(231 days)
Not Found
No
The device description and performance studies focus on mechanical and physical properties, with no mention of AI/ML or image processing.
No
The device is an accessory to an endoscope, intended to assist with optical visualization during endoscopic procedures by retaining insufflation air. It does not directly treat or diagnose a disease or condition.
No
The description states its purpose is to "assist with optical visualization" and to retain "insufflation air" to "increase visibility and facilitate the advancement of the colonoscope." These functions are for improving a procedure, not for diagnosing a condition.
No
The device description clearly describes a physical accessory (balloon, syringe, split section) intended for use with an endoscope, not a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Insufflation Retention Device (IRD) is an accessory used during an endoscopic procedure to improve visualization by retaining insufflation air. It does not analyze any biological samples from the patient.
- Intended Use: The intended use is to "assist with optical visualization in the large intestine during endoscopic procedures." This is a procedural aid, not a diagnostic test performed on a sample.
- Device Description: The description clearly states it's a mechanical accessory that creates a seal to retain air. It doesn't mention any components or processes related to analyzing biological samples.
Therefore, the IRD falls under the category of a medical device used in vivo (within the body) to facilitate a procedure, rather than an in vitro diagnostic device that analyzes samples outside the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FDF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
large intestine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intended Users: Licensed healthcare practitioners (physicians, nurses, and healthcare professionals (HCPs))
Intended Use Environment: Professional healthcare facilities
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)
Non-clinical tests were conducted to demonstrate substantial equivalence to the predicate device. These included Biocompatibility testing (Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity) and Performance Testing (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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 876.1500 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.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
1
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
2
Indications for Use
510(k) Number (if known) K213773
Device Name Insufflation Retention Device
Indications for Use (Describe)
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.
| 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:
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 (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 Interventional
Platform |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 Lumendi DiLumen is an accessory to
an endoscope. The DiLumen dual balloon
accessory is intended for use with any
standard endoscope that has a distal tip
outer diameter of 12.5-14.3 mm and a
working length of 1680mm or greater.
The device is indicated to ensure
complete positioning of an endoscope in
the large intestine, and assist with optical
visualization, diagnosis, and endoscopic
treatment |
| Intended Users | Licensed healthcare practitioners
(physicians, nurses, and healthcare
professionals (HCPs) | Licensed healthcare practitioners |
| Intended Use
Environment | Professional healthcare facilities | Professional healthcare facilities
(Presumed) |
| 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 DiLumen device 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 DiLumen devices contains two
urethane balloons which can be manually
inflated and deflated by the user. These
balloons, as part of the overall device is
inserted into the large intestine through
the anus in deflated states.
When temporarily inflated by the user, the
balloons allow increased visibility of the
balloon-bounded region of the large
intestine
The DiLumen device allows free
movement of the colonoscope, without
compromising the colonoscope function |
| Device Attribute | SUBJECT: [BPENDO]
Insufflation Retention Device | PREDICATE: [Lumendi]
DiLumen Endolumenal Interventional
Platform |
| 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
7
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.