(109 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and clinical effectiveness of a mechanical insert, with no mention of AI or ML technologies.
Yes.
The device is indicated for the management of accidental bowel leakage due to bowel incontinence, aiming to prevent the involuntary leakage of stool from the rectum, which is a direct therapeutic action to manage a medical condition.
No.
The device is designed for the management and prevention of accidental bowel leakage, not for diagnosing a condition. It is a physical barrier to prevent leakage.
No
The device description clearly states it consists of a soft silicone insert and a plastic fingertip applicator, which are physical components, not software.
Based on the provided information, the Renew Insert is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Renew Insert Function: The Renew Insert is a physical device designed for self-insertion into the anal canal to physically seal and prevent the leakage of stool. It does not analyze any bodily specimens or provide diagnostic information.
- Intended Use: The intended use is for the management of accidental bowel leakage, not for diagnosing the cause of the leakage.
- Device Description: The description details a physical barrier device, not a device that interacts with or analyzes biological samples.
Therefore, the Renew Insert falls under the category of a medical device, but specifically a physical barrier device for managing a condition, not an IVD.
N/A
Intended Use / Indications for Use
The Renew Insert is indicated for the management of accidental bowel leakage due to bowel incontinence. The Renew Insert is designed for self-insertion to seal and help prevent the involuntary leakage of stool from the rectum.
Product codes (comma separated list FDA assigned to the subject device)
PBP
Device Description
The Renew Insert is a simple, easy to use device consisting of two components: a soft silicone insert and a plastic fingertip applicator. The Insert is soft and easily deformable, making it safe and comfortable to use. The applicator is flexible and is preassembled inside the Insert and does not come in contact with the anal canal. Renew Inserts are available in two sizes, Regular and Large to accommodate a range of anatomies and incontinence severities. Users are instructed to start with the Regular size and move to the Large size if they experience an inadvertent loss of the Insert or stool leakage around the Insert. The device is provided and non-sterile in individual, single-use blister packs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anal canal, rectum
Indicated Patient Age Range
The study included subjects with a mean age of 68.6 years (range from 33.9 to 88.9 years).
Intended User / Care Setting
self-insertion by the user
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Pilot and pivotal clinical studies were conducted in Europe and in the United States to demonstrate the tolerability, safety and effectiveness of the Renew Insert. Users were required to follow the instructions provided, be capable of self-inserting the Renew Insert during the study, and complete daily diaries to record their episodes of accidental bowel leakage.
A pilot trial was conducted in the US with 22 subjects. These subjects rated the ease of insertion as 9.13 using a scale of 1-10.
A multi-center, prospective, open label, single-arm, non-randomized pivotal study was designed to establish the safety, effectiveness, and tolerability of the Renew Insert in subjects with moderate-to-severe bowel incontinence (defined as having a Wexner score greater than 12). Three (3) clinical sites participated in the US pivotal trial, enrolling a total of ninety-seven (97) subjects. The trial consisted of a 4-week baseline evaluation period, a 12-week treatment period and a 4-week return to baseline period.
For effectiveness, changes to accidental bowel leakage (ABL) were measured by the following two endpoints:
- reduction in ABL frequency (by comparing treatment results to pre-treatment results from the Baseline Period)
- reduction in post-treatment Wexner scores [by comparing post-treatment Wexner scores to pre-treatment (end of Baseline Period) Wexner scores].
The two safety endpoints of the study included:
- absence of Insert-related serious adverse events (primary)
- absence of any serious irritation of the anal canal or lower rectal mucosa from the use of the Insert during the study period (secondary).
Ninety-seven (97) subjects enrolled in the study. Six (6) of the 97 enrolled subjects discontinued participation during the pre-treatment Baseline Period. Ninety-one (91) subjects entered the Treatment Period. The Modified ITT Cohort included all subjects who completed at least one week of Insert use during the 12-week Treatment Period, which was a net population of 85 subjects. Effectiveness results are reported on this cohort of subjects.
During the pre-treatment Baseline Period, ABL frequency for the Modified ITT cohorts was about 8 ABL episodes per week (daily mean of 1.12 +/- SD 0.849 / median 0.89 per day). After treatment with Renew Inserts, ABL was reduced to about 1 ABL episode per week. The Modified ITT had a daily mean of 0.29 +/- SD 0.376 / median 0.17, and a median ABL reduction of 81.8% as compared to the Baseline Period.
Reduction in Wexner Score was analyzed on 77 subjects in the Modified ITT group who had both a pre-treatment and post-treatment Wexner score. The median Wexner Score before treatment with Renew Inserts was 16.0, whereas, the median post-treatment Wexner score was 11.0. There was a 29.4% median reduction in the Wexner score.
Safety was evaluated on any subject who used at least one (1) Renew Insert (N=91). Over half of the subjects experienced some adverse events (AE), with 64.6% of the events assessed by the investigators as 'probable' or 'possible' related to the use of the Insert. There were no events rated as severe, nor were there any reported serious, unanticipated adverse events. Almost all (98.7%) of these possible adverse events were rated as 'mild'. Anorectal events were the most frequent, 'probable/possible' related AEs among all treated subjects. Of these, the sensation of urge was reported by 26.4% of subjects and irritation reported by 13.2% of subjects.
An additional safety endpoint of the study was absence of any serious irritation of the anal or lower rectal mucosa. Pre-treatment and end of treatment anal canal and lower rectal mucosa evaluations (digital rectal examinations and anoscopies) were performed in 77 subjects. End of treatment anal canal and lower rectal mucosa evaluations showed normal digital rectal exams in 100% of the subjects. Anoscopic rectal exam results were normal in 97.4% of subjects, and 2.6% of the treated subjects were found with abnormal exams, and determined not Insert-related.
Overall satisfaction among the majority of Insert users was high and 91.4% of the subjects rated overall experience and ease of use as 9.5 (median) on a 10-point scale.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Median ABL reduction: 81.8%
- Median reduction in Wexner score: 29.4%
- Overall satisfaction: 4.7 (on a 5-point scale)
- Ease of insertion: 9.13 (on a 1-10 scale)
- Percentage of subjects with normal anoscopic rectal exam results: 97.4%
- Percentage of subjects with normal digital rectal exams: 100%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.5980 Gastrointestinal tube and accessories.
(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
0
Image /page/0/Picture/0 description: The image shows the word "Renew" in a stylized, cursive font. Above the word, there are several short, curved lines radiating upwards, resembling sun rays or a burst of energy. The overall design gives the impression of revitalization or freshness.
#KI22003 October 24, 2012
Attachment 1
510(k) Summary
Regulatory Authority
Safe Medical Devices Act of 1990, 21 CFR 807.92
Submitter Information
| Company: | Renew Medical, Inc. |
|---|---|
| 532 Emerson St. | |
| Palo Alto, CA 94301 | |
| Phone: 1-888-987-2929 | |
| Contact Person: | Victoria Mackinnon |
| Sr. Director, Regulatory and Clinical Affairs and Quality Assurance | |
| Summary Date: | October 24, 2012 |
Name and Classification
| Common Name: | Anal Insert |
|---|---|
| Proprietary Name: | Renew Insert |
| Classification Name: | Gastrointestinal tubes and accessories |
| Product Code: | PBP |
| Regulation Number: | 876.5980 |
| Class: | II |
Predicate Devices
The Renew Insert ("Insert") has the same intended use and function as commercially available medical devices:
- a) Procon2; Incontinent Control Device Inc. (#K042431)
Intended Use
The Renew Insert is indicated for the management of accidental bowel leakage due to bowel The Renew Insert is designed for self-insertion to seal and help prevent the incontinence. involuntary leakage of stool from the rectum.
Confidential
1
Renew
#KI22003 October 24, 2012
Description of Device
The Renew Insert is a simple, easy to use device consisting of two components: a soft silicone insert and a plastic fingertip applicator. The Insert is soft and easily deformable, making it safe and comfortable to use. The applicator is flexible and is preassembled inside the Insert and does not come in contact with the anal canal. Renew Inserts are available in two sizes, Regular and Large to accommodate a range of anatomies and incontinence severities. Users are instructed to start with the Regular size and move to the Large size if they experience an inadvertent loss of the Insert or stool leakage around the Insert. The device is provided and non-sterile in individual, single-use blister packs.
Summary of Technological Characteristics
The Renew Insert is self-inserted by the user through the anus into the anal canal. The top disk of the Insert rests against the bottom of the rectum to help prevent bowel leakage. The elastic stem of the Insert spans the anal canal and the bottom disk keeps the Insert in place by resting against the outer part of the anus. The removable fingertip applicator is flexible to allow easy insertion of the Insert. The insert is naturally expelled with voluntary bowel movement, or if desired, can be manually removed by the user.
Performance Testing
The Renew Insert has been verified for performance and functionality and tested to assure conformance to the requirements for its intended use.
The following performance tests were performed on the Renew Insert and its packaging:
- . Tensile testing
- . Detachment testing
- . Puncture testing
- . Buckling testing
- . Bending testing
- . Package integrity testing
Biocompatibility Testing
The biocompatibility of the Renew Insert was assessed in accordance with ISO 10993-1- Biological evaluation of medical devices, Part 1 – Evaluation and tests within a risk management process.
The biocompatibility tests listed below were conducted on the Renew Insert in accordance with the provisions of the FDA GLP regulations 21 CFR Part 58.
- . Cytotoxicity
- Sensitization .
- Irritation
- Rectal Irritation with Histology
- . Systemic Toxicity
- Genotoxicity
Confidential
2
The biocompatibility test results confirmed that the Renew Insert is non-cytotoxic, non-sensitizing, non-irritating, non-toxic, and non-mutagenic when evaluated under the respective test conditions described in ISO 10993.
Usability Evaluation
User assessment evaluations were conducted by consumer panelists under actual use conditions to verify ease of use. On a 5 point scale, overall satisfaction was rated a 4.7. The users were able to use the Renew Insert without difficulty. Usability testing demonstrated the Renew Insert performs as designed and intended.
Clinical Studies
Pilot and pivotal clinical studies were conducted in Europe and in the United States to demonstrate the tolerability, safety and effectiveness of the Renew Insert. Users were required to follow the instructions provided, be capable of self-inserting the Renew Insert during the study, and complete daily diaries to record their episodes of accidental bowel leakage.
A pilot trial was conducted in the US with 22 subjects. These subjects rated the ease of insertion as 9.13 using a scale of 1-10.
Pivotal Study Summary
Renew Medical conducted a multi-center, prospective, open label, single-arm, non-randomized pivotal study designed to establish the safety, effectiveness, and tolerability of the Renew Insert in subjects with moderate-to-severe bowel incontinence (defined as having a Wexner score greater than 12). Three (3) clinical sites participated in the US pivotal trial, enrolling a total of ninety-seven (97) subjects. The trial consisted of a 4-week baseline evaluation period, a 12-week treatment period and a 4-week return to baseline period.
For effectiveness, changes to accidental bowel leakage (ABL) were measured by the following two endpoints:
- reduction in ABL frequency (by comparing treatment results to pre-treatment results from the Baseline Period); and
- reduction in post-treatment Wexner scores [by comparing post-treatment Wexner scores to pre-treatment (end of Baseline Period) Wexner scores].
The two safety endpoints of the study included:
- absence of Insert-related serious adverse events (primary); and
- absence of any serious irritation of the anal canal or lower rectal mucosa from the use of the Insert during the study period (secondary).
Confidential
3
#KJ22003 October 24, 2012
Analysis Cohorts
The Baseline Period was included in the study design to establish the severity of each subject's baseline bowel incontinence (BI) condition, and to establish the frequency and severity of ABL for each subject. At the end of 4 weeks, subjects who continued to meet inclusion criteria were enrolled in the Treatment Period.
All subjects enrolled in the Treatment Period had at least one exposure to the Insert. Therefore, the Intent-to-Treat ("ITT") cohort and the Safety Cohort included the same group of subjects: all subjects who used the Renew Insert at least once during the Treatment Period of the study.
The primary cohort for the effectiveness analyses was the Modified Intent-To-Treat ("Modified ITT") Cohort. Subjects were getting acclimated to the Insert during the first few days of use and tried different sizes of Inserts (regular or large) for comfort and effectiveness. Therefore, the Modified ITT Cohort included all subjects who completed at least one week of Insert use during the 12-week Treatment Period.
Subject Disposition and Demographics
Ninety-seven (97) subjects enrolled in the study. Six (6) of the 97 enrolled subjects discontinued participation during the pre-treatment Baseline Period; 4 subjects did not meeting eligibility criteria and 2 subjects found the protocol too demanding.
Ninety-one (91) subjects entered the Treatment Period. Of these 91 subjects, 90.1% were female, with a mean age of 68.6 years (range from 33.9 to 88.9 years).
These 91 treated subjects were considered as the "ITT Cohort" for the safety endpoints. Of the 91 subjects entering the treatment phase, 6 subjects discontinued study participation before completing week 1. Reasons for discontinuation included: 2 found the protocol too demanding, 2 subjects with pre-existing hemorrhoids made Insert use uncomfortable, and 2 subjects experienced loss of the Renew Insert during urination or from excess anal mucous.
As stated previously, the Modified ITT Cohort included all subjects who completed at least one week of Insert use during the 12-week Treatment Period. The Modified ITT group was a net population of 85 subjects (as the 6 subjects who withdrew during week 1 were excluded). Effectiveness results are reported on this cohort of subjects.
Effectiveness Analysis Results: Summary of ABL Study Endpoints
Reduction in ABL was analyzed on the 85 subjects in the Modified ITT group.
During the pre-treatment Baseline Period, ABL frequency for the Modified ITT cohorts was about 8 ABL episodes per week (daily mean of 1.12 ± SD 0.849 / median 0.89 per day). After treatment with Renew Inserts, ABL was reduced to about 1 ABL episode per week. The Modified ITT had a daily mean of 0.29 ±SD 0.376 / median 0.17, and a median ABL reduction of 81.8% as compared to the Baseline Period (Table 1). ·
Confidential
4
Renew
| ABL Results for Modified ITT Cohort | |||
|---|---|---|---|
| Parameter | Statistic | Result | |
| (Daily) | % Change from End | ||
| of Baseline | |||
| Total Subjects | N | 85 | |
| BASELINE | |||
| PERIOD | MEAN +/- SD | 1.13 +/- 0.849 | |
| BASELINE | |||
| PERIOD | MEDIAN | 0.89 | |
| BASELINE | |||
| PERIOD | (Q1, Q3) | (0.54, 1.54) | |
| BASELINE | |||
| PERIOD | (MIN, MAX) | (0.14, 3.93) | |
| Total Subjects | N | 85 | |
| TREATMENT | |||
| PERIOD | MEAN +/- SD | 0.29 +/- 0.376 | -71.4 +/- 29.879 |
| TREATMENT | |||
| PERIOD | MEDIAN | 0.17 | -81.8 |
| TREATMENT | |||
| PERIOD | (Q1, Q3) | (0.05, 0.37) | (-91.7, -60.3) |
| TREATMENT | |||
| PERIOD | (MIN, MAX) | (0.00, 2.44) | (-100, 44.75) |
| P VALUE (U=0) | -29.4 | ||
| (Q1, Q3) | (8.0, 14.0) | (-46.2, -13.3) | |
| (MIN, MAX) | (0.0, 19.0) | (-100, 18.8) | |