DiLumen C1, EZ1 and Tool Mount

K221452 · Lumendi, LLC · FDF · Feb 10, 2023 · Gastroenterology, Urology

Device Facts

• Record ID: K221452
• Device Name: DiLumen C1, EZ1 and Tool Mount
• Applicant: Lumendi, LLC
• Product Code: FDF · Gastroenterology, Urology
• Decision Date: Feb 10, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Lumendi DiLumen C1 and EZ1 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment.

Device Story

DiLumen C1 and EZ1 are endoscope accessories consisting of a sleeve with a single inflatable distal balloon; fits over standard endoscopes to facilitate positioning and stabilization in the large intestine. C1 includes a flexible tool channel for instrument insertion; EZ1 lacks a tool channel. C1 utilizes a reusable stainless steel Tool Mount to fasten the tool channel to a surgical table rail. Devices are non-sterile, single-patient use. Operation involves manual inflation of the balloon via a bulb to grip the colon wall, stabilizing the endoscope for procedures. Provides a stable platform for clinicians to perform endoscopic treatments. Benefits include improved endoscope positioning and visualization during colonoscopy or surgical procedures.

Clinical Evidence

Bench testing only. Testing included instrument insertion force, tool channel separation force, balloon leak/bond leak testing, colon grip test, fatigue/cycling and system leakage, balloon scope centering, and user verification (usability). All tests met pre-defined specifications.

Technological Characteristics

Materials: Low durometer polyurethane (balloon), extruded polyurethane with hydrophilic coating (sleeve), FEP/Pellethane/stainless steel coil (tool channel), PEBAX (nose cone), stainless steel (Tool Mount). Single balloon design; manual inflation bulb; 60 mm balloon OD; 45 mmHg inflation pressure. Non-sterile; single-use (except reusable Tool Mount).

Indications for Use

Indicated for use in the large intestine to assist with endoscope positioning, optical visualization, diagnosis, and endoscopic treatment.

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.

Predicate Devices

• Lumendi, LLC's DiLumen C2 (K211819)

Submission Summary (Full Text)

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February 10, 2023

Lumendi, LLC % John Smith Partner Hogan Lovells U.S. LLP 555 13th Street NW Washington, DC 20004

Re: K221452

Trade/Device Name: DiLumen C1, EZ1 and Tool Mount Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FDF Dated: January 11, 2023 Received: January 11, 2023

Dear John Smith:

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 Federal statutes and regulations administered by other Federal agencies. You must comply with all the

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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 (QS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Sivakami Venkatachalam -S

for

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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# DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/23/2023 See PRA Statement below

510(k) Number (if known) K221452

#### Device Name

DiLumen C1, EZ1 and Tool Mount

Indications for Use (Describe)

The Lumendi DiLumen C1 and EZ1 is an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment.

Type of Use (Select one or both, as applicable)

[Z]Prescription Use (Part 21 CFR 801 Subpart D)

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# 510(k) SUMMARY

# Lumendi, LLC's DiLumen C1, EZ1 and Tool Mount - K221452

# Submitter's Information:

LUMENDI, LLC 253 Post Road West Westport, CT 06880 Phone: [phone] Fax: [phone]

# Contact Person:

Dennis J. Daniels Senior Director, Regulatory Affairs and Quality Assurance Telephone: [phone] Fax: [phone] Email: [e-mail]

Date Prepared: January 24, 2023

# Device Identification:

| Trade Name: | DiLumen C1, EZ1 and Tool Mount |
|----------------------------|--------------------------------|
| Common Name: | Endoscope Accessory |
| Device Classification: | Class II |
| Device Panel: | Gastroenterology/Urology |
| Regulation / Product Code: | 21 C.F.R. § 876.1500; FDF |
| Classification Name: | Endoscope and Accessories |

# Predicate/Reference Devices:

- . Lumendi, LLC's DiLumen C2 (K211819) (predicate device)
# Intended Use / Indications for Use:

The Lumendi DiLumen C1and EZ1 devices are an endoscope accessory intended to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment.

# Device Description:

The DiLumen C1 and EZ1 consists of a sleeve with an inflatable balloon at the distal end that fits over a standard endoscope to facilitate positioning and stabilization of the endoscope during surgical procedures. The DiLumen C1 includes an attached flexible tool channel to allow endoscopic tools to be inserted through it and used in conjunction with the endoscope. The DiLumen EZ1 does not have the tool channel. The C1 and EZ1 are provided non-sterile and do not require disinfection or sterilization prior to use. The devices are intended only for single patient use.

To stabilize the system during clinical use, the C1 is used with its own designated accessory, known as the Tool Mount, a metal holding system that fastens the tool channel to a surgical table rail. The

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Tool Mount is re-usable and is provided non-sterile; it must be cleaned, disinfected and sterilized prior to each use following the instructions in the device labeling. As the EZ1 does not have a tool channel, the Tool Mount is not used to perform its intended functions.

# Technical Characteristics / Substantial Equivalence:

The subject devices are identical to the predicate device except for minor technological differences. The C1 and EZ1 are single balloon devices that no longer have the fore balloon or extendable push rods. Since the fore balloon and push rods have been eliminated on the C1 and EZ1, the base handle of the subject devices has been simplified. The C1 and EZ1 both have a flexible nose cone attached to the distal end of the sleeve so that the sleeve terminates with an atraumatic tip. The nose cone for the C1 also serves as a component to attach the tool channel to the device. None of the changes alter the device's intended use/indications for use, principles of operation, or ability to meet key performance specifications as previously cleared by FDA. As such, they do not raise different questions of safety or effectiveness.

| | Subject Device:<br>Lumendi DiLumen C1, EZ1 and<br>Tool Mount | Predicate Device :<br>Lumendi DiLumen C2 and Tool<br>Mount (K211819) |
|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | 21 C.F.R. 876.1500, Product Code FDF | |
| Common name | Endoscope Accessory | |
| Intended Use /<br>Indications for Use | The Lumendi DiLumen C1and EZ1 is<br>an endoscope accessory intended to<br>ensure complete positioning of an<br>endoscope in the large intestine, and<br>assist with optical visualization,<br>diagnosis, and endoscopic treatment. | The Lumendi DiLumen C2 is an<br>endoscope accessory intended to<br>ensure complete positioning of an<br>endoscope in the large intestine,<br>and assist with optical<br>visualization, diagnosis, and<br>endoscopic treatment. |
| Sterility | Non-sterile | Non-sterile |
| Single use/reusable | Single Use | Single Use |
| Balloons | Low durometer Polyurethane | Low durometer Polyurethane |
| Sleeve | Extruded polyurethane with main lumen<br>having a hydrophilic coating. | Extruded polyurethane with main<br>lumen having a hydrophilic coating. |
| Tool Channel Tubing<br>(C1 only, EZ1 does not<br>have a tool channel) | FEP; Pellethane; stainless steel<br>internal coil | FEP; Pellethane; stainless steel<br>internal coil |
| Number of Tool<br>Channels | C1, one<br>EZ1, none | Two |
| Nose Cone | PEBAX | None |
| Number of balloons | One | Two |
| Balloon Outer Diameter | 60 mm | 60 mm |
| Balloon Pressure | 45 ± 12 mmHg | 45 ± 12 mmHg |
| Relief Pressure | 55 mmHg | 55 mmHg |
| Working Length | 130 cm and 103 cm | 130 cm and 103 cm |
| Balloon Inflation Source | Manual inflation bulb | Manual inflation bulb |
| Shelf Life | 24 months | 24 months |
| Accessories | A designated Tool Mount (DiLumen<br>Tool Mount model D-4000) that is<br>intended to mount to a surgical table<br>rail and hold the DiLumen C1 tool | A designated Tool Mount<br>(DiLumen Tool Mount model D-<br>4000) that is intended to mount to<br>a surgical table rail and hold the |

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| Subject Device:<br>Lumendi DiLumen C1, EZ1 and<br>Tool Mount | Predicate Device :<br>Lumendi DiLumen C2 and Tool<br>Mount (K211819) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| channel during endoscopic treatment.<br>The Tool Mount is made of stainless<br>steel and is provided non-sterile. Note:<br>DiLumen EZ1 does not have a Tool<br>Channel and therefore the Tool Mount<br>is not needed. The EZ1 does not have<br>any designated accessories. | DiLumen C2 tool channels during<br>endoscopic treatment. The Tool<br>Mount is made of stainless steel<br>and is provided non-sterile. |

# Performance Data:

Performance testing has demonstrated that the DiLumen C1 and EZ1 meet specifications and are as safe and effective as the predicate device. Bench testing primarily targeted verification of the balloon integrity and operation of the Device with an endoscope. The following performance data were provided in support of this 510(k) notice:

- 1. Instrument Insertion Force Test
- 2. Tool Channel Separation Force
- 3. Balloon Leak Force/Bond Leak Testing
- 4. Colon Grip Test
- 5. Fatique/Cycling and System Leakage Test
- Balloon Scope Centering Test 6.
- 7. User Verification Test (Device Usability)

In all instances, the device functioned as intended and the results observed were as expected.

# Conclusion:

In sum, the DiLumen C1 and EZ1 have the same intended use/indications for use and principles of operation, and very similar technological characteristics, as the predicate device. The minor differences between the devices do not raise different types of safety or effectiveness questions. Moreover, the data presented and referenced in this submission support that the subject device performs to its pre-defined specifications and is as safe and effective as the predicate. As such, the subject DiLumen C1, EZ1 and Tool Mount can be found substantially equivalent to the predicate DiLumen C2 and Tool Mount.