(59 days)
No
The device description and performance studies focus on mechanical manipulation and physical properties, with no mention of AI/ML, image processing, or data analysis.
Yes.
The device is intended to assist in "endoscopic treatment," which falls under the definition of a therapeutic use.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended to "assist with optical visualization, diagnosis, and endoscopic treatment."
No
The device description clearly outlines physical components like a Handpiece, End Cap, and Fingers, which are hardware. The performance studies also focus on bench testing of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "assist in positioning the distal end of an endoscope from the mucosal surface and assist with optical visualization, diagnosis, and endoscopic treatment." This describes a tool used during an endoscopic procedure to manipulate tissue and improve visualization, not a device used to perform tests on samples taken from the body.
- Device Description: The description details a mechanical accessory that attaches to an endoscope and has fingers to manipulate tissue. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), performing tests, generating diagnostic results based on sample analysis, or any of the typical characteristics of an IVD.
- Focus on Mechanical Function: The performance studies described focus on the mechanical performance, reliability, and biocompatibility of the device in a clinical setting, not on the accuracy or performance of a diagnostic test.
In summary, the GripTract-GI Endoscopic Tissue Manipulator is a surgical accessory used to facilitate endoscopic procedures, not a device that performs in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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 Distal Tip Outer Diameter (mm) | Endoscope Working Length (cm) | GripTract 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 |
Product codes
FDF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
large intestine
Natural orifice for access to colon.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical specialists who have proper training and competencies in endoscopic procedures and endoscopic equipment.
Clinical surgical settings (e.g., hospital, outpatient care facility) where endoscopic procedures are performed.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Performance Testing: Verification of Product Specification testing confirmed that GripTract Lower GI Models met all product specifications and acceptance criteria in 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.
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.
| Test Performed | Test Description | Results |
|---|---|---|
| Verification of Product Specification | Verification of Product Specifications after exposure to ambient, high temperature, and low temperature environmental conditions. | Pass |
| Reliability | Confirmation of Product Specifications following exposure to worst-case simulated use. | Pass |
| Bench Safety | Assessed safety of worst-case interactions between biological tissue and GripTract Lower GI Model Fingers. | Pass |
| Torsional Fatigue Strength | Confirmation of Products Specifications following exposure to repeated worst-case torsional load. | Pass |
| Torque Comparison | Comparison of the force transmitted to the Finger by different GripTract Lower GI Models. | Equivalent force transmission |
| End Cap Force Comparison | Comparison of the force required to remove the End Caps of different GripTract Lower GI Models. | Removal forces exceed reported maximum pull forces in colonoscopies |
| Accelerated Shelf Life | Confirmation of Product Specifications following exposure to accelerated conditions simulating a shelf life of two years. | Pass |
| Shelf Life | Confirmation of Product Specifications following exposure to real-time ambient conditions for two years. | Test is on-going |
| Biocompatibility | Final, finished devices tested in accordance with ISO 10993-1. Testing included cytotoxicity, sensitization, irritation, systemic toxicity, and pyrogenicity. | Pass |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.
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.
1
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
2
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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
GripTract-Gl Endoscopic Tissue Manipulator Lower Gl Models
Indications for Use (Describe)
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 |
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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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™ Endoscopic | |
| Tissue Manipulator | ||
| (Model GT-101) | Actuated Medical, Inc. |
Image /page/4/Picture/17 description: The image is an abstract design featuring shades of orange. The background consists of a pattern resembling a staircase or a series of steps, with alternating lighter and darker orange squares. A wavy line, also in a shade of orange, meanders across the patterned background, adding a dynamic element to the composition.
5
Image /page/5/Picture/1 description: The image is an abstract design featuring a combination of solid and patterned areas in shades of orange. The left side of the image is a solid, uniform orange color, while the right side transitions into a pattern of alternating lighter and darker orange squares, creating a checkerboard effect. A wavy line pattern overlays the checkerboard area, adding a dynamic element to the design.
K242325 Page 2 of 8
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.
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:
| Endoscope
Distal Tip Outer Diameter (mm) | Endoscope
Working Length (cm) | GripTract
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 |
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 Model | |||||
| GT-101 | GripTract | |||||
| Lower GI Models | Comparison | |||||
| Indications | ||||||
| for Use | The GripTract-GI 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. | 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: | ||||||
| Distal Tip | ||||||
| Outer | ||||||
| Diameter | ||||||
| (mm) | ||||||
| 12.8 – 13.3 | ||||||
| 12.8 – 13.3 | ||||||
| 11.5 – 12.0 | ||||||
| 11.5 – 12.0 | Working | |||||
| Length | ||||||
| (cm) | ||||||
| 168 – 170 | ||||||
| 130 – 133 | ||||||
| 168 – 170 | ||||||
| 130 – 133 | Model # | |||||
| GT-CL170 | ||||||
| GT-CL130 | ||||||
| GT-CM170 | ||||||
| GT-CM130 | Different – | |||||
| intended use is | ||||||
| the same. | ||||||
| GripTract Lower | ||||||
| GI Models are | ||||||
| designed for | ||||||
| endoscopes with | ||||||
| the same or | ||||||
| larger diameter | ||||||
| and the same or | ||||||
| shorter length | ||||||
| than the | ||||||
| Predicate Model. | ||||||
| The Indications | ||||||
| for Use differ only | ||||||
| by the specific | ||||||
| endoscope | ||||||
| dimensions. | ||||||
| Compatible | ||||||
| Endoscope | ||||||
| OD and | ||||||
| Working | ||||||
| Lengths | GT-101: | |||||
| OD: 11.5 – 12.0 mm | ||||||
| Length: 168 – 170 cm | GT-CL170: | |||||
| OD: 12.8 – 13.3 mm | ||||||
| Length: 168 – 170 cm |
GT-CL130:
OD: 12.8 – 13.3 mm
Length: 130 – 133 cm
GT-CM170:
OD: 11.5 – 12.0 mm
Length: 168 – 170 cm
GT-CM130
OD: 11.5 – 12.0 mm
Length: 130 – 133 cm | | | Different –
Predicate Device
and Model GT-
CM170 have
identical
endoscope
compatibility.
Additional Lower
GI Models are
compatible with
an expanded
range of
endoscopes. | |
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| Comparison of Predicate and GripTract Lower GI Models | ||||
|---|---|---|---|---|
| Category | Predicate GripTract Model | |||
| GT-101 | GripTract | |||
| Lower GI Models | Comparison | |||
| Finger | ||||
| Design | Stainless steel Fingers with | |||
| electrically insulative ETFE | ||||
| (ethylene tetrafluoroethylene) | ||||
| coating. | Stainless steel Fingers with | |||
| electrically insulative ETFE | ||||
| (ethylene tetrafluoroethylene) | ||||
| coating. | Different - | |||
| smaller diameter | ||||
| stainless steel | ||||
| rod for Fingers | ||||
| permit a smaller | ||||
| overall diameter | ||||
| for the End Cap. | ||||
| End Cap | ||||
| Diameter | GT-101: | |||
| 22.0 mm (0.865 in) OD | ||||
| 9.83 mm (0.387 in) ID | GT-CM130 & CM170: | |||
| 19.65 mm (0.772 in) OD | ||||
| 10.59 mm (0.417 in) ID | ||||
| GT-CL130 & CL170: | ||||
| 21.25 mm (0.835 in) OD | ||||
| 12.19 mm (0.480 in) ID | Different - | |||
| All GripTract | ||||
| Lower GI Models | ||||
| have smaller End | ||||
| Cap diameters | ||||
| than the | ||||
| Predicate. | ||||
| Torque Tube | ||||
| Design | Uniform flexibility along entire | |||
| length of device. | Distal 20 cm (8 in) of GripTract | |||
| Lower GI Models is more | ||||
| flexible. The remaining | ||||
| proximal length is identical to | ||||
| Predicate Device. | Different - Distal | |||
| 8 inches of | ||||
| GripTract Lower | ||||
| GI Models utilize | ||||
| different design | ||||
| and materials to | ||||
| allow greater | ||||
| flexibility in the | ||||
| region of the | ||||
| endoscope's | ||||
| bending section. | ||||
| Sheath | extruded | |||
| Polytetrafluoroethylene | ||||
| (PTFE) | expanded | |||
| Polytetrafluoroethylene | ||||
| (ePTFE) | Different - | |||
| GripTract Lower | ||||
| GI Models use | ||||
| expanded PTFE | ||||
| with slightly | ||||
| different ID and | ||||
| OD. In addition, | ||||
| the GripTract | ||||
| Lower GI Models | ||||
| CM130 and | ||||
| CL130 are | ||||
| shorter in length | ||||
| to accommodate | ||||
| shorter | ||||
| endoscopes. | ||||
| Comparison of Predicate and GripTract Lower GI Models | ||||
| Category | Predicate GripTract Model | |||
| GT-101 | GripTract | |||
| Lower GI Models | Comparison | |||
| Materials of | ||||
| Construction | End Cap: polyurethane, | |||
| polycarbonate | ||||
| Sheath: PTFE | ||||
| (polytetrafluoroethylene) | ||||
| Fingers: ETFE (ethylene | ||||
| tetrafluoroethylene) coated | ||||
| stainless steel | ||||
| Torque Tubes: stainless steel | ||||
| O-Rings: Viton | End Cap: polyurethane, | |||
| polycarbonate | ||||
| Sheath: ePTFE (expanded | ||||
| polytetrafluoroethylene) | ||||
| Fingers: ETFE (ethylene | ||||
| tetrafluoroethylene) coated | ||||
| stainless steel | ||||
| Torque Tubes: stainless steel | ||||
| O-Rings: Buna-N | ||||
| Shrink Tubing: PVDF | ||||
| (polyvinylidene fluoride) | Different - | |||
| GripTract Lower | ||||
| GI Models use | ||||
| different | ||||
| polymeric | ||||
| materials for the | ||||
| Sheath, O-Rings, | ||||
| and distal Torque | ||||
| Tube assemblies. | ||||
| Tissue | ||||
| Manipulation | ||||
| with Control | ||||
| Knobs | Tissue is manipulated using | |||
| the Control Knobs 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. Each Control Knob has a | ||||
| colored indicator that matches | ||||
| the color (blue or gray) of the | ||||
| Finger that the Control Knob | ||||
| manipulates and is printed with | ||||
| an arrow to help identify which | ||||
| direction that Finger's tip is | ||||
| facing. | Tissue is manipulated using | |||
| the Control Knobs 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. Each Control Knob has a | ||||
| colored indicator that matches | ||||
| the color (blue or gray) of the | ||||
| Finger that the Control Knob | ||||
| manipulates. | Different - | |||
| Identical in every | ||||
| respect except | ||||
| that the printed | ||||
| arrow on each | ||||
| Control Knob's | ||||
| colored indicator | ||||
| has been | ||||
| removed in the | ||||
| GripTract Lower | ||||
| GI Models. | ||||
| Biocompati- | ||||
| bility Testing | Biocompatibility tested per ISO | |||
| 10993-1: | ||||
| · Cytotoxicity | ||||
| · Sensitization | ||||
| • Irritation | ||||
| · Systemic Toxicity | ||||
| · Pyrogenicity | Biocompatibility tested per ISO | |||
| 10993-1: | ||||
| · Cytotoxicity | ||||
| · Sensitization | ||||
| • Irritation | ||||
| · Systemic Toxicity | ||||
| · Pyrogenicity | Same | |||
| Distal End | ||||
| Attachment | ||||
| Method | Low durometer End Cap fits | |||
| securely onto the distal end of | ||||
| the endoscope. | Low durometer End Cap fits | |||
| securely onto the distal end of | ||||
| the endoscope. | Same | |||
| Sterility | Non-sterile device that does | |||
| not require cleaning or | ||||
| sterilization prior to use. | Non-sterile device that does | |||
| not require cleaning or | ||||
| sterilization prior to use. | Same | |||
| Comparison of Predicate and GripTract Lower GI Models | ||||
| Category | Predicate GripTract Model | |||
| GT-101 | GripTract | |||
| Lower GI Models | Comparison | |||
| Single - | ||||
| Use/reusable | Single-Use | Single-Use | Same | |
| Shelf Life | 24 months | 24 months | Same | |
| Operating | ||||
| Principle | 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. | 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 | |||
| Accessories | GripTract 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 | |||
| Disposal | Dispose of the GripTract in | |||
| accordance with accepted | ||||
| medical practice and local, | ||||
| state, and federal regulations | ||||
| for single-use medical device | ||||
| disposal. | Dispose of the GripTract in | |||
| accordance with accepted | ||||
| medical practice and local, | ||||
| state, and federal regulations | ||||
| for 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 | |||
| 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 |
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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 Product | |||||
| Specification | Verification of Product Specifications after | ||||
| exposure to ambient, high temperature, and low | |||||
| temperature environmental conditions. | Pass | ||||
| Reliability | Confirmation of Product Specifications following | ||||
| exposure to worst-case simulated use. | Pass | ||||
| Bench Safety | Assessed safety of worst-case interactions | ||||
| between biological tissue and GripTract Lower GI | |||||
| Model Fingers. | Pass | ||||
| Torsional Fatigue | |||||
| Strength | Confirmation of Products Specifications following | ||||
| exposure to repeated worst-case torsional load. | Pass | ||||
| Torque Comparison | Comparison of the force transmitted to the Finger | ||||
| by different GripTract Lower GI Models. | Equivalent force | ||||
| transmission | |||||
| End Cap Force | |||||
| Comparison | Comparison of the force required to remove the | ||||
| End Caps of different GripTract Lower GI Models. | Removal forces | ||||
| exceed reported | |||||
| maximum pull forces | |||||
| in colonoscopies | |||||
| Accelerated Shelf Life | Confirmation of Product Specifications following | ||||
| exposure to accelerated conditions simulating a | |||||
| shelf life of two years. | Pass | ||||
| Shelf Life | Confirmation of Product Specifications following | ||||
| exposure to real-time ambient conditions for two | |||||
| years. | Test is on-going | ||||
| Biocompatibility | Final, finished devices tested in accordance with | ||||
| ISO 10993-1. Testing included cytotoxicity, | |||||
| sensitization, irritation, systemic toxicity, and | |||||
| pyrogenicity. | 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.