ScopeSeal Duodenoscope Protective Device

K183171 · Gi Scientific, LLC · ODB · Oct 8, 2019 · Gastroenterology, Urology

Device Facts

• Record ID: K183171
• Device Name: ScopeSeal Duodenoscope Protective Device
• Applicant: Gi Scientific, LLC
• Product Code: ODB · Gastroenterology, Urology
• Decision Date: Oct 8, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

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.

Device Story

Sterile, single-use protective device attaches to distal end of Olympus TJF-Q180V duodenoscope; creates physical barrier/shield over distal end and elevator area. Includes flexible Working Channel Extension allowing passage of instruments up to 10.7Fr (3.5mm) into GI tract without contacting elevator. Used in clinical environment by medical professionals. Device preserves mechanical/optical functionality; includes optically clear window for camera/light source. Delivery system enables consistent attachment. Protective barrier reduces contamination during use and pre-cleaning; prevents fluid/debris interference with visualization. Benefits include reduced scope contamination and improved reprocessing safety.

Clinical Evidence

Bench testing only. Testing included seal integrity under simulated use, contamination reduction, scope compatibility (irrigation, suction, articulation, device delivery, optics), and delivery/retention. Biocompatibility testing per ISO 10993-1 (cytotoxicity, intracutaneous irritation, sensitization, systemic toxicity) passed. No clinical or animal studies required.

Technological Characteristics

Sterile, single-use, distal-end attachment for duodenoscope. Materials: polymers and elastomers. Features optically clear window and flexible working channel extension. Compatible with Olympus TJF-Q180V. Sterilization: Gamma irradiation (SAL 10^-6). Biocompatibility: ISO 10993-1 compliant.

Indications for Use

Indicated for use with Olympus Duodenoscope Model TJF-Q180V to reduce distal end contamination during clinical procedures and pre-cleaning.

Regulatory Classification

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.

Special Controls

*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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

• Sheathing Technologies, Colonoscope/Sigmoidoscope Sheathes (K100966)

Reference Devices

• GI Scientific Endoscopic Optical Lens (K140295)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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) | |
|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| <div> <span>☑</span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span>☐</span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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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 1200<br>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<br>Device |
| Device Classification: | Class II |
| Classification Name | Endoscope and Accessories |
| Product Code and CommonName: | ODB, Endoscopic Contamination<br>Prevention Sheath |
| Subsequent Product Code (s) and<br>Common Name, Regulation Number: | FEI, Instrument, Special Lens, for<br>Endoscope, 876.1500<br>FDT, Duodenoscope and Accessories,<br>Flexible and Rigid, 876.1500 |
| Predicate Devices: | Sheathing Technologies,<br>Colonoscope/Sigmoidoscope Sheathes<br>(K100966), |
| Reference Device: | GI Scientific Endoscopic Optical Lens<br>(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/<br>Specification | ScopeSeal®<br>Duodenoscope<br>Protective Device | Sheathing<br>Technologies<br>Colonoscope/<br>Sigmoidoscope Sheath | Comparison to<br>Predicate |
| Regulatory<br>Clearance/<br>Approval<br>Reference | NA | K100966 | NA |
| Product Code | ODB, FEI, FDT | FDF, ODB | Same |
| 21 CFR<br>Regulation<br>Number | 876.1500 | 876.1500 | Same |
| Regulation<br>Name/Common<br>Name | Endoscopic Contamination<br>Prevention Sheath | Endoscopic Contamination<br>Prevention Sheath | Same |
| Indications for<br>Use | When properly installed: (i) the<br>ScopeSeal® Duodenoscope<br>Protective Device acts as<br>a protective barrier at the<br>scope's distal end to<br>significantly reduce the level of<br>contamination of the distal end<br>during use and prior to<br>reprocessing , and (ii) the<br>ScopeSeal®'s working channel<br>also provides a protective<br>barrier sealing the<br>duodenoscope's elevator area<br>during use, and (iii) the<br>ScopeSeal® device provides an<br>additional protective benefit<br>after use when kept in place<br>during the ScopeSeal Pre-<br>Cleaning Procedure™ | Colonoscope/Sigmoidoscop<br>e Sheaths are meant for use<br>in non-sterile colonoscopy<br>or<br>sigmoidoscopy procedures<br>to help reduce gross<br>contamination of the<br>endoscope,<br>reducing the exposure of<br>staff to gross contamination<br>during the cleaning<br>procedure. | Intended use is the same,<br>as a sheath or barrier at<br>the distal end of the scope<br>to reduce gross<br>contamination. The<br>ScopeSeal® Statement is<br>more detailed in terms of<br>the additional barrier to<br>the elevator by means of a<br>working channel, and is<br>more specific regarding<br>scope compatibility, and<br>benefits associated with<br>pre-cleaning. These<br>differences do not raise<br>new questions regarding<br>safety and efficacy |
| Device Comparison Demonstrating Substantial Equivalence | | | |
| Feature/<br>Specification | ScopeSeal®<br>Duodenoscope<br>Protective Device | Sheathing<br>Technologies<br>Colonoscope/<br>Sigmoidoscope Sheath | Comparison to<br>Predicate |
| | performed after use.<br>The ScopeSeal®<br>Duodenoscope Protective<br>Device is indicated for use with<br>the<br>Olympus EVIS EXERA II<br>Duodenoscope Model TJF-<br>Q180V. | | |
| Where used<br>(environment) | In a clinical environment | In a clinical environment | Same |
| Anatomical Sites | Trans oral insertion | Trans anal insertion | Similar. Both devices<br>access the gastrointestinal<br>tract through a natural<br>orifice |
| Principle of<br>operation | Attaches to the distal end of a<br>duodenoscope/endoscope to<br>provide a sterile disposable<br>barrier while preventing fluid<br>and debris from interfering with<br>visualization. Working channel<br>opening allows instruments to<br>pass through the endoscope to<br>the patient | Covers the scope shaft, open<br>at the proximal and distal<br>end to allow for devices to<br>pass through the endoscope<br>to the patient. | Similar, both devices in<br>some way shield the<br>endoscope while allowing<br>instruments to pass<br>through the endoscope.<br>The Endoscopic lens<br>(reference device) creates<br>an optically clear space to<br>visualize the tissue<br>surface. This difference<br>does not raise new<br>questions of safety and<br>effectiveness for the<br>subject device. |
| Endoscope<br>Compatibility | Only compatible with the<br>Olympus Duodenoscope Model<br>TJF-Q180V | Various models | Same, compatibility is<br>specified in the labeling |
| Working channel<br>portal that aligns<br>with the scope<br>working channel | Yes | The distal end is open, does<br>not specifically have an<br>aligned working channel | Same, the open ended<br>Sheathing Technologies<br>device allows for<br>instrument passage but<br>does not contain a<br>working channel portal.<br>This difference does not<br>raise new questions of<br>safety and effectiveness<br>for the subject device. |
| Compatibility for<br>device passage | Can pass devices up to 3.5mm | The distal end is open, does<br>not specifically have an<br>aligned working channel | Same, device dimensions<br>are designed for scope<br>compatibility. |
| Device Comparison Demonstrating Substantial Equivalence | | | |
| Feature/<br>Specification | ScopeSeal®<br>Duodenoscope<br>Protective Device | Sheathing<br>Technologies<br>Colonoscope/<br>Sigmoidoscope Sheath | Comparison to<br>Predicate |
| Allows for fluid<br>washing of the<br>area over the<br>scope camera and<br>for air to be used<br>to inflate the GI<br>tract | Yes, has a port that allows the<br>scope to still wash the area over<br>the camera and to deliver air to<br>inflate the gastrointestinal tract | Yes, the distal end is open,<br>there is no need for a<br>channel | Same |
| Optical Element | Includes an optically clear<br>window that covers the<br>duodenoscope's camera and<br>light source, but preserves<br>visualization through its design<br>and optical material | Grips around the distal end<br>of the endoscope, providing<br>a protective covering from<br>the distal end of the scope to<br>the proximal end of the<br>scope, while leaving the<br>optical area of the<br>endoscope uncovered | Same as the Endoscopic<br>Lens Reference Device-<br>all devices are designed to<br>not interfere with<br>visualization |
| Effect on<br>Endoscope Image | No effect | No effect | Same, all devices are<br>designed not to interfere<br>with visualization |
| Device Delivery | A Delivery System is provided<br>to enable consistent attachment<br>of the device to the scope | Manually aligned and<br>mounted - no delivery<br>system provided | Same as the Endoscopic<br>Optical Lens Reference<br>Device |
| Self Retained<br>Attachment | Yes | Yes | Same |
| Material | Multiple polymers and<br>elastomers | Polyurethane | Similar materials<br>appropriate for their<br>intended use. Difference<br>does not raise new<br>questions of safety and<br>effectiveness |
| Biocompatibility | Tissue contact materials are<br>biocompatible per ISO 10993 | Tissue contact materials are<br>biocompatible per ISO<br>10993 | Same |
| How Supplied | Sterile single use only | Sterile and nonsterile single<br>use only | Same |
| Sterilization | Gamma Irradiation | Unknown | Subject device uses a<br>traditional sterilization<br>method. This difference<br>does not raise new<br>questions of safety and<br>effectiveness |
| Sterility<br>Assurance Level | 10-6 | Unknown | Consistent with the<br>industry standard for this<br>device type. |

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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.