The GripTract-GI Endoscopic Tissue Manipulator (GripTract) Lower GI Models are accessories 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 Lower GI Models are indicated for use in the large intestine with any standard endoscope as follows:

Endoscope	Endoscope	GripTract
Distal Tip Outer Diameter (mm)	Working Length (cm)	Model #
12.8 - 13.3	168 - 170	GT-CL170
12.8 - 13.3	130 - 133	GT-CL130
11.5 - 12.0	168 - 170	GT-CM170
11.5 - 12.0	130 - 133	GT-CM130

Device Description

The GripTract-GI™ Endoscopic Tissue Manipulator (GripTract) Lower GI Models are disposable, non-sterile accessories intended to assist in positioning the distal end of an endoscope from the mucosal surface and assist with optical visualization, diagnosis, and endoscopic treatment. There are four (4) different GripTract Lower GI Models (GT-CL170, GT-CL130, GT-CM170, and GT-CM130) which are indicated for use in the large intestine with standard endoscopes that have specific tip outer diameters and working lengths.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided document, addressing each of your points:

Important Note: The provided document is a 510(k) summary for a medical device (GripTract-GI Endoscopic Tissue Manipulator Lower GI Models). This type of document focuses on demonstrating substantial equivalence to an existing predicate device rather than proving clinical efficacy or diagnostic accuracy for an AI/software device. Therefore, many of your questions, particularly those related to AI-specific studies (MRMC, standalone AI performance, ground truth establishment for training AI, etc.), are not applicable to this device and information. The device described is not an AI/software device.

The document primarily details non-clinical performance data to support the substantial equivalence claim.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal table of acceptance criteria with numerical performance targets against which the device was measured like typical AI/diagnostic studies. Instead, it lists various non-clinical tests performed and states whether the device "passed" or exhibited "equivalent force transmission" or "exceeded reported maximum pull forces."

Here's a summary derived from the "Summary of non-clinical performance testing" table and the subsequent paragraphs:

Test Performed	Acceptance Criteria (Implied)	Reported Device Performance
Verification of Product Specification	Device meets all product specifications after exposure to ambient, high temperature, and low temperature conditions.	Pass
Reliability	Device meets all product specifications following exposure to worst-case simulated use.	Pass
Bench Safety	Device is sufficiently safe during benchtop evaluations approximating worst-case scenarios and interactions with biological tissue.	Pass
Torsional Fatigue Strength	Device meets all product specifications following repeated worst-case torsional load.	Pass
Torque Comparison	Force transmitted to the Finger by different models is equivalent.	Equivalent force transmission
End Cap Force Comparison	Force required to remove End Caps exceeds reported maximum pull forces in colonoscopies.	Removal forces exceed reported maximum pull forces in colonoscopies
Accelerated Shelf Life	Device meets all product specifications after exposure to conditions simulating a two-year shelf life.	Pass
Shelf Life	Device meets all product specifications after exposure to real-time ambient conditions for two years.	Test is on-going
Biocompatibility	Device passes tests for cytotoxicity, sensitization, irritation, systemic toxicity, and pyrogenicity per ISO 10993-1.	Pass
Endoscope Viewing Area Comparison	The device does not block endoscope visualization.	Confirmed that GripTract Lower GI Models do not block visualization.

2. Sample Size Used for the Test Set and Data Provenance

As this is a physical medical device (endoscopic tissue manipulator) and not an AI/software, the concept of a "test set" in the context of diagnostic data doesn't apply directly.

Sample Size: The document does not specify particular "sample sizes" for the non-clinical tests in terms of number of devices tested. It refers to "worst-case simulated use," "repeated worst-case torsional load," and testing "at the dimensional extremes of the product line" for Torque Comparison. For Biocompatibility, it states "Final, finished devices tested."
Data Provenance: Not applicable in the context of retrospective/prospective patient data or country of origin for such data. The data provenance is from bench performance testing conducted by the manufacturer, Actuated Medical, Inc.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. "Ground truth" in the context of expert consensus on medical images or diagnostic outcomes is not relevant for this device's non-clinical performance testing. The "ground truth" for these tests would be the measured physical properties and performance characteristics against established engineering specifications and regulations.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies among expert readers in diagnostic AI studies. This is a non-clinical, bench testing document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance

Not applicable. This device is a physical medical instrument, not an AI or software that assists human readers in diagnostic interpretation. An MRMC study would not be performed for this type of device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithm or software. It is a physical device operated by a clinician.

7. The Type of Ground Truth Used

For the non-clinical performance tests, the "ground truth" is defined by:

Engineering specifications and design requirements.
Industry standards (e.g., ISO 10993-1 for biocompatibility).
Quantitative measurements derived from bench testing (e.g., force measurements, dimensional checks, fatigue cycles).
Simulated worst-case scenarios and interactions.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no training set of data in that sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no AI training set, there's no ground truth establishment process for it.

Summary

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October 4, 2024

Actuated Medical, Inc. Douglas Dillon Director, Quality Assurance and Regulatory Affairs 320 Rolling Ridge Drive Bellefonte, Pennsylvania 16823

Re: K242325

Trade/Device Name: GripTract-GI Endoscopic Tissue Manipulator Lower GI Models Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FDF Dated: August 2, 2024 Received: August 6, 2024

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.

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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" (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 QS 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 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-regulatory

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assistance/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,

Sivakami Venkatachalam -S

for

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

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K242325

Device Name

GripTract-Gl Endoscopic Tissue Manipulator Lower Gl Models

Indications for Use (Describe)

GripTract Lower GI Models are indicated for use in the large intestine with any standard endoscope as follows:

Endoscope	Endoscope	GripTract
Distal Tip Outer Diameter (mm)	Working Length (cm)	Model #
12.8 - 13.3	168 - 170	GT-CL170
12.8 - 13.3	130 - 133	GT-CL130
11.5 - 12.0	168 - 170	GT-CM170
11.5 - 12.0	130 - 133	GT-CM130

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

er-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/4/Picture/1 description: The image shows the logo for Actuated Medical. The logo has the word "ACTUATED" in gray and "MEDICAL" in orange. Below the logo is the text "Innovative motion + Positive outcomes" in gray.

320 Rolling Ridge Drive Bellefonte, PA 16823 + p 814-355-0003 +f 814-355-1532 ActuatedMedical.com

Certified ...

- ISO 13485:2016
- Medical Device Single Audit Program (MDSAP)
- Women's Business Enterprise (WBE)
- Women-Owned Small Business (WOSB)

K242325 510(k) SUMMARY

Applicant Information

Date Prepared:	October 1, 2024
----------------	-----------------

Name and Address: Actuated Medical, Inc. 320 Rolling Ridge Drive Bellefonte, PA 16823 p: (814) 355-0003 f: (814) 355-1523

Contact Person: Douglas R. Dillon Director, Quality Assurance and Regulatory Affairs p: (814) 355-0003 x107 f: (814) 355-1523 Email: Douglas.Dillon@actuatedmedical.com

Device Information

Trade Name	GripTract-GI™ Endoscopic Tissue Manipulator Lower G
	Models
Common Name:	GripTract-GI™ Endoscopic Tissue Manipulator Lower G
	Models
Classification:	21 CFR §876.1500
Classification Name:	Endoscope and accessories
Product Code:	FDF

Predicate Device

510(k) Number	Trade Name	Submitter
K231254	GripTract-GI™ EndoscopicTissue Manipulator(Model GT-101)	Actuated Medical, Inc.

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K242325 Page 2 of 8

Device Description

Indications for Use

The GripTract-Gl Endoscopic Tissue Manipulator (GripTract) Lower Gl Models are accessories 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 Lower GI Models are indicated for use in the large intestine with any standard endoscope as follows:

EndoscopeDistal Tip Outer Diameter (mm)	EndoscopeWorking Length (cm)	GripTractModel #
12.8 – 13.3	168 – 170	GT-CL170
12.8 – 13.3	130 – 133	GT-CL130
11.5 – 12.0	168 – 170	GT-CM170
11.5 – 12.0	130 – 133	GT-CM130

Technological Characteristics

The GripTract Lower GI Models and Predicate Device have the same intended use, user population, and anatomical area of use as well as nearly identical designs. The GripTract Lower GI Models do have different technological characteristics including dimensional changes, torque tube design changes, and differences in materials of construction. The table below provides a comparison of the technological characteristics of the Predicate Device and GripTract Lower GI Models:

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Comparison of Predicate and GripTract Lower GI Models
Category	Predicate GripTract ModelGT-101	GripTractLower GI Models			Comparison
Indicationsfor Use	The GripTract-GI EndoscopicTissue Manipulator (GripTract)is an accessory intended toassist in positioning the distalend of an endoscope from themucosal surface and assistwith optical visualization,diagnosis, and endoscopictreatment.GripTract is indicated for use inthe large intestine with anystandard endoscope that has adistal tip outer diameter of 11.5– 12.0 mm and working lengthof 168 – 170 cm.	The GripTract-GI EndoscopicTissue Manipulator (GripTract)Lower GI Models areaccessories intended to assistin positioning the distal end ofan endoscope from themucosal surface and assistwith optical visualization,diagnosis, and endoscopictreatment.GripTract Lower GI Models areindicated for use in the largeintestine with any standardendoscope as follows:	Distal TipOuterDiameter(mm)12.8 – 13.312.8 – 13.311.5 – 12.011.5 – 12.0	WorkingLength(cm)168 – 170130 – 133168 – 170130 – 133	Model #GT-CL170GT-CL130GT-CM170GT-CM130	Different –intended use isthe same.GripTract LowerGI Models aredesigned forendoscopes withthe same orlarger diameterand the same orshorter lengththan thePredicate Model.The Indicationsfor Use differ onlyby the specificendoscopedimensions.
CompatibleEndoscopeOD andWorkingLengths	GT-101:OD: 11.5 – 12.0 mmLength: 168 – 170 cm	GT-CL170:OD: 12.8 – 13.3 mmLength: 168 – 170 cmGT-CL130:OD: 12.8 – 13.3 mmLength: 130 – 133 cmGT-CM170:OD: 11.5 – 12.0 mmLength: 168 – 170 cmGT-CM130OD: 11.5 – 12.0 mmLength: 130 – 133 cm			Different –Predicate Deviceand Model GT-CM170 haveidenticalendoscopecompatibility.Additional LowerGI Models arecompatible withan expandedrange ofendoscopes.

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Comparison of Predicate and GripTract Lower GI Models
Category	Predicate GripTract ModelGT-101	GripTractLower GI Models	Comparison
FingerDesign	Stainless steel Fingers withelectrically insulative ETFE(ethylene tetrafluoroethylene)coating.	Stainless steel Fingers withelectrically insulative ETFE(ethylene tetrafluoroethylene)coating.	Different -smaller diameterstainless steelrod for Fingerspermit a smalleroverall diameterfor the End Cap.
End CapDiameter	GT-101:22.0 mm (0.865 in) OD9.83 mm (0.387 in) ID	GT-CM130 & CM170:19.65 mm (0.772 in) OD10.59 mm (0.417 in) IDGT-CL130 & CL170:21.25 mm (0.835 in) OD12.19 mm (0.480 in) ID	Different -All GripTractLower GI Modelshave smaller EndCap diametersthan thePredicate.
Torque TubeDesign	Uniform flexibility along entirelength of device.	Distal 20 cm (8 in) of GripTractLower GI Models is moreflexible. The remainingproximal length is identical toPredicate Device.	Different - Distal8 inches ofGripTract LowerGI Models utilizedifferent designand materials toallow greaterflexibility in theregion of theendoscope'sbending section.
Sheath	extrudedPolytetrafluoroethylene(PTFE)	expandedPolytetrafluoroethylene(ePTFE)	Different -GripTract LowerGI Models useexpanded PTFEwith slightlydifferent ID andOD. In addition,the GripTractLower GI ModelsCM130 andCL130 areshorter in lengthto accommodateshorterendoscopes.
Comparison of Predicate and GripTract Lower GI Models
Category	Predicate GripTract ModelGT-101	GripTractLower GI Models	Comparison
Materials ofConstruction	End Cap: polyurethane,polycarbonateSheath: PTFE(polytetrafluoroethylene)Fingers: ETFE (ethylenetetrafluoroethylene) coatedstainless steelTorque Tubes: stainless steelO-Rings: Viton	End Cap: polyurethane,polycarbonateSheath: ePTFE (expandedpolytetrafluoroethylene)Fingers: ETFE (ethylenetetrafluoroethylene) coatedstainless steelTorque Tubes: stainless steelO-Rings: Buna-NShrink Tubing: PVDF(polyvinylidene fluoride)	Different -GripTract LowerGI Models usedifferentpolymericmaterials for theSheath, O-Rings,and distal TorqueTube assemblies.
TissueManipulationwith ControlKnobs	Tissue is manipulated usingthe Control Knobs to extend,retract, and rotate the coatedFingers to enhance endoscopicvisualization and treatment.The Fingers can be used todirectly lift and retract tissue,and to help guide workingtools. Each Control Knob has acolored indicator that matchesthe color (blue or gray) of theFinger that the Control Knobmanipulates and is printed withan arrow to help identify whichdirection that Finger's tip isfacing.	Tissue is manipulated usingthe Control Knobs to extend,retract, and rotate the coatedFingers to enhance endoscopicvisualization and treatment.The Fingers can be used todirectly lift and retract tissue,and to help guide workingtools. Each Control Knob has acolored indicator that matchesthe color (blue or gray) of theFinger that the Control Knobmanipulates.	Different -Identical in everyrespect exceptthat the printedarrow on eachControl Knob'scolored indicatorhas beenremoved in theGripTract LowerGI Models.
Biocompati-bility Testing	Biocompatibility tested per ISO10993-1:· Cytotoxicity· Sensitization• Irritation· Systemic Toxicity· Pyrogenicity	Biocompatibility tested per ISO10993-1:· Cytotoxicity· Sensitization• Irritation· Systemic Toxicity· Pyrogenicity	Same
Distal EndAttachmentMethod	Low durometer End Cap fitssecurely onto the distal end ofthe endoscope.	Low durometer End Cap fitssecurely onto the distal end ofthe endoscope.	Same
Sterility	Non-sterile device that doesnot require cleaning orsterilization prior to use.	Non-sterile device that doesnot require cleaning orsterilization prior to use.	Same
Comparison of Predicate and GripTract Lower GI Models
Category	Predicate GripTract ModelGT-101	GripTractLower GI Models	Comparison
Single -Use/reusable	Single-Use	Single-Use	Same
Shelf Life	24 months	24 months	Same
OperatingPrinciple	GripTract is secured to theendoscope at both the distaland proximal end. The Usermanipulates the GripTractcontrols with the same hand asthe endoscope controls. TheFingers can be rotated,extended, and retracted toimprove endoscopicvisualization and treatment.	GripTract is secured to theendoscope at both the distaland proximal end. The Usermanipulates the GripTractcontrols with the same hand asthe endoscope controls. TheFingers can be rotated,extended, and retracted toimprove endoscopicvisualization and treatment.	Same
Accessories	GripTract can be used withvarious additional endoscopeaccessories but is not suppliedwith any designatedaccessories.	GripTract can be used withvarious additional endoscopeaccessories but is not suppliedwith any designatedaccessories.	Same
Disposal	Dispose of the GripTract inaccordance with acceptedmedical practice and local,state, and federal regulationsfor single-use medical devicedisposal.	Dispose of the GripTract inaccordance with acceptedmedical practice and local,state, and federal regulationsfor single-use medical devicedisposal.	Same
UseEnvironment	Clinical surgical settings (e.g.,hospital, outpatient carefacility) where endoscopicprocedures are performed.	Clinical surgical settings (e.g.,hospital, outpatient carefacility) where endoscopicprocedures are performed.	Same
UserPopulation	Medical specialists who haveproper training andcompetencies in endoscopicprocedures and endoscopicequipment.	Medical specialists who haveproper training andcompetencies in endoscopicprocedures and endoscopicequipment.	Same
AnatomicArea of Use	Natural orifice for access tocolon.	Natural orifice for access tocolon.	Same

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Non-Clinical Performance Data

The methods and performance data for evaluating the technological differences and questions of safety and effectiveness include bench performance testing and biocompatibility testing. This testing is summarized in the table below.

Summary of non-clinical performance testing.
Test Performed	Test Description	Results
Verification of ProductSpecification	Verification of Product Specifications afterexposure to ambient, high temperature, and lowtemperature environmental conditions.	Pass
Reliability	Confirmation of Product Specifications followingexposure to worst-case simulated use.	Pass
Bench Safety	Assessed safety of worst-case interactionsbetween biological tissue and GripTract Lower GIModel Fingers.	Pass
Torsional FatigueStrength	Confirmation of Products Specifications followingexposure to repeated worst-case torsional load.	Pass
Torque Comparison	Comparison of the force transmitted to the Fingerby different GripTract Lower GI Models.	Equivalent forcetransmission
End Cap ForceComparison	Comparison of the force required to remove theEnd Caps of different GripTract Lower GI Models.	Removal forcesexceed reportedmaximum pull forcesin colonoscopies
Accelerated Shelf Life	Confirmation of Product Specifications followingexposure to accelerated conditions simulating ashelf life of two years.	Pass
Shelf Life	Confirmation of Product Specifications followingexposure to real-time ambient conditions for twoyears.	Test is on-going
Biocompatibility	Final, finished devices tested in accordance withISO 10993-1. Testing included cytotoxicity,sensitization, irritation, systemic toxicity, andpyrogenicity.	Pass

Bench Performance Testing: Verification of Product Specification testing confirmed that GripTract Lower GI Models met all product specifications and acceptance criteria in

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K242325 Page 8 of 8

ambient, high temperature/humidity, and low temperature environmental conditions. Reliability testing confirmed that they met all product specifications and acceptance criteria following worst-case simulated use. Bench Safety testing confirmed that they are sufficiently safe during benchtop evaluations that approximate worst-case scenarios and interactions that may occur between biological tissue and the GripTract Lower GI Model Fingers. Torsional Fatigue Strength testing confirmed that GripTract Lower GI Models met all product specifications and acceptance criteria following repeated worst-case torsional load. Torque Comparison testing demonstrated that the force transmission capabilities of the two GripTract Lower GI Models at the dimensional extremes of the product line are equivalent. End Cap Force Comparison testing demonstrated the forces required to remove the End Caps under worst-case conditions exceed the reported maximum pull forces in colonoscopies. Accelerated Shelf Life testing confirmed that they met all product specifications and acceptance criteria after exposure to conditions simulating a shelf life of two years. A comparison of the endoscope viewing area between the Predicate Device and GripTract Lower GI Models confirmed that the GripTract Lower GI Models do not block visualization.

Biocompatibility Testing: GripTract Lower GI Models are categorized as surface devices contacting breached or compromised surfaces for a limited duration. Cytotoxicity, sensitization, irritation, acute systemic toxicity, and material mediated pyrogenicity testing was conducted on devices in their final finished form. All tests confirmed the suitability of GripTract Lower GI Models.

Conclusions

After evaluating GripTract Lower GI Models for their intended use, then identifying, evaluating, and mitigating the risks associated with use, foreseeable misuse, and the technological differences between the Predicate Device, it is concluded that the GripTract Lower GI Models are as safe and effective as GripTract Model GT-101 when used as indicated to ensure complete positioning of an endoscope and assist with optical visualization, diagnosis, and endoscopic treatment.

Regulation Number and Section

§ 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.