(186 days)
The GripTract-Gl Endoscopic Tissue Manipulator (GripTract) is an accessory intended to assist in positioning the distal end of an endoscope from the mucosal surface and assist with optical visualization, diagnosis, and endoscopic treatment.
GripTract is indicated for use in the large intestine with any standard endoscope that has a distal tip outer diameter of 11.5 - 12.0 mm and working length of 168 - 170 cm.
GripTract is a single-use, non-sterile, endoscope accessory intended to ensure complete positioning of an endoscope and assist with optical visualization, diagnosis, and endoscopic treatment. It is indicated for use in the large intestine with any standard endoscope that has a distal tip outer diameter of 11.5 - 12.0 mm and a working length of 168 - 170 cm.
The GripTract Handpiece attaches to the endoscope control body just below the working channel. The soft End Cap with two integrated Fingers for tissue manipulation is placed on the distal end of the endoscope. Two Control Knobs in the Handpiece each operate a corresponding Finger, permitting the User to rotate and extend/retract the Fingers for tissue manipulation and visualization independent of the endoscope's movement or the presence of other tools in the endoscope's working channel.
The provided text describes the regulatory clearance for the GripTract-GI Endoscopic Tissue Manipulator (K231254). It outlines the device's intended use and provides non-clinical performance data to demonstrate its safety and effectiveness.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Key Takeaway: The provided document is a 510(k) summary for a medical device (GripTract-GI Endoscopic Tissue Manipulator). It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific numerical performance acceptance criteria typical of AI/ML device studies. Therefore, many of the requested criteria (e.g., specific quantitative metrics, sample sizes for training/test sets for AI, expert numbers for ground truth, MRMC studies) are not directly applicable or explicitly stated in this type of regulatory submission for a mechanical device.
However, I can extract the information related to the device's performance and the studies conducted to show its safety and effectiveness.
Acceptance Criteria and Device Performance (based on provided text)
The acceptance criteria for this device are primarily related to its functional performance, safety, and compatibility, demonstrated through various non-clinical tests. The "performance" is reported as "Pass" for each test, indicating that the device met the pre-defined criteria for that specific test.
| Acceptance Criteria Category | Specific Criteria / Test Description | Reported Device Performance |
|---|---|---|
| Product Specifications | Verification of Product Specifications after exposure to ambient, high temperature, and low temperature environmental conditions. | Pass |
| Distribution / Packaging Integrity | Confirmation of Product Specifications following exposure to simulated distribution stress and conditions (per ASTM D4169-16). | Pass |
| Shelf Life (Accelerated) | Confirmation of Product Specifications following exposure to accelerated conditions simulating a shelf-life of two years. | Pass |
| Shelf Life (Real-Time) | Confirmation of Product Specifications following exposure to real-time ambient conditions for two years. | Test is on-going |
| Reliability | Confirmation of Product Specifications following worst-case simulated use. | Pass |
| Bench Safety | Assessed safety of worst-case interactions between biological tissue and GripTract Fingers. | Pass |
| Usability (Set-Up) | Assessment of whether the intended user population can successfully set up GripTract without serious use errors, failure to perform critical tasks, or encountering problems that affect the intended use and expected use environment. | Pass |
| Usability (Use) | Assessment of whether the intended user population can successfully use GripTract without serious use errors, failure to perform critical tasks, or encountering problems that affect the intended use and expected use environment. | Pass |
| Biocompatibility | Testing of final, finished devices for cytotoxicity, sensitization, irritation, acute systemic toxicity, and material mediated pyrogenicity (per ISO 10993-12, -5, -10, -23, -11). | Pass |
| In Vivo Safety & Effectiveness (Porcine) | In vivo porcine testing of GripTract against standard of care in worst-case procedure. Acute and chronic time points examined for differences in visual and histological mucosal damage as well as presence of device-attributable adverse events. Equivalent visual and histological mucosal damage compared to endoscope-only (control). | Pass |
| Endoscope Viewing Area (Bench Safety) | Comparison of the endoscope viewing area between GripTract and the Reference Device. | Does not block visualization relative to a standard distal end cap. |
Study Details (based on provided text)
-
Sample sizes used for the test set and the data provenance:
- Usability Testing: "A total of 15 Users" for both "Set-Up" and "Use" usability tests.
- Porcine Testing: Number of animals or procedures is not specified, but it's an "in vivo porcine testing" in "worst-case procedure."
- Other Bench Tests: Sample sizes are not explicitly stated for product specification verifications, distribution, shelf-life, reliability, or bench safety (other than the endoscope viewing area comparison).
- Data Provenance: The studies are non-clinical, primarily bench and animal (porcine) testing. No explicit mention of country of origin for the data or whether it's retrospective/prospective (these terms are more relevant for human clinical studies).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. For non-AI mechanical devices, the "ground truth" is typically established by engineering specifications, validated test methods, and potentially expert interpretation for things like tissue damage in animal studies. The "users" in usability testing are relevant, but their "qualification" is broadly "intended user population" (medical specialists).
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/mentioned for this type of non-clinical device testing.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a mechanical accessory, not an AI-powered diagnostic tool requiring human reader comparison studies.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a mechanical device, not an algorithm. Bench tests evaluate the device's standalone performance.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Bench Performance: Engineering specifications and ASTM/ISO standards.
- Usability: Defined user tasks and absence of serious use errors, likely determined by observation and user feedback against pre-defined criteria.
- Biocompatibility: ISO 10993 standards and their associated pass/fail criteria (e.g., lack of cytotoxicity, sensitization).
- Porcine Testing: Visual and histological mucosal damage assessment compared to a control (endoscope-only procedures), suggesting pathology as a component of ground truth for tissue effects.
-
The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no "training set."
-
How the ground truth for the training set was established:
- Not applicable.
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Image /page/0/Picture/0 description: The image contains 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 with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
November 3, 2023
Actuated Medical, Inc. Douglas Dillon Director, Ouality Assurance & Regulatory Affairs 320 Rolling Ridge Drive Bellefonte, Pennsylvania 16823
Re: K231254
Trade/Device Name: GripTract-GI Endoscopic Tissue Manipulator Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FDF Dated: October 6, 2023 Received: October 6, 2023
Dear Douglas Dillon:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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).
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Sincerely,
Shanil P. Haugen -S
Shanil P. Haugen, Ph.D. 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) K231254
Device Name
Griptract-GI Endoscopic Tissue Manipulator
Indications for Use (Describe)
The GripTract-Gl Endoscopic Tissue Manipulator (GripTract) is an accessory intended to assist in positioning the distal end of an endoscope from the mucosal surface and assist with optical visualization, diagnosis, and endoscopic treatment.
GripTract is indicated for use in the large intestine with any standard endoscope that has a distal tip outer diameter of 11.5 - 12.0 mm and working length of 168 - 170 cm.
| 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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K231254 510(k) SUMMARY
Applicant Information
Date Prepared: October 6, 2023
Name and Address: Actuated Medical, Inc. 320 Rolling Ridge Drive Bellefonte, PA 16823 Ph: (814) 355-0003 Fx: (814) 355-1523
Contact Person: Douglas R. Dillon Director, Quality Assurance and Regulatory Affairs Ph: (814) 355-0003 x107 Fx: (814) 355-1523 Email: Douglas.Dillon@actuatedmedical.com
Device Information
| Trade Name: | GripTract-GI™ Endoscopic Tissue Manipulator |
|---|---|
| Common Name: | GripTract-GI™ Endoscopic Tissue Manipulator |
| Classification: | 21 CFR §876.1500 |
| Classification Name: | Endoscope and accessories |
| Product Code: | FDF |
Image /page/4/Picture/16 description: The image is a close-up of an orange background with a pattern of lighter orange squares and wavy lines. The squares are arranged in a staggered pattern, creating a sense of depth. The wavy lines add a dynamic element to the composition. The overall effect is a textured and visually interesting design.
K231254 Page 1 of 11
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Image /page/5/Picture/1 description: The image is a close-up of an orange background with a pattern of squares and wavy lines. The squares are arranged in a checkerboard pattern, with alternating light and dark orange squares. The wavy lines are also orange and run diagonally across the image. The overall effect is a bright and cheerful design.
| Type | 510(k)Number | Trade Name | Submitter |
|---|---|---|---|
| PredicateDevice | K210851 | DiLumenEndolumenalInterventionalPlatform (DiLumen) | Lumendi Ltd. |
| ReferenceDevice | K984358 | D-201-12704Disposable DistalAttachment | Olympus Americas,Inc. |
Predicate & Reference Devices
Device Description
GripTract is a single-use, non-sterile, endoscope accessory intended to ensure complete positioning of an endoscope and assist with optical visualization, diagnosis, and endoscopic treatment. It is indicated for use in the large intestine with any standard endoscope that has a distal tip outer diameter of 11.5 - 12.0 mm and a working length of 168 - 170 cm.
The GripTract Handpiece attaches to the endoscope control body just below the working channel. The soft End Cap with two integrated Fingers for tissue manipulation is placed on the distal end of the endoscope. Two Control Knobs in the Handpiece each operate a corresponding Finger, permitting the User to rotate and extend/retract the Fingers for tissue manipulation and visualization independent of the endoscope's movement or the presence of other tools in the endoscope's working channel.
Indications for Use
The GripTract-Gl Endoscopic Tissue Manipulator (GripTract) is an accessory intended to assist in positioning the distal end of an endoscope from the mucosal surface and assist with optical visualization, diagnosis, and endoscopic treatment.
GripTract is indicated for use in the large intestine with any standard endoscope that has a distal tip outer diameter of 11.5 - 12.0 mm and working length of 168 - 170 cm.
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Image /page/6/Picture/1 description: The image is an abstract design featuring a combination of geometric and organic elements. The background is a gradient of orange hues, transitioning from a solid, darker shade on the left to a lighter, patterned area on the right. The pattern consists of alternating squares in two different shades of orange, creating a checkerboard effect. A wavy line in a similar orange shade meanders across the patterned area, adding a fluid, organic contrast to the geometric shapes.
K231254 Page 3 of 11
Technological Characteristics
The table below provides a comparison of the technological characteristics of the two devices. Many items, including intended use, user population, and anatomical area of use are identical. Key differences include method of manipulating tissue, method of attaching controls to endoscope, and materials of construction; none of which raise different questions of safety and efficacy as compared to the Predicate Device.
| Category | PredicateDiLumen | ProposedGripTract | Comparison |
|---|---|---|---|
| Intended / Indicationsfor use | The LumendiDiLumen is anaccessory to anendoscope. TheDiLumen dualballoon accessoryis intended foruse with anystandardendoscope thathas a distal tipouter diameter of12.5 - 14.3 mm.The device isindicated toensure completepositioning of anendoscope duringnavigation in thelarge intestine,while assistingwith opticalvisualization,diagnosis, tissuemanipulation, andendoscopictreatment. | GripTract is anaccessoryintended to assistin positioning thedistal end of anendoscope fromthe mucosalsurface and assistwith opticalvisualization,diagnosis, andendoscopictreatment. Thedevice isindicated for usein the largeintestine with anystandardendoscope thathas a distal tipouter diameter of11.5 - 12.0 mmand a workinglength of 168-170cm. | Same - intendeduse is the same.Indications differonly by thespecificendoscopedimensions.GripTract isdesigned forsmaller diameterendoscopes withthe same lengthas one specificmodel of thePredicate. |
| Category | PredicateDiLumen | ProposedGripTract | Comparison |
| CompatibleEndoscope OD | Standardendoscope withdiameter 12.5-14.3 mm | Standardendoscope withdiameter 11.5-12.0 mm | Different -GripTractdesigned forendoscopes withsmaller OD. |
| Working Length | 168 cm (differentmodels fordifferent lengthendoscopes) | 168-170 cm | Same |
| Sterility | DiLumen is anon-sterile devicethat does notrequire cleaningor sterilizationprior to use. | GripTract is anon-sterile devicethat does notrequire cleaningor sterilizationprior to use. | Same |
| Single Use/reusable | Single Use | Single Use | Same |
| Shelf Life | 24 months | 24 months | Same |
| Distal End AttachmentMethod | Close-fittingsleeve fitssecurely over thedistal end of theendoscope. | Low durometerEnd Cap fitssecurely onto thedistal end of theendoscope. | Same |
| Proximal ControlAttachment Method | Endoscope isplaced throughthe Device Lockthen a radial knobis twisted totighten the DeviceLock securing theDiLumen controlsin the same planeas the endoscopecontrols. | O-Rings wraparoundendoscopecontrol bodysecuring theGripTract controlsin the same planeas the endoscopecontrols. | Different - bothattachmentmethods securelyhold the deviceonto theendoscope controlbody and placecontrols in thesame location. |
| Category | PredicateDiLumen | ProposedGripTract | Comparison |
| Operating Principle | DiLumen issecured to theendoscope atboth the distaland proximalends. The Usermanipulates theDiLumen controlswith the samehand as theendoscopecontrols. TheFore Balloon canbe inflated,extended, andretracted toimproveendoscopicvisualization andtreatment. | GripTract issecured to theendoscope atboth the distaland proximal end.The Usermanipulates theGripTract controlswith the samehand as theendoscopecontrols. TheFingers can berotated, extended,and retracted toimproveendoscopicvisualization andtreatment. | Same |
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Image /page/7/Picture/1 description: The image is an abstract design featuring shades of orange. The left side of the image is a solid, lighter shade of orange, while the right side transitions into a pattern of alternating darker and lighter orange squares, creating a checkerboard effect. Overlaying the checkerboard pattern are wavy lines in a lighter shade of orange, adding a dynamic element to the design.
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Image /page/8/Picture/1 description: The image is an abstract design featuring a combination of geometric shapes and wavy lines. The color palette is dominated by shades of orange, with a lighter orange used for the background and a darker orange for the shapes and lines. The geometric shapes appear to be squares or rectangles arranged in a grid-like pattern, while the wavy lines meander across the image, adding a sense of movement and fluidity to the design.
K231254
Page 5 of 11
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Image /page/9/Picture/1 description: The image is an abstract design featuring shades of orange. The background consists of a pattern of squares in alternating light and dark orange hues, creating a checkerboard effect. Overlaying this pattern are wavy lines in a lighter shade of orange, adding a dynamic element to the composition.
K231254
Page 6 of 11
| Category | PredicateDiLumen | ProposedGripTract | Comparison |
|---|---|---|---|
| Tissue Manipulation | Tissue ismanipulatedusing the Controlsto inflate anddeflate the Foreand Aft Balloons,which maintainposition of or intissue. The ForeBalloon withSuture Loops canalso be extendedand retracted toenhanceendoscopicvisualization andtreatment.Attaching tissueto the SutureLoops allowslifting andretraction oftissue. | Tissue ismanipulatedusing the Controlsto extend, retract,and rotate thecoated Fingers toenhanceendoscopicvisualization andtreatment. TheFingers can beused to directly liftand retract tissue,and to help guideworking tools. | Different - tissuemanipulation toolsare different, butboth physicallymanipulate/retracttissue as neededin order tofacilitatevisualization anddiagnosis /treatment in thegastrointestinaltract. |
| Accessories | DiLumen can beused with variousadditionalendoscopeaccessories but isnot supplied withany designatedaccessories. | GripTract can beused with variousadditionalendoscopeaccessories but isnot supplied withany designatedaccessories. | Same |
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Image /page/10/Picture/1 description: The image is an abstract design featuring a combination of geometric and organic elements. The background consists of alternating squares of two shades of orange, creating a checkerboard pattern. Overlaying this pattern are wavy lines in a lighter shade of orange, adding a sense of movement and fluidity to the composition. The overall effect is a visually engaging and modern design.
K231254
Page 7 of 11
| Category | PredicateDiLumen | ProposedGripTract | Comparison |
|---|---|---|---|
| BiocompatibilityTesting | Biocompatibilitytested per ISO10993-1:Cytoxicity,Sensitization,Irritation,Systemic Toxicity,Pyrogenicity, andEO Residuals(Note: Predicateis NOT sterile) | Biocompatibilitytested per ISO10993-1:Cytotoxicity,Sensitization,Irritation,Systemic Toxicity,andPyrogenicity(Note: Proposedis NOT sterile) | Different -additional testperformed byPredicate is notrelevant to non-sterile devices. |
| Disposal | Dispose of theDiLumen inaccordance withaccepted medicalpractice and local,state, and federalregulations for asingle usemedical devicedisposal. | Dispose of theGripTract inaccordance withaccepted medicalpractice and local,state, and federalregulations for asingle usemedical devicedisposal. | Same |
| Use Environment | Clinical surgicalsettings (e.g.,hospital,outpatient carefacility) whereendoscopicprocedures areperformed. | Clinical surgicalsettings (e.g.,hospital,outpatient carefacility) whereendoscopicprocedures areperformed. | Same |
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Image /page/11/Picture/1 description: The image is an abstract design featuring shades of orange. The left side of the image is a solid, lighter shade of orange, while the right side transitions into a pattern of alternating darker and lighter orange squares, creating a checkerboard effect. A wavy line in a lighter shade of orange runs across the checkerboard pattern, adding a dynamic element to the design.
K231254 Page 8 of 11
| Category | PredicateDiLumen | ProposedGripTract | Comparison |
|---|---|---|---|
| User Population | Medicalspecialists whohave propertraining andcompetencies inendoscopicprocedures andendoscopicequipment. | Medicalspecialists whohave propertraining andcompetencies inendoscopicprocedures andendoscopicequipment. | Same |
| Anatomic Area of Use | Natural orifice foraccess to colon. | Natural orifice foraccess to colon. | Same |
| Materials ofConstruction | Sleeve:Pellathane(polyurethane)with 2.5%GlycolubeBalloon:polyurethaneInflationTube/PushRods: Isoplast(polyurethane),Pebax (polyetherblock amide),Pellathane(polyurethane) | End Cap:polyurethane,polycarbonateSheath: PTFE(polytetrafluoroethylene)Fingers: ETFE(ethylenetetrafluoroethylene) coatedstainless steelTorque Tubes:stainless steel | Different –GripTract usesdifferentbiocompatiblepolymericmaterials and alsouses stainlesssteel to ensureeffective forcetransmission. |
Non-Clinical Performance Data
The methods and performance data for evaluating the technological differences and questions of safety and effectiveness include bench performance testing, usability testing, biocompatibility testing, and in vivo porcine testing. This testing is summarized in the table below.
Bench Performance Testing: Verification of Product Specification testing confirmed that GripTract met all product specifications and acceptance criteria in ambient, high temperature/humidity, and low temperature environmental conditions. Distribution testing conforming to ASTM D4169-
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Image /page/12/Picture/1 description: The image is an abstract design featuring a pattern of orange squares and a wavy line. The squares are arranged in a checkerboard pattern, with alternating shades of orange. The wavy line runs diagonally across the image, adding a sense of movement and dynamism to the design. The overall effect is visually appealing and modern.
K231254 Page 9 of 11
16 (FDA Recognition Number 14-499) confirmed that GripTract met all product specifications and acceptance criteria after being exposed to simulated shipping and transportation conditions. Accelerated Shelf-Life testing confirmed that GripTract met all product specifications and acceptance criteria after exposure to conditions simulating a shelf-life of two years. Reliability testing confirmed that GripTract met all product specifications and acceptance criteria following worst-case simulated use. Bench Safety testing confirmed that GripTract is sufficiently safe during benchtop evaluations that approximate worst-case scenarios and interactions that may occur between biological tissue and the GripTract Fingers. A comparison of the endoscope viewing area between GripTract and the Reference Device confirmed that GripTract does not block visualization relative to a standard distal end cap.
Usability Testing: GripTract was tested with two different user populations based on their interactions with the device, and the tasks and responsibilities they perform. Specifically, there is a user population for setting up the device and another for actually using the device clinically with the Patient. Human factors validation testing of both user populations and tasks confirmed GripTract can safely and effectively be set-up and used for its intended use in the expected use environment without encountering serious use errors or other problems.
Biocompatibility Testing: GripTract is categorized as a surface device contacting breached or compromised surfaces for a limited duration. Cytotoxicity, sensitization, irritation, acute systemic toxicity, and material mediated pyroqenicity testing was conducted on GripTract in its final finished form. All tests confirmed the suitability of GripTract.
Porcine Testing: Worst-case procedures completed with GripTract exhibited equivalent visual and histological mucosal damage compared to endoscope-only (control) procedures and there were no device-attributable adverse events at either acute or chronic time points. This demonstrates that GripTract is safe and effective for its intended use.
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Image /page/13/Picture/1 description: The image is a background with a pattern of orange squares and squiggly lines. The squares are arranged in a checkerboard pattern, with alternating light and dark orange squares. The squiggly lines are a lighter shade of orange and run diagonally across the squares. The background is simple and abstract, and the colors are warm and inviting.
K231254
Page 10 of 11
| Summary of non-clinical performance testing. | |||
|---|---|---|---|
| TestPerformed | Test Description | StandardsOrganizationandDesignation | Results |
| Verification ofProductSpecification | Verification of Product Specificationsafter exposure to ambient, high temp,and low temperature environmentalconditions. | NA | Pass |
| Distribution | Confirmation of Product Specificationsfollowing exposure to simulateddistribution stress and conditions. | ASTMD4169-16 | Pass |
| AcceleratedShelf Life | Confirmation of Product Specificationsfollowing exposure to acceleratedconditions simulating a shelf-life oftwo years. | NA | Pass |
| Shelf Life | Confirmation of Product Specificationsfollowing exposure to real-timeambient conditions for two years. | NA | Test is on-going |
| Reliability | Confirmation of Product Specificationsfollowing worst-case simulated use. | NA | Pass |
| Bench Safety | Assessed safety of worst-caseinteractions between biological tissueand GripTract Fingers. | NA | Pass |
| Usability(Set-Up) | A total of 15 Users assessed whetherthe intended user population cansuccessfully set up GripTract withoutserious use errors, failure to performcritical tasks, or encounteringproblems that affect the intended useand expected use environment. | NA | Pass |
| Usability(Use) | A total of 15 Users assessed whetherthe intended user population cansuccessfully use GripTract withoutserious use errors, failure to performcritical tasks, or encounteringproblems that affect the intended useand expected use environment. | NA | Pass |
| Biocompatibility | Final, finished devices tested forcytotoxicity, sensitization, irritation,acute systemic toxicity, and materialmediated pyrogenicity. | ISO 10993-12ISO 10993-5ISO 10993-10ISO 10993-23ISO 10993-11 | Pass |
| Porcine Testing | In vivo porcine testing GripTractagainst standard of care in worst-caseprocedure. Acute and chronic timepoints examined for differences invisual and histological mucosaldamage as well as presence ofdevice-attributable adverse events. | NA | Pass |
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Image /page/14/Picture/1 description: The image is an abstract design featuring a combination of solid and patterned areas. The left side of the image is a solid orange color, which gradually transitions into a checkered pattern of alternating light and dark orange squares. Overlaying the checkered pattern are wavy lines in a lighter shade of orange, adding a dynamic element to the design.
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Conclusions
After evaluating GripTract for its intended use, then identifying, evaluating, and mitigating the risks associated with both use and foreseeable misuse, it is concluded that GripTract is substantially equivalent to DiLumen when used as indicated to assist in positioning the distal end of an endoscope from the mucosal surface and assist with optical visualization, diagnosis, and endoscopic treatment.
§ 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.