(326 days)
No
The device description and performance studies focus on the physical barrier and sealing properties of the device, with no mention of AI or ML technologies.
No.
The device is described as a protective barrier to reduce contamination and preserve duodenoscope functionality, not as a device for treating a medical condition.
No
The device description indicates that the ScopeSeal® is a protective barrier designed to reduce contamination of a duodenoscope during medical procedures and reprocessing, and it preserves the mechanical and optical functionality of the duodenoscope. It does not mention any function for detecting, monitoring, or diagnosing medical conditions.
No
The device description clearly states it is a "sterile, single-use device that attaches to the distal end of a duodenoscope" and describes physical components like a "flexible Working Channel Extension™", indicating it is a physical medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a protective barrier for a duodenoscope during and after use to reduce contamination. This is a device used during a medical procedure to protect the instrument, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a physical barrier that attaches to the duodenoscope and creates a sealed passageway. This is a mechanical device, not a reagent, instrument, or system intended for use in the in vitro examination of specimens derived from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on in vitro testing.
The device's function is to protect the duodenoscope from contamination during a procedure performed in vivo (within the body), which is not the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
ODB, FEI, FDT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Trans oral insertion
Indicated Patient Age Range
Not Found
Intended User / Care Setting
In a clinical environment
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)
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)
- 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.
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.
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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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
1
(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
2
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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3
510(k) Summary ScopeSeal® Duodenoscope Protective Device
Submitter Information:
| Submitter's Name: | GI Scientific LLC |
|---|---|
| Address: | 4601 North Fairfax Drive, Suite 1200 |
| Arlington, 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 Protective |
| Device | |
| Device Classification: | Class II |
| Classification Name | Endoscope and Accessories |
| Product Code and CommonName: | ODB, Endoscopic Contamination |
| Prevention Sheath | |
| Subsequent Product Code (s) and | |
| Common Name, Regulation Number: | FEI, Instrument, Special Lens, for |
| Endoscope, 876.1500 | |
| FDT, Duodenoscope and Accessories, | |
| Flexible and Rigid, 876.1500 | |
| Predicate Devices: | Sheathing Technologies, |
| Colonoscope/Sigmoidoscope Sheathes | |
| (K100966), | |
| Reference Device: | GI Scientific Endoscopic Optical Lens |
| (K140295) |
4
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.
5
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® | ||
| Duodenoscope | |||
| Protective Device | Sheathing | ||
| Technologies | |||
| Colonoscope/ | |||
| Sigmoidoscope Sheath | Comparison to | ||
| Predicate | |||
| Regulatory | |||
| Clearance/ | |||
| Approval | |||
| Reference | NA | K100966 | NA |
| Product Code | ODB, FEI, FDT | FDF, ODB | Same |
| 21 CFR | |||
| Regulation | |||
| Number | 876.1500 | 876.1500 | Same |
| Regulation | |||
| Name/Common | |||
| Name | Endoscopic Contamination | ||
| Prevention Sheath | Endoscopic Contamination | ||
| Prevention Sheath | Same | ||
| 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™ | Colonoscope/Sigmoidoscop | ||
| e Sheaths are meant for use | |||
| in non-sterile colonoscopy | |||
| or | |||
| sigmoidoscopy procedures | |||
| to help reduce gross | |||
| contamination of the | |||
| endoscope, | |||
| reducing the exposure of | |||
| staff to gross contamination | |||
| during the cleaning | |||
| procedure. | Intended use is the same, | ||
| as a sheath or barrier at | |||
| the distal end of the scope | |||
| to reduce gross | |||
| contamination. The | |||
| ScopeSeal® Statement is | |||
| more detailed in terms of | |||
| the additional barrier to | |||
| the elevator by means of a | |||
| working channel, and is | |||
| more specific regarding | |||
| scope compatibility, and | |||
| benefits associated with | |||
| pre-cleaning. These | |||
| differences do not raise | |||
| new questions regarding | |||
| safety and efficacy | |||
| Device Comparison Demonstrating Substantial Equivalence | |||
| Feature/ | |||
| Specification | ScopeSeal® | ||
| Duodenoscope | |||
| Protective Device | Sheathing | ||
| Technologies | |||
| Colonoscope/ | |||
| Sigmoidoscope Sheath | Comparison to | ||
| Predicate | |||
| performed after use. | |||
| The ScopeSeal® | |||
| Duodenoscope Protective | |||
| Device is indicated for use with | |||
| the | |||
| Olympus EVIS EXERA II | |||
| Duodenoscope 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 devices |
| access the gastrointestinal | |||
| tract through a natural | |||
| orifice | |||
| Principle of | |||
| operation | Attaches to the distal end of a | ||
| duodenoscope/endoscope to | |||
| provide a sterile disposable | |||
| barrier while preventing fluid | |||
| and debris from interfering with | |||
| visualization. Working channel | |||
| opening allows instruments to | |||
| pass through the endoscope to | |||
| the patient | Covers the scope shaft, open | ||
| at the proximal and distal | |||
| end to allow for devices to | |||
| pass through the endoscope | |||
| to the patient. | Similar, both devices in | ||
| some way shield the | |||
| endoscope while allowing | |||
| instruments to pass | |||
| through the endoscope. | |||
| The Endoscopic lens | |||
| (reference device) creates | |||
| an optically clear space to | |||
| visualize the tissue | |||
| surface. This difference | |||
| does not raise new | |||
| questions of safety and | |||
| effectiveness for the | |||
| subject device. | |||
| Endoscope | |||
| Compatibility | Only compatible with the | ||
| Olympus Duodenoscope Model | |||
| TJF-Q180V | Various models | Same, compatibility is | |
| specified in the labeling | |||
| Working channel | |||
| portal that aligns | |||
| with the scope | |||
| working channel | Yes | The distal end is open, does | |
| not specifically have an | |||
| aligned working channel | Same, the open ended | ||
| Sheathing Technologies | |||
| device allows for | |||
| instrument passage but | |||
| does not contain a | |||
| working channel portal. | |||
| This difference does not | |||
| raise new questions of | |||
| safety and effectiveness | |||
| for the subject device. | |||
| Compatibility for | |||
| device passage | Can pass devices up to 3.5mm | The distal end is open, does | |
| not specifically have an | |||
| aligned working channel | Same, device dimensions | ||
| are designed for scope | |||
| compatibility. | |||
| Device Comparison Demonstrating Substantial Equivalence | |||
| Feature/ | |||
| Specification | ScopeSeal® | ||
| Duodenoscope | |||
| Protective Device | Sheathing | ||
| Technologies | |||
| Colonoscope/ | |||
| Sigmoidoscope Sheath | Comparison to | ||
| Predicate | |||
| Allows for fluid | |||
| washing of the | |||
| area over the | |||
| scope camera and | |||
| for air to be used | |||
| to inflate the GI | |||
| tract | Yes, has a port that allows the | ||
| scope to still wash the area over | |||
| the camera and to deliver air to | |||
| inflate the gastrointestinal tract | Yes, the distal end is open, | ||
| there is no need for a | |||
| channel | Same | ||
| Optical Element | Includes an optically clear | ||
| window that covers the | |||
| duodenoscope's camera and | |||
| light source, but preserves | |||
| visualization through its design | |||
| and optical material | Grips around the distal end | ||
| of the endoscope, providing | |||
| a protective covering from | |||
| the distal end of the scope to | |||
| the proximal end of the | |||
| scope, while leaving the | |||
| optical area of the | |||
| endoscope uncovered | Same as the Endoscopic | ||
| Lens Reference Device- | |||
| all devices are designed to | |||
| not interfere with | |||
| visualization | |||
| Effect on | |||
| Endoscope Image | No effect | No effect | Same, all devices are |
| designed not to interfere | |||
| with visualization | |||
| Device Delivery | A Delivery System is provided | ||
| to enable consistent attachment | |||
| of the device to the scope | Manually aligned and | ||
| mounted - no delivery | |||
| system provided | Same as the Endoscopic | ||
| Optical Lens Reference | |||
| Device | |||
| Self Retained | |||
| Attachment | Yes | Yes | Same |
| Material | Multiple polymers and | ||
| elastomers | Polyurethane | Similar materials | |
| appropriate for their | |||
| intended use. Difference | |||
| does not raise new | |||
| questions of safety and | |||
| effectiveness | |||
| Biocompatibility | Tissue contact materials are | ||
| biocompatible per ISO 10993 | Tissue contact materials are | ||
| biocompatible per ISO | |||
| 10993 | Same | ||
| How Supplied | Sterile single use only | Sterile and nonsterile single | |
| use only | Same | ||
| Sterilization | Gamma Irradiation | Unknown | Subject device uses a |
| traditional sterilization | |||
| method. This difference | |||
| does not raise new | |||
| questions of safety and | |||
| effectiveness | |||
| Sterility | |||
| Assurance Level | 10-6 | Unknown | Consistent with the |
| industry standard for this | |||
| device 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.