(150 days)
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 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.
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.
Here's an analysis of the provided text to describe the acceptance criteria and the study proving the device meets them, based on your requested format:
Acceptance Criteria and Device Performance for ProdiGI
The ProdiGI device underwent non-clinical/bench studies and usability testing to demonstrate its safety and effectiveness. Importantly, no clinical data was provided. The primary studies proving the device meets acceptance criteria are summarized in the "Performance Testing - Bench", "Usability Testing", and "Performance Testing - Animal" sections of the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document presents acceptance criteria and reported performance in a narrative and tabular format for both bench and usability testing. I will consolidate the key performance criteria for each device type into a single table. Note that specific numerical results (e.g., 'b)(4)') were often redacted in the original text, so I will indicate where this occurs.
Table 1: Consolidated Acceptance Criteria and Reported Device Performance (Bench and Usability)
| Test Category | Specific Test / Needs ID | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | General | Conformance to ISO 10993-1:2003 for cytotoxicity, sensitization, irritation, material-mediated pyrogenicity, and acute systemic toxicity. | PASS: "The results supported the biocompatibility of the ProdiGI device." (Tests performed on final finished devices.) |
| Shelf Life/Sterility | Sterilization | Conformance to ANSI/AAMI/ISO 11135:2014, ensuring a sterility assurance level of 10^-6. | PASS: "Sterilization was evaluated for conformance..." (Implied successful validation as no issues reported and device granted.) |
| Accelerated Aging | Support 1.5-year shelf life per ASTM F1980-16, demonstrating packaging integrity (gross leak, pouch seal strength). | PASS: "Accelerated aging to support a 1.5-year shelf life was performed... The shelf life was verified by demonstrating packaging integrity..." (Implied successful validation.) | |
| Bench/Mechanical (Traction Wire) | Tensile Test (Grasper to Wire) | Grasper to wire tensile force should be above (b)(4) lbf. | PASS: "The device passed all the tests in Tables 1 and 2." (Table 1 states "The grasper to wire tensile force should be above (b)(4)" for both, implying the criteria was met.) |
| Tensile Test (Crimp to Wire) | Crimp to wire tensile test must be above (b)(4). lbf. | PASS: "The device passed all the tests in Tables 1 and 2." (Table 1 states "The crimp to wire tensile test must be above (b)(4)" for both, implying the criteria was met.) | |
| Torque Test | Torque to rotate device < (b)(4) in-oz; bond intact after torqued in tortuosity; graspers rotated to 4 quadrants in tortuosity; colonoscope angle change < (b)(4) degrees in retroflexed position. | PASS: "The device passed all the tests in Tables 1 and 2." (Implied compliance with all criteria based on "passed all tests" statement.) | |
| Insertion/Removal | Force to insert/remove Graspers <= average person's ability; graspers pass through (b)(4) scope channel in tortuosity w/o damage or particulate; 1st grasper sheath not kink/buckle; force to insert 1st/2nd graspers < (b)(4) lbf; removal 1st/2nd graspers < (b)(4) lbf. | PASS: "The device passed all the tests in Tables 1 and 2." (Implied compliance with all criteria based on "passed all tests" statement.) | |
| Grasper Detachment | Detachment Force of 1st grasper to tissue > (b)(4) lbf; 2nd grasper > (b)(4) lbf; 2nd grasper arms not come out of capsule; force to remove 2nd graspers from tissue < (b)(4) lbf. | PASS: "The device passed all the tests in Tables 1 and 2." (Implied compliance with all criteria based on "passed all tests" statement.) | |
| Grasper Cycling Test | Graspers open/close 5 times and maintain min opening span: 1st grasper (b)(4), 2nd grasper (b)(4). | PASS: "The device passed all the tests in Tables 1 and 2." (Implied compliance with all criteria based on "passed all tests" statement.) | |
| Wire Lift Force | Produce (b)(4) lbf upward force 10mm from free end; provide (b)(4) lbf upward force after (b)(4) flattening; lift force below (b)(4) lbf. | PASS: "The device passed all the tests in Tables 1 and 2." (Implied compliance with all criteria based on "passed all tests" statement.) | |
| Deployment Force | Force to deploy by squeezing handle: > (b)(4) lbf and < (b)(4) lbf in tortuosity. | PASS: "The device passed all the tests in Tables 1 and 2." (Implied compliance with all criteria based on "passed all tests" statement.) | |
| Tissue Test | ESD knife not cause perforation in (b)(4) colon if cuts wire; device edges not cause mucosal laceration when pulled through explanted esophageal tissue. | PASS: "The device passed all the tests in Tables 1 and 2." (Implied compliance with all criteria based on "passed all tests" statement.) | |
| Dimensional Inspection | Traction wire radius (b)(4); stance (b)(4); flattened lengths (b)(4); outer diameter graspers < (b)(4); working length both graspers (b)(4). | PASS: "The device passed all the tests in Tables 1 and 2." (Implied compliance with all criteria based on "passed all tests" statement.) | |
| Bench/Mechanical (Traction Magnet) | Tensile Test | 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. | PASS: "The device passed all the tests in Tables 1 and 2." (Implied compliance with all criteria based on "passed all tests" statement.) |
| Torque Test | Torque to rotate device < (b)(4) in-oz; bonds intact after torqued in tortuosity; graspers rotated to 4 quadrants in tortuosity; colonoscope angle change < (b)(4) degrees in retroflexed position. | PASS: "The device passed all the tests in Tables 1 and 2." (Implied compliance with all criteria based on "passed all tests" statement.) | |
| Insertion/Removal | Graspers pass through (b)(4) scope channel in tortuosity w/o damage or particulate; device pass through 2.8mm scope channel in tortuosity w/o damage; force to insert device < (b)(4) lbf; introducer not kink/buckle; removal < (b)(4) lbf. | PASS: "The device passed all the tests in Tables 1 and 2." (Implied compliance with all criteria based on "passed all tests" statement.) | |
| Grasper Detachment | Force to remove grasper from tissue > (b)(4) lbf; arms not come out of capsule during detachment; force to remove grasper from tissue < (b)(4) lbf. | PASS: "The device passed all the tests in Tables 1 and 2." (Implied compliance with all criteria based on "passed all tests" statement.) | |
| Grasper Cycling Test | Distance between grasper tines >= (b)(4) prior and after being opened/closed (b)(4). | PASS: "The device passed all the tests in Tables 1 and 2." (Implied compliance with all criteria based on "passed all tests" statement.) | |
| Deployment Force | Force to deploy by squeezing handle: > (b)(4) lbf and < (b)(4) lbf in tortuosity. | PASS: "The device passed all the tests in Tables 1 and 2." (Implied compliance with all criteria based on "passed all tests" statement.) | |
| Magnet Separation Force | Magnet to magnet strength: <(b)(4) lbf (upper), >(b)(4) lbf (lower); <(b)(4) lbf with 4 magnets. | PASS: "The device passed all the tests in Tables 1 and 2." (Implied compliance with all criteria based on "passed all tests" statement.) | |
| Magnet Field Sensitivity | Magnets join at min distance of (b)(4); magnet field <= (b)(4) at (b)(4). | PASS: "The device passed all the tests in Tables 1 and 2." (Implied compliance with all criteria based on "passed all tests" statement.) | |
| Magnet Tissue Damage Test | No mucosal laceration upon retraction of grasper. | PASS: "The device passed all the tests in Tables 1 and 2." (Implied compliance with all criteria based on "passed all tests" statement.) | |
| Dimensional Inspection | Length for ERD-TMSM (b)(4), ERD-TMLG (b)(4); outer diameter grasper < (b)(4); working length both graspers >= (b)(4). | PASS: "The device passed all the tests in Tables 1 and 2." (Implied compliance with all criteria based on "passed all tests" statement.) | |
| Usability (Traction Wire) | N1.1 (Visualization) | Average visualization score (dissection with traction wire) >= average visualization score (without traction wire). (3-point scale: 1=unacceptable, 2=acceptable, 3=exceeds expectations) | PASS: Test: 15/24, Control: (b)(4) (Specific average values are redacted, but "PASS" indicates the criterion was met. This implies the average score with the device was at least as good as without.) |
| N1.2 (Procedure Time) | Average procedure time (with traction device) <= average procedure time (without traction device). | PASS: Test: 16/24 minutes, Control: (b)(4) minutes (Specific average values are redacted, but "PASS" indicates the criterion was met. This implies the average time with the device was less than or equal to without.) | |
| N1.3 (Anatomical Locations) | Minimum of 3 successful dissections (complete resection) with Traction Wire in at least 2 organs (esophagus, stomach, and colorectal). | PASS: (b)(4) in stomach, 13/24 in esophagus, (b)(4) in colon. (Specific numbers are redacted, but indicates successful dissections in multiple target organs.) | |
| N1.4 (Perforation Rate) | Perforation rate with traction device <= perforation rate without traction device. | PASS: (b)(4) perforations with test, (b)(4) perforations with control. (Specific numbers are redacted, but "PASS" indicates the criterion was met, suggesting the rate with the device was not higher.) | |
| N1.5 (Lesion Size) | Minimum of 3 successful dissections (complete resection) with Traction Wire on 2 cm and 5 cm lesions. | PASS: (b)(4) procedures successfully completed with (b)(4) cm and (b)(4) procedures successfully completed with (b)(4) demonstrating the product functions over the designated range. (Specific numbers redacted, but shows successful completion for both lesion sizes.) | |
| N1.6 (Unintended Trauma) | No incidents of trauma from device that physician indicated they would intervene with tools not used in ESD procedure. | PASS: (b)(4) procedures completed with traction wire with no incidents of trauma noted. (Specific number redacted, but indicates successful completion without trauma.) | |
| N1.7 (Complications) | No incidents of complications that physician deems not typical for ESD procedure. | PASS: (b)(4) procedures completed with traction wire with no incidents of complications. (Specific number redacted, but indicates successful completion without complications.) | |
| Usability (Traction Magnet) | NL1 (Visualization) | Average visualization score (with traction magnet) >= average visualization score (without traction magnet). (5-point scale: 1=unacceptable, 2=poor, 3=clinically acceptable, 4=good, 5=exceeds expectations) | PASS: (Specific score values redacted, but "PASS" indicates the criterion was met. This implies the average score with the device was at least as good as without.) |
| NL2 (Procedure Time) | Average procedure time (with traction device) <= average procedure time (without traction device). | PASS: (Specific score values redacted, but "PASS" indicates the criterion was met. One control case with infinite time due to termination was excluded from statistical analysis, implying the remaining comparison still met the criterion.) | |
| NL3 (Anatomical Locations) | Minimum of successful dissections (complete resection) with Traction Magnet in at least [number] organs. | PASS: (Specific numbers redacted, but indicates successful dissections in stomach and colorectal tissue.) | |
| NL4 (Perforation Rate) | Perforation rate with traction device <= perforation rate without traction device. | PASS: Test: 1 case out of (b)(4) with perforation (prior to Magnet deployment). Control: (b)(4) cases with perforations and (b)(4) cases with muscle damage. (Specific numbers redacted, but indicates the criterion was met.) | |
| NL5 (Lesion Size) | Minimum of successful dissections (complete resection) with Traction Magnet on 1cm and [number]cm lesions. | PASS: (b)(4) procedures successfully completed with (b)(4) cm and (b)(4) procedures successfully completed with (b)(4) cm. (Specific numbers redacted, but shows successful completion for both lesion sizes.) | |
| Animal (In Vivo) Testing | Bleeding (Traction Wire) | "Traction better than Control" or "Traction similar to Control" expected outcome. | Traction better than Control (for Traction Wire) / Traction similar to Control (for Traction Magnet). (Specific scores redacted. For traction wire, control result (b)(4), traction wire result redacted.) |
| Perforation (Traction Wire) | "Traction better than Control" or "Traction similar to Control" expected outcome. | Traction similar to Control (for Traction Wire). (Specific scores redacted. For traction wire, control and traction values redacted. Note stated perforations (1 in each group) were unrelated to device/control and due to anatomy/fibrous tissue.) Traction better than Control (for Traction Magnet). (Specific scores redacted. For traction magnet, control and traction values redacted.) | |
| Laceration | "Traction better than Control" or "Traction similar to Control" expected outcome. | Traction similar to Control (for both Traction Wire and Magnet). (Specific scores redacted.) | |
| Ease of Removal | "Traction better than Control" or "Traction similar to Control" expected outcome. | Traction similar to Control (for both Traction Wire and Magnet). (Specific scores redacted.) | |
| Visualization (Start, Mid, End) | "Traction better than Control" or "Traction similar to Control" expected outcome. | Traction better than Control (for Traction Wire and Magnet at all three time points). (Specific scores redacted.) | |
| Ease of Procedure (Easiness, Temporal, Effect) | "Traction better than Control" or "Traction similar to Control" expected outcome. | Traction better than Control (for Traction Wire and Magnet). (Specific scores redacted.) | |
| Procedural Duration (Traction Wire) | "Traction better than Control" or "Traction similar to Control" expected outcome. | Traction similar to Control (for Traction Wire). (Specific scores redacted.) | |
| Procedural Duration (Traction Magnet) | "Traction better than Control" or "Traction similar to Control" expected outcome. | Control better than Traction (for Traction Magnet). This was deemed acceptable as deployment is expected to take additional time. (Specific scores redacted.) |
2. Sample Sizes and Data Provenance
- Bench Testing: The document states that the longest nitinol wire device (ERD-TW35) was used as a representative model for Traction Wire testing. For the Traction Magnet, both models (ERD-TMLG and ERD-TMSM) were used. The sample sizes for each mechanical test are not explicitly stated as numerical values (e.g., "n=X") but are implied by the performance claims that "The device passed all the tests." The provenance is internal bench testing, likely conducted prospectively by the sponsor.
- Usability Testing:
- Traction Wire: A total of (b)(4) procedures were performed (mixture of different organs and with/without traction). Specifically, (b)(4) procedures with Traction Wire and (b)(4) procedures without Traction (control) for Visualization (N1.1) and Perforation (N1.4). (b)(4) procedures with Traction and (b)(4) without for Procedure Time (N1.2). (b)(4) procedures each in esophagus, stomach, and colorectal for anatomical locations (N1.3). (b)(4) procedures with (b)(4) cm lesions for lesion size (N1.5). (b)(4) procedures for trauma (N1.6) and complications (N1.7). The data provenance is described as "Ex-vivo porcine and bovine tissue from the esophagus, stomach and colon."
- Traction Magnet: Sample sizes are largely redacted (indicated as (b)(4)). Two procedures each in the stomach and colon were used for testing. (b)(4) procedures with Traction Magnet and (b)(4) without Traction for Visualization (NL1), Procedure Time (NL2), and Perforation (NL4). Minimum (b)(4) successful dissections each in stomach and colorectal for anatomical locations (NL3). Minimum (b)(4) with (b)(4) lesions and minimum (b)(4) with (b)(4) lesions for lesion size (NL5). The data provenance is also "Ex-vivo porcine and bovine tissue from the esophagus, stomach and colon."
- Animal Testing (In Vivo):
- Animals: (b)(4) animals for traction wire testing and (b)(4) animals for traction magnet testing. Each animal was the subject of device procedures and control procedures.
- Procedures: Table 5 (redacted) outlines the number of procedures for each device and tissue type. Specifically, N=8 procedures for control and N=8 procedures for test for both Traction Wire and Traction Magnet endpoints in Tables 6 and 7, respectively. Lesions of (b)(4) to (b)(4) cm were created.
- Provenance: This was a GLP-compliant study using live porcine models, described as in vivo testing.
3. Number of Experts and Qualifications for Ground Truth
- Usability Testing: The document states "All clinicians participating in the study were trained in therapeutic endoscopy, including training in submucosal dissection." It specifically stratified physicians by experience:
- Novice: < 3 years and/or < 20 ESD cases to date.
- Moderate: 3-5 years of experience and/or 1-2 ESD cases per month.
- Skilled: > 5 years of experience and three or more ESD cases per month.
- For the Traction Wire, "skilled by moderate and provice physicians participated."
- For the Traction Magnet, "two skilled, two moderate and two novice physicians participated."
- The observations and ratings from these physicians formed the basis of the usability ground truth.
- Animal Testing: Bleeding, perforation, mucosal laceration, visualization, ease of removal, and ease of procedure were assessed by "study physicians intraoperatively via endoscopic visualization." No specific number of physicians is given for the animal studies, but they are implied to be experts in therapeutic endoscopy and ESD.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1) for the usability or animal studies. It appears that the expert physicians directly provided the ratings and assessments which were then used to calculate means and comparisons. For perforation in the animal study, it notes a singular assessment that was then reviewed for causality ("unrelated to the device use or design or the control procedure").
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
While not explicitly termed an "MRMC study," the usability testing and animal (in vivo) testing were designed as comparative effectiveness studies where human readers (physicians/experts) performed procedures with and without AI (device) assistance. The "AI" here refers to the device itself as providing assistance, not an AI algorithm in the traditional sense of image analysis.
- Effect Size of Human Readers (with device vs. without):
- Visualization: For both Traction Wire and Traction Magnet, the device showed PASS for visualization, meaning the average visualization score with the device was equal to or better than without. This indicates a positive effect on visualization compared to unassisted procedures. For the animal study, Visualization (Start, Mid, End) was consistently rated as Traction better than Control for both devices.
- Procedure Time: For the Traction Wire, procedure time was PASS (device time <= control time). For the Traction Magnet, procedure time was PASS but the result was "Control better than Traction," meaning the control group completed faster, but this was deemed acceptable due to expected deployment time.
- Perforation: For both usability and animal studies, "Perforation rate with traction device <= perforation rate without traction device" was generally met, indicating no increase in perforation risk. In the animal study, the Traction Magnet even showed "Perforation: Traction better than Control."
- Ease of Procedure: In the animal study, "Ease of Procedure (Easiness, Temporal, Effect)" was consistently rated as Traction better than Control for both devices, suggesting an improvement in user experience with the device assistance.
These results indicate that the device (as an assistive tool) leads to improved or similar performance across several key metrics for human operators, with specific advantages in visualization and ease of procedure.
6. Standalone (Algorithm Only) Performance
This question appears to be primarily applicable to AI/ML algorithms. The ProdiGI device is a physical endoscopic traction device, not a software algorithm. Therefore, no standalone (algorithm only) performance was conducted or is applicable. The "performance" of this device is inherently tied to its use by a human operator.
7. Type of Ground Truth Used
- Bench Testing: Engineered specifications, mechanical measurements, and direct observation of device function against predetermined thresholds.
- Usability Testing: Expert consensus/subjective rating scales (e.g., 3-point or 5-point visualization scales) provided by trained clinicians performing procedures on ex-vivo tissue, combined with objective measures like procedure time and observed adverse events.
- Animal Testing (In Vivo): Direct intraoperative observation by study physicians (using Likert scales for bleeding, binary for perforation, and subjective scales for visualization and ease of use) and necropsy findings (for perforation and mucosal laceration), performed on live porcine models. This represents a form of outcomes data (physiological effects, procedural outcomes) directly observed by experts.
8. Sample Size for the Training Set
This question is typically relevant for AI/ML models where a distinct "training set" and "test set" are used. For a physical medical device undergoing traditional non-clinical and usability testing, there isn't a "training set" in the AI sense. The development of the device itself would involve iterative design and testing, but not a formally defined "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
As noted above, a "training set" for a physical device is not typically defined in the same way as for an AI/ML model. The "ground truth" for the device's design and functionality would be established through engineering specifications, clinical needs assessments, and iterative testing/refinement during its development lifecycle, prior to formal validation studies described here.
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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.
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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.
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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
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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
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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
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- Sensitization
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- Irritation or Intracutaneous Reactivity
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- Material-Mediated Pyrogenicity
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- 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.
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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 WireTensile Test | Test the mechanical integrity of theattached wire. | The grasper to wire tensile force should beabove (b)(4)The crimp to wire tensile test must be above(b)(4) | |
| Traction GrasperTensile Test | Test the mechanical integrity of thegrasper and components. | Introducer sheath to hub bond strength shouldbe greater than (b)(4)The handle and deployment mechanism bondsincluding the following connections:- Proximal handle slider to crimp shouldhave a tensile strength greater than(b)(4)- Tine puller/jaw seat to nitinol wireshould have a tensile strength greaterthan (b)(4)Shaft to handle tensile strength must be greaterthan (b)(4) | |
| Torque Test andTorque Stabilityand articulation | The user should be able to rotate thegrasper vertically relative to the lesionand rotate it horizontally when grabbingthe wire. Rotation of graspers allows forcorrect placement of the graspers on theanatomy. | Torque to rotate device should be less than $(b)(4)$ in-oz.Bond must remain intact after being torqued inworst-case tortuosity.Graspers should be able to be rotated to fourquadrants in worst case tortuosity.The angle of the colonoscope should notchange by more than $(b)(4)$ degrees in the fullyretroflexed position after insertion of the | |
| Insertion/Removal | Force required to insert and remove thedevice is less than or equal to the averageperson's ability to push or remove thedevice through the minimum compatibleendoscope working channel. | device.The graspers must be able to be passed througha $(b)(4)$ scope channel in tortuosity withoutdamage to the scope channel as defined bygenerating macroscopic particulate.The graspers must be able to be passed througha $(b)(4)$ scope channel in tortuosity withoutdamage to any of the device components.The force to insert the 1st and 2nd graspersshould be less than $(b)(4)$ lbf.The 1st grasper sheath/introducer should notkink or buckle upon insertion into the scope.Removal of 1st and 2nd graspers should be lessthan $(b)(4)$ lbf.The graspers must be able to be removed froma $(b)(4)$ scope channel in tortuosity withoutdamage to the scope channel as defined by | |
| GrasperDetachment | Evaluate the detachment forces of thegraspers | generating macroscopic particulate.Detachment Force of the 1st grasper to tissuemust be above $(b)(4)$ lbf.Detachment force of the 2nd grasper to tissuemust be above $(b)(4)$ lbf.The arms of the 2nd grasper should not comeout of the capsule during grasper detachmentfrom tissue.Force to remove the 2nd graspers from thetissue should be less than $(b)(4)$ lbf. | |
| Grasper CyclingTest | Test that the graspers of the tractiondevices can be opened and closed fivetimes and still maintain their minimum | Prior to deployment graspers must be able tobe opened and closed $(b)(4)$ and maintaintheir 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 wirewas measured to assess that the force tolift tissue without pulling muscle intocutting plane was within specifications. | The traction wire should be able to produce(b)(4) lbf of upward force measured 10mmfrom the free end of the wire.The traction wire should be able to provide(b)(4) lbf of upward force after (b)(4) ofbeing flattened and released.The lift force of the traction wire should bebelow (b)(4) lbf. | |
| Deployment Force | The user must be able to deploy thegraspers in order to place the tractiondevice in an appropriate location. | The force to deploy graspers by squeezing thegrasper handle should be greater than (b)(4) lbf(b)(4) and less than (b)(4) lbf (b)(4) intortuosity. | |
| Traction WireTissue Test | Device should not cause mucosallaceration during use or removal of thedevice. | A standard ESD knife should not causeperforation in (b)(4) colon if the knife cutsthrough the wire during dissection.Device edges (deployed graspers, wireincluded wire after it is cut by knife, andcrimp) should not cause mucosal laceration inexplanted esophageal tissue when pulledthrough as an assembly. | |
| DimensionalInspection -SpecificationAssessment | Device conforms to dimensionalspecifications | The traction wire radius should be (b)(4)(b)(4) after assembly with the first grasper anddeployment.The traction wire stance should be (b)(4)The wire should be offered in flattened lengthsof: (b)(4)The outer diameter of the graspers must be lessthan (b)(4)The working length of both graspers must be | |
| Test | Description | Acceptance Criteria | |
| Traction MagnetTensile Test | Test the mechanical integrity of theattached suture and magnet. | Force to remove the suture from the grasper tobe ≥ (b)(4) lbf.Force to remove the magnet from the suture tobe ≥ (b)(4) lbf.Force to separate crimp from suture to be ≥(b)(4) lbf. | |
| Force to remove the magnet form the grasperbody to be ≤ (b)(4) lbf. | |||
| Traction GrasperTensile Test | Test the mechanical integrity of thegrasper and components. | Introducer sheath to hub bond strength shouldbe greater than (b)(4) lbf.The handle and deployment mechanism bonds,including the following connections:- Proximal handle slider to crimp tubeshould have a tensile strength greaterthan (b)(4) lbf.Shaft to handle tensile strength must be greaterthan (b)(4) lbf. | |
| Torque Test andTorque Stabilityand articulation | Device can be rotated in worst casetortuosity to the desired position in orderto successfully deploy the graspers. | Torque to rotate device should be less than (b)(4)in-oz.Bonds must remain intact after being torquedin worst case tortuosity.Graspers should be able to be rotated to fourquadrants in worst case tortuosity.The angle of the colonoscope should notchange by more than (b)(4) degrees in the fullyretroflexed position after insertion of thedevice. | |
| Insertion/Removal | Force required to insert and remove thedevice is less than or equal to the averageperson's ability to push or remove thedevice through the minimum compatibleendoscope working channel. | The graspers must be able to be passed througha (b)(4) scope channel in tortuosity withoutdamage to the scope channel as defined bygenerating macroscopic particulate.The device must be able to be passed through a2.8 mm scope channel in tortuosity without anydamage to any of the device components.The force to insert the device should be lessthan (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
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Table 2. Performance test results for the ProdiGI Traction Magnet Device
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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.
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| NeedsID | Needs Statement | Acceptance Criteria | Sample Size | Results |
|---|---|---|---|---|
| N1.1 | Device should provide endoscopic visualizationof the submucosa space during entire dissection, | Average visualization score for dissectionwith traction wire ≥ average visualizationscore without traction wire | n procedures with Tractionand b Procedures withoutTraction(See Deviation 8.1) | Visualization Score: PASSTest: 15/24Control: (h)(4) |
| N1.2 | Time to complete an ESD procedure with thedevice should be equivalent to or less than thetime to complete an ESD procedure without thedevice. | Average procedure time (start ofprocedure to end of procedure) withtraction device ≤ average procedure timewithout traction device | Min b Procedures withTraction and g Procedureswithout Traction(See Deviation 8.1) | Procedure Time: PASSTest: 16/24 minutesControl: (n)(4) minutes |
| N1.3 | Device should be able to be utilized in at leasttwo of the following anatomical locations: theesophagus, 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 inesophagus, stomach, andcolorectal | Locations: PASS(D)(4) in stomach13/24 in esophagusch(4) in colon |
| N1.4 | Perforation rate during an ESD procedure withthe device should be equivalent to or less thanan ESD procedure without the device. | Perforation rate with traction device ≤perforation rate without traction device | h Procedures with Tractionand i Procedures withoutTraction(See Deviation 8.1) | Perforation: PASSh perforations with testh perforation with control |
| N1.5 | Device should be able to provide adequatesubmucosal visibility for lesions sizes 2cm-5cm ata minimum. | Minimum of 3 successful dissections(defined as complete resection of lesion)with Traction Wire on 2 cm and 5 cmlesions | Min f procedures with hlesions | Lesion Size: PASSh procedures successfully completed withh cm and b procedures successfullycompleted with h demonstrating theproduct functions over the designatedrange |
| N1.6 | Device should not cause significant unintendedtrauma to the GI tract as defined by trauma thatrequires physician intervention using tools notalready utilized during an ESD procedure. | No incidents of trauma from device thatphysician indicated they would intervenewith tools not used in ESD procedure | m procedures(See Deviation 8.2) | Trauma: PASSm procedures completed with tractionwire with no incidents of trauma noted |
| N1.7 | Device should not introduce any new patientcomplications/serious adverse events that arenot currently observed in an ESD procedure. | No incidents of complications thatphysician deems not typical for ESDprocedure | h procedures(See Deviation 8.2) | Complications: PASSm procedures completed with tractionwire 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.
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| NeedsID | Needs Statement | Acceptance Criteria | Sample Size | Results |
|---|---|---|---|---|
| NL1 | Device should provide endoscopic visualizationof the submucosa space during entire dissection. | Average visualization score fordissection with traction magnet & average visualization score withouttraction magnet | withTraction andwithoutTraction | Visualization Score: PASSTest:Control: |
| NL2 | Time to complete an ESD procedure with thedevice should be equivalent to or less than thetime to complete an ESD procedure without thedevice. | Average procedure time (start ofprocedure to end of procedure) withtraction device & average proceduretime without traction device | withTraction andwithoutTraction | Procedure Time: PASSTest: minutesControl: minutes****Note: One Control case was terminated withoutcompletion due to poor visualization. This case hadan infinite procedure time, so was could not beincluded in statistical analysis. |
| NL3 | Device should be able to be utilized in at leasttwo of the following anatomical locations: theesophagus, stomach, and colorectal. | Minimum of successful dissections(defined as complete resection oflesion) with Traction Magnet in atleast organs | Minimumeach in stomachand colorectal | Locations: PASSin stomach tissuein colorectal tissue |
| NL4 | Perforation rate during an ESD procedure withthe device should be equivalent to or less thanan ESD procedure without the device. | Perforation rate with traction device& perforation rate without tractiondevice | withTraction andwithoutTraction | Perforation: PASSTest: case with perforation which happened priorto Magnet deployment (1 case out of )Control: cases with perforations and cases withmuscle damage, but not through cases out of |
| NL5 | Device should be able to provide adequatesubmucosal visibility for lesions sizes ata minimum. | Minimum of successful dissections(defined as complete resection oflesion) with Traction Magnet on and lesions | Minimum with lesionsMinimum with lesions | Lesion Size: PASSprocedures successfully completed with cm andprocedures successfully completed with cmdemonstrating the product functions over thedesignated 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.
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- 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.
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- · 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 | ||
| SubmucosalVisualization (Start) | Traction better than Control | ||
| SubmucosalVisualization (Middle) | Traction better than Control | ||
| SubmucosalVisualization (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 | ||
| SubmucosalVisualization (Start) | Traction better than Control | ||
| SubmucosalVisualization (Middle) | Traction better than Control | ||
| SubmucosalVisualization (End) | Traction better than Control | ||
| Ease of Procedure(Easiness) | Traction better than Control |
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| 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.
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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 erroror improper device use | In vivo performance testingNon-clinical performance testingUsability assessmentLabeling |
| Infection | Sterilization validationShelf life testingLabeling |
| Device failure/malfunction leading topatient injury | Non-clinical performance testing |
| Increased procedure time and sedationtime due to time needed to deploy device | In vivo performance testingUsability 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)
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- (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.
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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
N/A