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 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.

AI/ML Overview

The provided text is a 510(k) summary for the Insufflation Retention Device (IRD), a medical device accessory. This document details the device's characteristics, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the specific information requested regarding acceptance criteria for clinical performance and the detailed study that proves the device meets those criteria.

Specifically, the document focuses on:

Device Identification and Description: Trade name, common name, device class, regulation number, product code, and a description of the IRD's function and physical characteristics.
Indications for Use: The IRD is a single balloon accessory intended for use with standard endoscopes to assist with optical visualization in the large intestine during endoscopic procedures.
Predicate Device Comparison: A detailed table comparing the IRD to the predicate device (Lumendi DiLumen Endolumenal Interventional Platform) based on various attributes like device class, indications for use, technology, design, and principles of operation.
Substantial Equivalence Argument: An explanation of why the IRD is substantially equivalent to the predicate device, highlighting similarities and addressing differences in balloon count and the absence of a balloon extension/retraction mechanism in the IRD.
Non-clinical Tests: A list of non-clinical tests performed, including biocompatibility (Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity) and various performance tests (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, Connector leakage, Balloon burst).

Missing Information:

The document does not provide:

A table of acceptance criteria for device performance and reported performance metrics. While it lists performance tests, it does not specify the quantitative or qualitative acceptance criteria for these tests nor the results achieved against those criteria.
Details about specific studies (Clinical or otherwise) that prove the device meets acceptance criteria. The "Performance Testing" section lists types of tests, but not a study design, methodology, or results for any of them.
Sample sizes for test sets, data provenance, number/qualifications of experts, or adjudication methods related to any clinical performance evaluation. The document only mentions non-clinical testing.
Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
Information about standalone algorithm performance (human-in-the-loop performance is irrelevant as this is a physical device, not an AI/software device).
Type of ground truth used for performance evaluation.
Sample size for the training set (not applicable for this type of device submission).
How the ground truth for the training set was established (not applicable for this type of device submission).

In summary, the provided text describes a 510(k) clearance for a physical medical device based on non-clinical testing and substantial equivalence to a predicate. It does not include the detailed clinical performance acceptance criteria or studies that would be relevant for a device, especially an AI/software device, meeting specific performance metrics as commonly understood in the context of your request.

Summary

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July 21, 2022

Bpendo, LLC % James Fentress Director, R&D and Regulatory Policy Gilero, LLC 635 Davis Drive STE 100 Morrisville, NC 27560

Re: K213773

Trade/Device Name: Insufflation Retention Device Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FDF Dated: June 14, 2022 Received: June 21, 2022

Dear James Fentress:

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 (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 located 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.

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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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/medicaldevice-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-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-advicecomprehensive-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).

Sincerely,

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

510(k) Number (if known) K213773

Device Name Insufflation Retention Device

Indications for Use (Describe)

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

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Image /page/3/Picture/0 description: The image is a logo for BPENDO. The logo consists of a stylized hourglass symbol on the left, followed by the text "BPENDO" in a bold, sans-serif font. Below the text, there is a smaller line of text that reads "Insufflation Retention Device."

K213773 Page 1 of 5 510(k) Notification BPENDO

Insufflation Retention Device (IRD)

510(k) Summary

Company Name:
Company Address:

Company Phone:

Official Contact: Phone: E-mail:

BPENDO, LLC 216 Foreman Circle Norman, OK 73069 +1 (405) 974-0776

Jim Fentress +1 (919) 595-8236 jfentress@gilero.com

Submission Date:

November 18, 2021

Device Identification:

Trade Name: Common Name: Device Class: Regulation Number: Regulation Name: Product Code: Review Panel:

Insufflation Retention Device (IRD) Colonoscope Accessory 2 876.1500 Endoscope and Accessories FDF Gastroenterology/Urology

Predicate Device:

Manufacturer:	LUMENDI, LLC
Trade Name:	DiLumen Endolumenal Interventional Platform
510(k):	K162428

Device Description:

Indications for Use:

Technological Characteristics and Substantial Equivalence:

The following chart presents an overview of comparisons between the subject device (IRD) and the predicate device (DiLumen Endolumenal Interventional Platform):

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Image /page/4/Picture/1 description: The image shows the logo for BPENDO. The logo is in blue and consists of a stylized hourglass shape on the left, followed by the text "BPENDO" in a sans-serif font. Below the text "BPENDO" is the text "Insufflation Retention Device" in a smaller font.

510(k) Notification

Device Attribute	SUBJECT: [BPENDO]Insufflation Retention Device	PREDICATE: [Lumendi]DiLumen Endolumenal InterventionalPlatform
Device Class	2	2
Device ClassificationName	Colonoscope and Accessories,Flexible/rigid	Colonoscope and Accessories,Flexible/rigid
Regulation Number	876.1500	876.1500
Product Code	FDF	FDF
Indications for Use andIntended Use	The Insufflation Retention Device (IRD)is an accessory to an endoscope. The IRDis a single balloon accessory intended foruse with any standard endoscope that hasa distal tip outer diameter of 9.2-13.2 mm.The device is indicated to assist withoptical visualization in the large intestineduring endoscopic procedures.	The Lumendi DiLumen is an accessory toan endoscope. The DiLumen dual balloonaccessory is intended for use with anystandard endoscope that has a distal tipouter diameter of 12.5-14.3 mm and aworking length of 1680mm or greater.The device is indicated to ensurecomplete positioning of an endoscope inthe large intestine, and assist with opticalvisualization, diagnosis, and endoscopictreatment
Intended Users	Licensed healthcare practitioners(physicians, nurses, and healthcareprofessionals (HCPs)	Licensed healthcare practitioners
Intended UseEnvironment	Professional healthcare facilities	Professional healthcare facilities(Presumed)
Technology and Design	The IRD is constructed from polymericmaterials and is designed to access thelarge intestine through the anus as acolonoscope accessory placed over thecolonoscope.The IRD contains a urethane balloonwhich can be manually inflated anddeflated by the user. This balloon, as partof the overall device is inserted into thelarge intestine through the anus in adeflated stateWhen temporarily inflated by the user, theballoon allows increased visibility of thelarge intestine through the retention ofinsufflation gas introduced normally aspart of the colonoscopy procedure.The IRD allows free movement of thecolonoscope, without compromising thecolonoscope function	The DiLumen device is constructed frompolymeric materials and is designed toaccess the large intestine through the anusas a colonoscope accessory placed overthe colonoscope.The DiLumen devices contains twourethane balloons which can be manuallyinflated and deflated by the user. Theseballoons, as part of the overall device isinserted into the large intestine throughthe anus in deflated states.When temporarily inflated by the user, theballoons allow increased visibility of theballoon-bounded region of the largeintestineThe DiLumen device allows freemovement of the colonoscope, withoutcompromising the colonoscope function
Device Attribute	SUBJECT: [BPENDO]Insufflation Retention Device	PREDICATE: [Lumendi]DiLumen Endolumenal InterventionalPlatform
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 DiLumen device fits over a colonoscope. The device contains two deflated balloons. When positioned appropriately within the large intestines, the balloons are inflated with air using an inflation handle with a squeeze bulb to inflate the balloons within the large intestines. Balloon inflation allows greater visibility in the bounded region in the large intestine.
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

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Image /page/5/Picture/1 description: The image contains the logo for BPENDO. The logo consists of a stylized hourglass symbol on the left, followed by the text "BPENDO" in a bold, sans-serif font. Below the text, there is a smaller line of text that reads "Insufflation Retention Device". The text and hourglass symbol are all in a light blue color.

510(k) Notification

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Image /page/6/Picture/0 description: The image is a logo for BP ENDO Insufflation Retention Device. The logo features a stylized hourglass symbol on the left, followed by the text "BPENDO" in a bold, sans-serif font. Below the text, there is a smaller line of text that reads "Insufflation Retention Device".

K213773 Page 4 of 5

510(k) Notification BPENDO Insufflation Retention Device (IRD)

Substantial Equivalence:

The Insufflation Retention Device is substantially equivalent to the predicate: LUMENDI. LLC DiLumen Endolumenal Interventional Platform. 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 three primary technological differences between the subject IRD and the predicate DiLumen devices do not introduce new questions about the safety or efficacy of the subject device. First, while the DiLumen device utilizes two independently inflatable balloons to stabilize the endoscope compared to the single balloon used in the subject IRD device, the balloons serve similar function, and require similar evaluation to verify function. Second, the IRD does not require a balloon extension/retraction mechanism included in the DiLumen device. The omission of these features does not introduce new or different risks. Finally, the subject IRD and the predicate DiLumen devices utilized different materials for their construction, but the subject device was appropriately evaluated for biological safety consistent with its patient contact and duration of use.

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 support of this Premarket Notification:

Device Placement ●
Insertion Force ●
Pressure Leak
Scope diameter testing ●
Balloon diameter testing
Scope movement
Scope articulation ●
Device Removal

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K213773 Page 5 of 5

510(k) Notification BPENDO Insufflation Retention Device (IRD)

Image /page/7/Picture/2 description: The image is a logo for BPENDO Insufflation Retention Device. The logo features a stylized hourglass symbol to the left of the text "BPENDO" in a bold, sans-serif font. Below the company name is the text "Insufflation Retention Device" in a smaller, sans-serif font.

Device security ●
Device Shelf life ●
Multiple use testing
Package integrity
Glove usability ●
Use time
Attachment force
Balloon feedback ●
Connector leakage
Balloon burst ●

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 differences in external materials, technology and operation from the predicate device do not raise new questions about safety and effectiveness.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
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.(b)
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.