The Insufflation Retention Device (IRD) is an accessory to an endoscope. The IRD is a single balloon accessory intended for use with any standard endoscope that has a distal tip outer diameter of 9.2-13.2 mm. The device is indicated to assist with optical visualization in the large intestine during endoscopic procedures.
Device Story
The Insufflation Retention Device (IRD) is a non-sterile, single-use colonoscope accessory designed to improve visualization during colonoscopy. The device features a split-section design allowing it to be placed over the shaft of a standard colonoscope (9.2-13.2 mm distal tip diameter). It includes a polyurethane balloon that is manually inflated and deflated by a clinician using a non-sterile syringe. Once positioned at the anus, the inflated balloon creates an adjustable seal that retains insufflation air introduced during the procedure. This retention increases visibility and facilitates colonoscope advancement without compromising scope function or movement. The device is used in professional healthcare facilities by licensed healthcare practitioners. By maintaining insufflation, the device benefits the patient by providing clearer optical visualization of the large intestine.
Clinical Evidence
No clinical data provided. Substantial equivalence is supported by bench testing, including biocompatibility (cytotoxicity, sensitization, irritation/reactivity per ISO 10993-1) and performance testing (device placement, insertion/removal force, pressure leak, scope movement/articulation, balloon burst, and package integrity).
Technological Characteristics
Constructed from polymeric materials, specifically a polyurethane balloon. Designed as a split-section sleeve for colonoscopes. Manual inflation/deflation via syringe. Non-sterile. Compatible with endoscopes having 9.2-13.2 mm distal tip diameters. Biocompatibility per ISO 10993-1.
Indications for Use
Indicated for adults undergoing endoscopic procedures in the large intestine to assist with optical visualization.
Regulatory Classification
Identification
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Special Controls
*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, 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 for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
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July 2, 2026
BPEndo, LLC
% Ann Metz
Regulatory Affairs Specialist
Gilero, LLC
4319 S. Alston Ave.
Durham, North Carolina 27713
Re: K261587
Trade/Device Name: Insufflation Retention Device (IRD) (11173-325-101)
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: FDF
Dated: June 2, 2026
Received: June 2, 2026
Dear Ann Metz:
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.
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"
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K261587 - Ann Metz
Page 2
(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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 Management System Regulation (QMSR) (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-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).
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K261587 - Ann Metz
Page 3
Sincerely,
# SHANIL P. HAUGEN -S
Shanil P. Haugen, Ph.D.
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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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K261587 | ? |
| Please provide the device trade name(s). | | ? |
| Insufflation Retention Device (IRD) (11173-325-101) | | |
| Please provide your Indications for Use below. | | ? |
| The Insufflation Retention Device (IRD) is an accessory to an endoscope. The IRD is a single balloon accessory intended for use with any standard endoscope that has a distal tip outer diameter of 9.2-13.2 mm. The device is indicated to assist with optical visualization in the large intestine during endoscopic procedures. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
| Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? |
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BPENDO
Insufflation Retention Device
510(k) Notification
BPENDO
Insufflation Retention Device (IRD)
K261587
Page 1 of 5
### 510(k) Summary
| Company Name: | BPENDO, LLC |
| --- | --- |
| Company Address: | 216 Foreman Circle Norman, OK 73069 |
| Company Phone: | +1 (405) 974-0776 |
| Official Contact: | Ann Metz |
| --- | --- |
| Phone: | +1 (262) 955-9774 |
| E-mail: | ametz@gilero.com |
| Submission Date: | May 13, 2026 |
| --- | --- |
### Device Identification:
| Trade Name: | Insufflation Retention Device (IRD) |
| --- | --- |
| Common Name: | Colonoscope Accessory |
| Device Class: | 2 |
| Regulation Number: | 876.1500 |
| Regulation Name: | Endoscope and Accessories |
| Product Code: | FDF |
| Review Panel: | Gastroenterology/Urology |
### Predicate Device:
| Manufacturer: | BPEndo, LLC |
| --- | --- |
| Trade Name: | Insufflation Retention Device (IRD) |
| 510(k): | K213773 |
### Device Description:
The IRD is a non-sterile accessory for a colonoscope which provides an adjustable seal between a colonoscope and a patient's anus. This seal retains introduced insufflation air introduced during a colonoscopy. The retained insufflation air provides increased visibility and facilitates the advancement of the colonoscope. The IRD contains a split section which allows it to be placed over the continuous shaft of the colonoscope. The adjustable seal is inflated and deflated manually with a non-sterile syringe.
### Indications for Use:
The Insufflation Retention Device (IRD) is an accessory to an endoscope. The IRD is a single balloon accessory intended for use with any standard endoscope that has a distal tip outer diameter of 9.2-13.2 mm. The device is indicated to assist with optical visualization in the large intestine during endoscopic procedures.
### Technological Characteristics and Substantial Equivalence:
The following chart presents an overview of comparisons between the subject device (IRD) and the predicate device BPEndo Insufflation Retention Device (IRD)):
5-1
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[LOGO]
BPENDO
Insufflation Retention Device
510(k) Notification
BPENDO
Insufflation Retention Device (IRD)
K261587
Page 2 of 5
| Device Attribute | SUBJECT: K261587 [BPENDO] Insufflation Retention Device | PREDICATE: [BPENDO] Insufflation Retention Device, K213773 |
| --- | --- | --- |
| Device Class | 2 | 2 |
| Device Classification Name | Colonoscope and Accessories, Flexible/rigid | Colonoscope and Accessories, Flexible/rigid |
| Regulation Number | 876.1500 | 876.1500 |
| Product Code | FDF | FDF |
| Indications for Use and Intended Use | The Insufflation Retention Device (IRD) is an accessory to an endoscope. The IRD is a single balloon accessory intended for use with any standard endoscope that has a distal tip outer diameter of 9.2-13.2 mm. The device is indicated to assist with optical visualization in the large intestine during endoscopic procedures. | The Insufflation Retention Device (IRD) is an accessory to an endoscope. The IRD is a single balloon accessory intended for use with any standard endoscope that has a distal tip outer diameter of 9.2-13.2 mm. The device is indicated to assist with optical visualization in the large intestine during endoscopic procedures. |
| Intended Users | Licensed healthcare practitioners (physicians, nurses, and healthcare professionals (HCPs) | Licensed healthcare practitioners (physicians, nurses, and healthcare professionals (HCPs) |
| Intended Use Environment | Professional healthcare facilities | Professional healthcare facilities |
| Technology and Design | The IRD is constructed from polymeric materials and is designed to access the large intestine through the anus as a colonoscope accessory placed over the colonoscope. The IRD contains a urethane balloon which can be manually inflated and deflated by the user. This balloon, as part of the overall device is inserted into the large intestine through the anus in a deflated state When temporarily inflated by the user, the balloon allows increased visibility of the large intestine through the retention of insufflation gas introduced normally as part of the colonoscopy procedure. The IRD allows free movement of the colonoscope, without compromising the colonoscope function | The IRD is constructed from polymeric materials and is designed to access the large intestine through the anus as a colonoscope accessory placed over the colonoscope. The IRD contains a urethane balloon which can be manually inflated and deflated by the user. This balloon, as part of the overall device is inserted into the large intestine through the anus in a deflated state When temporarily inflated by the user, the balloon allows increased visibility of the large intestine through the retention of insufflation gas introduced normally as part of the colonoscopy procedure. The IRD allows free movement of the colonoscope, without compromising the colonoscope function |
| Principles of Operation | The IRD fits over a colonoscope. The device contains one deflated balloon. After the device has been positioned appropriately at the terminal end of the large intestine (anus), the balloon is manually inflated with air using a syringe. Balloon inflation allows introduced insufflation to provide greater visibility in the large intestine. | The IRD fits over a colonoscope. The device contains one deflated balloon. After the device has been positioned appropriately at the terminal end of the large intestine (anus), the balloon is manually inflated with air using a syringe. Balloon inflation allows introduced insufflation to provide greater visibility in the large intestine. |
5-2
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BPENDO
Insufflation Retention Device
510(k) Notification
BPENDO
Insufflation Retention Device (IRD)
K261587
Page 3 of 5
| Device Attribute | SUBJECT: K261587 [BPENDO] Insufflation Retention Device | PREDICATE: [BPENDO] Insufflation Retention Device, K213773 |
| --- | --- | --- |
| Biocompatibility | Acceptable biological risk established by demonstrating that the device meets ISO 10993. See Section 15 – Biocompatibility. | Acceptable biological risk established by demonstrating that the device meets ISO 10993 |
| Sterilization | Non-sterile | Non-sterile |
| Prescription | Rx only | Rx only |
5-3
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BPENDO
Insufflation Retention Device
510(k) Notification
BPENDO
Insufflation Retention Device (IRD)
# Substantial Equivalence:
The Insufflation Retention Device is substantially equivalent to the predicate: BPEndo Insufflation Retention Device (IRD). The subject device and the predicate device have similar indications for use and intended use. Both devices are accessories for colonoscopes which utilize manual, clinician inflation of elastomeric (polyurethane) balloons to stabilize the device in the large intestines. Both devices are used to assist the visibility for clinicians using the endoscope. Both devices accomplish this improved visibility without compromising the use of the endoscope. Both devices are single-use and non-sterile.
Comparison of the primary technological difference between the subject IRD and the predicate IRD devices do not introduce new questions about the safety or efficacy of the subject device. The subject IRD has a resin change to the inflation balloon.
# Discussion of Non-clinical Tests:
The following non-clinical tests were conducted to demonstrate substantial equivalence to the predicate device.
# Biocompatibility:
The IRD, like the predicate device, was evaluated for biocompatibility appropriate to the contact characterization (type and duration), in accordance with the requirements of ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process, and the FDA Guidance for Industry - Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Specific testing included:
- Cytotoxicity
- Sensitization
- Irritation or Intracutaneous Reactivity
# Performance Testing:
The following performance data were provided in the original 510K, K213773. The test methods used in support of this Premarket Notification are the same as in K213773.
- Device Placement
- Insertion Force
- Pressure Leak
- Scope diameter testing
- Balloon diameter testing
- Scope movement
- Scope articulation
- Device Removal
- Device security
- Device Shelf life
- Multiple use testing
- Package integrity
- Glove usability
- Use time
- Attachment force
- Balloon feedback
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K261587
Page 4 of 5
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BPENDO
Insufflation Retention Device
510(k) Notification
BPENDO
Insufflation Retention Device (IRD)
- Connector leakage
- Balloon burst
K261587
Page 5 of 5
## Conclusion
The information in this submission supports the safety and efficacy of the subject device for its intended use and demonstrates substantial equivalence with the predicate device. The IRD's difference in balloon material from the predicate device do not raise new questions about safety and effectiveness.
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