(150 days)
Not Found
Not Found
No
The device description and performance studies focus on mechanical properties and physician-assessed outcomes, with no mention of AI or ML.
Yes.
The device is used to grasp tissue to improve visualization during an Endoscopic Submucosal Dissection (ESD) procedure, which is a therapeutic intervention to remove lesions from the gastrointestinal tract. Therefore, the device aids in a therapeutic procedure.
No
The device is indicated to grasp tissue and provide improved visualization during an endoscopic submucosal dissection (ESD) procedure. It is a surgical tool used for manipulation and visualization, not for diagnosis.
No
The device description clearly outlines physical components (graspers, wire, magnet, suture, crimp) and their materials (nitinol, stainless-steel, neodymium). The performance studies focus on the mechanical and physical performance of these components in ex-vivo and in-vivo settings, not on software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Device Function: The ProdiGI Traction System is a surgical tool used inside the body (in vivo) during an endoscopic procedure. Its purpose is to physically grasp and manipulate tissue to improve visualization during the procedure. It does not analyze or test any biological samples.
- Intended Use: The intended use clearly states grasping tissue within the esophagus, stomach, and colon during an ESD procedure. This is a procedural aid, not a diagnostic test.
The information provided focuses on the mechanical function of the device, its usability during a surgical procedure, and its impact on procedural outcomes like visualization, bleeding, and perforation. This aligns with the characteristics of a surgical or procedural device, not an IVD.
N/A
Intended Use / Indications for Use
ProdiGI Traction Wire: The Medtronic ProdiGI Traction Wire is indicated to grasp tissue within the esophagus, stomach, and colon of adults during an Endoscopic Submucosal Dissection (ESD) procedure.
ProdiGI Traction Magnet: The Medtronic ProdiGI Traction Magnet is indicated to grasp tissue within the stomach and colon of adults during an Endoscopic Submucosal Dissection (ESD) procedure.
Product codes (comma separated list FDA assigned to the subject device)
OSW
Device Description
The ProdiGI Traction System includes the Traction Wire and Traction Magnet devices. The Traction Wire and Traction Magnet are not intended to be used together. Both devices are used in adults only and are used to provide improved visualization of the submucosal space during an endoscopic submucosal dissection (ESD) procedure.
Uniti Traction Wire Device
The Traction Wire consists of two graspers: a primary tissue grasper with traction wire attached (ERD-TW20 and ERD-TW35), and a secondary tissue grasper (ERD-TWSG) without a wire. The secondary tissue grasper is used to secure the distal end of the traction wire. The traction wire is a nitinol shape-memory loop (2.0 cm or 3.5 cm in length) that provides tension to the attached tissue after deployment. The nitinol wire is attached to the grasper with a stainless-steel crimp. No functional or mechanical differences are present in the 2.0 cm and 3.5 cm device lengths. Wire length size differences allow physicians to select a Traction Wire best suited for the location and size of the target treatment site.
The primary traction wire grasper has a long shaft and is designed to be inserted and passed through the working channel of an endoscope. It is compatible with endoscopes with a maximum working length of 1700 mm and working channels 2.8 mm or greater. After passing through the endoscope, the device is directed to the targeted gastrointestinal tissue by manipulation of the endoscope and grasper. Upon obtaining proper positioning, the traction wire is deployed onto the targeted tissue through the attached handle. The graspers themselves are constructed of stainless-steel.
The secondary tissue grasper (ERD-TWSG) is also designed to be inserted through the working channel of an endoscope. After passing through the endoscope, the device is used to grasp and secure the free end of the wire to the targeted gastrointestinal tissue. Upon obtaining proper positioning, the secondary grasper is deployed onto the tissue through the attached handle. An additional secondary tissue grasper (ERD-TWSG) can be used if desired to adjust secondary grasper position mid procedure. The secondary grasper has a shaft with distal end graspers controlled at the proximal handle. The graspers are constructed of stainless steel.
Once the Traction Wire is deployed and positioned, it facilitates cutting and improves visualization of the dissection plane by causing the lesion to progressively roll back on itself during dissection, as the nitinol wire bends back into its pre-shaped curved configuration. After the target lesion has been successfully excised from the treatment site, the tissue and traction device are removed from the patient.
To remove the excised lesion and graspers from the patient, the secondary grasper is removed from the tissue using endoscopic tools such as grasping forceps. Secondary graspers (those placed outside resection area) have been designed to be atraumatic allowing for removal without adding significant tissue trauma to the procedure, Traction Wire Secondary Graspers are rounded to allow for sliding over tissue.
ProdiGI Traction Magnet Device
The traction magnet (ERD-TMST and ERD-TMLG) consists of two identical tissue graspers with a permanent neodymium magnet attached to the grasper via a suture. The sutured magnet provides tension to the attached tissue after deployment. No functional or mechanical differences are present in the (TMLG) and (TMST) suture lengths. Suture length size differences allow physicians to select a traction magnet best suited for the location and size of the target treatment site.
The grasper is designed to be inserted and passed through the working channel of an endoscope. It is compatible with endoscopes with a maximum working length of 1700 mm and working channels 2.8 mm or greater. After passing through the endoscope, the device is directed to the targeted gastrointestinal tissue by manipulation of the endoscope and grasper. Upon obtaining proper positioning, the traction magnet is deployed onto the targeted tissue through the attached handle.
After passing the second grasper through the endoscope, the magnet of the second device is joined to the magnet of the first device on the lesion and positioned to the targeted gastrointestinal tissue opposite of the lesion. Upon obtaining proper positioning, the second grasper is deployed onto the tissue through the attached handle. Additional devices can be used if desired to adjust traction mid procedure.
The amount of traction provided during the procedure is controlled by inflating/deflating the organ in which the ESD procedure is being performed. The device on the opposing tissue from the lesion can be removed from the tissue with endoscopic tools such as grasping forceps.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Esophagus, stomach, and colon
Indicated Patient Age Range
Adults
Intended User / Care Setting
The traction device should only be used by a physician trained in therapeutic endoscopy, including training in submucosal dissection.
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
Usability Testing - ProdiGI Traction Wire Device
Ex-vivo porcine and bovine tissue from the esophagus, stomach and colon was used for evaluation. All clinicians participating in the study were trained in standard ESD procedures, and clinicians with varying experience were selected to conduct the usability testing. Novice physicians were those with less than 3 years and/or less than 20 ESD cases to date, moderate physicians were those with 3-5 years of experience and/or 1-2 ESD cases per month, and skilled physicians were those with greater than 5 years of experience and three or more ESD cases per month.
For the traction wire, skilled, moderate and novice physicians participated in the study. Testing was compared between procedures with and without the use of the traction device. Testing included procedures in the esophagus, in the stomach and in the colon. 104 procedures with the traction wire were done on 36 lesions and 17 procedures on 10 lesions. Visualization scores were rated on a three-point scale where 1 = unacceptable, insufficient visualization/insufficient tissue lift; 2 = acceptable, clinically sufficient to perform procedure/sufficient tissue lift; 3 = exceeds expectations, visualization is an improvement over current clinical settings/exceptional tissue lift to aid in direct visualization of procedure.
Usability Testing - ProdiGI Traction Magnet Device
For the traction magnet, two skilled, two moderate and two novice physicians participated in the study. Testing was compared between procedures with and without the use of the traction magnet device. Testing included procedures in the stomach and two in the colon. Four procedures with the traction wire were done on 3 cm lesions and three procedures on 1 cm lesions. Visualization scores were rated on a five-point scale where 1 = unacceptable, 2 = poor, 3 = clinically acceptable, 4 = good, and 5 = exceeds expectations.
Performance Testing - Animal
GLP-compliant animal studies were conducted using live porcine models to evaluate ESD procedures using the traction wire and traction magnet devices compared to standard ESD (performed without traction devices). Procedures were completed in the esophagus, stomach, and colon. The purpose of these studies was to evaluate in vivo performance of the traction wire and traction magnet, specifically with regards to assessing bleeding risk in comparison to the control treatment.
For the traction wire, the ERD-TW20 device was used as a representative model due to its size and anatomy suitability for the animal, and it is representative of the ERD-TW35. For the traction magnet both the ERD-TMLG and ERD-TMSM were used for testing. Lesions of 1 to 3 cm were created based on suitability of anatomy to perform an ESD procedure. Procedure time was counted from the time the device was first inserted in the instrument channel until all pieces were removed. Animals were then euthanized, and necropsy was performed.
8 animals were used for the traction wire testing, and 8 animals were used for the traction magnet testing. Each animal was the subject of device procedures and control procedures.
Assessment of endpoints were as follows:
- Bleeding: assessed intraoperatively via endoscopic visualization using a 6-point Likert scale (0=no bleeding, 5=clinically unacceptable bleeding).
- Perforation: visible signs assessed intraoperatively via endoscopic visualization (yes/no). Necropsy conducted for terminal procedures.
- Mucosal Laceration: visible signs assessed intraoperatively via endoscopic visualization. Necropsy conducted for terminal procedures.
- Visualization: assessed endoscopically by the physician at three time points (start, mid, end of dissection). Rated on a three-point scale (1=unacceptable, 2=acceptable, 3=exceeds expectations).
- Ease of Removal: Physicians ranked the ability to remove all devices and tissue upon completion of the procedure. Rated on a three-point scale (1=unacceptable, 2=acceptable, 3=exceeds expectations).
- Ease of Procedure: Physician feedback on satisfaction with ease of completing ESD, time taken, and observed traction. Rated on a five-point scale (1=strongly disagree, 5=strongly agree).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Studies:
Non-clinical/bench studies were conducted to demonstrate mechanical integrity and functionality.
ProdiGI Traction Wire Device:
- Tensile Test (Traction Wire): Grasper to wire tensile force above (b)(4). Crimp to wire tensile test above (b)(4).
- Tensile Test (Traction Grasper): Introducer sheath to hub bond strength greater than (b)(4) lbf. Handle and deployment mechanism bonds (Proximal handle slider to crimp, Tine puller/jaw seat to nitinol wire, Shaft to handle) met specified tensile strengths.
- Torque Test and Torque Stability and articulation: Torque to rotate device less than (b)(4) in-oz. Bonds remained intact in worst-case tortuosity. Graspers rotatable to four quadrants. Colonoscope angle change within (b)(4) degrees.
- Insertion/Removal: Force to insert 1st and 2nd graspers less than (b)(4) lbf. Removal less than (b)(4) lbf. No damage to scope channel or device components in tortuosity. No kinking/buckling.
- Grasper Detachment: Force to remove 1st grasper from tissue above (b)(4) lbf. Force to remove 2nd grasper from tissue above (b)(4) lbf. Arms of 2nd grasper did not come out of capsule. Force to remove 2nd graspers from tissue less than (b)(4) lbf.
- Grasper Cycling Test: Graspers maintained minimum opening span (b)(4) for 1st grasper and (b)(4) for 2nd grasper after 5 cycles.
- Wire lift force: Produced (b)(4) lbf upward force. Produced (b)(4) lbf after (b)(4) of flattening. Lift force below (b)(4) lbf.
- Deployment Force: Force to deploy graspers between (b)(4) lbf and (b)(4) lbf in tortuosity.
- Traction Wire Tissue Test: No perforation in (b)(4) colon if knife cuts through wire. No mucosal laceration in explanted esophageal tissue.
- Dimensional Inspection: Conformed to specified dimensions.
ProdiGI Traction Magnet Device:
- Tensile Test (Traction Magnet): Force to remove suture from grasper ≥ (b)(4) lbf. Force to remove magnet from suture ≥ (b)(4) lbf. Force to separate crimp from suture ≥ (b)(4) lbf. Force to remove magnet from grasper body ≤ (b)(4) lbf.
- Tensile Test (Traction Grasper): Introducer sheath to hub bond strength greater than (b)(4) lbf. Handle and deployment mechanism bonds (Proximal handle slider to crimp tube) greater than (b)(4) lbf. Shaft to handle tensile strength greater than (b)(4) lbf.
- Torque Test and Torque Stability and articulation: Torque to rotate device less than (b)(4) in-oz. Bonds remained intact in worst case tortuosity. Graspers rotatable to four quadrants. Colonoscope angle change within (b)(4) degrees.
- Insertion/Removal: No damage to scope channel or device components. Force to insert less than (b)(4) lbf. No kinking/buckling. Removal less than (b)(4) lbf.
- Grasper Detachment: Force to remove grasper from tissue > (b)(4) lbf. Arms did not come out of capsule. Force to remove from tissue less than (b)(4) lbf.
- Grasper Cycling Test: Graspers maintained minimum opening span ≥ (b)(4) after (b)(4) cycles.
- Deployment Force: Force to deploy graspers between (b)(4) lbf and (b)(4) lbf in tortuosity.
- Magnet Separation Force - Specification Assessment: Magnet to magnet strength (b)(4) lbf (lower boundary of separation). Force
N/A
0
DE NOVO CLASSIFICATION REQUEST FOR PRODIGI
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Endoscopic traction device. An endoscopic traction device is a prescription device that is endoscopically applied to retract tissue in the gastrointestinal tract during dissection procedures to increase visualization of the dissection plane and assist in tissue resection, exposure, and removal.
NEW REGULATION NUMBER: 21 CFR 876.4410
CLASSIFICATION: Class II
PRODUCT CODE: OSW
BACKGROUND
DEVICE NAME: ProdiGI
SUBMISSION NUMBER: DEN220006
DATE DE NOVO RECEIVED: January 14, 2022
SPONSOR INFORMATION:
Covidien LLC 3062 Bunker Hill Lane Santa Clara, California 95054
INDICATIONS FOR USE
The ProdiGI is indicated as follows:
ProdiGI Traction Wire: The Medtronic ProdiGI Traction Wire is indicated to grasp tissue within the esophagus, stomach, and colon of adults during an Endoscopic Submucosal Dissection (ESD) procedure.
ProdiGI Traction Magnet:
The Medtronic ProdiGI Traction Magnet is indicated to grasp tissue within the stomach and colon of adults during an Endoscopic Submucosal Dissection (ESD) procedure.
1
LIMITATIONS
The sale, distribution, and use of the ProdiGI are restricted to prescription use in accordance with 21 CFR 801.109.
The traction device should only be used by a physician trained in therapeutic endoscopy, including training in submucosal dissection.
No portion of the device is intended to be an implant. The entire device must be removed at the end of the procedure.
Device contains nickel in the form of nitinol and stainless steel. Caution should be taken for patients with potential nickel allergies.
The magnet of the device may cause interference with metallic (e.g., stent) or magnetic implants. Exercise care when passing the device near such implants and consult the implant's manufacturer's instruction for any safety concerns.
The Medtronic ProdiGl Traction Wire Device and Traction Magnet Device is contraindicated for use in patients with known or suspected varices or other structures at risk of significant bleeding at the targeted deployment location.
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS. PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
The ProdiGI Traction System includes the Traction Wire and Traction Magnet devices. The Traction Wire and Traction Magnet are not intended to be used together. Both devices are used in adults only and are used to provide improved visualization of the submucosal space during an endoscopic submucosal dissection (ESD) procedure.
ProdiGI Traction Wire Device
The Traction Wire consists of two graspers: a primary tissue grasper with traction wire attached (ERD-TW20 and ERD-TW35), and a secondary tissue grasper (ERD-TWSG) without a wire. The secondary tissue grasper is used to secure the distal end of the traction wire. The traction wire is a nitinol shape-memory loop (2.0 cm or 3.5 cm in length) that provides tension to the attached tissue after deployment. The nitinol wire is attached to the grasper with a stainless-steel crimp. No functional or mechanical differences are present in the 2.0 cm and 3.5 cm device lengths. Wire length size differences allow physicians to select a Traction Wire best suited for the location and size of the target treatment site.
2
Image /page/2/Picture/0 description: The image shows two medical instruments, likely forceps or graspers, against a white background. The instruments are long and slender, with a textured or coiled appearance along their shafts. At the ends, they have small, intricate grasping mechanisms, suggesting they are designed for delicate surgical procedures.
Figure 1. ProdiGl Traction Wire Device consists of two graspers, the primary grasper with nitinol wire attached and secondary grasper with no wire attached
Image /page/2/Figure/2 description: The image shows three different views of a medical device. The first view shows the device fully extended, with a needle-like tip on one end and a ring-shaped handle on the other. The second view shows the device with a different type of tip, which appears to be a small, rectangular box with a triangular opening. The third view shows the device with the rectangular tip bent into a curved shape, with a measurement of "2/3.5cm" indicating the length of the curve.
Figure 2. Diagram of traction wire device deployment device (top) and nitinol wire attached to grasper arm (bottom)
ID)(4) The primary traction wire grasper has a long shaft and is designed to be inserted and passed through the working channel of an endoscope. It is compatible with endoscopes with a maximum working length of 1700 mm and working channels 2.8 mm or greater. After passing through the endoscope, the device is directed to the targeted gastrointestinal tissue by manipulation of the endoscope and grasper. Upon obtaining proper positioning, the traction wire is deployed onto the targeted tissue through the attached handle. The graspers themselves are constructed of stainless-steel and open to a minimum distance of @14)
The secondary tissue grasper (ERD-TWSG) is also designed to be inserted through the working channel of an endoscope. After passing through the endoscope, the device is used to grasp and secure the free end of the wire to the targeted gastrointestinal tissue. Upon obtaining proper positioning, the secondary grasper is deployed onto the tissue through the attached handle. An additional secondary tissue grasper (ERD-TWSG) can be used if desired to adjust secondary grasper position mid procedure. The secondary grasper has a | [1](4] | |shaft with distal end graspers controlled at the proximal handle. The graspers are constructed of stainless steel and open to a minimum distance of | (0)4)
Once the Traction Wire is deployed and positioned, it facilitates cutting and improves visualization of the dissection plane by causing the lesion to progressively roll back on itself
3
during dissection, as the nitinol wire bends back into its pre-shaped curved configuration. After the target lesion has been successfully excised from the treatment site, the tissue and traction device are removed from the patient.
To remove the excised lesion and graspers from the patient, the secondary grasper is removed from the tissue using endoscopic tools such as grasping forceps. Secondary graspers (those placed outside resection area) have been designed to be atraumatic allowing for removal without adding significant tissue trauma to the procedure, Traction Wire Secondary Graspers are rounded to allow for sliding over tissue.
ProdiGI Traction Magnet Device
The traction magnet (ERD-TMST and ERD-TMLG) consists of two identical tissue graspers with a permanent neodymium magnet ( attached to the grasper 707.95 (8)(4) suture. The sutured magnet provides tension to the attached tissue after via a ਾਂ ਦੀ ਵਿੱਚ deployment. No functional or mechanical differences are present in the (TMLG) and b (TMST) suture lengths. Suture length size differences allow physicians to select a traction magnet best suited for the location and size of the target treatment site.
Image /page/3/Picture/4 description: In the image, there are two medical instruments that appear to be laparoscopic graspers. The instruments are positioned symmetrically, with their handles pointing downwards and their grasping ends facing each other. The background is a plain white, which helps to highlight the instruments.
Figure 3. ProdiGI Tration Magnet device consists of two graspers, both with a suture and magnet attached
Image /page/3/Figure/6 description: The image shows a medical instrument, possibly for a biopsy or aspiration procedure. The instrument consists of a long, thin needle or cannula with a handle or plunger mechanism at one end. There is also a hollow tube that the needle can be inserted into. The instrument appears to be designed for precise insertion and extraction of tissue or fluid samples.
Figure 4. Diagram of traction magnet device deployment device (top) and suture with magnet attached to grasper arm (bottom)
The grasper is designed to be inserted and passed through the working channel of an endoscope. It is compatible with endoscopes with a maximum working length of 1700 mm and working channels 2.8 mm or greater. After passing through the endoscope, the device is directed to the
4
targeted gastrointestinal tissue by manipulation of the endoscope and grasper. Upon obtaining proper positioning, the traction magnet is deployed onto the targeted tissue through the attached handle.
After passing the second grasper through the endoscope, the magnet of the second device is joined to the magnet of the first device on the lesion and positioned to the targeted gastrointestinal tissue opposite of the lesion. Upon obtaining proper positioning, the second grasper is deployed onto the tissue through the attached handle. Additional devices can be used if desired to adjust traction mid procedure.
The amount of traction provided during the procedure is controlled by inflating/deflating the organ in which the ESD procedure is being performed. The device on the opposing tissue from the lesion can be removed from the tissue with endoscopic tools such as grasping forceps.
SUMMARY OF NONCLINICAL/BENCH STUDIES
Non-clinical/bench studies conducted on the ProdiGI device demonstrate a reasonable assurance of safety and effectives of the device and are summarized below:
BIOCOMPATIBILITY/MATERIALS
The patient contacting components of the ProdiGI device include both the Traction Wire and the Traction Magnet devices. These devices were evaluated with respect to their intended use per ISO 10993-1:2003, Biological evaluation of medical devices and FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process."" Testing was performed on final finished devices. The following tests were performed on the ProdiGI devices:
-
- Cytotoxicity
-
- Sensitization
-
- Irritation or Intracutaneous Reactivity
-
- Material-Mediated Pyrogenicity
-
- Acute Systemic Toxicity
The results supported the biocompatibility of the ProdiGI device.
SHELF LIFE/STERILITY
The ProdiGI device is a sterile, single use system. Sterilization was evaluated for conformance to ANSI/AAMI/ISO 11135:2014 "Sterilization of health care products -Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices," to ensure a sterility assurance level of 10-6 before the device is marketed.
5
Accelerated aging to support a 1.5-year shelf life was performed for the EO sterilized ProdiGI devices per ASTM F1980-16, Standard Guidance for Accelerated Aging of Sterile Barrier Systems and Medical Devices. The shelf life was verified by demonstrating packaging integrity through gross leak detection testing and pouch seal strength testing on the stored devices.
PERFORMANCE TESTING - BENCH
Non-clinical performance tests were conducted to demonstrate mechanical integrity and functionality of the ProdiGI devices. The table below summarizes each of these bench tests, which includes appropriate acceptance criteria for the intended use of the device.
Bench testing was done to evaluate the mechanical performance and durability of the device. The traction wire comes in two models, ERD-TW20 and ERD-TW35. Both traction wires are also used with a secondary grasper ERD-TWSG. All three of these models are similar in all aspects of their materials and construction, except for the length of nitinol wire attached. The longest nitinol wire device, ERD-TW35, was used as a representative model for testing. Likewise, the traction magnet comes in two sizes, ERD-TWSM and ERD-TWLG. Both models are identical in construction and materials, except . for the length of the attached suture. Both models were used for testing. The device passed all the tests in Tables 1 and 2. below.
| Test | Description | Acceptance Criteria | |
|---|---|---|---|
| Traction Wire | |||
| Tensile Test | Test the mechanical integrity of the | ||
| attached wire. | The grasper to wire tensile force should be | ||
| above (b)(4) |
The crimp to wire tensile test must be above
(b)(4) | |
| Traction Grasper
Tensile Test | Test the mechanical integrity of the
grasper and components. | Introducer sheath to hub bond strength should
be greater than (b)(4)
The handle and deployment mechanism bonds
including the following connections:
- Proximal handle slider to crimp should
have a tensile strength greater than
(b)(4) - Tine puller/jaw seat to nitinol wire
should have a tensile strength greater
than (b)(4)
Shaft to handle tensile strength must be greater
than (b)(4) | |
| Torque Test and
Torque Stability
and articulation | The user should be able to rotate the
grasper vertically relative to the lesion
and rotate it horizontally when grabbing
the wire. Rotation of graspers allows for
correct placement of the graspers on the
anatomy. | Torque to rotate device should be less than $(b)(4)$ in-oz.
Bond must remain intact after being torqued in
worst-case tortuosity.
Graspers should be able to be rotated to four
quadrants in worst case tortuosity.
The angle of the colonoscope should not
change by more than $(b)(4)$ degrees in the fully
retroflexed position after insertion of the | |
| Insertion/Removal | Force required to insert and remove the
device is less than or equal to the average
person's ability to push or remove the
device through the minimum compatible
endoscope working channel. | device.
The graspers must be able to be passed through
a $(b)(4)$ scope channel in tortuosity without
damage to the scope channel as defined by
generating macroscopic particulate.
The graspers must be able to be passed through
a $(b)(4)$ scope channel in tortuosity without
damage to any of the device components.
The force to insert the 1st and 2nd graspers
should be less than $(b)(4)$ lbf.
The 1st grasper sheath/introducer should not
kink or buckle upon insertion into the scope.
Removal of 1st and 2nd graspers should be less
than $(b)(4)$ lbf.
The graspers must be able to be removed from
a $(b)(4)$ scope channel in tortuosity without
damage to the scope channel as defined by | |
| Grasper
Detachment | Evaluate the detachment forces of the
graspers | generating macroscopic particulate.
Detachment Force of the 1st grasper to tissue
must be above $(b)(4)$ lbf.
Detachment force of the 2nd grasper to tissue
must be above $(b)(4)$ lbf.
The arms of the 2nd grasper should not come
out of the capsule during grasper detachment
from tissue.
Force to remove the 2nd graspers from the
tissue should be less than $(b)(4)$ lbf. | |
| Grasper Cycling
Test | Test that the graspers of the traction
devices can be opened and closed five
times and still maintain their minimum | Prior to deployment graspers must be able to
be opened and closed $(b)(4)$ and maintain
their minimum opening span in simulated | |
| | | | tortuosity. For the 1st grasper this is (b)(4)
and for the 2nd grasper is (b)(4) |
| Wire lift force | The upward force of the traction wire
was measured to assess that the force to
lift tissue without pulling muscle into
cutting plane was within specifications. | The traction wire should be able to produce
(b)(4) lbf of upward force measured 10mm
from the free end of the wire.
The traction wire should be able to provide
(b)(4) lbf of upward force after (b)(4) of
being flattened and released.
The lift force of the traction wire should be
below (b)(4) lbf. | |
| Deployment Force | The user must be able to deploy the
graspers in order to place the traction
device in an appropriate location. | The force to deploy graspers by squeezing the
grasper handle should be greater than (b)(4) lbf
(b)(4) and less than (b)(4) lbf (b)(4) in
tortuosity. | |
| Traction Wire
Tissue Test | Device should not cause mucosal
laceration during use or removal of the
device. | A standard ESD knife should not cause
perforation in (b)(4) colon if the knife cuts
through the wire during dissection.
Device edges (deployed graspers, wire
included wire after it is cut by knife, and
crimp) should not cause mucosal laceration in
explanted esophageal tissue when pulled
through as an assembly. | |
| Dimensional
Inspection -
Specification
Assessment | Device conforms to dimensional
specifications | The traction wire radius should be (b)(4)
(b)(4) after assembly with the first grasper and
deployment.
The traction wire stance should be (b)(4)
The wire should be offered in flattened lengths
of: (b)(4)
The outer diameter of the graspers must be less
than (b)(4)
The working length of both graspers must be | |
| Test | Description | Acceptance Criteria | |
| Traction Magnet
Tensile Test | Test the mechanical integrity of the
attached suture and magnet. | Force to remove the suture from the grasper to
be ≥ (b)(4) lbf.
Force to remove the magnet from the suture to
be ≥ (b)(4) lbf.
Force to separate crimp from suture to be ≥(b)(4) lbf. | |
| | | Force to remove the magnet form the grasper
body to be ≤ (b)(4) lbf. | |
| Traction Grasper
Tensile Test | Test the mechanical integrity of the
grasper and components. | Introducer sheath to hub bond strength should
be greater than (b)(4) lbf.
The handle and deployment mechanism bonds,
including the following connections:
- Proximal handle slider to crimp tube
should have a tensile strength greater
than (b)(4) lbf.
Shaft to handle tensile strength must be greater
than (b)(4) lbf. | |
| Torque Test and
Torque Stability
and articulation | Device can be rotated in worst case
tortuosity to the desired position in order
to successfully deploy the graspers. | Torque to rotate device should be less than (b)(4)
in-oz.
Bonds must remain intact after being torqued
in worst case tortuosity.
Graspers should be able to be rotated to four
quadrants in worst case tortuosity.
The angle of the colonoscope should not
change by more than (b)(4) degrees in the fully
retroflexed position after insertion of the
device. | |
| Insertion/Removal | Force required to insert and remove the
device is less than or equal to the average
person's ability to push or remove the
device through the minimum compatible
endoscope working channel. | The graspers must be able to be passed through
a (b)(4) scope channel in tortuosity without
damage to the scope channel as defined by
generating macroscopic particulate.
The device must be able to be passed through a
2.8 mm scope channel in tortuosity without any
damage to any of the device components.
The force to insert the device should be less
than (b)(4) lbf. | |
| | | | |
| Grasper Detachment | Evaluate the detachment forces of the graspers | The introducer should not kink or buckle upon insertion into the scope.
Removal of graspers should be less than (b)(4) lbf.
Force to remove the grasper from tissue to be >(b)(4) lbf.
The arms of the grasper should not come out of the capsule during grasper detachment from tissue.
Force to remove the grasper from the tissue should be less than (b)(4) lbf. | |
| Grasper Cycling Test | Test that the graspers of the traction devices can be opened and closed five times and still maintain their minimum opening span in simulated tortuosity. | Distance between grasper tines to be ≥ (b)(4) prior and after the grasper being opened and closed (b)(4) | |
| Deployment Force | The user must be able to deploy the graspers in order to place the traction device in an appropriate location. | The force to deploy graspers by squeezing the grasper handle should be greater than (b)(4) lbf (b)(4) and less than (b)(4) lbf (b)(4) in tortuosity. | |
| Magnet Separation Force - Specification Assessment | The magnets must be able to readily join without becoming stuck to the deployment catheter. | Magnet to magnet strength to be (b)(4) lbf (lower boundary of magnet separation).
Magnet to magnet strength to be