Who is the manufacturer of ProdiGI?

Covidien, LLC filed the De Novo classification request for ProdiGI (DEN220006).

What is the FDA product code for ProdiGI?

QSW. It is classified under 21 CFR 876.4410 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for ProdiGI?

De Novo classification (submission type: Direct).

Who can help prepare an FDA De Novo submission like ProdiGI?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA De Novo submissions. See https://innolitics.com/services/regulatory/ or contact https://innolitics.com/contact.

ProdiGI

DEN220006 · Covidien, LLC · QSW · Jun 13, 2022 · Gastroenterology, Urology

Device Facts

Record ID	DEN220006
Device Name	ProdiGI
Applicant	Covidien, LLC
Product Code	QSW · Gastroenterology, Urology
Decision Date	Jun 13, 2022
Decision	DENG
Submission Type	Direct
Regulation	21 CFR 876.4410
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

ProdiGI consists of a traction wire and a traction magnet system used during endoscopic submucosal dissection (ESD). Device is endoscopically applied to grasp and retract gastrointestinal tissue; increases visualization of dissection plane; assists in tissue resection, exposure, and removal. Operated by physicians in clinical settings. Traction wire and magnet provide mechanical tissue manipulation. Benefits include improved procedural efficiency and visualization during complex endoscopic resections.

Clinical Evidence

No clinical trial data provided. Evidence basis consists of non-clinical performance testing (deployment, detachment, tensile strength, magnet strength, dimensional verification) and in vivo performance testing to evaluate perforation, bleeding, mucosal injury, ease of use, and visualization.

Technological Characteristics

System includes Traction Wire (nitinol shape-memory loop, stainless-steel crimp) and Traction Magnet (neodymium magnets, suture). Components are stainless steel. Sterile, single-use, EO-sterilized. Compatible with endoscopes (1700 mm max length, 2.8 mm+ working channel). Mechanical deployment via proximal handle. No software or electronic components.

Indications for Use

Indicated for adults undergoing Endoscopic Submucosal Dissection (ESD) procedures to grasp tissue in the esophagus, stomach, and colon (Traction Wire) or stomach and colon (Traction Magnet). Contraindicated for patients with known or suspected varices or structures at risk of significant bleeding.

Regulatory Classification

Identification

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. The ProdiGI system includes a Traction Wire (indicated for esophagus, stomach, and colon) and a Traction Magnet (indicated for stomach and colon) for use in adults during Endoscopic Submucosal Dissection (ESD) procedures.

Special Controls

In combination with the general controls of the FD&C Act, the endoscopic traction device is subject to the following special controls: - (1) In vivo performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must evaluate: - Perforation, bleeding, and mucosal injury; (i) - Ease of insertion and removal of the device; (ii) - Visualization during the procedure; and (iii) - Ease of procedure as reported by the intended user. (iv) - (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must include: - Device deployment and detachment: (i) - Ability to retract tissue; (ii) - (iii) Tensile strength; - Potential for laceration caused by the device or procedure using the device; (iv) - Dimensional verification; and (v) - (vi) For devices that contain a magnet, magnet strength verification and safety assessment. - (3) Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device. - (4) Performance data must demonstrate the sterility of the patient-contacting components of the device. - (5) The patient-contacting components of the device must be demonstrated to be biocompatible. - (6) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the intended shelf life. - (7) Labeling must include: - The recommended training for safe use of the device; (i) - (ii) Anatomical locations and lesion sizes that have been demonstrated to be safe to use with the device: and - A shelf life. (iii)

Related Devices

K222354 — Elastic Traction System · Micro-Tech (Nanjing) Co., Ltd. · Oct 3, 2022
K251041 — GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100 · Actuated Medical, Inc. · Oct 31, 2025
K173400 — ORISE Tissue Retractor System · Boston Scientific · Feb 9, 2018
K231254 — GripTract-GI Endoscopic Tissue Manipulator · Actuated Medical, Inc. · Nov 3, 2023

Submission Summary (Full Text)

{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](4) (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: - 1. Cytotoxicity - 2. Sensitization - 3. Irritation or Intracutaneous Reactivity - 4. Material-Mediated Pyrogenicity - 5. 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 (upper boundary of magnet separation). Magnet to magnet strength to be >(b)(4) lbf (lower boundary of magnet separation). Magnet to magnet strength to be <(b)(4) lbf with 4 magnets connected together. | | | Magnet Field Sensitivity | Evaluate the ability of the magnets to attract and assess magnetic field strength. | Magnets must join together at a minimum distance of (b)(4) Magnet field of the magnet to be ≤(b)(4) at (b)(4) | | | Magnet Tissue Damage Test | Device should not cause mucosal laceration during use or removal of the device. | No signs of mucosal laceration upon retraction of the grasper. | | | Dimensional Inspection - Specification Assessment | Device conforms to dimensional specifications | Length for ERD-TMSM to be (b)(4) and for ER_TMLG (b)(4) The outer diameter of the grasper must be less than (b)(4) The working length of both graspers must be greater than or equal to (b)(4) | | Table 1. Performance test results for the ProdiGI Traction Wire Device {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ # Table 2. Performance test results for the ProdiGI Traction Magnet Device {9}------------------------------------------------ {10}------------------------------------------------ ## MAGNET SAFETY ASSESSMENT The Traction Wire device uses a = = spherical magnet. Due to the potential for magnets to impact the function of electronic devices within a certain critical radius of a magnet, testing and analysis of the traction magnet device was conducted. The threshold magnetic field that will impact a pacemaker is 10 Gauss or 1 milli Tesla (mT). The results of such an event would be the external device entering magnet mode during which it may have reduced or altered performance while in the presence of the magnetic field. During an ESD procedure, up to a total of four magnets (two sets of graspers) can be used, making this the worst-case scenario in which a magnetic field would be present. [014) [groups of four magnets were scanned to determine the field strength data for the furthest point at which the measured filed was greater than [ DMA] Historical data was analyzed from a set of @11 physically small patients with pacemakers to determine the worst-case distance from the esophagus to the pacemaker. Analysis for the critical radius using the worst-case scenario of four stacked magnets showed that the upper tolerance limit for the distance in which the magnet stack achieves IDXO Iis Analysis of the worst-case anatomical data shows that the lower tolerance limit of the distance from the esophagus to a pacemaker is | Therefore, it is unlikely that the magnets of the traction magnet device would cause interference with other implanted devices. #### USABILITY TESTING Usability testing was provided to demonstrate the traction wire meets the user need/performance needs and has acceptable usability. 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 by moderate and provice physicians participated in the study. Testing was compared between procedures with and without the use of the traction device. Testing included | 1000 procedures in the esophagus, In the stomach and in the colon. 1 ( ) procedures with the traction wire were done on (b) lesions and (b)(2) procedures on 10) lesions. Visualization scores for the traction wire device were rated on a three-point scale where I = 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. Table 3 summarizes the results. {11}------------------------------------------------ | Needs ID | Needs Statement | Acceptance Criteria | Sample Size | Results | |-------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | N1.1 | Device should provide endoscopic visualization of the submucosa space during entire dissection, | Average visualization score for dissection with traction wire ≥ average visualization score without traction wire | n procedures with Traction and b Procedures without Traction (See Deviation 8.1) | Visualization Score: PASS Test: 15/24 Control: (h)(4) | | N1.2 | Time to complete an ESD procedure with the device should be equivalent to or less than the time to complete an ESD procedure without the device. | Average procedure time (start of procedure to end of procedure) with traction device ≤ average procedure time without traction device | Min b Procedures with Traction and g Procedures without Traction (See Deviation 8.1) | Procedure Time: PASS Test: 16/24 minutes Control: (n)(4) minutes | | N1.3 | Device should be able to be utilized in at least two of the following anatomical locations: the esophagus, stomach, and colorectal. | Minimum of 3 successful dissections (defined as complete resection of lesion) with Traction Wire in at least 2 organs | h procedures each in esophagus, stomach, and colorectal | Locations: PASS (D)(4) in stomach 13/24 in esophagus ch(4) in colon | | N1.4 | Perforation rate during an ESD procedure with the device should be equivalent to or less than an ESD procedure without the device. | Perforation rate with traction device ≤ perforation rate without traction device | h Procedures with Traction and i Procedures without Traction (See Deviation 8.1) | Perforation: PASS h perforations with test h perforation with control | | N1.5 | Device should be able to provide adequate submucosal visibility for lesions sizes 2cm-5cm at a minimum. | Minimum of 3 successful dissections (defined as complete resection of lesion) with Traction Wire on 2 cm and 5 cm lesions | Min f procedures with h lesions | Lesion Size: PASS h procedures successfully completed with h cm and b procedures successfully completed with h demonstrating the product functions over the designated range | | N1.6 | Device should not cause significant unintended trauma to the GI tract as defined by trauma that requires physician intervention using tools not already utilized during an ESD procedure. | No incidents of trauma from device that physician indicated they would intervene with tools not used in ESD procedure | m procedures (See Deviation 8.2) | Trauma: PASS m procedures completed with traction wire with no incidents of trauma noted | | N1.7 | Device should not introduce any new patient complications/serious adverse events that are not currently observed in an ESD procedure. | No incidents of complications that physician deems not typical for ESD procedure | h procedures (See Deviation 8.2) | Complications: PASS m procedures completed with traction wire with no incidents of complications | ## Table 3. Usability test results for the ProdiGI Traction Wire Device Note: The results for visualization score and procedure time are provided as mean ± standard deviation 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 com lesions and three procedures on 1 cm lesions. Visualization scores for the traction magnet device were rated on a five-point scale where 1 = unacceptable, 2 = poor, 3 = clinically acceptable, 4 = good, and 5 = exceeds expectations. Table 4 summarizes the results. {12}------------------------------------------------ | Needs ID | Needs Statement | Acceptance Criteria | Sample Size | Results | |-------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | NL1 | Device should provide endoscopic visualization of the submucosa space during entire dissection. | Average visualization score for dissection with traction magnet & average visualization score without traction magnet | with Traction and without Traction | Visualization Score: PASS Test: Control: | | NL2 | Time to complete an ESD procedure with the device should be equivalent to or less than the time to complete an ESD procedure without the device. | Average procedure time (start of procedure to end of procedure) with traction device & average procedure time without traction device | with Traction and without Traction | Procedure Time: PASS Test: minutes Control: minutes** **Note: One Control case was terminated without completion due to poor visualization. This case had an infinite procedure time, so was could not be included in statistical analysis. | | NL3 | Device should be able to be utilized in at least two of the following anatomical locations: the esophagus, stomach, and colorectal. | Minimum of successful dissections (defined as complete resection of lesion) with Traction Magnet in at least organs | Minimum each in stomach and colorectal | Locations: PASS in stomach tissue in colorectal tissue | | NL4 | Perforation rate during an ESD procedure with the device should be equivalent to or less than an ESD procedure without the device. | Perforation rate with traction device & perforation rate without traction device | with Traction and without Traction | Perforation: PASS Test: case with perforation which happened prior to Magnet deployment (1 case out of ) Control: cases with perforations and cases with muscle damage, but not through cases out of | | NL5 | Device should be able to provide adequate submucosal visibility for lesions sizes at a minimum. | Minimum of successful dissections (defined as complete resection of lesion) with Traction Magnet on and lesions | Minimum with lesions Minimum with lesions | Lesion Size: PASS procedures successfully completed with cm and procedures successfully completed with cm demonstrating the product functions over the designated range | ## Table 4. Usability test results for the ProdiGI Traction Magnet Device Image /page/12/Figure/2 description: This image is a table that outlines the needs, acceptance criteria, sample size, and results of a study. The table has two rows, one for needs ID N1.6 and another for N1.7. For N1.6, the sample size is (n=41) and the results show "Trauma: PASS", while for N1.7, the sample size is (n=41) and the results show "Complications: PASS". The table also includes a note at the bottom that statistical comparisons were made between the test and control procedures. ere not included in the comparison since there were no equivalent paired lesions for control, Note: The results for visualization score and procedure time are provided as mean ± standard deviation ## PERFORMANCE TESTING - ANIMAL Animal studies evaluated ESD procedures using the traction wire and traction magnet devices compared to standard ESD (performed without traction devices) using live porcine models. Procedures were completed in the esophagus, stomach, and colon. The purpose of the GLP-compliant studies was to evaluate in vivo performance of the traction wire and traction magnet. The use of live animals was necessary to demonstrate performance of the device in perfused tissue. 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 in animals based on size and anatomy of 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 to to com were created based on suitability of anatomy to perform an ESD procedure. Procedure time was counted as the time the device was first inserted in the instrument channel until all the pieces were removed. Animals were then euthanized, and necropsy was performed. {13}------------------------------------------------ 1010) animals were used for the traction wire testing, and mals were used for the traction magnet testing. Each animal was the subject of device procedures and control procedures, as outline in Table 5. | Table 5. Animal testing: Number of procedures for each device and tissue type | | | | | | | | | | | | | | |-------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--| |-------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--| | Tissue/Arm | Traction Wire | Control | Traction Magnet | Control | |------------|---------------|---------|-----------------|---------| | Esophagus | | | (b)(4) | | | Stomach | | | | | | Colon | | | | | The animal studies evaluated sufficient traction and visualization, lesion sizes, en bloc resection rate, perforation, tissue damage, procedure time and ease of use. Treatment sites were evaluated intraoperatively in terms of localized tissue trauma, including assessing for laceration, perforation and/or other tissue trauma. Assessment of endpoints were as follows: - Bleeding: bleeding was assessed by study physicians intraoperatively via endoscopic . visualization. A 6-point Likert scale was used where "0" was no bleeding and "5" was clinically unacceptable bleeding. - Perforation: visible signs of perforation were assessed during the intraoperative procedure . via endoscopic visualization. Assessments were recorded as yes or no. Upon completion of terminal procedures, treatment sites were assessed for signs of perforation at necropsy. - . Mucosal Laceration: visible signs of mucosal laceration with respect to each treatment site were assessed during the intraoperative procedure via endoscopic visualization. Upon completion of terminal procedures, treatment sites were assessed for signs of mucosal laceration at necropsy. - . Visualization: Visualization was assessed endoscopically by the physician at three time points, start of dissection, mid-dissection, and end of dissection. Visualization was characterized as the ability to view critical aspects and features of the target treatment site. Visualization was rated on a three-point scale where "1" was unacceptable. "2" acceptable, and "3" exceeds expectations. - · Ease of Removal: Physicians ranked the ability to remove all devices and tissue upon completion of the procedure. Ease of removal was rated on a three-point scale where "1" was unacceptable, "2" acceptable, and "3" exceeds expectations. {14}------------------------------------------------ - · Ease of Procedure: The physician was asked to provide feedback on how satisfied they were with the ease of completing the ESD procedure, time it took to complete the ESD procedure and observed traction during the submucosal dissection. A five-point scale was used where "1" was strongly disagree and "5" was strongly agree. | Endpoint | Control Result (N=8) | Traction Wire Result (N=8) | Performance Comparison | |--------------------------------------|----------------------|----------------------------|------------------------------| | Bleeding | (b)(4) | | Traction better than Control | | Perforation | | | Traction similar to Control | | Laceration | | | Traction similar to Control | | Ease of Removal | | | Traction similar to Control | | Submucosal Visualization (Start) | | | Traction better than Control | | Submucosal Visualization (Middle) | | | Traction better than Control | | Submucosal Visualization (End) | | | Traction better than Control | | Ease of Procedure (Easiness) | | | Traction better than Control | | Ease of Procedure (Temporal) | | | Traction better than Control | | Ease of Procedure (Effect) | | | Traction better than Control | | Procedural Duration | | | Traction similar to Control | #### Table 6. Animal testing results for ProdiGI Traction Wire Device Noto: All results in the table, except for perforation, are provided as mean = standard deviation. MII performions were unrelated to the device use or design or the control procedure and resulted from emplicated unitony and fibrous tissue. # Table 7. Animal testing results for ProdiGI Traction Magnet Device | Endpoint | Control Result (N=8) | Traction Wire Result (N=8) | Performance Comparison | |--------------------------------------|----------------------|----------------------------|------------------------------| | Bleeding | (b)(4) | | Traction similar to Control | | Perforation | | | Traction better than Control | | Laceration | | | Traction similar to Control | | Ease of Removal | | | Traction similar to Control | | Submucosal Visualization (Start) | | | Traction better than Control | | Submucosal Visualization (Middle) | | | Traction better than Control | | Submucosal Visualization (End) | | | Traction better than Control | | Ease of Procedure (Easiness) | | | Traction better than Control | {15}------------------------------------------------ | Ease of Procedure (Temporal) | (b)(4) | Traction better than Control | |---------------------------------|--------|------------------------------| | Ease of Procedure (Effect) | | Traction better than Control | | Procedural Duration | | Control better than Traction | Nota: All results in the table, except for my loceration, are provided as mon # standard deviation. For the traction wire device all assessment of endpoints showed the traction device performed better than the control or similar to the control. For the traction magnet device assessment of all endpoints except procedural time showed the traction device performed better than control or similar to control. For procedural time, the control performed better than the traction magnet. This is acceptable as deployment of the device is expected to take additional time. Necropsy showed no visual evidence of laceration, and no other abnormalities were identified. Macroscopic features of the test treatment sites were comparable to the control treatment sties. #### SUMMARY OF CLINICAL INFORMATION No clinical data was provided. #### Pediatric Extrapolation In this De Novo request, existing clinical data were not leveraged to support the use of the device in a pediatric patient population. ## LABELING The sponsor provided labeling that included the instructions for use and package labels. The instructions for use addresses the known hazards and risks of the intended use and incorporates safety statements to mitigate these risks. The labeling includes safety instructions intended to minimize the risk of improper use of the ProdiGI device. Important components of the labeling include: The traction device should only be used by a physician trained in therapeutic endoscopy, including training in endoscopic submucosal dissections. No portion of the device is intended to be an implant and the entire device must be removed at the end of the procedure. Inclusion of tissue types in which the device has demonstrated to be effective. The traction device must be used with concurrent endoscopic visualization. {16}------------------------------------------------ The traction device should be used with caution in patients who present with anatomic variations of the targeted portion of the organ to be treated. Such disorders may include but are not limited to stricture. Inclusion of the endoscopic specifications with which the traction device can be used with. The traction device may be less effective in tissue with thin mucosa and fibrotic or other nonlifting tissue. ## RISKS TO HEALTH The table below identifies the risks to health that may be associated with use of the endoscopic traction device and the measures necessary to mitigate these risks. | Identified Risk to Health | Mitigation Measures | |------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------| | Adverse tissue reaction | Biocompatibility evaluation | | Tissue trauma including bleeding. perforation, or laceration due to use error or improper device use | In vivo performance testing Non-clinical performance testing Usability assessment Labeling | | Infection | Sterilization validation Shelf life testing Labeling | | Device failure/malfunction leading to patient injury | Non-clinical performance testing | | Increased procedure time and sedation time due to time needed to deploy device | In vivo performance testing Usability assessment | 1 - 2 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 #### SPECIAL CONTROLS In combination with the general controls of the FD&C Act, the endoscopic traction device is subject to the following special controls: - (1) In vivo performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must evaluate: - Perforation, bleeding, and mucosal injury; (i) - Ease of insertion and removal of the device; (ii) - Visualization during the procedure; and (iii) - Ease of procedure as reported by the intended user. (iv) {17}------------------------------------------------ - (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must include: - Device deployment and detachment: (i) - Ability to retract tissue; (ii) - (iii) Tensile strength; - Potential for laceration caused by the device or procedure using the device; (iv) - Dimensional verification; and (v) - (vi) For devices that contain a magnet, magnet strength verification and safety assessment. - (3) Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device. - (4) Performance data must demonstrate the sterility of the patient-contacting components of the device. - (5) The patient-contacting components of the device must be demonstrated to be biocompatible. - (6) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the intended shelf life. - (7) Labeling must include: - The recommended training for safe use of the device; (i) - (ii) Anatomical locations and lesion sizes that have been demonstrated to be safe to use with the device: and - A shelf life. (iii) ## BENEFIT-RISK DETERMINATION The risks of the device are based on data collected in animal studies described above and postmarket complaint data. There is a risk of the graspers that are part of the traction devices not deploying on the target tissue or detaching from the tissue during the procedure. The probability of such events is low and occurrence can be managed with sufficient instructions. Additional traction devices can be used if a grasper does not deploy properly or if a grasper detaches during the procedure. No bleeding was seen in the procedures completed in animals using the traction device compared to one case of bleeding seen in the control group. One case of perforation was noted in both the control group and traction group. This perforation was identified as being unrelated to use of the traction device or control procedure and was from complicated anatomy and fibrous tissue. The perforations occurred during the circumferential cut made at the start of the ESD procedure prior to grasper deployment and lesion resection. The probable benefits of the device are also based on data collected in animal studies described above. The animal studies demonstrated use of the traction device provides sufficient traction and visualization when compared to the control group where procedures were performed with no traction device. Use of the traction device also does not require the use of multi-channel scopes or additional accessories to perform the procedure. This increases the ease of use of the device as demonstrated by the ease-of-use scores provided by physicians for the procedures completed with the traction device and without the traction device. {18}------------------------------------------------ # PATIENT PERSPECTIVES This submission did not include specific information on patient perspectives for this device. #### BENEFIT/RISK CONCLUSION In conclusion, given the available information above, for the following indication statement: 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. The probable benefits outweigh the probable risks for the ProdiGI. The device provides benefits and the risks can be mitigated by the use of general controls and the identified special controls. #### CONCLUSION The De Novo request for the ProdiGI is granted and the device is classified as follows: Product Code: OSW Device Type: Endoscopic traction device Regulation Number: 21 CFR 876.4410 Class: II