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 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 is provided non-sterile and does not require disinfection or sterilization prior to use. The device is 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 surqical table rail. The 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.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (DiLumen C2 and Tool Mount) and thus focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study description of how acceptance criteria were met for a novel AI/software device. Consequently, many of the requested details about acceptance criteria, study design for AI models, ground truth, and expert involvement are not applicable or available in this document.

However, I can extract the general "performance data" that was provided to support the device's substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists performance tests but does not explicitly state quantitative acceptance criteria for each. Instead, it generally states that the device "meets specifications" and "functioned as intended."

Performance Test	Reported Device Performance
Biocompatibility	Meets specifications (cytotoxicity, sensitization, systemic toxicity, material mediated pyrogenicity)
Fore and Aft Balloon Diameter	Meets specifications; functioned as intended
Therapeutic Zone Creation	Meets specifications; functioned as intended
Balloon/Endoscope Centering	Meets specifications; functioned as intended
Endoscope Insertion Force	Meets specifications; functioned as intended
Instrument Insertion and Removal Force	Meets specifications; functioned as intended
Tool Channel Deflection	Meets specifications; functioned as intended
User Verification Testing	Meets specifications; functioned as intended

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

Sample Size: Not specified.
Data Provenance: Not applicable as this is a physical medical device, not an AI/software device generating data. The testing would have been conducted on physical units of the device.

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

Not applicable. This is a physical device submission; ground truth in the context of expert consensus for AI models is not relevant here. "User Verification Testing" implies evaluation by users/clinicians, but specific numbers or qualifications are not provided.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. This is a physical device.

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:

Not applicable. This is a physical device, not an AI or software product that assists human readers.

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

Not applicable. This is a physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable in the context of AI/software ground truth. For a physical device, "ground truth" would refer to established engineering and performance specifications and industry standards for safety and effectiveness.

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI/software product requiring a training set.

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

Not applicable. This is a physical device.

Study that proves the device meets the acceptance criteria:

The document states: "Performance testing has demonstrated that the DiLumen C2 meets specifications and is as safe and effective as the predicate device. As the DiLumen C2 shares many of the same components as the predicate and reference devices, bench testing primarily targeted verification of the balloon integrity and operation of the DiLumen C2 with an endoscope."

The specific studies performed were:

Biocompatibility (cytotoxicity, sensitization, systemic toxicity, material mediated pyrogenicity)
Fore and Aft Balloon Diameter
Therapeutic Zone Creation
Balloon/Endoscope Centering
Endoscope Insertion Force
Instrument Insertion and Removal Force
Tool Channel Deflection
User Verification Testing

The conclusion is that "In all instances, the device functioned as intended and the results observed were as expected," supporting its substantial equivalence to the predicate device. The details of these "bench tests" are not provided in this summary.

Summary

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October 22, 2021

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

Re: K211819

Trade/Device Name: DiLumen C2 and Tool Mount Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FDF Dated: September 17, 2021 Received: September 17, 2021

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 Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809 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-safety-reportingcombination-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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

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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) K211819

Device Name

DiLumen C2 and Tool Mount

Indications for Use (Describe)

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

区Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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: (203) 463-2669 Fax: (203) 557-0459

Contact Person:

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

Date Prepared: June 11, 2021

Device Identification:

Trade Name:	DiLumen C² 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

Predicate/Reference Devices:

Lumendi, LLC's DiLumen C2 (K173317) (predicate device) .
Lumendi, LLC's DiLumen Endolumenal Interventional Platform (K210851) (reference device)

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.

Device Description:

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Technical Characteristics / Substantial Equivalence:

The subject device is identical to the predicate device except for minor technological differences. These include provision of the device in two shorter lengths, instead of the original 168 cm length; addition and removal of certain secondary components to further facilitate use of the device by clinicians without altering the clinical workflow; modifying certain dimensions and features of other components (again, without altering how the device is used); the endoscope insertion tube seal type; lengthening the Tool Flange to accommodate changes in a 510(k)-exempt accessory used with the device; and adding a hydrophilic coating to the inner lumen of the Sleeve. 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:Lumendi DiLumenC² and Tool Mount	Predicate Device :Lumendi DiLumen C²and Tool Mount(K173317)	Reference Device :Lumendi DiLumenEndolumenal InterventionalPlatform (K210851)
Classification	21 C.F.R. 876.1500, Product Code FDF
Common Name	Endoscope Accessory
Intended Use /Indications forUse	The LumendiDiLumen C² is anendoscope accessoryintended to ensurecomplete positioningof an endoscope inthe large intestine,and assist with opticalvisualization,diagnosis, andendoscopic treatment.	The Lumendi DiLumenC² is an endoscopeaccessory intended toensure completepositioning of anendoscope in the largeintestine, and assistwith opticalvisualization, diagnosis,and endoscopictreatment.	The Lumendi DiLumen is anaccessory to an endoscope. TheDiLumen dual balloon accessoryis intended for use with anyendoscope that has an outerdiameter of 12.5 - 14.3 mm and aminimum working length of 1680mm. The device is indicated toensure complete positioning of anendoscope in the large intestine,and assist with opticalvisualization, diagnosis, andendoscopic treatment.
Sterility	Non-sterile	Sterile EO	Non-sterile
Singleuse/reusable	Single Use	Single Use	Single Use
Balloons	Low durometerPolyurethane	Low durometerPolyurethane	Low durometer Polyurethane
Sleeve	Extruded polyurethanewith main lumen havinga hydrophilic coating.	Extruded polyurethane	Extruded polyurethane with mainlumen having a hydrophiliccoating.
Tool ChannelTubing	FEP; Pellethane;stainless steel internalcoil	FEP; Pellethane;stainless steel internalcoil	NA
Fore and AftBalloon OuterDiameter	60 mm	60 mm	60 mm
Fore BalloonInner Diameter	17.6 mm	28.5 mm	17.6 mm
BalloonPressure	$45 ± 12 mmHg$	$45 ± 12 mmHg$	$45 ± 12 mmHg$
Relief Pressure	55 mmHg	55 mmHg	55 mmHg
Working Length	130 cm and 103 cm	168 cm	130 cm and 103 cm
	Subject Device:Lumendi DiLumenC2 and Tool Mount	Predicate Device :Lumendi DiLumen C2and Tool Mount(K173317)	Reference Device :Lumendi DiLumenEndolumenal InterventionalPlatform (K210851)
Inflation Source	Manual inflation bulb	Manual inflation bulb	Manual inflation bulb
Shelf Life	24 months	12 months	24 months
Accessories	A designated Tool Mount (DiLumen Tool Mountmodel D-4000) that is intended to mount to asurgical table rail and hold the DiLumen C2 toolchannels during endoscopic treatment. The ToolMount is made of stainless steel and is providednon-sterile.	A designated Tool Mount (DiLumen Tool Mountmodel D-4000) that is intended to mount to asurgical table rail and hold the DiLumen C2 toolchannels during endoscopic treatment. The ToolMount is made of stainless steel and is providednon-sterile.	Can be used with variousadditional endoscopeaccessories but is not suppliedwith any designatedaccessories.

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Performance Data:

Performance testing has demonstrated that the DiLumen C2 meets specifications and is as safe and effective as the predicate device. As the DiLumen C2 shares many of the same components as the predicate and reference devices, bench testing primarily targeted verification of the balloon integrity and operation of the DiLumen C2 with an endoscope. The following performance data were provided in support of this 510(k) notice:

1. Biocompatibility (cytotoxicity, sensitization, systemic toxicity, material mediated pyrogenicity)
1. Fore and Aft Balloon Diameter
1. Therapeutic Zone Creation
1. Balloon/Endoscope Centering
1. Endoscope Insertion Force
1. Instrument Insertion and Removal Force
1. Tool Channel Deflection
1. User Verification Testing

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

Conclusion:

In sum, the subject device has 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 and are further supported by the subject device's similarities in technology to the reference device. 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 C° and Tool Mount can be found substantially equivalent to the predicate DiLumen C2 and Tool Mount.

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.