into contact with the duodenoscope's elevator, effectively sealing over the elevator area of the duodenoscope. The ScopeSeal® allows passage of device up to 10.7Fr (3.5mm) in diameter.
The provided text describes the regulatory clearance of a medical device, the ScopeSeal® Duodenoscope Protective Device, via a 510(k) premarket notification. This process determines substantial equivalence to a legally marketed predicate device, rather than requiring the extensive clinical studies typically associated with proving a device meets specific acceptance criteria in the comprehensive manner of a de novo or PMA submission.
Therefore, the information focuses on non-clinical performance testing and a comparison to a predicate device to demonstrate substantial equivalence rather than defining a detailed set of acceptance criteria for clinical efficacy and a direct study proving the device meets those criteria.
However, based on the provided "Performance Data" section, we can infer the implied acceptance criteria and the nature of the study that was conducted (non-clinical performance testing).
Here's an attempt to answer your request based on the available information, acknowledging that a full clinical trial with precise acceptance criteria for human outcomes is not detailed as part of this 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied from Performance Data) | Reported Device Performance (Summary) |
|---|---|
| Seal integrity under simulated use conditions | Met acceptance criteria; demonstrated necessary performance characteristics. |
| Contamination reduction | Met acceptance criteria; demonstrated necessary performance characteristics. |
| Scope compatibility | Met acceptance criteria; demonstrated necessary performance characteristics. |
| Maintenance of scope function | Met acceptance criteria, specifically for irrigation, suction, articulation, device delivery, and optics. |
| ScopeSeal® delivery and retention | Met acceptance criteria; demonstrated necessary performance characteristics. |
| Biocompatibility: | |
| - Cytotoxicity (non-cytotoxic) | Pass - noncytotoxic |
| - Intracutaneous Irritation | Pass - Test requirements for intracutaneous reactivity were met |
| - Sensitization | Pass - did not elicit a sensitization response |
| - Systemic Toxicity | Pass - Test requirements for systemic toxicity were met |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No animal or clinical studies were required to demonstrate substantial equivalence."
The performance data described are stated as "Nonclinical performance testing."
- Test Set Sample Size: Not specified for the non-clinical tests. The tests would likely involve a specific number of devices or simulated use cycles, but the exact number is not provided.
- Data Provenance: The data is from "Nonclinical performance testing" conducted by G.I. Scientific LLC. There is no mention of country of origin for this testing or whether it was retrospective or prospective in the sense of a clinical study. It would inherently be prospective in the context of laboratory testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Given that "No animal or clinical studies were required," there was no "test set" in the sense of patient data requiring expert ground truth for diagnosis/outcomes. The performance data seems to be based on engineering and laboratory testing. Therefore, this information is not applicable from the provided text.
4. Adjudication Method for the Test Set
Not applicable, as there was no test set of patient data requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No animal or clinical studies were required to demonstrate substantial equivalence."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This pertains to an AI/Software as a Medical Device (SaMD). The ScopeSeal® Duodenoscope Protective Device is a physical medical device. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable to this device.
7. The Type of Ground Truth Used
For the non-clinical performance testing and biocompatibility, the "ground truth" would be established by:
- Engineering specifications and test methodologies: For seal integrity, scope compatibility, function maintenance, and delivery/retention.
- Established ISO standards (ISO 10993) and laboratory protocols: For biocompatibility testing (Cytotoxicity, Intracutaneous Irritation, Sensitization, Systemic Toxicity).
8. The Sample Size for the Training Set
This refers to a training set for an AI/machine learning model. Since the ScopeSeal® is a physical device and not an AI/ML product, the concept of a "training set" in this context is not applicable.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an AI/ML model for this device.
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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 logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 8, 2019
GI Scientific LLC % Michele Lucey President Lakeshore Medical Device Consulting LLC 128 Blye Hill Landing Newbury, NH 03255
Re: K183171 Trade/Device Name: ScopeSeal Duodenoscope Protective Device Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: II Product Code: ODB, FEI, FDT Dated: August 8, 2019 Received: August 12, 2019
Dear Michele Lucey:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling
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(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 (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 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,
Martha Betz, Ph.D. Acting Assistant 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) K183171
Device Name ScopeSeal® Duodenoscope Protective Device
Indications for Use (Describe)
When properly installed: (i) the ScopeSeal® Duodenoscope Protective barrier at the scope's distal end to significantly reduce the level of contamination of the distal end during use and prior to reprocessing, and (ii) the ScopeSeal®'s working channel also provides a protective barrier sealing the duodenoscope's elevator area during use, and (iii) the ScopeSeal® device provides an additional protective benefit after use when kept in place during the ScopeSeal Pre-Cleaning Procedure™ performed after use.
The ScopeSeal® is compatible for use with the Olympus Duodenoscope Model TJF-Q180V.
| 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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510(k) Summary ScopeSeal® Duodenoscope Protective Device
Submitter Information:
| Submitter's Name: | GI Scientific LLC |
|---|---|
| Address: | 4601 North Fairfax Drive, Suite 1200Arlington, VA 22203 |
| Telephone: | 508-494-3777 |
| Fax: | 866-637-9409 |
| Contact Person: | Michele Lucey |
| Telephone: | 603-748-1374 |
| Date Prepared: | October 1, 2019 |
| Device Trade Name: | ScopeSeal® Duodenoscope ProtectiveDevice |
| Device Classification: | Class II |
| Classification Name | Endoscope and Accessories |
| Product Code and CommonName: | ODB, Endoscopic ContaminationPrevention Sheath |
| Subsequent Product Code (s) andCommon Name, Regulation Number: | FEI, Instrument, Special Lens, forEndoscope, 876.1500FDT, Duodenoscope and Accessories,Flexible and Rigid, 876.1500 |
| Predicate Devices: | Sheathing Technologies,Colonoscope/Sigmoidoscope Sheathes(K100966), |
| Reference Device: | GI Scientific Endoscopic Optical Lens(K140295) |
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Indications for Use:
When properly installed: (i) the ScopeSeal® Duodenoscope Protective Device acts as a protective barrier at the scope's distal end to significantly reduce the level of contamination of the distal end during use and prior to reprocessing, and (ii) the ScopeSeal®'s working channel also provides a protective barrier sealing the duodenoscope's elevator area during use, and (iii) the ScopeSeal® device provides an additional protective benefit after use when kept in place during the ScopeSeal Pre-Cleaning Procedure™ performed after use.
The ScopeSeal® is compatible for use with the Olympus Duodenoscope Model TJF-Q180V.
Device Description/Technological Characteristics:
The GI Scientific ScopeSeal® Duodenoscope Protective Device is provided as a sterile, single-use device that attaches to the distal end of a duodenoscope. When properly installed the device creates a protective barrier or shield that seals the distal end of the duodenoscope to protect it from contamination during the procedure. The device is designed to preserve the mechanical and optical functionality of the duodenoscope. The ScopeSeal® Duodenoscope Protective Device includes a flexible Working Channel Extension™ that seals against the end of the duodenoscope's working channel, providing a sealed, passageway from the end of the duodenoscope's working channel through the ScopeSeal® device's working channel extension and out to the patient's gastrointestinal tract. This element of ScopeSeal®'s design allows instruments to be passed down the duodenoscope's working channel, through the ScopeSeal® device's Working Channel Extension™, and out to the patient's gastrointestinal tract, without instruments coming into contact with the duodenoscope's elevator, effectively sealing over the elevator area of the duodenoscope. The ScopeSeal® allows passage of device up to 10.7Fr (3.5mm) in diameter.
Performance Data:
Nonclinical performance testing conducted on the ScopeSeal® Duodenoscope Protective Device is provided as follows:
- Seal integrity under simulated use conditions ●
- Contamination reduction
- Scope compatibility maintenance of scope function (i.e. irrigation, suction, ● articulation, device delivery, optics)
- 0 ScopeSeal® delivery and retention
All product performance testing met the acceptance criteria demonstrating that the device has the necessary performance characteristics for its intended use.
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Biocompatibility
Categorized as Externally Communicating Device, Tissue Contact, Limited Duration(≤ 24 hours), per ISO 10993-1, the following testing was conducted:
| Test Name | Results |
|---|---|
| Cytotoxicity | Pass - noncytotoxic |
| Intracutaneous Irritation | Pass - Test requirements for intracutaneous reactivity were met |
| Sensitization | Pass - did not elicit a sensitization response |
| Systemic Toxicity | Pass - Test requirements for systemic toxicity were met |
No animal or clinical studies were required to demonstrate substantial equivalence.
Substantial Equivalence:
The table below shows how the intended use, device design, principle of operation, and technological characteristics of the ScopeSeal® Duodenoscope Protective Device compared to the predicate device:
| Device Comparison Demonstrating Substantial Equivalence | |||
|---|---|---|---|
| Feature/Specification | ScopeSeal®DuodenoscopeProtective Device | SheathingTechnologiesColonoscope/Sigmoidoscope Sheath | Comparison toPredicate |
| RegulatoryClearance/ApprovalReference | NA | K100966 | NA |
| Product Code | ODB, FEI, FDT | FDF, ODB | Same |
| 21 CFRRegulationNumber | 876.1500 | 876.1500 | Same |
| RegulationName/CommonName | Endoscopic ContaminationPrevention Sheath | Endoscopic ContaminationPrevention Sheath | Same |
| Indications forUse | When properly installed: (i) theScopeSeal® DuodenoscopeProtective Device acts asa protective barrier at thescope's distal end tosignificantly reduce the level ofcontamination of the distal endduring use and prior toreprocessing , and (ii) theScopeSeal®'s working channelalso provides a protectivebarrier sealing theduodenoscope's elevator areaduring use, and (iii) theScopeSeal® device provides anadditional protective benefitafter use when kept in placeduring the ScopeSeal Pre-Cleaning Procedure™ | Colonoscope/Sigmoidoscope Sheaths are meant for usein non-sterile colonoscopyorsigmoidoscopy proceduresto help reduce grosscontamination of theendoscope,reducing the exposure ofstaff to gross contaminationduring the cleaningprocedure. | Intended use is the same,as a sheath or barrier atthe distal end of the scopeto reduce grosscontamination. TheScopeSeal® Statement ismore detailed in terms ofthe additional barrier tothe elevator by means of aworking channel, and ismore specific regardingscope compatibility, andbenefits associated withpre-cleaning. Thesedifferences do not raisenew questions regardingsafety and efficacy |
| Device Comparison Demonstrating Substantial Equivalence | |||
| Feature/Specification | ScopeSeal®DuodenoscopeProtective Device | SheathingTechnologiesColonoscope/Sigmoidoscope Sheath | Comparison toPredicate |
| performed after use.The ScopeSeal®Duodenoscope ProtectiveDevice is indicated for use withtheOlympus EVIS EXERA IIDuodenoscope Model TJF-Q180V. | |||
| Where used(environment) | In a clinical environment | In a clinical environment | Same |
| Anatomical Sites | Trans oral insertion | Trans anal insertion | Similar. Both devicesaccess the gastrointestinaltract through a naturalorifice |
| Principle ofoperation | Attaches to the distal end of aduodenoscope/endoscope toprovide a sterile disposablebarrier while preventing fluidand debris from interfering withvisualization. Working channelopening allows instruments topass through the endoscope tothe patient | Covers the scope shaft, openat the proximal and distalend to allow for devices topass through the endoscopeto the patient. | Similar, both devices insome way shield theendoscope while allowinginstruments to passthrough the endoscope.The Endoscopic lens(reference device) createsan optically clear space tovisualize the tissuesurface. This differencedoes not raise newquestions of safety andeffectiveness for thesubject device. |
| EndoscopeCompatibility | Only compatible with theOlympus Duodenoscope ModelTJF-Q180V | Various models | Same, compatibility isspecified in the labeling |
| Working channelportal that alignswith the scopeworking channel | Yes | The distal end is open, doesnot specifically have analigned working channel | Same, the open endedSheathing Technologiesdevice allows forinstrument passage butdoes not contain aworking channel portal.This difference does notraise new questions ofsafety and effectivenessfor the subject device. |
| Compatibility fordevice passage | Can pass devices up to 3.5mm | The distal end is open, doesnot specifically have analigned working channel | Same, device dimensionsare designed for scopecompatibility. |
| Device Comparison Demonstrating Substantial Equivalence | |||
| Feature/Specification | ScopeSeal®DuodenoscopeProtective Device | SheathingTechnologiesColonoscope/Sigmoidoscope Sheath | Comparison toPredicate |
| Allows for fluidwashing of thearea over thescope camera andfor air to be usedto inflate the GItract | Yes, has a port that allows thescope to still wash the area overthe camera and to deliver air toinflate the gastrointestinal tract | Yes, the distal end is open,there is no need for achannel | Same |
| Optical Element | Includes an optically clearwindow that covers theduodenoscope's camera andlight source, but preservesvisualization through its designand optical material | Grips around the distal endof the endoscope, providinga protective covering fromthe distal end of the scope tothe proximal end of thescope, while leaving theoptical area of theendoscope uncovered | Same as the EndoscopicLens Reference Device-all devices are designed tonot interfere withvisualization |
| Effect onEndoscope Image | No effect | No effect | Same, all devices aredesigned not to interferewith visualization |
| Device Delivery | A Delivery System is providedto enable consistent attachmentof the device to the scope | Manually aligned andmounted - no deliverysystem provided | Same as the EndoscopicOptical Lens ReferenceDevice |
| Self RetainedAttachment | Yes | Yes | Same |
| Material | Multiple polymers andelastomers | Polyurethane | Similar materialsappropriate for theirintended use. Differencedoes not raise newquestions of safety andeffectiveness |
| Biocompatibility | Tissue contact materials arebiocompatible per ISO 10993 | Tissue contact materials arebiocompatible per ISO10993 | Same |
| How Supplied | Sterile single use only | Sterile and nonsterile singleuse only | Same |
| Sterilization | Gamma Irradiation | Unknown | Subject device uses atraditional sterilizationmethod. This differencedoes not raise newquestions of safety andeffectiveness |
| SterilityAssurance Level | 10-6 | Unknown | Consistent with theindustry standard for thisdevice type. |
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K183171
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K183171
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Conclusion:
The GI Scientific ScopeSeal® Duodenoscope Protective Device is substantially equivalent to the predicate device and presents no new questions of safety or effectiveness.
§ 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.