Who is the manufacturer of GripTract-GI Endoscopic Tissue Manipulator?

Actuated Medical, Inc. filed the 510(k) submission for GripTract-GI Endoscopic Tissue Manipulator (K231254).

What is the FDA product code for GripTract-GI Endoscopic Tissue Manipulator?

FDF. It is classified under 21 CFR 876.1500 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for GripTract-GI Endoscopic Tissue Manipulator?

510(k) clearance (submission type: Traditional).

What are the predicate devices for GripTract-GI Endoscopic Tissue Manipulator?

DiLumen Endolumenal Interventional Platform (K210851).

Who can help prepare an FDA 510(k) submission like GripTract-GI Endoscopic Tissue Manipulator?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

GripTract-GI Endoscopic Tissue Manipulator

K231254 · Actuated Medical, Inc. · FDF · Nov 3, 2023 · Gastroenterology, Urology

Device Facts

Record ID	K231254
Device Name	GripTract-GI Endoscopic Tissue Manipulator
Applicant	Actuated Medical, Inc.
Product Code	FDF · Gastroenterology, Urology
Decision Date	Nov 3, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1500
Device Class	Class 2

Intended 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.

Device Story

GripTract-GI is a single-use, non-sterile endoscopic accessory for large intestine procedures. It consists of a handpiece attaching to the endoscope control body and a distal end cap with two integrated fingers. The physician operates two control knobs on the handpiece to rotate, extend, or retract the fingers independently of the endoscope. This allows for direct tissue lifting, retraction, and guidance of working tools to improve visualization, diagnosis, and treatment. The device is used in clinical surgical settings by trained medical specialists. It provides mechanical tissue manipulation to facilitate endoscopic tasks. Benefits include improved endoscope positioning and enhanced visualization compared to endoscope-only procedures.

Clinical Evidence

No human clinical data. Evidence includes bench performance testing (verification of specifications, distribution per ASTM D4169-16, accelerated shelf-life, reliability, and bench safety), human factors/usability testing (n=15 users for setup and use), biocompatibility testing (per ISO 10993 series), and in vivo porcine testing. Porcine study compared GripTract to endoscope-only procedures, showing equivalent visual and histological mucosal damage with no device-attributable adverse events at acute or chronic time points.

Technological Characteristics

Non-sterile, single-use accessory. Materials: polyurethane, polycarbonate (End Cap); PTFE (Sheath); ETFE-coated stainless steel (Fingers); stainless steel (Torque Tubes). Mechanical actuation via manual control knobs and torque tubes. Compatible with 11.5-12.0 mm OD endoscopes. Biocompatibility per ISO 10993-1. Distribution testing per ASTM D4169-16.

Indications for Use

Indicated for use in the large intestine to assist in positioning the distal end of an endoscope from the mucosal surface and to assist with optical visualization, diagnosis, and endoscopic treatment. Compatible with standard endoscopes having a distal tip outer diameter of 11.5-12.0 mm and a working length of 168-170 cm.

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.

Predicate Devices

DiLumen Endolumenal Interventional Platform (K210851)

Reference Devices

D-201-12704 Disposable Distal Attachment (K984358)

Related Devices

K251041 — GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100 · Actuated Medical, Inc. · Oct 31, 2025
K242325 — GripTract-GI Endoscopic Tissue Manipulator Lower GI Models · Actuated Medical, Inc. · Oct 4, 2024
K050253 — USGI SHAPELOCK ENDOSCOPIC GUIDE · Usgi Medical · Feb 28, 2005
K222354 — Elastic Traction System · Micro-Tech (Nanjing) Co., Ltd. · Oct 3, 2022
K120084 — ENDOSCOPIC RETRIEVAL DEVICE · United States Endoscopy Group, Inc. · May 30, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ 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" {1}------------------------------------------------ (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). {2}------------------------------------------------ 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 {3}------------------------------------------------ # 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) | | |--------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> □ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### 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." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Actuated Medical. The logo consists of a brown plus sign with a curved line through it, followed by the word "ACTUATED" in gray and "MEDICAL" in orange. Below the logo is the tagline "Innovative motion + Positive outcomes" in gray. 310 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) ## 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 {5}------------------------------------------------ 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 | |---------------------|------------------|----------------------------------------------------------------|---------------------------| | Predicate Device | K210851 | DiLumen Endolumenal Interventional Platform (DiLumen) | Lumendi Ltd. | | Reference Device | K984358 | D-201-12704 Disposable Distal Attachment | 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. {6}------------------------------------------------ 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 | Predicate DiLumen | Proposed GripTract | Comparison | |---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended / Indications for use | The Lumendi DiLumen is an accessory to an endoscope. The DiLumen dual balloon accessory is intended for use with any standard endoscope that has a distal tip outer diameter of 12.5 - 14.3 mm. The device is indicated to ensure complete positioning of an endoscope during navigation in the large intestine, while assisting with optical visualization, diagnosis, tissue manipulation, and endoscopic treatment. | 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. The device 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. | Same - intended use is the same. Indications differ only by the specific endoscope dimensions. GripTract is designed for smaller diameter endoscopes with the same length as one specific model of the Predicate. | | Category | Predicate DiLumen | Proposed GripTract | Comparison | | Compatible Endoscope OD | Standard endoscope with diameter 12.5- 14.3 mm | Standard endoscope with diameter 11.5- 12.0 mm | Different - GripTract designed for endoscopes with smaller OD. | | Working Length | 168 cm (different models for different length endoscopes) | 168-170 cm | Same | | Sterility | DiLumen is a non-sterile device that does not require cleaning or sterilization prior to use. | GripTract is a non-sterile device that does not require cleaning or sterilization prior to use. | Same | | Single Use/reusable | Single Use | Single Use | Same | | Shelf Life | 24 months | 24 months | Same | | Distal End Attachment Method | Close-fitting sleeve fits securely over the distal end of the endoscope. | Low durometer End Cap fits securely onto the distal end of the endoscope. | Same | | Proximal Control Attachment Method | Endoscope is placed through the Device Lock then a radial knob is twisted to tighten the Device Lock securing the DiLumen controls in the same plane as the endoscope controls. | O-Rings wrap around endoscope control body securing the GripTract controls in the same plane as the endoscope controls. | Different - both attachment methods securely hold the device onto the endoscope control body and place controls in the same location. | | Category | Predicate DiLumen | Proposed GripTract | Comparison | | Operating Principle | DiLumen is secured to the endoscope at both the distal and proximal ends. The User manipulates the DiLumen controls with the same hand as the endoscope controls. The Fore Balloon can be inflated, extended, and retracted to improve endoscopic visualization and treatment. | GripTract is secured to the endoscope at both the distal and proximal end. The User manipulates the GripTract controls with the same hand as the endoscope controls. The Fingers can be rotated, extended, and retracted to improve endoscopic visualization and treatment. | Same | {7}------------------------------------------------ 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. {8}------------------------------------------------ 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 {9}------------------------------------------------ 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 | Predicate DiLumen | Proposed GripTract | Comparison | |---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Tissue Manipulation | Tissue is manipulated using the Controls to inflate and deflate the Fore and Aft Balloons, which maintain position of or in tissue. The Fore Balloon with Suture Loops can also be extended and retracted to enhance endoscopic visualization and treatment. Attaching tissue to the Suture Loops allows lifting and retraction of tissue. | Tissue is manipulated using the Controls to extend, retract, and rotate the coated Fingers to enhance endoscopic visualization and treatment. The Fingers can be used to directly lift and retract tissue, and to help guide working tools. | Different - tissue manipulation tools are different, but both physically manipulate/retract tissue as needed in order to facilitate visualization and diagnosis / treatment in the gastrointestinal tract. | | Accessories | DiLumen can be used with various additional endoscope accessories but is not supplied with any designated accessories. | GripTract can be used with various additional endoscope accessories but is not supplied with any designated accessories. | Same | {10}------------------------------------------------ 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 | Predicate DiLumen | Proposed GripTract | Comparison | |-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------| | Biocompatibility Testing | Biocompatibility tested per ISO 10993-1: Cytoxicity, Sensitization, Irritation, Systemic Toxicity, Pyrogenicity, and EO Residuals (Note: Predicate is NOT sterile) | Biocompatibility tested per ISO 10993-1: Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, and Pyrogenicity (Note: Proposed is NOT sterile) | Different - additional test performed by Predicate is not relevant to non- sterile devices. | | Disposal | Dispose of the DiLumen in accordance with accepted medical practice and local, state, and federal regulations for a single use medical device disposal. | Dispose of the GripTract in accordance with accepted medical practice and local, state, and federal regulations for a single use medical device disposal. | Same | | Use Environment | Clinical surgical settings (e.g., hospital, outpatient care facility) where endoscopic procedures are performed. | Clinical surgical settings (e.g., hospital, outpatient care facility) where endoscopic procedures are performed. | Same | {11}------------------------------------------------ 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 | Predicate DiLumen | Proposed GripTract | Comparison | |------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | User Population | Medical specialists who have proper training and competencies in endoscopic procedures and endoscopic equipment. | Medical specialists who have proper training and competencies in endoscopic procedures and endoscopic equipment. | Same | | Anatomic Area of Use | Natural orifice for access to colon. | Natural orifice for access to colon. | Same | | Materials of Construction | Sleeve: Pellathane (polyurethane) with 2.5% Glycolube Balloon: polyurethane Inflation Tube/Push Rods: Isoplast (polyurethane), Pebax (polyether block amide), Pellathane (polyurethane) | End Cap: polyurethane, polycarbonate Sheath: PTFE (polytetrafluoroeth ylene) Fingers: ETFE (ethylene tetrafluoroethylen e) coated stainless steel Torque Tubes: stainless steel | Different – GripTract uses different biocompatible polymeric materials and also uses stainless steel to ensure effective force transmission. | # 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- {12}------------------------------------------------ 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. {13}------------------------------------------------ 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. | | | | |----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|----------------------| | Test Performed | Test Description | Standards Organization and Designation | Results | | Verification of Product Specification | Verification of Product Specifications after exposure to ambient, high temp, and low temperature environmental conditions. | NA | Pass | | Distribution | Confirmation of Product Specifications following exposure to simulated distribution stress and conditions. | ASTM D4169-16 | Pass | | Accelerated Shelf Life | Confirmation of Product Specifications following exposure to accelerated conditions simulating a shelf-life of two years. | NA | Pass | | Shelf Life | Confirmation of Product Specifications following exposure to real-time ambient conditions for two years. | NA | Test is on- going | | Reliability | Confirmation of Product Specifications following worst-case simulated use. | NA | Pass | | Bench Safety | Assessed safety of worst-case interactions between biological tissue and GripTract Fingers. | NA | Pass | | Usability (Set-Up) | A total of 15 Users assessed 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. | NA | Pass | | Usability (Use) | A total of 15 Users assessed 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. | NA | Pass | | Biocompatibility | Final, finished devices tested for cytotoxicity, sensitization, irritation, acute systemic toxicity, and material mediated pyrogenicity. | ISO 10993-12 ISO 10993-5 ISO 10993-10 ISO 10993-23 ISO 10993-11 | Pass | | Porcine Testing | In vivo porcine testing 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. | NA | Pass | {14}------------------------------------------------ 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. K231254 Page 11 of 11 # 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.