The fecal incontinence insert is indicated for the management of accidental bowel leakage (ABL) due to bowel incontinence. The rectal insert is designed for self insertion to seal and help prevent the involuntary leakage of stool from the rectum.

Device Description

The device is a simple rectal insert which is used to control accidental bowel leakage in adult patients. The single use device is inserted via the anus into the anal canal and rectum. The device engages with and conforms to the anorectal junction and the anal canal to control the accidental leakage of fecal matter.

The device consists of two components: a soft, pre-lubricated, liquid-filled silicone Insert device, and a plastic applicator. The Insert device is soft and flexible which allows engagement with the anorectal junction and the anal canal. The applicator is preassembled inside the Insert device to facilitate insertion of the device and is removed and discarded after the device is in place. The device is available in two sizes, Standard and Large. The device is provided preassembled and non-sterile in individual single-use packages.

AI/ML Overview

The provided text is a 510(k) clearance letter and summary for a medical device, the Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle). It does not describe an AI/ML-driven device or study. Therefore, several sections of your request regarding AI/ML-specific details (like multi-reader multi-case studies, effect size of AI assistance, standalone algorithm performance, training set details, and ground truth for the training set) are not applicable to this document.

However, I can extract information related to the acceptance criteria, the study details, and ground truth as it pertains to the clinical performance of this medical device.

1. A table of acceptance criteria and the reported device performance

The document defines "effectiveness" based on a primary endpoint. While it doesn't explicitly state a pre-defined "acceptance criterion" as a specific threshold that had to be met for clearance, it presents the study's primary effectiveness endpoint and the result. We can infer the "acceptance criterion" was that the device demonstrate a statistically significant reduction in ABL episodes.

Acceptance Criterion (Primary Effectiveness Endpoint)	Reported Device Performance
Effectiveness: Relative percentage change in episodes of Accidental Bowel Leakage (ABL) determined by comparing treatment results to pre-treatment results from the baseline period as measured by daily diary recordings.	44 of 58 subjects (75.9%, 95% CI: 62.8%, 86.1%) achieved a ≥ 50% reduction in ABL episodes. This demonstrated a highly significant device effect (p < .0001).
Safety: Device-related serious adverse events, unanticipated serious adverse events, device deficiencies, and device malfunctions.	No device-related serious AEs, or unanticipated serious AEs. No device deficiencies or malfunctions. One AE (device over-insertion or migration) was definitely related to the device. Post-treatment anoscopy showed no evidence of insert-related trauma.

2. Sample sized used for the test set and the data provenance

Test Set Sample Size: 58 subjects were included in the effectiveness evaluation. The safety population included all 124 enrolled subjects.
Data Provenance: The study was a "prospective, open label, single-arm, non-randomized clinical study" conducted in the US.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The ground truth for effectiveness was based on the patients' own daily diary recordings of ABL episodes. For safety, adverse events were assessed by clinical staff. Post-treatment anoscopy evaluations were performed to assess for device-related trauma. The document does not specify the number or qualifications of clinicians involved in the anoscopy or AE assessment beyond stating it was a clinical trial.

4. Adjudication method for the test set

The document does not describe a formal "adjudication method" in the sense of multiple experts reviewing and reaching consensus on individual cases for the primary effectiveness endpoint, as it was based on patient-reported data. For adverse events, they were classified (e.g., possibly, probably, definitely related to the device), but the adjudication process (e.g., by an independent committee) is not detailed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This device is a physical medical insert for fecal incontinence, not an AI/ML-driven diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This device is a physical medical insert.

7. The type of ground truth used

Effectiveness: Patient-reported daily diary recordings of Accidental Bowel Leakage (ABL) episodes.
Safety: Clinical observation and reporting of adverse events, device deficiencies, malfunctions, and post-treatment anoscopy results.

8. The sample size for the training set

Not Applicable (or not provided/relevant in this context). This is not an AI/ML device that requires a training set in the conventional sense. The "training" for the device would be its design and manufacturing process, which is evaluated through bench testing and clinical trials.

9. How the ground truth for the training set was established

Not Applicable (or not provided/relevant outside of device design/development). As this is not an AI/ML device, there isn't a "ground truth for a training set" in the context of machine learning. The device's design effectiveness and safety were evaluated through extensive bench testing and a clinical trial.

Summary

U.S. Food & Drug Administration 510(k) Clearance Letter

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

July 22, 2025

Minnesota Medical Technologies
℅ Gregory Sachs
Consultant
Sachs & Associates, Inc.
16 Crescent Lane
North Oaks, Minnesota 55127

Re: K243367
Trade/Device Name: Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)
Regulation Number: 21 CFR 876.5980
Regulation Name: Gastrointestinal Tube and Accessories
Regulatory Class: Class II
Product Code: PBP
Dated: June 17, 2025
Received: June 17, 2025

Dear Gregory Sachs:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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K243367 - Gregory Sachs
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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K243367 - Gregory Sachs
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

STEPHANIE COLE -S

for Anthony C. Lee, Ph.D., M.B.A.
Assistant Director
DHT3A: Division of Renal, Gastrointestinal,
Obesity, and Transplant Devices
OHT3: Office of Gastrorenal, ObGyn,
General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Indications for Use

Submission Number (if known)
K243367

Device Name
Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)

Indications for Use (Describe)
The fecal incontinence insert is indicated for the management of accidental bowel leakage (ABL) due to bowel incontinence. The rectal insert is designed for self insertion to seal and help prevent the involuntary leakage of stool from the rectum.

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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K243367
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510(k) Summary

Minnesota Medical Technologies Fecal Incontinence Insert

I. SUBMITTER

Minnesota Medical Technologies
2446 Henry Road NW, Stewartville, MN 55976

Contact person: Robert Anglin, VP, Quality & Regulatory
Phone: 507-533-0366
Fax: 507-533-0388
Date prepared: October 28, 2024

II. DEVICE

Name of the device: Minnesota Medical Technologies Fecal Incontinence Insert
Common name: Rectal Insert
Regulation number: 21 CFR 876.5980
Regulation name: Gastrointestinal tube and accessories
Regulatory Class: II
Product Code: PBP

III. PREDICATE DEVICE

Renew Medical Inc., Renew Insert, K122003
Reference device: Eclipse System DEN140020

IV. DEVICE DESCRIPTION

V. INDICATION FOR USE

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K243367
Page 2 of 6

The Fecal Incontinence Insert is indicated for the management of Accidental Bowel Leakage (ABL) due to bowel incontinence. The rectal insert is designed for self-insertion to seal and help prevent the involuntary leakage of stool from the rectum.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

At a high level, the subject and predicate device are based on the following same technological elements:

Product Code
Device Classification Name
21 CFR Regulation Number
Indications for Use
Principle of Operation
Patient Population
Anatomical Site
Location Where Used
Placement/Human Factors
Single Use Only
Provided Non-sterile
Packaging
Assembly
Applicator
Diameter
Shaft Length
Strength Test
Detachment Test
Puncture Test
Buckling Test
Bending Test
Packaging Integrity
Instructions For Use
Labeling
Warning, Precautions
Shelf Life
Applicator Material
Biocompatibility Test Results

The following technological differences exist between the subject and predicate device:

Anorectal Junction Sealing Feature
Shaft Configuration
External Retaining Feature at Anus
Sizes (different in name only)
External Retainer Diameter
Simulated Use Testing Results
Contraindications
Disk or Bulb Material
Shaft Material
External Retainer Material
Patient Lube

VII. NON-CLINICAL PERFORMANCE DATA

Bench Testing

The following bench performance data was provided in support of the substantial equivalence.

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Strength Test
Detachment Test
Puncture Test
Buckling Test
Bending Test
Sealing Function in Simulated Use
Package Functional Testing
Package Stability Testing
Shelf Life Testing

Biocompatibility Testing

The device was assessed in accordance with ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. The following tests were performed per GLP:

ISO 10993-5, Cytotoxicity Using the ISO Elution Method
ISO 10993-10, ISO Guinea Pig Maximization Sensitization Test
ISO 10993-10, Rectal Irritation Study in Rabbits
ISO 10993-11, Material Mediated Pyrogenicity
ISO 10993-3, Bacterial Reverse Mutation Study
ISO 10993-3, Mouse Lymphoma Assay

A biological risk assessment was performed to identify areas of concern to be addressed by literature review, clinical experience, and testing with consideration given to type of patient contact, potential hazards of the materials of construction, the history of clinical use, and testing of the materials of construction, biocompatibility and chemical characterization testing on the device, and other information available in the literature.

Based upon examination of the device materials and test results, use of the Minnesota Medical Technologies Fecal Incontinence Insert would not be expected to result in an adverse biological response when used as intended.

Based on the design verification performance, the Minnesota Medical Technologies Fecal Incontinence Insert was found to have a safety and effectiveness profile that is substantially equivalent to the predicate device.

VIII. CLINICAL PERFORMANCE DATA

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A prospective, open label, single-arm, non-randomized clinical study designed to establish the safety and effectiveness of the Minnesota Medical Technologies Fecal Incontinence Insert in subjects with fecal incontinence. The US clinical trial was performed with male and female patients, aged 18 and above, with a diagnosis of fecal incontinence and have also failed conservative medical therapy and biofeedback therapy as appropriate for fecal incontinence. The trial consisted of a 4-week baseline evaluation period, a 4-week fitting period, and a 4-week treatment period.

Effectiveness of the insert was evaluated by the primary effectiveness endpoint:

A relative percentage change in episodes of Accidental Bowel Leakage (ABL) determined by comparing treatment results to pre-treatment results from the baseline period as measured by daily diary recordings.

The primary endpoint was satisfied with 44 of 58 subjects (75.9%, 95% CI: 62.8%, 86.1%) achieved a ≥ 50% reduction in ABL episodes demonstrating a highly significant device effect (p < .0001).

Safety of the insert was evaluated through safety endpoints which included adverse events, serious adverse events, unanticipated serious adverse events, device deficiencies, and device malfunctions.

The safety population included all 124 enrolled subjects (enrolled = signed informed consent prior to initial screening). There were 15 adverse events (AEs) reported in 12 subjects of which ten AEs were not related to the device, where one of these was serious. Three AEs were classified as possibly related to the device, one AE was classified as probably related to the device, and one AE was classified as definitely related to the device.

The one AE classified as definitely related to the device was device over-insertion or device migration into the anal canal or rectum.

There were no device-related serious AEs, or unanticipated serious AEs. There were no device deficiencies or malfunctions.

After the treatment period, all individuals who withdrew from the study for reasons other than personal preference (i.e., for medical reasons) and a minimum of 50% of all subjects who completed the study, underwent an evaluation by anoscopy following the treatment period to assess for device related trauma. No patients necessitated an anoscopy due to new anorectal bleeding or moderate or severe pain noted in the bowel diary. Post-

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treatment period anoscopy results do not show evidence of insert-related trauma.

Comparison of the insert to the predicate shows that the insert performs as well as or better than the legally marketed predicate device. The clinical trials for the proposed device and predicate device have similar design, compared a treatment period to a baseline period, and were performed on male and female adult patients with a diagnosis of fecal incontinence.

The clinical study results support that the Minnesota Medical Technologies Fecal Incontinence Insert is safe and effective when used for the intended purpose. The clinical performance (safety and effectiveness) of the insert support the determination of substantial equivalence of the insert to the predicate device.

IX. SUBSTANTIAL EQUIVALENCE

The indication for use for the Minnesota Medical Technologies Fecal Incontinence Insert is substantially equivalent to the predicate. The technological characteristics of the Minnesota Medical Technologies Fecal Incontinence Insert are similar to the predicate device. Both the proposed device and the predicate device have a bar-bell design which incorporates both an internal and external retention feature which are connected by a central shaft. Both are inserted with a removable applicator. Both control accidental bowel leakage through engagement of the device with the anorectal junction.

The Minnesota Medical Technologies Fecal Incontinence Insert has the same intended use, patient population, and anatomical sites as well as similar technological characteristics as the predicate device. The differences in technological characteristics have been analyzed and addressed through testing and clinical evaluation. Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness.

The nonclinical and clinical testing demonstrate that the Minnesota Medical Technologies Fecal Incontinence Insert is as safe, as effective, and performs as well as or better than the predicate device. Thus, the Minnesota Medical Technologies Fecal Incontinence Insert is substantially equivalent to the predicate device.

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X. CONCLUSION

Based on the same indications for use, technological characteristics, performance testing, and clinical evaluation, safety, and performance, the Minnesota Medical Technologies Fecal Incontinence Insert, is substantially equivalent to the Renew Medical, Inc. Renew Insert (K122003).

Regulation Number and Section

§ 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.