(186 days)
No
The description focuses on mechanical manipulation and visualization, with no mention of AI/ML terms, image processing for analysis, or data sets for training/testing.
Yes.
The device's intended use includes assisting with "endoscopic treatment" and its device description elaborates on "tissue manipulation," supporting its classification as a therapeutic device.
Yes
The device description explicitly states that the GripTract is intended to "assist with optical visualization, diagnosis, and endoscopic treatment."
No
The device description clearly outlines physical components like a Handpiece, End Cap, Fingers, and Control Knobs, indicating it is a hardware device with mechanical manipulation capabilities.
Based on the provided information, the GripTract-Gl Endoscopic Tissue Manipulator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- GripTract's Function: The GripTract is an accessory that assists in the physical manipulation and visualization during an endoscopic procedure. It helps position the endoscope and the tissue.
- No Specimen Analysis: The device itself does not analyze any biological specimens. It facilitates the visual examination and physical interaction with tissue in situ within the body.
Therefore, the GripTract falls under the category of a surgical or endoscopic accessory, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FDF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
large intestine, 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 met all product specifications and acceptance criteria in ambient, high temperature/humidity, and low temperature environmental conditions. Distribution testing conforming to ASTM D4169-16 (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.
Summary of non-clinical performance testing.
Test Performed: Verification of Product Specification; Test Description: Verification of Product Specifications after exposure to ambient, high temp, and low temperature environmental conditions.; Standards Organization and Designation: NA; Results: Pass
Test Performed: Distribution; Test Description: Confirmation of Product Specifications following exposure to simulated distribution stress and conditions.; Standards Organization and Designation: ASTM D4169-16; Results: Pass
Test Performed: Accelerated Shelf Life; Test Description: Confirmation of Product Specifications following exposure to accelerated conditions simulating a shelf-life of two years.; Standards Organization and Designation: NA; Results: Pass
Test Performed: Shelf Life; Test Description: Confirmation of Product Specifications following exposure to real-time ambient conditions for two years.; Standards Organization and Designation: NA; Results: Test is on-going
Test Performed: Reliability; Test Description: Confirmation of Product Specifications following worst-case simulated use.; Standards Organization and Designation: NA; Results: Pass
Test Performed: Bench Safety; Test Description: Assessed safety of worst-case interactions between biological tissue and GripTract Fingers.; Standards Organization and Designation: NA; Results: Pass
Test Performed: Usability (Set-Up); Test Description: 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.; Standards Organization and Designation: NA; Results: Pass
Test Performed: Usability (Use); Test Description: 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.; Standards Organization and Designation: NA; Results: Pass
Test Performed: Biocompatibility; Test Description: Final, finished devices tested for cytotoxicity, sensitization, irritation, acute systemic toxicity, and material mediated pyrogenicity.; Standards Organization and Designation: ISO 10993-12, ISO 10993-5, ISO 10993-10, ISO 10993-23, ISO 10993-11; Results: Pass
Test Performed: Porcine Testing; Test Description: 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.; Standards Organization and Designation: NA; Results: Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
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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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K231254 510(k) SUMMARY
Applicant Information
Date Prepared: October 6, 2023
Name and Address: Actuated Medical, Inc. 320 Rolling Ridge Drive Bellefonte, PA 16823 Ph: (814) 355-0003 Fx: (814) 355-1523
Contact Person: Douglas R. Dillon Director, Quality Assurance and Regulatory Affairs Ph: (814) 355-0003 x107 Fx: (814) 355-1523 Email: Douglas.Dillon@actuatedmedical.com
Device Information
| Trade Name: | GripTract-GI™ Endoscopic Tissue Manipulator |
|---|---|
| Common Name: | GripTract-GI™ Endoscopic Tissue Manipulator |
| Classification: | 21 CFR §876.1500 |
| Classification Name: | Endoscope and accessories |
| Product Code: | FDF |
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K231254 Page 1 of 11
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| 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.
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Image /page/6/Picture/1 description: The image is an abstract design featuring a combination of geometric and organic elements. The background is a gradient of orange hues, transitioning from a solid, darker shade on the left to a lighter, patterned area on the right. The pattern consists of alternating squares in two different shades of orange, creating a checkerboard effect. A wavy line in a similar orange shade meanders across the patterned area, adding a fluid, organic contrast to the geometric shapes.
K231254 Page 3 of 11
Technological Characteristics
The table below provides a comparison of the technological characteristics of the two devices. Many items, including intended use, user population, and anatomical area of use are identical. Key differences include method of manipulating tissue, method of attaching controls to endoscope, and materials of construction; none of which raise different questions of safety and efficacy as compared to the Predicate Device.
| Category | 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 |
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Image /page/7/Picture/1 description: The image is an abstract design featuring shades of orange. The left side of the image is a solid, lighter shade of orange, while the right side transitions into a pattern of alternating darker and lighter orange squares, creating a checkerboard effect. Overlaying the checkerboard pattern are wavy lines in a lighter shade of orange, adding a dynamic element to the design.
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Image /page/8/Picture/1 description: The image is an abstract design featuring a combination of geometric shapes and wavy lines. The color palette is dominated by shades of orange, with a lighter orange used for the background and a darker orange for the shapes and lines. The geometric shapes appear to be squares or rectangles arranged in a grid-like pattern, while the wavy lines meander across the image, adding a sense of movement and fluidity to the design.
K231254
Page 5 of 11
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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 |
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Image /page/10/Picture/1 description: The image is an abstract design featuring a combination of geometric and organic elements. The background consists of alternating squares of two shades of orange, creating a checkerboard pattern. Overlaying this pattern are wavy lines in a lighter shade of orange, adding a sense of movement and fluidity to the composition. The overall effect is a visually engaging and modern design.
K231254
Page 7 of 11
| Category | 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 |
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Image /page/11/Picture/1 description: The image is an abstract design featuring shades of orange. The left side of the image is a solid, lighter shade of orange, while the right side transitions into a pattern of alternating darker and lighter orange squares, creating a checkerboard effect. A wavy line in a lighter shade of orange runs across the checkerboard pattern, adding a dynamic element to the design.
K231254 Page 8 of 11
| Category | 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-
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Image /page/12/Picture/1 description: The image is an abstract design featuring a pattern of orange squares and a wavy line. The squares are arranged in a checkerboard pattern, with alternating shades of orange. The wavy line runs diagonally across the image, adding a sense of movement and dynamism to the design. The overall effect is visually appealing and modern.
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16 (FDA Recognition Number 14-499) confirmed that GripTract met all product specifications and acceptance criteria after being exposed to simulated shipping and transportation conditions. Accelerated Shelf-Life testing confirmed that GripTract met all product specifications and acceptance criteria after exposure to conditions simulating a shelf-life of two years. Reliability testing confirmed that GripTract met all product specifications and acceptance criteria following worst-case simulated use. Bench Safety testing confirmed that GripTract is sufficiently safe during benchtop evaluations that approximate worst-case scenarios and interactions that may occur between biological tissue and the GripTract Fingers. A comparison of the endoscope viewing area between GripTract and the Reference Device confirmed that GripTract does not block visualization relative to a standard distal end cap.
Usability Testing: GripTract was tested with two different user populations based on their interactions with the device, and the tasks and responsibilities they perform. Specifically, there is a user population for setting up the device and another for actually using the device clinically with the Patient. Human factors validation testing of both user populations and tasks confirmed GripTract can safely and effectively be set-up and used for its intended use in the expected use environment without encountering serious use errors or other problems.
Biocompatibility Testing: GripTract is categorized as a surface device contacting breached or compromised surfaces for a limited duration. Cytotoxicity, sensitization, irritation, acute systemic toxicity, and material mediated pyroqenicity testing was conducted on GripTract in its final finished form. All tests confirmed the suitability of GripTract.
Porcine Testing: Worst-case procedures completed with GripTract exhibited equivalent visual and histological mucosal damage compared to endoscope-only (control) procedures and there were no device-attributable adverse events at either acute or chronic time points. This demonstrates that GripTract is safe and effective for its intended use.
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Image /page/13/Picture/1 description: The image is a background with a pattern of orange squares and squiggly lines. The squares are arranged in a checkerboard pattern, with alternating light and dark orange squares. The squiggly lines are a lighter shade of orange and run diagonally across the squares. The background is simple and abstract, and the colors are warm and inviting.
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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 |
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Image /page/14/Picture/1 description: The image is an abstract design featuring a combination of solid and patterned areas. The left side of the image is a solid orange color, which gradually transitions into a checkered pattern of alternating light and dark orange squares. Overlaying the checkered pattern are wavy lines in a lighter shade of orange, adding a dynamic element to the design.
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.