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

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

AI/ML Overview

The provided text describes the 510(k) summary for the DiLumen Endolumenal Interventional Platform, a medical device. However, it does not contain the specific details about the acceptance criteria or a dedicated study that rigorously proves the device meets specific performance criteria with quantitative metrics like sensitivity, specificity, or reader improvement. The document focuses on demonstrating substantial equivalence to predicate devices through various performance tests, but these tests are not presented as a formal study with detailed acceptance criteria and reported numerical performance.

Therefore, I cannot generate the exact table or detailed information requested without that specific data.

However, I can extract the types of performance tests conducted, which imply underlying acceptance criteria, and some general statements about the studies.

General Information Extracted:

Device Name: DiLumen Endolumenal Interventional Platform
Intended Use: Accessory to an endoscope, intended for use with standard endoscopes with specific distal tip outer diameter and working length. Indicated to ensure complete positioning of an endoscope in the large intestine, and assist with optical visualization, diagnosis, and endoscopic treatment.
Predicate Devices: Fujinon EC-450B15 Double Balloon Enteroscopy System (K090116), Smart Medical Systems NaviAID™ BGE (K060923), and Smart Medical Systems NaviAID™ BGC (K102616).
Performance Data Provided: The document lists 18 performance tests conducted to support the premarket notification.

Here's how I can answer the prompt based on the available information, noting the absence of specific quantitative acceptance criteria and results:

1. A table of acceptance criteria and the reported device performance

Based on the provided text, specific numerical acceptance criteria (e.g., "burst pressure must be > X psi") and reported quantitative performance values are not detailed. The document lists the types of performance tests conducted and generally states that the device "meets specifications" and "has substantially equivalent performance to the predicates."

Performance Test Name	Implied Acceptance Criterion (General)	Reported Device Performance
Biocompatibility	Device materials must be biocompatible (non-cytotoxic, non-sensitizing, etc.)	Met (implied by "Performance testing has demonstrated that the DiLumen meets specifications")
Balloon Burst Pressure Test	Balloons must withstand specified pressure without bursting	Met (implied by "Performance testing has demonstrated that the DiLumen meets specifications")
Balloon Diameter, Inflation/Deflation, and Leakage Test	Balloons must inflate/deflate correctly, reach specified diameter, and not leak	Met (implied by "Performance testing has demonstrated that the DiLumen meets specifications")
Relief Valve Test	Relief valve must function as intended	Met (implied by "Performance testing has demonstrated that the DiLumen meets specifications")
Device Slip Relative to Scope Test	Device must not excessively slip on the endoscope	Met (implied by "Performance testing has demonstrated that the DiLumen meets specifications")
Sleeve Buckling Test	Sleeve must not buckle under intended use conditions	Met (implied by "Performance testing has demonstrated that the DiLumen meets specifications")
Fore Balloon Extension Test	Fore Balloon must extend as intended	Met (implied by "Performance testing has demonstrated that the DiLumen meets specifications")
Colon Grip Test	Device must provide adequate grip in the colon	Met (implied by "Performance testing has demonstrated that the DiLumen meets specifications")
Articulation Test	Endoscope articulation must not be impeded by the device	Met (implied by "Performance testing has demonstrated that the DiLumen meets specifications")
Sleeve Leak Test	Sleeve must not leak	Met (implied by "Performance testing has demonstrated that the DiLumen meets specifications")
Therapeutic Zone Creation Test	Device must effectively create an isolated therapeutic zone	Met (implied by "Performance testing has demonstrated that the DiLumen meets specifications")
Fatigue/Cycling Test	Device must withstand repeated use cycles	Met (implied by "Performance testing has demonstrated that the DiLumen meets specifications")
Extension Position Locking Test	Extension mechanism must lock in position	Met (implied by "Performance testing has demonstrated that the DiLumen meets specifications")
Flexibility Test	Device must maintain appropriate flexibility	Met (implied by "Performance testing has demonstrated that the DiLumen meets specifications")
Force/Bond Test	Bonds and components must withstand specified forces	Met (implied by "Performance testing has demonstrated that the DiLumen meets specifications")
Insertion Force Test	Device must be inserted with acceptable force	Met (implied by "Performance testing has demonstrated that the DiLumen meets specifications")
Packaging and Transit Test	Packaging must protect the device during transit	Met (implied by "Performance testing has demonstrated that the DiLumen meets specifications")
User Validation	User interface and functionality must be acceptable	Met (implied by "Performance testing has demonstrated that the DiLumen meets specifications")

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes used for any of the listed "Performance Data" tests. It also does not mention an explicit "test set" in the context of clinical data or patient images for algorithm evaluation. The tests listed are primarily bench tests and engineering validations. Data provenance (country of origin, retrospective/prospective) is not applicable or provided for these types of tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The listed performance data are mainly physical/mechanical bench tests. "User Validation" implies involvement of users, likely medical professionals, but their number and specific qualifications for establishing a "ground truth" (in the diagnostic sense) are not provided.

4. Adjudication method for the test set

Not applicable. The listed performance data are mainly physical/mechanical bench tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No such study is mentioned or provided in the document. The device itself is an accessory for an endoscope, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used

For the bench tests, the "ground truth" is typically established by engineering specifications, physical measurements, and functional requirements of the device. For example, a burst pressure test would compare actual burst pressure to a pre-defined minimum specification. For "User Validation," the ground truth would be user feedback and ability to complete tasks effectively with the device.

8. The sample size for the training set

Not applicable. This is not an algorithm-based device requiring a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an algorithm-based device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, featuring a triple-stranded helix or ribbon-like design.

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
☑ 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 Endolumenal Interventional Platform

Submitter's Information:

LUMENDI, LLC 253 Post Road West Westport, CT 06880 Phone: (203) 463-2669 Fax: (203) 557-0459

Contact Person:

Dennis J. Daniels Director, Regulatory Affairs and Quality Assurance Telephone: (203) 557-6335 Fax: (203) 557-0459 Email: Dennis.Daniels@Lumendi.com

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:

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)
1. Balloon Burst Pressure Test
1. Balloon Diameter, Inflation/Deflation and Leakage Test

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1. Relief Valve Test
1. Device Slip Relative to Scope Test
1. Sleeve Buckling Test
1. Fore Balloon Extension Test
1. Colon Grip Test
1. Articulation Test
1. Sleeve Leak Test
1. Therapeutic Zone Creation Test
1. Fatigue/Cycling Test
1. Extension Position Locking Test
1. Flexibility Test
1. Force/Bond Test
1. Insertion Force Test
1. Packaging and Transit Test
1. 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.

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.