DiLumen Endolumenal Interventional Platform

K162428 · Lumendi, LLC · FDF · Dec 6, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K162428
• Device Name: DiLumen Endolumenal Interventional Platform
• Applicant: Lumendi, LLC
• Product Code: FDF · Gastroenterology, Urology
• Decision Date: Dec 6, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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 1680 mm 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.

Device Story

DiLumen is a single-use, close-fitting sleeve accessory for standard endoscopes; used in large intestine procedures. Device features two balloons: an Aft Balloon attached to the sleeve and a Fore Balloon deployed via flexible extension push rods at the distal end of the endoscope. Clinician manually inflates/deflates balloons using an inflation handle with a squeeze bulb (ambient air). Once inflated, balloons stabilize the endoscope and create an isolated diagnostic or therapeutic zone within the colon. Allows use of standard endoscopic tools (forceps, snares) through the endoscope working channel. Does not interfere with endoscope visualization or maneuverability. Benefits include improved endoscope positioning and stabilization for complex endoscopic interventions.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included biocompatibility, balloon burst pressure, inflation/deflation/leakage, relief valve, device slip, sleeve buckling, fore balloon extension, colon grip, articulation, therapeutic zone creation, fatigue/cycling, extension position locking, flexibility, force/bond, insertion force, packaging/transit, and user validation.

Technological Characteristics

Non-sterile, single-use sleeve accessory. Features dual-balloon system (Aft and Fore) for stabilization. Manual inflation system using ambient air via squeeze bulb. Compatible with standard endoscopes (12.5-14.3 mm distal tip). Mechanical operation; no electronic or software components.

Indications for Use

Indicated for use in the large intestine to ensure complete positioning of an endoscope and assist with optical visualization, diagnosis, and endoscopic treatment. Intended for use with standard endoscopes (12.5-14.3 mm distal tip diameter, ≥1680 mm working length). Prescription use only.

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.

Predicate Devices

• Fujinon EC-450B15 Double Balloon Enteroscopy System (K090116)

Reference Devices

• Smart Medical Systems NaviAID™ BGE (K060923)
• Smart Medical Systems NaviAID™ BGC (K102616)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 6, 2016

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

Re: K162428

> Trade/Device Name: DiLumen Endolumenal Interventional Platform Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: FDF Dated: October 24, 2016 Received: October 24, 2016

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. 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 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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Joyce M. Whang -S

for

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) K162428

Device Name

DiLumen Endolumenal Interventional Platform

#### Indications for Use (Describe)

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 1680 mm 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.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| <div> <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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#### 510(k) SUMMARY

#### Lumendi, LLC's DiLumen Endolumenal Interventional Platform

#### Submitter's Information:

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

#### Contact Person:

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

Date Prepared: August 30, 2016

#### Device Identification:

Trade Name: DiLumen Endolumenal Interventional Platform Common Name: Endoscope Accessory Device Class: II Device Panel: Gastroenterology/Urology

#### Classification:

21 C.F.R. § 876.1500 (Endoscope and accessories) Product Code: FDF

#### Predicate/Reference Devices:

- . Fujinon EC-450B15 Double Balloon Enteroscopy System (K090116)
- Smart Medical Systems NaviAID™ BGE (K060923) (reference device) ●
- Smart Medical Systems NaviAID™ BGC (K102616) (reference device) ●

#### Intended Use / Indications for Use:

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 1680 mm 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.

#### Device Description/Technological Characteristics:

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

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The DiLumen utilizes two balloons to position and stabilize the endoscope within a patient's large intestine. After the DiLumen is installed over the endoscope, 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 sleeve, will be inflated until it contacts the intestinal wall near the proximal end of the articulating section of an 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 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 and are inflated or deflated independently.

The balloons and sleeve are designed to permit the usage of any standard endoscopic tool (such as biopsy forceps, snare, needle, etc.) through the endoscope working channel. The endoscope flexibility, maneuverability and functionalities (such as visualization, insufflations, etc.) are unaffected by the presence of the DiLumen.

### Substantial Equivalence:

The DiLumen device has the same intended use and similar indications and technological characteristics as the Fujinon EC-450B15 system (K090116) and Smart Medical Systems' NaviAID™ BGE (K060923) and NaviAID™ BGC (K102616) devices.

The subject device and the Fujinon predicate consist of the same basic components to ensure complete positioning of the endoscope - specialized balloons, an over-tube/sleeve, and an inflation system; the NaviAid reference devices do not have a sleeve but include a balloon(s) and inflation/extension tube. While the DiLumen is not used to advance the endoscope to the target location like the Fujinon predicate, it shares key functional characteristics including balloon inflation pressure, extension of a balloon from the endoscope distal tip at a variable distance, and use of the balloons to stabilize the endoscope. The balloon diameter is also the same in the DiLumen and the NaviAID™ BGC; the balloons in the NaviAid™ BGE and Fujinon predicate are slightly smaller to accommodate use in the small intestine.

The DiLumen and its predicate and reference devices are prescription-use devices used by medical professionals in a healthcare facility. Each device is intended for single use only and should not be re-used. Performance testing has demonstrated that the DiLumen meets specifications and is as safe and effective as the cited predicates.

In sum, the minor technological differences between the DiLumen and its predicate and reference devices do not raise different types of safety or efficacy questions; as such, the DiLumen can be found substantially equivalent.

#### Performance Data:

The following performance data were provided in support of this Premarket Notification:

- 1. Biocompatibility (cytotoxicity, sensitization, and systemic toxicity)
- 2. Balloon Burst Pressure Test
- 3. Balloon Diameter, Inflation/Deflation and Leakage Test

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- 4. Relief Valve Test
- 5. Device Slip Relative to Scope Test
- 6. Sleeve Buckling Test
- 7. Fore Balloon Extension Test
- 8. Colon Grip Test
- 9. Articulation Test
- 10. Sleeve Leak Test
- 11. Therapeutic Zone Creation Test
- 12. Fatigue/Cycling Test
- 13. Extension Position Locking Test
- 14. Flexibility Test
- 15. Force/Bond Test
- 16. Insertion Force Test
- 17. Packaging and Transit Test
- 18. User Validation

## Conclusion:

From the data presented it is concluded that the subject device is substantially equivalent to the predicates based on intended use/indications for use and technological characteristics. The minor technological differences between the DiLumen and its predicate devices raise no new issues of safety or effectiveness. Bench testing data demonstrate that the DiLumen has substantially equivalent performance to the predicates.