DiLumen C2; DiLumen Tool Mount

K173317 · Lumendi, LLC · FDF · Apr 17, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K173317
• Device Name: DiLumen C2; DiLumen Tool Mount
• Applicant: Lumendi, LLC
• Product Code: FDF · Gastroenterology, Urology
• Decision Date: Apr 17, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Lumendi DiLumen C2 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 C2 is a sterile, single-use sleeve fitting over standard endoscopes; features two inflatable balloons (Fore and Aft) for positioning and stabilization within the large intestine. Clinician manually inflates/deflates balloons using an inflation handle with a squeeze bulb. Once inflated, balloons create an isolated diagnostic/therapeutic zone. Device includes two 6-mm tool channels for flexible endoscopic tools (graspers, scissors, knives). System includes a reusable Tool Mount (stainless steel) that attaches to surgical table rails to hold tool channels in fixed positions. Used by physicians in clinical settings during endoscopic procedures. Benefits include improved endoscope stability and access for endolumenal interventions.

Clinical Evidence

Bench testing only. No clinical or animal data required. Testing included biocompatibility, balloon diameter/inflation/leakage, device slip, fore balloon extension, articulation, colon grip, therapeutic zone creation, Tuohy leak/bond leak, insertion force, packaging/transit, user validation, EO residuals, and Tool Mount cleaning/sterilization/positioning/locking validation.

Technological Characteristics

Sterile, single-use sleeve; materials include low durometer polyurethane (balloons), Pellethane with 2.5% Glycolube (sleeve), Isoplast/Pebax (tubing), Lexan (collet), and FEP/stainless steel braid (tool channels). Manual inflation via ambient air squeeze bulb. Tool Mount uses stainless steel articulating arm. Dimensions: 1680 mm working length, 60 mm outer balloon diameter. Sterilization: Ethylene Oxide (EO).

Indications for Use

Indicated for use as an endoscope accessory in the large intestine to ensure complete positioning, assist with 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

• DiLumen Endolumenal Interventional Platform (K162428)

Reference Devices

• FISSO Holding System (K070509)

Submission Summary (Full Text)

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April 17, 2018

Lumendi, LLC % John J. Smith, MD, JD Partner Hogan Lovells U.S. LLP 553 13th Street NW Washington, DC 20004

Re: K173317

Trade/Device Name: DiLumen C2: DiLumen Tool Mount Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FDF Dated: March 6, 2018 Received: March 6, 2018

Dear John J. 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. 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.

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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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Image /page/1/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold font. The text is black and is set against a white background. The letters are clearly legible and well-spaced.

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K173317

Device Name DiLumen C2; DiLumen Tool Mount

Indications for Use (Describe)

The Lumendi DiLumen C2 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)

| <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> |
|--------------------------------------------------------------------------------------------------------|
| <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

> Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) SUMMARY Lumendi, LLC's DiLumen C2 and Tool Mount

### 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: April 5, 2018

### Device Identification:

Trade Name: DiLumen C2 and Tool Mount Common Name: Endoscope Accessory Classification Regulation: 21 C.F.R. § 876.1500 (Endoscope and accessories) Product Codes: FDF Device Class: II

Predicate Device: DiLumen Endolumenal Interventional Platform (K162428)

Reference Device: FISSO Holding System (K070509)

### Device Description:

The DiLumen C² consists of a sleeve including two inflatable balloons that fits over a standard endoscope to facilitate positioning and stabilization of the endoscope during surgical procedures. The C2 comes into limited (<24 hour) contact with breached or compromised surfaces of the patient. The C2 is provided sterile and intended only for single patient use.

To stabilize the system during clinical use, the C2 is provided with its own designated accessory, known as the Tool Mount, a metal holding system that fastens the tool channels to a surgical table rail. The Tool Mount is re-usable and is provided non-sterile; it must be cleaned and sterilized prior to each use following the instructions in the device labeling.

### Intended Use / Indications for Use:

The Lumendi DiLumen C 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.

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The identified predicate device for the DiLumen C2 has similar indications for use as the subject device. Like the predicate Lumen (K162428), the DiLumen C² device is intended for use as an accessory to an endoscope to position/stabilize the endoscope and assist in optical visualization, diagnosis, and endoscopic treatment in the large intestine. Accordingly, the differences in indications for use between the DiLumen C2 and its predicate device are not critical to the intended therapeutic/diagnostic use of the device and do not affect its safety or effectiveness when used as labelled.

## Technological Characteristics and Principles of Operation:

The DiLumen C2 Endolumenal Interventional Platform is a sterile, single-use, close-fitting sleeve that fits securely over a standard endoscope.

The DiLumen C2 utilizes two balloons to position and stabilize the endoscope within a patient's large intestine. After the DiLumen C2 is installed over the endoscope, a collet is secured to the endoscope distal tip. The endoscope and DiLumen are navigated to the target zone with the balloons deflated. Once the clinician is at the area of interest, the Aft Balloon, which is attached to the DiLumen C2 sleeve, will be inflated until it contacts the intestinal wall near the proximal end of the articulating section of the endoscope. The second balloon, the Fore Balloon, is also attached to the sleeve via two flexible extension push rods and is deployed at the distal end of the endoscope at a variable distance. Once extended and inflated, the Fore Balloon contacts the patient's intestinal wall, and in combination with the Aft Balloon, creates an isolated diagnostic or therapeutic zone. Both balloons are controlled independently using an Inflation Handle with a squeeze bulb to manually inflate and deflate the two balloons with ambient air. The balloons assist in stabilizing the endoscope and the therapeutic area.

The flexibility, maneuverability and functionalities (such as visualization, suction, insufflations, etc.) of the endoscope are unaffected by the presence of the DiLumen C2. The DiLumen C2 has two 6-mm diameter tool channels. The tool channels are located 180° apart at the distal end of the sleeve. The tool channels provide the clinician access at the therapeutic site so that the clinician can use flexible endoscopic tools such as graspers, scissors, knives, etc. to perform endolumenal interventions.

The DiLumen C-is provided with a designated accessory, the Tool Mount, which holds the tool channels in a fixed position to facilitate their use. The Tool Mount consists of the previously cleared FISSO Holding System (K070509) articulating arm with an added permanently attached tool bar to firmly hold the C-tool channels in the clinician's preferred orientation. The tool bar has flanges that firmly hold the proximal ends of the DiLumen C² tool channels and are adjustable in three angular positions. The Tool Mount and holding system is attached to a standard surgical table rail using a rail clamp. The Tool Mount has similar indications for use and function as the FISSO Holding System reference device, namely to hold endoscopes, equipment, and patient positioning accessories during diagnostic and therapeutic procedures, but because the Tool Mount is designed for use with only the DiLumen C2, its intended use is narrower.

### Performance Data:

Performance testing has demonstrated that the DiLumen C2 meets specifications and is as safe and effective as the predicate. As the DiLumen C2 shares many of the same components as the predicate devices, bench testing primarily targeted verification of the balloon integrity and operation of the DiLumen C2 with an endoscope and with the Tool Mount. The following performance data were provided in support of this Premarket Notification:

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- 1. Biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, material mediated pyrogenicity)
- 2. Balloon Diameter, Inflation/Deflation and Leakage Test
- 3. Device Slip Relative to Scope Test
- 4. Fore Balloon Extension Test
- 5. Articulation Test
- 6. Colon Grip Test
- 7. Therapeutic Zone Creation Test
- 8. Tuohy Leak Force / Bond Leak Test
- 9. Insertion Force Test
- 10. Packaging and Transit Test
- 11. User Validation
- 12. EO residuals
- 13. Tool Mount Cleaning and Sterilization Validation
- 14. Tool Mount Positioning and Locking Test
- 15. Tool Mount Validation

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

No animal or clinical testing was required to demonstrate substantial equivalence to the predicate.

#### Substantial Equivalence:

The subject Dilumen C² device has nearly identical technological characteristics as the DiLumen Endolumenal Interventional Platform cleared under K162428, with the main differences between the devices being:

- 1. The subject device has two tool channels;
- 2. The subject device has a dedicated Tool Mount accessory;
- 3. The subject device is secured to the endoscope distal tip using a collet;
- 4. The internal diameter of the DiLumen C2's balloons is slightly larger; and
- 5. The subject device is EO-sterilized.

Because the DiLumen C2 and the predicate consist of many of the same components to ensure complete positioning of the endoscope and advance the endoscope to the target location in the same manner, and as further demonstrated by performance testing, these minor technological differences do not raise different types of safety or efficacy questions. In addition, the Tool Mount accessory - which is limited to use with the C2 device - is very similar to the FISSO Holding System reference device (K070509).

A table comparing the key features of the subject and predicate devices is provided below.

| | Lumendi DiLumen C2 | Lumendi DiLumen Endolumenal<br>Interventional Platform |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | TBD | K162428 |
| Intended Use /<br>Indications for Use | 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 | The Lumendi DiLumen is an accessory to an<br>endoscope. The DiLumen dual balloon<br>accessory is intended for use with any<br>endoscope that has an outer diameter of 12.5 –<br>14.3 mm and a minimum working length of 1680 |
| | Lumendi DiLumen C2 | Lumendi DiLumen Endolumenal<br>Interventional Platform |
| | visualization, diagnosis, and<br>endoscopic treatment. | mm. The device is indicated to ensure complete<br>positioning of an endoscope in the large<br>intestine, and assist with optical visualization,<br>diagnosis, and endoscopic treatment. |
| Sterility | Sterile - EO | Non-sterile |
| Single use/reusable | Single Use | Single Use |
| Balloon | Low durometer Polyurethane | Low durometer Polyurethane |
| Sleeve | Pellethane with 2.5% Glycolube<br>translucent | Pellethane with 2.5% Glycolube translucent |
| Inflation tube/<br>Pushrod Assembly | Isoplast<br>Pebax<br>Pellethane | Isoplast<br>Pebax<br>Pellethane |
| Collet | Lexan | NA |
| Tool Channel<br>Tubing | FEP; Pellethane; stainless steel<br>internal braid; | NA |
| Tool Channel<br>Components | Polyurethane; Pellethane with<br>2.5% Glycolube ;ePTFE Lexan;<br>silicone; | NA |
| Compatible<br>Endoscope Tip<br>Diameter | 11.5 - 14.5 mm | 12.5 - 14.3 mm |
| Fore/Aft Balloons<br>- Inner Diameter | 28.5 mm | 21.5 mm |
| Fore/Aft Balloons<br>- Outer Diameter | 60 mm | 60 mm |
| Balloon Pressure | 45 ± 12 mmHg | 45 ± 12 mmHg |
| Relief Pressure | 55 mmHg | 55 mmHg |
| Working Length | 1680 mm | 1680 mm |
| Inflation Source | Manual inflation bulb | Manual inflation bulb |
| Shelf Life | 12 months | 12 months |
| Accessories | The Lumendi DiLumen C2 has a<br>designated Tool Mount that is<br>intended to mount to a surgical<br>table rail and hold the DiLumen<br>C2 tool channels during<br>endoscopic treatment. The Tool<br>Mount is made of stainless steel | The Lumendi DiLumen can be used with various<br>additional endoscope accessories, but is not<br>supplied with any designated accessories. |

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## Conclusion:

The DiLumen C² is as safe and effective as the DiLumenal Interventional Platform cleared under K162428. The device has the same intended use and principles of operation, and similar indications for use and technological characteristics, as the predicate device, and its designated accessory (the Tool Mount) has similar indications and function as the identified reference device (the FISSO Holding System cleared under K070509). The minor differences in indications and technology do not alter the intended therapeutic use of the device and do not raise any new questions of safety or effectiveness when the device is used as labelled. In addition, bench testing data demonstrate that the DiLumen C2 is as safe and effective as the predicate device. Thus, the DiLumen C2 is substantially equivalent to the DiLumen Endolumenal Interventional Platform.